Decapeptyl SR 11.25 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 11.25 mg. Its active ingredient is triptorelin. Each vial contains 15 mg triptorelin (as acetate). There is an extra amount in the vial to make sure you receive the required dose of 11.25 mg. The formulation contains a lactide-glycolide copolymer, mannitol, polysorbate 80 and carmellose sodium.
Decapeptyl SR 11.25 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 11.25 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 11.25 mg?
Decapeptyl SR 11.25 mg is a slow release formulation of triptorelin with an action lasting for 3 months. 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 11.25 mg?
Decapeptyl SR 11.25 mg is manufactured by
The Product Licence holder is
What is Decapeptyl SR 11.25 mg used for?
For the treatment of advanced prostate cancer.
Is there any reason for not being given Decapeptyl SR 11.25 mg?
Decapeptyl SR 11.25 mg may not be suitable for you if you have experienced any of the following:
- back pain or tingling ('pins and needles') in your hands and feet
- if you had an allergic reaction to triptorelin, any other ingredients of Decapeptyl SR 11.25mg 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 three months. Your doctor will decide for how long you need treatment.
Where will I be injected?
The injection will usually 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 11.25 mg?
You may experience a worsening of your symptoms such as more pain, hot flushes, difficulty in passing water.
Which side effects can Decapeptyl SR 11.25 mg have?
Prostate cancer:
Decapeptyl SR 11.25 mg can cause unwanted side effects such as hot flushes, impotence, less desire for sex, bone pain, back pain, numbness or tingling sensations in lower limbs, pain or difficulty in passing water. These effects usually occur during the first month of treatment.
Less common side effects are temporary increase of blood pressure, breast enlargement, sleeplessness, changes in mood or personality, vertigo and dizziness.
The following side effects have been observed rarely: allergic reactions (rash, inflammation and itching), dry mouth or watering mouth, inflammation of veins, headache, recurrence of asthma, fever, sweating, stomach ache, feeling or being sick, weight gain, slight hair loss, blurred or abnormal vision and pain/hardened tissue at the injection site.
If any side effect is troublesome, or causes you concern, you should tell your doctor.
Further information
Keep your medicine out of the reach and sight of children.
Do not store above 25ºC 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 11.25 mg PL Number: 06958/0016.
Suspension vehicle PL Number: 06958/0019.
Decapeptyl is a registered trademark.
Indication: Endometriosis
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 11.25 mg. Its active ingredient is triptorelin. Each vial contains 15 mg triptorelin (as acetate). There is an extra amount in the vial to make sure you receive the required dose of 11.25 mg. The formulation contains a lactide-glycolide copolymer, mannitol, polysorbate 80 and carmellose sodium. Decapeptyl SR 11.25 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 11.25 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 11.25 mg?
Decapeptyl SR 11.25 mg is a slow release formulation of triptorelin with an action lasting over 3 months. Triptorelin is a decapeptide, an analogue of GnRH. It lowers the levels of the 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 11.25 mg?
Decapeptyl SR 11.25 mg is manufactured by
The Product Licence holder is
What is Decapeptyl SR 11.25 mg used for?
Decapeptyl SR 11.25 mg is used for the treatment of endometriosis.
Is there any reason for not being given Decapeptyl SR 11.25 mg?
You should not be given Decapeptyl SR 11.25 mg if you are pregnant, trying to become pregnant, or breastfeeding. Decapeptyl SR 11.25 mg may not be suitable for you if you are suffering from a disease which affects the strength of your bones. Also, it may not be suitable for you if you have had an allergic reaction to triptorelin, to any of the ingredients of Decapeptyl SR 11.25 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 11.25 mg, and for at least 3 months after the last injection, your doctor may recommend you use a barrier method of contraception such as the condom or diaphragm (cap). This will ensure that you do not become pregnant whilst being treated with Decapeptyl SR 11.25 mg. Oral contraceptives (the 'pill') should not be taken when receiving Decapeptyl SR 11.25 mg. Your doctor may wish to give you additional treatment to reduce thinning of the bones. 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.
How many injections will I need?
You will be given one injection every three months for up to six months. Only one course of treatment with Decapeptyl SR 11.25 mg (two injections) should be given.
Where will I be injected?
The injection will usually 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 11.25 mg?
You may experience a return of your symptoms such as painful periods and pain during sexual intercourse.
Which side effects can Decapeptyl SR 11.25 mg have?
At the start of treatment, you may experience a worsening of symptoms (pelvic pain, painful periods) even though the treatment is producing a favourable effect. These symptoms normally disappear after the first or second week.
The most common side effects during treatment are hot flushes, sweating, vaginal dryness, less desire for sex, painful intercourse and irregular menstrual bleeding during the first month of treatment. After stopping treatment it may be some time before your periods return. You may also have sleeplessness, headaches or mood changes. Temporary pain, reddening or swelling at the injection site may occur.
Other less common side effects which may occur include breast pain, muscle cramps, painful joints, weight gain, feeling or being sick, stomach pain or discomfort, feelings of weakness, temporary increase of blood pressure, blurred or abnormal vision, rash, swelling, slight hair loss.
This type of medicine can cause a small loss of calcium from the bones (thinning of the bones). A partial recovery of this loss may occur when treatment is stopped.
If any side effect is troublesome, or causes you concern, you should tell your doctor.
Further information
Keep your medicine out of the reach and sight of children.
Do not store above 25ºC 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 11.25 mg PL Number: 06958/0016.
Suspension vehicle PL Number: 06958/0019.
Decapeptyl is a registered trademark.
Indication: Precocious Puberty
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 11.25 mg. Its active ingredient is triptorelin. Each vial contains 15 mg triptorelin (as acetate). There is an extra amount in the vial to make sure you receive the required dose of 11.25 mg. The formulation contains a lactide-glycolide copolymer, mannitol, polysorbate 80 and carmellose sodium.
Decapeptyl SR 11.25 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 11.25 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 11.25 mg?
Decapeptyl SR 11.25 mg is a slow release formulation of triptorelin with an action lasting for 3 months. Triptorelin is a decapeptide, an analogue of GnRH. It lowers the levels of the hormone testosterone, 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 11.25 mg?
Decapeptyl SR 11.25 mg is manufactured by
The Product Licence holder is
What is Decapeptyl SR 11.25 mg used for?
For the treatment of precocious puberty (onset before 8 years in girls and 9 years in boys).
Is there any reason for not being given Decapeptyl SR 11.25 mg?
Decapeptyl SR 11.25 mg may not be suitable for you if you have experienced the following:
- if you had an allergic reaction to triptorelin, any other ingredients of Decapeptyl SR 11.25 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.
How many injections will I need?
You will be given one injection every three months. Your doctor will decide for how long treatment should be continued.
Where will I be injected?
The injection will usually 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 11.25 mg?
Secondary sexual characteristics will reappear. In girls, periods may occur.
Which side effects can Decapeptyl SR 11.25 mg have?
Precocious puberty: Mild to moderate withdrawal bleeding (common) may occur in girls in the first month of treatment. Additional common adverse reactions may be observed such as injection site reactions and pain in the joints.
The following rare reactions have been reported: allergic reactions, headache, weight gain, increased blood pressure, blurred or abnormal vision, gastrointestinal disorders including abdominal pain and vomiting, nose bleeding, feeling unwell, muscle pain, mood disorders and nervousness.
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 25ºC 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 11.25 mg PL Number: 06958/0016.
Suspension vehicle PL Number: 06958/0019.
Decapeptyl is a registered trademark.
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