Patient leaflet - Teriparatide Teva 20 micrograms / 80 microlitres solution for injection in Pre-filled pen
What Teriparatide Teva is and what it is used for
Teriparatide Teva 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 Teva 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.
What you need to know before you use Teriparatide Teva
Do not use Teriparatide Teva if you:
are allergic to teriparatide or any of the
other ingredients of this medicine (listed in section 6)
suffer from high calcium levels
(pre-existing hypercalcaemia)
- suffer from serious kidney problems
have ever been diagnosed with bone
cancer or other cancers that have spread (metastasised) to your bones
have certain bone diseases. If you have a
bone disease, tell your doctor.
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.
have had radiation therapy involving your
bones
- are pregnant or breast-feeding.
Warnings and precautions
Teriparatide Teva 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 Teva if you:
have continuing nausea, vomiting,
constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
suffer from kidney stones or have a
history of kidney stones
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 Teva 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 Teva should not be used in growing adults.
Package leaflet: Information for the user
Teriparatide Teva 20 micrograms/80 microlitres
Solution for Injection in Pre-filled Pen
teriparatide
Children and adolescents
Teriparatide Teva should not be used in children and adolescents (less than 18 years).
Other medicines and Teriparatide Teva
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, breast-feeding and fertility
Do not use Teriparatide Teva 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 Teva. If you become pregnant, Teriparatide Teva 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 Teva. If you feel dizzy you should not drive or use machines until you feel better.
Important information about some of the ingredients of Teriparatide Teva:
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
How to use Teriparatide Teva
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 micrograms 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.
Inject Teriparatide Teva each day for as long as your doctor prescribes it for you. The total duration of treatment with Teriparatide Teva should not exceed 24 months. You should not receive more than one treatment course of 24 months over your lifetime.
Teriparatide Teva can be injected at mealtimes.
Read the user manual booklet, which is included in the carton for instructions on how to use the Teriparatide Teva pen.
Injection needles are not included with the pen. Becton, Dickinson and Company pen needles 29 to 31 gauge (diameter 0.25-0.33 mm) and 12.7, 8 or 5 mm length can be used. You should take your Teriparatide Teva 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 Teva pen with others. Your doctor may advise you to take Teriparatide Teva with calcium and vitamin D. Your doctor will tell you how much you should take each day.
Teriparatide Teva can be given with or without food.
If you use more Teriparatide Teva than you should
If, by mistake, you have used more Teriparatide Teva 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 Teva 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.
What is in this leaflet
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243895_s3 If you stop taking Teriparatide Teva
If you are considering stopping Teriparatide Teva treatment, please discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with Teriparatide Teva.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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. If you experience any of these symptoms, STOP taking Teriparatide Teva and contact your doctor IMMEDIATELY.
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.
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 breastbone)
- 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 the Yellow
Card Scheme Website at:
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.
How to store Teriparatide Teva
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 Teva should be stored in a refrigerator (2°C to 8°C). You can use Teriparatide Teva 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 Teriparatide Teva. Avoid placing the pens close to the ice compartment of the refrigerator to prevent freezing. Do not use Teriparatide Teva 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 Teva contains a clear and colourless solution. Do not use Teriparatide Teva if solid particles appear or if the solution is cloudy or coloured.
Unopened product
The unopened product may be removed from the refrigerator and stored at a temperature up to 25 °C for one single period of up to 5 days, after which you should return it to the refrigerator (2 °C – 8 °C). Discard the unopened product if stored above 8 °C for more than 5 days.
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.
Contents of the pack and other information
What Teriparatide Teva contains
- The active substance is teriparatide. One pre-filled pen of 2.4 mL contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL).
- The other ingredients are glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, and water for injections. In addition, hydrochloric acid and/or sodium hydroxide solution may have been added for pH adjustment.
What Teriparatide Teva looks like and contents of the pack
Teriparatide Teva 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.
The pens are available in cartons containing 1 or 3 pens or in a multipack containing 3 pens (3 packs of 1 pen). Not all pack sizes may be marketed.
Marketing Authorisation Holder: Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom
Manufacturer: PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovica 25, Zagreb, 10000, Croatia
This leaflet was last revised in April 2025.
PL 00289/2005
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