Summary of Product Characteristics Updated 12-Mar-2014 | Meda Pharmaceuticals
Dosage:Adults: One 100 mg capsule every 24 hours.Children over 12 years: One 100 mg capsule every 24 hours.Children under 12 years: MINOCIN is not recommended.Elderly: No special dosing requirements.
Administration:To reduce the risk of oesophageal irritation and ulceration, the capsules should be swallowed whole with plenty of fluid, while sitting or standing. Unlike earlier tetracyclines, absorption of Minocin MR is not significantly impaired by food or moderate amounts of milk.Treatment of acne should be continued for a minimum of 6 weeks. If, after six months, there is no satisfactory response Minocin MR should be discontinued and other therapies considered. If Minocin MR is to be continued for longer than six months, patients should be monitored at least three monthly thereafter for signs and symptoms of hepatitis or SLE or unusual pigmentation (see Special Warnings and Precautions).
Use in the elderly:Dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Use in children: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.
Laboratory monitoring:Periodic laboratory evaluations of organ system function, including haematopoietic, renal and hepatic should be conducted.
Use in pregnancy:Minocin MR should not be used in pregnancy unless considered essentialResults of animal studies indicate that tetracyclines cross the placenta, 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. Minocin MR therefore, should not be used in pregnancy unless considered essential.In humans, Minocin, like other tetracycline-class antibiotics, crosses the placenta and may cause foetal harm when administered to a pregnant woman. In addition, there have been post marketing reports of congenital abnormalities including limb reduction. If Minocin is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to the foetus.The use of drugs of the tetracycline class during tooth development (last half of pregnancy) may cause permanent discolouration 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 administered during the last trimester form a stable calcium complex throughout the human skeleton. A decrease in fibula growth rate has been observed in premature human infants given oral tetracyclines in doses up to 25mg/kg every 6 hours. Changes in fibula growth rate were shown to be reversible when the drug was discontinued.
Use in lactation:Tetracyclines have been found in the milk of lactating women who are taking a drug in this class. Permanent tooth discolouration may occur in the developing infant and enamel hypoplasia has been reported.
Infections and InfestationsVery Rare: Oral and anogenital candidiasis, vulvovaginitis.
Blood and Lymphatic System DisordersRare: Eosinophilia, leucopenia, neutropenia, thrombocytopenia.Very Rare: Haemolytic anaemia, pancytopenia.There are also reports of: Agranulocytosis
Immune System DisordersRare: Anaphylaxis /anaphylactoid reaction (including shock), including fatalities.There are also reports of: Hypersensitivity, pulmonary infiltrates, anaphylactoid purpura.
Endocrine DisordersVery Rare: Abnormal thyroid function, brown-black discolouration ofthe thyroid.
Metabolism and Nutrition DisordersRare: Anorexia
Nervous System DisordersCommon: Dizziness (light-headedness).Rare: Headache, hypesthesia, paraesthesia, intracranial hypertension, vertigo.Very Rare: Bulging fontanelle.There are also reports of: convulsions, sedation.
Ear and Labyrinth DisordersRare: Impaired hearing, tinnitus.
Cardiac DisordersRare: Myocarditis, pericarditis.
Respiratory, Thoracic and Mediastinal DisordersRare: Cough, dyspnoea.Very Rare: Bronchospasm, exacerbation of asthma, pulmonary eosinophilia.There are also reports of: Pneumonitis.
Gastrointestinal DisordersRare: Diarrhoea, nausea, stomatitis, discolouration of teeth including adult tooth discolouration), vomiting.Very Rare: Dyspepsia, dysphagia, enamel hypoplasia, enterocolitis, oesophagitis, oesophageal ulceration, glossitis, pancreatitis, pseudomembranous colitis.There are also reports of: Oral cavity discolouration (including tongue, lip and gum).
Hepatobiliary DisordersRare: Increased liver enzymes, hepatitis, autoimmune hepatoxicity. (See Section 4.4 Special warnings and precautions for use).Very Rare: Hepatic cholestatis, hepatic failure (including fatalities), hyperbilirubinaemia, jaundice.There are also reports of: Autoimmune hepatitis.
Skin and Subcutaneous Tissue DisordersRare: 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.
Musculoskeletal, Connective Tissue and Bone DisordersRare: 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.
Renal and Urinary DisordersRare: Increased serum urea, acute renal failure, interstitial nephritis.Reproductive System and Breast DisordersVery Rare: Balanitis.
General Disorders and Administration Site ConditionsUncommon: Fever.Very Rare: Discolouration of secretions.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: Hypersensitivity syndrome consisting of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, pericarditis. Fever and lymphadenopathy may be present. Lupus-like syndrome consisting of positive antinuclear antibody, arthralgia, arthritis, joint stiffness or joint swelling, and one or more of the following: fever, myalgia, hepatitis, rash, vasculitis. Serum sickness-like syndrome consisting fever, urticaria or rash, and arthralgia, arthritis,joint stiffness or joint swelling. Eosinophilia may be present.Hyperpigmentation of various body sites including the skin, nails, teeth, oral mucosa, bones, thyroid, eyes (including sclera and conjunctiva), breast mille, 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 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 at: www.mhra.gov.uk/yellowcard.
|Pellets:||Microcrystalline cellulose Croscarmellose sodium Hypromellose phthalate 50 Hypromellose (E464) Light liquid paraffin Methylene Chloride Methanol Purified Water Opaspray K-1-7000 (white), (containing: Titanium dioxide Hydroxypropylcellulose)-|
|Capsule shells:||Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (El72) Gelatin|
|Capsule Cap:||Titanium Dioxide Iron Oxide red (El72) Iron Oxide black (E 172) Iron Oxide yellow (E172) Gelatin|
|Blisters:||Store in the original package Keep the container in the outer carton|
|Bottles:||Store in the original container Keep the container tightly closed|
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