SALVACYL

25 mg triptorelin (1 vial) administered every twelve weeks as a single intramuscular injection. Paediatric population The safety and efficacy of Salvacyl in children have not been established. Salvacyl is not indicated for use in neonates, infants, children and adolescents.

Patients with renal or hepatic impairment No dosage adjustment is necessary for patients with renal or hepatic impairment. 6. Precautions to be taken before handling or administrating the medicinal product Since Salvacyl is a suspension of microgranules, inadvertent intravascular injection must be strictly avoided.

Salvacyl must be administered under the supervision of a medically qualified person (nurse or physician). The therapeutic benefit should be monitored regularly, for example prior to any new injection. The injection site should be varied periodically.

As seen 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 include hot flushes and erectile dysfunction (observed in more than 10% of the patients).

With the exception of hypersensitivity reactions (rare) and injection site pain (<5%), all adverse events are known to be related to testosterone changes. The long-term use of synthetic GnRH analogues may be associated with increased bone loss and may lead to osteoporosis and increases the risk of bone fracture.

The following adverse reactions considered as at least possibly related to triptorelin treatment were reported in clinical studies performed in men suffering from advanced prostate cancer and in healthy male volunteers. Most of these events are known to be related to biochemical or surgical castration.

The frequency of the adverse reactions is classified as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); not known (cannot be estimated from the available data). 5) Ear and labyrinth disorders Tinnitus Vertigo System Organ Class Very Common AEs Common AEs Uncommon AEs Rare AEs Additional post-marketing Frequency not known Endocrine disorders Pituitary apoplexy** Eye disorders Visual impairment Abnormal sensation in eye Visual disturbance Gastrointestinal disorders Dry mouth Nausea Abdominal pain Constipation Diarrhoea Vomiting Abdominal distension Dysgeusia Flatulence General disorders and administration site conditions Asthenia Injection site reaction (including erythema inflammation and pain) Oedema Lethargy Oedema peripheral Pain Rigors Somnolence Chest pain Dysstasia Influenza like illness Pyrexia Malaise Immune system disorders Hypersensitivity Anaphylactic reaction Anaphylactic shock Infections and infestations Nasopharyngitis Investigations Weight increased Alanine aminotransferase increased Aspartate aminotransferase increased Blood creatinine increased Blood pressure increased Blood urea increased Gamma- glutamyl transferase increased Weight decreased Blood alkaline phosphatase increased Metabolism and Anorexia System Organ Class Very Common AEs Common AEs Uncommon AEs Rare AEs Additional post-marketing Frequency not known nutrition disorders Diabetes mellitus Hyperlipidaemia Gout Increased appetite Musculoskeletal and connective tissue disorders Back pain Musculoskeletal pain Pain in extremity Arthralgia Bone pain Muscle cramp Muscular weakness Myalgia Joint stiffness Joint swelling Musculoskeletal stiffness Osteoarthritis Nervous system disorders Paraesthesia in lower limbs Dizziness Headache Paraesthesia Memory impairment Psychiatric disorders Libido decreased Loss of libido Depression* Mood changes* Insomnia Irritability Confusional state Decreased activity Euphoric mood Anxiety Renal and urinary disorders Nocturia Urinary retention Urinary incontinence Reproductive system and breast disorders Erectile dysfunction (including ejaculation failure, ejaculation disorder) Pelvic pain Gynaecomastia Breast pain Testicular atrophy Testicular pain Respiratory, thoracic and mediastinal disorders Dyspnoea Epistaxis Orthopnoea Skin and subcutaneous tissue disorders Hyperhidrosis Acne Alopecia Erythema Pruritus Rash Urticaria Blister Purpura Angioneurotic oedema Vascular Hot flush Hypertension Hypotension System Organ Class Very Common AEs Common AEs Uncommon AEs Rare AEs Additional post-marketing Frequency not known disorders *This frequency is based on class-effect frequencies common for all GnRH agonists.

Treatment with Salvacyl should be considered on an individual basis and only be initiated if the benefits of treatment outweigh the risk following a very careful appraisal. Initially triptorelin causes a transient increase in serum testosterone levels.

During the initial phase of treatment, the patient should be closely monitored by the treating psychiatrist and consideration should be given to the additional administration of a suitable anti-androgen to counteract the initial rise in serum testosterone levels in order to control possible increase in sexual drive, if considered appropriate.

Following treatment interruption, there is a risk of an increased sensitivity to the restored testosterone, which can lead to a highly increased sexual drive. For this reason, the addition of an adequate anti-androgen before stopping Salvacyl treatment should be considered.

Once the castration levels of testosterone have been achieved by the end of the first month, they are maintained for as long as the patient receives their injection every twelve weeks. The evaluation of the treatment effect is essentially clinical.

g. before each 3-month injection of triptorelin. Serum testosterone levels may be measured in case there is any doubt of treatment effect, which could be related to compliance with triptorelin treatment or to a technical problem with the injection.

Caution is required in patients treated with anti-coagulants, due to the potential risk of haematomas at the site of injection. Administration of triptorelin in therapeutic doses results in suppression of the pituitary gonadal system.

Normal function is usually restored after treatment is discontinued. Diagnostic tests of pituitary gonadal function conducted during treatment and after discontinuation of therapy with a GnRH agonist may therefore be misleading. Long term androgen deprivation either by bilateral orchidectomy or administration of GnRH analogues is associated with increased risk of bone loss and may lead to osteoporosis and increased risk of bone fracture.

Patients with serious osteoporosis. 1.