Salvacyl 11.25 mg powder and solvent for prolonged-release suspension for injection

• 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

• 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).

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. Your doctor may want to monitor your depression during your treatment.
• 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 or sex organs. 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.
• Testosterone decreasing agents may cause changes in ECG associated with heart rhythm abnormalities (QT prolongation).
• Treatment with GnRH analogues including Salvacyl might increase the risk of anaemia (defined as a decrease in the count of red blood cells).

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.

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

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).

Salvacyl is not to be used by women.

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.

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.

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,
• Allergic reaction
• 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
• Urinary incontinence
• If an existing pituitary tumour, an increased risk of bleeding to the area
• Anaemia (decrease in the count of red blood cells).

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

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.

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.

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.

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