Patient leaflet - Eperzan

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

GlaxoSmithKline LLC

Building 40

893 River Road

Conshohocken, PA 19428

USA

Name and address of the manufacturer responsible for batch release

Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations)

Harmire Road

Barnard Castle

Durham, DL12 8DT

United Kingdom

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

At the request of the European Medicines Agency;
Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
1. NAME OF THE MEDICINAL PRODUCT

Eperzan 30 mg powder and solvent for solution for injection. albiglutide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each dose contains 30 mg per 0.5 ml following reconstitution.

3. LIST OF EXCIPIENTS

Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Single use only.

Discard pen after use.

Read package leaflet

After mixing, wait 15 minutes before injection

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store refrigerated at 2°C to 8°C.

Do not freeze.

Pens may be stored at room temperature, not exceeding 30°C, for no more than a total of 4 weeks prior to use.

Use within 8 hours of reconstitution.

Use immediately after needle is attached.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Trading Services Limited

Currabinny

Carrigaline

County Cork

Ireland

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE eperzan 30
17. UNIQUE IDENTIFIER – 2D BARCODE 2D barcode carrying the unique identifier included.

PC:

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PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING

CARTON – Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles ) – without blue box

1. NAME OF THE MEDICINAL PRODUCT

Eperzan 30 mg powder and solvent for solution for injection. Albiglutide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each dose contains 30 mg per 0.5 ml following reconstitution.

3. LIST OF EXCIPIENTS

Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose dihydrate, mannitol (E421), polysorbate 80, water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Component of a multipack comprising 3 packs, each containing 4 pens and 4 pen needles. Do not sell separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read package leaflet. Subcutaneous use Once weekly.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Single use only.

Discard pen after use.

Read package leaflet

After mixing, wait 15 minutes before injection

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store refrigerated at 2°C to 8°C. Do not freeze.

A single carton of 4 pens and 4 needles may be stored at room temperature, not exceeding 30°C, for no more than a total of 4 weeks prior to use. Remaining cartons must be stored at 2°C to 8°C until required.

Use within 8 hours of reconstitution.

Use immediately after needle is attached.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUc TS, IF APPROPRIATE

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11. NAME AND ADDRESS OF THE MARKETING AUTHORi SATION HOLDER

GlaxoSmithKline Trading Services Limited

Currabinny

Carrigaline

County Cork

Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/908/003

13. BATCH NUMBER

Lot
14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE eperzan 30

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER LABEL – Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles ) -with blue box

1. NAME OF THE MEDICINAL PRODUCT

Eperzan 30 mg powder and solvent for solution for injection. albiglutide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each dose contains 30 mg per 0.5 ml following reconstitution.

3. LIST OF EXCIPIENTS

Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose dihydrate, mannitol (E421), polysorbate 80, water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Multipack:12 pens (3 cartons of 4 pens/4 needles) Do not sell separately

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet. Subcutaneous use Once weekly.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Single use only.

Discard pen after use.

Read package leaflet

After mixing, wait 15 minutes before injection

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store refrigerated at 2°C to 8°C.

Do not freeze.

Use within 8 hours of reconstitution.

Use immediately after needle is attached.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Trading Services Limited

Currabinny

Carrigaline

County Cork

Ireland

12. MARKETING AUTHORISATION NUMBeR(S)

EU/1/13/908/003

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE eperzan 30
17. UNIQUE IDENTIFIER – 2D BARCODE 2D barcode carrying the unique identifier included.

PC:

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON – 4 pen pack

1. NAME OF THE MEDICINAL PRODUCT

Eperzan 50 mg powder and solvent for solution for injection. Albiglutide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each dose contains 50 mg per 0.5 ml following reconstitution.

3. LIST OF EXCIPIENTS

Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose dihydrate, mannitol (E421), polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection 4 pens

4 pen needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read package leaflet. Subcutaneous use Once weekly.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Single use only.

Discard pen after use.

Read package leaflet

Reconstitution time

After mixing, wait 30 minutes before injection

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store refrigerated at 2°C to 8°C.

Do not freeze.

Pens may be stored at room temperature, not exceeding 30°C, for no more than a total of 4 weeks prior to use.

Use within 8 hours of reconstitution.

Use immediately after needle is attached.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Trading Services Limited

Currabinny

Carrigaline

County Cork

Ireland

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE eperzan 50
17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

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PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING

CARTON – Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles) – without blue box

1. NAME OF THE MEDICINAL PRODUCT

Eperzan 50 mg powder and solvent for solution for injection. albiglutide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each dose contains 50 mg per 0.5 ml following reconstitution.

3. LIST OF EXCIPIENTS

Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose dihydrate, mannitol (E421), polysorbate 80, water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Component of a multipack comprising 3 packs, each containing 4 pens and 4 pen needles Do not sell separately

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read package leaflet. Subcutaneous use Once weekly.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE REACH AND SIGHT OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Single use only.

Discard pen after use.

Read package leaflet

Reconstitution time

After mixing, wait 30 minutes before injection

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store refrigerated at 2°C to 8°C. Do not freeze.

Use within 8 hours of reconstitution.

Use immediately after needle is attached.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUC TS, IF APPROPRIATE

J?/

11. NAME AND ADDRESS OF THE MARKETING AUTHORi SATION HOLDER

GlaxoSmithKline Trading Services Limited

Currabinny

Carrigaline

County Cork

Ireland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/908/004

13. BATCH NUMBER

Lot
14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE eperzan 50

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER LABEL – Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles ) -with blue box

1. NAME OF THE MEDICINAL PRODUCT

Eperzan 50 mg powder and solvent for solution for injection. albiglutide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each dose contains 50 mg per 0.5 ml following reconstitution.

3. LIST OF EXCIPIENTS

Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose dihydrate, mannitol (E421), polysorbate 80, water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Multipack:12 pens (3 cartons of 4 pens/4 needles)

Do not sell separately

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet. Subcutaneous use Once weekly.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Single use only.

Discard pen after use.

Read package leaflet

Reconstitution time

After mixing, wait 30 minutes before injection

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store refrigerated at 2°C to 8°C. Do not freeze.

Use within 8 hours of reconstitution.

Use immediately after needle is attached.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Trading Services Limited

Currabinny

Carrigaline

County Cork

Ireland

12. MARKETING AUTHORISATION N UMBER(S)

EU/1/13/908/004

13. BATCH NUMBER
14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE eperzan 50

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

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PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Eperzan 30 mg powder and solvent for solution for injection albiglutide

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Eperzan 50 mg powder and solvent for solution for injection albiglutide

Subcutaneous use

Once weekly

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. BATCH NUMBER

6. OTHER

5. CONTENTS BY WEIGHT, BY VOL

EXP

Lot

50 mg

R BY UNIT

Package leaflet: Information for the patient

Eperzan 30 mg powder and solvent for solution for injection

Albiglutide

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if

their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.See section 4.

What is in this leaflet:

1. What Eperzan is and what it is used for

2. What you need to know before you take Eperzan

3. How to take Eperzan

4. Possible side effects

5. How to store Eperzan

6. Contents of the pack and other information

Instructions for use of the pre-filled pen

(overleaf)

Questions and answers about the instructions for use of the pre-filled pen

Read both sides of this leaflet

1. What Eperzan is and what it is used for

Eperzan contains the active ingredient albiglutide which belongs to a group of medicines called GLP-1 receptor agonists that are used to lower blood sugar (glucose) in adults with Type 2 diabetes.

You have Type 2 diabetes either:

because y our body does not make enough insulin to control the level of sugar in your blood or
because your body is not able to use the insulin properly.

Eperzan helps your body to increase the production of insulin when your blood sugar is high.

Eperzan is used to help control your blood sugar, either:

– on its own if your blood sugar is not properly controlled by diet and exercise alone, and you can’t take metformin (another diabetes medicine)

– in combination with other diabetes medicines that are taken by mouth (such as metformin, or medicines known as sulphonylureas or thiazolidinediones), or with insulin.

It is very important that you continue to follow any diet and lifestyle advice from your doctor while taking Eperzan.

2. What you need to know before you use Eperzan

Don’t use Eperzan:

if you are allergic to albiglutide or any of the other ingredients of this medicine (listed in section 6).

