Decapeptyl semestral 22,5 mg polvo y disolvente para suspension de liberacion prolongada inyectable

Product Information:Information for the User

Decapeptylsemestral22,5 mg powder and solvent for prolonged release suspension for injection

Triptorelin

Read this entire product information carefully before starting to use this medicine, because it contains important information for you

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

1. What isDecapeptylsemestraland for what it is used

2. What you need to know before starting to useDecapeptyl semestral

3. How to useDecapeptyl semestral

4. Possible adverse effects

5. Storage ofDecapeptyl semestral

6. Contents of the pack and additional information.

Decapeptyl semestral contains triptorelin, which is similar to a hormone called gonadotropin-releasing hormone (GnRH analogue).It is a prolonged-action formulation designed to slowly release 22.5 mg of triptorelin over a period of 6 months (24 weeks).In men, triptorelin decreases testosterone hormone levels. In women, it reduces estrogen levels.

In adult men, Decapeptyl semestral is used to treat locally advanced hormone-dependent prostate cancer and hormone-dependent prostate cancer that has spread to other parts of the body (metastatic cancer).It is also used to treat high-risk or locally advanced prostate cancer in combination with radiation therapy.

In children, from 2 years old, Decapeptyl semestral is used to treat early puberty, which appears at a very young age, before 8 years old in girls and 10 years old in boys (precocious puberty).

No use Decapeptyl semestral

If you areallergicto triptorelin pamoate, 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

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 are taking blood-thinning medications, as they may causehematomasat the injection site.
• If you experience 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 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. The risk factors may include:

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

• If you have any problems with blood vessels or the heart, including arrhythmia, or if you are being treated with medications for this condition. The risk of arrhythmia problems may be increased when using Decapeptyl semestral.

• If you havediabetesor if you havecardiovascular problems.
• When starting treatment, there will be a temporary increase in the amount of testosterone in your body, which may makesymptomsof cancerworse. Consult your doctor if this happens. Your doctor may give you a medication (an antiandrogen) to prevent symptoms from worsening.
• As with other GnRH analogs, you may experience symptoms due to spinal cord compression (e.g., pain, numbness, or weakness in the legs) or urethral blockage during the first weeks of treatment. If any of these symptoms occur, consult your doctor immediately, who will evaluate and provide appropriate treatment for these problems.
• If you have undergonecastration surgery, triptorelin does not induce any additional decrease in serum testosterone levels and should not be used.
• If you are to undergo diagnostic tests for pituitary gland or sex organ function, during treatment or after stopping treatment with Decapeptyl semestral, test results may be erroneous.
• If you have anunrecognizedbenign tumor of thepituitary gland, it may be discovered during treatment with Decapeptyl semestral. Symptoms include headache, vomiting, visual problems, and eye paralysis.
• Medications that decrease testosterone may cause changes in the ECG associated with cardiac rhythm anomalies (prolongation of QT).
• The treatment with GnRH analogs like 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 vaginal bleeding during the first month of treatment.
• If your child experiences intense or recurring headaches, visual problems, and ringing or buzzing in the ears, contact a doctor immediately (see section 4).
• When treatment is stopped, pubertal signs will appear.

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

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

The amount of minerals in bones decreases during treatment but returns to normal levels after stopping treatment.

• After stopping treatment, you may experience a hip pathology (slipping of the femoral head epiphysis in the hip). This causes hip stiffness, limp, and/or intense pain in the groin that radiates to the thigh. If this occurs, consult your doctor.

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

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 interact with some 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), moxifloxacino (an antibiotic), antipsychotics used for severe mental illnesses).

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant or planning to become pregnant, 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 operating machinery

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

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.

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

In men

The cancer of the prostate therapy with Decapeptyl semestral 22.5mg requires long-term treatment.

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

The usual dose is1 vialof Decapeptyl semestral injected into the muscle everysix 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

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

If you feel that the action 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Difficulty swallowing or breathing, 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 side effects that may occur:

In men

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

An increase in the number of lymphocytes has been reported in patients receiving GnRH analogs. Except for 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
• 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, arm and leg pain, edema (concentration of fluids in the body tissues), lower abdominal pain
• High blood pressure
• Allergic reaction
• Weight gain
• Dizziness, headache
• Decreased libido, depression, mood changes

Rare: may affect up to 1 in 100 people:

• Increased platelet count
• Feeling 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), high 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 lipids
• Joint pain, muscle cramps, muscle weakness, muscle pain, swelling and sensitivity, bone pain
• Numbness or tingling
• Inability to sleep, feeling irritable
• Development of breast tissue in men, chest pain, reduction in testicular size

Testicular pain

• Difficulty breathing
• Acne, hair loss, itching, rash, redness of the skin, hives
• Waking up to urinate, problems urinating
• Nosebleeds

Rare: may affect up to 1 in 1000 people

• Red or purple discoloration of the skin
• Abnormal sensation in the eye, alteration of vision or blurred vision
• Feeling of full abdomen, flatulence, abnormal sense of taste
• Chest pain
• Difficulty standing
• Flu-like symptoms, fever
• Pharyngitis
• Increased body temperature
• Joint stiffness, joint swelling, muscle stiffness, osteoarthritis
• Memory loss
• Feeling of confusion, decreased activity, feeling of euphoria
• Difficulty breathing when lying down
• Blisters
• Low blood pressure

Not known: the frequency cannot be estimated from the available data

• Changes in ECG (prolongation of QT),
• General discomfort,
• Anxiety
• Urinary incontinence.
• If there is a pre-existing pituitary tumor, increased risk of bleeding in 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

Rare: may affect up to 1 in 100 people

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

Not known: the frequency cannot be estimated from the 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
• Convulsions
• Affecting some blood tests that include hormone levels
• Rapid formation of nodules due to inflammation of the skin or mucous membranes
• Muscle pain
• Mood changes
• Depression
• Anxiety.
• Idiopathic intracranial hypertension (increase in intracranial pressure around the brain characterized by headache, double vision, and other visual symptoms, and ringing or buzzing in the ears).

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

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 prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano.www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use Decapeptyl semi-annual after the expiration date listed on the packaging and labels after CAD. The expiration date is the last day of the month indicated.

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

The reconstituted suspension must be used immediately.

Do not store at a temperature above 25°C.

Composition of Decapeptyl semestral

The active ingredient is triptorelin.

One vial contains triptorelina 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 carmelose, and polisorbate 80.

Solvent: Water for injection.

Appearance of the product and contents of the Decapeptyl semestral packaging

This medication is a lyophilized powder and solvent for injectable suspension, the powder is a white to almost white powder and the solvent is a transparent solution.

Package with1 vial, 1 ampoule, and 1 blister with 1 injection syringe and 2 injection needles.

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

Chemin départemental Nº 402

83870 Signes

France

This medication is authorized in the EEA member states with 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 mgpowder and solvent for prolonged release injectable suspension
FR: Decapeptyl LP 22.5 mg

HU:Diphereline SR 22,5 mgfor prolonged release injectable suspension

LV: Diphereline 22.5 mg

SI: Pamorelin 22.5 mg powder and solvent for injectable suspension with prolonged release

Last review date of this leaflet:January 2025

<>

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

This information is intended solely for healthcare professionals:

INSTRUCTIONS FOR RECONSTITUTION