TETRIDAR 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen

Introduction

Leaflet:information for the user

Tetridar 20 micrograms/80 microliters solution for injection in pre-filled pen

Teriparatide

Read the entire leaflet carefully before starting to use this medicine,as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Tetridar and what is it used for
2. What you need to know before taking Tetridar
3. How to use Tetridar
4. Possible side effects

5 Conservation of Tetridar

1. Package contents and additional information

1. What is Tetridar and what is it used for

Tetridar contains the active ingredient teriparatide, which is used to increase bone strength and reduce the risk of fractures by stimulating bone formation.

Tetridar is used to treat osteoporosis in adults. Osteoporosis is a disease that causes your bones to wear down and become fragile. This disease is especially common in women after menopause, but it can also occur in men. Osteoporosis is also common in patients treated with corticosteroids.

2. What you need to know before taking Tetridar

Do not use Tetridar:

• if you are allergic to the active ingredient or any of the other components of this medicine (listed in section 6).
• if you have high levels of calcium (pre-existing hypercalcemia).
• if you have severe kidney problems.
• if you have ever been diagnosed with bone cancer or other types of cancer that have spread (metastasized) to your bones.
• if you have certain bone diseases. If you have a bone disease, consult your doctor.
• if you have high levels of alkaline phosphatase in your blood without apparent explanation, which could indicate that you have Paget's disease of the bone (a disease with abnormal bone changes). If you are unsure, consult your doctor.
• if you have received radiation therapy that may have affected your bones.
• if you are pregnant or breastfeeding.

Warnings and precautions

Tetridar may cause an increase in the amount of calcium in your blood or urine.

Consult your doctor or pharmacist before or while using Tetridar:

• if you constantly experience nausea, vomiting, constipation, low energy, or muscle weakness, tell your doctor. These may be symptoms of 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 insufficiency), you should tell your doctor.

Some patients, after the first doses, experience dizziness or increased heart rate. For the first doses, use Tetridar in a place where you can sit or lie down immediately if you feel dizzy.

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

Tetridar should not be used in growing adults.

Children and adolescents

Tetridar should not be used in children and adolescents (under 18 years of age).

Using Tetridarwithother medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine, as interactions may occasionally occur (e.g., digoxin/digitals, a medicine used to treat heart diseases).

Pregnancy,breastfeeding, and fertility

Do not use Tetridar if you are pregnant or breastfeeding. If you are a woman of childbearing age, you should use effective contraceptive methods during treatment with Tetridar. If you become pregnant, treatment with Tetridar should be discontinued. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Some patients may feel dizzy after injecting Tetridar. If you feel dizzy, do not drive or use machines until you feel better.

Tetridar contains sodium:

This medicine contains less than 23 mg (1 mmol) of sodium per dose, so it is considered essentially "sodium-free".

3. How to use Tetridar

Follow your doctor's instructions for administering this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is 20 micrograms administered once a day by subcutaneous injection (under the skin) in the thigh or abdomen. To help you remember to inject your medicine, inject it at the same time every day.

Inject Tetridar every day for as long as your doctor prescribes it. The total duration of treatment with Tetridar should not exceed 24 months. You should not receive more than one 24-month cycle of treatment with Tetridar in your lifetime.

Tetridar can be injected at mealtime.

Consult the User Manual included in the package for instructions on how to use the Tetridar pen.

No needles are included with the pen. Becton, Dickinson and Company needles with a gauge of 29 to 31 (diameter 0.25-0.33 mm) and a length of 12.7, 8, or 5 mm can be used.

The injection of Tetridar should be performed shortly after removing the pen from the refrigerator, as indicated in the User Manual. Return the pen to the refrigerator immediately after use. You should use a new needle for each injection and discard it after each use. Do not store the pen with the needle attached. Never share your Tetridar pen with others.

Your doctor may recommend using Tetridar with calcium and vitamin D. Your doctor will tell you how much to take each day.

Tetridar can be used with or without food.

If you use more Tetridar than you should

If you have accidentally administered more Tetridar than prescribed, consult your doctor or pharmacist.

The effects that could be expected from an overdose include nausea, vomiting, dizziness, and headache.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount administered.

If you forget or are unable to inject Tetridar at the usual time,do so as soon as possible on the same day. Do not use a double dose to make up for forgotten doses. Do not inject more than once on the same day. Do not try to make up for the forgotten dose.

If you interrupt treatment with Tetridar

If you are thinking of interrupting treatment with Tetridar, please consult your doctor. Your doctor will advise and decide how long you should be treated with Tetridar.

If you have any other questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The most common side effects are pain in the limbs (very common, may affect more than 1 in 10 patients), discomfort, headache, and dizziness (common). If you feel dizzy after an injection, sit or lie down until you feel better. If it does not improve, consult your doctor before continuing treatment. Cases of fainting associated with the use of teriparatide have been reported.

If you experience discomfort such as redness of the skin, pain, swelling, itching, bruising, or slight bleeding around the injection site (common), these should disappear within a few days or weeks. If not, tell your doctor as soon as possible.

Some patients may have experienced allergic reactions shortly after injection, consisting of difficulty breathing, swelling of the face, rash, and chest pain (rare). In rare cases, severe and potentially life-threatening allergic reactions, including anaphylaxis, may occur. If you experience any of these symptoms STOP USING Tetridar IMMEDIATELY and contact your doctor.

