TERIPARATIDE AMBIO PHARMA 20 MICROGRAMS / 80 MICROLITRE SOLUTION FOR INJECTION IN PRE-FILLED PEN - patient leaflet, side effects, dosage

1. what is teriparatide ambio pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen and what it is used for

Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation.

Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen is used to treat osteoporosis in adults. Osteoporosis is a disease that causes your bones to become thin and fragile. This disease is especially common in women after the menopause, but it can also occur in men. Osteoporosis is also common in patients receiving corticosteroids.

2. what you need to know before you use teriparatide ambio pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen

Do not use Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen

• if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from high calcium levels or if you have previously had high calcium levels.
• if you suffer from serious kidney problems.
• if you have ever been diagnosed with bone cancer or other cancers that have spread (metastasised) to your bones.
• if you have certain bone diseases. If you have a bone disease, tell your doctor.
• if you have unexplained high levels of alkaline phosphatase in your blood, which means you might have Paget’s disease of bone (disease with abnormal bone changes). If you are not sure, ask your doctor.
• if you have had radiation therapy involving your bones.
• if you are pregnant or breast-feeding.

Warning and precautions

Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen may cause an increase in the amount of calcium in your blood or urine.

Talk to your doctor or pharmacist before or while using Teriparatide Ambio Pharma 20 microgram /

80 microliter, solution for injection in pre-filled pen:

• if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
• if you suffer from kidney stones or have a history of kidney stones
• if you suffer from kidney problems (moderate renal impairment)

Some patients get dizzy or get a fast heartbeat after the first few doses. For the first doses, inject Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen where you can sit or lie down right away if you get dizzy.

The recommended treatment time of 24 months should not be exceeded. Teriparatide

Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen should not be used in growing adults.

Children and adolescents

Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen should not be used in children and adolescents (less than 18 years).

Other medicines and Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, because occasionally they may interact (e.g. digoxin/digitalis, a medicine used to treat heart disease).

Pregnancy and breast-feeding

Do not use Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in prefilled pen if you are pregnant or breast-feeding. If you are a woman of child-bearing potential, you should use effective methods of contraception during use of Teriparatide Ambio Pharma

20 microgram / 80 microliter, solution for injection in pre-filled pen. If you become pregnant, Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen should be discontinued. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Some patients may feel dizzy after injecting Teriparatide Ambio Pharma 20 microgram /

80 microliter, solution for injection in pre-filled pen. If you feel dizzy you should not drive or use machines until you feel better.

Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen

Contains sodium :

This medicine contains less than 1 mmol sodium (23 mg) per dose. This means that it is essentially “sodium-free”.

3. how to use teriparatide ambio pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen

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

The recommended dose is 20 microgram given once daily by injection under the skin (subcutaneous injection) in the thigh or abdomen. To help you remember to take your medicine, inject it at about the same time each day.

Your doctor will arrange for you to receive training in how to use the pen.

Inject Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in prefilled pen each day for as long as your doctor prescribes it for you. The total duration of treatment with Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen should not exceed 24 months. You should not receive more than one treatment course of 24 months over your lifetime.

Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen can be injected at mealtimes.

Read the user manual booklet, which is included in the carton for instructions on how to use the Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen.

Injection needles are not included with the pen. Becton, Dickinson and Company pen needles can be used.

You should take your Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen injection shortly after you take the pen out of the refrigerator as described in the user manual. Put the pen back into the refrigerator immediately after you have used it. Use a new injection needle for each injection and dispose of it after each use. Never store your pen with the needle attached. Never share your Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen with others.

Your doctor may advise you to take Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen with calcium and vitamin D. Your doctor will tell you how much you should take each day.

Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen can be given with or without food.

If you use more Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen than you should

If, by mistake, you have used more Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen than you should, contact your doctor or pharmacist.

The effects of overdose that might be expected include nausea, vomiting, dizziness, and headache.

If you forget or cannot take Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen at your usual time , take it as soon as possible on that day. Do not take a double dose to make up for a forgotten dose. Do not take more than one injection in the same day. Do not try to make up for a missed dose.

If you stop taking Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen

If you are considering stopping Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen treatment, please discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen.

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 common side effects are pain in limb (frequency is very common, may affect more than 1 in 10 people) and feeling sick, headache and dizziness (frequency is common). If you become dizzy (light-headed) after your injection, you should sit or lie down until you feel better. If you do not feel better, you should call a doctor before you continue treatment. Cases of fainting have been reported in association with teriparatide use.

If you experience discomfort such as redness of the skin, pain, swelling, itching, bruising or minor bleeding around the area of the injection (frequency is common), this should clear up in a few days or weeks. Otherwise tell your doctor as soon as possible.

Some patients may have experienced allergic reactions soon after injection, consisting of breathlessness, swelling of the face, rash and chest pain (frequency is rare). In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis can occur.

Other side effects include:

Common: may affect up to 1 in 10 people

• increase in blood cholesterol levels
• depression
• neuralgic pain in the leg
• feeling faint
• irregular heart beats
• breathlessness
• increased sweating
• muscle cramps
• loss of energy
• tiredness
• chest pain
• low blood pressure
• heartburn (painful or burning sensation just below the breast bone)
• being sick (vomiting)
• a hernia of the tube that carries food to your stomach
• low haemoglobin or red blood cell count (anaemia)

Uncommon: may affect up to 1 in 100 people

• increased heart rate
• abnormal heart sound
• shortness of breath
• haemorrhoids (piles)
• accidental loss or leakage of urine
• increased need to pass water
• weight increase
• kidney stones
• pain in the muscles and pain in the joints. Some patients have experienced severe back cramps or pain which lead to hospitalisation.
• increase in blood calcium level
• increase in blood uric acid level
• increase in an enzyme called alkaline phosphatase.

