What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.


Decapeptyl SR 22.5mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

Decapeptyl® SR 22.5mg 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 22.5mg is and what it is used for
2. What you need to know before you use Decapeptyl SR 22.5mg
3. How to use Decapeptyl SR 22.5mg
4. Possible side effects
5. How to store Decapeptyl SR 22.5mg
6. Contents of the pack and other information

1. WHAT DECAPEPTYL SR 22.5mg 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 analogue).

Triptorelin belongs to a group of medicines called GnRH analogues. It is a long acting formulation designed to slowly deliver 22.5 mg of triptorelin over a 6-month period (twenty four weeks). In men, triptorelin lowers the levels of the hormone testosterone. In women, it lowers the levels of the hormone oestrogen.

In men: Decapeptyl SR 22.5 mg is used to treat prostate cancer.

In children 2 years of age and older Decapeptyl SR 22.5 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 (Precocious Puberty). This is called ‘early puberty’ in the rest of this leaflet.

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 22.5mg

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

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.

The product should only be injected in the muscle

In men:

  • 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 anti-convulsants (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 eye sight and paralysis of the eye muscles.

In children:

  • If you have a progressive brain tumour, tell your doctor. This may affect the way your doctor decides to treat you.
  • Girls who have an early puberty may have some vaginal bleeding in the first month of treatment.

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).

Pregnancy and breast-feeding

Do not take Decapeptyl SR 22.5 mg if you are pregnant.

Do not take Decapeptyl SR 22.5 mg if you are 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.

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

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

3. HOW TO USE DECAPEPTYL SR 22.5mg

Decapeptyl SR 22.5mg 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 22.5mg.

In men:

Therapy of prostrate cancer with Decapeptyl SR 22.5 mg requires long term treatment.

The usual dose is 1 vial of Decapeptyl SR 22.5mg injected into a muscle every 6 months (24 weeks). Decapeptyl SR 22.5mg is for injection into the muscle only

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

Decapeptyl SR 22.5mg 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.

In children:

You will usually receive an injection into a muscle every 6 months (24 weeks). Decapeptyl SR 22.5mg is for injection into the muscle only

Your doctor will decide when treatment should be stopped (normally when you are about 12-13 years old if you are a girl and about 13-14 years old if you are a boy).

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

If you have any further questions on the use of this product, ask your 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.

In men:

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 of immuno-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 or 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 the skin, hives
  • Waking up at night to pass urine, problems passing urine
  • 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)
  • 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.

During post-marketing surveillance the following side effects have also been reported:

Anaphylactic reaction (serious allergic reaction which causes difficulty in breathing or dizziness), changes in ECG (QT prolongation), general discomfort, anxiety and rapid formation of wheals due to swelling of the skin or mucous membranes and urinary incontinence.

In children:

Side effects which are very common (may affect more than 1 in 10 people) are:

  • 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) are:

  • Acne
  • Headache
  • Hot flushes
  • Weight increased
  • Pain in the abdomen
  • Hypersensitvity reactions
  • Pain, redness and swelling at injection site.

Side effects that are uncommon (may affect up to 1 in 100 people) are:

  • Itching
  • Neck pain
  • Nosebleeds
  • Consitipation
  • Blurred vision
  • Rash or hives
  • Nausea, vomiting
  • Overweight
  • Pain in the breast
  • Changes in mood
  • General discomfort.

During post-marketing surveillance, the following side effects have also been reported:

High blood pressure, abnormal vision, anaphylactic reaction (serious allergic reaction which causes difficulty in breathing or dizziness), some blood tests affected including hormone levels, rapid formation of wheals due to swelling of the skin or mucous membranes, muscle pain, mood disorders, depression and nervousness.

Your doctor will determine the countermeasures be to taken.

Reporting of side effects

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 at www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE DECAPEPTYL SR 22.5mg

Keep this medicine out of the sight and reach of children.

Do not use Decapeptyl SR 22.5mg after the expiry date which is stated on the box and on the labels after EXP. The expiry date refers to the last day of that month.

The reconstituted suspension must be used immediately.

Do not store above 25°C.

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.t.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Decapeptyl SR 22.5mg contains

The active substance is triptorelin.

The other ingredients are:

Powder: poly (D,L-lactide-co-glycolide), mannitol, carmellose sodium, polysorbate 80.

Solvent: water for injections.

What Decapeptyl SR 22.5mg looks like and the contents of the pack

1 vial Decapeptyl SR 22.5mg contains triptorelin pamoate equivalent to 22.5mg triptorelin.

1 ampoule contains 2mL water for injections.

After dispersion in 2mL solvent, 1mL of the reconstituted suspension contains 11.25mg triptorelin.

Decapeptyl SR 22.5mg is available in boxes of:

1 vial, 1 ampoule and 1 blister containing 1 injection syringe and 2 injection needles.

Marketing Authorisation Holder

Ipsen Limited
190 Bath Road
Slough
Berkshire
SL1 3XE
UK

Manufacturer

Ipsen Pharma Biotech
83870 Signes
France

The leaflet was last revised in June 2017

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