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 can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet are: EU/1/14/940/001, EU/1/14/940/002.

Salvacyl

Package leaflet: Information for the user

Salvacyl

11.25 mg powder and solvent for prolonged-release 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 or pharmacist.
  • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

1. What Salvacyl is and what it is used for

Salvacyl contains triptorelin, which is similar to a hormone called gonadotropin releasing hormone (GnRH analogue). It is a long acting formulation designed to slowly deliver 11.25 mg of triptorelin over twelve weeks. It acts by lowering the levels of the male hormone, testosterone, in the body.

Salvacyl is used to decrease sexual drive in adult men with severe sexual deviations.

The treatment with Salvacyl is to be initiated and controlled by a psychiatrist. The treatment should be given in combination with psychotherapy, in order to decrease deviating sexual behaviour.

2. What you need to know before you use Salvacyl

Do not use Salvacyl

  • If you suffer from serious osteoporosis (a condition that weakens your bones).
  • If you are allergic to triptorelin, other medicines that regulate the production and release of sex hormones, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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 counteract this effect.

Talk to your doctor:

  • If you develop a depressed mood while taking Salvacyl. There have been reports of depression in patients taking Salvacyl which may be severe.
  • If you are using anticoagulants (medicines that inhibit the blood clotting ability), since you may experience bruises at the site of injection.
  • 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. When Salvacyl is used for a long period of time the risk of developing weak bones is increased, especially if any of the above applies. In order to prevent brittleness of the bones, a healthy lifestyle including no smoking, moderation of alcohol consumption and regular weight bearing exercises that put a load on and strengthens the skeleton, is recommended (e.g. walking, jogging, other forms of sports that put a load on the skeleton). Adequate dietary calcium and vitamin D intake should also be maintained.
  • If you are about to take a diagnostic test of pituitary gonadal function. The result can be misleading if you are on Salvacyl treatment or after discontinuation of Salvacyl treatment.
  • If you experience sudden headache, vomiting, problems with eyesight and paralysis 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 problems
  • 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 Salvacyl.

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

Children and adolescents

Salvacyl is not indicated for use in neonates, infants, children and adolescents.

Other medicines and Salvacyl

When Salvacyl is taken with medicines which affect the release of hormones from the pituitary (part of the brain), your doctor may need to do additional checks.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Salvacyl 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

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.

Salvacyl contains sodium

This medicinal product contains sodium but less than 1 mmol (23 mg) sodium per vial. This medicine is almost ‘sodium-free’ and may be taken with a low sodium diet.

3. How to use Salvacyl

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

The usual dose is 11.25 mg (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.

4. Possible side effects

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

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

In rare cases (may affect up to 1 in 1,000 people) you may experience a severe allergic reaction and commonly (may affect up to 1 in 10 people) you may experience an allergic reaction. Stop taking Salvacyl and contact a doctor or go to your nearest emergency department immediately if you experience any of the following symptoms: swallowing or breathing problems, swelling of your lips, face, throat or tongue, or a rash.

Other side effects that may occur:

Very common: may affect more than 1 in 10 people:

  • Hot flushes
  • Weakness
  • Excessive sweating
  • Back pain
  • Pins and needles sensation in the legs
  • Reduced libido
  • Impotence

Common: may affect up to 1 in 10 people:

  • Nausea, dry mouth
  • Pain, bruising, redness and swelling at injection site, muscle and bone pain; pain in the arms and legs; swelling caused by a build up of fluid in the body tissues, lower abdominal pain,
  • High blood pressure
  • Increase in weight
  • Dizziness, headache
  • Loss of libido, depression, mood changes

Uncommon: may affect up to 1 in 100 people:

  • Increase in blood platelet count
  • Feeling your heartbeat
  • Ringing in the ears, vertigo (sensation of spinning or whirling motion),
  • 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 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 cramps, muscle weakness, muscle pain, swelling and tenderness, bone 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, redness of skin, hives
  • The need to wake up to pass urine, problems passing urine
  • Nosebleeds

Rare: may affect up to 1 in 1,000 people:

  • Red or purple discolorations on the skin
  • Abnormal sensation in the eye, or disturbance in vision
  • Distended abdomen (sensation of fullness in the stomach), flatulence, abnormal sense of taste
  • Chest pain
  • Difficulty in standing
  • Flu-like illness, fever
  • Inflammation of the nose/throat
  • Increase in an enzyme present in your body such as bones and liver
  • Increased body temperature
  • Stiff joints, joint swelling, musculoskeletal stiffness, osteoarthritis
  • Memory impairment
  • Feeling confused, decreased activity, having a feeling of elation
  • Shortness of breath when lying flat
  • Blisters
  • Low blood pressure

Not known: frequency cannot be estimated from the available data

  • Changes in ECG (QT prolongation)
  • General discomfort
  • Anxiety

An increase in white blood cell count may be found, as with other GnRH analogues, in patients being treated with Salvacyl.

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 Salvacyl

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

Do not use this medicine after the expiry date which is stated on the carton, vial and ampoule after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25° C.

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°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.

6. Contents of the pack and other information

What Salvacyl contains

The active substance is triptorelin.

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

Reconstituted suspension (2 ml) contains 11.25 mg of triptorelin, as triptorelin embonate.

The other ingredients are:

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

Solvent: water for injection.

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 2 ml of solvent

1 injection syringe

2 needles.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Ipsen Limited
190 Bath Road
Slough
Berkshire
SL1 3XE
UK

Manufacturer

Ipsen Pharma Biotech
Parc d' Activité du Plateau de signes
Chemin Départemental n° 402
83870 Signes
France

This medicinal product is authorised in the Member States of the EEA under the following names:

Sweden: Moapar 11.25 mg

Belgium, Germany, Denmark, Finland, Netherlands, United Kingdom, Austria, Ireland andPolandSalvacyl 11.25 mg

France: Salvacyl LP

Norway and Greece: Salvapar

Is this leaflet hard to see or read? Please phone +44 (0) 1753 627777 and ask for help.

This leaflet was last revised in September 2018