Rare: may affect up to 1 in 1,000 people

• reduced kidney function, including renal failure
• swelling, mainly in the hands, feet and legs.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via via the Yellow Card Scheme a www/mhra.gov.uk/y­ellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store teriparatide ambio pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen

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 pen after EXP. The expiry date refers to the last day of that month.

Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen should be stored in a refrigerator (2°C to 8°C) at all times. You can use Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen for up to 28 days after the first injection, as long as the pen is stored in a refrigerator (2°C to 8°C).

Do not freeze. Avoid placing the pens close to the ice compartment of the refrigerator to prevent freezing. Do not use Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen if it is, or has been, frozen.

Each pen should be properly disposed of after 28 days, even if it is not completely empty.

Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen contains a clear and colourless solution. Do not use Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen if solid particles appear or if the solution is cloudy or coloured.

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 to protect the environment.

6. contents of the pack and other information

What Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen contains

• The active substance is teriparatide. Each milliliter of the solution for injection contains

250 microgram of teriparatide.

• Each dose of 80 microliter contains 20 microgram of teriparatide.
• The other ingredients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injections. In addition, hydrochloric acid and/or sodium hydroxide solution may have been added for pH adjustment.

What Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in prefilled pen looks like and contents of the pack

Teriparatide Ambio Pharma 20 microgram / 80 microliter, solution for injection in pre-filled pen is a colourless and clear solution. It is supplied in a cartridge contained in a pre-filled disposable pen.

Each pen contains 2.4 ml of solution enough for 28 doses. Each pack contains one pen.

Marketing Authorisation Holder

Ambio Pharma Europe, North Point Business Park, T23AT2P Cork, Ireland

Manufacturer

Novocol Pharmaceutical of Canada, Inc. 25 Wolseley Court, Cambridge, Ontario N1R-6X3, Canada

Batch release manufacturer

Viatris Sante, 1 rue de Turin, 69007 Lyon, France

This leaflet was last revised in January 2022

PACKAGE LEAFLET

PEN USER MANUAL

Teriparatide Ambio Pharma Europe

TERIPARATIDE AMBIO PHARMA EUROPE 20 microgram / 80 microliter, Solution for Injection in pre-filled pen

INSTRUCTIONS FOR USE

Before you use your new pen, please read the section

Instructions for use

Also read the package leaflet provided.

Do not share your pen or your needles as this may risk transmission of infectious agents.

Your pen contains 28 days of medicine.

Ask your doctor or pharmacist which needle gauge and length are best for you.

ALWAYS WASH YOUR HANDS BEFORE EVERY INJECTION. PREPARE THE INJECTION SITE AS DIRECTED BY YOUR DOCTOR OR PHARMACIST.

• 1. PULL OFF WHITE CAP:

• 2. ATTACH NEW NEEDLE:

Large needle

Pull off paper tab.

Pull off large needle cover and save it.

Push needle straight onto Screw on needle until medicine cartridge. firmly attached.

• 3. SET DOSE

  
  
  
  
  
  

Pull out black injection button until it stops.

Check to make sure red stripe shows.

Pull off small needle protector and throw away.

If you cannot pull out the black injection button see Troubleshooting, Problem E.

• 4. INJECT DOSE

  
  
  
  

Gently hold a fold of skin from thigh or abdomen and insert needle straight into skin.

Push in black injection button until it stops. Hold it in and count to 5 s-l-o-w-l-y. Then pull the needle from skin.

• 5. CONFIRM DOSE

IMPORTANT

After completing the injection :

Once the needle is removed from the skin, check to make sure the black injection button is all the way in.

If the yellow shaft does not show, you have completed the injection steps correctly.

You should NOT see any of the yellow shaft.

If you do. and have already injected, do not inject yourself a second time on the same day.

Instead, you MUST reset.

(see Troubleshooting Problem A).

• 6. REMOVE NEEDLE

  
  

Put large needle cover on needle.

Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.

Pull off needle and throw away as directed by your doctor or pharmacist.

Push white cap back on. Place the product in the refrigerator immediately after use.

Teriparatide Ambio Pharma Europe

TERIPARATIDE AMBIO PHARMA EUROPE 20 microgram (gg) 80 microliter, solution for injection in pre-filled pen

Cleaning and Storage

Cleaning Your injector pen

• Wipe the outside of the-injector pen with a damp cloth.
• Do not place the injector pen in water, or wash, or clean it with any liquid.

Storing Your injector pen

• Refrigerate the injector pen immediately after every use. Read and follow the instructions in the Information for the Patient leaflet on how to store your pen.
• Do not store the injector pen with a needle attachedas this may cause air bubbles to form in the cartridge.
• Store the-injector pen with the white cap on.
• Never store the injector pen in the freezer.
• If the medicine has been frozen, throw the device away and use a new injector pen.
• If the injector pen has been left out of the refrigerator, do not throw the pen away. Place the pen back inthe refrigerator and contact your doctor-or pharmacist.

Other Important Notes

• The injector pen contains 28 days of medicine.
• Do not transfer the medicine into a syringe.
• Write down your first injection date on a calendar.
• Read and follow the instructions in the Information for the Patient leaflet for using the product.
• Check the injector pen label to make sure you have the correct medicine and that it has not expired.
• Contact your doctor or pharmacist if you notice any of the following:

o The injector pen appears damaged

o The solution is NOT clear, colourless and free of particles

• Use a new needle for each injection.
• During injection, you may hear one or more clicks – this is a normal device operation.
• The injector pen is not recommended for use by the blind or visually impaired persons without the assistance of a person trained in the proper use of the device.
• Keep the injector pen out of the sight and reach of children.