LYMECYCLINE

Posology Adults:

The usual dosage for the chronic treatment of acne is 408 mg daily: treatment should be continued for at least 8 weeks. For other infections, the usual dosage is 408 mg twice a day. If higher doses are required, 1224-1632 mg may be given over 24 hours.

The capsules should always be taken with a glass of water. In the management of sexually transmitted disease both partners should be treated.

Older people:

As for other tetracyclines, no specific dose adjustment is required. Paediatric population The safety and efficacy of Lymecycline 408 mg Capsules in children aged under 12 years of age have not been established. No data are available.

For children over the age of 12 years the adult dosage may be given. For children under the age of 8 years, see section

The most frequently reported adverse events with lymecycline are gastrointestinal disorders of nausea, abdominal pain, diarrhoea and nervous system disorder of headache. The most serious adverse events reported with lymecycline are Stevens Johnson syndrome, anaphylactic reaction, angioneurotic oedema and intracranial hypertension.

Adverse reactions are ranked by frequency, the most frequent first, using the following convention: Very Common: (≥1/10), Common: (≥1/100 to <1/10), Uncommon: (≥1/1,000 to <1/100), Rare: (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and Not known (cannot be estimated from the available data).

System Organ Class Frequency Adverse Reaction Blood and lymphatic system disorders Not known Neutropenia Thrombocytopenia Eye disorders Not known Visual disturbance* Gastrointestinal disorders Common Nausea Abdominal pain Diarrhoea Not known Epigastralgia Glossitis Vomiting Enterocolitis General disorders and administration site conditions Not known Pyrexia Hepatobiliary disorders Not known Jaundice Hepatitis Immune system disorder Not known Anaphylactic reaction Hypersensitivity Urticaria Angioneurotic oedema Investigations Not known Transaminases increased Blood alkaline phosphatase increased Blood bilirubin increased Nervous system disorders Common Headache Not known Dizziness Intracranial hypertension Skin and subcutaneus tissues disorders Not known Erythematous rash Photosensitivity Pruritus Stevens Johnson syndrome Psychiatric disorders Not known Depression Nightmare *The manifestation of clinical symptoms, including vision disorders, or headache, must suggests the possibility of a cranial hypertension diagnosis.

If increased intracranial pressure is suspected during treatment with lymecycline, administration should be stopped.

General tetracyclines adverse events:

Benign intracranial hypertension and bulging fontanelles in infants were reported with tetracyclines with possible symptoms of headaches, vomiting, visual disturbances including blurring of vision, scotomata, diplopia or permanent visual loss.

Oesophageal irritation and ulceration Solid dosage forms of the tetracyclines may cause oesophageal irritation and ulceration. 2). Antibiotic resistance Prolonged use of broad spectrum antibiotics may result in the appearance of resistant organisms and superinfection.

Cross-resistance between tetracyclines may develop in micro-organisms, and cross sensitisation in patients. Renal impairment Caution should be exercised if the product is administered to patients with impaired renal functions. Hepatic impairment Tetracyclines should only be used with caution in patients with hepatic dysfunction, lest accumulation occurs with increased toxicity.

Careful monitoring of dosage by serum levels is necessary. Hepatotoxicity High dosage of tetracyclines may be hepatotoxic and great care should be used with concurrent administration of other hepatotoxic drugs. Phototoxicity Tetracyclines may cause photosensitivity reactions; however, very rare cases have been reported with lymecycline.

Due to the risks of photosensitivity, it is recommended to avoid exposure to direct sunlight and ultraviolet light during the treatment which should be discontinued if erythematous cutaneous manifestations occur. Expired medication The use of expired tetracyclines can lead to renal tubular acidosis (Pseudo-Fanconi syndrome) readily reversible when treatment is discontinued altogether.

Systemic lupus erythematosus May cause exacerbation of systemic lupus erythematosus. Myasthenia Gravis Can cause weak neuromuscular blockade so should be used with caution in Myasthenia Gravis. Paediatric population Tetracyclines are absorbed to some extent by developing bones and teeth and may produce staining and enamel hypoplasia.

3).

3. Method of administration Lymecycline 408mg Capsules, hard is for oral administration. 4). 5).