Find similiar products:
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL 34926/0003.
Decapeptyl SR 11.25mg (triptorelin pamoate)
Decapeptyl® SR 11.25 mg
Powder and solvent for suspension for injection
Triptorelin
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
The active ingredient in Decapeptyl SR 11.25 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 11.25 mg has three different uses. It is used in men, women and children to treat completely different conditions.
Decapeptyl SR is available in two other strengths: Decapeptyl SR 3 mg is used once a month 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 all three uses of Decapeptyl SR 11.25 mg. Please read all the sections that are about you and your condition.
In men, Decapeptyl SR 11.25 mg is used to treat prostate cancer.
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.
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:
Warnings and precautions:
Talk to your doctor or pharmacist before taking Decapeptyl SR 11.25 mg.
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, i.e., essentially ‘sodium-free‘.
Do not use Decapeptyl SR 11.25 mg:
Warnings and precautions:
Talk to your doctor or pharmacist before taking Decapeptyl SR 11.25 mg.
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, i.e., essentially ‘sodium-free‘.
Do not use Decapeptyl SR 11.25 mg:
Warnings and precautions:
Talk to your doctor or pharmacist before taking Decapeptyl SR 11.25 mg.
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, i.e., essentially ‘sodium-free‘.
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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Decapeptyl SR 11.25 mg can have side effects although not everybody gets them.
In rare cases you may experience a severe allergic reaction (angioedema, anaphylactic reaction). Tell your doctor immediately if you develop symptoms such as swallowing or breathing problems, dizziness, a rash, swelling of your lips, face, throat or tongue.
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), 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.
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, diarrhoea, 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), some blood tests affected (including raised liver function tests) 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.
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), 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.
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.
Keep this medicine out of the sight and reach of children.
Do not use the vial or ampoule after the expiry date printed on the box.
This medicine should not be stored above 25°C. The vial and ampoule should be kept in the outer box.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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.
This leaflet was last revised in May 2022.
Is this leaflet hard to see or read? Please phone +44 (0) 1753 627777 and ask for help.