If you think this applies to you, don’t use Eperzan until you have checked with your doctor, nurse or pharmacist.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before using Eperzan:

if you have Type 1 (insulin-dependent) diabetes or ketoacidosis (a very serious complication of

diabetes which happens when your body is not able to break down glucose because there is not enough insulin), this medicine will not be right for you. Speak to your doctor about how to recognise the symptoms of ketoacidosis and seek urgent medical treatment if they occur.

if you have ever had pancreatitis (inflammation of the pancreas). Your doctor will decide if you can

use Eperzan, and will explain the symptoms of pancreatitis (see ‘Conditions you need to look out for' in section 4).

if you are taking a sulphonylurea or insulin for your diabetes, as low blood sugar (hypoglycaemia)

can occur. Your doctor may need to change your dose of these other medicines to reduce this risk. (See ‘Very common side effects’ in section 4 for signs of low blood sugar).

if you have a serious problem with emptying your stomach (gastroparesis) or if you have severe

bowel disease (severe gastrointestinal disease). Eperzan is not recommended if you have these conditions.

When initiating treatment with albiglutide, you may experience fluid loss from vomiting, nausea, diarrhoea or dehydration. It is important to avoid dehydration by drinking plenty of fluids.

Check with your doctor, nurse or pharmacist before you use Eperzan if you think any of these apply to you.

Children and adolescents

It is not known if Eperzan is safe and effective in people under 18 years of age. Eperzan is not recommended for children and adolescents.

Other medicines and Eperzan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines , (see also earlier in section 2 ‘Warnings and precautions’).

You should not take acarbose if you suffer from bowel obstruction.

Talk to your doctor if you are taking acarbose and Eperzan at the same time.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, if you think you may be pregnant, or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before using this medicine. If there is a possibility that you could become pregnant, you must use effective contraception while using this medicine.

Pregnancy

Tell your doctor, nurse or pharmacist immediately if you become pregnant during treatment with Eperzan.

There is no information about the safety of Eperzan in pregnant women. Eperzan should not be used while you're pregnant.

If you are planning to have a baby, your doctor may decide to stop your treatment with Eperzan at least one month before you try to get pregnant. This is because it takes time for Eperzan to clear from your body.

Breast-feeding

If you are breast-feeding you must check with your doctor before you use Eperzan. It is not known if Eperzan passes into your breast milk. You and your doctor should decide whether you will use Eperzan or breast-feed. You should not do both.

Fertility x*

For both men and women, it is not known if Eperzan could affect your fertility.

Driving and using machines

Eperzan has no or negligible influence on your ability to drive or use machines. However, if you take Eperzan with sulphonylurea or insulin, you may get low blood sugar (hypoglycaemia). This can make it difficult to concentrate and make you dizzy or sleepy. If this happens, don’t drive or use machines.

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per 0.5 ml dose, so is essentially ‘sodium free’.

3. How to use Eperzan

Always use this medicine exactly as your doctor, nurse or pharmacist has told you. Check with your doctor, nurse or pharmacist if you are not sure.

The recommended dose is 30 mg once a week, injected on the same day each week. Your doctor may increase your dose to 50 mg once weekly if your blood sugar is not controlled by the 30 mg dose. If necessary you can change the day of the week on which you use Eperzan, as long as it is at least 4 days since your last dose.

You can use Eperzan at any time of day, with or without meals.

Eperzan comes in a pen injector that you can inject yourself. Talk to your doctor, nurse or pharmacist about how to inject Eperzan the right way. You inject Eperzan under your skin in your stomach area, upper leg (thigh) or in the back of your upper arm. You can inject the same area of your body each week, but don’t inject in exactly the same place every time.

Eperzan must not be injected into a vein (intravenously) or into a muscle (intramuscularly).

The pen injector contains powder and water which you need to mix before you can use it. After section 6 of this leaflet there are

Instructions For Use

giving you step-by-step instructions on how to mix your medicine and how to inject it. If you have questions or do not understand how to use your pen, talk to your doctor, nurse or pharmacist.

Never mix insulin and Eperzan together. If you need to give yourself both at the same time, use two separate injections. You may give both injections in the same body area (for example, your stomach area), but you should not give the injections very close together.

If you use more Eperzan than you should

If you use too much Eperzan, contact a doctor or pharmacist for advice. If possible show them the pack, or this leaflet. You may feel very sick (severe nausea), be sick (vomit), or get a headache.

If you forget to use Eperzan

If you miss a dose, inject the next dose as soon as possible within 3 days after the missed dose. After that, you can go back to having your injection on the usual day. If it is more than 3 days since you missed your dose, wait until your usually scheduled day for your next injection. Do not inject a double dose to make up for a forgotten dose.

If you stop using Eperzan

Use Eperzan for as long as your doctor recommends. If you stop using Eperzan, your blood sugar levels may be affected. Don’t stop unless your doctor advises you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions you need to look out for:

Risk of acute pancreatitis (an inflamed pancreas)

Pancreatitis has been reported as an uncommon side effect. It may affect up to 1 in 100 people.

Pancreatitis can be severe and life-threatening.

If you get:

severe stomach (abdominal) pain that does not go away, tins can be a symptom of pancreatitis. The pain may happen with or without you being sick (vomiting). You may feel the pain going from your front (abdomen) tirougi to your back.

Stop taking Eperzan and talk to your doctor straight away

Severe allergic reactions

Tiese are rare in people taking Eperzan (may affect up to 1 in 1000 people).

Signs include:

raised and itciy rasies,
swelling, sometimes of tie face, mouti or tiroat, causing difficulty in breatiing.

Get medical help immediately if you get tiese symptoms. Stop taking Eperzan.

Otier side effects reported witi Eperzan

Very common : may affect more than 1 in 10 people :

low blood sugar (iypoglycaemia) wien you use Eperzan in combination witi insulin or sulpionylurea. Tie warning signs of low blood sugar may include cold sweat, cool pale skin, ieadacie, feeling drowsy, weakness, dizziness, feeling confused or irritable, feeling iungry, fast ieart beat and feeling jittery. Your doctor will tell you wiat to do if you get low blood sugar.
diarrioea
feeling sick (nausea)
rasi, redness or itciing of tie skin wiere you iave injected Eperzan

Common : may affect up to 1 in 10 people :

ciest infection (pneumonia)
low blood sugar (iypoglycaemia) if you use Eperzan on its own or in combination witi metformin or pioglitazone
irregular ieartbeat
being sick (vomiting)
constipation
indigestion
heartburn (gastro-oesophageal reflux)

Uncommon : may affect up to 1 in 100 people :

bowel obstruction

Rare : may affect up to 1 in 1000 people :

allergic reaction (hypersensitivity); this includes symptoms such as local or widespread rash, redness or itching of the skin and difficulty breathing (also see ‘Conditions you need to look out for’ at the beginning of this section)

In addition some other side effects have been reported (frequency not known, cannot be estimated from the available data):

reduced appetite

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Eperzan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pen and the carton after ‘EXP’. The expiry date refers to the last day of that month.

Store pens and needles in the original carton until use.

Store in a refrigerator (between 2°C and 8°C). Do not freeze. The medicine can be stored at room temperature (less than 30°C) for no more than a total of 4 weeks before use. After this time, pens should be used or thrown away.

After the powder and liquid are mixed within the pen, the pen should be used within 8 hours.
Use the pen immediately after you have attached and primed the needle otherwise the solution can dry up inside the needle and block it.

Use each pen only once.

After you have used the pen, do not remove the needle. Dispose of the pen as instructed by your doctor, pharmacist or nurse.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Eperzan contains

– The active substance is albiglutide.

Each 30 mg pen delivers 30 mg albiglutide in a volume of 0.5 ml.

– The solvent is water for injections.
– The other ingredients are: sodium dihydrogen phosphate monohydrate and disodium phosphate, anhydrous (see section 2 under ‘Sodium content’), trehalose dihydrate, mannitol, polysorbate 80.

What Eperzan looks like and contents of the pack

Eperzan is supplied as a pen for self injection. Each pen contains a white to yellow powder and a colourless solvent in separate compartments. A needle is provided with each pen.

Pens are supplied in packs of 4 pens and 4 needles and multipacks comprising 3 packs, each containing 4 pens and 4 needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland

Name and address of the manufacturer responsible for batch release:

Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations) Harmire Road

Barnard Castle

Durham

DL12 8DT

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tél/Tel: + 32 (0)10 85 52 00

Etnrapua rnakcoCMumKnaÖH EOOfl

Ten.: + 359 2 953 10 34

Česká republika

GlaxoSmithKline s.r.o.

Tel: + 420 222 001 111

Luxembourg/Luxemburg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Belgique/Belgien

Tel/Tel: + 32 (0)10 85 52 00

Magyarorszag

GlaxoSmithKline Kft.

