Patient leaflet - Movymia 20 micrograms / 80 Microliters solution for injection
1. What Movymia® is and what it is used for
Movymia® contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation.
Movymia® 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 medicines called corticosteroids.
2. What you need to know before you use Movymia®
Do not use Movymia®:
- 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.
Warnings and precautions
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.
Children and adolescents
Movymia® should not be used in children and adolescents (aged less than 18 years).
Other medicines and Movymia®
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.
Pregnancy and breast-feeding
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.
Driving and using machines
Some patients may feel dizzy after injecting Movymia®. If you feel dizzy you should not drive or use machines until you feel better.
Movymia® contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially “sodium-free”.
3. How to use Movymia®
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 (corresponding to 80 microliters) given once a day 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. Movymia® can be injected at meal times. Inject Movymia® each day for as long as your doctor prescribes it for you. The total duration of treatment with Movymia® should not exceed 24 months. You should not receive more than one treatment course of 24 months over your lifetime.
Your doctor may advise you to take Movymia® with calcium and vitamin D. Your doctor will tell you how much you should take each day.
Movymia® can be given with or without food.
Movymia® cartridges are designed to be used only with the Movymia® Pen reusable, multidose delivery system and compatible pen needles. The pen and injection needles are not included with Movymia®. However, for treatment initiation a cartridge and pen pack should be used containing one carton of Movymia® cartridge and one carton of Movymia® Pen.
Before the first use, insert the cartridge into the pen. For the correct use of this medicine it is very important to closely follow the detailed Instructions for Use of your pen which are provided with the pen.
Use a new injection needle for each injection to prevent contamination and safely dispose of the needle after use.
Never store your pen with the needle attached.
Never share your pen with others.
Do not use your Movymia® Pen to inject any other medicine (e.g. insulin). The pen is customised for use with Movymia® only.
Do not refill the cartridge.
Do not transfer the medicine into a syringe.
You should inject Movymia® shortly after you take the pen with inserted cartridge out of the refrigerator. Put the pen with inserted cartridge back into the refrigerator immediately after you have used it. Do not remove the cartridge from the pen after each use. Store it in the cartridge sleeve during the whole 28-day treatment period.
Preparing the pen for use
- 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.
Injecting Movymia®
- 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 you use more Movymia® than you should
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 to use Movymia®
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 stop using Movymia®
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 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 (which may affect more than 1 in 10 people). Other common side effects (affecting up to 1 in 10 people) include feeling sick, headache and dizziness. 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 occured after teriparatide use.
If you have discomfort around the area of the injection such as redness of the skin, pain, swelling, itching, bruising or minor bleeding (which can occur in up to 1 in 10 people), this should clear up in a few days or weeks. Otherwise tell your doctor.
Rarely, patients may suffer allergic reactions consisting of breathlessness, swelling of the face, rash and chest pain. These reactions usually occur soon after injection. 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
- nerve pain in the leg
- feeling faint
- spinning sensation
- irregular heartbeats
- breathlessness
- increased sweating
- muscle cramps
- loss of energy
- tiredness
- chest pain
- low blood pressure
- heartburn (painful or burning sensation just below the breast bone) • vomiting
- a hernia of the tube that carries food to your stomach (hiatus hernia) • 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
- piles (haemorrhoids)
- leakage of urine
- increased need to pass water
- weight increase
- kidney stones
- pain in the muscles and pain in the joints. Some patients have had severe back cramps or pain which led to admission into hospital.
- 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 Movymia®
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 the cartridge after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the cartridge in the outer carton in order to protect from light.
You can use Movymia® for up to 28 days after the first injection, as long as the cartridge/pen with the cartridge inserted is stored in a refrigerator (2 °C to 8 °C).
Avoid placing the cartridge close to the ice compartment of the refrigerator to prevent freezing. Do not use Movymia® if it is, or has been, frozen.
Each cartridge should be properly disposed of after 28 days of first use, even if it is not completely empty.
Movymia® contains a clear and colourless solution. Do not use Movymia® 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.
6. Contents of the pack and other information
What Movymia® contains
- 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.
What Movymia® looks like and contents of the pack
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.
Marketing Authorisation Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Genus Pharmaceutical Holdings Ltd.
Tel: + 44 1484848164
This leaflet was last revised in 04/2025.
