MOVYMIA

Patient Information Leaflet: Information for the User

Movymia 20 micrograms/80 microliters injectable solution

teriparatide
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Movymia is and what it is used for
2. What you need to know before using 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, which is used to strengthen bones and reduce the risk of fractures by stimulating bone formation.
Movymia is used to treat osteoporosis in adults. Osteoporosis is a disease that causes bones to become thin and fragile. This condition is particularly common in women after menopause, but can also occur in men. Osteoporosis is also common in patients being treated with medicines called corticosteroids.

2. What you need to know before using Movymia

Do not use Movymia

• If you are allergic to teriparatide or to any of the other ingredients of this medicine (listed in section 6).
• If you have high levels of calcium in your blood (pre-existing hypercalcemia).
• If you have severe kidney problems.
• If you have had bone cancer or if other cancers have spread (metastasized) to your bones.
• If you have other bone diseases. If you have a bone disease, inform your doctor.
• If you have elevated levels of alkaline phosphatase in your blood of unknown origin, which may indicate Paget's disease of the bone (a disease causing abnormal bone changes). If you are unsure, ask your doctor.
• If you have received radiation therapy involving the bones.
• If you are pregnant or breastfeeding.

Warnings and precautions
Movymia may increase calcium levels in your blood or urine.
Contact your doctor before or during treatment with Movymia:

• If you continuously experience nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs of too much calcium in your blood.
• If you suffer or have suffered from kidney stones.
• If you have kidney problems (moderate renal impairment).

Some patients may feel dizzy or experience a rapid heartbeat after taking the first doses of Movymia. During the initial doses, if you feel dizzy, administer Movymia in a place where you can sit or lie down.
The recommended treatment period of 24 months must not be exceeded.
Before inserting a cartridge into the Movymia Pen, record the batch number and the date of the first injection on the outer cartridge container and provide this information if reporting any adverse effects.
Movymia must not be used in adults who are still growing.
Children and adolescents
Movymia must not be used in children and adolescents (under 18 years of age).
Other medicines and Movymia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is important because certain medicines (e.g., digoxin/digitalis, a medicine used to treat heart conditions) may interact with teriparatide.
Pregnancy and breastfeeding
Do not take Movymia if you are pregnant or breastfeeding. If you are a woman of childbearing potential, you must use effective contraceptive methods during treatment with Movymia. If you become pregnant while using Movymia, treatment must be stopped. Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Some patients may feel dizzy after injection of Movymia. If you feel dizzy, do not drive or operate machinery until you feel better.
Movymia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".

3. How to use Movymia

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 20 micrograms (corresponding to 80 microlitres) administered once daily by subcutaneous injection (subcutaneous injection) in the thigh or abdomen.
To help you remember to take the medicine, inject it at the same time each day. Movymia may be injected around mealtimes. Inject Movymia every day for the entire duration prescribed by your doctor. The total duration of treatment with Movymia must not exceed 24 months. You must not receive more than one 24-month course of treatment in your lifetime.
Your doctor may advise you to take Movymia with calcium and vitamin D. Your doctor will tell you how much calcium and vitamin D you should take each day.
Movymia may be administered with or without food.
Movymia cartridges are designed for exclusive use with the reusable multidose delivery system, Movymia Pen, and compatible needles. The pen and injection needles are not supplied with Movymia. However, at the start of treatment, you should use the cartridge and pen pack, containing an inner carton with one Movymia cartridge and an inner carton containing the Movymia Pen.
The pen can be used with injection needles developed according to the ISO standard for pen needles with a gauge between 29 G and 31 G (diameter 0.25 – 0.33 mm) and a length between 5 mm and 12.7 mm for subcutaneous injection only.
Before first use, insert the cartridge into the pen. For correct use of this medicine, it is very important to carefully follow the detailed instructions for using the pen provided with the pen.
Always use a new needle for each injection to prevent contamination and dispose of the needle safely after use.
Never store the pen with the needle attached.
Never share your pen with others.
Do not use the Movymia Pen to inject other medicines (e.g. insulin).
The pen is customized for exclusive use with Movymia.
Do not refill the cartridge.
Do not transfer the medicine into a syringe.
You must inject Movymia shortly after removing the pen with the inserted cartridge from the refrigerator. After use, immediately return the pen with the inserted cartridge to the refrigerator. Do not remove the cartridge from the pen after use. Store it in the cartridge holder for the entire 28-day treatment period.
Preparing the pen for use

• To ensure proper administration of Movymia, always read the instructions for use of the

Movymia Pen, included in the pen case.

• Wash your hands before handling the cartridge or pen.
• Check the expiry date on the cartridge label before inserting the cartridge into the pen. Ensure that at least 28 days remain before expiry. Insert the cartridge into the pen before first use, as indicated in the pen instructions. Record the batch number of each cartridge and the date of the first injection on a calendar. You should also record the date of the first injection on the outer case of Movymia (see the designated 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 provided. Do not re-prime the pen after the first dose.