Tel.: + 36 1 225 5300

Malta

GlaxoSmithKline Malta

Tel: + 356 21 238131

Danmark

GlaxoSmithKline Pharma A/S

Nederland

GlaxoSmithKline BV

Tlf: + 45 36 35 91 00

Deutschland

GlaxoSmithKline GmbH & Co. KG

Tel.: + 49 (0)89 36044 8701

Eesti

GlaxoSmithKline Eesti OU

Tel: + 372 6676 900

EXXáSa

GlaxoSmithKline A.E.B.E.

Tql: + 30 210 68 82 100

España

GlaxoSmithKline, S.A.

Tel: + 34 902 202 700

France

Laboratoire GlaxoSmithKline

Tél: + 33 (0)1 39 17 84 44

Hrvatska

GlaxoSmithKline d.o.o.

Tel:++385 1 6051 999

Ireland

GlaxoSmithKline (Ireland) Limited

Tel: + 353 (0)1 4955000

<^x

Ísland

Vistor hf.

Sími: + 354 535 7000

Italia

GlaxoSmithKline S.p.A.

Tel: + 39 (0)45 9218 111

Kúnpog

GlaxoSmithKline (Cyprus) Ltd

Tql: + 357 22 39 70 00

Latvija

GlaxoSmithKline Latvia SIA

Tel: + 371 67312687

Tel: + 31 (0)30 6938100

Norge

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00

Österreich

GlaxoSmithKline Pharma GmbH

Tel: + 43 (0)1 97075 0

Polska

GSK Services Sp. z.o.o.

Tel.: + 48 (0)22 576 9000

Portugal

GlaxoSmithKline – Produtos Farmacéuticos, Lda.

Tel: + 351 21 412 95 00

Romania

GlaxoSmithKline (GSK) S.R.L.

Tel: + 4021 3028 208

o°

Slovenija

GlaxoSmithKline d.o.o.

Tel: + 386 (0)1 280 25 00

Slovenská republika

GlaxoSmithKline Slovakia s. r. o.

Tel: + 421 (0)2 48 26 11 11

Suomi/Finland

GlaxoSmithKline Oy

Puh/Tel: + 358 (0)10 30 30 30

Sverige

GlaxoSmithKline AB

Tel: + 46 (0)31 67 09 00

United Kingdom

GlaxoSmithKline UK

Tel: + 44 (0)800 221441

Lietuva

GlaxoSmithKline Lietuva UAB

Tel: + 370 5 264 90 00

This leaflet was last revised in < {MM/YYYY }>

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

INSTRUCTIONS FOR USE

Once weekly Eperzan pen 30 mg

Read all of this leaflet carefully before you start taking this medicine, as well as all the instructions including the Pen Storage and Important Warnings.

Follow the steps below in the exact order they are presented.

This medicine is injected once a week. The pen has the medicine powder in one compartment and the water in another compartment. You will mix them together by twisting the pen. Each pen is used to deliver one dose. A pen cannot be re-used.

Pen storage
Store your pens at room temperature, not to exceed 30°C, for up to 4 weeks. Always store in the box. If a box of pens will be stored for more than 4 weeks, keep them refrigerated (2°C to 8°C). If stored in the refrigerator, allow the pen to sit at room temperature for 15 minutes before starting Step 1. DO NOT allow the pen to freeze. Throw away the pen if frozen.
Important warnings
DO NOT attach needle until instructed in Step 5 DO NOT reuse needles, recap needles, or remov container for pen disposal right away after inject Throw away the pen if leaking or jammed. Keep your pen out of the sight and reach of child	. e used needles from the pen. Throw out the pen in a ing, as shown in Step 9. ren
For each injection, gather the following items: A new pen (Figure A). A new needle (Figure B). A clean empty cup (Figure C). A clock or timer (Figure C). A container for pen disposal. The cup, timer and container are not provided in the pack.	Pen Injection Button* Viewing Window Number Window fl Hp ¿T\| EperzarC3g_[2g^Bff Clear Cartridge t y Figure A * Injection Button is inside the pen until the pen is ready for injection. f The numbers on the clear cartridge represent stages of preparation for your medicine.

Pen Needle

o Outer Needle Cap t. Nilc

m, Inner Needle Cap t-

1 Needle

„— „-J Tab

Figure B

Other Supplies Needed

Clean Empty Cup Clock/Timer

Figure C

Step 1 Check Pen

1a Wash your hands (Figure D).

Wash Hands and Check Pen

Figure D

1b Check dosage and expiration date on pen (Figure E).

DO NOT use if the pen is expired or shows the incorrect dose.

\o<>

® 1 Eprrean* 30 mg^^B

Figure E

1c Check that the pen has a [1] in the number window (Figure F).

DO NOT use if the [1] is not showing.

Figure F

Step 2 Mix Medicine

2a Hold pen body with clear cartridge pointing up so that you can see the [1] in the window.

Twist clear cartridge several times in the direction of the arrow until you feel/hear the pen “click” into place. You should see the [2] in the number window (Figure G). This will mix the medicine powder and liquid.

Twist Pen to Mix Medicine

fJ! …

“Click”

—- ^B

H J n ----------

Figure G

2b Slowly and gently rock the pen side-to-side 5 times (like a windscreen wiper) (Figure H).

This will help mix the medicine.

DO NOT shake the pen to avoid foaming, which may affect your dose.

Rock Pen

5 Times r

Figure H

Step 3 Wait 15 minutes

3 Place pen into cup with clear cartridge pointing up (Figure I).

Set a timer for 15 minutes. You must wait 15 minutes for the medicine to dissolve before continuing.

Wait 15 Minutes

■m^^secB /*/

Figure I

IMPORTANT: Make sure you have waited 15 minutes before continuing onto step 4. This is to make sure the medicine has dissolved.

Step 4 Rock Pen and Check Medicine

4a Again, slowly and gently rock the pen side-to-side side 5 times (like a windscreen wiper) (Figure J).

DO NOT shake the pen to avoid foaming, which may affect your dose.

Rock Pen Again

5 Times A

Figure J

4b Check medicine through the viewing window. It should be yellow and see-through, without any particles (Figure K).

DO NOT use pen if there are still particles in the liquid.

It is okay to have large air bubbles on top of the liquid. These are removed in step 6.

Check Medicine

Look for Particles ¡QI

Figure K

IMPORTANT: Make sure you do not twist the pen to [3] until you have attached the needle in step 5. The needle must be attached to allow air to escape while turning the cartridge from [2] to [3] in the number window.

Step 5 Attach needle

5a Peel tab from outer needle cap (Figure L).

Hold the pen upright before attaching the needle.

Peel Off Tab

FigureL

5b Push needle straight down onto the clear cartridge until you hear a “click” and feel the needle “snap” into place. This means the needle is attached (Figure M).

DO NOT attach at an angle.

DO NOT attach by screwing the needle on

Attach Needle

Push Straight Down

“Click” gjj

Figure M

IMPORTANT: After the needle has been securely attached, make sure to complete the remaining steps of the injection procedure right away. Waiting may result in a blocked or clogged needle.

Step 6 Remove Air from Cartridge

6a With needle pointing up, gently tap the clear cartridge 2–3 times to bring large air bubbles to the top (Figure N). Small air bubbles are okay and do not need to rise to the top.

Tap Pen Cartridge

Q ! i'" k

Figure N

6b Hold pen upright, slowly twist the clear cartridge several times in the direction of the arrow until you feel/hear the pen “click” and you see the [3] in the number window (Figure O). This removes the large air bubbles.

The white injection button will also pop out from the bottom of the pen.

DO NOT use the pen if the injection button does not pop out.

Hold Upright and Twist to 3

Twist Pen to Prime the Needle

“Click”

. 1 m \ \ 1 * *■J

J J ’S > ——

Figure O

IMPORTANT: You may hear a “click” when you first start twisting the cartridge from [2] to [3]. Keep twisting until you see [3] in the window.

