Package leaflet: Information for the user

* Decapeptyl® SR 22.5 mg

powder and solvent 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, 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.

What is in this leaflet

1.    What Decapeptyl SR 22.5 mg is and what it is used for

2.    What you need to know before you use Decapeptyl SR 22.5 mg

3.    How to use Decapeptyl SR 22.5 mg

4.    Possible side effects

5.    How to store Decapeptyl SR 22.5 mg

6.    Contents of the pack and other information

1. What Decapeptyl SR 22.5 mg is and what it is used for

Decapeptyl SR 22.5 mg contains triptorelin, which is similar to a hormone called gonadotropin releasing hormone (GnRH). Triptorelin belongs to a group of medicines called GnRH agonists. It is a long acting formulation designed to slowly deliver 22.5 mg of triptorelin over a 6-month period. It acts by lowering the levels of the male hormone, testosterone, in the body.

Decapeptyl SR 22.5 mg is used to treat prostate cancer.

Decapeptyl SR is available in two other strengths: Decapeptyl SR 3 mg is used once a month and Decapeptyl SR 11.25 mg is used once every 3 months. Ask your doctor if you would like to discuss changing your treatment.

2. What you need to know before you use Decapeptyl SR 22.5 mg

Do not use Decapeptyl SR 22.5 mg

•    If you are allergic (hypersensitive) to triptorelin pamoate, gonadotropin releasing hormone (GnRH), other GnRH agonists or any of the ingredients of this medicine (listed in section 6).

Warnings and precautions

•    There have been reports of depression in patients taking Decapeptyl SR 22.5 mg, which may be severe. If you are taking Decapeptyl SR 22.5 mg, and develop depressed mood, inform your doctor.

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

•    At the beginning of treatment there will be an increased amount of testosterone in your body. This may cause the symptoms of the cancer to worsen. Contact your doctor if this happens. The doctor may give you some medicine (an anti-androgen) to prevent your symptoms from getting worse.

•    During the first weeks of treatment, Decapeptyl SR 22.5 mg may, as with other GnRH agonists, in isolated cases, cause the spinal cord to compress or the urethera (where you pass urine) to block. You will be monitored by your doctor and given treatment for these conditions if they occur.

•    Treatment with Decapeptyl SR 22.5 mg, as with other GnRH agonists, 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.

•    If you need any tests to check your hormone function during or after your Decapeptyl SR 22.5 mg treatment, the results may be misleading. Please tell your doctor you have been treated with Decapeptyl SR 22.5 mg.

•    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 22.5 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 22.5 mg. Symptoms include sudden headache, vomiting, problems with eyesight and paralysis of the eye muscles.

Please talk with your doctor if you are concerned about any of the above.

Other medicines and Decapeptyl SR 22.5 mg

Tell your doctor or pharmacist if you are taking, have recently taken or

might take any other medicines.

Decapeptyl SR 22.5 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).

Children and adolescents

Decapeptyl SR 22.5 mg is not for use in neonates, infants, children and adolescents.

Pregnancy and breast-feeding

Decapeptyl SR 22.5 mg is not for use in women.

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.

Important information about some of the ingredients of Decapeptyl SR 22.5 mg

Decapeptyl SR 22.5 mg is essentially'sodium free'since it contains less than 1 mmol sodium (23 mg) per dose and may be taken if you are on a low sodium diet.

3. How to use Decapeptyl SR 22.5 mg

Decapeptyl SR 22.5 mg will be administered to you under the supervision of a physician. Your doctor or another healthcare professional should explain your treatment before you are given Decapeptyl SR 22.5 mg.

The usual dose is 1 vial of Decapeptyl SR 22.5 mg injected into a muscle every 6 months.

Also read 'Other medicines and Decapeptyl SR 22.5 mg'in section 2.

Decapeptyl SR 22.5 mg will be given to you regularly to reduce testosterone levels. Your doctor will determine the treatment duration.

Blood tests may be performed by your doctor to measure how effective the treatment is.

If you think the effect of Decapeptyl SR 22.5 mg is too strong or too weak, contact your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause 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, swelling of your lips, face, throat or tongue, a rash.

As seen following treatment with other GnRH agonist therapies or after surgical castration, the most commonly observed adverse events related to triptorelin treatment were due to its expected pharmacological effects. These effects included hot flushes and decreased libido.

Increased lymphocyte count has been reported with patients undergoing GnRH analogue treatment.

With the exception ofimmuno-allergic reactions and injection site reactions, all adverse events are known to be related to changed testosterone levels.

As with other GnRH agonist, hypersensitivity and allergic (anaphylactic) reactions have been reported with triptorelin.

In other triptorelin products, uncommonly pressure sensitive infiltration at the injection site have been reported after subcutaneous injection.

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

•    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, 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

•    Nosebleeds.

Side effects which are rare (may affect up to 1 in 1000 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

•    Difficuty 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, having a feeling of elation

•    Shortness of breath when lying flat

•    Blisters

•    Low blood pressure.