Teriparatide Cipla 20 micrograms/80 microlitres solution for injection in Pre-filled pen – patient leaflet, side effects, dosage

1. What Teriparatide Cipla is and what it is used for

Teriparatide Cipla 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 Cipla 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.

2. What you need to know before you use Teriparatide Cipla

Do not use Teriparatide Cipla

• if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from high calcium levels (pre-existing hypercalcaemia).
• if you suffer from serious kidney problems.
• if you have ever been diagnosed with bone cancer or other cancers that have spread (metastasised) to your bones.
• if you have certain bone diseases. If you have a bone disease, tell your doctor.
• if you 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.
• if you have had radiation therapy involving your bones.
• if you are pregnant or breast-feeding.

Warnings and precautions

Teriparatide Cipla 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 Cipla:

• if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is 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 impairment).

Some patients get dizzy or get a fast heartbeat after the first few doses. For the first doses, inject Teriparatide Cipla 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 Cipla should not be used in growing adults.

Children and adolescents

Teriparatide Cipla should not be used in children and adolescents (less than 18 years).

Other medicines and Teriparatide Cipla

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 and breast-feeding

Do not use Teriparatide Cipla 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 Cipla. If you become pregnant, Teriparatide Cipla 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 Cipla. If you feel dizzy you should not drive or use machines until you feel better.

Type : Readability

SAP Code: 99352731 (Ver. 05)

PIL size: 449 x 319 mm

Teriparatide Cipla contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.

3. How to use Teriparatide Cipla

Always use this medicine exactly as your doctor has told you. 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 Cipla each day for as long as your doctor prescribes it for you. The total duration of treatment with Teriparatide Cipla should not exceed 24 months. You should not receive more than one treatment course of 24 months over your lifetime.

Teriparatide Cipla can be injected at meal times.

Read the user manual booklet, which is included in the carton for instructions on how to use the Teriparatide Cipla pen.

Injection needles are not included with the pen. Becton, Dickinson and Company pen needles can be used.

You should take your Teriparatide Cipla 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 Cipla pen with others.

Your doctor may advise you to take Teriparatide Cipla with calcium and vitamin D. Your doctor will tell you how much you should take each day.

Teriparatide Cipla can be given with or without food.

If you use more Teriparatide Cipla than you should

If, by mistake, you have used more Teriparatide Cipla 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 Cipla

If you forget or cannot take Teriparatide Cipla 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.

If you stop taking Teriparatide Cipla

If you are considering stopping Teriparatide Cipla treatment, please discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with Teriparatide Cipla.

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 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.

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.

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 breast bone)

• 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 Yellow Card Scheme. Website: 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.

5. How to store Teriparatide Cipla

• 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 pre-filled pen label after EXP. The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C to 8°C). You can use Teriparatide Cipla for up to 28 days after the first injection, as long as the pen is stored in a refrigerator (2°C to 8°C).
• Recap the delivery device (pen) when not in use to protect the cartridge from physical damage and light.
• When using Teriparatide Cipla, minimise the time out of the refrigerator, deliver the dose immediately following removal from the refrigerator.
• Do not freeze Teriparatide Cipla. Avoid placing the pens close to the ice compartment of the refrigerator to prevent freezing.
• Each pen should be properly disposed of after 28 days, even if it is not completely empty.
• Do not use Teriparatide Cipla if solid particles appear or if the solution is cloudy or coloured.
• 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 protect the environment.
• Do not store the injection device with the needle attached,

6. Contents of the pack and other information

What Teriparatide Cipla contains

• The active substance is teriparatide (as acetate). Each millilitre of the solution for injection contains 250 micrograms of teriparatide.
• The other ingredients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injections. In addition, hydrochloric acid and sodium hydroxide is may have been added for pH adjustment.

What Teriparatide Cipla looks like and contents of the pack

Teriparatide Cipla is a colourless and clear solution.

Teriparatide Cipla is a 2.4 mL solution in glass cartridge with bromobutyl rubber plunger, polyisoprene/bromobutyl rubber/aluminium disc seal assembled in a pre-filled pen.

Teriparatide Cipla is available in pack sizes of 1 or 3 pre-filled pens. Each pre-filled pen contains 28 daily doses of 20 micrograms (equivalent to 80 microlitres of drug product).

Not all pack sizes may be available.

Marketing Authorisation Holder

Cipla (EU) Limited

Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE,

United Kingdom

Manufacturer

Cipla (EU) Limited

Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, KT15 2LE,

United Kingdom

This leaflet was last revised in January 2026.

Large

needle

cover

Small

needle protector Red stripe

1... 2... 3... 4... 5...

Large

needle

cover

Type : PEN USER MANUAL-Readability SAP Code: 99352732 (Ver. 05)

PIL size: 297 x 425 mm

99352732 Teriparatide Injection Delivery Device Parts*

Yellow Shaft

Injection

Button

Red Stripe Blue Body Medicine Cartridge Light Grey Cap

Paper Tab Needle Large Needle Cover *Needles not included.

Becton, Dickinson and

Company pen needles

are recommended for

use with this device.

Small needle

Protector

Label

PEN USER MANUAL

Teriparatide Cipla 20 micrograms/80 microlitres solution for injection in pre-filled pen

Important: First read the Medication Guide that comes inside your teriparatide carton.

Instructions for use

Before you use your new teriparatide delivery device, please read the entire front and back section of Instructions for use completely. Follow the directions carefully when using the delivery device.

Do not share your delivery device or needles because infection or disease can be spread from one person to another.

The teriparatide delivery device contains 28 days of medicine. Throw away the teriparatide delivery device after 28 days, even if it is not completely empty. Do not inject more than one dose of teriparatide in the same day.

Do not transfer teriparatide to a syringe.

Wash your hands before every injection. Prepare the injection site as your healthcare provider instructed.

1. 1.

   Pull off light grey cap

   Check the teriparatide delivery device label to make sure you have the right medicine and that it has not expired

   Do not use if the teriparatide delivery device looks damaged, if the medicine in the cartridge is not clear and colourless, or if it has particles in it.

2. 2.

   Attached new needle

   Pull off paper tab. Push needle straight Screw on needle Pull off large needle cover onto medicine cartridge. clockwise until firmly attached. and save it.

3. 3.

   Set dose

   Pull out black injection button until it stops. Check to make sure red stripe shows. Pull off small needle protector and throw away. If you cannot pull out the black injection button

   see Troubleshooting, Problem E.

4. 4.

   Inject dose

   Gently hold a fold of skin on your thigh or Push in black injection button until it stops. Hold it in and count to 5 slowly. abdomen and insert needle straight into skin. You must wait until the count of 5 to make sure you receive the correct dose. Then pull the needle from skin.

   IMPORTANT

5. 5. Confirm dose After completing the injection: You should NOT see any of the yellow shaft. Once the needle is removed from the skin, If you do and have already injected the medicine, do not take your thumb off the black injection button. inject yourself a second time on the same day. Instead, you Check to make sure the black injection button is MUST reset the teriparatide delivery device (see all the way in. If the yellow shaft does not show, Troubleshooting Problem A). you have finished the injection steps the right way.
6. 6.

   Remove needle

   Put large needle cover Unscrew the covered Pull off needle and throw away Push light grey cap back on. on needle. needle all the way by in a puncture-resistant container. Right after use, place teriparatide Do not try to put the needle giving the large needle cover delivery device in the refrigerator. cover back on with your hands. 3 to 5 counter-clockwise turns.

For more information, or if you have any questions, turn to the back of this page.