Terrosa

Package leaflet: Information for the user

Terrosa 20 micrograms/80 microlitres injection solution

teriparatide
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Terrosa is and what it is used for

Terrosa contains the active substance teriparatide, which is used to strengthen bones and reduce the risk of fractures by stimulating bone formation.
Terrosa 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 it can also occur in men. Osteoporosis is also common in patients receiving treatment with medicines called corticosteroids.

2. What you should know before using Terrosa

Do not use Terrosa

• 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 unexplained high levels of alkaline phosphatase in your blood, which may indicate Paget's disease of the bone (a disorder 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
Terrosa may increase calcium levels in your blood or urine.
Contact your doctor before or during treatment with Terrosa:

• 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 have had or currently have kidney stones.
• If you have kidney problems (moderate renal impairment).

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

3. How to use Terrosa

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 (under the skin) in the thigh or abdomen.
To help you remember to take your medicine, inject it at the same time each day. Terrosa may be injected at mealtimes. Inject Terrosa every day for the entire duration prescribed by your doctor. The total duration of treatment with Terrosa must not exceed 24 months. You must not receive more than one 24-month course of treatment during your lifetime.
Your doctor may advise you to take Terrosa together with calcium and vitamin D. Your doctor will tell you how much calcium and vitamin D you should take each day.
Terrosa can be administered with or without food.
Terrosa cartridges are designed for exclusive use with the reusable multidose delivery system Terrosa Pen and compatible needles. The pen and injection needles are not supplied with Terrosa. However, at the start of treatment, you should use the cartridge and pen pack, which contains an inner carton with one Terrosa cartridge and an inner carton containing the Terrosa 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 use of 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 Terrosa Pen to inject other medicines (e.g. insulin).
The pen is specifically designed for exclusive use with Terrosa.
Do not refill the cartridge.
Do not transfer the medicine into a syringe.
You must inject Terrosa shortly after removing the pen with the cartridge inserted from the refrigerator. After use, immediately return the pen with the cartridge inserted to the refrigerator. Do not remove the cartridge from the pen after use. Store it in the cartridge holder throughout the 28-day treatment period.
Preparing the pen for use

• To ensure correct administration of Terrosa, always read the instructions for use of the pen

Terrosa 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 Terrosa (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 provided instructions. Do not re-prime the pen after the first dose.

Injecting Terrosa

• Before injecting Terrosa, 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 and hold the button down 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 is complete, 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 avoid needle blockage.
• Replace the cap on the pen. Leave the cartridge inside the pen.

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

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

If you stop using Terrosa
If you are considering stopping treatment with Terrosa, please discuss this with your doctor. Your doctor will advise you and determine how long your treatment should continue.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The most common side effect is limb pain (very common frequency, 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 (lightheadedness) after the injection, you should sit or lie down until you feel better. If you do not feel better, contact your 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 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 that carries 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
• leakage of urine
• 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Terrosa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 case to protect it from light.
You may use Terrosa 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
Terrosa if it has been frozen or if freezing has occurred.
After 28 days from first use, each cartridge must be properly disposed of, even if it is not completely empty.
Terrosa contains a clear, colourless solution. Do not use Terrosa if you notice solid particles or if the
solution appears cloudy or coloured.
Do not dispose of any medicine 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 Terrosa 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 “Terrosa contains sodium”)

Description of the appearance of Terrosa and contents of the pack
Terrosa is a clear, colourless injectable solution. Terrosa 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 peelable lid, contained in a box.
Pack containing Terrosa cartridge and pen: 1 Terrosa cartridge packed in a sealed plastic tray with a peelable lid, packed in an inner box, and 1 Terrosa Pen packed in an inner box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary

Other sources of information
Detailed information on this product is also available by scanning with a smartphone the QR code included below or on the outer packaging. The same information is available at the following URL: www.terrosapatient.com
QR code to be included
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu/

Instructions for use

Terrosa Pen

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

button; dial (display); threaded rod; flange; Terrosa cartridge; protective sheet; pen needle; inner needle cap; outer needle cap; pen cap; cartridge compartment,
dose selection knob, housing.
Preparing the pen – First use/cartridge change 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 Terrosa package leaflet).
Follow these instructions every time a new Terrosa cartridge is inserted into the Terrosa Pen system.
Do not repeat this procedure before each daily injection, otherwise the Terrosa dose will not be sufficient for the 28 days of treatment.
Read the package leaflet of the Terrosa cartridge provided separately.
A: Remove the pen cap.

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

C: If changing the cartridge, remove the empty cartridge. Insert a new Terrosa 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 its starting position, as in first use. The threaded rod cannot be fully pushed into the pen housing.

E: Reattach 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 film.

