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The product code for this leaflet is: PL034926/012

 

Company Details

Ipsen Ltd


190 Bath RoadSloughBerkshireSL1 3XE
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Medical Information e-mail:medical.information.uk@ipsen.com
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PACKAGE LEAFLET: INFORMATION FOR THE USER

Salvacyl 11.25mg powder and solvent for suspension for injection

Triptorelin

Read all of this leaflet carefully before you start using this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Salvacyl is and what it is used for
2. Before you use Salvacyl
3. How to use Salvacyl
4. Possible side effects
5. How to store Salvacyl
6. Further information

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1. WHAT SALVACYL IS AND WHAT IT IS USED FOR

Salvacyl reduces the level of male sex hormone (testosterone) and is used to decrease the sexual drive in men with a sexually-deviant behaviour. The treatment should be combined with psychotherapy.

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2. BEFORE YOU USE SALVACYL

Do not use Salvacyl

  • if you suffer from severe osteoporosis, a condition that affects the strength of your bones.
  • if you are allergic (hypersensitive) to triptorelin, other medicines that regulate the production and release of sex hormones, or any of the other ingredients of Salvacyl.

Take special care with Salvacyl

Check with your doctor before taking your medicine:

  • There have been reports of depression in patients taking Salvacyl, which may be severe. If you are taking Salvacyl and develop depressed mood, inform your doctor.
  • If you are using anticoagulants (medicines that reduce blood clotting), since you may experience bruising at the site of injection.
  • At the beginning of treatment there will be an increased amount of testosterone in your body. This might result in an increase in sexual drive. Your doctor may give you some medicine (an anti-androgen) to control this effect.
  • When Salvacyl is used for a long period of time, the risk of developing weak bones is increased, especially if any of the following applies: If you are a heavy drinker, a smoker, have osteoporosis (a condition that weakens your bones) or have a family history of osteoporosis, have a poor diet or take anticonvulsants (medicines for epilepsy or fits) or corticosteroids (steriods). In order to reduce the risk of brittle bones, a healthy lifestyle is recommended including no smoking, moderate alcohol intake and regular weight bearing exercises (e.g. walking, jogging or other sports that put a load on the skeleton and therefore strengthen it). You should make sure that your diet contains enough calcium and vitamin D.
  • If you need any tests to check your hormone function during or after your Salvacyl treatment, the results may be misleading. Please tell your doctor you have been treated with Salvacyl.
  • If you experience sudden headache, problems with eye sight and weakness of the eye muscles, these can be signs of a benign tumour of the pituitary gland which may be discovered following treatment with Salvacyl.
  • If you have diabetes, or if you suffer from heart or vascular (circulation) problems.

When the treatment is stopped, testosterone will return to normal levels and your sexual drive may increase again. Your doctor may give you another medicine in order to control this effect.

Using other medicines

When Salvacyl is taken at the same time as medicines that affect the release of hormones from the pituitary (part of the brain), your doctor may need to check your hormone levels.

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

Pregnancy and breast-feeding

Salvacyl is not to be used by women.

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. If you experience any of these side effects you should not drive or use machines.

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3. HOW TO USE SALVACYL

Salvacyl is prepared and is always given to you by a doctor or nurse.

The usual dose is 11.25mg (one vial) of Salvacyl, given as a single injection into a muscle every twelve weeks.

If you think the effect of Salvacyl 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.

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4. POSSIBLE SIDE EFFECTS

Like all medicines, Salvacyl can cause side effects, although not everybody gets them.

Many of the side effects are expected and are due to the change in the level of testosterone in your body. These effects include hot flushes and impotence.

In rare cases you may experience a severe allergic reaction. Tell your doctor immediately if you develop symptoms such as swallowing or breathing problems, a rash, swelling of your lips, face, throat or tongue.

Very common side effects affecting more than 1 in 10 patients:

  • Hot flushes
  • Excessive sweating
  • Back pain
  • Pins and needles sensation in the legs
  • Loss of strength

Common side effects affecting more than 1 in 100 patients but less than 1 in 10 patients:

  • Nausea
  • Tiredness; redness, inflammation, pain and/or other reactions at the injection site; muscle and bone pain; pain in the arms and legs; swelling caused by a build up of fluid in the body tissues.
  • Dizziness, headache
  • Depression, mood changes
  • Impotence

Uncommon side effects affecting more than 1 in 1000 patients but less than 1 in 100 patients:

  • Ringing in the ears
  • Pain in abdomen, constipation, diarrhoea, vomiting
  • Drowsiness, shaking, sleepiness, pain
  • Some blood tests affected (including abnormal liver function tests)
  • Increase in weight
  • Loss of appetite, gout (severe pain and swelling in the joints, usually in the big toe),
  • Increase in appetite
  • Joint pain, muscle cramp, muscle weakness, muscle pain
  • Tingling or numbness
  • Inability to sleep, irritability
  • Development of enlarged breasts, breast pain, reduction in testicular size, pain in testicles
  • Difficulty in breathing
  • Acne, hair loss, itching, rash
  • High blood pressure

Rare side effects affecting less than 1 in 1000 patients:

  • Red or purple discolorations on the skin
  • Diabetes
  • Vertigo (dizziness and a feeling of movement when you are stationary)
  • Abnormal sensation in the eye, blurring or disturbance in vision
  • Sensation of fullness in the stomach, flatulence, dry mouth, abnormal sense of taste
  • Chest pain
  • Difficulty in standing
  • Flu-like illness, fever
  • Allergic reaction, Anaphylactic reaction (serious allergic reaction which can cause dizziness or difficulty in breathing)
  • Inflammation of the nose/throat
  • Increase in an enzyme present in the bones and liver.
  • Increased body temperature
  • Weight loss
  • Stiff joints, joint swelling, musculoskeletal stiffness, osteoarthritis
  • Memory impairment,
  • Feeling confused, decreased activity, having a feeling of elation or well-being
  • Inability to ejaculate
  • Shortness of breath when lying flat
  • Blisters
  • Nose bleeds
  • Low blood pressure

In studies and observations after marketing of Salvacyl, the following side effects have also been reported: blurred vision, blood pressure increased, general discomfort, bone pain, anxiety, rapid formation of wheals due to swelling of the skin or mucous membranes.

As with other medicines of this class, an increase in white blood cell count may be found in patients being treated with Salvacyl.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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5. HOW TO STORE SALVACYL

Keep out of the reach and sight of children.

Do not use Salvacyl after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.

Do not store above 25° C.

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

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6. FURTHER INFORMATION

What Salvacyl contains

The active substance is triptorelin 11.25mg.

One vial of powder contains 11.25mg of triptorelin, as triptorelin pamoate.

Reconstituted suspension (2mL) contains 11.25mg of triptorelin, as triptorelin pamoate.

The other ingredients are:

Powder : poly (d, l-lactide-co-glycolide), mannitol, carmellose sodium and polysorbate 80.

Solvent : water for injections

What Salvacyl looks like and contents of the pack

Salvacyl is a white to off-white powder.

The solvent is a clear solution

The package contains:

1 vial with powder

1 ampoule with 2mL of solvent

1 injection syringe

2 needles

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Ipsen Limited
190 Bath Road
Slough
SL1 3XE
UK

Manufacturer

Ipsen Pharma Biotech
Parc d' Activité du Plateau de signes
Chemin Départemental n° 402
83870 Signes
France
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This leaflet was last revised in 12/2012

Is this leaflet hard to see or read? Please phone 01753 627777 and ask for help.

Document name: 3_SAL_UK

Document replaced:2_SAL_UK

Date of preparation: 121220


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