Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
As with other drugs of similar structure, tinidazole is contraindicated in patients having, or with a history of, blood dyscrasia, although no persistent haematological abnormalities have been noted in clinical or animal studies.
Tinidazole should be avoided in patients with organic neurological disorders.
Tinidazole, other 5-nitroimidazole derivatives or any of the components of this product should not be administered to patients with known hypersensitivity to the drug.
Use of tinidazole is contraindicated during the first trimester of pregnancy and in nursing mothers (see section 4.6).
As with related compounds, alcoholic beverages should be avoided during Fasigyn therapy because of the possibility of a disulfiram-like reaction (flushing, abdominal cramps, vomiting, tachycardia). Alcohol should be avoided until 72 hours after discontinuing Fasigyn.
Drugs of similar chemical structure have also produced various neurological disturbances such as dizziness, vertigo, incoordination and ataxia. If during therapy with Fasigyn abnormal neurological signs develop, therapy should be discontinued.
Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent. Although carcinogenicity data is not available for tinidazole, the two drugs are structurally related and therefore there is a potential for similar biologic effects. Mutagenicity results with tinidazole were mixed (positive and negative) (see section 5.3). The use of tinidazole for longer treatment than usually required should be carefully considered.
Concurrent use of tinidazole and alcohol may produce a disulfiram-like reaction and should be avoided, (see section 4.4, Special warnings and precautions for use).
Drugs of similar chemical structure have been shown to potentiate the effects of oral anticoagulants. Prothrombin time should be closely monitored and adjustments to the dose of the anticoagulants should be made as necessary.
Fertility studies in rats receiving 100mg and 300mg tinidazole/kg had no effect on fertility, adult and pup weights, gestation, viability or lactation. There was a slight, not significant, increase in resorption rate at the 300mg/kg dose.
Tinidazole crosses the placental barrier. Since the effects of compounds of this class on foetal development are unknown, the use of tinidazole during the first trimester is contraindicated. There is no evidence that Fasigyn is harmful during the latter stages of pregnancy, but its use during the second and third trimesters requires that the potential benefits be weighed against possible hazards to mother or foetus.
Tinidazole is excreted in breast milk. Tinidazole may continue to appear in breast milk for more than 72 hours after administration. Women should not nurse until at least 3 days after having discontinued taking Fasigyn.
No special precautions should be necessary. However, drugs of similar chemical structure, including Fasigyn, have been associated with various neurological disturbances such as dizziness, vertigo, ataxia, peripheral neuropathy (paraesthesia, sensory disturbances, hypoaesthesia) and rarely convulsions. If any abnormal neurological signs develop during Fasigyn therapy, the drug should be discontinued.
Reported side effects have generally been infrequent, mild and self-limiting.
The reported undesirable effects are listed below according to MedDRA system organ class classification and frequency. Within each frequency category, the ADRs are presented in the order of clinical importance. Frequency categories are expressed as: 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); not known (the frequency cannot be estimated from the available data).
Not known: Leukopenia
Not known: Drug hypersensitivity
Common: Decreased appetite
Common: Headache
Not known: Convulsions, Neuropathy peripheral, Paraesthesia, Hypoaesthesia, Sensory disturbances, Ataxia, Dizziness, Dysgeusia
Common: Vertigo
Not known: Flushing
Common: Vomiting, Diarrhoea, Nausea, Abdominal pain
Not known: Glossitis, Stomatitus, Tongue discolouration
Common: Dermatitis allergic, Pruritis
Not known: Angioedema, Urticaria
Not known: Chromaturia
Not known: Pyrexia, Fatigue
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 at: www.mhra.gov.uk/yellowcard.
Not applicable.
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