Decapeptyl SR 11.25mg Powder and solvent for suspension for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Decapeptyl SR 11.25 mg is and what it is used for
2. What you need to know before you use Decapeptyl SR 11.25 mg
3. How to use Decapeptyl SR 11.25 mg
4. Possible side effects
5. How to store Decapeptyl SR 11.25 mg
6. Contents of the pack and other information

MEN

In men, Decapeptyl SR 11.25 mg is used to treat prostate cancer.

WOMEN

In women, Decapeptyl SR 11.25 mg is used to treat Endometriosis - a condition in which the tissue that normally lines the uterus (endometrium) grows in other places.

CHILDREN

In children, Decapeptyl SR 11.25 mg is used to treat puberty that occurs at a very young age, i.e. before 8 years in girls and 10 years in boys (Central Precocious Puberty). This is called ‘early puberty’ in the rest of this leaflet.

Do not use Decapeptyl SR 11.25 mg:

• If you are allergic to triptorelin or similar types of drugs (other GnRH agonists) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:

Talk to your doctor or pharmacist before taking Decapeptyl SR 11.25 mg.

• Patients taking GnRH analogues have reported depression. Sometimes depression can be severe and in rare cases lead to suicidal thoughts. These reports include cases where symptoms improved or stopped after the treatment was discontinued. Suicidal thoughts have mostly been reported in patients with a previous history of depression. If you are taking Decapeptyl SR 11.25 mg and subsequently develop depressed mood, worsening depression, or suicidal thoughts inform your doctor as soon as possible. Your doctor may want to monitor your depression during treatment.
• If you are using medicines for delaying your normal blood clotting, you may experience bruising at the site of the intramuscular injection.
• In adults, triptorelin may cause thinning of the bones (osteoporosis) with an increased risk of bone fractures. You should therefore tell your doctor if you have any of the below risk factors as he/she might give you bisphosphonate (drugs used to treat wark bones) to treat bone loss. Risk factors may include:
  • If you or any of your close family have thinning of the bones.
  • If you drink excessive amounts of alcohol, and/or smoke heavily.
  • If you take medicines over a long period of time that may cause thinning of the bones, for example medicines for epilepsy or steroids (such as hydrocortisone or prednisolone).
• If any convulsions occur, inform immediately your doctor. There have been reports of convulsions in patients receiving triptorelin or similar medicines. These occurred in patients with or without medical history of epilepsy.
• When you first start treatment with Decapeptyl SR 11.25 mg it actually increases the level of your hormones for a short time. This means that you may feel worse to begin with (see section 4 'Possible side effects' for more information). The doctor may give you some medicine (an anti-androgen) to prevent your symptoms from getting worse. After a short time, the amount of hormone will drop, and your symptoms will get better.
  If you suffer from urinary obstruction or spinal cord (nerves in your backbone) compression due to your prostate cancer spreading, your doctor will supervise you closely for the first few weeks of treatment. If you experience difficulty passing urine, bone pain, weakness of lower limbs or pins and needles sensation, contact your doctor immediately, who will assess and treat you appropriately.
• Tell your doctor if you have diabetes.
• Tell your doctor if you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using Decapeptyl SR 11.25 mg.
• If you have an enlargement (benign tumour) of the pituitary gland that you were unaware of, this may be discovered during treatment. Symptoms include sudden headache, problems with eyesight and paralysis of the eye muscles.
• After surgical castration triptorelin does not induce any further decrease in serum testosterone levels.
• Diagnostic tests of pituitary gonadal function or sex organs conducted during treatment or after discontinuation of therapy with Decapeptyl SR 11.25 mg may be misleading.
• Testosterone decreasing agents may cause changes in ECG associated with heart rhythm abnormalities (QT prolongation).
• Tell your doctor if you have back pain, weakness, numbness or tingling in your legs.
• Treatment with GnRH analogues including Decapeptyl SR 11.25mg might increase the risk of anaemia (defined as a decrease in the count of red blood cells).

Your doctor may give you another drug to help you feel better during this time.

