Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable

Leaflet: information for the user

Decapeptyl daily 0.1 mg powder and solvent for injectable solution

Triptorelin

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

1. What you need to know before starting to use Decapeptyl daily.
2. How to use Decapeptyl daily.
3. Possible side effects.
4. Storage of Decapeptyl daily.

Contents of the pack and additional information

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

Decapeptyl diario is indicated in women, for the treatmentfemale infertility,ascomplementary treatment associated with gonadotropin hormones (HMG, FSH, HCG) during ovulation induction for in vitro fertilization and embryo transfer (IVF-ET).

Do not use Decapeptyl daily:

• if you areallergic(hypersensitive) to triptorelin, gonadotropin-releasing hormone (GnRH), other GnRH analogs, or any of the other components of this medication (listed in section 6).
• if you are pregnant or breastfeeding.

Warnings and precautions:

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

If you have an unknown pituitary gland tumor (benign), it may be discovered during treatment with Decapeptyl daily. Symptoms include headaches, visual problems, and eye paralysis.

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

• if you or a close relative has less dense bones.
• if you consume excessive amounts of alcohol, and/or are a heavy smoker.
• if you have taken medications that may cause bones to be less dense for a long time, such as epilepsy medications or steroids (e.g., hydrocortisone or prednisolone).

If seizures occur, inform your doctor immediately. Cases of seizures have been reported in patients treated with triptorelin or similar medications. These occurred in patients with or without a history of epilepsy.

During fertility treatment, gonadotropins (hormones to stimulate the ovaries) combined with the product may cause 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 have close medical supervision with regular radiological, clinical, and biological controls.

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

Other medications and Decapeptyl daily

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased without a prescription.

Pregnancy and breastfeeding

Decapeptyl daily should not be used during pregnancy or breastfeeding.

If you discover you are pregnant and are taking this medication, inform your doctor immediately so they can discontinue treatment.

Driving and operating machinery

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

Decapeptyl daily contains sodium

This medication contains sodium, but less than 1 mmol (23 mg) of sodium per vial; 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.

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

The dose will be established by the doctor according to the needs of each patient. The normal doses are as follows:

Short protocol: A daily 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 treatment duration is 10 to 12 days per cycle.

Long protocol: A daily subcutaneous injection of one vial of Decapeptyl daily 0.1 mg from day 2 of the cycle. When hypophyseal desensitization appears (E2 <50)

If you use more Decapeptyl daily than you should

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

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

If you forgot to use Decapeptyl daily

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Decapeptyl daily

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

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

Many of the side effects are expected due to the change in the level of testosterone in your body. These side effects may 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 enlargement (benign tumor) of the pituitary gland that you were not aware of, it may be discovered during treatment with Decapeptyl daily. Symptoms include sudden headache, vomiting, vision problems, and eye paralysis.

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

Many of the side effects are expected as a result of the change in the level of estrogens in your body.

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

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

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

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

Rare side effects (affect 1 in 10 patients in 1000):

• feeling heartbeats,
• dizziness,
• dry eyes, blurred vision,
• abdominal distension, vomiting, dry mouth, flatulence, mouth ulcers,
• weight loss,
• loss of appetite, fluid retention,
• back pain, muscle pain,
• abnormal taste, numbness, 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 sex, prolapse, irregular periods, intense and painful periods, small cysts (swelling) in the ovaries that may cause pain, vaginal discharge,
• difficulty breathing, nasal bleeding,
• 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
• effects on certain blood tests (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, a higher risk of bleeding in the area.

During fertility treatment, combined gonadotropins with the 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 type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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 medication.

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

Store Decapeptyl daily in its original packaging.

Store below 25 °C.

Do not use this medication after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Decapeptyl daily

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

The other components are:

• Powder: mannitol
• Solvent: sodium chloride and water for injectable preparations.

Appearance of the product and contents of the packaging

Each package contains:

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

IPSEN PHARMA, S.A.U.

Gran Via de les Corts Catalanes 130-136

08038 Barcelona

Spain

Responsible for manufacturing:

IPSEN PHARMA-BIOTECH

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

83870 Signes

France

Last review date of this leaflet: February 2025

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