• Screw the pen needle clockwise onto the cartridge compartment. Ensure the pen needle is correctly attached and securely tightened onto 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: Loading
After inserting a new cartridge and before the first injection from each cartridge, the pen must be loaded and tested.

• Rotate the dose selection knob clockwise until a drop symbol appears on the dial (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 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 visible. Do not repeat step G more than 4 times, but follow the instructions provided in the troubleshooting section on the back of the page.

Administration using the Terrosa Pen System
Wash hands thoroughly with soap to minimize the risk of infection.
Ensure you have the following items ready:

• the Terrosa Pen system with cartridge inserted
• a compatible pen needle
• a sharps container for safe disposal of used needles. Do not use the pen if the cartridge is cloudy, discolored, or contains particles. Read the package leaflet of the Terrosa cartridge provided separately.

1. Attach 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 preparation. In this case, proceed directly to 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 properly attached and securely tightened on 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. Dose Setting 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 cannot be turned further. Make sure the dial (display) shows the arrow mark aligned with the indicator strip. During dose selection, the pen will emit an audible click and offer 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 pen preparation steps described above.

• Select an appropriate injection site and prepare the skin according to your doctor's instructions. Gently pinch a portion of skin between the 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 embedded in the skin. Seek immediate medical attention if a needle breaks and remains in the skin.

• Press the button until the dose indicator returns 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 administered.

3. Removing the pen needle

• Carefully place 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-resistant sharps container.

4. Replace the pen cap

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

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

Note for healthcare professionals
Instructions regarding handling and disposal of needles may be replaced by local, healthcare or institutional policies.
Additional information
The fixed-dose reusable pen is designed for easy administration of Terrosa for the treatment of osteoporosis. Each Terrosa cartridge contains 28 fixed doses of 80 microliters of Terrosa.
The Terrosa Pen system must be used only as prescribed by a physician, according to these Instructions for Use and the Terrosa package leaflet.
For self-injection, the Terrosa Pen system may be used by patients over 18 years of age, healthcare professionals, and third parties, such as adult family members.
The Terrosa Pen system must not be used by blind or visually impaired patients without the assistance of a physically capable and trained person.
Consult your physician if you have hearing or manual dexterity difficulties.
Pen needles must be used only once, and the Terrosa cartridge must be used by only one person.
Storage and care of the Terrosa 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 Terrosa Pen system, use a damp cloth only. Do not use alcohol, other solvents, or cleaning agents. Do not immerse the Terrosa Pen system in water, as this could damage the pen.
• Do not use the Terrosa Pen system if it is damaged or if you have doubts about its proper functioning.
• Transport and store the Terrosa Pen system with the cartridge inserted at the temperatures specified in the Terrosa package leaflet, provided separately.
• Store the Terrosa Pen system, cartridges, and pen needles out of reach of children.
• Do not store the Terrosa Pen system with the needle attached, as this may cause air bubbles to form in the cartridge.

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

Package leaflet: Information for the user

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

teriparatide
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Terrosa is and what it is used for

Terrosa contains the active substance teriparatide, which is used to strengthen bones and reduce the risk of fractures by stimulating bone formation.
Terrosa 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 should know before using Terrosa

Do not use Terrosa

• 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 high 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 undergone radiation therapy involving the bones.
• If you are pregnant or breastfeeding.

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

• 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 have or have had kidney stones.
• If you have kidney problems (moderate renal impairment).

Some patients may experience dizziness or a rapid heartbeat after taking the first doses of Terrosa. During the initial doses, if you feel dizzy, inject Terrosa in a place where you can sit or lie down.
The recommended treatment period of 24 months must not be exceeded.
Before starting to use a new pre-filled pen, record the medicine's batch number and the date of the first injection on the outer pen container and in your calendar, and provide this information if reporting any adverse reactions.
Terrosa must not be used in growing adults.
Children and adolescents
Terrosa must not be used in children and adolescents (under 18 years of age).
Other medicines and Terrosa
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 use Terrosa if you are pregnant or breastfeeding. If you are a woman of childbearing potential, you must use effective contraceptive methods during treatment with Terrosa. If you become pregnant while using Terrosa, treatment must be stopped. Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Some patients may experience dizziness after injection of Terrosa. If you feel dizzy, do not drive or operate machinery until you feel better.
Terrosa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".

3. How to use Terrosa

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 microliters) administered once daily by subcutaneous injection (under-the-skin injection) in the thigh or abdomen.
To help you remember to take your medicine, inject it at the same time each day. Terrosa may be injected at mealtimes. Inject Terrosa every day for the entire duration prescribed by your doctor. The total duration of treatment with Terrosa must not exceed 24 months. You must not receive more than one 24-month treatment course during your lifetime.
Your doctor may advise you to take Terrosa with calcium and vitamin D. Your doctor will tell you how much calcium and vitamin D you should take each day.
Terrosa can be administered with or without food.
Compatible injection needles are not supplied with Terrosa.
The pre-filled pen can be used with injection needles designed 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.
For proper use of this medicine, it is very important to carefully follow the detailed instructions for using the pre-filled pen provided with the medicine.
Always use a new needle for each injection to prevent contamination, and dispose of the needle safely after use.
Never store the pre-filled pen with the needle attached.
Do not transfer the medication into a syringe.
You must inject Terrosa shortly after removing the pre-filled pen from the refrigerator. After use, replace the pen cap on the pre-filled pen and immediately return it to the refrigerator. Store it in the refrigerator before and throughout the 28-day treatment period.
Preparation for injection

• To ensure 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. Ensure that there are at least 28 days remaining before expiry. Record the batch number and the actual date of the first injection of the pre-filled pen on a calendar. You must also record the date of the first injection on the outer carton of Terrosa (see the designated space on the box: {First use:}).
• Attach a new injection needle to the pre-filled pen and set the dose in the display window by rotating the dose-setting knob.

Injecting Terrosa

• Before injecting Terrosa, 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 and hold the dose-setting knob for at least six seconds to ensure the full dose is delivered.
• Immediately after completing the injection, place the protective cap over the needle and screw it counterclockwise to remove the needle from the pen. This will keep the remaining medicine sterile and prevent leakage from the pre-filled pen. It will also prevent air from entering the pre-filled pen and blockage of the needle.
• Replace the cap onto the pre-filled pen.
• Dispose of used pen needles safely using a sharps container or as advised by your doctor.

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

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

If you stop using Terrosa
If you are considering stopping treatment with Terrosa, please discuss this with your doctor. Your doctor will advise you and determine how long you should continue treatment with Terrosa.

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 everyone gets them.

The most common side effect is limb pain (very common, 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 following 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 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 blood cholesterol levels
• depression
• neuropathic leg pain
• feeling faint
• dizziness
• 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 that carries food to the stomach (hiatal hernia)
• decrease in haemoglobin or number of red blood cells in the blood (anaemia)

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

• increased heart rate
• abnormal heart sounds
• shortness of breath
• 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Terrosa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the prefilled pen after SCAD/EXP. The expiry date refers to the last day of that month.
Store always in the refrigerator (2°C to 8°C). The prefilled pen must be returned to the refrigerator immediately after use. Do not freeze.
Replace the pen cap on the prefilled pen to protect it from light.
You may use Terrosa for up to 28 days after the first injection, provided that the prefilled pen is stored in the refrigerator (2°C–8°C).
Avoid placing the prefilled pen near the freezer compartment of the refrigerator to prevent freezing. Do not use Terrosa if it has been frozen or is frozen.
After 28 days from first use, each prefilled pen must be properly disposed of, even if it is not completely empty.
Terrosa contains a clear, colourless solution. Do not use Terrosa if you notice solid particles or if the solution appears cloudy or discoloured.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Terrosa contains

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

Description of the appearance of Terrosa and contents of the pack
Terrosa is a clear, colourless injectable solution. Terrosa is supplied in a pre-filled pen. Each
pre-filled pen contains 2.4 mL of solution, sufficient for 28 doses.
Pack contents: 1 pre-filled pen or 3 pre-filled pens contained in a box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
Other sources of information
Detailed information about this product is also available by scanning with a smartphone the
QR code included below or on the outer packaging. The same information is also available
on the following URL: www.terrosapatient.com
QR code to be included
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/
User manual for the pen
Terrosa 20 micrograms (µg)/80 microlitres solution for injection in pre-filled pen
Instructions for use
Important information
This pre-filled Terrosa pen is for administering a fixed daily dose of 80 microlitres of injectable
Terrosa solution for the treatment of osteoporosis.
Your pre-filled pen contains 28 doses.
It is not possible to set a dose different from 80 microlitres.
If you are unable to set the 80 microlitre dose, this means the pen is nearly empty.

Terrosa pen is not recyclable, do not use after 28 doses
Guide to pen parts

1. Cap
2. Needle connector
3. Cartridge holder
4. Cartridge plunger
5. Dose viewing window
6. Dose setting knob
7. Pen needle
8. Inner needle shield
9. Outer needle cap
10. Removable seal

The pen needle is not included in the pen packaging. It must be attached before using the pen (see step 1c).
Before you start
Before starting to use your new Terrosa pen, please read these instructions completely. Follow the instructions carefully when using the pen. Also read the package leaflet provided.
Write the date of first injection on a calendar.

Do not share the pen or needles, as this could pose a risk of transmission of infectious agents.

Wash your hands before each injection.
Do not use the Terrosa pen if it is damaged or if you have doubts about its proper functioning.
Prepare everything you need: • alcohol swabs • the pre-filled pen • a pen needle
1 Preparation of the pen
1/a Remove the pen cap

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

1/b Check the medicine

• Check the label on the Terrosa pen to make sure you have the correct medicine and that it has not expired.

• Do not use the Terrosa pen if:
  o The pen is damaged.
  o The solution is cloudy, discoloured, or contains particles.
  1/c Attach the needle
• Use a new pen needle for each injection and only use pen needles recommended in the “Compatible pen needles” section on the back page of these instructions for use.
• Do not use the pen needle if the removable seal is damaged or loose – discard it and take a new one.
• Remove the removable seal (10).
• Press the needle onto the tip of the pen and screw it on until firmly attached.
• Remove the outer needle cap (9) and keep it, as you will need it later to remove the needle. Keep the inner needle shield (8) on the needle to prevent accidental injury.

1. Injection

2/a Setting the dose
The pen contains 28 fixed doses of 80 microliters. This fixed dose must be set
for each daily injection.

• Rotate the dose-setting knob (6) until the display window (5) shows the arrow symbol and the knob locks into place – you should hear a click when the dose is correctly set.
• The arrow mark indicates that the daily fixed dose is set and the pen is ready for injection.
• If you are unable to set the dose, this means the pen is nearly empty. Use a new pen.

2/b Choose the injection site

• Use the abdomen or the upper thigh for the injection. Prepare the skin as recommended by your doctor.
• Clean the selected area with an alcohol swab.
• Carefully remove the inner needle cap (8) and dispose of it immediately.

2/c Administering the dose

• Gently pinch a fold of skin between your thumb and index finger. Insert the needle straight and gently into the skin.
• Press the dose-setting knob (6) fully down and keep it pressed for at least 6 seconds to ensure the complete dose is delivered.
  You will hear a click when you start pressing the knob, which is normal.

• Slowly withdraw the pen. Important: check whether the dial (display) shows “0”.

2. After injection

3/a Remove the needle

• Carefully place the outer needle cap (9) over the pen needle (7).
• Hold the outer needle cap (9) and unscrew the pen needle (7).
• Always dispose of used pen needles safely using a sharps container or as advised by your doctor.

3/b Storing the pen

• Replace the pen cap (1) on the pen.

• Immediately after use, store the pen in the refrigerator at 2–8 °C.

3/c Disposal of the pen
When the pen needs to be disposed of after 28 days of use, do so carefully and as described in the section "Disposal of Terrosa pen and used needles" on the back of these Instructions for Use.

Troubleshooting
If you have any questions about using the Terrosa pen system, follow the instructions provided in the table:

Important additional information

• The pre-filled Terrosa pen contains 28 fixed daily doses of 80 microliters. Terrosa injectable solution is for the treatment of osteoporosis.
• Do not transfer the medicine into a syringe.
• Use Terrosa pen only as prescribed by your doctor, as described in these Instructions for Use and in the Terrosa package leaflet.
• Use a new needle for each injection.
• Terrosa pen may be used by patients over 18 years of age for self-injection, or by healthcare professionals or third parties, such as adult family members.
• Terrosa pen must not be used by blind patients or by those with visual impairments without the assistance of someone trained in the proper use of the pen. Consult your doctor if you have hearing or manual dexterity problems.

If you have any questions about using Terrosa pen, contact our customer service.
Phone number: 0039 02 495 39 950
E-mail: [email protected]
Needles compatible with the pen

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

Storage and care of the Terrosa pen system

• Do not store Terrosa pen with the needle attached, as this may cause air bubbles to form in the cartridge.
• Transport and store Terrosa pen at temperatures between 2 - 8 °C.
• Do not store Terrosa pen in the freezer. If the medicine has been frozen, discard the device and use a new Terrosa pen.
• Keep 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 moisture.
• To clean the Terrosa pen system, use a damp cloth only. Do not use alcohol, other solvents, or cleaning agents. Never immerse Terrosa pen in water, as this could damage the

pen.

• Do not use Terrosa pen if it is damaged or if you are unsure about its proper functioning.

Disposal of used Terrosa pen and needles

• Discard Terrosa pen 28 days after first use.
• Always remove the needle from the pen before disposing of Terrosa pen.
• Place used needles in a sharps disposal container or in a hard plastic container with a secure lid. Do not dispose of needles directly into household waste.
• Do not recycle the full sharps disposal container.
• Ask your doctor or pharmacist how to properly dispose of the pen and the sharps container.
• The instructions regarding needle handling are not intended to replace local, healthcare or institutional regulations.

Marketing Authorization Holder: Gedeon Richter Plc., Hungary
Manufactured by Gedeon Richter Plc., Hungary
This user manual was last revised in MM/YYYY