9354050 2505 GB
Produkt/Product: MOVYMIA 20UG/80UL INJ SD GB:PIL
STADA Mat.-Nr./Mat.-No.: 9354050 DZ: 2505
STADA Art.-Nr./Art.-No.: 166360
Hersteller/Manufacturer:
Hersteller Art.-Nr./ Manufacturer Art.-No.: -
Format/Size: 259 x 560 mm
Schriftgröße/Font-size: 10 pt - 18 pt
PZN/EAN: -
Flattermarke/Collating mark: -
1.. arbe/Colour: Black
3.. arbe/Colour: -
4.. arbe/Colour: -
5.. arbe/Colour: -
6.. arbe/Colour: -
7.. arbe/Colour: -
8.. arbe/Colour: Contour
Version: 3. Loop Datum/Date: 13.06.2025.
Agentur/Agency:
Grafik erstellt von/Graphic made by:
Aktueller Umlauf/Current loop:
Genehmigt/Approved
Package leaflet: Information for the user
Movymia® 20 micrograms/80 microliters solution for injection
Teriparatide
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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.
What is in this leaflet
- 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
- 1. What Movymia® is and what it is used for
Movymia® contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation.
Movymia® 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 medicines called corticosteroids.
- 2. What you need to know before you use Movymia®
Do not use Movymia®:
- 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.
Warnings and precautions
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.
Children and adolescents
Movymia® should not be used in children and adolescents (aged less than 18 years).
Other medicines and Movymia®
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.
Pregnancy and breast-feeding
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.
Driving and using machines
Some patients may feel dizzy after injecting Movymia®. If you feel dizzy you should not drive or use machines until you feel better.
Movymia® contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially “sodium-free”.
- 3. How to use Movymia®
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 (corresponding to 80 microliters) given once a day 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. Movymia® can be injected at meal times. Inject Movymia® each day for as long as your doctor prescribes it for you. The total duration of treatment with Movymia® should not exceed 24 months. You should not receive more than one treatment course of 24 months over your lifetime.
Your doctor may advise you to take Movymia® with calcium and vitamin D. Your doctor will tell you how much you should take each day.
Movymia® can be given with or without food.
Movymia® cartridges are designed to be used only with the Movymia® Pen reusable, multidose delivery system and compatible pen needles. The pen and injection needles are not included with Movymia®. However, for treatment initiation a cartridge and pen pack should be used containing one carton of Movymia® cartridge and one carton of Movymia® Pen.
Before the first use, insert the cartridge into the pen. For the correct use of this medicine it is very important to closely follow the detailed Instructions for Use of your pen which are provided with the pen.
Use a new injection needle for each injection to prevent contamination and safely dispose of the needle after use.
Never store your pen with the needle attached.
Never share your pen with others.
Do not use your Movymia® Pen to inject any other medicine (e.g. insulin). The pen is customised for use with Movymia® only.
Do not refill the cartridge.
Do not transfer the medicine into a syringe.
You should inject Movymia® shortly after you take the pen with inserted cartridge out of the refrigerator. Put the pen with inserted cartridge back into the refrigerator immediately after you have used it. Do not remove the cartridge from the pen after each use. Store it in the cartridge sleeve during the whole 28-day treatment period.
Preparing the pen for use
- 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.
Injecting Movymia®
- 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 you use more Movymia® than you should
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 to use Movymia®
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 stop using Movymia®
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 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 (which may affect more than 1 in 10 people). Other common side effects (affecting up to 1 in 10 people) include feeling sick, headache and dizziness. 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 occured after teriparatide use.
If you have discomfort around the area of the injection such as redness of the skin, pain, swelling, itching, bruising or minor bleeding (which can occur in up to 1 in 10 people), this should clear up in a few days or weeks. Otherwise tell your doctor.
Rarely, patients may suffer allergic reactions consisting of breathlessness, swelling of the face, rash and chest pain. These reactions usually occur soon after injection. 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
- nerve pain in the leg
- feeling faint
- spinning sensation
- irregular heartbeats
- breathlessness
- increased sweating
- muscle cramps
- loss of energy
- tiredness
- chest pain
- low blood pressure
- heartburn (painful or burning sensation just below the breast bone)
- vomiting
- a hernia of the tube that carries food to your stomach (hiatus hernia)
- 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
- piles (haemorrhoids)
- leakage of urine
- increased need to pass water
- weight increase
- kidney stones
- pain in the muscles and pain in the joints. Some patients have had severe back cramps or pain which led to admission into hospital.
- 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.
K-00000-0.0 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 Movymia®
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 the cartridge after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the cartridge in the outer carton in order to protect from light.
You can use Movymia® for up to 28 days after the first injection, as long as the cartridge/pen with the cartridge inserted is stored in a refrigerator (2 °C to 8 °C).
Avoid placing the cartridge close to the ice compartment of the refrigerator to prevent freezing. Do not use Movymia® if it is, or has been, frozen.
