TERIPARATIDE SUN 20 micrograms/80 microliters injectable solution in a pre-filled pen
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Introduction
Package Leaflet: Information for the User
Teriparatide SUN 20 micrograms/80 microliters solution for injection in pre-filled pen
teriparatide
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Teriparatide SUN and what is it used for
- What you need to know before you use Teriparatide SUN
- How to use Teriparatide SUN
- Possible side effects
- Storage of Teriparatide SUN
- Contents of the pack and further information
1. What is Teriparatide SUN and what is it used for
Teriparatide SUN contains the active substance teriparatide, which is used to increase bone strength and reduce the risk of fractures by stimulating bone formation.
Teriparatide SUN is used for the treatment of osteoporosis in adults. Osteoporosis is a disease that makes your bones waste away 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 you use Teriparatide SUN
Do not use Teriparatide SUN
- if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6).
- if you have high levels of calcium in your blood (pre-existing hypercalcaemia).
- if you have severe kidney problems.
- if you have ever been diagnosed with bone cancer or other types of cancer that have spread 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 any apparent explanation, which could indicate that you have Paget's disease of the bone (a disease with abnormal bone changes). If you are not sure, consult your doctor.
- if you have received radiation therapy that may have affected your bones.
- if you are pregnant or breastfeeding.
Warnings and precautions
Teriparatide SUN may cause an increase in the amount of calcium in your blood or urine.
Talk to your doctor or pharmacist before you start using or while you are using Teriparatide SUN:
- if you constantly feel nauseous, vomit, are constipated, feel low in energy or have muscle weakness. These can be symptoms of too much calcium in your blood.
- if you have kidney stones or have a history of kidney stones.
- if you have kidney problems (moderate renal insufficiency).
Some patients, after the first doses, feel dizzy or have an increased heart rate. For the first doses, use Teriparatide SUN in a place where you can sit or lie down immediately if you feel dizzy.
The recommended treatment period of 24 months should not be exceeded.
Teriparatide SUN should not be used in growing adults.
Children and adolescents
Teriparatide SUN should not be used in children and adolescents (under 18 years of age).
Other medicines and Teriparatide SUN
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, because occasionally interactions may occur (e.g. digoxin/digitalis, a medicine used to treat heart diseases).
Pregnancy and breastfeeding
Do not use Teriparatide SUN if you are pregnant, think you may be pregnant or are breastfeeding. If you are a woman of childbearing potential, you should use effective contraceptive methods during treatment with Teriparatide SUN. If you become pregnant, you should stop treatment with Teriparatide SUN. Talk to your doctor or pharmacist before using any medicine.
Driving and using machines
Some patients may feel dizzy after the injection of Teriparatide SUN. If you feel dizzy, do not drive or use machines until you feel better.
Teriparatide SUN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".
3. How to use Teriparatide SUN
Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.
The recommended dose is 20 micrograms administered once a day by injection under the skin (subcutaneous injection) in the thigh or abdomen. To help you remember to inject your medicine, inject it at the same time every day.
Inject Teriparatide SUN every day for as long as your doctor prescribes it. The total duration of treatment with Teriparatide SUN should not exceed 24 months. You should not receive more than one 24-month treatment cycle with Teriparatide SUN in your lifetime.
Teriparatide SUN can be injected at mealtimes.
Consult the user manual section of the pen provided at the end of this leaflet.
No needles are included with the pen. 31G, 5mm long pen needles can be used.
The injection of Teriparatide SUN should be performed shortly after removing the pen from the refrigerator, as indicated in the user manual at the end of this leaflet. Put the pen back in the refrigerator immediately after use. You should use a new 31G, 5mm long needle for each injection and discard it after each use. Do not store the pen with the needle attached. Never share your Teriparatide SUN pen with others.
Your doctor may recommend that you take calcium and vitamin D with Teriparatide SUN. Your doctor will tell you how much to take each day.
Teriparatide SUN can be used with or without food.
If you use more Teriparatide SUN than you should
If you have accidentally administered more Teriparatide SUN than prescribed, talk to your doctor or pharmacist. The effects that could be expected from an overdose include nausea, vomiting, dizziness, and headache.
If you forget or are unable to inject Teriparatide SUN at the usual time, do it as soon as you can that same day. Do not administer 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 missed dose.