Other side effects are:

Common: may affect up to 1 in 10 patients

• increase in cholesterol levels in the blood
• depression
• neuralgic pain in the leg
• feeling of fainting
• irregular palpitations
• difficulty breathing
• increased sweating
• muscle cramps
• loss of energy
• fatigue
• chest pain
• low blood pressure
• heartburn (pain or burning sensation just below the sternum)
• vomiting
• hiatal hernia (a condition where the stomach bulges up into the chest)
• low hemoglobin or low red blood cell count (anemia)

Uncommon: may affect up to 1 in 100 patients

• increased heart rate
• abnormal heart sound
• shortness of breath
• hemorrhoids (piles)
• accidental or involuntary loss of urine
• increased need to urinate
• weight gain
• kidney stones
• pain in the muscles and joints. Some patients have experienced severe back cramps or pain and had to be hospitalized
• increase in calcium levels in the blood
• increase in uric acid levels in the blood
• increase in the levels of an enzyme called alkaline phosphatase.

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

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Tetridar

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

Do not use this medicine after the expiration date that appears on the box and the pen after CAD or EXP. The expiration date is the last day of the month indicated.

Tetridar should be stored in the refrigerator (between 2°C and 8°C). You can use Tetridar for 28 days after the first injection, as long as the pen is stored in the refrigerator (between 2°C and 8°C).

Do not freeze Tetridar. Avoid placing the pens near the freezer compartment of the refrigerator to prevent freezing. Do not use Tetridar if it has been frozen.

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

Tetridar contains a clear and colorless solution. Do not use Tetridar if it has solid particles or if the solution is cloudy or discolored.

Unopened product

The unopened product can be removed from the refrigerator and stored at a temperature of up to 25°C for a single period of up to 5 days, after which it should be returned to the refrigerator (between 2°C and 8°C). Discard the unopened product if it is stored above 8°C for more than 5 days.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Container Contents and Additional Information

Tetridar Composition

• The active ingredient is teriparatide. A preloaded pen with 2.4 ml contains 600 micrograms of teriparatide (corresponding to 250 micrograms per ml).
• The other excipients are glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, and water for injectables. Additionally, hydrochloric acid solution and/or sodium hydroxide solution may be added for pH adjustment.

Product Appearance and Container Contents

Tetridar is a clear and colorless solution. It is presented in a cartridge included in a disposable preloaded pen. Each pen contains 2.4 ml of solution sufficient for 28 doses. The pens are available in packs containing one or three pens. Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª floor

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.)

Prilaz baruna Filipovica 25, Zagreb 10000

Croatia

Local Representative:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36

28027 Madrid

Spain

Date of Last Revision of this Leaflet:July 2021

Other Sources of Information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/

User Manual

Tetridar Pen®

Teriparatide Injectable in Preloaded Pen

Important: Read the leaflet included in the Tetridar package first.

Before using your new Tetridar pen, please read this User Manual completely. Follow the instructions carefully when using the pen.

The Tetridar pen contains medication for 28 days. Discard the pen 28 days after the first use, even if it is not completely empty. Do not inject more than one dose of teriparatide on the same day.

Do not transfer Tetridar to a syringe.

Parts of the Tetridar Pen

*Needles are not included.It is recommended to use needles for pens with a gauge of 29 to 31 (Becton, Dickinson and Company) with this device. Consult your doctor or pharmacist what gauge and length of needle are most suitable for you. Always use a NEW needle for each injection.

Always wash your hands before each injection. Prepare the injection site as your doctor or pharmacist has indicated.

Teriparatide Injectable in Preloaded Pen

Troubleshooting

Cleaning and Storage

Cleaning your Tetridar pen

• Clean the outside of your pen with a damp cloth.
• Do not submerge your pen in water, or wash or clean it with any liquid.

Storing your Tetridar pen

• Store your pen in the refrigerator immediately after each use. Read and follow the instructions on how to store your pen from the Leaflet: Information for the user,section Storage of Tetridar
• Do not store your pen with the needle attached, as this could cause air bubbles to form in the cartridge.
• Store the pen with the blue cap on.
• Never store the pen in the freezer. If the medication has frozen, discard the device and use a new pen.
• If you have left the pen out of the refrigerator, do not discard it. Return it to the refrigerator and contact your doctor or pharmacist.

Other points of interest

• The pen contains medication for 28 days.
• Do not transfer the medication to a syringe. This may result in using an incorrect dose of the medication.
• Write down the date of your first injection on a calendar.
• Read and follow the instructions in the User Manual to use the pen correctly.
• Check the pen label to ensure you have the correct medication and that it has not expired.
• Do not use Tetridar if the pen appears damaged. Check the teriparatide solution in the cartridge. If the solution is not clear and colorless or contains particles, do not use it. Consult your doctor or pharmacist if you notice any of these situations.
• Use a new needle for each injection.
• During injection, you may hear one or more clicks; this is the normal operation of the device.
• It is not recommended that blind or visually impaired individuals use the pen without the help of a trained person in the proper use of the device.
• Keep the pen and needles out of sight and reach of children.

Disposal of Needles and Tetridar Pen

• Before disposing of the pen, ensure you have removed the needle from the pen.
• Dispose of the pen and used needles as your doctor or pharmacist has instructed.
• Discard your pen 28 days after the first use.

Date of first use _/_/_

Discard after _/_/_

Contact information:

Manufactured for: Teva Pharma, S.L.U.

Local representative:

Grünenthal Pharma, S.A.

Date of last revision of this user manual: April 2022