Label: information for the user

20 micrograms/80 microliters injectable solution in a preloaded EFG pen

Teriparatide

Read this label carefully before starting to use this medication, 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 medication 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.

1. What is Duratil and how is it used

2. What you need to know before starting to use Duratil

3. How to use Duratil

4. Possible adverse effects

5. Storage of Duratil

6. Contents of the package and additional information

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

This medication 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 corticosteroids.

Do not use Duratil

• If you are allergic to teriparatide or any of the other ingredients in 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 ever been diagnosed with bone cancer or other types of cancer that 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 an 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

Duratil may cause an increase in the amount of calcium in your blood or urine.

Consult your doctor or pharmacist before starting to use or while using Duratil:

• 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 a history of kidney stones.
• If you have kidney problems (moderate renal insufficiency), tell your doctor.

Some patients experience dizziness or increased heart rate after the first doses. For the first doses, use Duratil 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.

Duratil should not be used in adults in growth.

Children and adolescents

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

Other medicines and Duratil

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, as occasional interactions may occur (e.g. digoxin/digitals, a medicine used to treat heart diseases).

Pregnancy and breastfeeding

Do not use Duratil if you are pregnant or breastfeeding. If you are a fertile woman, use effective contraceptive methods during Duratil treatment. If you become pregnant, discontinue Duratil treatment. Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

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

Important information about some excipients in Duratil

This medicine contains less than 23 mg of sodium (1 mmol) per dose; 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 it at the same time every day.

Before using the pen for the first time, you need to prepare it. Please, consult the User Manual.

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

Consult the User Manual included in the package with instructions on how to use the Duratil pen. The pen can be used with insulin injection needles. Some product presentations include the number of insulin injection needles needed for 28 injections (plus 2 additional replacement needles) (see Section 6).

The Duratil injection should be performed shortly after removing the pen from the refrigerator, as indicated in the User Manual. Return the pen to the refrigerator immediately after use. You should use a new needle for each injection and discard it after each use. Do not store the pen with the needle attached. Never share your Duratil pen with others.

Your doctor may recommend taking calcium and vitamin D with Duratil. Your doctor will tell you how much to take each day.

Duratil can be used with or without food.

If you use more Duratil than you should

If you accidentally administer more Duratil than prescribed, consult your doctor or pharmacist. The expected effects of an overdose may include nausea, vomiting, dizziness, and headache. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you interrupt treatment with Duratil

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

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

Like all medicines, this medicine may 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), discomfort, headache, and dizziness (common). 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. Cases of fainting associated with the use of Duratil have been reported.

If you experience discomfort such as skin redness, pain, swelling, itching, bruises, or light bleeding around the injection site (common), these should disappear in a few days or weeks. If not, inform your doctor as soon as possible.

Some patients may have experienced allergic reactions just after the injection, which consist of difficulty breathing, facial swelling, skin rash, and chest pain (rare frequency). 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
• Sensation of fainting
• Sensation of everything spinning
• Irregular heart palpitations
• Difficulty breathing
• Increased sweating
• Muscle cramps
• Loss of energy
• Fatigue
• Chest pain
• Low blood pressure
• Acid reflux (pain or burning sensation just below the sternum)
• Vomiting
• Hernia of the tube that carries food to the stomach
• Anemia (low hemoglobin or low red blood cell count)

Uncommon: may affect up to 1 in 100 patients

• Increased heart rate
• Abnormal heart sound
• Shortness of breath
• Hemorrhoids (piles)
• Accidental loss or leakage of urine
• Increased need to urinate
• Weight gain
• Kidney stones
• Pain in the muscles and joints.Some patients have experienced severe back spasms 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

• Reduction in kidney function, including renal insufficiency
• Swelling, mainly in the hands, feet, and legs

Reporting of 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 Spanish System for Pharmacovigilance of Medicines for Human Use: 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 pen after CAD. The expiration date is the last day of the month indicated.

Cap the pen with the cap after each use (due to the light sensitivity of the injectable solution).

