MINOTREX

This medicine must never be used in the following situations:

· Known hypersensitivity to minocycline hydrochloride (see section 4.8) or allergy to other antibiotics of the tetracycline family or to any of the product's constituents.

· In combination with systemic retinoids (see section 4.5).

· The use of this medicine must be avoided during dental development i.e. in pregnant women from the 4th month of pregnancy and in children under eight years of age due to the risk of permanent tooth discoloration (yellow-grey-brown) and dental enamel hypoplasia (see section 4.4).

These effects are more frequent during long-term treatment but they have also been observed after short and repeated use.

· In case of hepatic impairment and when taking other hepatotoxic medicines concomitantly.

Pregnancy

A teratogenic effect of cyclines was found in animal experimentation but in an inconsistent manner.

In clinical practice, the use of cyclines during a limited number of pregnancies has apparently revealed no particular malformative effect to date. However, additional studies are necessary to evaluate the consequences of exposure during pregnancy.

Administration of cyclines during the second and third trimesters exposes the fetus to the risk of discoloration of deciduous teeth.

Consequently, as a precautionary measure, it is preferable not to use cyclines during the first trimester of pregnancy.

From the second trimester of pregnancy, the administration of cyclines is contraindicated.

Breastfeeding

In case of treatment with this medicine, breastfeeding is not recommended.

Drivers or machine users should be drawn to the risks of dizzy sensations with an impression of slowed ideation.

Hematological and lymphatic system disorders

Eosinophilia, neutropenia, thrombocytopenia and hemolytic anemia have been observed.

Isolated cases of agranulocytosis have been reported.

Cardiac disorders

Cases of myocarditis and pericarditis have been observed.

Ear and labyrinth disorders

Impairment of hearing, tinnitus.

Endocrine disorders

Possibility of abnormal thyroid function.

Gastrointestinal disorders

Diarrhea, nausea, vomiting, anorexia. Possible occurrence of dysphagia, enterocolitis, esophagitis, esophageal ulceration, glossitis, pancreatitis and pseudomembranous colitis.

General disorders and administration site abnormalities

Fever.

Hepatobiliary disorders

An increase in liver enzymes, jaundice, hyperbilirubinemia and hepatitis have been reported. Cases of hepatic failure (sometimes fatal) have been observed.

Musculoskeletal and systemic disorders

Arthralgia, myalgia, arthritis.

Nervous system disorders

Dizziness, vertigo, headache, signs of benign intracranial hypertension, bulging of the fontanelle.

Renal and urinary disorders

Increase in blood urea.

Cases of interstitial nephritis with acute renal failure have been reported.

Respiratory, thoracic and mediastinal disorders

Cough, dyspnea, pulmonary infiltrates and eosinophilia.

Skin and subcutaneous tissue disorders

Erythema multiforme, erythema nodosum, fixed pigmented erythema, photosensitization, pruritus, rash, urticaria, hyperpigmentation, angioedema, exfoliative dermatitis, Stevens-Johnson syndrome, Lyell syndrome, vasculitis.

Isolated cases of alopecia have been reported.

Immune system disorders

Anaphylactic / anaphylactoid reactions (including shocks) sometimes fatal have been reported.

The following syndromes have been reported:

· Hypersensitivity syndrome consisting of a skin reaction (such as rash or exfoliative dermatitis), eosinophilia and one or more of the following manifestations: hepatitis, pneumopathy, nephritis, myocardia, pericarditis. Fever and lymphadenopathy may be present (see section 4.4).

· Lupus syndrome consisting of the appearance of antinuclear antibodies, arthralgia, arthritis, joint stiffness or joint edema, and one or more of the following manifestations: fever, myalgia, hepatitis, erythema, vasculitis

· Pseudo-serum sickness consisting of the presence of fever, urticaria or rash, arthralgia, arthritis, joint stiffness or joint edema. Eosinophilia may be present.

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - https://signalement.social-sante.gouv.fr/ .