TETRALYSAL

Adults:

The usual dosage for the chronic treatment of acne is 1 capsule daily (300 mg/day): treatment should be continued for at least 8 weeks. d. (600 mg/day). If higher doses are required, 3-4 capsules (900-1200 mg) may be given over 24 hours.

Lower doses may be given for prophylaxis. In the management of sexually transmitted disease both partners should be treated.

Elderly:

As for other tetracyclines, no specific dose adjustment is required.

Paediatric population:

The safety and efficacy of Tetralysal 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

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

System Organ Class Frequency Adverse Reaction Blood and lymphatic system disorders Unknown Neutropenia Thrombocytopenia Eye disorders Unknown Visual disturbance* Gastrointestinal disorders Common (≥1/100 and <1/10) Nausea Abdominal pain Diarrhoea Unknown Epigastralgia Glossitis Vomiting Enterocolitis General disorders and administration site conditions Unknown Pyrexia Hepatobiliary disorders Unknown Jaundice Hepatitis Immune system disorder Unknown Anaphylactic reaction Hypersensitivity Urticaria Angioneurotic oedema Investigations Unknown Transaminases increased Blood alkaline phosphatase increased Blood bilirubin increased Nervous system disorders Common (≥1/100 and <1/10) Headache Unknown Dizziness Intracranial hypertension Skin and subcutaneus tissues disorders Unknown Erythematous rash Photosensitivity Pruritus Stevens Johnson syndrome Psychiatric disorders, Unknown Depression Nightmare Description of selected adverse reactions *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 Tetralysal, administration should be stopped. 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.

The following adverse effects were reported with tetracyclines in general and may occur with Tetralysal: dysphagia, oesophagitis, oesophageal ulceration, systemic lupus erythematosus, pancreatitis, teeth discolouration, hepatitis, hepatic failure.

Dental dyschromia and/or enamel hypoplasia may occur if the product is administered in children younger than 8 years of age. As with all antibiotics overgrowth of non susceptible organisms may cause candidiasis, pseudomembranous colitis (Clostridium Difficile overgrowth), glossitis, stomatitis, vaginitis or staphyloccocal enterocolitis.

Reporting of suspected adverse reactions 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.

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Oesophageal irritation and ulceration Solid dosage forms of the tetracyclines may cause oesophageal irritation and ulceration. To avoid oesophageal irritation and ulceration, adequate fluids (water) should be taken with this medicinal product (see section Posology and method of administration).

Caution should be exercised if the product is administered to patients with impaired renal or hepatic functions. Hepatotoxicity Overdosage could result in hepatotoxicity Antibiotic resistance Prolonged use of broad spectrum antibiotics may result in the appearance of resistant organisms and superinfection.

Phototoxicity 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. Hepatic impairment Care should be exercised in administering tetracyclines to patients with hepatic impairment.

Paediatric population The product should not be used in children below 12 years of age due to the risk of permanent dental staining and enamel hypoplasia (see Contraindications).

3. Methods of administration The capsules should be taken with a glass of water in order to reduce the risk of oesophageal irritation and ulceration (see section Special warnings and precautions for use). 1. Its use is contraindicated in patients with overt renal insufficiency and in children less than 8 years due to a risk of permanent dental staining and enamel hypoplasia.

Concurrent treatment with oral retinoids (see Interaction with other Medications).