Injecting Movymia

• Before injecting Movymia, clean the skin at the injection site (thigh or abdomen) as instructed by your doctor.
• Gently pinch a fold of clean skin and insert the needle perpendicularly into the skin. Press the button and keep it pressed until the dose indicator returns to its starting position.
• After the injection, leave the needle in the skin for six seconds to ensure the full dose is delivered.
• Immediately after the injection, place the protective cap over the pen needle and twist it counterclockwise to remove the needle. This will keep the remaining medicine sterile and prevent leakage from the pen. It will also prevent air from entering the cartridge and clogging the needle.
• Replace the cap on the pen. Leave the cartridge inside the pen.

If you use more Movymia than you should
If you accidentally use more Movymia than prescribed, contact your doctor or pharmacist.
Expected effects of an overdose include nausea, vomiting, dizziness, and headache.

If you forget to use Movymia
If you miss an injection or are unable to take it at your usual time, inject it as soon as possible during the day. Do not use a double dose to make up for the missed dose.
Do not administer more than one injection on the same day.

If you stop using Movymia
If you are considering stopping treatment with Movymia, please discuss this with your doctor.
Your doctor will advise you and determine how long you should continue treatment with Movymia.
If you have any questions about the use of this medicine, consult 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 limb pain (very common frequency, which may affect more than 1 in 10 people). Other common side effects (may affect up to 1 in 10 people) include nausea, headache and dizziness. If you feel dizzy (lightheaded) after the injection, you should sit or lie down until you feel better. If you do not feel better, you must contact a doctor before continuing treatment. Cases of fainting have occurred after the use of teriparatide.
If you experience discomfort around the injection site, such as redness of the skin, pain, swelling, itching, bruising or minor bleeding (which may commonly occur), this should resolve within a few days or weeks. Otherwise, inform your doctor.
Rarely (may affect up to 1 in 1,000 people), some patients have experienced allergic reactions including shortness of breath, facial swelling, skin rash and chest pain. Such reactions usually occur shortly after the injection. In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis may occur.
Other side effects include:
Common (may affect up to 1 in 10 people)

• increased cholesterol levels in the blood
• depression
• neuropathic leg pain
• feeling faint
• feeling dizzy
• irregular heartbeat
• shortness of breath
• increased sweating
• muscle cramps
• loss of energy
• fatigue
• chest pain
• decrease in blood pressure
• heartburn (a sensation of pain or burning felt just below the breastbone)
• vomiting
• presence of a hernia in the tube carrying food to the stomach (hiatal hernia)
• decrease in haemoglobin or red blood cell count in the blood (anaemia)

Uncommon (may affect up to 1 in 100 people)

• increased heart rate
• abnormal heart sounds
• laboured breathing
• haemorrhoids
• urinary incontinence
• increased need to pass fluids
• weight gain
• kidney stones
• muscle pain and joint pain. Some patients have experienced severe cramps or back pain leading to hospitalisation.
• increased calcium levels in the blood
• increased uric acid levels in the blood
• increase in an enzyme called alkaline phosphatase

Rare (may affect up to 1 in 1,000 people)

• reduced kidney function, including kidney failure
• development of swelling, particularly in the hands, feet and legs

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex V. 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 stated on the box and cartridge after
EXP/SCAD. The expiry date refers to the last day of that month.
Store in the refrigerator (from 2°C to 8°C). Do not freeze.
Keep the cartridge in the outer carton to protect it from light.
You may use Movymia for up to 28 days after the first injection. During this period, the cartridge/pen
with the cartridge inserted should be stored in the refrigerator (2°C–8°C).
Avoid placing the pens near the freezer compartment of the refrigerator to prevent freezing.
Do not use Movymia if it has been frozen or if it freezes.
After 28 days from first use, every cartridge must be properly disposed of, even if it is not completely empty.
Movymia contains a clear, colourless solution. Do not use Movymia if you notice solid particles or if the solution appears cloudy or coloured.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Movymia contains

• The active substance is teriparatide. Each 80 microlitre dose contains 20 micrograms of teriparatide. A 2.4 mL cartridge contains 600 micrograms of teriparatide (equivalent to 250 micrograms per mL).
• The other components are: glacial acetic acid, mannitol, metacresol, sodium acetate trihydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections (see section 2 “Movymia contains sodium”).

