Decapeptyl Daily 0.1 mg powder and solvent for solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

Decapeptyl Daily 0.1 mg powder and solvent for injectable solution

Triptorelin

Read all of this 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 must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

Pack contents and additional 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 reduce 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 gonadotropin hormones (HMG, FSH, HCG) during ovulation induction for in vitro fertilization and embryo transfer (IVF-ET).

2. What you need to know before using Decapeptyl daily

Do not use Decapeptyl daily:

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

Warnings and precautions:

Cases of depression, which may be severe, have been reported in patients treated with Decapeptyl daily. If you are being treated with Decapeptyl daily and experience depression, inform your doctor.

If you have an undiagnosed enlargement (benign tumor) of the pituitary gland, this may be discovered during treatment with Decapeptyl daily. Symptoms include headache, visual disturbances, and eye paralysis.

In adults, triptorelin may cause reduced bone density (osteoporosis), increasing the risk of bone fractures. Therefore, inform your doctor if you have any of the following risk factors:

• If you or a close family member has reduced bone density.
• If you drink excessive amounts of alcohol, and/or are a heavy smoker.
• If you have long-term used medications that may reduce your bone density, for example, medications for epilepsy or steroids (such as hydrocortisone or prednisolone).

If seizures occur, 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 infertility treatment, gonadotropins (hormones stimulating the ovaries) used in combination with this product may cause ovarian enlargement or ovarian hyperstimulation syndrome (abnormal increase in egg production leading to fluid accumulation in the abdominal area, causing swelling, pain, and breathing difficulties). If this occurs, consult your doctor immediately.

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

Consult your doctor if you have any concerns regarding these issues.

Other medicines and Decapeptyl daily

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

Decapeptyl daily must not be used during pregnancy or breastfeeding.

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

Driving and using machines

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

Decapeptyl daily contains sodium

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

3. How to use Decapeptyl daily

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

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

The dose will be determined by the physician according to each patient's needs. The usual doses are as follows:

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

Long protocol: One daily subcutaneous injection of one vial of Decapeptyl daily 0.1 mg starting on day 2 of the cycle. When pituitary desensitization occurs (E2 < 50 pg/ml), approximately on day 15 after starting treatment, gonadotropin stimulation is initiated while continuing administration of Decapeptyl daily 0.1 mg until the day before the expected induction day. The duration of this treatment may be 18 to 25 days per cycle.

If you use more Decapeptyl daily than you should

No 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 at telephone number: 91 562 04 20.

If you forget to use Decapeptyl daily

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

If you stop treatment with Decapeptyl daily

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

4. Possible adverse effects

Like all medicines, Decapeptyl daily 0.1 mg may cause adverse effects, although not everyone will experience them.

Many of the adverse effects are expected due to changes in your testosterone levels. These effects may include hot flushes, impotence, and decreased libido.

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

If you have an undiagnosed enlargement (benign tumor) of the pituitary gland, it may become apparent during treatment with Decapeptyl daily. Symptoms include sudden headache, vomiting, visual disturbances, and eye paralysis.

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

Many of the adverse effects are expected as a consequence of changes in your estrogen levels.

Very common adverse effects (may 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 flushes,
• weakness.

Common adverse effects (may affect from 1 to 10 in 100 people):

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

Uncommon adverse effects (may affect 1 in 1,000 people):

• awareness of heartbeat,
• dizziness,
• 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, difficulty concentrating, tingling and numbness, involuntary muscle movements,
• mood changes, anxiety, disorientation, depression (with short-term treatment),
• bleeding after sexual intercourse, prolapse, irregular periods, heavy and painful periods, small ovarian cysts (swelling) which may cause pain, vaginal discharge,
• difficulty breathing, nosebleeds,
• hair loss, dry skin, excessive body hair growth, brittle nails, itching, skin rash.

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

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

During infertility treatment, gonadotropins used in combination with this product may cause abdominal and/or pelvic pain or difficulty breathing. If this occurs, consult your doctor as soon as possible.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, 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 Decapeptyl daily

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

Store Decapeptyl daily in its original packaging.

Store below 25 °C.

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

Medicines should not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be taken to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This 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 components are:

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

Nature of the product and pack contents

Each pack contains:

• seven vials containing the lyophilized powder with the active substance
• seven 1-millilitre ampoules of solvent for reconstituting 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 the most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es