Prospecto:information for the user

Tetridar 20 micrograms/80 microliters injectable solution in preloaded pen

Teriparatide

Read this prospectus carefully before starting to use this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience adverse effects,consult your doctor or pharmacist,eveniftheyare not listed in this prospectus. See section 4.

1.What is Tetridar and what is it used for

2.What you need to knowbeforestarting touse Tetridar

3.How to use Tetridar

4.Possible adverse effects

5Storage of Tetridar

6.Contents of the package and additional information

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

Tetridaris used to treat osteoporosis in adults. Osteoporosis is a disease that causes 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.

Do not use Tetridar:

• if you are allergic to the active ingredient or any of the other components of this medication (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 have persistent nausea, vomiting, constipation, low energy, or muscle weakness, tell your doctor. These may be symptoms of too much calcium in your blood.
• If you have kidney stones or a history of kidney stones.
• If you have kidney problems (moderate renal insufficiency), tell your doctor.

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

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

Tetridar should not be used in adults in growth.

Children and adolescents

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

Use of Tetridar with other medications

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

Pregnancy, breastfeeding, and fertility

Do not use Tetridar if you are pregnant or breastfeeding. If you are a fertile woman, use effective contraceptive methods during Tetridar treatment. If you become pregnant, discontinue Tetridar treatment. Consult your doctor or pharmacist before using any medication.

Driving and operating machines

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

Tetridar contains sodium:

This medication contains less than 23 mg (1 mmol) of sodium per dose, making it essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor.This medicationas indicated by your doctor.Consult your doctor or pharmacist again if you are unsure.

The recommended doseis20 micrograms administered once a day via subcutaneous injection in the thigh or abdomen. To help you remember to inject your medication, inject it at the same time every day.

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

Tetridarcan be injected with meals.

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

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

The Tetridar injection 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. Use a new needle for each injection and discard it after 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 indicate how much you should take each day.

Tetridarcan be used with or without food.

If you use more Tetridar than you should

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

Expected effects of an overdose may include nausea, vomiting, dizziness, and headache.

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

If you forget or cannot inject Tetridar at the usual time,do it as soon as possible that same day. Do not use a double dose to compensate for missed doses. Do not inject more than once in the same day. Do not attempt to compensate for the missed dose.

If you interrupt treatment with Tetridar

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The most common side effects are pain in the extremities (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 you do 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 skin redness, pain, swelling, itching, bruises, or light bleeding around the injection site (common), these should disappear in a few days or weeks. If not, tell your doctor as soon as possible.

Some patients may have experienced allergic reactions just after the injection, which consist of difficulty breathing, facial swelling, skin rash, and chest pain (rare frequency). In rare cases, severe and potentially life-threatening allergic reactions, including anaphylaxis, may occur. If you experience any of these symptomsIMMEDIATELY STOP using Tetridar and contact your doctor.

Other side effects are:

Common: may affect up to 1 in 10 patients

• Elevated blood cholesterol levels

• Depression

• Leg neuralgic pain

• Feeling of fainting

• Irregular heart palpitations

• Difficulty breathing

• Increased sweating

• Muscle cramps

• Loss of energy

• Fatigue

• Chest pain

• Low blood pressure

• Stomach acid (burning or pain just below the sternum)

• Vomiting

• Hernia of the tube that carries food to the stomach

• 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 loss or leakage of urine

• Increased need to urinate

• Weight gain

• Kidney stones

• Muscle and joint pain.Some patients have experienced severe back cramps or pain and had to be hospitalized

• Elevated blood calcium levels

• Elevated blood uric acid levels

• Elevated levels of an enzyme called alkaline phosphatase.

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

• Kidney function reduction, including renal insufficiency

• Swelling, mainly in the hands, feet, and legs

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and the penafter CAD or EXP. The expiration date is the last day of the month indicated.

Tetridarmust be stored in a refrigerator (between 2°C and 8°C). Tetridarcan be used for 28 days after the first injection while the pen is stored in a refrigerator (between 2°C and 8°C).

Do not freezeTetridar. Avoid placing the pens near the freezer of the refrigerator to prevent freezing. Do not useTetridarif it is or has been frozen.

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

Tetridarcontains a clear and colorless solution. Do not useTetridarif it has solid particles or if the solution is cloudy or colored.

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 must 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 thrown away through the drains or in the trash. Deposit the containers and medicines that you do not need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need.This way, you will help protect the environment.

Composition of Tetridar

• The active principle 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 injection. Additionally, hydrochloric acid solution and/or sodium hydroxide solution may be added to adjust the pH.

Appearance of the product and contents of the package

Tetridar is a transparent 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 cases containing one or three pens. Some package sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva Pharma, S.L.U.

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

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing:

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

Last review date of this prospectus:july 2021

Other sources of information

The detailed information on this medication is available on the website of the {Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/

User Manual

Tetridar Pen®

Teriparatide injectable in preloaded pen

Important: Read the prospectus 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. Dispose of the pen 28 days after the first use, even if it is not completely empty. Do not inject more than one dose of teriparatide in 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 of caliber 29 to 31 (Becton, Dickinson and Company) with this device.Consult your doctor or pharmacist for the most suitable caliber and length of needle for you. Use a new needle for each injection.

Wash your hands before each injection. Prepare the injection site as instructed by your doctor or pharmacist.

Teriparatide injectable in preloaded pen

Troubleshooting

Cleaning and Storage

Cleaning your Tetridar pen

• Clean the exterior of your pen with a damp cloth.
• Do not submerge your pen in water, or clean or wash 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 theProspectus: Information for the user,sectionStorage of Tetridar
• Do not store your pen with the needle attached, as this may 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, dispose of the device and use a new pen.
• If you have left the pen out of the refrigerator, do not dispose of it. Put it back in 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 an incorrect dose of the medication.
• Mark 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 that you have the correct medication and that it has not expired.
• Do not use Tetridar if the pen appears damaged. Observe the teriparatide solution in the cartridge. If the solution is not transparent and colorless, or if it contains particles, do not use it. Consult your doctor or pharmacist if you observe any of these situations.
• Use a new needle for each injection.
• During the injection, you may hear one or more clicks, which is the normal functioning of the device.
• It is not recommended that the blind or people with visual impairments use the pen without the help of a trained person in the correct 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, make sure you have removed the needle.
• Dispose of the pen and used needles as instructed by your doctor or pharmacist.
• Dispose of your pen 28 days after the first use.

First use date _/_/_

Dispose of after _/_/_

Contact information:

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

Local Representative:

Grünenthal Pharma, S.A.

Last review date of this user manual: April 2022