Other medicines and Decapeptyl SR 11.25 mg:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Decapeptyl SR 11.25 mg might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs (e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).

Drugs which increase the level of a hormone called prolactin may react with Decapeptyl SR 11.25 mg.

Many different kinds of drugs may increase prolactin levels.

Driving and using machines:

You may feel dizzy, tired or have problems with your sight such as blurred vision. These are possible side effects of treatment or from the underlying disease. If you experience any of these side effects, you should not drive or use machines.

Decapeptyl SR 11.25 mg contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially ‘sodium-free ‘.

This medicine contains 2 mg of polysorbate 80 in each vial. Polysorbates may cause allergic reactions. Tell your doctor if you or your child have any know allergies.

Do not use Decapeptyl SR 11.25 mg:

• If you are allergic to triptorelin or similar types of drugs (other GnRH agonists) or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breast-feeding.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Decapeptyl SR 11.25 mg.

• Due to lack of clinical experience in women under 18 years of age, Triptorelin is not recommended in adolescent and young women as it might cause thinning of bone.
• Patients taking GnRH analogues have reported depression. Sometimes depression can be severe and in rare cases lead to suicidal thoughts. These reports include cases where symptoms improved or stopped after the treatment was discontinued. Suicidal thoughts have been mostly reported in patients with a previous history of depression. If you are taking Decapeptyl SR 11.25 mg and subsequently develop depressed mood, worsening depression, or suicidal thoughts inform your doctor as soon as possible. Your doctor may want to monitor your depression during treatment.
• If you are using medicines for delaying your normal blood clotting, you may experience bruising at the site of the intramuscular injection.
• In adults, triptorelin may cause thinning of the bones (osteoporosis) with an increased risk of bone fractures. You should therefore tell your doctor if you have any of the below risk factors as he/she might give you bisphosphonate (drugs used to treat wark bones) to treat bone loss. Risk factors may include:
  • If you or any of your close family have thinning of the bones.
  • If you drink excessive amounts of alcohol, and/or smoke heavily.
  • If you take medicines over a long period of time that may cause thinning of the bones, for example medicines for epilepsy or steroids (such as hydrocortisone or prednisolone).
• If any convulsions occur, inform immediately your doctor. There have been reports of convulsions in patients receiving triptorelin or similar medicines. These occurred in patients with or without medical history of epilepsy.
• When you first start treatment with Decapeptyl SR 11.25 mg it actually increases the level of your hormones for a short time. This means that you may feel worse to begin with (see section 4 'Possible side effects' for more information). After a short time the amount of hormone will drop and your symptoms will get better.
• Tell your doctor if you have diabetes.
• Tell your doctor if you have any heart conditions.
• If you have an enlargement (benign tumour) of the pituitary gland that you were unaware of, this may be discovered during treatment. Symptoms include sudden headache, problems with eyesight and paralysis of the eye muscles.
• You may have some vaginal bleeding in the first month of treatment. After that your periods normally stop.
• Tell your doctor if you have bleeding after the first month of treatment.
• Your periods should start approximately 5 months after the last injection.

You must use some form of contraception other than the ‘pill’ while you are having treatment and until you start your next period. Your doctor may suggest using a barrier method of contraception such as a condom or diaphragm (cap).

Other medicines and Decapeptyl SR 11.25 mg:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Drugs which increase the level of a hormone called prolactin may react with Decapeptyl SR 11.25 mg. Many different kinds of drugs may increase prolactin levels.

Pregnancy and breast-feeding:

Do not take Decapeptyl SR 11.25 mg if you are pregnant or breast-feeding.

Driving and using machines:

You may feel dizzy, tired or have problems with your sight such as blurred vision. These are possible side effects of treatment or from the underlying disease. If you experience any of these side effects, you should not drive or use machines.

Decapeptyl SR 11.25 mg contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially ‘sodium-free ‘.

This medicine contains 2 mg of polysorbate 80 in each vial. Polysorbates may cause allergic reactions. Tell your doctor if you or your child have any know allergies.

Do not use Decapeptyl SR 11.25 mg:

• If you are allergic to triptorelin or similar types of drugs (other GnRH agonists) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:

Talk to your doctor or pharmacist before taking Decapeptyl SR 11.25 mg.

• Patients taking GnRH analogues have reported depression. Sometimes depression can be severe and in rare cases lead to suicidal thoughts. These reports include cases where symptoms improved or stopped after the treatment was discontinued. Suicidal thoughts have been mostly reported in patients with a previous history of depression. If you are taking Decapeptyl SR 11.25 mg and subsequently develop depressed mood, worsening depression, or suicidal thoughts inform your doctor as soon as possible. Your doctor may want to monitor your depression during treatment.
• If you are using medicines for delaying your normal blood clotting, you may experience bruising at the site of the intramuscular injection.
• If you have a progressive brain tumour, tell your doctor. This may affect the way your doctor decides to treat you.
• If your child suffers from a bad or recurrent headache, problems with eyesight and ringing or buzzing in the ears, contact a doctor immediately (see section 4).
• Girls who have an early puberty may have some vaginal bleeding in the first month of treatment.
• In girls, menstrual bleeding will start on average one year after stopping treatment.
• Early puberty caused by other diseases should be ruled out by your doctor.
• Tell your doctor if you have diabetes.
• Tell your doctor if you have any heart conditions.
• If you have an enlargement (benign tumour) of the pituitary gland that you were unaware of, this may be discovered during treatment. Symptoms include sudden headache, problems with eyesight and paralysis of the eye muscles.
• A pathology of the hip may occur after stopping treatment (slipped capital femoral epiphysis of the hip). It results in stiffness of the hip, a limp and / or severe pain in the groin radiating to the thigh. If this occurs, you should consult your doctor.
• If any convulsions occur, inform immediately your doctor. There have been reports of convulsions in patients receiving triptorelin or similar medicines. These occurred in patients with or without medical history of epilepsy.

Other medicines and Decapeptyl SR 11.25 mg:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Drugs which increase the level of a hormone called prolactin may react with Decapeptyl SR 11.25 mg. Many different kinds of drugs may increase prolactin levels.

Decapeptyl SR 11.25 mg contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially ‘sodium-free ‘.

This medicine contains 2 mg of polysorbate 80 in each vial. Polysorbates may cause allergic reactions. Tell your doctor if you or your child have any know allergies.

Decapeptyl SR 11.25 mg will be injected into a muscle, usually your bottom, by a doctor or nurse. On this leaflet there are instructions for them that explain how to prepare the injection.

You will normally receive an injection once every 3 months.

Also read 'Other medicines and Decapeptyl SR 11.25 mg' in section 2.

If you are given more Decapeptyl SR 11.25 mg than you should

If you are given too much Decapeptyl SR 11.25 mg you may experience additional or more severe side effects (see section 4 'Possible side effects').

If you forget to take a dose of Decapeptyl SR 11.25 mg

As soon as you realise that you have missed an injection you should tell your doctor. You will then be given your next injection.

If you stop receiving Decapeptyl SR 11.25 mg

If you stop receiving your Decapeptyl SR 11.25 mg injection before your doctor tells you to then your symptoms are likely to return.

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

Decapeptyl SR 11.25 mg will be injected into a muscle, usually your bottom, by a doctor or nurse. On this leaflet there are instructions for them that explain how to prepare the injection.

You will normally receive two injections, the second one three months after the first. Each injection will be given in the first five days of your period.

Also read 'Other medicines and Decapeptyl SR 11.25 mg' in section 2.

If you are given more Decapeptyl SR 11.25 mg than you should

If you are given too much Decapeptyl SR 11.25 mg you may experience additional or more severe side effects (see section 4 'Possible side effects').

If you forget to take a dose of Decapeptyl SR 11.25 mg

As soon as you realise that you have missed an injection you should tell your doctor. You will then be given your next injection.

If you stop receiving Decapeptyl SR 11.25 mg

If you stop receiving your Decapeptyl SR 11.25 mg injection before your doctor tells you to then your symptoms are likely to return.