Each cartridge should be properly disposed of after 28 days of first use, even if it is not completely empty.
Movymia® contains a clear and colourless solution. Do not use Movymia® 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.
- 6. Contents of the pack and other information
What Movymia® contains
- 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.
What Movymia® looks like and contents of the pack
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.
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Genus Pharmaceuticals Holdings Ltd.
Tel: + 44 1484848164
This leaflet was last revised in October 2024.
9354050 2409 GB K-00000-0.0
Produkt/Product: MOVYMIA 20UG/80UL INJ SD GB:PIL
STADA Mat.-Nr./Mat.-No.: 9354050 DZ: 2409
STADA Art.-Nr./Art.-No.: 166360
Hersteller/Manufacturer:
Hersteller Art.-Nr./ Manufacturer Art.-No.: -
Format/Size: 259 x 560 mm
Schriftgröße/Font-size: 10 pt - 18 pt
PZN/EAN: -
Flattermarke/Collating mark: -
1.. arbe/Colour: Black
3.. arbe/Colour: -
4.. arbe/Colour: -
5.. arbe/Colour: -
6.. arbe/Colour: -
7.. arbe/Colour: -
8.. arbe/Colour: Contour
Version: 2. Loop Datum/Date: 24.10.2024.
Agentur/Agency:
Grafik erstellt von/Graphic made by:.
Aktueller Umlauf/Current loop:
Genehmigt/Approved
K-00000-0.0, 00000000
Always follow instructions provided below and on the back page when using the Movymia® Pen.
Movymia® Pen parts
* The cartridge and the pen needles are not supplied in the package.
cartridge
sleeve
dose
knob
*
Getting Ready
Before you start the administration of Movymia® make sure you check the Movymia® Pen for defects.
Wash your hands carefully with soap to minimise the risk of infection.
Make sure you have ready:
your Movymia® Pen and a new
Movymia® cartridge/your Movymia® Pen with inserted Movymia® cartridge • a compatible pen needle
a puncture-resistant sharps disposal
container for used needles.
desinfection materials for treating the
injection site
Do not use the pen if the cartridge is cloudy, discoloured or contains particles.
Read the package leaflet for Movymia® cartridge provided separately.
Pen preparation - First use/ changing cartridges
Follow the instructions every time you insert a new Movymia® cartridge into your Movymia® Pen. Do not repeat this before each daily injection, otherwise you will not have enough Movymia® for 28 days. Read the package leaflet for Movymia® cartridge provided separately.
A: Remove the pen cap.
B: Remove the cartridge sleeve by turning
it 90 degrees, as shown in the picture.
C: Remove the empty cartridge, in the
case of changing cartridge. Insert a new Movymia® cartridge into the cartridge sleeve, with the metal cap of the cartridge first.
Warning: Ensure the use of the correct medicine. Check the label of the cartridge before its insertion into the cartridge sleeve. Do not use cartridge if it is damaged.
Write down the first injection date of each new cartridge. This helps you to remember when the 28 daily doses per cartridge are used.
D: Push the threaded rod with your finger
carefully back into the housing, as far as it will go. The threaded rod cannot be pushed back entirely into the pen housing. This step is not necessary when the rod is already in the starting position, such as at the very first use.
E: Attach the cartridge sleeve to the
housing by turning it 90 degrees, until it stops.
F: Attach a new pen needle as follows:
- Pull off the peel foil.
Screw the pen needle clockwise onto
the cartridge sleeve. Make sure that the pen needle is attached correctly and sits firmly on the cartridge sleeve.
Remove the outer needle cap and
keep it for later. You will need it for the safe removal of the needle after the injection.
Remove and dispose the inner
needle cap.
While attaching the needle some drops may escape, this is normal.
G: Priming
Caution: The pen must be primed and tested after inserting a new cartridge and prior the first injection from each cartridge.
Turn the dose knob clockwise until
you see a droplet sign on the dose display. Make sure that the two indicator stripes are aligned. During dose dialling the pen provides an audible clicking sound and a noticeable resistance.
Caution: Hold the pen with
the needle pointing upwards. Never hold the pen with exposed needle towards your face or other persons.
Press the push button fully in. Hold
it pressed in until the dose indication has turned back to the start position. Some medicine must be expelled from the needle tip.
If no liquid appears, repeat step G up to four times until some liquid appears at the needle tip. Do not repeat step G more than four times, but follow the instructions given under Troubleshooting section on the back page.
Administration using the Movymia® Pen
- 1. Attach the pen needle
Use a new needle for every injection. Do not use the pen needle if the packaging is damaged or not opened by yourself.