Step 7 Prepare for injection
7a Choose your injection site (Figure P). You can use your abdomen, thigh, or upper arm.	Choose Injection Site Figure P
IMPORTANT: There are two needle caps, an outer and inner need'	e cap.
7b While holding the pen in the air, remove outer needle cap (Figure Q) and inner needle cap (Figure R). A few drops of liquid may come out of the needle. This is normal. DO NOT rest the back of the device (where the injection button is exposed) on a flat surface while removing needle caps. 7c Place both needle caps into a container for pen disposal.	Pull off Needle Caps and Discard Step 1 Step 2 Remove Outer RemoveInner Needle Cap Needle Cap ♦W t T nr ■ i Figure Q Figure R
Step 8 Deliver injection
8a Insert needle straight into the injection site. 8b Press the injection button down slowly and steadily until you hear a “click” (Figure S). The slower you press, the easier the injection will feel.	Push Down Slowly gpp v Figure S

8c After hearing the “click,” continue holding down the injection button and slowly count to 5 to deliver the full dose of medicine (Figure T).

“Click”

Co I \

Ççn J

Figure T

-------WAIT! Count to 5-------

Count to 5

Step 9 Dispose pen

9a Pull the needle out of your skin (Figure U).

DO NOT recap the needle or take the needle off the pen.

9b Immediately put the pen (with needle attached) in a container for pen disposal. Do not dispose of the used pen in the household waste. Dispose of it as your doctor or pharmacist has instructed.

Lift Pen from Skin

COIL

¿S «Lt

I T

-----.

Figure U

QUESTIONS AND ANSWERS

MIXING YOUR MEDICINE AND WAITING 15 MINUTES (STEPS 2–3)

> What if I do not wait 15 minutes after turning the pen to the Number 2?

If you do not wait the full 15 minutes the medicine may not be mixed with the water the right way. This can result in particles floating in the clear cartridge, not getting your full dose, or a blocked needle. Waiting the full 15 minutes ensures that the medicine powder and water are mixed the right way, even though it may look like it is mixed sooner.

> What if I leave my pen for more than 15 minutes after turning the pen to the Number 2 (Step 2)?

As long as the needle has not been attached, the pen can be used for up to 8 hours from the time Step 2 was started. If it has been more than 8 hours since the medicine was mixed in Step 2 , throw away the pen and use another pen. If you have attached the needle, EPERZAN should be used right away.

ATTACHING NEEDLE, REMOVING AIR FROM CARTRIDGE, AND PREPARING PEN FOR INJECTION (STEPS 5–7)

> What if I leave my pen with the needle attached (Step 5), and then come back to finish the next step much later?

This can cause your needle to block, you should continue from Step 5 to Step 6 right away.

> What if I do not attach the needle at Step 5?

If the needle is attached before Step 5 , some of the medicine may be lost during mixing.

DO NOT attach the needle before Step 5.

DO NOT turn the cartridge to [3] (Step 6b) before attaching the needle (Step 5).

The needle must be attached to allow air to escape while turning the cartridge from [2] to [3] in the number window.

> What if I do not attach the needle as instructed?

If you do not push the needle on completely, the pen may jam or leak.

If the pen is jammed or leaking, throw it away and use another pen.

> What if I do not hear the “click” when the [2] or when the [3] is moved into the Number Window?

If you do not hear a “click” when the [2] or when the [3] is moved into the number window, you may not have the number fully centered in the window. Twist the clear cartridge slightly in the direction of the arrows (clockwise) to complete the “click” and center the number in the window.

If you are unable to turn to position [3] , throw it away and use another pen.

REMOVING BOTH NEEDLE CAPS AND INJECTING YOUR MEDICINE (STEPS 7–8)

> After I turn the pen to Number 3 (Step 6), there are still some small air bubbles remaining.

Can I still use the pen?

Seeing small air bubbles remaining is normal and you can still use the pen.

> After I give my medicine, there is some liquid still seen in the clear cartridge.

This is normal. If you have heard and felt the injection button “click” and slowly counted to 5 before pulling the needle out of your skin, you should have received the full dose of your medicine.

Package leaflet: Information for the patient

Eperzan 50 mg powder and solvent for solution for injection

Albiglutide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if

their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.See section 4.

What is in this leaflet:

1. What Eperzan is and what it is used for

2. What you need to know before you take Eperzan

3. How to take Eperzan

4. Possible side effects

5. How to store Eperzan

6. Contents of the pack and other information

Instructions for use of the pre-filled pen

(overleaf)

Questions and answers about the instructions for use of the pre-filled pen

Read both sides of this leaflet

1. What Eperzan is and what it is used for

Eperzan contains the active ingredient albiglutide which belongs to a group of medicines called GLP-1 receptor agonists that are used to lower blood sugar (glucose) in adults with Type 2 diabetes.

You have Type 2 diabetes either:

< because your body does not make enough insulin to control the level of sugar in your blood or
because your body is not able to use the insulin properly.

Eperzan helps your body to increase the production of insulin when your blood sugar is high.

Eperzan is used to help control your blood sugar, either:

– on its own if your blood sugar is not properly controlled by diet and exercise alone, and you can’t take metformin (another diabetes medicine)

– in combination with other diabetes medicines that are taken by mouth (such as metformin, or medicines known as sulphonylureas or thiazolidinediones), or with insulin.

It is very important that you continue to follow any diet and lifestyle advice from your doctor while taking Eperzan.

2. What you need to know before you use Eperzan

Don’t use Eperzan:

if you are allergic to albiglutide or any of the other ingredients of this medicine (listed in section 6).

If you think this applies to you, don’t use Eperzan until you have checked with your doctor, nurse or pharmacist.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before using Eperzan:

if you have Type 1 (insulin-dependent) diabetes or ketoacidosis (a very serious complication of

if you have ever had pancreatitis (inflammation of the pancreas). Your doctor will decide if you can

use Eperzan, and will explain the symptoms of pancreatitis (see ‘Conditions you need to look out for' in section 4).

if you are taking a sulphonylurea or insulin for your diabetes, as low blood sugar (hypoglycaemia)

can occur. Your doctor may need to change your dose of these other medicines to reduce this risk. (See ‘Very common side effects’ in section 4 for signs of low blood sugar).

if you have a serious problem with emptying your stomach (gastroparesis) or if you have severe

bowel disease (severe gastrointestinal disease). Eperzan is not recommended if you have these conditions.

When initiating treatment with albiglutide, you may experience fluid loss from vomiting, nausea, diarrhoea or dehydration. It is important to avoid dehydration by drinking plenty of fluids.

Check with your doctor, nurse or pharmacist before you use Eperzan if you think any of these apply to you.

Children and adolescents

It is not known if Eperzan is safe and effective in people under 18 years of age. Eperzan is not recommended for children and adolescents.

Other medicines and Eperzan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines , (see also earlier in section 2 ‘Warnings and precautions’).

You should not take acarbose if you suffer from bowel obstruction.

Talk to your doctor if you are taking acarbose and Eperzan at the same time.

Pregnancy, breast-feeding and fertility

Pregnancy

Tell your doctor, nurse or pharmacist immediately if you become pregnant during treatment with Eperzan.

There is no information about the safety of Eperzan in pregnant women. Eperzan should not be used while you're pregnant.

Breast-feeding

Fertility

For both men and women, it is not known if Eperzan could affect your fertility.

Driving and using machines

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per 0.5 ml dose, so is essentially ‘sodium free’.

3. How to use Eperzan

Always use this medicine exactly as your doctor, nurse or pharmacist has told you. Check with your doctor, nurse or pharmacist if you are not sure.

You can use Eperzan at any time of day, with or without meals.

Eperzan must not be injected into a vein (intravenously) or into a muscle (intramuscularly).

The pen injector contains powder and water which you need to mix before you can use it. After section 6 of this leaflet there are

Instructions For Use

giving you step-by-step instructions on how to mix your medicine and how to inject it. If you have questions or do not understand how to use your pen, talk to your doctor, nurse or pharmacist.

If you use more Eperzan than you should

If you use too much Eperzan, contact a doctor or pharmacist for advice. If possible show them the pack, or this leaflet. You may feel very sick (severe nausea), be sick (vomit), or get a headache.

If you forget to use Eperzan

If you stop using Eperzan

Use Eperzan for as long as your doctor recommends. If you stop using Eperzan, your blood sugar levels may be affected. Don’t stop unless your doctor advises you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions you need to look out for:

Risk of acute pancreatitis (an inflamed pancreas)

Pancreatitis has been reported as an uncommon side effect. It may affect up to 1 in 100 people.

Pancreatitis can be severe and life-threatening.

If you get:

severe stomach (abdominal) pain that does not go away, this can be a symptom of pancreatitis. The pain may happen with or without you being sick (vomiting). You may feel the pain going from your front (abdomen) through to your back.

Stop taking Eperzan and talk to your doctor straight away

Severe allergic reactions

These are rare in people taking Eperzan (may affect up to 1 in 1000 people).

