Package Insert: Information for the User

Movymia 20 micrograms/80 microliters Injectable Solution

teriparatida

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Movymia contains the active ingredient teriparatide, which is used to increase bone strength and reduce the risk of fractures by stimulating bone formation.

Movymia is used for the treatment of osteoporosis in adults. Osteoporosis is a disease that causes bones to wear away and become fragile. This disease is especially common in women after menopause, but it can also occur in men. Osteoporosis is also common in patients treated with medications called corticosteroids.

No use Movymia

• If you are allergic to teriparatide or any of the other components of this medication (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 ever had bone cancer or if other types of cancer have spread (metastasized) to your bones.
• If you have certain bone diseases. If you have a bone disease, consult your doctor.
• If you have high levels of alkaline phosphatase in your blood without apparent explanation, which could indicate that you have Paget's disease of the bone (a disease with abnormal bone changes). If you are unsure, consult your doctor.
• If you have received radiation therapy that may have affected your bones.
• If you are pregnant or breastfeeding.

Warnings and precautions

Movymia may increase calcium in your blood or urine.

Consult your doctor before or while using Movymia:

• If you have persistent nausea, vomiting, constipation, low energy, or muscle weakness, tell your doctor. These may be symptoms of too much calcium in your blood.
• If you have kidney stones or have had kidney stones.
• If you have kidney problems (moderate renal insufficiency), tell your doctor.

Some patients, after the first doses of Movymia, experience dizziness or increased heart rate. For the first doses, use Movymia in a place where you can sit or lie down immediately if you feel dizzy.

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

Before inserting a cartridge into Movymia Pen, note the batch number (Batch) of the cartridge and the date of the first injection on the cartridge box and provide this information when reporting any adverse reactions.

Movymia should not be used in adults in growth.

Children and adolescents

Movymia should not be used in children and adolescents (under 18 years).

Other medications and Movymia

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

This is important because some medications (e.g. digoxin/digitals, a medication used to treat heart diseases) may interact with teriparatide.

Pregnancy and breastfeeding

Do not use Movymia if you are pregnant or breastfeeding. If you are a fertile woman, you should use effective contraceptive methods during Movymia treatment. If you become pregnant while using Movymia, treatment should be discontinued. Consult your doctor or pharmacist before using this medication.

Driving and operating machines

Some patients may feel dizzy after Movymia injection. If you feel dizzy, do not drive or operate machines until you feel better.

Movymia contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose unit; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 20 micrograms (corresponding to 80 microliters) administered once a day through a subcutaneous injection in the thigh or abdomen.

To help you remember to inject your medication, inject Movymia at the same time every day.

Movymia can be injected at mealtime. Inject Movymia every day for as long as your doctor prescribes. The total duration of treatment with Movymia should not exceed 24 months. You should not receive more than one 24-month treatment cycle throughout your life.

Your doctor may advise you to use Movymia with calcium and vitamin D. Your doctor will indicate how much you should take each day.

Movymia can be administered with or without food.

Movymia cartridges are designed for exclusive use with the reusable multidose administration system Movymia Pen and compatible pen needles. The pen and injection needles are not included with Movymia. However, for the start of treatment, a package with a cartridge and pen containing a Movymia cartridge case and a Movymia Pen case is required.

The pen can be used with injection needles developed according to the ISO standard for pen needles with a caliber between 29 G and 31 G (diameter of 0.25 – 0.33 mm) and a length between 5 mm and 12.7 mm only for subcutaneous injection.

Before the first use, insert the cartridge into the pen. It is very important to follow the detailed usage instructions of the pen provided with this.

Use a new injection needle for each injection to prevent contamination and dispose of the needle safely after use.

Never store the pen with the needle in place.

Never share your pen with other people.

Do not use Movymia Pen to inject any other medication (e.g., insulin). The pen is designed for use with Movymia exclusively.

Do not refill the cartridge.

Do not transfer the medication to a syringe.

You must inject Movymia shortly after removing the pen with the inserted cartridge from the refrigerator. Put the pen with the inserted cartridge back in the refrigerator immediately after use. Do not remove the cartridge from the pen after each use. Keep it in the cartridge holder during the complete treatment period of 28 days.

Preparation of the pen for use

-To ensure correct administration of Movymia, always read the Movymia Pen usage instructions included in the pen case.

-Wash your hands before handling the cartridge or pen.

-Check the expiration date on the cartridge label before inserting it into the pen.

Ensure that at least 28 days remain until the expiration date. Insert the cartridge into the pen before the first use, as detailed in the pen instructions. Note the batch number (Batch) of each cartridge and your first injection date in a calendar.

You should also record the date of the first injection in the Movymia case (see the space provided in the box: {First use:}).

-After inserting a new cartridge and before the first injection of the cartridge, prepare the pen according to the provided instructions. Do not reprepare it after the first dose.

Injection of Movymia

-Before injecting Movymia, clean the skin where you plan to inject it (thigh or abdomen) as instructed by your doctor.

-Gently pinch the cleaned skin and insert the needle perpendicularly into the skin. Press the button and keep it pressed until the dose indicator returns to the starting position.

-After the injection, leave the needle in the skin for six seconds to ensure you receive the complete dose.

-Once you have finished the injection, place the needle protection cap on the pen needle; screw the cap in the opposite direction of the clock hands to remove the needle from the pen. This will maintain the sterility of the remaining Movymia and prevent leaks from the pen. It will also prevent air from entering the cartridge and the needle from becoming clogged.

-Put the cap back on the pen. Leave the cartridge in the pen.

If you use more Movymia than you should

If you accidentally administer more Movymia than prescribed, consult your doctor or pharmacist.

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

If you forget to use Movymia

If you forget a dose or cannot inject your medication at the usual time, do it as soon as possible that same day. Do not use a double dose to compensate for missed doses. Do not inject more than once in the same day.

If you interrupt treatment with Movymia

If you are thinking of interrupting treatment with Movymia, please consult with your doctor. Your doctor will advise you and decide how long you should be treated with Movymia.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most common side effects are pain in the extremities (very common, may affect more than 1 in 10 patients). Other common side effects (affecting up to 1 in 10 patients) are discomfort, headache, and dizziness. If you feel dizzy after an injection, sit or lie down until you feel better. If you do not improve, consult your doctor before continuing treatment. There have been cases of fainting after the use of teriparatide.

If you have discomfort around the injection site, such as redness of the skin, pain, swelling, itching, bruises, or mild bleeding (which may occur frequently), these should disappear within a few days or weeks. If not, tell your doctor.

Rarely (may affect up to 1 in 10,000 patients), some patients may experience allergic reactions, which consist of difficulty breathing, facial swelling, skin rash, and chest pain. These reactions usually occur shortly after the injection. In rare cases, they may cause severe and potentially life-threatening allergic reactions, including anaphylaxis.

Other side effects are:

Common(may affect up to 1 in 10 patients):

•increase in blood cholesterol levels

•depression

•neuropathic pain in the leg

•sensation of fainting

•sensation of spinning

•irregular heart palpitations

•difficulty breathing

•increased sweating

•muscle cramps

•loss of energy

•fatigue

•chest pain

•low blood pressure

•heartburn (pain or burning sensation just below the sternum)

•vomiting

•hiatal hernia

•low hemoglobin or low red blood cell count (anemia)

Uncommon(may affect up to 1 in 100 patients):

•increased heart rate

•abnormal heart sound

•shortness of breath

•hemorrhoids

•urine loss

•increased need to urinate

•weight gain

•kidney stones

•muscle and joint pain. Some patients have hadsevere back cramps or pain and had to be hospitalized.

•increase in blood calcium levels

•increase in blood uric acid levels

•increase in levels of an enzyme called alkaline phosphatase

Rare(may affect up to 1 in 1,000 patients):

•reduction in kidney function, including renal insufficiency

•swelling, mainly in the hands, feet, and legs

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and the cartridge after CAD and EXP respectively. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2 °C and 8 °C). Do not freeze. Keep the cartridge in the case to protect it from light.

You can use Movymia for 28 days after the first injection as long as the cartridge / pen with the cartridge inserted is stored in the refrigerator (between 2 °C and 8 °C).

Avoid placing the cartridge near the freezer of the refrigerator to prevent its freezing. Do not use Movymia if it is or has been frozen.

Each cartridge must be disposed of properly after 28 days of the first use, even if it is not completely empty.

Movymia contains a transparent and colorless solution. Do not use Movymia if you have solid particles or if the solution is cloudy or has color.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. This way, you will help protect the environment.

Composition of Movymia

-The active principle is teriparatide. Each dose of 80 microliters contains 20 micrograms of teriparatide. A cartridge of 2.4 ml contains 600 micrograms of teriparatide (corresponding to 250 micrograms per ml).

-The other components are: glacial acetic acid, mannitol, metacresol, sodium acetate trihydrate, hydrochloric acid (to adjust the pH), sodium hydroxide (to adjust the pH) and water for injectable preparations (see section 2 “Movymia contains sodium”).

Aspect of the product and contents of the package

Movymia is a transparent and colorless injectable solution. It is presented in a cartridge. Each cartridge contains 2.4 ml of solution sufficient for 28 doses.

Package sizes:1cartridgeor 3cartridges packaged in a sealed plastic tray with a lid andpackaged ina case.

Package with cartridge and Movymia Pen: 1 cartridge of Movymia packaged in a sealed plastic tray with a lid and packaged in a case and 1 Movymia Pen packaged in a case.

It may only be marketed in some package sizes.

Marketing Authorization Holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Responsible for manufacturing

Gedeon Richter Plc.

Gyömroi út 19-21.

1103Budapest

Hungary

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Laboratorio STADA, S.L.

Tel: +34 934738889

Date of the last review of this leaflet:September 2021.

Other sources of information

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu/

The detailed information about this product is also available by scanning the QR code below or the case with a smartphone. The same information is also available at the following URL:movymiapatients.com

Instructions for use

Movymia Pen

Reusable injection pen for use with Movymia cartridges for subcutaneous injection

When using the Movymia Pen, always follow the instructions given below and on the reverse.

Parts of the Movymia Pen

Preparing the pen - First use / cartridge change

Follow the instructions each time you place a new Movymia cartridge on the Movymia Pen. Do not repeat this step before each daily injection, as otherwise you will not have enough Movymia for 28 days.

Read the Movymia cartridge leaflet separately.

A: Remove the pen cap.

B: Turn the cartridge holder to remove it (bayonet coupling).

C: If you want to change the cartridge, remove the empty cartridge. Place a new Movymia cartridge in the cartridge holder with the metal cap folded first.

Note the date of the first injection of each new cartridge. This will help you know when the 28 daily doses per cartridge are finished.

D: Gently push the threaded rod with your finger in a straight line and to the top. This is not necessary when the threaded rod is already in its initial position, such as the first time it is used. The threaded rod cannot be inserted completely into the pen casing.

E: Attach the cartridge holder to the casing by turning it 90 degrees to the top.

F: Attach a new pen needle as follows:

• Remove the foldable sheet.

• Screw the pen needle into the cartridge holder in a clockwise direction. Make sure the pen needle is correctly positioned and firmly supported in the cartridge holder.

• Remove the external cap of the pen needle and store it.

• Remove and discard the internal cap of the pen needle.

When attaching the pen needle, some drops may escape; this is normal.

G: Priming

The pen must be primed and tested before inserting a new cartridge and before the first injection of each cartridge.

• Turn the dose button clockwise until you see the drop symbol in the dose indicator. Make sure the two lines of the indicator are aligned. During the dose adjustment, the pen emits a click and offers a perceptible resistance.

• Hold the pen with theneedle pointing upwards.

• Press the button until the dose indicator returns to its initial position. Some drops of the medicine should come out of the tip of the needle.

Otherwise, repeat step G until you see some drops. Do not repeat step G more than four times; if necessary, follow the instructions in the Troubleshooting section on the reverse.

Administration using the Movymia Pen

Wash your hands with soap carefully to reduce the risk of infection.

Make sure you have:

• the Movymia Pen with the cartridge inserted

• a compatible pen needle

• a puncture-resistant container for used needles.

Do not usethe pen if thecartridge is cloudy or colored or contains particles.

Read the Movymia cartridge leaflet separately.

1. Place the pen needle

Use a new needle for each injection. Do not use the pen needle if the packaging is damaged or you did not open it.

Nota:you do not need to change the needle when using it immediately after preparing the pen. In this case, continue with the “2. Dose adjustment and injection” step.

• Remove the foldable sheet.

• Screw the pen needle into the cartridge holder in a clockwise direction. Make sure the pen needle is correctly positioned and firmly supported in the cartridge holder.

• Remove the external cap of the pen needle and store it.

• Remove and discard the internal cap of the pen needle.

When attaching the pen needle, some drops may escape; this is normal.

2. Dose adjustment and injection

Warning:make sure you use the correct liquid medicine. Check the Movymia cartridge label before inserting it into the cartridge holder.

• To adjust the daily fixed dose of 80microliters, turn the dose button clockwise until it stops and cannot be turned further.Make sure the arrow symbol appears in the dose indicator and is aligned with the indicator line.During the dose adjustment, the pen emits a click and offers a perceptible resistance. Do not try to force the dose button.

Nota:if the cartridge contains less than 80microliters, the dose button cannot be turned clockwise to the arrow symbol. In this case, remove the pen cap, change the cartridge and perform a priming as described in the pen preparation steps.

• Select a suitable injection site and prepare the skin according to the doctor's recommendations. Take a skin fold between your index and middle fingers. Insert the pen needle straight and carefully into the skin, as shown in the illustration.

Warning:avoid bending or breaking the pen needle. Do not tilt the pen after inserting the needle into the skin. Tilt the pen may bend or break the needle. Broken needles may remain in the skin. If a broken needle remains in the skin, consult your doctor immediately.

• Press the button until the dose indicator returns to its initial position. Leave the needle in the skin fold for 6 seconds more.

• Remove the pen slowly. Check if the dose indicator is in its initial position to make sure the full dose has been injected.

3. Remove the pen needle

• Carefully place the external cap of the pen needle over the pen needle.

• Screw the cap of the pen needle counterclockwise to remove the pen needle from the pen. Dispose of it properly, for example in a puncture-resistant container.

4. Replace the pen cap

• Do not remove the cartridge from the Movymia Pen before emptying it.

• Replace the pen cap after each use.

• Place the Movymia Pen with the cartridge in the refrigerator at a temperature of 2 to 8°C immediately after use.

Nota for healthcare professionals

Local policies, healthcare professionals or institutions may replace the instructions regarding the handling and disposal of needles.

Additional information

The reusable dose pen is designed for easy administration of Movymia for the treatment of osteoporosis. Each Movymia cartridge contains 28 fixed doses of 80microliters of Movymia.

Use the Movymia Pen only as instructed by your doctor and according to the information in these instructions for use and the Movymia leaflet.

The Movymia Pen can be used by patients who inject and are over 18years old, healthcare professionals or third parties such as, for example, adult family members.

The Movymia Pen should not be used by blind patients or visually impaired patients without the help of a physically capable person properly trained. Consult your doctor if you have hearing or manipulation problems.

If you have any questions about the use of the Movymia Pen, contact ourcustomer serviceat any time.

Phone number:XXXXXXXXXXX

Email:XXXXXXXXXXX

Compatible needles with the pen

• Ypsomed mylife™ Clickfine®, gauge 29 to 31 (diameter 0.25 – 0.33mm) and length of 12, 10, 8 or 6mm
• BD Micro-Fine Ultra™ needles, gauge 29 to 31 (diameter 0.25 – 0.33mm) and length of 12.7, 8 or 5mm

Needles from othermanufacturers may be used in accordance with the details of compatibility indicated.

Thepen needles must be used only onceandonly one person should use the Movymia cartridge.

Storage and care of the Movymia Pen

• Handle the pen carefully. Do not drop the pen and avoid hitting it against hard surfaces. Protect it from water, dust and moisture.
• You can use a damp cloth to clean the Movymia Pen. Do not use alcohol, solvents or cleaning agents. Do not submerge the Movymia Pen in water, as it may be damaged.
• Do not use the Movymia Pen if it is damaged or if you have any doubts about its proper functioning.
• Transport and store the Movymia Pen with the cartridge in place at the temperature indicated in the Movymia leaflet separately.
• Store the Movymia Pen, cartridges and needles out of the reach of children.
• Do not store the Movymia Pen with the needle attached, as it may cause the formation of air bubbles in the cartridge.

How to dispose of the Movymia Pen and used accessories

The Movymia Pen has a two-year lifespan. Before disposing of the Movymia Pen, remove the needle and the cartridge. Used needles and cartridges must be disposed of safely and separately. The Movymia Pen can be disposed of in accordance with local instructions.

Warnings

Follow the instructions presented in these instructions for use. If you do not follow these instructions, there is a risk of medication errors, inadequate doses, disease transmission or infection. If you have any health problems, seek medical attention immediately.

Warranty

The warranty covers material and manufacturing defects of the Movymia Pen for two years of use from the date of purchase. It is limited to replacing the pen. The warranty does not cover damage caused by:

• use of cartridges that are not Movymia cartridges
• incorrect or negligent use, handling or cleaning
• use contrary to the instructions for use
• use of Movymia Pen with sanitary products, accessories or consumables other than those mentioned in these instructions for use
• falls, blows, application of force, contact with liquids
• other cases of exposure and wear that are not in accordance with the instructions for use.

Troubleshooting

If you have any questions about the use of the Movymia Pen, follow the instructions given in the table on the following page:

Distributor:

XXXXXXXXXX

Importer:

Gedeon Richter Plc.

Gyömroi út 19-21

1103 Budapest

Hungary

Authorized Representative in the European Community:

Ypsomed Distribution GmbH

Warmbacher Strasse 80

79618 Rheinfelden

Germany

Legal Manufacturer:

Ypsomed AG

Brunnmattstrasse 6

3401 Burgdorf

Switzerland

CE 0123

Date of review of the text: