Enzepi - patient leaflet, side effects, dosage

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

Name and address of the manufacturer of the biological active substance

Nordmark Arzneimittel GmbH & Co. KG

Pinnauallee 4

25436 Uetersen

GERMANY

Name and address of the manufacturer(s) responsible for batch release

Adare Pharmaceuticals Srl Via Martin Luther King 13 20060 Pessano Con Bornago ITALY

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND US

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.

The marketing authorisation holder shall s within 6 months following authorisation.

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

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.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – 5,000 unit strength

• 1. NAME OF THE MEDICINAL PRODUCT

Enzepi 5,000 units gastro-resistant hard capsules Pancreas powder

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

One capsule contains 39.8 mg of pancreas powder of porcine origin including the following enzymatic

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

Do not swallow the desiccant.

• 8. EXPIRY DATE

EXP

After first opening, the product may be stored for a maximum of 6 months below 25°C in its tightly closed container.

Opening date :

• 9. SPECIAL STORAGE CONDITIONS

Keep the bottle tightly closed in order to protect from moisture.

• 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Enzepi 5,000

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – 10,000 unit strength

• 1. NAME OF THE MEDICINAL PRODUCT

Enzepi 10,000 units gastro-resistant hard capsules Pancreas powder

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

One capsule contains 83.7 mg of pancreas powder of porcine origin including the following enzymatic activities:

• 3. LIST OF EXCIPIENTS

• 4. PHARMACEUTICAL FORM AND CONTENTS 20 gastro-resistant hard capsules

50 gastro-resistant hard capsules 100 gastro-resistant hard capsules

200 gastro-resistant hard capsules

5.

Do not chew the capsules.

Read the package leaflet before use.

Oral use.

NING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Do not swallow the desiccant.

EXP

After first opening, the product may be stored for a maximum 6 months below 25°C in its tightly closed container.

Opening date :

• 9. SPECIAL STORAGE CONDITIONS

Keep the bottle tightly closed in order to protect from moisture.

• 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 AUTHORISATIO

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate

Coolock

Dublin 17

Ireland

• 12. MARKETING AUTHORISATION NUMB

EU/1/16/1113/005 20 gastro-resistant hard capsules

EU/1/16/1113/006 50 gastro-resistant hard capsules

EU/1/16/1113/­007 100 gastro-resistant h

EU/1/16/1113/­008 200 gastro-resistant h

• 13. BATCH NUMBER

Lot

• 15. INSTRUCTIONS ON USE

• 16. INFORMATION IN BRAILLE

Enzepi 10,000

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – 25,000 unit strength

1. NAME OF THE MEDICINAL PRODUCT

Enzepi 25,000 units gastro-resistant hard capsules Pancreas powder

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Do not swallow the desiccant.

EXP

After first opening, the product may be stored for a maximum 6 months below 25°C in its tightly closed container.

Opening date :

9. SPECIAL STORAGE CONDITIONS

Keep the bottle tightly closed in order to protect from moisture.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Enzepi 25,000

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – 40,000 unit strength

• 1. NAME OF THE MEDICINAL PRODUCT

Enzepi 40,000 units gastro-resistant hard capsules Pancreas powder

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

One capsule contains 334.9 mg of pancreas powder of porcine origin including the following enzymatic

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Do not swallow the desiccant.

EXP

After first opening, the product may be stored for a maximum 6 months below 25°C in its tightly closed container.

Opening date :

• 9. SPECIAL STORAGE CONDITIONS

Keep the bottle tightly closed in order to protect from moisture.

• 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 AUTHORISATIO

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate

Coolock

Dublin 17

Ireland

• 12. MARKETING AUTHORISATION NUMB

EU/1/16/1113/013 20 gastro-resistant hard capsules

EU/1/16/1113/014 50 gastro-resistant hard capsules

EU/1/16/1113/­015 100 gastro-resistant h

EU/1/16/1113/­016 200 gastro-resistant h

• 13. BATCH NUMBER

Lot

• 15. INSTRUCTIONS ON USE

• 16. INFORMATION IN BRAILLE

Enzepi 40,000

PARTICULARS TO APPEAR ON THE INNER PACKAGING

BOTTLE LABEL – 5,000 unit strength

• 1. NAME OF THE MEDICINAL PRODUCT

Enzepi 5,000 units gastro-resistant hard capsules Pancreas powder

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains :

Do not swallow the desiccant.

8. EXPIRY DATE

EXP

After first opening, the product may be stored for a maximum 6 months below 25°C in its tightly closed container.

Keep the bottle tightly closed in order to protect from moisture.

• 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

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate

Coolock

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOTTLE LABEL – 10,000 unit strength

• 1. NAME OF THE MEDICINAL PRODUCT

Enzepi 10,000 units gastro-resistant hard capsules Pancreas powder

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains:

Do not swallow the desiccant.

8. EXPIRY DATE

EXP

After first opening, the product may be stored for a maximum 6 months below 25°C in its tightly closed container

Keep the bottle tightly closed in order to protect from moisture.

• 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

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate

Coolock

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOTTLE LABEL – 25,000 unit strength

• 1. NAME OF THE MEDICINAL PRODUCT

Enzepi 25,000 units gastro-resistant hard capsules Pancreas powder

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains:

Do not swallow the desiccant.

8. EXPIRY DATE

EXP

After first opening, the product may be stored for a maximum 6 months below 25°C in its tightly closed container.

Keep the bottle tightly closed in order to protect from moisture.

• 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

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate

Coolock

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOTTLE LABEL – 40,000 unit strength

• 1. NAME OF THE MEDICINAL PRODUCT

Enzepi 40,000 units gastro-resistant hard capsules Pancreas powder

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains:

Do not swallow the desiccant.

8. EXPIRY DATE

EXP

After first opening, the product may be stored for a maximum 6 months below 25°C in its tightly closed container.

Keep the bottle tightly closed in order to protect from moisture.

• 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

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate

Coolock

What Enzepi is and what it is used for

2. What you need to know before you take Enzepi

taking pancreatic enzymes exceeding10,000 li­pase units per kilogram body weight per day and have unusual abdominal symptoms (such as severe stomach pain, trouble passing stools, nausea or vomiting) or changes in abdominal symptoms, tell your doctor straightaway.

Severe allergic reaction

If an allergic reaction occurs, stop your treatment and talk to your doctor. An allergic reaction could include itching, hives or rash. Rarely, a more serious allergic reaction may include a feeling of warmth, dizziness and fainting, trouble breathing; these are symptoms of a severe, potentially life-threatening condition called ‘anaphylactic shock’. If this occurs, call for urgent medical attention straightaway.

Mouth irritation

Enzepi capsules or its contents should not be crushed or chewed as they can cause irritation inside your mouth. Enzepi can only be sprinkled on certain food (see section 3).

Other medicines and Enzepi

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are breast-feeding or plan to breast-feed, or if you are pregnant, think you planning to have a baby, ask your doctor or pharmacist for advice before taking

It is not known if Enzepi passes into your breast-milk. You and your doc Enzepi or breast-feed.

It is not known if Enzepi will affect your ability to get pregnant or if it harms your unborn baby

Driving and using machines

Enzepi does not affect your ability to drive or use tools or machines.

3. How to take Enzepi

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

The dose is measured in ‘lipase units’.

Your doctor will adjust your dose which will depend on: □ the severity of yo ur illness,

• □ how much fat is in your stools, □ your diet, □ your weight.

How much Enzepi to take

Infants (below 1 year of age)

The recommended starting dose for infants below 1 year of age is 5,000 lipase units per 120 ml of formula milk or breast-milk.

Children (between 1 and 4 years of age)

The recommended starting dose for children between 1 and 4 years of age is 1,000 lipase units per kg of body weight with each meal.

Children (over 4 years of age), adolescents and adults (including elderly)

The recommended starting dose for children over 4 years of age, adolescents (12 to 18 years) and adults is

500 lipase units per kg of body weight per meal.

If your doctor advises you to increase the number of capsules you take each day, you should do so slowly over several days. If you still have fatty stools (smelly, loose, oily, pale stools) or other stomach or gut problems (gastrointestinal symptoms), talk to your doctor as your dose may need to be adjusted again.

Do not take more capsules in a day than the amount your doctor has told you (total daily dose). Depending on what strength of Enzepi you take, your doctor will tell you how many capsules you need to take with each meal or snack.

Your total daily dose should not exceed 2,500 lipase units per kg of body weight per meal (or 10,000 lipase units per kg of body weight per day).

How to take Enzepi

Children (over 1 year of age), adolescents and adults

Enzepi should always be taken with a meal or snack. The capsules should be swallowed whole and take them with a drink of water or juice. If you or your child eat a lot of meals or snacks in a day, be careful not to go over your total daily dose of Enzepi.

If you or your child have trouble swallowing Enzepi capsules, open carefully the

contents (granules) on a small amount of acidic food such as fruit puree (apple/ (orange/pineap­ple/apple). Do not mix the Enzepi granules with water, milk, flavoured milk or hot food. Ask your doctor about other foods you can spri

If you sprinkle the Enzepi granules on food, swallow the mixture or give it to your child straight after you have mixed it, followed by a drink of water or juice. Make sure t edicine and food mixture is swallowed completely and that no granules are left in your or your child’s m

Do not store Enzepi that has been sprinkled on food.

Enzepi capsules or the granules inside them should not be crushed or chewed and the capsules or the granules inside them should not be held in your or your child’s mouth. Crushing, chewing or holding the Enzepi capsules in your or your child’s mouth may cause irritation in your or your child’s mouth or change the way Enzepi works in your or your child’s body.

Infants (below 1 year of age)

For infants below 1 year of age, give Enzepi just before each feed of formula or breast-milk. Do not sprinkle the capsule contents directly into the formula or breast-milk. Carefully open the capsule and empty the granules on a small amount of acidic food (see above). If you sprinkle the Enzepi granules on food, give the medicine and food mixture to your child right away and do not store Enzepi that is sprinkled on food. Your child should take all the food mixture and should then drink enough liquid straight after to wash down all the medicine.

You may also sprinkle the granules directly into your child’s mouth. Immediately give them milk, formula or breast-milk to drink to ensure the granules are completely swallowed and none remain in your child’s mouth.

Look into your child’s mouth to make sure that all the medicine has been swallowed.

If you take more Enzepi than you should

If you take more Enzepi than you should drink plenty of water and talk to your doctor as soon as possible.

If you forget to take Enzepi

Do not take a double dose or extra capsules to make up for a forgotten dose. Wait until your next meal, and take your usual number of capsules with your meal.

If you stop taking Enzepi

Keep taking your medicine until your doctor tells you to stop. Many patients will need to take pancreatic enzyme replacement medicines for the rest of their life.

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.

The most important serious side effects seen with other pancreatic enzyme replacement medicines are ‘anaphylactic shock’ and fibrosing colonopathy. The frequency of these two side effects is not known. Anaphylactic shock is a severe, potentially life-threatening allergic reaction that can develop rapidly. If you notice any of the following seek urgent medical attention straightaway :

• □ itching, hives or rash

• □ swollen eyes, lips, hands or feet

• □ feeling lightheaded or faint

• □ trouble breathing or swallowing

• □ dizziness, collapse or unconsciousness.

Repeated high doses of pancreatic enzyme replacement medicines can also cause scarring or thickening of the bowel wall that can lead to blockage of the intestines, a condition called fibrosing colonopathy. If you have severe stomach pain, trouble passing stools (constipation), nausea or vomiting, tell your doctor straightaway.

Other possible side effects may include:

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

• □ stomach pain.

Common (may affect up to 1 in 10 people):

• □ abdominal discomfort or bloating

• □ flatulence/passing wind

• □ diarrhoea

• □ headache.

Not known (frequency cannot be estimated from the available data):

• □ abnormal/disco­loured faeces (stools) or frequent bowel movements

• □ shortness of breath ♦

• □ indigestion

• □ swelling, pain, soreness or irritation in the mouth

• □ tiredness or general feeling of being unwell (malaise)

• □ changes (increase or decrease) in blood glucose levels

• □ changes (increase or decrease) in body weight

• □ decreased appetite

• □ high uric acid level in the urine (hyperuricosuria)

• □ high uric acid level in the blood (hyperuricemia).

5. How to store Enzepi

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 carton and the bottle after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

After first opening, the medicine may be stored for a maximum of 6 months below 25°C in its tightly closed container. Keep the bottle tightly closed in order to protect from moisture. Do not discard the sachets (desiccant) from the bottle, these help protect your medicine from moisture. Do not eat or open the desiccant sachets.

