DECAPEPTYL SEMESTRAL 22.5 mg powder and solvent for prolonged-release injectable suspension

2. What you need to know before using Decapeptyl semestral

Do not use Decapeptyl semestral

If you are allergic to triptorelin pamoate, gonadotropin-releasing hormone (GnRH), other GnRH analogues, or any of the other components of this medication (listed in section 6).

If you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Decapeptyl semestral:

• If you develop depressive behavior. Cases of depression have been reported in patients treated with Decapeptyl semestral, which can be severe. Your doctor may want to monitor your depression during treatment.
• If you use medications to prevent blood clotting, as bruising may occur at the injection site.
• In case of seizures, inform your doctor immediately. Cases of seizures have been reported in patients receiving triptorelin or similar medications. These occurred in patients with or without a medical history of epilepsy.

The product should only be injected into the muscle.

In men

• In adults, triptorelin may cause bones to be less dense (osteoporosis) with an increased risk of bone fractures. Therefore, inform your doctor if you have any of the following risk factors, as they may prescribe a bisphosphonate (a medication used to treat weak bones) to treat bone loss. Risk factors may include:

• If you or a close relative has less dense bones.
• If you drink excessive amounts of alcohol, and/or are a heavy smoker and/or have a poor diet.
• If you have taken medications for a long time that can cause your bones to be less dense, such as medications for epilepsy or steroids (such as hydrocortisone or prednisolone).

• If you have vascular or heart problems, including heart rhythm problems (arrhythmia), or if you are being treated with medications for this condition. The risk of heart rhythm problems may be increased when using Decapeptyl semestral.

• If you have diabetes or heart or vascular problems.
• When starting treatment, there will be a transient increase in testosterone levels in your body, which can worsen cancer symptoms. Consult your doctor if this happens. The doctor may give you a medication (an anti-androgen) to prevent symptoms from worsening.
• As with other GnRH analogues, you may experience symptoms due to spinal cord compression (e.g., pain, numbness, or weakness in the legs) or urethral blockage during the first few weeks of treatment. If any of these symptoms appear, consult your doctor immediately, who will evaluate and provide appropriate treatment for these problems.
• If you have undergone surgical castration, triptorelin will not induce any further decrease in serum testosterone levels and should not be used.
• If you are going to undergo diagnostic tests for pituitary or sexual organ function, during treatment or after discontinuation of Decapeptyl semestral, the results may be erroneous.
• If you have an existing pituitary tumor, it may be discovered during treatment with Decapeptyl semestral. Symptoms include headache, vomiting, vision problems, and eye paralysis.
• Medications that decrease testosterone may cause changes in the ECG associated with cardiac rhythm abnormalities (QT prolongation).
• Treatment with GnRH analogues such as Decapeptyl semestral may increase the risk of anemia (defined as a decrease in red blood cell count).

In children

• If you have a progressive brain tumor, inform your doctor. This may affect how your doctor decides to treat you.
• Girls with precocious puberty may experience some vaginal bleeding during the first month of treatment.
• If your child experiences severe or recurrent headache, vision problems, or ringing in the ears, contact a doctor immediately (see section 4).
• When treatment is discontinued, signs of puberty appear.

In girls, menstrual bleeding will begin on average one year after treatment is discontinued.

Your doctor should rule out precocious puberty caused by other diseases.

Bone mineral density decreases during treatment but returns to normal levels after treatment is discontinued.

• After treatment is discontinued, a hip condition (slipped capital femoral epiphysis of the hip) may occur. This causes stiffness in the hip, limping, and/or severe pain in the groin that radiates to the thigh. If this happens, you should consult your doctor.

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

Other medications and Decapeptyl semestral

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

Decapeptyl semestral may interfere with certain medications used to treat heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (e.g., methadone (used for pain relief and as part of drug detoxification), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor before using this medication.

Do not use Decapeptyl semestral if you are pregnant.

Do not use Decapeptyl semestral if you are breastfeeding.

Driving and using machines

Although administered according to the instructions, Decapeptyl semestral may modify certain reactions to the point of altering the ability to drive or use machines. This is particularly noticeable in combination with alcohol. You may feel dizzy, be tired, or have vision problems, such as blurred vision. These are possible adverse effects of treatment or due to the underlying disease. If you experience any of these adverse effects, you should not drive or operate machines.

Decapeptyl semestral contains sodiumbut less than 1 mmol (23 mg) of sodium per vial, so it is considered "sodium-free" and can be taken with a low-sodium diet.

3. How to use Decapeptyl semestral

Decapeptyl semestral 22.5 mg will be administered under the supervision of a doctor.

In men

Therapy for prostate cancer with Decapeptyl semestral 22.5 mg requires long-term treatment.

For hormone-dependent prostate cancer that is high-risk or locally advanced in combination with radiotherapy, the recommended treatment duration is 2-3 years.

The usual dose is 1 vial of Decapeptyl semestral injected into the muscle every six months (24 weeks). Decapeptyl semestral is only for injection into the muscle.

Your doctor may perform blood tests to measure the effectiveness of the treatment.

Use in children

Normally, you will receive an injection every 6 months (24 weeks). Decapeptyl semestral is only for injection into the muscle. Your doctor will decide when treatment should be discontinued (usually when you are 12-13 years old, in the case of girls, and 13-14 years old in boys).

If you feel that the effect of Decapeptyl semestral is too strong or too weak, inform your doctor or pharmacist.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

Seek medical attention immediately if you experience any of the following symptoms:

Difficulty swallowing or breathing problems, swelling of your lips, face, throat, or tongue, or hives. These may be signs of a severe allergic reaction or angioedema, which have been reported in rare cases (may affect up to 1 in 1000 people).

