INTETRIX Capsule Ref.[108196] Active ingredients: Tilbroquinol Tilbroquinol and Tiliquinol

Source: Web Search  Publisher: IPSEN PHARMA, 65 Quai Georges Gorse, 92100 Boulogne Billancourt, France

4.3. Contraindications

Hypersensitivity to any component of the drug.

Age under 18.

Pregnancy, breastfeeding.

Lactase insufficiency, lactose intolerance, glucose or galactose malabsorption.

Associated use with drugs containing Hydroxyquinoline or its derivatives as an active agent.

4.4. Special warnings and precautions for use

Recent studies have confirmed that in healthy volunteers INTETRIX frequently causes an increase in the transaminases levels, which is moderate, asymptomatic and regressive. Consequently, in case of increased transminases levels, and especially in case of icterus, the treatment must be stopped.

Prolonged use of INTETRIX is highly inadvisable due to the risk of peripheral neuropathy (see 4.8. undesirable effects).

INTETRIX must not be prescribed in association with other medicines containing hydroxyquinolines.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucoseโ€galactose malabsorption should not take this medicine.

4.5. Interaction with other medicinal products and other forms of interaction

It is not recommended to use with drugs containing Hydroxyquinoline or its derivatives as an active agent.

4.6. Pregnancy and lactation

There are no reliable data on the potential teratogenic effects of INTETRIX in animals.

Nowadays, there is no pertinent data, nor in sufficient number, to evaluate a potential malformative or foetotoxic effect of this medicine when it is given during pregnancy.

Consequently, the use of medicine is not advised during pregnancy. If having systematic abortion is not recommended, this element leads to a careful attitude and a well positioned antenatal monitoring.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

Increase of transaminases hepatic levels have been reported rarely, the majority of them were asymptomatic and decreased after treatment stopping.

Some rare skin reactions have been reported, either hypersensitive types (urticaria, Quincke’s oedema) or bullous types (fixed pigmented eruption).

Exceptionally, during prolonged treatments, peripheral neuropathies or optical nerve disorders have been reported.

6.2. Incompatibilities

Not applicable.

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