LYMECYCLINE

Posology Adults:

The usual dosage for the chronic treatment of acne is 1 capsule (408 mg) daily; treatment should be continued for at least eight (8) weeks. For other infections, the usual dosage is one capsule (408 mg) twice a day. In the event higher doses are required, 3 – 4 capsules (1224 mg – 1632 mg) may be given over 24 hours.

In the management of sexually transmitted disease, both partners should be treated.

Elderly:

As for other tetracyclines, no specific dosage adjustment is required. 3). 4).

Paediatric population:

The safety and efficacy of Lymecycline 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 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.

000) and Not known (cannot be estimated from the available data). System Organ Class (SOC) Frequency Adverse Reaction Blood and lymphatic system disorders Not known Neutropenia Thrombocytopenia Eye disorders Not known Visual disturbances Common Nausea Abdominal pain Diarrhoea Gastrointestinal disorders Not known Epigastralgia Glossitis Vomiting Enterocolitis General disorders and administration site conditions Not known Pyrexia Hepatobiliary disorders Not known Jaundice Hepatitis Immune system disorders Not known Anaphylactic reaction Hypersensitivity Urticaria Angioneurotic oedema Investigations Not known Transaminases increased Blood alkaline phosphatase increased Blood bilirubin increased Common HeadacheNervous system disorders Not known Dizziness Intracranial hypertension Skin and subcutaneous tissues disorders Not known Erythematous rash Photosensitivity Pruritus Stevens Johnson syndrome Psychiatric disorders, Not known Depression Nightmare Description of selected adverse reactions 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 Lymecycline: • Dysphagia, oesophagitis, oesophageal ulceration, pancreatitis, teeth discolouration, hepatitis, hepatic failure. Dental dyschromia and / or enamel hypoplasia may occur if the product is administered in children younger than eight (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 staphylococcal 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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). 066 mg / capsule: this may cause allergic reactions.

3. Method of administration Lymecycline 408 mg capsule, hard are for oral administration. The capsules should always be taken with a glass of water. 1. • Its use is contraindicated in patients with overt renal insufficiency and in children less than 8 years due to the risk of permanent dental staining and enamel hypoplasia Concurrent treatment with oral retinoids (see Interaction with other Medications).