Tetridar 20 micrograms/80 microliters solution for injection in pre-filled pen
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Tetridar 20 micrograms/80 microliters injectable solution in a prefilled pen
Teriparatide
Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Tetridar is and what it is used for
- What you need to know before using Tetridar
- How to use Tetridar
- Possible side effects
- How to store Tetridar
- Contents of the pack and other information
1. What Tetridar is and what it is used for
Tetridar contains the active substance teriparatide, which is used to increase bone strength and reduce the risk of fractures by stimulating bone formation.
Tetridar is used for the treatment of osteoporosis in adults. Osteoporosis is a disease that causes your bones to weaken and become fragile. This condition is particularly common in women after menopause, but can also occur in men. Osteoporosis is also common in patients being treated with corticosteroids.
2. What you need to know before using Tetridar
Do not use Tetridar:
- if you are allergic to the active substance or to 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 elevated levels of alkaline phosphatase in your blood without apparent cause, which could indicate Paget's disease of the bone (a disease involving abnormal bone changes). If you are unsure, consult your doctor.
- if you have received radiotherapy 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 continuously experience nausea, vomiting, constipation, low energy, or muscle weakness, inform your doctor. These may be symptoms of having too much calcium in your blood.
- if you suffer from kidney stones or have a history of kidney stones.
- if you have kidney problems (moderate renal insufficiency), inform your doctor.
Some patients may experience dizziness or increased heart rate after the first doses. For the initial 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 must not be exceeded.
Tetridar must not be used in growing adults.
Children and adolescents
Tetridar must not be used in children and adolescents (under 18 years of age).
Use of Tetridar with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, as interactions may occasionally occur (e.g., digoxin/digitalis, a medicine used to treat heart conditions).
Pregnancy, breastfeeding, and fertility
Do not use Tetridar if you are pregnant or breastfeeding. If you are a woman of childbearing age, you must use effective contraceptive methods during treatment with Tetridar. If you become pregnant, treatment with Tetridar must be discontinued. Consult your doctor or pharmacist before using any medicine.
Driving and operating machinery
Some patients may feel dizzy after injection of Tetridar. If you feel dizzy, you must not drive or operate machinery until you feel better.
Tetridar contains sodium:
This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore considered essentially "sodium-free".
3. How to use Tetridar
Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose is 20 micrograms administered once daily by subcutaneous injection (injection under the skin) in the thigh or abdomen. To help you remember to take your medicine, inject at about the same time each day.
Inject Tetridar every day for as long as your doctor prescribes it. The total duration of treatment with Tetridar must not exceed 24 months. You must not receive more than one 24-month course of treatment with Tetridar during your lifetime.
Tetridar may be injected at mealtimes.
Refer to the User Manual included in the pack for instructions on how to use the Tetridar pen.
Needles are not included with the pen. Becton, Dickinson and Company needles with gauge 29 to 31 (diameter 0.25–0.33 mm) and length 12.7, 8, or 5 mm may 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. A new needle must be used for each injection and discarded after each use. Do not store the pen with the needle attached. Never share your Tetridar pen with others.
Your doctor may recommend that you take Tetridar with calcium and vitamin D. Your doctor will advise you on how much to take each day.
Tetridar may 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.
Effects that could be expected from an overdose include nausea, vomiting, dizziness, and headache.
In case of overdose or accidental ingestion, contact 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 missed doses. Do not inject more than once on the same day. Do not attempt to compensate for a missed dose.
If you stop treatment with Tetridar
If you are considering stopping treatment with Tetridar, please consult your doctor. Your doctor will advise you and decide on how long you should be treated with Tetridar.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most common adverse effects are limb pain (very common, may affect more than 1 in 10 patients), malaise, headache, and dizziness (common). If you feel dizzy after an injection, sit or lie down until you feel better. If symptoms 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 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 they do not, inform your doctor as soon as possible.
Some patients may have experienced allergic reactions immediately after injection, consisting 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 symptoms, STOP USING Tetridar IMMEDIATELY and contact your doctor.
Other adverse effects include:
Common: may affect up to 1 in 10 patients
- increased blood cholesterol levels
- depression
- neuralgic leg pain
- feeling of fainting
- irregular palpitations
- difficulty breathing
- increased sweating
- muscle cramps
- loss of energy
- fatigue
- chest pain
- low blood pressure
- stomach acidity (pain or burning sensation just below the sternum)
- vomiting
- hernia of the tube carrying food to your stomach (hiatal hernia)
- low hemoglobin or low red blood cell count (anemia)
Uncommon: may affect up to 1 in 100 patients
- increased heart rate
- abnormal heart sounds
- shortness of breath
- haemorrhoids (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 required hospitalization
- increased blood calcium levels
- increased blood uric acid levels
- increase in levels of an enzyme called alkaline phosphatase
Rare: may affect up to 1 in 1,000 patients
- reduced kidney function, including renal failure
- swelling, mainly in the hands, feet, and legs
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tetridar
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and pen after CAD or EXP. The expiry date refers to the last day of the month indicated.
Tetridar should be stored in a refrigerator (between 2°C and 8°C). You may use Tetridar for up to 28 days after the first injection, provided the pen is kept refrigerated (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 or is frozen.
Each pen must be properly discarded after 28 days, even if it is not completely empty.
Tetridar contains a clear, colourless solution. Do not use Tetridar if it contains solid particles or if the solution is cloudy or discoloured.
Unopened product
The unopened product may 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 has been stored above 8°C for more than 5 days.
Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to your local pharmacy’s SIGRE point. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Tetridar
- The active substance is teriparatide. A pre-filled pen containing 2.4 ml includes 600 micrograms of teriparatide (equivalent to 250 micrograms per ml).
- The other excipients are glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, and water for injections. Additionally, hydrochloric acid solution and/or sodium hydroxide solution may be added to adjust the pH.
Appearance of the product and contents of the container
Tetridar is a clear, colourless solution. It is supplied in a cartridge contained within a disposable pre-filled pen. Each pen contains 2.4 ml of solution, sufficient for 28 doses. Pens are available in packs containing one or three pens. Only certain 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, 1st 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 the most recent 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 of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/}
User Manual
Tetridar® Pen
Injectable teriparatide in a pre-filled pen
Important: First read the package leaflet included in the Tetridar® package.
Before using your new Tetridar® pen, please read this User Manual thoroughly. Carefully follow the instructions when using the pen.
The Tetridar® pen contains medication for 28 days. Discard the pen 28 days after 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® into a syringe.
Parts of the Tetridar® pen*
*Needles are not included. It is recommended to use pen needles of gauge 29 to 31 (Becton, Dickinson and Company) with this device. Consult your doctor or pharmacist to determine the most suitable gauge and length of needle for you. Always use a NEW needle for each injection.
Always wash your hands before each injection. Prepare the injection site as instructed by your doctor or pharmacist.
1 Remove the blue cap
Check the pen label to make sure you have the correct medicine and that it has not expired. Do not use the pen if it appears damaged, if the solution in the cartridge is not clear and colorless, or if it contains particles. |
2 Attach the new needle
Remove the paper tab.
Attach the needle by pressing it directly onto the medication cartridge.
Screw the needle on until it stops (3 to 5 turns clockwise). Make sure the needle is securely attached.
Remove the outer needle cap and keep it. |
3 Adjust the Dose
Pull the black injection button until it stops and the red band becomes visible. If you cannot pull the black injection button, see the Troubleshooting section, Problem E.
Make sure the red band is visible.
Remove the inner needle cap and discard it. |
4 Inject the dose
Gently pinch your skin on the thigh or abdomen and insert the needle directly under your skin.
Press the black injection button until it stops. Keep the button pressed and count slowly to 5. You must wait until you have counted to 5 to ensure you receive the correct dose. Then, remove the needle from your skin. |
IMPORTANT |
5 Confirm the dose IMPORTANT
After completing the injection: Once the needle has been removed from your skin, remove your thumb from the injection button. Make sure that the black injection button has been fully depressed. If the yellow cylinder is not visible, you have correctly completed the injection steps.
The yellow cylinder should not be visible. If it is visible and you have already administered the injection, do not inject a second dose on the same day. Instead, you must re-prime your pen (see section Troubleshooting, Problem A). |
6 Remove the needle
Place on the outer needle cap. Do not attempt to recap the outer needle cap with your hands.
Completely unscrew the needle by turning the outer needle cap 3 to 5 full turns.
Remove the needle and dispose of it as instructed by your doctor or pharmacist.
Replace the blue cap. Store the pen in the refrigerator immediately after use. For more information, or if you have any questions, see the bottom or the back of this page. |
Injectable Teriparatide in a Prefilled Pen
Locating and Troubleshooting
Problem | Solution |
| You can prevent this problem by always using a NEW needle for each injection, ensuring the needle is properly attached, and fully pressing the black injection button. Follow these steps to reset the pen:
“Attach the new needle” and step 3 “Set the dose” from the instructions.
Proceed to step 6 “Remove the needle”.
Repeatedly resetting your pen may lead to loss of daily doses. |
| The black injection button should be fully depressed to confirm that the pen has delivered the full dose. Remember to use a new needle for each injection to ensure your pen functions properly. |
| A small air bubble will not affect your dose or cause harm. You may proceed with administering your dose as usual. |
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| Consult your doctor for further information; you may need to use a new pen. If the black injection button cannot be pulled out, this indicates there is not enough medication left in your pen for another dose. You may notice that some medication remains in the cartridge. |
Cleaning and Storage
Cleaning your Tetridar® pen
- Clean the outside of your pen with a damp cloth.
- Do not immerse your pen in water, or wash or clean it with any liquid.
Storage of your Tetridar® pen
- Store your pen in the refrigerator immediately after each use. Read and follow the instructions on how to store your pen in the Package Leaflet: Information for the user, section Storage 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 in place.
- Never store the pen in the freezer. If the medicine has been frozen, discard the device and use a new pen.
- If the pen has been left outside the refrigerator, do not discard it. Return it to the refrigerator and contact your doctor or pharmacist.
Other points of interest
- The pen contains medicine for 28 days.
- Do not transfer the medicine to a syringe. This may result in an incorrect dose of the medicine being administered.
- Record the date of your first injection on a calendar.
- Read and follow the instructions in the User Manual to ensure correct use of the pen.
- Check the label on the pen to make sure you have the correct medicine and that it has not expired.
- Do not use Tetridar® if the pen appears damaged. Inspect the teriparatide solution in the cartridge. Do not use if the solution is not clear and colourless or if it contains particles. Consult your doctor or pharmacist if you observe any of these conditions.
- 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 assistance of a person trained in the proper use of the device.
- Keep the pen and needles out of the sight and reach of children.
Disposal of Needles and the Tetridar® Pen
- Before disposing of the pen, make sure the needle has been removed from the pen.
- Dispose of the used pen and needles as instructed by your doctor or pharmacist.
- 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