DECAPEPTYL DAILY 0.1 mg powder and solvent for injectable solution

Introduction

Package Leaflet: Information for the User

Decapeptyl Daily 0.1 mg Powder and Solvent for Solution for Injection

Triptorelin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Decapeptyl Daily is and what it is used for.
   1. What you need to know before you use Decapeptyl Daily.
   2. How to use Decapeptyl Daily.
   3. Possible side effects.
   4. Storing Decapeptyl Daily.

Contents of the pack and other information

1. What Decapeptyl Daily is and what it is used for

This medicine contains triptorelin. Triptorelin belongs to a group of medicines known as gonadotropin-releasing hormone (GnRH) analogues. One of its actions is to decrease the levels of sex hormones in the body.

Decapeptyl Daily is indicated in women, for the treatment of female infertility, as a complementary treatment associated with gonadotropins (HMG, FSH, HCG) during ovulation induction for in vitro fertilization and embryo transfer (IVF-ET).

2. What you need to know before you use Decapeptyl Daily

Do not use Decapeptyl Daily:

• if you are allergic (hypersensitive) to triptorelin, to gonadotropin-releasing hormone (GnRH), to other GnRH analogues or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breast-feeding.

Warnings and precautions:

Depression has been reported in patients treated with Decapeptyl Daily, which can be severe. If you are being treated with Decapeptyl Daily and you experience depression, inform your doctor.

If you have an unknown benign tumor (adenoma) of the pituitary gland, this may be discovered during treatment with Decapeptyl Daily. Symptoms include headache, visual problems, and paralysis of the eyes.

In adults, triptorelin may cause bones to become less dense (osteoporosis) with an increased risk of bone fractures. Therefore, inform your doctor if you have any of the following risk factors:

• If you or a close relative have osteoporosis.
• If you drink excessive amounts of alcohol and/or are a heavy smoker.
• If you have been taking medications that can cause your bones to become less dense, such as medications for epilepsy or steroids (such as hydrocortisone or prednisolone).

If you experience seizures, inform your doctor immediately. Seizures have been reported in patients treated with triptorelin or similar medicines. These occurred in patients with or without a medical history of epilepsy.

During fertility treatment, gonadotropins (hormones that stimulate the ovaries) combined with this product may induce an increase in ovarian size or cases of ovarian hyperstimulation syndrome (abnormal production of eggs leading to fluid accumulation in the abdominal area, causing swelling and pain, and difficulty breathing). If this happens, consult your doctor immediately.

Patients receiving this treatment should be under close medical supervision with regular radiological, clinical, and biological checks.

Consult your doctor if you are concerned about any of these issues.

Other medicines and Decapeptyl Daily

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Pregnancy and breast-feeding

Decapeptyl Daily must not be used during pregnancy or breast-feeding.

If you discover that you are pregnant while taking this medicine, inform your doctor immediately so that the treatment can be discontinued.

Driving and using machines

You may feel dizzy, tired, or experience vision problems, such as blurred vision. These are possible side effects of the treatment or the underlying disease. If you experience any of these side effects, do not drive or operate machinery.

Decapeptyl Daily contains sodium

This medicine contains sodium, but less than 1 mmol (23 mg) of sodium per vial; this is essentially "sodium-free".

3. How to use Decapeptyl Daily

Follow exactly the administration instructions of this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Decapeptyl Daily must be administered exclusively by subcutaneous route (under the skin).

The dose will be established by the doctor based on the needs of each patient. The usual doses are as follows:

Short protocol: One subcutaneous injection of one vial of Decapeptyl Daily 0.1 mg from day 2 of the cycle (concurrently with the start of ovarian stimulation) until the day before the planned induction. The average duration of treatment is 10 to 12 days per cycle.

Long protocol: One subcutaneous injection of one vial of Decapeptyl Daily 0.1 mg from day 2 of the cycle. When pituitary desensitization appears (E2 <50 pg ml) approximately on day 15 after the start of treatment, gonadotropin stimulation is initiated while continuing administration decapeptyl daily 0.1 mg until before planned induction. duration this treatment can be 18 to 25 days per cycle.< p>

If you use more Decapeptyl Daily than you should

No cases of adverse reactions due to overdose have been reported.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20.

