Movymia 20 micrograms/80 microliters solution for injection

• 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.

1. What Movymia^® is and what it is used for
2. What you need to know before you use Movymia^®
3. How to use Movymia^®
4. Possible side effects
5. How to store Movymia^®
6. Contents of the pack and other information

• 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 (hypercalcaemia).
• if you suffer from serious kidney problems.
• if you have ever had bone cancer or if other cancers 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.

Movymia^® may increase calcium in your blood or urine.

Talk to your doctor before or while using Movymia^®:

• 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 had 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 of Movymia^®. For the first doses, inject Movymia^® in a place where you can sit or lie down right away if you get dizzy.

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

Before inserting a cartridge in Movymia^® Pen write down the batch (Lot) number of the cartridge and its first injection date on a calendar. The date of first injection should also be recorded on the outer carton of Movymia^® (see the provided space on the box: {First use:}) (see section 3.).

Movymia^® should not be used in growing adults.

Movymia^® should not be used in children and adolescents (aged less than 18 years).

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

This is important, because some medicines (e.g. digoxin/digitalis, a medicine used to treat heart disease) may interact with teriparatide.

Do not use Movymia^® 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 Movymia^®. If you become pregnant while using Movymia^®, Movymia^® should be discontinued. Ask your doctor or pharmacist for advice before taking any medicine.

Some patients may feel dizzy after injecting Movymia^®. If you feel dizzy you should not drive or use machines until you feel better.

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

• To ensure the correct administration of Movymia^® always read the instructions for use of Movymia^® Pen, which is included in the carton of the pen.
• Wash your hands before handling the cartridge or pen.
• Check the expiry date on the cartridge label before inserting the cartridge into the pen. Make sure that there are at least 28 days remaining before its expiry date. Insert the cartridge into the pen before the first use as detailed in the pen instructions. Write down the batch (Lot) number of each cartridge and its first injection date on a calendar. The date of first injection should also be recorded on the outer carton of Movymia^® (see the provided space on the box: {First use:}).
• After inserting a new cartridge and before the first injection from this cartridge prime the pen according to the instructions which are provided. Do not prime again after the first dose.

• Before you inject Movymia^®, clean your skin where you intend to inject (thigh or abdomen) as instructed by your doctor.
• Gently hold a fold of cleansed skin and insert the needle straight into the skin. Press the push button and hold it pressed in until the dose indication has returned to the start position.
• After your injection, leave the needle in the skin for six seconds to make sure that you receive the whole dose.
• As soon as you have finished the injection, attach the outer needle protective cap on the pen needle and screw the cap anti-clockwise to remove the pen needle. This will keep the remaining Movymia^® sterile and prevent leaking from the pen. It will also stop air going back into the cartridge and the needle from clogging.
• Replace the cap on your pen. Leave the cartridge in the pen.

If, by mistake, you have used more Movymia^® than you should, contact your doctor or pharmacist.

The expected effects of overdose include nausea, vomiting, dizziness, and headache.

If you forget an injection or cannot use your medicine at your usual time, inject it as soon as possible on that day. Do not use a double dose to make up for a forgotten dose. Do not take more than one injection in the same day.

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

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

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.

• The active substance is teriparatide. Each dose of 80 microliters contains 20 micrograms of teriparatide. One cartridge of 2.4 mL contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL).
• The other ingredients are: glacial acetic acid, mannitol, metacresol, sodium acetate trihydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

Movymia^® is a colourless and clear solution. It is supplied in a cartridge. Each cartridge contains 2.4 mL of solution, enough for 28 doses.

Movymia^® 20 micrograms/80 microliters solution for injection: 1 or 3 cartridge(s) packed in a plastic tray sealed with lid foil and packed in a carton.

Movymia^® cartridge and pen pack: 1 Movymia^® cartridge packed in a plastic tray sealed with lid foil and packed in a carton and 1 Movymia^® Pen packed into a separate carton.

Not all pack sizes may be marketed.