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