Tabulated list of adverse reactions 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 subcutaneous tissues disorders Unknown Erythematous rash Photosensitivity Pruritus Stevens Johnson syndrome Psychiatric disorders Unknown 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. 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, 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.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store