Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Patients with rare heriditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Breathing difficulties: Cases of breathing difficulties including dyspnoea, bronchospasm, exacerbation of asthma, pulmonary eosinophilia and pneumonitis (see section 4.8) have been reported with minocycline use. If patients develop breathing difficulties they should seek urgent medical advice and minocycline should be discontinued.
Paediatric population: The use of tetracyclines during tooth development in children under the age of 12 years may cause permanent discoloration (see above). Enamel hypoplasia has been reported.
Use in Hepatic Dysfunction: Minocycline should be used with caution in patients with hepatic dysfunction and in conjunction with alcohol and other hepatotoxic drugs.
Auto–immune Disorders: Rare cases of auto-immune hepatotoxicity and isolated cases of systemic lupus erythematosus (SLE) and also exacerbation or pre-existing SLE have been reported. If patients develop signs or symptoms of SLE or hepatotoxicity, or suffer exacerbation or pre-existing SLE, minocycline should be discontinued.
Renal Impairment: Clinical studies have shown that there is no significant drug accumulation in patients with renal impairment when they are treated with minocycline in the recommended doses. In cases of severe renal insufficiency, reduction of dosage and monitoring of renal function may be required.
Cross-sensitivities: Cross-resistance between tetracyclines may develop in micro-organisms and cross-sensitisation in patients. Minocycline should be discontinued if there are signs/symptoms of overgrowth of resistant organisms, enteritis eg glossitis, stomatitis, vaginitis, pruritus ani or staphylococcal enteritis.
Myasthenia Gravis: Tetracyclines can cause weak neuromuscular blockade – use with caution in Myasthenia Gravis.
Intracranial hypertension: As with other tetracyclines, bulging fontanelles in infants and benign intracranial hypertension in juveniles and adults have been reported. Presenting features were headache and visual disturbances including blurring of vision, scotoma and diplopia. Permanent vision loss has been reported. Treatment should cease if evidence of raised intracranial pressure develops.
Hyperpigmentation: As with other tetracyclines, minocycline may cause hyperpigmentation at various body sites (see also sections 4.2 and 4.8). Hyperpigmentation may present regardless of dose or duration of therapy but develops more commonly during long term treatment. Patients should be advised to report any unusual pigmentation without delay and minocycline should be discontinued. This is generally reversible on cessation of therapy.
Photosensitivity: If photosensitivity occurs, patients should be warned to avoid direct exposure to natural or artificial light and to discontinue therapy at the first sign of discomfort.
Results of animal studies indicate that tetracyclines cross the placenta and are found in foetal tissues and can have toxic effects on the developing foetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. Minocycline should not therefore be used in pregnancy unless considered essential.
The use of drugs of the tetracycline class during tooth development (last half of pregnancy) may cause permanent discoloration of the teeth (yellow-grey brown). This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.
Tetracyclines have been found in the milk of lactating women who are taking a drug in this class. Permanent tooth discoloration may occur in the developing infant and enamel hypoplasia has been reported.
Lightheadedness, visual disturbances, dizziness, tinnitus and vertigo have occurred with minocycline and patients should be warned about the possible hazards of driving or operating machinery during treatment.
Adverse reactions are listed in the Table in CIOMS frequency categories under MedDRA system/organ classes.
The frequency of adverse reactions Minocycline Tablets is defined using the following convention:
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 (cannot be estimated from the available data)
Very rare: Oral and anogenital candidiasis, vulvovaginitis.
Rare: Eosinophilia, leucopenia, neutropenia, thrombocytopenia
Very rare: Haemolytic anaemia, pancytopenia.
Not known (cannot be estimated from the available data): Agranulocytosis
Rare: Anaphylaxis/anaphylactoid reaction (including shock and fatalities).
Not known (cannot be estimated from the available data): Hypersensitivity, pulmonary infiltrates, anaphylactoid purpura, polyarteritis nodosa.
Very rare: Abnormal thyroid function, brown-black discolouration of the thyroid.
Rare: Anorexia.
Common: Dizziness (lightheadedness).
Rare: Headache, hypaesthesia, paraesthesia, intracranial hypertension, vertigo.
Very rare: Bulging fontanelle.
Not known (cannot be estimated from the available data): Convulsions, sedation.
Rare: Impaired hearing, tinnitus.
Rare: Myocarditis, pericarditis.
Rare: Cough, dyspnoea.
Very rare: Bronchospasm, exacerbation of asthma, pulmonary eosinophilia.
Not known (cannot be estimated from the available data): Pneumonitis.
Rare: Diarrhoea, nausea, stomatitis, discolouration of teeth, vomiting.
Very rare: Dyspepsia, dysphagia, enamel hypoplasia, enterocolitis, oesophagitis, oesophageal ulceration, glossitis, pancreatitis, pseudomembranous colitis.
Rare: Increased liver enzymes, hepatitis, autoimmune hepatoxicity. (See Section 4.4 Special warnings and Special precautions for use).
Very rare: Hepatic cholestatis, hepatic failure (including fatalities), hyperbilirubinaemia, jaundice.
Not known: Autoimmune hepatitis*
Rare: Alopecia, erythema multiforme, erythema nodosum, fixed drug eruption, hyperpigmentation of skin, photosensitivity, pruritis, rash, urticaria, vasculitis.
Very rare: Angioedema, exfoliative dermatitis, hyperpigmentation of nails, Stevens-Johnson Syndrome, toxic epidermal necrolysis.
Not known: Drug rash with eosinophilia and systemic symptoms (DRESS)
Rare: Arthralgia, lupus-like syndrome, myalgia.
Very rare: Arthritis, bone discolouration, cases of or exacerbation of systemic lupus erythematosus (SLE)(See Section 4.4 Special warnings and precautions for use), joint stiffness, joint swelling.
Rare: Increased serum urea, acute renal failure, interstitial nephritis.
Very rare: Balanitis.
Uncommon: Fever
Very rare: Discolouration of secretions.
* Autoimmune hepatitis: See Section 4.4 Special warnings and precautions for use
The following syndromes have been reported. In some cases involving these syndromes, death has been reported. As with other serious adverse reactions, if any of these syndromes are recognised, the drug should be discontinued immediately:
Hyperpigmentation of various body sites including the skin, nails, teeth, oral mucosa, bones, thyroid, eyes (including sclera and conjunctiva), breast milk, lacrimal secretions and perspiration has been reported. This blue/black/grey or muddy-brown discolouration may be localised or diffuse. The most frequently reported site is in the skin. Pigmentation is often reversible on discontinuation of the drug, although it may take several months or may persist in some cases. The generalised muddy-brown skin pigmentation may persist, particularly in areas exposed to the sun.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
None known.
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