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

Decapeptyl SR 11.25 mg will be injected into a muscle, usually your bottom, by a doctor or nurse. On this leaflet there are instructions for them that explain how to prepare the injection.

You will normally receive an injection once every 3 months.

Your doctor will decide when treatment should be stopped (normally when you are about 12-13 if you are a girl and about 13-14 if you are a boy).

Also read 'Other medicines and Decapeptyl SR 11.25 mg' in section 2.

If you are given more Decapeptyl SR 11.25 mg than you should

If you are given too much Decapeptyl SR 11.25 mg you may experience additional or more severe side effects (see section 4 'Possible side effects').

If you forget to take a dose of Decapeptyl SR 11.25 mg

As soon as you realise that you have missed an injection you should tell your doctor. You will then be given your next injection.

If you stop receiving Decapeptyl SR 11.25 mg

If you stop receiving your Decapeptyl SR 11.25 mg injection before your doctor tells you to then your symptoms are likely to return.

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

Side effects which are very common (may affect more than 1 in 10 people) are hot flushes, weakness, excessive sweating, back pain, pins and needles sensation in the legs, reduced libido and impotence.

Side effects which are common (may affect up to 1 in 10 people) are nausea, dry mouth, pain, bruising, redness and swelling at injection site, muscle and bone pain, pain in the arms and legs, oedema (build-up of fluid in the body tissues), lower abdominal pain, high blood pressure, allergic reaction, increase in weight, dizziness, headache, loss of libido, depression and mood changes.

Side effects which are uncommon (may affect up to 1 in 100 people) are increase of blood platelets, feeling your heartbeat, ringing in the ears, vertigo, blurred vision, pain in abdomen, constipation, diarrhoea, vomiting, drowsiness, severe shivering associated with sweating and a fever, sleepiness, pain, swelling of the ankles, feet or fingers, some blood tests affected (including raised liver function tests), blood pressure increased, weight loss, loss of appetite, increase of appetite, gout (severe pain and swelling in the joints usually in the big toe), diabetes, excessive lipids in the blood, joint pain, muscle cramp, muscle weakness, muscle pain, swelling and tenderness, bone pain, tingling or numbness, inability to sleep, feeling of irritability, development of enlarged breasts in men, breast pain, reduction in testicular size, pain in testicles, difficulty in breathing, acne, hair loss, itching, rash, redness of skin, hives, waking up to pass urine, problems passing urine and nosebleeds.

Side effects which are rare (may affect up to 1 in 1,000 people) are red or purple discolorations on the skin, abnormal sensation in the eye, blurring or disturbance in vision, sensation of fullness in the abdomen, flatulence, abnormal sense of taste, chest pain, difficulty in standing, flu-like symptoms, fever, anaphylactic reaction (serious allergic reaction which can cause dizziness or difficulty in breathing, swelling of the face or throat), inflammation of the nose/throat, increased body temperature, stiff joints, joint swelling, musculoskeletal stiffness, osteoarthritis, memory loss, feeling confused, decreased activity, having a feeling of elation, shortness of breath when lying flat, blisters and low blood pressure.

During post-marketing surveillance the following side effects have also been reported (their frequency cannot be estimated from the available data): changes in ECG (QT prolongation), serious allergic reaction which can lead to a swelling of the face, the tongue and the neck, dizziness or breathing difficulties (Quincke oedema, anaphylactic shock), convulsions, general discomfort, anxiety, rapid formation of wheals due to swelling of the skin or mucous membranes and urinary incontinence, if there is an existing pituitary tumour there is an increased risk of bleeding to the area, anaemia (decrease in the count of red blood cells).

As with other GnRH agonists, an increase in white blood cell count may be found in patients being treated with Decapeptyl SR 11.25 mg.

Patients receiving long-term treatment by GnRH analogue in combination with radiation may have more side effects especially gastrointestinal, related to radiotherapy.

Many of the side effects are expected due to the change in the level of oestrogens in your body.