Description of the appearance of Movymia and contents of the pack
Movymia is a colourless and clear injectable solution. Movymia is supplied in a cartridge. Each cartridge contains 2.4 mL of solution, sufficient for 28 doses.
Pack contents:
1 cartridge or 3 cartridges packed in a sealed plastic tray with a lid foil, contained in a carton.
Pack of Movymia containing cartridge and pen: 1 Movymia cartridge packed in a sealed plastic tray with a lid foil, packed in an inner carton, and 1 Movymia Pen packed in a separate inner 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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
EG (Eurogenerics) NV UAB „STADA Baltics“
Tél/Tel: +32 4797878 Tel: +370 52603926
България Luxembourg/Luxemburg
STADA Bulgaria EOOD EG (Eurogenerics) NV
Teл.: +359 29624626 Tél/Tel: +32 4797878
Česká republika Magyarország
STADA PHARMA CZ s.r.o. STADA Hungary Kft
Tel: +420 257888111 Tel.: +36 18009745
Danmark Malta
STADA Nordic ApS Pharma.MT Ltd
Tlf: +45 44859999 Tel: +356 21337008
Deutschland Nederland
STADAPHARM GmbH Centrafarm B.V.
Tel: +49 61016030 Tel.: +31 765081000
Eesti Norge
UAB „STADA Baltics“ STADA Nordic ApS
Tel: +370 52603926 Tlf: +45 44859999
Ελλάδα Österreich
FΑRAN S.A. STADA Arzneimittel GmbH
Τηλ: +30 2106254175 Tel: +43 136785850
España Polska
Laboratorio STADA, S.L. STADA Poland Sp. z.o.o.
Tel: +34 934738889 Tel: +48 227377920
France Portugal
EG LABO - Laboratoires EuroGenerics Stada, Lda.
Tél: +33 146948686 Tel: +351 211209870
Hrvatska România
STADA d.o.o. STADA M&D SRL
Tel: +385 13764111 Tel: +40 213160640
Ireland Slovenija
Clonmel Healthcare Ltd. Stada d.o.o.
Tel: +353 526177777 Tel: +386 15896710
Ísland Slovenská republika
STADA Arzneimittel AG STADA PHARMA Slovakia, s.r.o.
Sími: +49 61016030 Tel: +421 252621933
Italia Suomi/Finland
EG SpA STADA Nordic ApS, Suomen sivuliike
Tel: +39 028310371 Puh/Tel: +358 207416888
Κύπρος Sverige
STADA Arzneimittel AG STADA Nordic ApS
Τηλ: +30 2106664667 Tel: +45 44859999
Latvija United Kingdom (Northern Ireland)
UAB „STADA Baltics“ STADA Arzneimittel AG
Tel: +370 52603926 Tel: +49 61016030

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu/

Instructions for use

Movymia Pen

Reusable pen injector for use with Movymia cartridges for subcutaneous injections
When using the Movymia Pen system, always follow the instructions provided below and on the back
of this page.
Parts of the Movymia Pen system

Preparing the pen – First use/cartridge replacement
Write the date of the first injection on each new cartridge. This will help you remember
when the 28 daily doses from the cartridge have been used (see section 2 “Warnings and
precautions” and section 3 “Preparing the pen for use” in the Movymia package leaflet).
Follow these instructions every time a new Movymia cartridge is inserted into the Movymia Pen system.
Do not repeat this procedure before each daily injection, otherwise the Movymia dose will not be sufficient for 28 days of treatment.
Read the package leaflet of the Movymia cartridge supplied separately.
A: Remove the pen cap.

B: Remove the cartridge compartment by rotating it (bayonet fitting system).

C: If replacing the cartridge, remove the empty cartridge. Insert a new Movymia cartridge into the cartridge compartment, placing the metal end of the cartridge in first.

D: Carefully reposition the threaded rod by pressing straight down with one finger until fully seated. This step is not necessary if the threaded rod is already in the starting position, as in the case of first use. The threaded rod cannot be fully pushed into the pen housing.

E: Attach the cartridge compartment to the housing by rotating it 90 degrees until it locks into place.

F: Attach a new pen needle as follows:

• Remove the protective seal.

• Screw the pen needle clockwise onto the cartridge compartment. Ensure the pen needle is correctly and securely attached to the cartridge compartment.

• Remove and keep the outer needle cap.

• Remove and discard the inner needle cap.

A few drops may leak during needle attachment; this is normal.
G: Priming
After inserting a new cartridge and before the first injection from each cartridge, the pen must be primed and tested.

• Rotate the dose selection dial clockwise until the drop symbol appears on the display. Ensure the two indicator marks are aligned. While selecting the dose, the pen will produce an audible click and offer noticeable resistance.

• Hold the pen with the needle pointing upwards.
• Press the injection button fully. Keep it pressed until the dose indicator returns to its initial position. A few drops of medication should appear at the needle tip.

If no drops appear, repeat step G until drops are observed. Do not repeat step G more than 4 times; instead, follow the troubleshooting instructions provided on the back of this page.

Administration using the Movymia Pen System
Wash hands thoroughly with soap to minimize the risk of infection.
Ensure the following are ready:

• the Movymia Pen system with cartridge inserted
• a compatible pen needle
• a sharps container for safe disposal of used needles and other sharp objects.

Do not use the pen if the cartridge is cloudy, discolored, or contains particles.
Refer to the package leaflet of the separately supplied Movymia cartridge.

1. Insert the pen needle

Use a new needle for each injection. Do not use the pen needle if the packaging is
damaged or has not been opened by you.
Note: it is not necessary to change the needle when using the pen immediately after its
preparation. In this case, proceed with step "2. Setting the dose and injection".

• Remove the protective film.

• Screw the pen needle clockwise onto the cartridge compartment. Make sure the pen needle is correctly attached and securely fastened to the cartridge compartment.

• Remove the outer needle cap and keep it for later use.

• Remove and discard the inner needle cap.

A few drops may leak during needle attachment; this is normal.

2. Setting the Dose and Injection

Warning: Ensure the correct use of the medicine. Check the cartridge label before inserting it into the cartridge compartment.

• To set the prescribed daily dose of 80 microliters, rotate the dose selection knob clockwise until it stops and can no longer be turned. Ensure that the dial (display) shows an arrow mark aligned with the indicator line. During dose selection, the pen will emit an audible click and provide noticeable resistance. Do not force the dose selection knob further.

Warning: If the cartridge contains less than 80 microliters, the dose selection knob cannot be rotated clockwise to the arrow mark. In this case, remove the needle from the pen, replace the cartridge, and proceed with loading according to the previously described pen preparation steps.

• Select an appropriate injection site and prepare the skin according to your doctor's recommendations. Gently pinch a fold of skin between your thumb and index finger. Insert the needle perpendicularly and gently into the skin, as shown in the figure.

Warning: Avoid bending or breaking the needle. Do not tilt the pen after inserting the needle into the skin. Tilting the pen may cause the needle to bend or break. Broken needles may remain in the skin. Seek immediate medical advice if a broken needle remains in the skin.

• Press the injection button until the dose indicator returns completely to its starting position. Keep the needle in the skin for an additional 6 seconds.

• Slowly withdraw the pen. Check that the dial (display) has returned to its initial position to confirm that the full dose has been injected.

3. Removing the pen needle

• Carefully insert the outer needle cap onto the pen needle.

• Unscrew the needle cap counterclockwise to remove the pen needle. Dispose of it properly, for example, in a puncture-proof container for sharp objects.

4. Replace the pen cap

• Do not remove the cartridge from the Movymia Pen system until it is empty.
• Replace the pen cap after each use.

• Immediately after use, return the Movymia Pen system, with the cartridge inserted, to the refrigerator at a temperature between 2 and 8 °C.

Note for healthcare professionals
Instructions regarding needle handling and disposal may be replaced by local, healthcare or institutional policies.
Additional information
The reusable fixed-dose pen is designed for easy administration of Movymia for the treatment of osteoporosis. Each Movymia cartridge contains 28 fixed doses of 80 microliters of Movymia.
The Movymia Pen system must be used only as prescribed by a physician, according to these instructions for use and the Movymia package leaflet.
For self-injection, the Movymia Pen system can be used by patients over 18 years of age, healthcare professionals, or third parties such as adult family members.
The Movymia Pen system must not be used by blind patients or those with impaired vision without the assistance of a physically capable and trained person.
Consult a physician in case of hearing or handling difficulties.
Pen needles must be used only once, and the Movymia cartridge must be used by a single individual only.

Storage and care of the Movymia Pen system

• Handle the pen carefully. Do not drop the pen and avoid impacts against hard surfaces. Keep away from water, dust, and moisture.
• To clean the Movymia Pen system, use a damp cloth only. Do not use alcohol, other solvents, or cleaning agents. Do not immerse the Movymia Pen system in water, as this could damage the pen.
• Do not use the Movymia Pen system if it is damaged or if you have doubts about its proper functioning.
• Transport and store the Movymia Pen system with the cartridge inserted at the temperatures specified in the Movymia package leaflet, provided separately.
• Store the Movymia Pen system, cartridges, and pen needles out of the reach of children.
• Do not store the Movymia Pen system with the needle attached, as this may cause air bubbles to form in the cartridge.

Disposal of the used Movymia Pen system and accessories
The Movymia Pen system has a service life of 2 years. Before disposing of the Movymia Pen system, always remove the needle and the cartridge. Used needles and cartridges must be disposed of separately and safely. The Movymia Pen system may be disposed of according to instructions provided by local authorities.
Warnings
Follow the instructions provided in these instructions for use. Failure to follow these instructions may result in incorrect therapy, inaccurate dosing, disease transmission, or infection. In case of any health-related problems, seek immediate medical assistance.
Troubleshooting
If you have any doubts about using the Movymia Pen system, follow the instructions provided in the table:

These instructions for use were last reviewed on: