Informations for option: Decapeptyl Sr 3mg Powder For Suspension For Injection, show other option

Select option:

1. Decapeptyl Sr 3mg Powder For Suspension For Injection
2. Decapeptyl Sr 3mg Powder For Suspension For Injection

Package leaflet: Information for the user

* Decapeptyl® SR 3 mg

powder for suspension for injection

Triptorelin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    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 foryou 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.

What is in this leaflet

1.    What Decapeptyl SR 3 mg is and what it is used for

2.    What you need to know before you use Decapeptyl SR 3 mg

3.    How to use Decapeptyl SR 3 mg

4.    Possible side effects

5.    How to store Decapeptyl SR 3 mg

6.    Contents of the pack and other information

1. What Decapeptyl SR 3 mg is and what it is used for

The active ingredient in Decapeptyl SR 3 mg is triptorelin.Triptorelin belongs to a group of medicines called gonadotropin releasing hormone (GnRH) agonists.Triptorelin is similar to the gonadotropin releasing hormone which occurs naturally in your body. In men, triptorelin lowers the levels of the hormone testosterone. In women, it reduces oestrogen levels.

Decapeptyl SR 3 mg is used in men and women to treat completely different conditions.

Decapeptyl SR is available in two other strengths: Decapeptyl SR 11.25 mg is used once every 3 months and Decapeptyl SR 22.5 mg is used once every 6 months. Not all dose strengths are approved for all indications. Ask your doctor if you would like to discuss changing your treatment.

This leaflet gives information for the use of Decapeptyl SR 3 mg in men and women. Please read all the sections that are about you and your condition.

MEN

In men, Decapeptyl SR 3 mg is used to treat prostate cancer.

WOMEN

In women, Decapeptyl SR 3 mg is used to treat:

•    Endometriosis - a condition in which the tissue that normally lines the uterus (endometrium) grows in other places.

•    Uterine fibroids - abnormal (benign) growth of cells in your uterus.

2. What you need to know before you use Decapeptyl SR 3 mg

MEN

Do not use Decapeptyl SR 3 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:

•    There have been reports of depression in patients taking Decapeptyl SR 3 mg which may be severe. If you are taking Decapeptyl SR 3 mg and develop depressed mood, inform your doctor.

•    If you are using medicines for preventing your blood clotting, you may experience bruising at the site of injection.

•    In adults If triptorelin or other GnRH agonists are used for a long period of time you may increase the risk of developing thin or weak bones, especially if you are a heavy drinker, a smoker, have a family history of osteoporosis (a condition that affects the strength of your bones), have a poor diet or take anticonvulsants (medicines for epilepsy or fits) or corticosteroids (steroids). If you have anything wrong with you that affects your bones, such as osteoporosis, tell your doctor. This may affect the way your doctor decides to treat you.

•    When you first start treatment with Decapeptyl SR 3 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.

•    During the first weeks of treatment, Decapeptyl SR 3 mg may, as with other GnRH agonists, in isolated cases, cause the spinal cord to compress or the urethra (where you pass urine) to block. You will be monitored by your doctor and given treatment for these conditions if they occur.

•    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 3 mg.

•    If you have an enlargement (benign tumour) of the pituitary gland that you were unaware of, this may be discovered during treatment with Decapeptyl SR 3 mg. Symptoms include sudden headache, problems with eyesight and paralysis of the eye muscles.

•    Tell your doctor if you notice blood in your urine or if you find it difficult or painful to urinate.

•    Tell your doctor if you have back pain, weakness, numbness or tingling in your legs.

Your doctor may give you another drug to help you feel better during this time. Other medicines and Decapeptyl SR 3 mg:

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

Decapeptyl SR 3 mg might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the riskof 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 3 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.

WOMEN

Do not use Decapeptyl SR 3 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:

■ There have been reports of depression in patients taking Decapeptyl SR 3 mg which may be severe. If you are taking Decapeptyl SR 3 mg and develop depressed mood, inform your doctor.

• Ifyou are using medicines for preventing your blood clotting, you may experience bruising at the site of injection.

•    In adults if triptorelin or other GnRH agonists are used for a long period of time you may increase the risk of developing thin or weak bones, especially if you are a heavy drinker, a smoker, have a family history of osteoporosis (a condition that affects the strength of your bones), have a poor diet or take anticonvulsants (medicines for epilepsy or fits) or corticosteroids (steroids). If you have anything wrong with you that affects your bones, such as osteoporosis, tell your doctor. This may affect the way your doctor decides to treat you.

•    You may have some vaginal bleeding in the first month of treatment. After that your periods normally stop.

•    Tell your doctor ifyou have bleeding after the first month of treatment.

•    Your periods should start about 2 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).

•    Tell your doctor if you have diabetes

•    Tell your doctor if you have any heart conditions.

•    Ifyou 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.

Other medicines and Decapeptyl SR 3 mg:

Tell your doctor or pharmacist ifyou 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 3 mg. Many different kinds of drugs may increase prolactin levels.

Pregnancy and breast-feeding:

Do not take Decapeptyl SR 3 mg ifyou 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. Ifyou experience any of these side effects, you should not drive or use machines.

3. How to use Decapeptyl SR 3 mg MEN

Decapeptyl SR 3 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 28 days.

Also read 'Other medicines and Decapeptyl SR 3 mg' in section 2.

Ifyou are given more Decapeptyl SR 3 mg than you should:

If you are given too much Decapeptyl SR 3 mg you may experience additional or more severe side effects (see section 4'Possible side effects').

Ifyou forget to take a dose of Decapeptyl SR 3 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.

Ifyou stop receiving Decapeptyl SR 3 mg:

Ifyou stop receiving your Decapeptyl SR 3 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.

WOMEN

Decapeptyl SR 3 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 one injection every 28 days. This injection should be given in the first 5 days of your menstrual cycle.

Ifyou are being treated for uterine fibroidsyou should be treated for at least 3 months. You should not need to be treated for more than 6 months.

Also read 'Other medicines and Decapeptyl SR 3 mg' in section 2.

Ifyou are given more Decapeptyl SR 3 mg than you should:

If you are given too much Decapeptyl SR 3 mg you may experience additional or more severe side effects (see section 4'Possible side effects').

Ifyou forget to take a dose of Decapeptyl SR 3 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.

Ifyou stop receiving Decapeptyl SR 3 mg:

Ifyou stop receiving your Decapeptyl SR 3 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.

4. Possible side effects

Like all medicines, Decapeptyl SR 3 mg can have side effects although not everybody gets them.

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

MEN

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, 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), inflammation of the nose/throat, increased body temperature, stiff joints, joint swelling, musculoskeletal stiffness, osteoarthritis, memory loss, feeling confused, decreased activity.

Decapeptyl_SR-Signes-3_mg-Leaflet-UK-1043130-(3.1).indd 1

1043130-MOCK UP!