TERROSA 20 micrograms/80 microliters Injectable Solution in Pre-filled Pen

Introduction

Package Leaflet: Information for the User

Terrosa 20 micrograms/80 microliters solution for injection in pre-filled pen

Teriparatide

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.

Contents of the pack

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

1. What is Terrosa and what is it used for

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

Terrosa is used for the treatment of osteoporosis in adults. Osteoporosis is a disease that causes your 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 medicines called corticosteroids.

2. What you need to know before you use Terrosa

Do not use Terrosa

• 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 (pre-existing hypercalcaemia).
• 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 reason, which could indicate that you have Paget's disease of the bone (a disease with abnormal bone changes). If you are not sure, consult your doctor.
• if you have received radiation therapy that may have affected your bones.
• if you are pregnant or breast-feeding.

Warnings and precautions

Terrosa may increase calcium in your blood or urine.

Talk to your doctor before or while using Terrosa:

• If you constantly have 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).

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

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

Before starting to use a new pre-filled pen, write down the batch number (Batch) of the medicine and the date of the first injection on the pen box and on a calendar, and provide this information when reporting any adverse reaction.

Terrosa should not be used in adults who are still growing.

Children and adolescents

Terrosa should not be used in children and adolescents (under 18 years of age).

Other medicines and Terrosa

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 diseases) may interact with teriparatide.

Pregnancy and breast-feeding

Do not use Terrosa if you are pregnant or breast-feeding. If you are a woman of childbearing age, you should use effective contraceptive methods during treatment with Terrosa. If you become pregnant while using Terrosa, treatment with Terrosa should be discontinued. Consult your doctor or pharmacist before using this medicine.

Driving and using machines

Some patients may feel dizzy after the injection of Terrosa. If you feel dizzy, do not drive or use machines until you feel better.

Terrosa contains sodium

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

3. How to use Terrosa

Follow exactly the administration instructions of this medicine 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 by subcutaneous injection in the thigh or abdomen.

To help you remember to inject your medicine, inject it at the same time every day. Terrosa can be injected at mealtime.

Inject Terrosa every day for as long as your doctor prescribes it. The total duration of treatment with Terrosa should not exceed 24 months. You should not receive more than one 24-month treatment cycle in your lifetime.

Your doctor may advise you to use Terrosa with calcium and vitamin D. Your doctor will tell you how much to take each day.

Terrosa can be administered with or without food.

Compatible injection needles are not provided with Terrosa.

The pre-filled 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 of 0.25 - 0.33 mm) and a length between 5 mm and 12.7 mm only for subcutaneous injection.

For the correct use of this medicine, it is very important to follow the detailed instructions for use of the pre-filled pen provided with the medicine.

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

Never store the pen with the needle attached.

Do not transfer the medicine to a syringe.

You should inject Terrosa shortly after removing the pre-filled pen from the refrigerator. Place the pen cap on the pre-filled pen and put the pen back in the refrigerator immediately after use. Keep it in the refrigerator before and during the complete 28-day treatment period.

Preparation for injection

• To ensure the correct administration of Terrosa, always read the Instructions for use of the Terrosa pre-filled pen, included in the medicine carton.
• Wash your hands before handling the pre-filled pen.
• Check the expiry date on the label of the pre-filled pen before starting to use the medicine. Make sure that there are at least 28 days left until the expiry date. Write down the batch number (Batch) and the date of the first injection of the pre-filled pen in use on a calendar. You should also write down the date of the first injection on the Terrosa carton (see the space provided on the box: {First use:}).
• Place a new injection needle on the pre-filled pen and set the dose in the viewing window by turning the dose adjustment button.

Injection of Terrosa

• Before injecting Terrosa, clean the skin where you plan to inject it (thigh or abdomen) as indicated by your doctor.
• Gently pinch the cleaned skin and insert the needle perpendicular to the skin. Press the dose adjustment button and keep it pressed for at least 6 seconds to ensure you receive the full dose.
• As soon as the injection is complete, place the needle protective cap on the pen needle; screw the cap counterclockwise to remove the needle from the pen. This will maintain the sterility of the remaining Terrosa and prevent leaks from the pen. It will also prevent air from entering the pre-filled pen and the needle from becoming clogged.
• Put the cap back on the pen.
• Safely dispose of the pen needles using a puncture-proof container or follow your doctor's instructions.

If you use more Terrosa than you should

If you have accidentally administered more Terrosa than prescribed, talk to your doctor or pharmacist.

The effects that can be expected from an overdose include nausea, vomiting, dizziness, and headache.

If you forget to use Terrosa

If you miss an injection or cannot inject your medicine at the usual time, do so as soon as possible on the same day. Do not use a double dose to make up for missed doses. Do not inject more than once on the same day.

If you stop treatment with Terrosa

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

If you have any other questions about 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 the limbs (very common, may affect more than 1 in 10 patients). Other common side effects (affecting up to 1 in 10 patients) are nausea, headache, and dizziness. If you feel dizzy after an injection, sit or lie down until you feel better. If it does not improve, consult your doctor before continuing treatment. There have been cases of fainting after the use of teriparatide.

If you experience discomfort around the injection site such as redness of the skin, pain, swelling, itching, bruising, or slight 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 1,000 patients), some patients may experience allergic reactions, which consist of difficulty breathing, swelling of the face, rash, and chest pain. These reactions usually occur shortly after injection. In rare cases, severe and potentially life-threatening allergic reactions, including anaphylaxis, may occur.

Other side effects are:

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

• increased levels of cholesterol in the blood
• depression
• neuropathic pain in the leg
• feeling of fainting
• feeling that everything is spinning
• irregular palpitations
• difficulty breathing
• increased sweating
• muscle cramps
• loss of energy
• fatigue
• chest pain
• low blood pressure
• heartburn (pain or burning sensation just below the breastbone)
• vomiting
• hiatus hernia (hernia of the tube that carries food to the stomach)
• 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 (piles)
• loss of urine
• increased need to urinate
• weight gain
• kidney stones
• pain in the muscles and joints. Some patients have had severe back cramps or pain and had to be hospitalized.
• increased levels of calcium in the blood
• increased levels of uric acid in the blood
• increased levels of an enzyme called alkaline phosphatase

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

• reduced kidney function, including kidney failure
• swelling, mainly in the hands, feet, and legs

Reporting of side effects

If you experience 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 through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Terrosa

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 on the pre-filled pen after CAD and EXP respectively. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C). The pre-filled pen should be put back in the refrigerator immediately after use. Do not freeze.

Keep the pen cap on the pre-filled pen to protect it from light.

You can use Terrosa for 28 days after the first injection while the pre-filled pen is stored in a refrigerator (between 2°C and 8°C).

Avoid placing the pre-filled pen near the freezer compartment of the refrigerator to prevent freezing. Do not use Terrosa if it has been frozen.

Each pre-filled pen should be disposed of properly after 28 days of first use, even if it is not empty.

Terrosa contains a clear and colorless solution. Do not use Terrosa if it has solid particles or if the solution is cloudy or discolored.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Terrosa Composition

• The active ingredient is teriparatide. Each 80 microliter dose contains 20 micrograms of teriparatide. A 2.4 ml pre-filled pen 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 (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injectable preparations (see section 2 "Terrosa contains sodium").

Product Appearance and Container Contents

Terrosa is a clear and colorless injectable solution. It is presented in a pre-filled pen. Each pre-filled pen contains 2.4 ml of solution sufficient for 28 doses.

Package sizes: boxes containing 1 or 3 pre-filled pens.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this product is also available by scanning the QR code below or the packaging with a smartphone. The same information is also available at the following URL: www.terrosapatient.com

The QR code must be included.

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu/

User Manual

Terrosa 20 micrograms (µg)/80 microliters solution for injection in pre-filled pen

Instructions for Use

Important Information

This Terrosa pre-filled pen is for the daily administration of a fixed dose of 80 microliters of the Terrosa injection solution for the treatment of osteoporosis.

Your pre-filled pen contains 28 doses.

There is no possibility of setting a different dose than 80 microliters.

If you cannot set the 80 microliter dose, it is because your pen is almost empty.

The Terrosa Pen is not rechargeable, do not use it after administering 28 doses.

Pen Parts

1. Pen cap
2. Needle connector
3. Cartridge holder
4. Cartridge plunger
5. Viewer/screen
6. Dose adjustment button

1. Pen needle
2. Inner needle cap
3. Outer needle cap
4. Removable label

The pen needle is not supplied with the pen. It must be placed before using the pen (see step 1c).

Before Starting

Before starting to use a new pen, please read these instructions completely. Follow the guidelines carefully when using the pen. Also, read the leaflet.

Write down the date of the first injection on a calendar.

Do not share your pen or needles as you may risk transmitting infectious agents.

Wash your hands before each injection.

Do not use your Terrosa pen if it is damaged or if you have any doubts about its proper functioning.

Prepare everything you will need: • alcohol swab • pre-filled pen • pen needle

1. Pen Preparation

1/a Remove the pen cap

• Remove the pen cap (1) by pulling it.

1/b Check the medication

• Check the pen label to ensure you have the correct medication and that it is not expired.
• Do not use the Terrosa pen if:

• the pen is damaged.
• the solution is cloudy, colored, or contains particles.

1/c Attach the needle

• Take a new needle for each injection, use only the needles recommended in the "Compatible Needles" section on the last page of the instructions for use.
• Do not use the pen needle if the removable label is damaged or not removed - discard it and take a new one.

• Remove the removable label (10).

• Press the needle against the end of the pen and screw ituntil it is firmly secured.

• Remove the outer needle cap (9) and store itin a safe place, as you will need it to remove the needle later. Keep the inner needle protector (8) on the needle to avoid accidental needlestick injuries.

1. Injection

2/a Set the dose

Your pen contains 28 fixed doses of 80 microliters. This fixed dose must be set for each daily injection.

• Turn the dose adjustment button (6) until the viewer (5) shows an arrow symbol and the dial is locked. You should hear a click when the dose is correctly set.
• The arrow symbol means that the daily fixed dose is set and the pen is ready for injection.
• If you cannot set the dose, the pen is almost empty. Use a new pen.

2/b Choose the injection site

• Use your abdomen or the top of your thigh for the injection. Prepare your skin as recommended by your doctor.
• Clean the chosen area with an alcohol swab.

• Carefully remove the inner needle protector (8) and discard it immediately.

2/c Dispense the dose

• Gently hold a skin fold between your thumb and index finger.

Insert the needle straight and gently into the skin.

• Press the dose adjustment button (6) all the way down and hold itfor at least 6 secondsto ensure the complete administration of the dose – You will hear a "click" when you start pressing the button, this is normal.

• Slowly remove the pen. Important: Check if the screen shows '0'.

1. After Injection

3/a Remove the needle

• Carefully replace the outer needle cap (9) covering the needle (7).

• Hold the outer needle cap (9) and unscrew the needle (7).
• Always discard the needles safely using a puncture-proof container or following your doctor's instructions.

3/b How to store the pen

• Put the cap (1) back on the pen.
• Return the pen to the refrigerator between 2 and 8 ºC immediately after use.

3/c How to dispose of the pen

When disposing of the pen after 28 days of use, do so carefully, and as described in the section "How to dispose of the Terrosa pen and used needles" on the last page of these Instructions for Use.

Troubleshooting

If you have any questions regarding the use of the Terrosa Pen, follow the instructions given in the table on the next page:

Important Additional Information

• The pre-filled Terrosa pen contains 28 daily fixed doses of 80 microlitersof Terrosa injectable solution for the treatment of osteoporosis.
• Do not transfer the medication to a syringe.
• Use the Terrosa pen only as directed by your doctor and according to the information in these Instructions for Use and the Terrosa leaflet.
• Use a new needle for each injection.
• The Terrosa pen can be used by patients over 18 years of age, healthcare professionals, or third parties such as adult family members.
• The Terrosa pen should not be used by blind or visually impaired patients without the help of a trained person without a disability. Consult your doctor if you have hearing or handling problems.

If you have any doubts about the use of the Terrosa pen, please contact the patient service.

Phone: XXXXXXXXXX

Email: XXXXXXXX

Compatible Needles

• Clickfine needle, 29 to 31 gauge (0.25 - 0.33 mm diameter) and 12, 10, 8, or 6 mm length.
• BD Micro-Fine needle, 29 to 31 gauge (0.25 - 0.33 mm diameter) and 12.7, 8, or 5 mm length.

Storage and Care of the Terrosa Pen

• Do not store the Terrosa pen with the needle attached as it may cause air bubbles to form in the cartridge.
• Transport and store the Terrosa pen at temperatures between 2 and 8 ºC.
• Do not store the Terrosa pen in the freezer. If the medication has frozen, discard the device and use a new Terrosa pen.
• Keep the Terrosa pen and needles out of the reach of children.
• Handle the pen with care. Do not drop the pen and avoid hitting it against hard surfaces. Protect it from water, dust, and humidity.
• You can use a damp cloth to clean the Terrosa pen. Do not use alcohol, solvents, or cleaning agents. Do not submerge the Terrosa pen in water, as it may damage it.
• Do not use the Terrosa pen if it is damaged or if you have doubts about its proper functioning.

How to Dispose of the Terrosa Pen and Used Needles

• Discard the Terrosa pen 28 daysafter the first use.
• Always remove the needle before disposing of the Terrosa pen.
• Place used needles in a puncture-proof container or a hard plastic container with a secure lid. Do not throw the needles directly into household waste.
• Do not recycle the filled puncture-proof container.
• Ask your doctor or pharmacist about the different options for properly disposing of the pen and the puncture-proof container.
• The instructions for handling needles are not intended to replace local, healthcare professional, or institutional policies.

Marketing Authorization Holder: Gedeon Richter Plc., Hungary

Manufactured by Gedeon Richter Plc., Hungary

This user manual was last revised on