Other adverse effects that may occur:

In men

As can be observed during treatment with other GnRH agonists or after surgical castration, the most frequent adverse reactions related to treatment with triptorelin were due to its expected pharmacological effects. These effects included hot flashes and decreased libido.

An increase in lymphocyte count has been described in patients receiving GnRH analogues. With the exception of immune-allergic reactions and reactions at the injection site, all adverse reactions are related to changes in testosterone levels.

Very common: may affect more than 1 in 10 people:

• Hot flashes
• Weakness
• Excessive sweating
• Back pain
• Feeling of tingling and numbness in the legs
• Decreased libido
• Impotence

Common: may affect up to 1 in 10 people:

• Nausea, dry mouth
• Pain, bruising, redness, and swelling at the injection site, muscle and bone pain, pain in arms and legs, edema (fluid accumulation in body tissues), lower abdominal pain
• High blood pressure
• Allergic reaction
• Weight gain
• Dizziness, headache
• Loss of libido, depression, mood changes

Uncommon: may affect up to 1 in 100 people:

• Increased platelet count
• Feeling of heartbeats
• Ringing in the ears, dizziness, blurred vision
• Abdominal pain, constipation, diarrhea, vomiting
• Drowsiness, intense shivering associated with sweating and fever, somnolence, pain
• Certain analytical parameters affected (including increased liver function tests), increased blood pressure
• Weight loss
• Loss of appetite, increased appetite, gout (severe pain and swelling of the joints, usually in the big toe), diabetes, high blood lipid levels
• Joint pain, muscle cramps, muscle weakness, muscle pain, swelling, and sensitivity, bone pain
• Tingling or numbness
• Insomnia, feeling of irritability
• Breast development in men, chest pain, reduced testicular size, testicular pain

Rare: may affect up to 1 in 1000 people

• Red or purple discoloration of the skin
• Abnormal sensation in the eye, vision changes, or blurred vision
• Feeling of abdominal fullness, flatulence, abnormal taste
• Chest pain
• Difficulty standing
• Flu-like symptoms, fever
• Nasal/throat inflammation
• Increased body temperature
• Joint stiffness, joint swelling, musculoskeletal stiffness, osteoarthritis
• Memory loss
• Feeling of confusion, decreased activity, feeling of euphoria
• Difficulty breathing when lying down
• Blisters
• Low blood pressure

Unknown: frequency cannot be estimated from available data

• ECG changes (QT prolongation),
• General malaise,
• Anxiety
• Urinary incontinence.
• If there is a pre-existing pituitary tumor, increased risk of bleeding from the area.
• Anemia (decrease in red blood cell count)

In children

Very common: may affect more than 1 in 10 people

• Vaginal bleeding that may occur in girls in the first month of treatment

Common: may affect up to 1 in 10 people

• Abdominal pain
• Pain, redness, and swelling at the injection site
• Headache
• Hot flashes
• Weight gain
• Acne
• Hypersensitivity reactions

Uncommon: may affect up to 1 in 100 people

• Blurred vision
• Vomiting
• Constipation
• Nausea
• General malaise
• Overweight
• Neck pain
• Mood changes
• Chest pain
• Nosebleeds
• Itching
• Rash or hives on the skin

Unknown: frequency cannot be estimated from available data

• High blood pressure
• Abnormal vision
• Severe allergic reaction that causes difficulty swallowing, breathing problems, swelling of the lips, face, throat, or tongue, or hives
• Seizures
• Affectation of certain blood tests, including hormone levels
• Rapid formation of habits due to skin or mucous membrane inflammation
• Muscle pain
• Mood changes
• Depression
• Nervousness.
• Idiopathic intracranial hypertension (increased pressure around the brain, characterized by headache, double vision, and other visual symptoms, and ringing in the ears).

Your doctor will determine the measures to be taken to counteract them.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Decapeptyl semestral

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

Do not use Decapeptyl semestral after the expiration date stated on the packaging and labels after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

The reconstituted suspension should be used immediately.

Do not store above 25°C.

6. Container Content and Additional Information

Composition of Decapeptyl Semestral

The active ingredient is triptorelin.

A vial contains triptorelin pamoate equivalent to 22.5 mg of triptorelin.

After reconstitution in 2 ml of solvent, 1 ml of reconstituted suspension contains 11.25 mg of triptorelin.

The other components are:

Powder: D,L-lactide-co-glycolide polymer, mannitol, sodium carmellose, and polysorbate 80.

Solvent: water for injectable preparations.

Appearance of the Product and Container Content of Decapeptyl Semestral

This medicinal product is a powder and solvent for injectable suspension, the powder is a white to almost white powder and the solvent is a clear solution.

Container with 1 vial, 1 ampoule, and 1 blister pack with 1 injection syringe and 2 injection needles.

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

Chemin départemental Nº 402

83870 Signes

France

This medicinal product is authorized in the EEA Member States under the following names:

AT, DE: Pamorelin LA 22.5 mg

BE, LU: Decapeptyl Sustained Release 22.5 mg

CZ, PL, SK: Diphereline SR 22.5 mg

DK, FI, NL, NO, SE: Pamorelin 22.5 mg

EL: Arvekap 22.5 mg

ES: Decapeptyl Semestral 22.5 mg powder and solvent for prolonged-release injectable suspension

FR: Decapeptyl LP 22.5 mg

HU: Diphereline SR 22.5 mg por és oldószer retard szuszpenziós injekcióhoz

LV: Diphereline 22.5 mg

SI: Pamorelin 22.5 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sprošcanjem

Date of the Last Revision of this Leaflet:January 2025

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The detailed and updated 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

This information is intended only for healthcare professionals:

INSTRUCTIONS FOR RECONSTITUTION