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

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Duratil 20 micrograms/80 microliters injectable solution in a pre-filled pen EFG

Teriparatide

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Duratil is and what it is used for

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

This medicine is used for the treatment of osteoporosis in adults. Osteoporosis is a disease that causes your bones to weaken and become fragile. This condition is especially common in women after menopause, but it can also occur in men. Osteoporosis is also common in patients being treated with corticosteroids.

2. What you need to know before using Duratil

Do not use Duratil

• 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 (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 elevated alkaline phosphatase levels in your blood without apparent cause, which could indicate Paget's disease of the bone (a disorder involving 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 or while using Duratil:

• If you continuously experience nausea, vomiting, constipation, low energy, or muscle weakness, inform your doctor. These may be symptoms of high calcium levels in your blood.
• If you suffer from kidney stones or have a history of kidney stones.
• If you suffer from kidney problems (moderate renal insufficiency), you must inform your doctor.

Some patients, after the first doses, may experience dizziness or increased heart rate. For the initial 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 must not be exceeded.

Duratil must not be used in growing adults.

Children and adolescents

Duratil must not be used in children and adolescents (under 18 years of age).

Other medicines and Duratil

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, as interactions may occasionally occur (e.g., digoxin/digitalis, a medicine used to treat heart conditions).

Pregnancy and breastfeeding

Do not use Duratil if you are pregnant or breastfeeding. If you are a woman of childbearing age, you must use effective contraceptive methods during treatment with Duratil. If you become pregnant, treatment with Duratil must be discontinued. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Some patients may feel dizzy after an injection of Duratil. If you feel dizzy, you must not drive or operate machinery until you feel better.

Important information about some excipients in Duratil

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

3. How to use Duratil

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 20 micrograms (corresponding to 80 microliters), administered once daily by subcutaneous injection (injection under the skin) in the thigh or abdomen. To help you remember to take your medicine, inject it around the same time each day.

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

Inject Duratil every day for as long as your doctor prescribes. The total duration of treatment with Duratil must not exceed 24 months. You must not receive more than one 24-month course of treatment with Duratil during your lifetime. Duratil may be injected at mealtimes.

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

The Duratil injection should be administered shortly after removing the pen from the refrigerator, as indicated in the User Manual. Return the pen to the refrigerator immediately after use. A new needle must be used for each injection and discarded after each use. Do not store the pen with the needle attached. Never share your Duratil pen with others.

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

Duratil may be used with or without food.

If you use more Duratil than you should

If you have accidentally administered more Duratil than prescribed, consult your doctor or pharmacist. Effects that could be expected from an overdose include nausea, vomiting, dizziness, and headache. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget or are unable to inject Duratil at the usual time, do so as soon as possible on the same day. Do not administer a double dose to make up for missed doses. Do not inject more than once on the same day. Do not attempt to compensate for a missed dose.

If you stop treatment with Duratil

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The most common adverse effects are limb pain (very common, may affect more than 1 in 10 people), malaise, headache, and dizziness (common). If you feel dizzy after an injection, sit or lie down until you feel better. If symptoms do not improve, consult your doctor before continuing treatment. Cases of fainting have been reported with the use of Duratil.

If you experience discomfort such as redness of the skin, pain, swelling, itching, bruising, or slight bleeding around the injection site (common), these should disappear within a few days or weeks. If they do not, inform your doctor as soon as possible.

Some patients may have experienced allergic reactions immediately after injection, consisting of difficulty breathing, facial swelling, skin rash, and chest pain (rare frequency). In rare cases, severe and potentially life-threatening allergic reactions may occur, including anaphylaxis.

Other adverse effects are:

Common: may affect up to 1 in 10 patients

• Increased blood cholesterol levels
• Depression
• Neuralgic leg pain
• Sensation of fainting
• Sensation of spinning (vertigo)
• 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 sternum)
• Vomiting
• Hiatal hernia (hernia of the tube carrying 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 sounds
• Shortness of breath
• Hemorrhoids
• Involuntary loss or leakage of urine
• Increased need to urinate
• Weight gain
• Kidney stones
• Muscle and joint pain. Some patients have experienced severe back cramps or pain and required hospitalization.
• Increased blood calcium levels
• Increased blood uric acid levels
• Increased levels of an enzyme called alkaline phosphatase

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

• Reduced kidney function, including renal failure
• Swelling, mainly in the hands, feet, and legs

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Duratil

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

Do not use this medicine after the expiry date stated on the packaging and pen after EXP. The expiry date refers to the last day of the month indicated.

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

Duratil must always be stored in a refrigerator (between 2°C and 8°C). After first opening, Duratil may be kept at temperatures up to 25°C for a maximum of seven days when refrigeration is unavailable. After this period, the medicine must be returned to the refrigerator and used within 28 days of the first injection. The Duratil pen must be discarded if it has been kept outside the refrigerator at temperatures up to 25°C for more than seven days.

Do not freeze. Avoid placing the pens near the freezer compartment of the refrigerator to prevent freezing. Do not use Duratil if it has been frozen or is frozen.

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

Duratil contains a clear, colourless solution. Do not use Duratil if it contains solid particles or if the solution is cloudy or discoloured.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Duratil

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

Appearance of the product and contents of the pack

Duratil is a clear, colourless solution. It is supplied in a cartridge contained within a disposable pre-filled pen. Each pen contains 2.4 ml of solution, sufficient for 28 doses. The product is available in packs containing:

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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 medicinal product is authorised in the European Economic Area member states under the following names:

• Spain: Duratil 20 micrograms/80 microlitres solution for injection in pre-filled pen EFG

Date of the most recent review of this leaflet: April 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

USER MANUAL FOR THE PEN

User Manual

Instructions for Use

Overview of the pen components

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

Use a new needle for each injection.

Needles may not be supplied with the pen; in this case, the pen can be used with insulin injection needles. Please consult your doctor or pharmacist to determine the most suitable needle for you.

1. Pen cap
2. Medication cartridge
3. Label
4. Dose window
5. Dose selector
6. Dose button
7. Needle outer cap
8. Needle inner cap
9. Needle
10. Seal foil

For your safety

Important information

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

Prevention of infectious diseases

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

Using the pen

• Check the pen label when removing the pen from the refrigerator. Make sure you are using the correct medicine.
• Verify the expiry date; do not use the pen if the expiry date has passed.
• Inspect the medicine: it should be clear, colourless, and free from 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 day of injection in the Injection Diary on the reverse of these instructions. Calculate the date of the 28th injection using a calendar and also record this date in the Injection Diary.
• The use of the pen is not recommended for 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.

Troubleshooting

• If you experience a problem during injection, do not administer a second injection on the same day.
• Read the section “What to do if…” in these Instructions for Use.
• Do not use the pen if it is damaged.
• Use the pen only if the medicine is clear, colourless, and free from 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.

This step must be performed only once. You do NOT need to repeat this procedure for the second or any subsequent injections.

Attaching the needle

1. Remove the pen cap.
2. Take a new needle and remove the seal foil from the needle outer cap.

1. Attach the needle with the needle outer cap onto the pen. Screw the needle outer cap clockwise until it stops.

1. Remove the needle outer cap and keep it for later use.

Setting the dose

1. Turn the dose selector until it stops. Ensure that the number “80” is fully visible and centred in the dose window, with the white mark aligned in the slot of the dose window.

1. Remove the needle inner cap and discard it.

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

1. Confirm the dose. Ensure that the number “0” is fully visible and centred in the dose window, the white mark is aligned in the slot of the dose window, and the engraved marks on the dose selector and pen body are aligned.

Removing the needle

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

1. Carefully insert the needle back into the needle outer cap saved in step 4 (see figure on the next page). Do not touch the needle to avoid accidental needlestick.

1. Unscrew the needle by turning the needle outer cap counterclockwise and remove the needle from the pen.

1. Dispose of the needle with the needle outer cap in a sharps disposal container, which you can obtain from your pharmacy or doctor.

Maintaining the Injection Diary

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

Your pen is now ready for the first and all subsequent injections as described in the following section:

Injecting Duratil

Preparing for injection

• Wash your hands before each injection.
• Prepare the injection site (on the thigh or abdomen) as instructed by your doctor, pharmacist, or caregiver.

Use a new needle for each injection, as a new needle is sharp and allows for an almost painless injection. A used needle may be blocked or contaminated.

Attaching the needle

1. Remove the pen cap.
2. Take a new needle and remove the seal foil from the needle outer cap.

1. Attach the needle with the needle outer cap onto the pen. Screw the needle outer cap clockwise until it stops.

1. Remove the needle outer cap and keep it for later use.

Setting the dose

1. Turn the dose selector until it stops. Ensure that the number “80” is fully visible and centred in the dose window, with the white mark aligned in the slot of the dose window.

1. Remove the needle inner cap and discard it.

1. Gently pinch a skin fold on the thigh or abdomen.
2. Insert the needle into the prepared injection site, preferably at a 90-degree angle. Press the dose button until it stops and hold it for 5 seconds. Count slowly to 5.

1. Remove the needle from the skin.

1. Confirm dose delivery. Ensure that the number “0” is fully visible and centred in the dose window, the white mark is aligned in the slot of the dose window, and the engraved marks on the dose selector and pen body are aligned.

Removing the needle

Always remove the needle immediately after using the pen.

1. Carefully insert the needle back into the needle outer cap saved in step 4. Do not touch the needle to avoid accidental needlestick.

1. Unscrew the needle by turning the needle outer cap counterclockwise and remove the needle from the pen.

1. Dispose of the needle with the needle outer cap in a sharps disposal container, which you can obtain from your pharmacy or doctor.

2. Replace the pen cap onto the pen.

Storing the pen

Do not store the pen with a needle attached. This may cause air bubbles to form in the medication 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 against the back wall of the refrigerator or in the freezer. The medicine becomes unusable if frozen.

If your pen has not been stored in the refrigerator for a prolonged period, do not discard it. Return the pen to the refrigerator and consult your doctor, pharmacist, or caregiver.

Disposable pen

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

Dispose of the pen as instructed by your doctor or pharmacist.

Place the pen cap on the pen before disposal. Do not discard the pen with the needle attached.

What to do if…

Air bubbles in the cartridge: You may use your pen without any problem.

During preparation for first use, the pen does not expel medicine: Repeat the steps described in the section “Setting the dose” (page 5).

The dose button is blocked or you feel that the full dose was not injected: Do not administer a second injection on the same day. Continue with your next scheduled injection the following day. Make sure to turn the dose selector fully until it stops and that the number “80” is fully visible and centred in the dose window, with the white mark aligned in the slot of the dose window.

Injection Diary

Date of first injection:	Day 1
	Day 2
	Day 3
	Day 4
	Day 5
	Day 6
	Day 7
	Day 8
	Day 9
	Day 10
	Day 11
Manufacturer GP-PHARM, S.A. Polígono Industrial Els Vinyets-Els Fogars, Sector 2, Carretera Comarcal C-244, Km 22 08777 Sant Quintí de Mediona Spain	Day 12
Day 13
Day 14
Day 15
Day 16
Day 17
Day 18
Day 19
Day 20
	Day 21
	Day 22
	Day 23
	Day 24
	Day 25
	Day 26
	Day 27
Date of last injection:	Day 28

The User Manual was last updated in August 2020.