Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: Codal-Synto Ltd, 21 Constantinoupoleos Street, 3011 Limassol, Cyprus
Syntovir is not indicated for patients with known hypersensitivity to aciclovir or to any of the excipients of Syntovir listed in section 6.1 or to valaciclovir.
In severely immunocompromised patients (e.g. AIDS patients or bone marrow transplant recipients) oral Syntovir dosing should be considered. Such patients should be encouraged to consult a physician concerning the treatment of any infection.
Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported only at doses of aciclovir greatly in excess of those employed therapeutically. Two generation studies in mice did not reveal any effect of (orally administered) aciclovir on fertility. Syntovir tablets have been shown to have no definite effect upon sperm count, morphology or motility in man.
The results of a wide range of mutagenicity tests in vitro and in vivo indicate that aciclovir does not pose a genetic risk to man. Aciclovir was not found to be carcinogenic in long term studies in the rat and the mouse.
Hydration status: Care should be taken to maintain adequate hydration in patients receiving higher dose oral regimens e.g. for the treatment of herpes zoster infections (4g daily) in order to avoid the risk of possible renal toxicity. The data currently available from clinical studies is not sufficient to conclude that treatment with Syntovir reduces the incidence of chickenpox-associated complications in immunocompetent patients.
Syntovir contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
No clinically significant interactions have been identified.
Aciclovir is eliminated primarily unchanged in the urine via active renal tubular secretion. Any drugs administered concurrently that compete with this mechanism may increase aciclovir plasma concentrations. Probenecid and cimetidine increase the AUC of aciclovir by this mechanism and reduce aciclovir renal clearance. Similarly increases in plasma AUCs of aciclovir and of the inactive metabolite of mycophenolate mofetil, an immunosuppressant agent used in transplant patients have been shown when the drugs are co-administered. However, no dosage adjustment is necessary because of the wide therapeutic index of aciclovir.
A post marketing aciclovir pregnancy registry has documented pregnancy outcome in women exposed to any formulation of Syntovir. The birth defects described amongst Syntovir exposed subjects have not shown any uniqueness of consistent pattern to suggest a common cause.
Caution should however be exercised by balancing the potential benefits of treatment against any possible hazard.
Following oral administration of 200mg aciclovir five times a day aciclovir has been detected in breast milk at concentration ranging from 0.6 to 4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to aciclovir dosages of up to 0.3 mg/kg/day. Caution is therefore advised if aciclovir is to be administered to a nursing woman.
Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rats, rabbits or mice.
In a non-standard test in rats, foetal abnormalities were observed but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain. Limited human data show that the drug does pass into breast milk following systemic administration.
None known (see also “Undesirable effects”).
The following convention has been used for the classification of undesirable effects in terms of frequency: Very common 1/10, Common 1/100 and <1/10, Uncommon 1/1000 and <1/100, Rare 1/10,000 and <1/1000, Very rare <1/10,000.
Very rare: decreases in haematological indices- anaemia, leucopenia, thrombocytopenia.
Rare: Anaphylaxis.
Common: Headache, dizziness.
Very rare: Confusion, hallucinations, convulsions, somnolence, coma.
The above events are generally reversible and usually reported in patients with renal impairment (see 4.4 Special warnings and precautions for use).
Rare: Dyspnoea.
Common: Nausea, vomiting, diarrhoea, abdominal pains.
Rare: Reversible rises in bilirubin and liver related enzymes.
Very rare: Hepatitis, jaundice.
Common: Pruritus, rashes (including photosensitivity). Such rashes resolve on withdrawal of aciclovir.
Uncommon: Urticaria. Accelerated diffuse hair loss. Accelerated diffuse hair loss has occasionally been reported, as this type of hair loss is associated with a variety of medicines and disease states, the causality in respect to acyclovir has not been established.
Rare: Angioedema.
Rare: mild transient increases in blood urea and creatinine
Very rare: Acute renal failure.
Common: Fatigue.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.
Not applicable.
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