These very common side effects (may affect more than 1 in 10 people) include headache, decreased libido, mood swings, difficulty in sleeping, breast disorder, ovarian hyperstimulation syndrome, pain during or after sexual intercourse, painful periods, genital bleeding, pelvic pain, dryness of the vagina, weakness, excessive sweating, acne, oily skin and hot flushes.

Side effects which are common (may affect up to 1 in 10 people) are breast pain, muscle cramps, painful joints, weight gain, feeling sick, depression (long term treatment), nervousness, abdominal pain or discomfort, pain, bruising, redness and swelling at injection site, swelling and tenderness, allergic reaction, pain in the arms and legs, dizziness and swelling of ankles, feet or fingers.

Side effects which are uncommon (may affect up to 1 in 100 people) are feeling your hearbeat, vertigo, dry eye, blurred vision, bloating, vomiting, dry mouth, flatulence, mouth ulcer, weight decrease, decrease in appetite, water retention, back pain, muscle pain, abnormal taste, loss of sensations, temporary loss of consciousness, memory loss, lack of concentration, tingling or numbness, involuntary muscle movement, mood change, anxiety, disorientation, depression (short term treatment), bleeding after sex, prolapse, irregular period, painful period and heavy period, small cysts (swelling) on the ovaries which can cause pain, discharge from the vagina, difficulty breathing, nosebleed, hair loss, dry skin, excessive bodily hair, brittle nails, itching, hives and skin rash.

During post-marketing surveillance the following side effects have also been reported (their frequency cannot be estimated from the available data): general discomfort, increased blood pressure, increased body temperature, serious allergic reaction which can lead to a swelling of the face, the tongue and the neck, dizziness or breathing difficulties (Quincke oedema, anaphylactic shock), convulsions, some blood tests affected (including raised liver function tests), diarrhoea, muscle weakness, confusion, absence of menstrual periods, rapid formation of wheals due to swelling of the skin or mucous membranes, abnormal sensations in the eyes and/or changes in sight, hives, if there is an existing pituitary tumour there is an increased risk of bleeding to the area.

In endometriosis treatment, the disorders for which the treatment has been justified (pelvic pain, dysmenorrhea) may be exacerbated at the beginning of the treatment, but should disappear in one to two weeks. This may occur even if the treatment is producing a favorable effect. You should nevertheless immediately notify your doctor of this phenomenon.

Side effects which are very common (may affect more than 1 in 10 people) include vaginal bleeding which may occur in girls in the first month of treatment.

Side effects which are common (may affect up to 1 in 10 people) include pain in abdomen, pain, bruising, redness and swelling at injection site, headache, hot flushes, weight gain, acne, allergic reactions.

Side effects which are uncommon (may affect up to 1 in 100 people) are blurred vision, vomiting, constipation, nausea, general discomfort, overweight, neck pain, changes in mood, pain in breast, nosebleeds, itching, rash or hives in the skin.

Long term trial (up to 4 years) did not bring any new and significant safety concerns.

During post-marketing surveillance the following side effects have also been reported (their frequency cannot be estimated from the available data): high blood pressure, abnormal vision, serious allergic reaction which can lead to a swelling of the face, the tongue and the neck, dizziness or breathing difficulties (Quincke oedema, anaphylactic shock), convulsions, some blood tests affected include hormone levels, rapid formation of wheals due to swelling of the skin or mucous membranes, muscle pain, mood disorders, depression, nervousness, Idiopathic intracranial hypertension (increased intracranial pressure around the brain characterised by headache, double vision and other visual symptoms, and ringing or buzzing in the ears).

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance of Decapeptyl SR 11.25 mg is triptorelin. Each vial contains sufficient quantity of triptorelin (as triptorelin pamoate) to ensure that the minimum triptorelin quantity injected is 11.25 mg.

The other ingredients are D,L lactide-glycolide copolymer, mannitol, carmellose sodium, polysorbate 80.

Each pack contains:

1 clear glass vial with a rubber stopper and an aluminium cap containing the powder

1 glass ampoule containing the suspension vehicle

1 syringe

2 needles.