Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
Known hypersensitivity to tetracyclinesor to any of the components of Minocin SA, use inpregnancy, lactation, children under the age of 12 years, complete renal failure. Severe liver disease. Minocin SA contains a small quantity of soya oil and is, therefore, contraindicated in patients who are allergic to peanuts or soya.
Minocin SA should be used with caution in patients with mild to moderate hepatic dysfunction and in conjunction with alcohol and other hepatotoxic drugs. It is recommended that alcohol consumption should remain within the Government’s recommended limits. Rare cases of auto-immune hepatotoxicity (including acute liver failure), isolated cases ofsystemic lupus erythematosus (SLE) and also exacerbation of pre-existing SLE have been reported. If patients develop signs or symptoms of SLE or hepatotoxicity, or suffer exacerbation of pre-existing SLE, Minocin SA should be discontinued.
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. The anti-anabolic action of the tetracyclines may cause an increase in blood urea nitrogen (BUN). In patients with significantly impaired renal function, higher serum levels of tetracyclines may lead to azotaemia, hyperphosphataemia and acidosis. If renal impairment exists, even usual oral and parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity.
Caution is advised in patients with myasthenia gravis as tetracyclines can cause weak neuromuscular blockade.
Cross-resistance between tetracyclines may develop in micro-organisms and cross-sensitisation in patients. Minocin SA should be discontinued if there are signs/symptoms of overgrowth of resistant organisms, e.g. enteritis, glossitis, stomatitis, vaginitis, pruritus ani or Staphylococcal enteritis.
Patients taking oral contraceptives should be warned that if diarrhoea or breakthrough bleeding occur there is a possibility of contraceptive failure.
Minocycline may cause hyperpigmentation at various body sites (see administration and side effects). 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 Minocin should be discontinued.
If photosensitivity reaction occurs, patients should be warned to avoid direct exposure to natural or artificial light and to discontinue therapy at the first sign of skin discomfort.
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.
Clinical studies of Minocin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
The use of tetracyclines during tooth development in children under the age of 12 years may cause permanent discolouration. Enamel hypoplasia has also been reported.
Periodic laboratory evaluations of organ system function, including haematopoietic, renal and hepatic, should be conducted.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
Tetracyclines have been shown to depress plasma prothrombin activity and reduced doses of concomitant anticoagulants may be necessary.
Diuretics may aggravate nephrotoxicity by volume depletion.
Bacteriostatic drugs may interfere with the bactericidal action of penicillin. Avoid giving tetracycline-class drugs in conjunction with penicillin. Absorption of minocycline is impaired by the concomitant administration of antacids, iron, calcium, magnesium, aluminium, bismuth and zinc salts (interactions with specific salts and antacids, bismuth containing ulcer-healing drugs, quinapril which contains a magnesium carbonate excipient). It is recommended that any indigestion remedies, vitamins, or other supplements containing these are taken at least 3 hours before or after a dose of Minocin SA. Unlike earlier tetracyclines, absorption of Minocin is not significantly impaired by food or moderate amounts of milk. There is an increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.
The concomitant use of tetracyclines may reduce the efficacy of oral contraceptives.
Administration of isotretinoin or other systemic retinoids or retinal should be avoided shortly before, during and shortly after minocycline therapy. Each of these agents alone has been associated with pseudotumor cerebri (benign intracranial hypertension) (see 4.4 Special warnings and precautions).
Interference with laboratory and other diagnostic tests: False evaluations of urinary catecholamine levels may occur due to interference with the fluorescence test.
Minocin SA should not be used in pregnancyunlessconsidered essential.
Results of animal studies indicate thattetracyclinescross the placenta, are found in foetal tissues and can have toxiceffects onthe developing foetus (often related to retardation of skeletaldevelopment).Evidence of embryotoxicity has also been noted in animals treatedearly inpregnancy.
Minocin, like other tetracycline-classantibiotics,crosses the placenta and may cause foetal harm when administered toa pregnantwoman. In addition, there have been post-marketing reports ofcongenitalabnormalities including limb reduction. If Minocin is used duringpregnancy orif the patient becomes pregnant while taking this drug, the patientshould beinformed of the potential hazard to the foetus.