If you stop treatment with Teriparatide SUN
If you are thinking of stopping treatment with Teriparatide SUN, please consult your doctor. Your doctor will advise and decide how long you should be treated with Teriparatide SUN.
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 the limbs (very common, may affect more than 1 in 10 people), discomfort, headache, and dizziness (common, may affect up to 1 in 10 people). If you feel dizzy after an injection, sit or lie down until you feel better. If it does not improve, talk to 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 immediately after the injection, consisting of difficulty breathing, swelling of the face, skin rash, and chest pain (rare, may affect up to 1 in 1,000 people). In rare cases, severe and potentially life-threatening allergic reactions, including anaphylaxis, may occur.
Other side effects are:
Common (may affect up to 1 in 10 people)
- increase in blood cholesterol levels
- 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 breastbone)
- vomiting
- hiatus hernia (a condition where part of the stomach slides up into the chest)
- low haemoglobin or low 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 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 blood calcium levels
- increase in blood uric acid levels
- increase in the levels of an enzyme called alkaline phosphatase.
Rare (may affect up to 1 in 1,000 people)
- reduced kidney function, including kidney failure
- swelling, mainly in the hands, feet, and legs.
Reporting of side effects
If you experience 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 the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Teriparatide SUN
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 is the last day of the month stated.
Teriparatide SUN can be stored before first use at 25°C for 24 hours.
Teriparatide SUN should always be stored in a refrigerator (between 2°C and 8°C). You can use Teriparatide SUN for 28 days after performing the first injection while the pen is stored in a refrigerator (between 2°C and 8°C).
Do not freeze Teriparatide SUN. Avoid placing the pens near the freezer compartment of the refrigerator to prevent freezing. Do not use Teriparatide SUN if it is or has been frozen.
Each pen should be disposed of properly after 28 days, even if it is not empty.
Teriparatide SUN contains a clear and colourless solution. Do not use Teriparatide SUN if it has solid particles or if the solution is cloudy or discoloured.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Container Contents and Additional Information
Teriparatide SUN Composition
- The active ingredient is teriparatide. Each 80 microliter dose contains 20 micrograms of teriparatide.
Each 2.4 ml pre-filled pen contains 600 micrograms of teriparatide (corresponding to 250 micrograms per ml).
- The other components are glacial acetic acid (E260), anhydrous sodium acetate (E262), mannitol (E421), metacresol, and water for injectable preparations. Additionally, a hydrochloric acid (E507) and/or sodium hydroxide (E524) solution may have been added to adjust the pH (see section 2 Teriparatide SUN contains sodium).
Product Appearance and Container Contents
Teriparatide SUN is a clear, colorless solution. It is presented in a cartridge included in a disposable pre-filled pen. Each pen contains 2.4 ml of solution sufficient for 28 doses.
The pens are available in packs containing one or three pre-filled pens.
Only some pack sizes may be available.
Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Netherlands
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Netherlands
Terapia S.A.
Str. Fabricii nr 124
Cluj-Napoca, 400632
Romania
You can request more information about this medication by contacting the local representative of the marketing authorization holder:
België/Belgique/Belgien//Ceská republika/
Danmark/Eesti/Ελλáδα/Hrvatska/Ísland/Κúπρος/
Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/
Malta/Nederland/Norge/Österreich/Portugal/Slovenija/
Slovenská republika/Suomi/Finland/Sverige
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Nederland/Pays-Bas/Niederlande//Nizozemsko/
Nederlandene/Oλλaνδía/Nizozemska/ Holland/
Oλλaνδía/Niderlande/Nyderlandai/Pays-Bas/Niederlande/
Hollandia/L-Olanda/Nederland/Niederlande/Países Baixos/
Nizozemska/Holandsko/Alankomaat/Nederländerna
Tel./Teπ./tlf./tηλ./Sími/tηλ./Tlf./Puh./
+31 (0)23 568 5501
Deutschland
Sun Pharmaceuticals Germany GmbH
Hemmelrather Weg 201
51377 Leverkusen
Deutschland
tel. +49 214 403 990
España
Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55
08007 Barcelona
España
tel. +34 93 342 78 90
France
Sun Pharma France
11-15, Quai de Dion Bouton
92800 Puteaux
France
tel. +33 1 41 44 44 50
Italia
Sun Pharma Italia Srl
Viale Giulio Richard, 3
20143 Milano
Italia
tel. +39 02 33 49 07 93
Polska
Ranbaxy (Poland) Sp. Z. o. o.
ul. Kubickiego 11
02-954 Warszawa
Polska
tel. +48 22 642 07 75
România
Terapia S.A.