Note: There is no need to change the needle when using directly after the pen preparation. In this case continue with step “2. Setting the dose and injection”.
Pull off the peel foil.
- Screw the pen needle clockwise onto the cartridge sleeve. Make sure that the pen needle is attached correctly and sits firmly on the cartridge.
- Remove the outer needle cap and keep it for later. You will need it for the safe removal of the needle after the injection.
- Remove and dispose the inner needle cap.
While attaching the needle some drops may escape, this is normal.
- 2. Setting the dose and injection
- •
To set the fixed daily dose of
80 microliters, turn the dose knob clockwise until it stops and cannot be rotated any further. Make sure the display shows an arrow sign and it is aligned with the indicator stripe. During dose dialling the pen provides an audible clicking sound and a noticeable resistance. Do not try to force the dose knob any further.
Caution: If the cartridge contains less than 80 microliters, the dose knob cannot be turned clockwise up to the arrow sign. In this case, remove the pen needle according to step "3. Removing the pen needle", change the cartridge and proceed with priming according the pen preparation steps.
Re-usable pen injector to be used with Movymia® cartridges for subcutaneous injections
Intended purpose
Movymia® Pen is a non-sterile, reusable medical device intended for the
subcutaneous administration of Movymia® from compatible cartridges.
The reusable Movymia® Pen is intended to assist adult patients with osteoporosis, health care professionals, caregivers and third parties with the delivery of once daily subcutaneous injections of Movymia® either in a clinical environment or self-administered at home.
Movymia® Pen is part of a pen system which consists of the pen itself, a cartridge and a pen needle. The cartridge and the pen needles are not supplied in the package.
Intended patient population:
Patients are persons for whom the prescribing physician has prescribed a therapy with Movymia® using Movymia® Pen. The responsible physician determines the suitability of the Movymia® Pen for a specific patient.
Intended user population:
Users are persons with sufficient visual, manual and tactile skills to operate the Movymia® Pen according to the instructions for use (IFU). In case of impairments, a consultation with the prescribing physician is required.
Select an appropriate injection site and
prepare your skin as recommended by your doctor.
- Clean the injection site with an alcohol
swab. Let the area air dry before you
inject. Do not blow on the disinfected site to accelerate drying process.
Gently hold a skin fold between the thumb and index finger. Insert the needle straight and gently into the skin, as shown in the illustration.
Warning: Prevent the pen needle from bending or breaking. Do not tilt the pen 
after the needle has been inserted into the skin. Tilting the pen may result in bending or breaking of the needle. Broken needles can get stuck in the skin. Immediately consult the doctor if a broken needle gets stuck in the skin.
Press and hold down the push button
until the dose indication has returned to the start position. Keep the needle in the skin fold for a further 6 seconds.
Pull out the pen slowly. Check if the
display is at the start position as shown in the picture, to make sure that the full dose has been injected.
- 3. Removing the pen needle
- •
Carefully attach the outer needle cap on
the pen needle.
- •
Screw the needle cap anti-clockwise to
remove the pen needle. Dispose of it correctly, for example, in a puncture-resistant sharps disposal container.
- 4. Re-attach pen cap
- •
Do not remove the cartridge from the
Movymia® Pen before it is empty. • Re-attach the pen cap after each use.
Put the Movymia® Pen, with the
cartridge inserted, back into the refrigerator between 2 and 8 °C immediately after each use.
If you see blood at the injection site after the needle is removed, gently apply pressure on your skin by using a cotton pad or similar. Do not rub the injection site.
Note for healthcare professionals
Local, healthcare professional or institutional policies may replace the instructions regarding needle handling and disposal.
Additional information
The reusable fixed dose pen is designed for easy administration of Movymia® to treat osteoporosis. Each Movymia® cartridge contains 28 doses of fixed 80 microlitres Movymia®.
Use your Movymia® Pen only as prescribed by your doctor, in this instructions for use and the Movymia® package leaflet. The Movymia® Pen can be used by self-injecting patients above the age of 18 years, healthcare professionals, caregivers or third parties such as, for instance, adult relatives.
The Movymia® Pen must not be used by blind or visually impaired patients without 
help from a trained able-bodied person. Consult your doctor in the case of hearing or handling problems.
If you have any questions concerning the use of the Movymia® Pen refer to the instructions given under troubleshooting section or contact our customer service at any time.
Genus Pharmaceuticals Holdings Ltd. telephone number: Tel: +44 (0)1484 848164 e-mail: thorntonross@medinformation.co.uk
Compatible pen needles
Ypsomed mylife™ Clickfine® 29 to
32 gauge (diameter 0.25 – 0.33 mm) and 12, 10, 8, 6 or 4 mm length • BD Micro-Fine Ultra™ needles 29 to
31 gauge (diameter 0.25 – 0.33 mm) and 12.7, 8 or 5 mm length
Pen needles from other manufacturers can be used according to their stated compatibility details.
Warning: The pen needles must be used only once and the Movymia® Pen may only be used on one patient, otherwise there is a risk of transmitting infectious diseases.
Storage and care of Movymia® Pen
Handle your pen with care. Do not drop
your pen and avoid knocking it against hard surfaces. Protect it from water, dust and moisture.
A damp cloth is sufficient to clean the
Movymia® Pen. Do not use alcohol, other solvents or cleaning agents. Never immerse the Movymia® Pen in water, as this could damage the pen.
Do not use your Movymia® Pen if it
is damaged or if you have any doubts about its correct functioning.
Transport and store the Movymia® Pen
with inserted cartridge at temperatures specified in the Movymia® package leaflet, provided separately.
Warning: Store your Movymia® Pen,
cartridges and pen needles out of reach of others. Prevent access to pen, cartridges and pen needles especially for children. Movymia® Pen contains small parts that might be swallowed. • Do not store the Movymia® Pen with a
needle attached as this may cause air bubbles to form in the cartridge.
Disposal of Movymia® Pen and used accessories
Caution: The Movymia® Pen has a service life of two years. Do not use the Movymia® Pen after the end of service life.
Before disposing of the Movymia® Pen always remove the pen needle and the cartridge. Needles and used cartridges must be disposed separately and safely. The Movymia® Pen can be disposed according to local waste regulations or along with your household waste.
Warnings
Follow the instructions presented in this instructions for use. If the instructions are not followed, there are risks of incorrect medication, inaccurate dosage, disease transmission or infection. Seek immediate medical advice if you have any health concern.
Warranty
The warranty covers manufacturing and material defects of your Movymia® Pen for two years of use, from purchase. It is limited to replacement of the pen. The warranty does not cover damages caused by: • using cartridges other than Movymia® cartridges
- improper or careless use, handling or cleaning
- use contrary to the instructions for use • the pen being used with a medical device, accessories or consumables other than those mentioned in this instructions for use
- dropping, impact, application of force, contact with fluids
other cases of exposure and wear, not in accordance with the instructions for use.
Troubleshooting
Follow the instructions given in the table if you have any questions regarding the use of Movymia® Pen:
| Question | Answer |
| A small air bubble will not affect the dose, or harm. |
| Use another needle instead. Contact customer service if the second needle cannot be attached. |
| Use another needle instead. |
| Do not use this pen; contact customer service. |
| Make sure a cartridge is inserted. Change the needle and repeat the priming as described in pen preparation sections “F” and “G”. If still no medicine is expelled, do not use this pen; contact customer service. |
| The amount of Movymia® left in the cartridge is less than 80 microlitres. Change the cartridge and the pen needle and perform priming according to the pen preparation. |
| Do not repeat the injection on the same day. Use a new needle for your injection on the following day. Set the dose and complete the injection as described in section “2. Setting the dose and injection”. If the display still does not return to start position after injection, do not use this pen; contact customer service. |
| Do not use this pen; contact customer service. |
| Do not press the push button. Reset the pen by simply turning back the dose knob anti-clockwise to the start position. |
Importer for EU:
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
Manufacturer:
Ypsomed AG
Brunnmattstrasse 6
3401 Burgdorf
Switzerland
Authorised representative in the European Union: Ypsomed Produktion GmbH Ludwig-Bölkow-Straße 15 19061 Schwerin
Germany
UK Responsible Person: Qserve Group UK Ltd. 282 Farnborough Road Farnborough, GU14 7NA United Kingdom
This instructions for use was last revised January 2026.
Instructions for use
9288118 2604 GB
Importer for UK: Genus
Pharmaceuticals Holdings Ltd. Linthwaite
Huddersfield HD7 5QH
United Kingdom Produkt/Product: MOVYMIA PEN 1PC SD GB:PIL
STADA Mat.-Nr./Mat.-No.: 9288118 DZ: 2604 STADA Art.-Nr./Art.-No.: 166362,166363
Hersteller/Manufacturer:
Hersteller Art.-Nr./ Manufacturer Art.-No.:
Format/Size: 780 x 176 (65 x 176 mm)
Schriftgröße/Font-size: 9 pt - 18 pt
PZN/EAN: -
Version: 2. Loop Datum/Date: 08.06.2026
Agentur/Agency:
Grafik erstellt von/Graphic made by: S.S.
Aktueller Umlauf/Current loop: S.S.
Genehmigt/Approved