Zolarem 0

1. Trade Name of the medical product
2. Qualitative and quantitative composition
Minocycline HCI 53.98mg equivalent to 50 mg Minocycline, Magnesium stearate Hard Gelatin: Body: Red iron oxide, titanium dioxide, yellow iron oxide, gelatin Cap: Red iron oxide, titanium dioxide, yellow iron oxide, gelatin 3. Pharmaceutical form
4. Clinical information
4.1 Therapeutic Indications
Minocycline is a broad spectrum antibiotic used for the treatment of infections caused by tetracycline-sensitive organisms. Some tetracycline-resistant strains of Typical indications include: Gonorrhoea. Non-gonococcal urethritis. Prostatitis.
Acne. Acute and chronic bronchitis. Bronchiectasis. Lung abscess. Ear, nose and throat infections. Urinary tract infections. Pelvic inflammatory disease (eg salpingitis, oophoritis). Skin and soft tissue infections caused by minocycline sensitive organisms. Ophthalmological infections. Nocardiosis. Prophylactic treatment of asymptomatic meningococcal carriers. Pre- and post-operative prophylaxis of 4.2 Posology and method of administration
Routine antibiotic use:200mg daily in divided doses. Acne: 50mg twice daily for a minimum of six weeks. Gonorrhoea: In adult males: 200mg initially, followed by 100mg every 12 hours for a minimum of 4 days with post-therapy cultures within 2-3 days. Adult females may Prophylaxis of asymptomatic meningococcal carriers: 100mg bid for five days,
usually followed by a course of rifampicin. Children:
For children above 12 years of age the recommended dosage for MINAXEN is one 50mg tablet every 12 hours. MINAXEN is not recommended for children under 12 Elderly:
MINAXEN may be used at the normal recommended dosage in elderly patients even with mild to moderate renal impairment, however, caution is advised in patients with Administration:
To reduce the risk of oesophageal irritation and ulceration, the tablets should be swallowed whole with plenty of fluid, while sitting or standing. Unlike earlier tetracyclines, absorption of MINAXEN is not significantly impaired by food or Treatment of acne should be continued for a minimum of six weeks. If, after six months, there is no satisfactory response MINAXEN should be discontinued and other therapies considered. If MINAXEN 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 4.3 Contraindications
Known hypersensitivity to tetracyclines, or to any of the components of Minaxen. Use in pregnancy, lactation, children under the age of 12 years, complete renal failure. 4.4 Special warnings and precautions for use
Minaxen should be used with caution in patients with 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 and isolated cases of systemic 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, minocycline should be discontinued. Clinical studies have shown that there is no significant drug accumulation in patients with renal impairment when they are treated with Minaxen 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 serum urea. In patients with significantly impaired renal function, higher serum levels of tetracyclines may lead to uraemia, hyperphosphataemia and acidosis. If renal impairment exists, even usual oral and parenteral doses may lead to excessive systemic accumulations of the drug and Caution is advised in patients with myasthenia gravis as tetracyclines can cause Cross-resistance between tetracyclines may develop in micro-organisms and cross- sensitisation in patients. Minaxen 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 4.8 Undesirable 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 If a photosensitivity reaction occurs, patients should be warned to avoid direct exposure to natural or artificial light and to discontinue therapy at the first signs of As with other tetracyclines, bulging fontanelleles 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 Dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant The use of tetracyclines during tooth development in children under the age of 12 years may cause permanent discolouration. Enamel hypoplasia has also been Periodic laboratory evaluations of organ system function, including haematopoietic, 4.5 Interactions with other medications and other forms of interactions
Tetracyclines 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 Minaxen is impaired by the concomitant administration of antacids, iron, calcium, magnesium, aluminium bismuth and zinc salts (interactions with specific salts, 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 salts are taken at least 3 hours before or after a dose of Minaxen. Unlike earlier tetracyclines, absorption of Minaxen 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 The concomitant use of tetracyclines may reduce the efficacy of oral contraceptives. Administration of isotretinoin or other systemic retinoids or retinol 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 elevations of urinary catecholamine levels may occur due to interference with 4.6 Pregnancy and lactation
Use in pregnancy:
Minaxen should not be used in pregnancy unless considered essential. Results 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. Minaxen therefore, should not be used in In humans, Minaxen, 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 Minaxen 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 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 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 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 4.7 Effects on ability to drive and use machines
Headache, light-headedness, dizziness, tinnitus and vertigo (more common in women) and, rarely, impaired hearing have occurred with Minaxen. Patients should be warned about the possible hazards of driving or operating machinery during treatment. These symptoms may disappear during therapy and usually disappear 4.8 Undesirable effects
Adverse reactions are listed in the Table in CIOMS frequency categories under Very Rare: Oral and anogenital candidiasis, vulvovaginitis. Rare: Eosinophilia, leucopenia, neutropenia, thrombocytopenia. Very Rare: Haemolytic anaemia, pancytopenia. There are also reports of: Agranulocytosis Rare: Anaphylaxis /anaphylactoid reaction (including shock), including fatalities. There are also reports of: Hypersensitivity, pulmonary infiltrates, anaphylactoid Very Rare: Abnormal thyroid function, brown-black discolouration of the thyroid. Rare: Headache, hypaesthesia, paraesthesia, intracranial hypertension, vertigo. There are also reports of: convulsions, sedation. Respiratory, Thoracic and Mediastinal Disorders Very Rare: Bronchospasm, exacerbation of asthma, pulmonary eosinophilia. Rare: Diarrhoea, nausea, stomatitis, discolouration of teeth (including adult tooth 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). Rare: Increased liver enzymes, hepatitis, autoimmune hepatoxicity. (See Section 4.4 Special warnings and precautions for use). Very Rare: Hepatic cholestatis, hepatic failure (including fatalities), There are also reports of: 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. Musculoskeletal, Connective Tissue and Bone Disorders 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), Rare: Increased serum urea, acute renal failure, interstitial nephritis. Reproductive System and Breast Disorders General Disorders and Administration Site Conditions 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 • Lupus-like syndrome consisting of positive antinuclear antibody, arthralgia, arthritis, joint stiffness or joint swelling, and one or more of the following: fever, myalgia, • Serum sickness-like syndrome consisting of 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 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. 4.9 Overdose
Dizziness, nausea and vomiting are the adverse effects most commonly seen with overdose. There is no specific antidote. In cases of overdose, discontinue medication, treat symptomatically with appropriate supportive measures. Minaxen is not removed in significant quantities by haemodialysis or peritoneal dialysis. 5. Pharmacological properties
5.1 Pharmacodynamic properties
MINAXEN Capsules contain the active ingredient minocycline as minocycline hydrochloride, a semi-synthetic derivative of tetracycline. 5.2 Pharmacokinetic properties
MINAXEN Capsules have been formulated as a "double pulse" delivery system in which a portion of the minocycline dose is delivered in the stomach, and a second portion of the dose is available for absorption in the duodenum and upper GI tract. 5.3 Preclinical safety data
6. Pharmaceutical information
6.1 List of excipients: Maize starch, Magnesium stearate.
Hard gelatin capsules: Red iron oxide, Titanium dioxide, Yellow iron dioxide, Gelatin. 6.2 Incompatibilities: Not applicable
6.3 Shelf-life: Three years
6.4 Special precautions for storage:
Store in a dry place protected from light, below 25oC. 6.5 Nature and contents of container
6.6 Instructions for use/handling:
7. Marketing authorization holder
Aegis Ltd, Ergates industrial Area, P.O. Box 28629, 2081 Nicosia, CYPRUS 8. Marketing authorization number
9. Date of first authorization/renewal of authorization
10. Date of (partial) revision of the text

Source: http://www.aegispharma.eu/portals/0/pdf/Minocycline-Capsules-SPC%203-5-2010.pdf


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