Signs include:

raised and itchy rashes,
swelling, sometimes of the face, mouth or throat, causing difficulty in breathing.

Get medical help immediately if you get these symptoms. Stop taking Eperzan.

Other side effects reported with Eperzan

Very common : may affect more than 1 in 10 people :

low blood sugar (hypoglycaemia) when you use Eperzan in combination with insulin or sulphonylurea. The warning signs of low blood sugar may include cold sweat, cool pale skin, headache, feeling drowsy, weakness, dizziness, feeling confused or irritable, feeling hungry, fast heart beat and feeling jittery. Your doctor will tell you what to do if you get low blood sugar.
diarrhoea
feeling sick (nausea)
rash, redness or itching of the skin where you have injected Eperzan

Common : may affect up to 1 in 10 people :

chest infection (pneumonia)
low blood sugar (hypoglycaemia) if you use Eperzan on its own or in combination with metformin or pioglitazone
irregular heartbeat
being sick (vomiting)
constipation
indigestion
heartburn (gastro-oesophageal reflux)

Uncommon : may affect up to 1 in 100 people :

bowel obstruction

Rare : may affect up to 1 in 1000 people :

allergic reaction (hypersensitivity) ; this includes symptoms such as local or widespread rash, redness or itching of the skin and difficulty breathing (also see ‘Conditions you need to look out for’ at the beginning of this section)

In addition some other side effects have been reported (frequency not known, cannot be estimated from the

available data):

reduced appetite

Reporting of side effects

5. How to store Eperzan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pen and the carton after ‘EXP’. The expiry date refers to the last day of that month.

Store pens and needles in the original carton until use.

Store in a refrigerator (between 2°C and 8°C). Do not freeze. The medicine can be stored at room temperature (’ess than 30°C) for no more than a total of 4 weeks before use. After this time, pens should be used or thrown away.

Aftet the powder and liquid are mixed within the pen, the pen should be used within 8 hours.
Use.he pen immediately after you have attached and primed the needle otherwise the solution can dry up inside the needle and block it.

Use each pen only once.

After you have used the pen, do not remove the needle. Dispose of the pen as instructed by your doctor, pharmacist or nurse.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Eperzan contains

– The active substance is albiglutide.

Each 50 mg pen delivers 50 mg albiglutide in a volume of 0.5 ml.

– The solvent is water for injections.
– The other ingredients are: sodium dihydrogen phosphate monohydrate and disodium phosphate, anhydrous (see section 2 under ‘Sodium content’), trehalose dihydrate, mannitol, polysorbate 80.

What Eperzan looks like and contents of the pack

Eperzan is supplied as a pen for self injection. Each pen contains a white to yellow powder and a colourless solvent in separate compartments. A needle is provided with each pen.

Pens are supplied in packs of 4 pens and 4 needles and multipacks comprising 3 packs, each containing 4 pens and 4 needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland

Name and address of the manufacturer responsible for batch release:

Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations)

Harmire Road

Barnard Castle

Durham

DL12 8DT

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgique/Belg'en

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tél/Tel: + 32 (0)10 85 52 00

Et^rapu.’

rnakcoCMumKnaÖH EOOfl

Ten.: + 359 2 953 10 34

Česká republika

GlaxoSmithKline s.r.o.

Tel: + 420 222 001 111

Danmark

GlaxoSmithKline Pharma A/S

Tlf: + 45 36 35 91 00

Luxembourg/Luxemburg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Belgique/Belgien

Tel/Tel: + 32 (0)10 85 52 00

Magyarorszag

GlaxoSmithKline Kft.

Tel.: + 36 1 225 5300

Malta

GlaxoSmithKline Malta

Tel: + 356 21 238131

Nederland

GlaxoSmithKline BV Tel: + 31 (0)30 6938100

Deutschland

GlaxoSmithKline GmbH & Co. KG

Tel.: + 49 (0)89 36044 8701

Norge

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00

Eesti

GlaxoSmithKline Eesti OU

Tel: + 372 6676 900

Österreich

GlaxoSmithKline Pharma GmbH

Tel: + 43 (0)1 97075 0

EÀÀàôa

GlaxoSmithKline A.E.B.E.

Tql: + 30 210 68 82 100

Polska

GSK Services Sp. z.o.o.

Tel.: + 48 (0)22 576 9000

España

GlaxoSmithKline, S.A.

Tel: + 34 902 202 700

Portugal

GlaxoSmithKline – Produtos Farmacéuticos, Lda.

Tel: + 351 21 412 95 00

France

Laboratoire GlaxoSmithKline

Tél: + 33 (0)1 39 17 84 44

Romania

GlaxoSmithKline (GSK) S.R.L.

Tel: + 4021 3028 208

Hrvatska

GlaxoSmithKline d.o.o.

Tel:++385 1 6051 999

Ireland

GlaxoSmithKline (Ireland) Limited

Tel: + 353 (0)1 4955000

Slovenija

GlaxoSmithKline d.o.o.

Tel: + 386 (0)1 280 25 00

island

Vistor hf.

Simi: + 354 535 700oX

Slovenská republika

GlaxoSmithKline Slovakia s. r. o.

Tel: + 421 (0)2 48 26 11 11

Italia

GlaxoSmithKline S.p.A.

Tel: + 39 (0)45 9218 111

Suomi/Finland

GlaxoSmithKline Oy

Puh/Tel: + 358 (0)10 30 30 30

Kvnpog

GlaxoSmithKline (Cyprus) Ltd

Tql: + 357 22 39 70 00

Sverige

GlaxoSmithKline AB

Tel: + 46 (0)31 67 09 00

Latvija

GlaxoSmithKline Latvia SIA

Tel: + 371 67312687

United Kingdom

GlaxoSmithKline UK

Tel: + 44 (0)800 221441

Lietuva

GlaxoSmithKline Lietuva UAB

Tel: + 370 5 264 90 00

This leaflet was last revised in < {MM/YYYY }>

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

INSTRUCTIONS FOR USE

Once weekly Eperzan pen 30 mg

Read all of this leaflet carefully before you start taking this medicine, as well as all the instructions including the Pen Storage and Important Warnings.

Follow the steps below in the exact order they are presented.

Pen storage
Store your pens at room temperature, not to exceed 30°C, for up to 4 weeks. Always store in the box. If a box of pens will be stored for more than 4 weeks, keep them refrigerated (2°C to 8°C). If stored in the refrigerator, allow the pen to sit at room temperature for 15 minutes before starting Step 1. DO NOT allow the pen to freeze. Throw away the pen if frozen.
Important warnings
DO NOT attach needle until instructed in Step 5 DO NOT reuse needles, recap needles, or remov container for pen disposal right away after inject Throw away the pen if leaking or jammed. Keep your pen out of the sight and reach of child	. e used needles from the pen. Throw out the pen in a ing, as shown in Step 9. ren
For each injection, gather the following items: A new pen (Figure A). A new needle (Figure B). A clean empty cup (Figure C). A clock or timer (Figure C). A container for pen disposal. The cup, timer and container are not provided in the pack.	Pen Injection Button* Viewing Window Number Window fl Hp ¿T\| EperzarC3g_[2g^Bff Clear Cartridge t y Figure A * Injection Button is inside the pen until the pen is ready for injection. f The numbers on the clear cartridge represent stages of preparation for your medicine.

Pen Needle

o Outer Needle Cap t. Nilc

m, Inner Needle Cap t-

1 Needle

„— „-J Tab

Figure B

Other Supplies Needed

Clean Empty Cup Clock/Timer

Figure C

Step 1 Check Pen

1a Wash your hands (Figure D).

Wash Hands and Check Pen

Figure D

1b Check dosage and expiration date on pen (Figure E).

DO NOT use if the pen is expired or shows the incorrect dose.

\o<>

® 1 Eprrean* 30 mg^^B

Figure E

1c Check that the pen has a [1] in the number window (Figure F).

DO NOT use if the [1] is not showing.

Figure F

Step 2 Mix Medicine

2a Hold pen body with clear cartridge pointing up so that you can see the [1] in the window.

Twist Pen to Mix Medicine

fJ! …

“Click”

—- ^B

H J n ----------

Figure G

2b Slowly and gently rock the pen side-to-side 5 times (like a windscreen wiper) (Figure H).

This will help mix the medicine.

DO NOT shake the pen to avoid foaming, which may affect your dose.

Rock Pen

5 Times r

Figure H

Step 3 Wait 15 minutes

3 Place pen into cup with clear cartridge pointing up (Figure I).

Set a timer for 15 minutes. You must wait 15 minutes for the medicine to dissolve before continuing.

Wait 15 Minutes

■m^^secB /*/

Figure I

IMPORTANT: Make sure you have waited 15 minutes before continuing onto step 4. This is to make sure the medicine has dissolved.

Step 4 Rock Pen and Check Medicine

4a Again, slowly and gently rock the pen side-to-side side 5 times (like a windscreen wiper) (Figure J).

DO NOT shake the pen to avoid foaming, which may affect your dose.

Rock Pen Again

5 Times A

Figure J

4b Check medicine through the viewing window. It should be yellow and see-through, without any particles (Figure K).

DO NOT use pen if there are still particles in the liquid.

It is okay to have large air bubbles on top of the liquid. These are removed in step 6.

Check Medicine

Look for Particles ¡QI

Figure K

Step 5 Attach needle

5a Peel tab from outer needle cap (Figure L).

Hold the pen upright before attaching the needle.

Peel Off Tab

FigureL

5b Push needle straight down onto the clear cartridge until you hear a “click” and feel the needle “snap” into place. This means the needle is attached (Figure M).

DO NOT attach at an angle.

DO NOT attach by screwing the needle on

Attach Needle

Push Straight Down

“Click” gjj

Figure M

IMPORTANT: After the needle has been securely attached, make sure to complete the remaining steps of the injection procedure right away. Waiting may result in a blocked or clogged needle.

Step 6 Remove Air from Cartridge

6a With needle pointing up, gently tap the clear cartridge 2–3 times to bring large air bubbles to the top (Figure N). Small air bubbles are okay and do not need to rise to the top.

Tap Pen Cartridge

Q ! i'" k

Figure N

The white injection button will also pop out from the bottom of the pen.

DO NOT use the pen if the injection button does not pop out.

Hold Upright and Twist to 3

Twist Pen to Prime the Needle

“Click”

. 1 m \ \ 1 * ■J

J J ’S > ——

Figure O

IMPORTANT: You may hear a “click” when you first start twisting the cartridge from [2] to [3]. Keep twisting until you see [3] in the window.

Step 7 Prepare for injection
7a Choose your injection site (Figure P). You can use your abdomen, thigh, or upper arm.	Choose Injection Site Figure P
IMPORTANT: There are two needle caps, an outer and inner need'	e cap.
7b While holding the pen in the air, remove outer needle cap (Figure Q) and inner needle cap (Figure R). A few drops of liquid may come out of the needle. This is normal. DO NOT rest the back of the device (where the injection button is exposed) on a flat surface while removing needle caps. 7c Place both needle caps into a container for pen disposal.	Pull off Needle Caps and Discard Step 1 Step 2 Remove Outer RemoveInner Needle Cap Needle Cap ♦W t T nr ■ i Figure Q Figure R
Step 8 Deliver injection
8a Insert needle straight into the injection site. 8b Press the injection button down slowly and steadily until you hear a “click” (Figure S). The slower you press, the easier the injection will feel.	Push Down Slowly gpp v Figure S

8c After hearing the “click,” continue holding down the injection button and slowly count to 5 to deliver the full dose of medicine (Figure T).

“Click”

Co I \

Ççn J

Figure T

-------WAIT! Count to 5-------

Count to 5

Step 9 Dispose pen

9a Pull the needle out of your skin (Figure U).

DO NOT recap the needle or take the needle off the pen.

9b Immediately put the pen (with needle attached) in a container for pen disposal. Do not dispose of the used pen in the household waste. Dispose of it as your doctor or pharmacist has instructed.

Lift Pen from Skin

COIL

¿S «Lt

I T

-----.

Figure U

QUESTIONS AND ANSWERS

MIXING YOUR MEDICINE AND WAITING 15 MINUTES (STEPS 2–3)

> What if I do not wait 15 minutes after turning the pen to the Number 2?

> What if I leave my pen for more than 15 minutes after turning the pen to the Number 2 (Step 2)?

ATTACHING NEEDLE, REMOVING AIR FROM CARTRIDGE, AND PREPARING PEN FOR INJECTION (STEPS 5–7)

> What if I leave my pen with the needle attached (Step 5), and then come back to finish the next step much later?

This can cause your needle to block, you should continue from Step 5 to Step 6 right away.

> What if I do not attach the needle at Step 5?

If the needle is attached before Step 5 , some of the medicine may be lost during mixing.

DO NOT attach the needle before Step 5.

DO NOT turn the cartridge to [3] (Step 6b) before attaching the needle (Step 5).

The needle must be attached to allow air to escape while turning the cartridge from [2] to [3] in the number window.

> What if I do not attach the needle as instructed?

If you do not push the needle on completely, the pen may jam or leak.

If the pen is jammed or leaking, throw it away and use another pen.

> What if I do not hear the “click” when the [2] or when the [3] is moved into the Number Window?

If you are unable to turn to position [3] , throw it away and use another pen.

REMOVING BOTH NEEDLE CAPS AND INJECTING YOUR MEDICINE (STEPS 7–8)

> After I turn the pen to Number 3 (Step 6), there are still some small air bubbles remaining.

Can I still use the pen?

Seeing small air bubbles remaining is normal and you can still use the pen.

> After I give my medicine, there is some liquid still seen in the clear cartridge.

Package leaflet: Information for the patient

Eperzan 50 mg powder and solvent for solution for injection

Albiglutide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if

their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.See section 4.

What is in this leaflet:

1. What Eperzan is and what it is used for
2. What you need to know before you take Eperzan
3. How to take Eperzan
4. Possible side effects
5. How to store Eperzan
6. Contents of the pack and other information

Instructions for use of the pre-filled pen

(overleaf)

Questions and answers about the instructions for use of the pre-filled pen

Read both sides of this leaflet

1. What Eperzan is and what it is used for

Eperzan contains the active ingredient albiglutide which belongs to a group of medicines called GLP-1 receptor agonists that are used to lower blood sugar (glucose) in adults with Type 2 diabetes.

You have Type 2 diabetes either:

< because your body does not make enough insulin to control the level of sugar in your blood or
because your body is not able to use the insulin properly.

Eperzan helps your body to increase the production of insulin when your blood sugar is high.

Eperzan is used to help control your blood sugar, either:

– on its own if your blood sugar is not properly controlled by diet and exercise alone, and you can’t take metformin (another diabetes medicine)

– in combination with other diabetes medicines that are taken by mouth (such as metformin, or medicines known as sulphonylureas or thiazolidinediones), or with insulin.

It is very important that you continue to follow any diet and lifestyle advice from your doctor while taking Eperzan.

2. What you need to know before you use Eperzan

Don’t use Eperzan:

if you are allergic to albiglutide or any of the other ingredients of this medicine (listed in section 6).

If you think this applies to you, don’t use Eperzan until you have checked with your doctor, nurse or pharmacist.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before using Eperzan:

if you have Type 1 (insulin-dependent) diabetes or ketoacidosis (a very serious complication of

if you have ever had pancreatitis (inflammation of the pancreas). Your doctor will decide if you can

use Eperzan, and will explain the symptoms of pancreatitis (see ‘Conditions you need to look out for' in section 4).

if you are taking a sulphonylurea or insulin for your diabetes, as low blood sugar (hypoglycaemia)

can occur. Your doctor may need to change your dose of these other medicines to reduce this risk. (See ‘Very common side effects’ in section 4 for signs of low blood sugar).

if you have a serious problem with emptying your stomach (gastroparesis) or if you have severe

bowel disease (severe gastrointestinal disease). Eperzan is not recommended if you have these conditions.

When initiating treatment with albiglutide, you may experience fluid loss from vomiting, nausea, diarrhoea or dehydration. It is important to avoid dehydration by drinking plenty of fluids.

Check with your doctor, nurse or pharmacist before you use Eperzan if you think any of these apply to you.

Children and adolescents

It is not known if Eperzan is safe and effective in people under 18 years of age. Eperzan is not recommended for children and adolescents.

Other medicines and Eperzan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines , (see also earlier in section 2 ‘Warnings and precautions’).

You should not take acarbose if you suffer from bowel obstruction.

Talk to your doctor if you are taking acarbose and Eperzan at the same time.

Pregnancy, breast-feeding and fertility

Pregnancy

Tell your doctor, nurse or pharmacist immediately if you become pregnant during treatment with Eperzan.

There is no information about the safety of Eperzan in pregnant women. Eperzan should not be used while you're pregnant.

