Decapeptyl SR (Triptorelin)

Decapeptyl SR 11.25 mg for Injection

Triptorelin

1. What Decapeptyl SR is and What it is Used For

The active ingredient in Decapeptyl SR is triptorelin. Triptorelin belongs to a group of medicines called gonadotrophin releasing hormone (GnRH) analogues. Triptorelin is similar to the gonadotrophin 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 has three different uses. It is used in men, women and children to treat completely different conditions.

2. Before You Are Given Decapeptyl SR

 

Men Women Children
In men Decapeptyl SR is used to treat advanced

Prostate Cancer

In women Decapeptyl SR 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 is used to treat Puberty that occurs at a very young age (Precocious Puberty). This is called’early puberty’in the rest of this post.
2. Before You Are Given Decapeptyl SR
Men Women Children
You should not be given Decapeptyl SR:

• if you know that you are allergic to triptorelin or similar types of drugs (other GnRH analogues) or any of the other ingredients.

• if your prostate cancer has spread to your spine or if the tumour is pressing on your spine.

Take special care with Decapeptyl SR:

In adults if triptorelin or other GnRH analogues are used for a long period of time you may increase the risk of developing thin or weak bones. 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 it actually increases the level of your hormones for a short time. This means that you may feel worse to begin with.

After a short time the amount

of hormone will drop and your symptoms will get better.

Tell your doctor if you:

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

• 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.

Taking other medicines:

Drugs which increase the level of a hormone called prolactin may react with Decapeptyl SR. Many different kinds of drugs may increase prolactin levels.

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine – including medicines obtained without a prescription.

Driving and using machines:

Decapeptyl SR should not affect your ability to drive or operate machinery.

You should not be given Decapeptyl SR:

• if you know that you are allergic to triptorelin or similar types of drugs (other GnRH analogues) or any of the other ingredients.

• if you are pregnant.

Take special care with Decapeptyl SR:

In adults if triptorelin or other GnRH analogues are used for a long period of time you may increase the risk of developing thin or weak bones. 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

it actually increases the level of your hormones for a short time. This means that you may feel worse to begin with.

After a short time the amount of hormone will drop and your symptoms will get better. You may have some vaginal bleeding in the first month of treatment. After that your periods normally stop.

Tell your doctor if you have bleeding after the first month of treatment. Your periods should start about 5 months after the last injection. You must use some form of contraception other than the “pill” while you are having treatment and for 3 months after the last injection. Your doctor may suggest using a barrier method of contraception such as a condom or diaphragm (cap).

Taking other medicines:

Drugs which increase the level of a hormone called prolactin may react with Decapeptyl SR. Many different kinds of drugs may increase prolactin levels.

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine -including medicines obtained without a prescription.

Pregnancy and breast feeding:

Do not take Decapeptyl SR if you are pregnant or breastfeeding.

Driving and using machines:

Decapeptyl SR should not affect your ability to drive or operate machinery.

You should not be given Decapeptyl SR:

• if you know that you are allergic to triptorelin

or similar types of drugs (other GnRH analogues) or any of the other ingredients. Take special care with Decapeptyl SR:

Girls who have an early puberty may have some vaginal bleeding in the first month of treatment.

Taking other medicines:

Drugs which increase the level of a hormone called prolactin may react with Decapeptyl SR. Many different kinds of drugs may increase prolactin levels. Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine – including medicines obtained without a prescription.

 

3. How Decapeptyl SR is Given

Men Women Children
Decapeptyl SR will be injected into a muscle, usually your bottom, by a doctor or nurse. On this post there are instructions for them that explain how to prepare the injection.

You will normally receive an injection once every 3 months.

If you are given more Decapeptyl SR than you should:

If you are given too much Decapeptyl SR you may experience additional or more severe side effects.

If you forget to take a dose of Decapeptyl SR:

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:

If you stop receiving your Decapeptyl SR 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 will be injected into a muscle, usually your bottom, by a doctor or nurse. On this post 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.

If you are given more Decapeptyl SR than you should:

If you are given too much Decapeptyl SR you may experience additional or more severe side effects.

If you forget to take a dose of Decapeptyl SR:

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:

If you stop receiving your Decapeptyl SR 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 will be injected into a muscle, usually your bottom, by a doctor or nurse. On this post 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 if you are a girl and about 13-14 if you area boy).

If you are given more Decapeptyl SR than you should:

If you are given too much Decapeptyl SRyou may

experience additional or more severe side effects.

(see Section 4.,Possible Side Effects‘).

If you forget to take a dose of Decapeptyl SR:

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:

If you stop receiving your Decapeptyl SR 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

Men Women Children
Like all medicines, Decapeptyl SR can have side effects although not everybody gets them.

Side effects which are very common (more than 1 in 10 patients treated) are hot flushes, decreased sex drive and impotence.

At the beginning of treatment, increased bone pain, getting blood in your urine, back pain, weakness and numbness or tingling in your legs are common.

Side effects that are uncommon (less than 1 in 100 patients treated) are high blood pressure, increased size of your breasts, difficulty in sleeping, mood swings, mental illness and a feeling of dizziness or ‘spinning’.

Side effects that are rare (less than 1 in 1000 patients treated) are allergic reactions e.g. rash, itching, inflammation of the vein (phlebitis), dry mouth or excessive salivation, headaches, asthma coming back, fever, sweating, weight increase, pain/redness/ hardening where you had the injection, stomach ache, feeling or being sick, slight hair loss and problems with your eyesight.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this post, please tell your doctor or pharmacist.

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

At the beginning of treatment the symptoms of endometriosis (pelvic pain, painful periods) may be worse. These symptoms should disappear in one or two weeks. Vaginal bleeding may occur in the month after the first injection.

During treatment you may have side effects due to low oestrogen levels such as hot flushes, sweating, sleep disturbances, headache, mood swings, vaginal dryness, pain during sex, and a lower sex drive than usual.

Pain, redness or swelling may occur where you had the injection.

You may also have breast pain, muscle cramps, Joint pain, weight gain, sickness, stomach ache, weakness, increased blood pressure, problems with your eyesight, skin rash, swelling and hair loss.

You may have some thinning or weakening of bone during treatment. This is thought to be reversible.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this post, please tell your doctor or pharmacist.

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

Girls commonly (less than 1 in 10 patients treated) may get some vaginal bleeding in the first month of treatment. Pain, redness or swelling where you had the injection and pain in your joints are also common.

Children have rarely (less than 1 in 1000 patients treated) had side effects such as: allergic reactions, headache, weight gain, increased blood pressure, problems with your eyesight, stomach ache, being sick, having nosebleeds, feeling tired and ill, having aching muscles, feeling emotional and feeling nervous.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this post, please tell your doctor or pharmacist.

 

5. How to store Decapeptyl SR

Keep Decapeptyl SR out of the reach and sight of children.

Do not use the vials or ampoules after the expiry date printed on the box.

This medicinal product should be stored below 25°C.The vials and ampoules should be kept in the outer box.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to

protect the environment.

 

6. What Decapeptyl SR contains:

The active substance of Decapeptyl SR is triptorelin. The vial contains extra triptorelin (15mg in total) to make sure that you receive a sufficient dose. The other ingredients are D,L lactide-glycolide copolymer, Mannitol, Carmellose sodium, Poiysorbate 80.

What Decapeptyl SR looks like and contents of the pack

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

 


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