Decapeptyl SR 3 mg for injection
triptorelin
Information For The Patient
Please read this leaflet carefully. It provides some information about your medicine. If you have any questions please ask your doctor. The name of your medicine is Decapeptyl SR 3 mg . Its active ingredient is triptorelin. Each vial contains 4.2 mg triptorelin (as acetate). There is an extra amount in the vial to make sure you receive the required dose of 3 mg. The formulation contains a lactide-glycolide copolymer, mannitol, polysorbate 80, and carmellose sodium. Decapeptyl SR 3 mg is a powder for suspension for injection and the suspension will be made up with the suspension vehicle just before injection. The suspension vehicle contains mannitol in water.
This pack contains one vial of Decapeptyl SR 3 mg , one ampoule of suspension vehicle containing mannitol in water, one syringe and two needles. It is for single use only.
What is Decapeptyl SR 3 mg?
Decapeptyl SR 3 mg is a slow release formulation of triptorelin.
Triptorelin is a decapeptide, an analogue of GnRH. It lowers the levels of oestrogens and progesterone in the body.
The instructions for preparing the injection are given overleaf. Your doctor or nurse will make up the injection and give it to you.
Who makes Decapeptyl SR 3 mg?
Decapeptyl SR 3 mg is manufactured by
The Product Licence holder is
What is Decapeptyl SR 3 mg used for?
Decapeptyl SR 3 mg is used for the treatment of endometriosis and uterine fibroids.
Is there any reason for not being given Decapeptyl SR 3 mg?
You should not be given Decapeptyl SR 3 mg if you are pregnant or breastfeeding. Decapeptyl SR 3 mg may not be suitable for you if you have a metabolic bone disease. Also, it may not be suitable for you if you have had an allergic reaction to triptorelin, to any other ingredients of Decapeptyl SR 3 mg or to a similar type of drug (GnRH analogues). Your doctor will know if the medicine is suitable for you. Consult your doctor if you are concerned.
Do I need to take any other medicines?
During the course of your treatment with Decapeptyl SR 3 mg, your doctor may wish to give you a non-hormonal form of contraception during the first month of treatment and once you have completed the course. This will ensure that you do not become pregnant whilst being treated with Decapeptyl SR 3 mg . During the first month of therapy your doctor may want to monitor your condition carefully.
Tell your doctor if:
You think your symptoms have worsened or changed. Tell him if you have an abnormal bleed during your course of treatment. He will be able to decide if changes are needed to your treatment. If you are taking any other medicines, tell your doctor about them. However, there are no known interactions with other medications or other forms of interaction.
How many injections will I need?
You will be given one injection every four weeks for up to six months. Only one course of treatment with Decapeptyl SR 3 mg should be given.
Where will I be injected?
The injection usually will be given in your buttock.
What shall I do if I miss an injection?
As soon as you realise that you have missed an injection, contact your doctor. He will then be able to give you your next injection.
What will happen if I stop taking Decapeptyl SR 3 mg?
You may experience a return of your symptoms such as painful periods and pain during sexual intercourse.
Which side effects can Decapeptyl SR 3 mg have?
Decapeptyl SR 3 mg can cause unwanted side effects such as hot flushes and vaginal dryness. Skin rash, hair loss, feelings of weakness, headache, weight gain, fluid retention, painful joints, painful muscles, transient sight disturbances and temporary increases in blood pressure may occur. A small loss in bone density occurs during treatment. If any side effect is troublesome, or causes you concern, you should tell your doctor. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Further information
Keep your medicine out of the reach and sight of children.
Do not store above 25°C and keep the container in the outer carton, to protect from light.
Do not use after the expiry date shown on the box.
Date of the last revision of this leaflet
November 2009
Product Licence Numbers
Decapeptyl SR 3 mg PL Number: 06958/0017
Suspension vehicle PL Number: 06958/0019
Decapeptyl SR 3 mg for injection
triptorelin
Indication: Advanced Prostate Cancer
Information For The Patient
Please read this leaflet carefully. It provides some information about your medicine. If you have any questions please ask your doctor. The name of your medicine is Decapeptyl SR 3 mg . Its active ingredient is triptorelin. Each vial contains 4.2 mg triptorelin (as acetate). There is an extra amount in the vial to make sure you receive the required dose of 3 mg. The formulation contains a lactide-glycolide copolymer, mannitol, polysorbate 80, and carmellose sodium.
Decapeptyl SR 3 mg is a powder for suspension for injection and the suspension will be made up with the suspension vehicle just before injection. The suspension vehicle contains mannitol in water.
This pack contains one vial of Decapeptyl SR 3 mg , one ampoule of suspension vehicle containing mannitol in water, one syringe and two needles. It is for single use only.
What is Decapeptyl SR 3 mg?
Decapeptyl SR 3 mg is a slow release formulation of triptorelin. Triptorelin is a decapeptide, an analogue of GnRH. It lowers the levels of the male hormone testosterone in the body.
The instructions for preparing the injection are given overleaf. Your doctor or nurse will make up the injection and give it to you.
Who makes Decapeptyl SR 3 mg?
Decapeptyl SR 3 mg is manufactured by
The Product Licence holder is
What is Decapeptyl SR 3 mg used for?
Decapeptyl SR 3 mg is used for the treatment of advanced prostate cancer.
Is there any reason for not being given Decapeptyl SR 3 mg?
Decapeptyl SR 3 mg may not be suitable for you if you have experienced any back pain or tingling ("pins and needles") in your hands and feet. Also, it may not be suitable for you if you have had an allergic reaction to triptorelin, to any other ingredients of Decapeptyl SR 3 mg or to a similar type of drug (GnRH analogues). Your doctor will know if the medicine is suitable for you. Consult your doctor if you are concerned.
Do I need to take any other medicines?
Your doctor may wish to give to you another medicine at the same time. This medicine will help to stop the increase in some symptoms which may occur at first. During the first month of therapy your doctor may want to monitor your condition carefully.
Tell your doctor if:
You think your symptoms have worsened or changed. Tell him if you are having more pain or if you are having difficulty in passing water.
He will be able to decide if any changes are needed to your treatment. If you are taking any other medicines, tell your doctor about them.
How many injections will I need?
You will be given one injection every four weeks. Your doctor will decide for how long you need treatment.
Where will I be injected?
The injection usually will be given in your buttock.
What shall I do if I miss an injection
As soon as you realise that you have missed an injection, contact your doctor. He will then be able to give you your next injection.
What will happen if I stop Decapeptyl SR 3 mg?
You may experience a worsening of your symptoms such as more pain, hot flushes or difficulty in passing water .
Which side effects can Decapeptyl SR 3 mg have?
Decapeptyl SR 3 mg can cause unwanted side effects such as hot flushes, bone pain, impotence and less desire for sex. These usually occur during the first month of treatment. Also, temporary increases in blood pressure, inflammation of veins and pain at the injection site have been reported. Occasionally, breast enlargement, stomach ache, dry mouth, headache, recurrence of asthma, increased pain or difficulty in passing water, fever, itching, sweating, pins and needles, burning or prickling sensations, dizziness, sleeplessness, watering mouth, stomach upset, sick feeling, slight hair loss, and hardness at injection site may occur. If any side effect is troublesome, or causes you concern, you should tell your doctor. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Further information
Keep your medicine out of the reach and sight of children.
Do not store above 25°C and keep the container in the outer carton, to protect from light.
Do not use after the expiry date shown on the box.
Date of the last revision of this leaflet
November 2009
Product Licence Numbers
Decapeptyl SR 3 mg PL Number: 06958/0017
Suspension vehicle PL Number: 06958/0019
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