Duratil must be stored in the refrigerator (between 2°C and 8°C) at all times. You can use Duratil for 28 days after the first injection as long as the pen is stored in the refrigerator (between 2°C and 8°C). Do not freeze. Avoid placing the pens near the freezer of the refrigerator to prevent freezing. Do not use Duratil if it has been frozen.

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

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

Medications should not be thrown away through the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Duratil

• The active principle is teriparatide. Each milliliter of injectable solution contains 250 micrograms of teriparatide.
• The other components are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injectable preparations. Additionally, a solution of hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH.

Aspect of the product and content of the package

Duratil is a transparent and colorless solution. It is presented in a cartridge included in a preloaded disposable pen. Each pen contains 2.4 ml of solution sufficient for 28 doses. The product is available in packages containing:

• 1 pen with 28 injection needles (plus 2 additional replacement needles)
• 1 pen
• 3 pens

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

GP-PHARM, S.A.

Polígono Industrial Els Vinyets-Els Fogars, Sector 2, Carretera Comarcal C-244, Km 22

08777 Sant Quintí de Mediona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

• Spain:Duratil 20 micrograms/80 microliters injectable solution in preloaded pen EFG
• Germany:Teriparatid BCN Peptides 20 Mikrogramm/80 Mikroliter Injektionslösung im Fertigpen

Date of the last review of this leaflet:August 2020

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

USER MANUAL OF THE PEN

User Manual

Usage instructions

General description of the pen parts

Duratil is a medicine supplied in a pen. The pen contains medicine for a once-daily injection for 28 consecutive days.

Use a new needle for each injection.

You may not receive needles with the pen; in this case, the pen can be used with insulin injection needles. Consult your doctor or pharmacist to determine which needle is best for you.

1. Pen cap
2. Medicine cartridge
3. Label
4. Dosage window
5. Dose selector
6. Dosage button
7. Outer needle protector
8. Inner needle protector
9. Needle
10. Sealing film

For your safety

Important information

• Read the instructions carefully. Follow all instructions carefully.
• Read the leaflet provided with the pen.
• If you have questions, contact your doctor, pharmacist, or caregiver.

Prevention of infectious diseases

• Do not share your pen, as this may transmit infectious diseases.
• Use a new sterile needle for each injection. Used needles pose a risk of transmitting infectious diseases.

Pen usage

• Check the pen label when removing the pen from the refrigerator. Ensure you are using the correct medicine.
• Verify the expiration date; do not use the pen if the expiration date has passed.
• Check the medicine: it should be transparent, colorless, and free of particles.
• Do not transfer the medicine to a syringe. Duratil must be administered using this pen.
• Do not use the pen after 28 injections. Record the first injection date in the Injection Diary on the reverse of these usage instructions. Calculate the date for the 28th injection using a calendar and also record this date in the Injection Diary.
• It is not recommended to use the pen in blind or visually impaired individuals without the assistance of a support person.

Storage

• Keep the pen in the refrigerator, preferably in the door compartment.
• Keep the pen and needles out of the reach of children.

Problem-solving

• If you encounter a problem with the injection, do not administer a second injection on the same day.
• Read the "What to do if..." section in these Usage Instructions.
• Do not use the pen if it is damaged.
• Use the pen only if the medicine is transparent, colorless, and free of particles.
• If you cannot resolve the problem yourself or are unsure, contact your doctor, pharmacist, or caregiver.

Preparing the pen before the first injection

Before the FIRST injection, you must prepare your pen as described below.

You must perform this step only once. You do not need to repeat this procedure for the second injection or any subsequent injections.

Placing the needle

1. Remove the pen cap.

2. Take a new needle and remove the sealing film from the outer needle protector.

3. Place the needle with the outer needle protector in the pen. Turn the outer needle protector clockwise until it stops.

4. Remove the outer needle protector and store it for later use.

Adjusting the dose

5. Turn the dose selector until it stops. Ensure that the number "80" is completely visible and centered in the dosage window with the white mark aligned in the dosage window.

