SEBOMIN

Posology Adults:

One 100mg capsule every 24 hours.

Children over 12 years:

One 100mg capsule every 24 hours.

Children under 12 years:

Sebomin MR is not recommended.

Elderly:

No special dosing requirements. Treatment of acne should be continued for a minimum of 6 weeks. If there is no satisfactory response to Sebomin MR after six months, the treatment should be discontinued and other therapies considered.

If Sebomin 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 of the skin. (see Special warnings and precautions for use).

Renal Impairment: minocycline may be used at the normal recommended dosage in mild to moderate renal impairment, however caution is advised in patients with severe renal impairment.

Method of Administration:

For oral administration. To reduce the risk of oesophageal irritation and ulceration, the capsules should be swallowed whole with plenty of fluid, while sitting or standing. They should not be taken with food as this affects the absorption of minocycline.

01% MedDRA system organ class Symptom Blood and lymphatic system disorders Rare Eosinophilia, leucopenia, neutropenia, thrombocytopenia Very rare Isolated reports Haemolytic anaemia, pancytopenia. Agranulocytosis Cardiac disorders Rare Myocarditis, pericarditis.

Ear and labyrinth disorders Rare Impaired hearing, tinnitus. Endocrine disorders Very rare Abnormal thyroid function, brown-black discolouration of the thyroid. Gastrointestinal disorders Rare Diarrhoea, nausea, stomatitis, discolouration of teeth, vomiting.

Very rare Dyspepsia, dysphagia, enamel hypoplasia, MedDRA system organ class Symptom enterocolitis, oesophagitis, oesophageal ulceration, glossitis, pancreatitis, pseudomembranous colitis. General disorders and administration site conditions Uncommon Fever Very rare Discolouration of secretions.

Hepatobiliary disorders Common Rare Increases in liver function test values Increased liver enzymes, hepatitis, autoimmune hepatoxicity. 4 Special warnings and Special precautions for use). Very rare Not known Hepatic cholestatis, hepatic failure (including fatalities), hyperbilirubinaemia, jaundice.

*Autoimmune hepatitis Immune system disorders Rare Anaphylaxis/anaphylactoid reaction (including shock and fatalities), polyarteritis nodosa. Isolated reports Hypersensitivity, pulmonary infiltrates, anaphylactoid purpura. Infections and infestations Very rare Oral and anogenital candidiasis, vulvovaginitis.

Metabolism and nutrition disorders Rare Anorexia. Musculoskeletal and connective tissue disorders Rare Arthralgia, lupus-like syndrome, myalgia. 4 Special warnings and precautions for use), joint stiffness, joint swelling. Nervous system disorders Common Dizziness (lightheadedness).

Rare Headache, hypaesthesia, paraesthesia, intracranial hypertension, vertigo. MedDRA system organ class Symptom Very rare Isolated reports Bulging fontanelle. Convulsions, sedation. Renal and urinary disorders Rare Increased serum urea, acute renal failure, interstitial nephritis.

Reproductive system and breast disorders Very rare Balanitis. Respiratory, thoracic and mediastinal disorders Common Wheezing. Rare Cough, dyspnoea. Very rare Isolated reports Bronchospasm, exacerbation of asthma, pulmonary eosinophilia.

Pneumonitis. Skin and subcutaneous tissue disorders Common Maculopapular and erythematous rashes. Rare Alopecia, erythema multiforme, erythema nodosum, fixed drug eruption, hyperpigmentation of skin, photosensitivity, pruritis, rash, urticaria, vasculitis.

Very rare Not known Angioedema, exfoliative dermatitis, hyperpigmentation of nails, Stevens-Johnson Syndrome, toxic epidermal necrolysis. 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: • 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 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. 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. uk/yellowcard

Hypersensitivity pneumonitis:

Pulmonary infiltrates and eosinophilia have been reported with monicycline. In most cases the pneumonitis resolved when minocycline was stopped but steroids may be needed in some cases, and residual lung damage can occur. Patients should be advised that if they develop breathing difficulties they should stop taking minocycline and immediately contact a physician.

Use in Hepatic Dysfunction:

Minocycline 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.

Auto-immune Disorders:

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.

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. g. enteritis, 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. 8). Hyperpigmentation may be 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. The capsule shell contains sunset yellow (E110), which can cause allergic - type reactions including asthma.

Allergy is more common in those people who are allergic to aspirin.

Use in children:

The use of tetracyclines during tooth development in children under the age of 12 years may cause permanent discolouration (see above). Enamel hypoplasia has also been reported.

• Known hypersensitivity to tetracyclines or to any of the excipients. • Pregnancy and lactation • Children under 12 years • Complete renal failure.