Str. Fabricii nr 124
Cluj-Napoca, 400632
România
tel. +40 (264) 501 500
Date of Last Revision of this Leaflet: September 2024
Other Sources of Information
Detailed information on this medication is available on the European Medicines Agency website http://www.ema.europa.eu/
USER MANUAL FOR THE PEN
Teriparatide SUN 20 micrograms/ 80 microliters injectable solution in pre-filled pen
Instructions for Use
Before using your new pen, please read the entire Instructions for Use section. Carefully follow the instructions when using the pen. Also, read the leaflet included in the package.
Do not share your pen or needles as this may pose a risk of infection transmission.
Your pen contains medication for 28 days.
Parts of Teriparatide SUN*
*Needles are not included. 31-gauge, 5 mm long needles can be used. Consult your doctor or pharmacist to determine the most suitable gauge and length for you. |
Always wash your hands before each injection. Prepare the injection site as directed by your doctor or pharmacist.
Step 1 Remove the White Cap
Remove the white cap by pulling it outward from the pen |
Step 2 Attach the Needle | External needle cap | ||
a) Remove the paper tab | b) Attach the needle by pressing it directlyonto the medication cartridge. | c) Screw the needle on until it is securely attached. | d) Remove the external needle cap and keep it. |
Step 3 Adjust the Dose | ||
c) Pullthe black injection button until it stops. | Red band f) Make sureyou see the red band. | Internal needle protector g) Remove the internal needle protector and discard it. |
If you cannot pull the black injection button, see the section Troubleshooting, Problem E | Note: After removing the internal needle protector, you may see drops of medication coming out of the needle. This is normal and does not affect your dose. |
Step 4 Inject the Dose | ||
h) Gently pinch your skin on the thigh or abdomen and insert the needle directly under your skin. | i) Pressthe black injection button until it stops. Hold it pressed and count slowly to 5. Then, remove the needle from the skin. |
IMPORTANT |
Step 5 Confirm the Dose |
j) After completing the injection Once the needle is removed from the skin, make surethe black injection button has been pushed all the way in. If the yellow cylinder is not visible, you have correctly completed the injection steps. |
k) DO NOTsee any part of the yellow cylinder. If you do, and you have already injected, DO NOTinject a second time in the same spot. Instead, YOU MUSTre-adjust your Teriparatide SUN pen (see section Troubleshooting, Problem A). |
Step 6 Remove the Needle | |||
l) Put the external needle cap back on the needle. | m) Completely unscrew the needle by giving the external needle cap 3 to 5 full turns. | n) Remove the needle and discard it as directed by your doctor or pharmacist. | o) Put the white cap back on the pen. Store the Teriparatide SUN pen in the refrigerator immediately after use. |
Instructions for handling needles do not intend to replace local, institutional, or professional guidelines. |
Troubleshooting | ||
Problem
| Solution Follow these steps to re-adjust the Teriparatide SUN pen.
When you are finished, the black injection button should be pushed all the way in.
Remove the needle and discard it as directed by your doctor or pharmacist. Put the white cap back on the pen and store the Teriparatide SUN pen in the refrigerator. (See step 6) | |
| ||
| ||
You can avoid this problem by always using a NEW needle for each injection and pressing the black injection button all the way in while counting slowly to 5. |
| The Teriparatide SUN pen is designed to inject a full dose each time it is used, following the instructions in the Instructions for Usesection. The black injection button should be pushed all the way in to confirm that the Teriparatide SUN pen has injected the full dose. Remember to use a new needle for each injection to ensure your Teriparatide SUN pen works correctly. |
| A small air bubble will not affect your dose or harm you. You can proceed with administering your dose as usual. |
|
|
| Switch to a new Teriparatide SUN pen to administer your dose as directed by your doctor or pharmacist. This means you have used up all the medication that could be injected accurately, even if you can still see some medication left in the cartridge. |
Cleaning and Storage |
Cleaning Your Teriparatide SUN Pen
Storing Your Teriparatide SUN Pen
|
Disposal of Needles and Pre-filled Pens |
Disposal of Teriparatide SUN Needles and Pre-filled Pen
|
Other Points of Interest |
|
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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