Tabulated list of adverse reactions The most frequently reported adverse events with Lymecycline Hard Capsules are gastrointestinal disorders of nausea, abdominal pain, diarrhoea and nervous system disorder of headache. The most serious adverse events reported with Lymecycline Hard Capsules are Stevens Johnson syndrome, anaphylactic reaction, angioneurotic oedema and intracranial hypertension.
System organ class Frequency Adverse drug reactions Blood and the lymphatic system disorders Unknown Neutropenia, Thrombocytopenia Immune system disorders Unknown Anaphylactic reaction, Hypersensitivity, Urticaria, Angioneurotic oedema Common (≥1/100 and <1/10) HeadacheNervous system disorders Unknown Dizziness, Intracranial hypertension Eye disorders Unknown Visual disturbance* Common (≥1/100 and <1/10) Nausea, Abdominal pain, Diarrhoea Gastrointestinal disorders Unknown Epigastralgia, Glossitis, Vomiting, Enterocolitis Hepatobiliary disorders Unknown Jaundice, Hepatitis Skin and subcutaneous tissue disorders Unknown Erythematous rash, Photosensitivity, Pruritus, Stevens Johnson syndrome General disorders and administration site conditions Unknown Pyrexia Investigations Unknown Transaminases increased, Blood alkaline phosphatase increased, Blood bilirubin increased 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 this medicine, 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 Lymecycline Hard Capsules: 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 8 years of age. As with all antibiotics overgrowth of non-susceptible organisms may cause candidiasis, pseudomembranous colitis (Clostridium Difficile overgrowth), glossitis, stomatitis, and 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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