Aknemin
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
AKNEMIN 50
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Minocycline base 50 mg (as the hydrochloride PhEur) per capsule.
3 PHARMACEUTICAL FORM
Capsule.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Minocycline is an antibiotic with a spectrum of activity similar to other tetracyclines but more active against Staphylococcus aureus and Nocardia spp.
It is indicated for the treatment of organisms sensitive to tetracyclines such as acne, respiratory infections, gonorrhoea, nocardiosis, staphylococcal infections; the chemoprophylaxis of meningococcal infections.
4.2 Posology and method of administration
For oral administration Adults:
1) Routine antibiotic use: 200 mg daily in divided doses.
2) Acne: 50 mg twice daily or 100 mg once daily.
3) Gonorrhoea: In adult males, 200 mg initially followed by 100 mg every 12 hours for a minimum of 4 days with post-therapy cultures within 2 -3 days. Adult females may require more prolonged therapy.
4) Prophylaxis of meningococcal infections: 100 mg twice daily for 5 days, usually followed by a course of rifampicin.
Aknemin 50 is not recommended for children under 12 years old. For children above 12 years old the recommended dose is 50 mg every 12 hours or 100 mg once daily.
The Elderly:
Aknemin 50 may be used at the normal recommended dosage in elderly patients but caution is advised in patients with renal impairment.
Unlike earlier tetracyclines, absorption of Aknemin 50 is not impaired significantly by the intake of food or moderate amounts of milk.
The treatment of acne should be continued for a minimum of 6 weeks. If after 6 months there is no satisfactory response, Aknemin 50 should be discontinued and other therapies considered. If Aknemin 50 is to be continued for more than 6 months, patients should be monitored at least 3 monthly thereafter for signs and symptoms of hepatitis or SLE (See 4.4).
4.3 Contraindications
Hypersensitivity to tetracyclines, systemic lupus erythematosus, renal impairment, children under 12 years old, pregnancy, lactation.
4.4 Special warnings and precautions for use
Aknemin 50 should be used with caution in patients with hepatic dysfunction and in conjunction with alcohol and other hepatotoxic drugs.
Cross-resistance between tetracyclines may develop in micro-organisms and cross-sensitisation in patients. Aknemin 50 should be discontinued if there are signs or symptoms of overgrowth of resistant organisms, eg enteritis, glossitis, stomatitis, vaginitis, pruritis ani, or staphylococcal enteritis.
Patients taking oral contraceptives should be warned that if diarrhoea or breakthrough bleeding occurs there is a possibility of contraceptive failure.
Rare cases of autoimmune hepatotoxicity and isolated cases of systemic lupus erythematosus (SLE) and also exacerbations of pre-existing SLE have been reported. If patients develop signs or symptoms of SLE or hepatotoxicity, or suffer exacerbation of existing SLE, minocycline should be discontinued.
Caution should be exercised in patients with Myasthenia Gravis as tetracyclines can cause weak neuromuscular blockade.
4.5 Interaction with other medicinal products and other forms of interaction
Tetracyclines decrease plasma prothrombin activity; reduced doses of concomitant anticoagulants may therefore be required. Aknemin 50 should not be used with penicillins. The absorption of Aknemin 50 is impaired by concomitant administration of antacids, and preparations containing iron, calcium, aluminium, magnesium, bismuth or zinc salts. Diuretics may aggravate nephrotoxicity by volume depletion.
4.6 Pregnancy and lactation
Aknemin 50 should not be used in pregnancy unless essential. Animal studies have indicated that tetracyclines cross the placenta, are found in foetal tissues, and can cause toxicity in the foetus usually related to a retardation of skeletal development. Yellow-brown discolouration of the teeth and enamel hypoplasia can occur when drugs of the tetracycline group are administered after the first trimester of pregnancy.
Aknemin 50 should not be given to lactating women.
4.7 Effects on ability to drive and use machines
Patients should be warned of the hazards of driving or operating machinery until the effect of treatment is known (See 4.8).
4.8 Undesirable effects
Blood and lymphatic system disorders: Haemolytic anaemia, thrombocytopenia, neutropenia and eosinophilia have been reported with tetracyclines.
Hypersensitivity reactions: Urticaria, fever, arthralgia, angioneurotic oedema, anaphylaxis and anaphylactoid purpura. Frequency unknown: polyarteritis nodosa.
Nervous system disorders: Hypaesthesia, paraesthesia have rarely been reported.
Headache, dizziness, vertigo and ataxia may occur. These disturbances are reversible within 3-48 hours of discontinuing therapy and occur less frequently when a low dose is given.
As with other tetracyclines, bulging fontanelles in infants and benign intracranial hypertension in adults have been reported. Treatment should be stopped if evidence of raised intracranial pressure develops.
Eye disorders: There are isolated cases of discolouration of the conjunctiva and acrimal secretions. (See 4.6).
Ear and labyrinth disorders: Impaired hearing has rarely been reported. Tinnitus may occur.
Cardiac disorders: Rarely pericarditis has been reported.
Respiratory, thoracic and mediastinal disorders: Rarely pulmonary infiltration has been reported. Frequency unknown: pulmonary eosinophilia.
Gastrointestinal disorders: Disturbances like anorexia, nausea, vomiting, diarrhoea, dyspepsia, dysphagia, antibiotic-associated colitis may occur. There have been isolated incidences of pancreatitis. A few cases of oesophagitis and oesophageal ulceration have been reported. To reduce the risk of oesophageal irritation and ulceration the capsules should be administered with adequate amount of fluids and probably not be given at bedtime or to patients with oesophageal obstruction or compression
Hepato-biliary disorders: In common with other tetracyclines transient increases in liver function test values and, rarely, hepatitis have been reported. Some hepatic reactions have an autoimmune basis, and may occur after several months of minocycline treatment (See 4.2). Frequency unknown: Acute hepatic failure, liver injury, jaundice, hyperbilirubinaemia.
Skin and subcutaneous tissue disorders: Dermatological reactions are rare but erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, photosensitivity and alopecia have been reported.
Hyperpigmentation of skin have been reported occasionally.
Frequency unknown: Rash (including rash maculo-papular), drug rash with eosinophilia and systemic symptoms (DRESS)
Renal and urinary disorders: Rarely acute renal failure has been reported. Other: When given over long periods, tetracyclines have been reported to produce brownish-black microscopic discolouration of thyroid tissue; no abnormalities of function are known to occur.
Discolouration of teeth, buccal mucosa and tongue discolouration have been reported occasionally. These are generally reversible on cessation of therapy. There are isolated cases of breast secretions and perspiration. (See 4.6). 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, Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
There is no specific antidote. Treatment is gastric lavage with appropriate supportive treatment.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Minocycline is an antibiotic with a spectrum of activity similar to other tetracyclines but is more active against Staphylococcus aureus and Nocardia
spp.
5.2 Pharmacokinetic properties
Minocycline is almost completely absorbed after oral administration. Absorption is not significantly affected by the presence of food or milk. Doses of 200 mg followed by 100 mg every 12 hours produce plasma concentrations of 1 to 4 mg per ml.
Plasma half-life is 12 - 16 hours in patients with normal renal function but increased in renal impairment.
Minocycline is widely distributed in body fluids and tissue. It crosses the placenta and is excreted in breast milk.
5.3 Preclinical safety data
No relevant preclinical safety data have been generated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Polyethylene glycol Erythrosine (E127)
Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin.
6.2 Incompatibilities
None stated.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store below 25 °C.
6.5 Nature and contents of container
Aluminium/PVC strip of 14 in a cardboard outer carton containing 56 or 112 capsules.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Almirall Hermal GMGH
Scholtzstrasse 3
D-21465
Reinbek
Germany
8 MARKETING AUTHORISATION NUMBER(S)
PL 33016/0005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/04/2005
10 DATE OF REVISION OF THE TEXT
30/06/2015