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 Enzepi contains

– The active substance is pancreas powder of porcine origin.

Enzepi 5,000 units gastro-resistant hard capsules

One capsule contains 39.8 mg of pancreas powder includi

lipolytic activity: amylolytic activity: proteolytic activity:

der including the following enzymatic activites:

10,000 units 3,200 units 270 units

Enzepi 25,000 units : hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water, yellow iron oxide (E172), indigotine E132.

Enzepi 40,000 units : hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water, indigotine (E132).

o Printing ink: shellac, propylene glycol, indigotine (E132).

What Enzepi looks like and contents of the pack

The Enzepi 5,000 units gastro-resistant hard capsule has a white opaque cap and a white opaque body with ‘Enzepi 5’ printed on it and contains light-brown gastro-resistant granules.

The Enzepi 10,000 units gastro-resistant hard capsule has a yellow opaque cap and a white opaque body with ‘Enzepi 10’ printed on it and contains light-brown gastro-resistant granules.

The Enzepi 25,000 units gastro-resistant hard capsule has a green opaque cap and a white opaque body with ‘Enzepi 25’ printed on it and contains light-brown gastro-resistant granules.

The Enzepi 40,000 units gastro-resistant hard capsule has a blue opaque cap and a ‘Enzepi 40’ printed on it and contains light-brown gastro-resistant granules.

Enzepi is supplied in plastic (HDPE) bottles with desiccant sachets, closed with a lined polypropylene childresistant closure and a peel-off sealing liner.

Pack size: one bottle of 20, 50, 100 or 200 gastro-resistant hard capsules.

Marketing Authorisation Holder

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate

Coolock

Dublin 17

Ireland

Manufacturer

Adare Pharmaceuticals Srl

Via Martin Luther King, 13 20060, Pessano Con Bornago Milan

Italy

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

België/Belgiqu­e/Belgien/

Luxembourg/Lu­xemburg

Allergan n.v

Tel: + 32 2 709 21 64 (Nederlands)

Tél : + 32 2 709 21 58 (Français)

Česká republika Allergan CZ s.r.o.

Tel: +420 800 188 818

Magyarország

Allergan Hungary Kft.

Tel.: +36 80 100 101

Deutschland

Pharm-Allergan GmbH

Tel: + 49 69 92038–1050

Nederland

Allergan b.v.

Tel: +31 (0)76 790 10 49

Danmark

Allergan Norden AB

Tlf: + 4580884560

Allergan Norden AB

Tlf: +47 80 01 04 97

Eesti

Allergan Baltics UAB

Tel: + 37 2634 6109

Österreich

Pharm-Allergan GmbH

Tel: +4 43 1 99460 6355

EXÀâôa/ Kûnpoç

Allergan Hellas Pharmaceuticals S.A.

Tql: +30 210 74 73 300

España

Allergan S.A.

Tel: + 34 918076130

Portugal

Profarin Lda

Tel: + 351214253242

Hrvatska

Ewopharma d.o.o.

Tel: +385 1 6646 563

România

Allergan S.R.L.

Tel: +40 21 301 53 02

Slovenská re

Allergan S Tel: +42

Ísland

Actavis ehf.

Sími: +354 550 3300

Sverige

Allergan Norden AB

Tel: + 46859410000

Italia

Allergan S.p.A

Tel: + 39 06 509 562 90

Suomi/Finland

Allergan Norden AB

United Kingdom/Malta/I­reland

Allergan Ltd

Tel: + 44 (0) 1628 494026

Other sources of information

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

39

Ph. Eur. units

The other ingredients are:

o Capsule content: croscarmellose s odium, hydrogenated castor oil, colloidal anhydrous silica, cellulose microcrystalline, magnesium stearate, hypromellose phthalate, talc, triethyl citrate.

o Capsule shell :

Enzepi 5,000 units : hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water.

Enzepi 10,000 units : hypromellose, carrageenan (E407), potassium chloride, titanium dioxide

E171, carnauba wax, water, yellow iron oxide (E172).

ard capsules

g of pancreas powder including the following enzymatic activites: 25,000 units*

not less than 4,800 units*

not less than 410 units*

;pi 40,000 units gastro-resitant hard capsules

capsule contains 334.9 mg of pancreas powder including the following enzymatic activites:

lipolytic activity: amylolytic activity: proteolytic activity: