Label: information for the user

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

teriparatida

Read this label carefully before starting to use this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they 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 label. See section 4.

Terrosa contains the active ingredient 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 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.

Do not use Terrosa

• 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 may 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

Terrosa may increase calcium levels in your blood or urine.

Consult your doctor before or while using Terrosa:

• 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).

Some patients may experience dizziness or increased heart rate after the first doses of Terrosa. For the first doses, use Terrosa 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 starting to use a new pre-filled pen, note the batch number (Batch) of the medication and the date of the first injection on the pen's box and on a calendar, and provide this information when reporting any adverse reactions.

Terrosa should not be used in adults in growth.

Children and adolescents

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

Other medications and Terrosa

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 Terrosa if you are pregnant or breastfeeding. If you are a fertile woman, you should use effective contraceptive methods during Terrosa treatment. If you become pregnant while using Terrosa, discontinue Terrosa treatment. Consult your doctor or pharmacist before using this medication.

Driving and operating machines

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

Terrosa contains sodium

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

Follow exactly the administration instructions for 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 via subcutaneous injection in the thigh or abdomen.

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

Inject Terrosa every day for as long as your doctor prescribes. The total duration of treatment with Terrosa 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 Terrosa with calcium and vitamin D. Your doctor will indicate how much you should take each day.

Terrosa can be administered with or without food.

Needle-compatible syringes are not supplied with Terrosa.

The pre-filled pen can be used with 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.

To use this medication correctly, it is very important to follow the detailed usage instructions for the pre-filled pen provided with the medication strictly.

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 in place.

Do not transfer the medication 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 correct administration of Terrosa, always read the Terrosa pre-filled pen usage instructions, included in the medication packaging.
• Wash your hands before handling the pre-filled pen.
• Check the expiration date on the pre-filled pen label before starting to use the medication. Ensure that at least 28 days remain until the expiration date. Note the batch number (Batch) and the date of the first injection of the pre-filled pen in use on a calendar. You must also record the date of the first injection in the Terrosa packaging (see the provided space in the box: {First use:}).
• Place a new needle on the pre-filled pen and set the dose on the viewing window by rotating the dose adjustment button.

Terrosa injection

• Before injecting Terrosa, 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 dose adjustment button and keep it pressed for at least 6 seconds to ensure you receive the full dose.
• Once you have finished the injection, place the needle protection cap on the needle of the pen; screw the cap in the opposite direction to the needles of a clock 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.
• Dispose of the needles safely using a sharp object container or following your doctor's instructions.

If you use more Terrosa than you should

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

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

If you forget to use Terrosa

If you forget a dose or cannot inject your medication at the usual time, do it as soon as possible that 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 Terrosa

If you are thinking of interrupting 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 doubts about using 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 experience discomfort around the injection site, such as skin redness, 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 1,000 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
• gastric acid reflux (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 had severe 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):

• kidney function reduction, including renal insufficiency
• swelling, mainly in the hands, feet, and legs

Reporting side effects

If you experience any 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 national notification system included in Appendix V. 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 on the preloaded pen after CAD and EXP respectively. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2 °C and 8 °C). The preloaded pen must be returned to the refrigerator immediately after use. Do not freeze.

Keep the pen cap placed on the preloaded pen to protect it from light.

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

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

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

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

Medicines should not be thrown away through 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 Terrosa

• The active ingredient is teriparatide. Each dose of 80 microliters contains 20 micrograms of teriparatide. A preloaded pen 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 injection preparations (see section 2 “Terrosa contains sodium”).

Appearance of the product and contents of the package

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

Package sizes: boxes containing 1 or 3 preloaded pens.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

Last review date of this leaflet:

Other sources of information

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

The QR code must be included.

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

User manual

Terrosa 20 micrograms (µg)/80 microliters injectable solution in preloaded pen

Instructions for use

Important information

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

Your preloaded pen contains 28 doses.

No other dose can be established other than 80 microliters.

If you cannot establish the dose of 80 microliters, it is because your pen is almost empty.

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

Parts of the pen

1. Pen cap

2. Needle connector

3. Cartridge holder

4. Cartridge plunger

5. Visor/sensor

6. Dose adjustment button

7. Pen needle

8. Internal needle cap

9. External needle cap

10. 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.

Record the date of the first injection in 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-impregnated swab • preloaded 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 that it has 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 Adjust 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 – discard it and take a new one.

• Remove the removable label (10).

• Press the needle against the end of the pen andpush ituntil it is firmly seated.

• Remove the external needle cap (9) andstore itin a safe place, as you will need it to remove the needle later. Keep the internal needle cap (8) on the needle to avoid accidental needlestick injuries.

1. Injection

2/a Dose setting

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 visor (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 adjust the dose, the pen is almost empty. Use another pen.

2/b Choose the injection site

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

• Carefully remove the internal needle cap (8) and discard it immediately.

2/c Dose delivery

• Gently pinch a fold of skin 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 andhold itfor at least6 secondsto ensure the delivery of the full dose – You will hear a “click” when you start pressing the button, this is normal.

• Withdraw the pen slowly. Important: Check if the screen shows ‘0’.

1. After injection

3/a Remove the needle

• Put the external needle cap (9) back over the needle (7).

• Hold the external needle cap (9) and unscrew the needle (7).
• Always dispose of needles safely using a sharps container or following your doctor's instructions.

3/b How to store the pen

• Put the pen cap (1) back on the pen.
• Put the pen in the refrigerator at a temperature between 2 and 8 °C immediately after use.

3/c How to dispose of the pen

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

Problem-solving

If you have any questions about using the Terrosa Pen, follow the instructions given in the table on the next page:

Additional important information

• The Terrosa preloaded pen contains28 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 instructed 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 old, healthcare professionals, or third parties such as adult family members.
• The Terrosa pen should not be used by blind patients or visually impaired patients without the help of a trained person without visual impairment. Consult your doctor if you have hearing or manipulation problems.

If you have any doubts about using the Terrosa pen, please contact the patient support service.

Phone: XXXXXXXXXX

Email: XXXXXXXX

Compatible needles

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

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 °C.
• Do not store the Terrosa pen in the freezer. If the medication has frozen, discard the device and use a new Terrosa pen.
• Store the Terrosa pen and needles out of the reach of children.
• 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 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 any doubts about its proper functioning.

How to dispose of the Terrosa pen and used needles

• Dispose of the Terrosa pen after28 daysof first use.
• Always remove the needle before disposing of the Terrosa pen.
• Put used needles in a sharps container or a plastic container with a secure lid. Do not throw used needles directly in the household trash.
• Do not recycle a sharps container that is full.
• Ask your doctor or pharmacist about the different options for disposing of the pen and the sharps container properly.
• The instructions for handling needles do not replace local policies, healthcare professional policies, or institutional policies.

Marketing authorization holder: Gedeon Richter Plc., Hungary

Manufactured by Gedeon Richter Plc., Hungary

This user manual was last reviewed on