6. Remove the inner needle protector and discard it.

7. Hold the pen with the needle pointing upwards. Press the dosage button until it stops and hold it pressed for 5 seconds (see the figure on the next page).

8. Confirm the dose. Ensure that the number "0" is completely visible and centered in the dosage window, the white mark is aligned in the dosage window, and the marks on the dose selector and the pen body are aligned.

Removing the needle

Remove the needle after preparing the pen, as it poses a risk of contamination.

9. Carefully insert the needle into the outer needle protector that you stored in step 4 (see the figure on the next page). Do not touch the needle to avoid puncturing yourself.

10. Turn the outer needle protector counterclockwise and remove the needle from the pen.

11. Dispose of the needle with the outer needle protector in a sharps disposal container that you can obtain from your pharmacy or doctor.

Maintaining the Injection Diary

12. Record the current date and the date of the 28th injection in the Injection Diary on the reverse of these usage instructions.

Now your pen is prepared for the first and all subsequent injections as described in the following section:

Injecting Duratil

Prepare for injection

• Wash your hands before each injection.
• Prepare the injection site (in the thigh or abdomen) according to the instructions of your doctor, pharmacist, or caregiver.

Use a new needle for each injection because a new needle is sharp and allows for a virtually painless injection. A used needle poses the risk of being clogged or contaminated.

Placing the needle

1. Remove the pen cap.

2. Take a new needle and remove the sealing film from the outer needle protector.

3. Place the needle with the outer needle protector in the pen. Turn the outer needle protector clockwise until it stops.

4. Remove the outer needle protector and store it for later use.

Adjusting the dose

5. Turn the dose selector until it stops. Ensure that the number "80" is completely visible and centered in the dosage window with the white mark aligned in the dosage window.

6. Remove the inner needle protector and discard it.

7. Gently pinch a fold of skin on the thigh or abdomen.

8. Insert the needle, preferably at a 90-degree angle, into the prepared injection site. Press the dosage button until it stops and hold it pressed for 5 seconds. Count slowly to 5.

9. Remove the needle from the skin.

10.Confirm administration of the dose. Ensure that the number "0" is completely visible and centered in the dosage window, the white mark is aligned in the dosage window, and the marks on the dose selector and the pen body are aligned.

Removing the needle

Remove the needle immediately after using the pen.

1. Carefully insert the needle into the outer needle protector that you stored in step 4. Do not touch the needle to avoid puncturing yourself.

12. Turn the outer needle protector counterclockwise and remove the needle from the pen.

13. Dispose of the needle with the outer needle protector in a sharps disposal container that you can obtain from your pharmacy or doctor.

14. Replace the pen cap on the pen.

Storing the pen

Do not store the pen with a needle attached. This may cause air bubbles to form in the medicine cartridge. Always cover the pen with the pen cap.

Remove the pen from the refrigerator only when you are ready to use it. Store the pen in the refrigerator, preferably in the door compartment. Do not store the pen near the back of the refrigerator or in the freezer. The medicine becomes ineffective if it freezes.

If your pen has not been stored in the refrigerator for a long time, do not dispose of it. Return the pen to the refrigerator and consult your doctor, pharmacist, or caregiver.

Disposable pen

The pen must be disposed of on the day of the last injection (see the Injection Diary). Dispose of the pen even if there is medicine remaining in the cartridge.

Dispose of the pen according to the instructions of your doctor or pharmacist.

Place the pen cap on the pen before disposing of it. Do not dispose of the pen with the needle attached.

What to do if...

Air bubbles in the cartridge: you can use your pen without any problems.

While preparing the pen for the first use, the pen does not expel medicine: repeat the steps described again in the "Adjusting the dose" section (page 5).

The dosage button is blocked or you think you have not administered the full dose: Do not administer a second injection on the same day. Continue with your regular injection the next day. Ensure that you turn the dose selector to the top and that the number "80" is completely visible and centered in the dosage window with the white mark aligned in the dosage window.

The User Manual was last updated in August 2020.