If you forget to use Decapeptyl Daily

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Decapeptyl Daily

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

4. Possible side effects

Like all medicines, Decapeptyl Daily 0.1 mg can cause side effects, although not everybody gets them.

Many of the side effects are expected due to the change in testosterone levels in your body. These effects can include hot flashes, impotence, and decreased libido.

In rare cases, you may experience a severe allergic reaction. Consult your doctor immediately if you develop symptoms such as difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue, rash.

If you have an unknown benign tumor (adenoma) of the pituitary gland, this may be discovered during treatment with Decapeptyl Daily. Symptoms include sudden headache, vomiting, vision problems, and paralysis of the eyes.

As with other GnRH analogues, an increase in white blood cell count may occur in patients treated with Decapeptyl Daily.

Many of the side effects are expected due to the change in estrogen levels in your body.

Very common side effects (affect more than 1 in 10 people):

• headache,
• decreased libido, mood changes, difficulty sleeping,
• breast disorders, ovarian hyperstimulation syndrome, pain during or after sexual intercourse, enlarged ovaries, genital bleeding, pelvic pain, vaginal dryness,
• excessive sweating, acne, oily skin,
• hot flashes
• weakness.

Common side effects (affect 1 to 10 people in 100):

• breast pain,
• muscle cramps, painful joints, pain in arms and legs,
• weight gain,
• feeling unwell, nausea, abdominal pain or discomfort,
• depression (long-term treatment), nervousness,
• painful bruising, redness, and swelling at the injection site,
• swelling of the ankles, feet, or fingers,
• allergic reaction,
• dizziness.

Uncommon side effects (affect 1 in 100 to 1 in 1,000 people):

• feeling your heartbeat,
• vertigo,
• dry eyes, blurred vision,
• abdominal distension, vomiting, dry mouth, flatulence, mouth ulcers,
• weight loss,
• decreased appetite, fluid retention,
• back pain, muscle pain,
• abnormal taste, loss of sensation, temporary loss of consciousness, memory loss, lack of concentration, tingling, and numbness, involuntary muscle movement,
• mood changes, anxiety, disorientation, depression (short-term treatment)
• bleeding after sexual intercourse, prolapse, irregular period, intense and painful period, small cysts (swelling) in the ovaries that can cause pain, vaginal discharge,
• difficulty breathing, nosebleeds,
• hair loss, dry skin, excessive body hair, brittle nails, itching, skin rash.

During post-marketing surveillance, the following side effects have also been reported (their frequency cannot be estimated from the available data):

• fever, general malaise,
• anaphylactic reaction (severe allergic reaction that causes difficulty breathing or dizziness and swelling of the face and throat),
• seizures
• abnormal blood test results (including elevated liver function tests),
• muscle weakness,
• confusion,
• absence of menstrual periods,
• rapid formation of papules due to skin or mucous membrane inflammation,
• increased blood pressure,
• diarrhea,
• abnormal sensations in the eyes and/or changes in vision,
• if there is a pituitary tumor, an increased risk of bleeding in the area.

During fertility treatment, gonadotropins combined with this product may induce abdominal or pelvic pain or difficulty breathing. If this happens, consult your doctor as soon as possible.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Decapeptyl Daily

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

Store Decapeptyl Daily in its original package.

Store below 25°C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

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

6. Contents of the pack and other information

Composition of Decapeptyl Daily

The active substance is triptorelin (acetate), 0.1 mg per vial.

The other ingredients are:

• Powder: mannitol
• Solvent: sodium chloride and water for injections.

Appearance of the product and contents of the pack

Each pack contains:

• seven vials containing the lyophilized powder with the active substance
• seven ampoules of 1 milliliter of solvent to reconstitute the solution.

Marketing authorization holder and manufacturer

Marketing authorization holder:

IPSEN PHARMA, S.A.U.

Gran Via de les Corts Catalanes 130-136

08038 Barcelona

Spain

Manufacturer:

IPSEN PHARMA-BIOTECH

Parc d'Activité du Plateau de Signes, C.D. 402,

83870 Signes

France

Date of last revision of this leaflet: February 2025

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