Breast-feeding

Fertility

For both men and women, it is not known if Eperzan could affect your fertility.

Driving and using machines

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per 0.5 ml dose, so is essentially ‘sodium free’.

3. How to use Eperzan

Always use this medicine exactly as your doctor, nurse or pharmacist has told you. Check with your doctor, nurse or pharmacist if you are not sure.

You can use Eperzan at any time of day, with or without meals.

Eperzan must not be injected into a vein (intravenously) or into a muscle (intramuscularly).

The pen injector contains powder and water which you need to mix before you can use it. After section 6 of this leaflet there are

Instructions For Use

giving you step-by-step instructions on how to mix your medicine and how to inject it. If you have questions or do not understand how to use your pen, talk to your doctor, nurse or pharmacist.

If you use more Eperzan than you should

If you use too much Eperzan, contact a doctor or pharmacist for advice. If possible show them the pack, or this leaflet. You may feel very sick (severe nausea), be sick (vomit), or get a headache.

If you forget to use Eperzan

If you stop using Eperzan

Use Eperzan for as long as your doctor recommends. If you stop using Eperzan, your blood sugar levels may be affected. Don’t stop unless your doctor advises you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions you need to look out for:

Risk of acute pancreatitis (an inflamed pancreas)

Pancreatitis has been reported as an uncommon side effect. It may affect up to 1 in 100 people.

Pancreatitis can be severe and life-threatening.

If you get:

severe stomach (abdominal) pain that does not go away, this can be a symptom of pancreatitis. The pain may happen with or without you being sick (vomiting). You may feel the pain going from your front (abdomen) through to your back.

Stop taking Eperzan and talk to your doctor straight away

Severe allergic reactions

These are rare in people taking Eperzan (may affect up to 1 in 1000 people).

Signs include:

raised and itchy rashes,
swelling, sometimes of the face, mouth or throat, causing difficulty in breathing.

Get medical help immediately if you get these symptoms. Stop taking Eperzan.

Other side effects reported with Eperzan

Very common : may affect more than 1 in 10 people :

low blood sugar (hypoglycaemia) when you use Eperzan in combination with insulin or sulphonylurea. The warning signs of low blood sugar may include cold sweat, cool pale skin, headache, feeling drowsy, weakness, dizziness, feeling confused or irritable, feeling hungry, fast heart beat and feeling jittery. Your doctor will tell you what to do if you get low blood sugar.
diarrhoea
feeling sick (nausea)
rash, redness or itching of the skin where you have injected Eperzan

Common : may affect up to 1 in 10 people :

chest infection (pneumonia)
low blood sugar (hypoglycaemia) if you use Eperzan on its own or in combination with metformin or pioglitazone
irregular heartbeat
being sick (vomiting)
constipation
indigestion
heartburn (gastro-oesophageal reflux)

Uncommon : may affect up to 1 in 100 people :

bowel obstruction

Rare : may affect up to 1 in 1000 people :

allergic reaction (hypersensitivity) ; this includes symptoms such as local or widespread rash, redness or itching of the skin and difficulty breathing (also see ‘Conditions you need to look out for’ at the beginning of this section)

In addition some other side effects have been reported (frequency not known, cannot be estimated from the

available data):

reduced appetite

Reporting of side effects

5. How to store Eperzan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pen and the carton after ‘EXP’. The expiry date refers to the last day of that month.

Store pens and needles in the original carton until use.

Aftet the powder and liquid are mixed within the pen, the pen should be used within 8 hours.
Use.he pen immediately after you have attached and primed the needle otherwise the solution can dry up inside the needle and block it.

Use each pen only once.

After you have used the pen, do not remove the needle. Dispose of the pen as instructed by your doctor, pharmacist or nurse.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Eperzan contains

– The active substance is albiglutide.

Each 50 mg pen delivers 50 mg albiglutide in a volume of 0.5 ml.

– The solvent is water for injections.
– The other ingredients are: sodium dihydrogen phosphate monohydrate and disodium phosphate, anhydrous (see section 2 under ‘Sodium content’), trehalose dihydrate, mannitol, polysorbate 80.

What Eperzan looks like and contents of the pack

Eperzan is supplied as a pen for self injection. Each pen contains a white to yellow powder and a colourless solvent in separate compartments. A needle is provided with each pen.

Pens are supplied in packs of 4 pens and 4 needles and multipacks comprising 3 packs, each containing 4 pens and 4 needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland

Name and address of the manufacturer responsible for batch release:

Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations)

Harmire Road

Barnard Castle

Durham

DL12 8DT

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgique/Belg'en

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tél/Tel: + 32 (0)10 85 52 00

Et^rapu.’

rnakcoCMumKnaÖH EOOfl

Ten.: + 359 2 953 10 34

Česká republika

GlaxoSmithKline s.r.o.

Tel: + 420 222 001 111

Danmark

GlaxoSmithKline Pharma A/S

Tlf: + 45 36 35 91 00

Luxembourg/Luxemburg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Belgique/Belgien

Tel/Tel: + 32 (0)10 85 52 00

Magyarorszag

GlaxoSmithKline Kft.

Tel.: + 36 1 225 5300

Malta

GlaxoSmithKline Malta

Tel: + 356 21 238131

Nederland

GlaxoSmithKline BV Tel: + 31 (0)30 6938100

Deutschland

GlaxoSmithKline GmbH & Co. KG

Tel.: + 49 (0)89 36044 8701

Norge

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00

Eesti

GlaxoSmithKline Eesti OU

Tel: + 372 6676 900

Österreich

GlaxoSmithKline Pharma GmbH

Tel: + 43 (0)1 97075 0

EÀÀàôa

GlaxoSmithKline A.E.B.E.

Tql: + 30 210 68 82 100

Polska

GSK Services Sp. z.o.o.

Tel.: + 48 (0)22 576 9000

España

GlaxoSmithKline, S.A.

Tel: + 34 902 202 700

Portugal

GlaxoSmithKline – Produtos Farmacéuticos, Lda.

Tel: + 351 21 412 95 00

France

Laboratoire GlaxoSmithKline

Tél: + 33 (0)1 39 17 84 44

Romania

GlaxoSmithKline (GSK) S.R.L.

Tel: + 4021 3028 208

Hrvatska

GlaxoSmithKline d.o.o.

Tel:++385 1 6051 999

Ireland

GlaxoSmithKline (Ireland) Limited

Tel: + 353 (0)1 4955000

Slovenija

GlaxoSmithKline d.o.o.

Tel: + 386 (0)1 280 25 00

island

Vistor hf.

Simi: + 354 535 700oX

Slovenská republika

GlaxoSmithKline Slovakia s. r. o.

Tel: + 421 (0)2 48 26 11 11

Italia

GlaxoSmithKline S.p.A.

Tel: + 39 (0)45 9218 111

Suomi/Finland

GlaxoSmithKline Oy

Puh/Tel: + 358 (0)10 30 30 30

Kvnpog

GlaxoSmithKline (Cyprus) Ltd

Tql: + 357 22 39 70 00

Sverige

GlaxoSmithKline AB

Tel: + 46 (0)31 67 09 00

Latvija

GlaxoSmithKline Latvia SIA

Tel: + 371 67312687

United Kingdom

GlaxoSmithKline UK

Tel: + 44 (0)800 221441

Lietuva

GlaxoSmithKline Lietuva UAB

Tel: + 370 5 264 90 00

This leaflet was last revised in < {MM/YYYY }>

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

INSTRUCTIONS FOR USE

Once weekly Eperzan pen 50 mg

Read all of this leaflet carefully before you start taking this medicine, as well as all the instructions including the Pen Storage and Important Warnings.

Follow the steps below in the exact order they are presented.

Pen storage
Store your pens at room temperature, not to exceed 30°C, for up to 4 weeks. Always store in the box. If a box of pens will be stored for more than 4 weeks, keep them refrigerated (2°C to 8°C). If stored in the refrigerator, allow the pen to sit at room temperature for 15 minutes before starting Step 1. DO NOT allow the pen to freeze. Throw away the pen if frozen.
Important warnings
DO NOT attach needle until instructed in Step 5 DO NOT reuse needles, recap needles, or remov container for pen disposal right away after inject Throw away the pen if leaking or jammed. Keep your pen out of the sight and reach of child	. e used needles from the pen. Throw out the pen in a ing, as shown in Step 9. ren
For each injection, gather the following items: A new pen (Figure A). A new needle (Figure B). A clean empty cup (Figure C). A clock or timer (Figure C). A container for pen disposal. The cup, timer and container are not provided in the pack.	Pen aa – j . Injection Button Viewing Window Number Window CLjL H A Eperzan' 50 mg Pen Body Clear Cartridge t Figure A * Injection Button is inside the pen until the pen is ready for injection. f The numbers on the clear cartridge represent stages of preparation. for your medicine.

Pen Needle

m Outer Needle Cap

m, Inner Needle Cap t-

,L^_ Needle

Tab

Figure B

Other Supplies Needed

Clean Empty Cup Clock/Timer

\ / hiss* ]

■iiiriTwsef

Figure C

Step 1 Check pen

1a Wash your hands (Figure D).

Wash Hands and Check Pen

Figure D

1b Check dosage and expiration date on pen (Figure E).

DO NOT use if the pen is expired or shows the incorrect dose.

EPcr;an'50

1 |—

Figure E

1c Check that the pen has a [1] in the number window (Figure F).

DO NOT use if the [1] is not showing.

.rv7

< ^=■1

Figure F

Step 2 Mix Medicine

2a Hold pen body with clear cartridge pointing up so that you can see the [1] in the window.

Twist Pen to Mix Medicine

“Click”

■ J ------------

Figure G

2b Slowly and gently rock the pen side-to-side 5 times (like a windscreen wiper) (Figure H).

This will help mix the medicine.

DO NOT shake the pen to avoid foaming, which may affect your dose.

Rock Pen

5 Times r / "o

Figure H

Step 3 Wait 30 minutes

3 Place pen into cup with clear cartridge pointing up (Figure I).

Set a timer for 30 minutes. You must wait 30 minutes for the medicine to dissolve before continuing.

Wait 30 Minutes

■m™iwsew /«/i

Figure I

IMPORTANT: Make sure you have waited 30 minutes before continuing onto step 4. This is to make sure the medicine has dissolved.

Step 4 Rock pen and check medicine

4a Again, slowly and gently rock the pen side-to-side side 5 times (like a windscreen wiper) (Figure J).

DO NOT shake the pen to avoid foaming, which may affect your dose.

Rock Pen Again

5 Times / °o

Figure J

4b Check medicine through the viewing window. It should be yellow and see-through, without any particles (Figure K).

DO NOT use pen if there are still particles in the liquid.

It is okay to have large air bubbles on top of the liquid. These are removed in step 6.

Check Medicine

Look for Particles Q

LffiJ

Figure K

Step 5 Attach needle

5a Peel tab from outer needle cap (Figure L).

Hold the pen upright before attaching the needle.

Peel Off Tab

FigureL

5b Push needle straight down onto the clear cartridge until you hear a “click” and feel the needle “snap” into place. This means the needle is attached (Figure M).

DO NOT attach at an angle.

DO NOT attach by screwing the needle on

Attach Needle

Push Straight Down

“Click”

Figure M

IMPORTANT: After the needle has been securely attached, make sure to complete the remaining steps of the injection procedure right away. Waiting may result in a blocked or clogged needle.

Step 6 Remove air from cartridge

6a With needle pointing up, gently tap the clear cartridge 2–3 times to bring large air bubbles to the top (Figure N). Small air bubbles are okay and do not need to rise to the top.

Tap Pen Cartridge

-Jf

Figure N

The white injection button will also pop out from the bottom of the pen.

DO NOT use the pen if the injection button does not pop out.

Hold Upright and Twist to 3

Twist Pen to Prime the Needle

“Click”

Or. 1 rn \ \ * * * * | 1 "O I –

Figure O

IMPORTANT: You may hear a “click” when you first start twisting the cartridge from [2] to [3]. Keep twisting until you see [3] in the window.

Step 7 Prepare for injection
7a Choose your injection site (Figure P). You can use your abdomen, thigh, or upper arm.	Choose Injection Site Figure P
IMPORTANT: There are two needle caps, an outer and inner need	le cap.
7b While holding the pen in the air, remove outer needle cap (Figure Q) and inner needle cap (Figure R). A few drops of liquid may come out of the needle. This is normal. DO NOT rest the back of the device (where the injection button is exposed) on a flat surface while removing needle caps. 7c Place both needle caps into a container for pen disposal.	Pull off Needle Caps and Discard Step 1 Step 2 Remove Outer RemoveInner Needle Cap Needle Cap * w n /tTd^T ’■ q// Figure Q Figure R
Step 8 Deliver injection
8a Insert needle straight into the injection site. 8b Press the injection button down slowly and steadily until you hear a “click” (Figure S). The slower you press, the easier the injection will feel.	Push Down Slowly ♦ a Figure S

8c After hearing the “click,” continue holding down the injection button and slowly count to 5 to deliver the full dose of medicine (Figure T).

“Click”

Gxm \

Figure T -------WAIT! Count to 5-------

Count io 5

Step 9 Dispose pen

9a Pull the needle out of your skin (Figure U).

DO NOT recap the needle or take the needle off the pen.

9b Immediately put the pen (with needle attached) in a container for pen disposal. Do not dispose of the used pen in the household waste. Dispose of it as your doctor or pharmacist has instructed.

Lift Pen from Skin

LOII

—-

Figure U

QUESTIONS AND ANSWERS

MIXING YOUR MEDICINE AND WAITING 30 MINUTES (STEPS 2–3)

> What if I do not wait 30 minutes after turning the pen to the Number 2?

If you do not wait the full 30 minutes the medicine may not be mixed with the water the right way. This can result in particles floating in the clear cartridge, not getting your full dose, or a blocked needle. Waiting the full 30 minutes ensures that the medicine powder and water are mixed the right way, even though it may look like it is mixed sooner.

> What if I leave my pen for more than 30 minutes after turning the pen to the Number 2 (Step 2)?

ATTACHING NEEDLE, REMOVING AIR FROM CARTRIDGE, AND PREPARING PEN FOR INJECTION (STEPS 5–7)

> What if I leave my pen with the needle attached (Step 5), and then come back to finish the next step much later?

This can cause your needle to block, you should continue from Step 5 to Step 6 right away.

> What if I do not attach the needle at Step 5?

If the needle is attached before Step 5 , some of the medicine may be lost during mixing.

DO NOT attach the needle before Step 5.

DO NOT turn the cartridge to [3] (Step 6b) before attaching the needle (Step 5).

The needle must be attached to allow air to escape while turning the cartridge from [2] to [3] in the number window.

> What if I do not attach the needle as instructed?

If you do not push the needle on completely, the pen may jam or leak.

If the pen is jammed or leaking, throw it away and use another pen.

> What if I do not hear the “click” when the [2] or when the [3] is moved into the Number Window?

If you are unable to turn to position [3] , throw it away and use another pen.

REMOVING BOTH NEEDLE CAPS AND INJECTING YOUR MEDICINE (STEPS 7–8)

> After I turn the pen to Number 3 (Step 6), there are still some small air bubbles remaining.

Can I still use the pen?

Seeing small air bubbles remaining is normal and you can still use the pen.

> After I give my medicine, there is some liquid still seen in the clear cartridge.

Eperzan - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - Eperzan

1. What Eperzan is and what it is used for

2. What you need to know before you take Eperzan

3. How to take Eperzan

4. Possible side effects

5. How to store Eperzan

6. Contents of the pack and other information

1. What Eperzan is and what it is used for

2. What you need to know before you use Eperzan

3. How to use Eperzan

4. Possible side effects

5. How to store Eperzan

6. Contents of the pack and other information

1. What Eperzan is and what it is used for

2. What you need to know before you take Eperzan

3. How to take Eperzan

4. Possible side effects

5. How to store Eperzan

6. Contents of the pack and other information

1. What Eperzan is and what it is used for

2. What you need to know before you use Eperzan

3. How to use Eperzan

4. Possible side effects

5. How to store Eperzan

6. Contents of the pack and other information

– If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.See section 4.

1. What Eperzan is and what it is used for

2. What you need to know before you take Eperzan

3. How to take Eperzan

4. Possible side effects

5. How to store Eperzan

6. Contents of the pack and other information

Instructions for use of the pre-filled pen

Questions and answers about the instructions for use of the pre-filled pen

1. What Eperzan is and what it is used for

2. What you need to know before you use Eperzan

3. How to use Eperzan

Instructions For Use

4. Possible side effects

5. How to store Eperzan

6. Contents of the pack and other information

What Eperzan looks like and contents of the pack

INSTRUCTIONS FOR USE