The use of drugs of the tetracycline class duringtoothdevelopment (last half of pregnancy) may cause permanent discolouration oftheteeth (yellow-grey-brown). This adverse reaction is more common duringlongterm use of the drugs but has been observed following repeated short termcourses. Enamel hypoplasia has also been reported.
Tetracyclines administered during the last trimesterforma stable calcium complex throughout the human skeleton. A decrease infibulagrowth-rate has been observed in premature human infants given oraltetracyclinesin doses of 25mg/kg every 6 hours. Changes in fibula growth-ratewere shown tobe reversible when the drug was discontinued.
Tetracyclines have been found in the milk oflactatingwomen who are taking a drug in this class. Permanent toothdiscolouration mayoccur in the developing infant and enamel hypoplasia has beenreported.
Headache, lightheadedness, dizziness, tinnitus and vertigo (more common in women) and, rarely, impaired hearing have occurred with Minocin. Patients should be warned about the possible hazards of driving or operating machinery during treatment. These symptoms may disappear during therapy and usually disappear when the drug is discontinued.
Adverse reactions are listed in the table in CIOMS frequency categories under MedDRA system/organ classes: Common: ≥ 1% Uncommon: ≥ 0.1% and <1% Rare: ≥0.01% and <0.1% Very rare: <0.01%.
Very Rare: Oral and anogenital candidiasis, vulvovaginitis.
Rare: Eosinophilia, leucopenia, neutropenia, thrombocytopenia.
Very rare: Haemolytic anaemia, pancytopenia.
Frequency undetermined: Agranulocytosis.
Rare: Anaphylaxis/anaphylactoid reaction (including shock), including fatalities.
Frequency undetermined: Hypersensitivity.
Very Rare: Abnormal thyroid function, brown-black discolouration of the thyroid.
Rare: Anorexia.
Common: Dizziness (lightheadedness).
Rare: Headache, hypaesthesia, paraesthesia, pseudotumour cerebri, vertigo.
Very Rare: Bulging fontanelle.
Frequency undetermined: convulsions, sedation.
Rare: Impaired hearing, tinnitus.
Very rare: Myocarditis, pericarditis.
Rare: Cough, dyspnoea.
Very Rare: Bronchospasm, exacerbation of asthma, pulmonary eosinophilia.
Frequency undetermined: Pneumonitis.
Rare: Diarrhoea, nausea, stomatitis, discolouration of teeth (including adult tooth discolouration), vomiting.
Very Rare: Dyspepsia, dysphagia, enamel hypoplasis, enterocolitis, oesophagitis, oesophageal ulceration, glossitis, pancreatitis, pseudomembranous colitis.
There are also reports of: Oral cavity discolouration (including tongue, lip and gum).
Rare: Increased liver enzymes, hepatitis, rare cases of autoimmune toxicity. (see section 4.4 Special warnings and precaution for use).
Very rare: Hepatic cholestatis, hepatic failure (including fatalities), hyperbilirubinaemia, jaundice.
There are also reports of: Autoimmune hepatitis.
Rare: Alopecia, erythema multiforme, erythema nodosum, fixed drug eruption, hyperpigmentation of skin, photosensitivity, pruritus, rash, urticaria.
Very Rare: Angioedema, exfoliative dermatitis, hyperpigmentation of nails, Stevens-Johnson Syndrome, toxic epidermal necrolysis, vasculitis.
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: Increase BUN
Very Rare: Acute renal failure, interstitial nephritis.
Very Rare: Balanitis.
Uncommon: Fever
Rare: Injection site erythema (injection only), injection site pain (injection only).
Very rare: Discolouration of secretions.
Benign intracranial hypertension and bulging fontanelles in infants were reported with tetracyclines with possible symptoms of headaches, visual disturbances including blurring of vision, scotomata, diplopia or permanent visual loss (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 black/blue/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 HPRA Pharmacovigilance, Website: www.hpra.ie.
Not applicable.
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