Rubozinc 15mg Gel Plq/60

Acne: The daily dosage is 2 capsules per day – which corresponds to 30 mg of elemental zinc in a single dose, taken in the morning on an empty stomach with a glass of water, or between meals. This dosage of 2 capsules per day is maintained for 3 months, then reduced to one capsule.

• Acrodermatitis enteropathica: The daily dosage to be followed, at least until puberty, is 1 capsule: treatment must be continued very strictly to avoid relapse. At the time of puberty, it may be necessary to increase the dosage to 2 capsules daily. After this growth phase, it is possible to return to 1 capsule per day, while monitoring plasma zinc levels.

capsule (number 2, opaque white, weighing 200 mg): Zinc gluconate, i.e. Zinc 15 mg.

Excipients: Wheat starch, Hydrated colloidal silica (Levilite), Magnesium stearate, Lactose, Gelatin, q.s. 1 capsule.

Excipient(s) with known effect: wheat starch, lactose.

Contraindications:

Hypersensitivity to the active substance or to any of the excipients listed in section List of excipients.

This medication is contraindicated in patients with a wheat allergy (other than celiac disease).

Warnings and other special precautions for use:

To achieve maximum absorption, the medication should be taken away from meals (more than 2 hours if possible), as food can alter the intestinal absorption of the drug (see section Interactions with other medicinal products and other forms of interaction).

Given the risk of upper gastrointestinal distress, the capsules should be taken with a large glass of water while sitting up. Lying down should be avoided for 30 minutes after taking the capsules.

Taking this medication is not recommended for children under 6 years of age due to the risk of choking associated with the capsule form.

This medication can be administered in cases of celiac disease. The wheat starch may contain gluten, but only in trace amounts, and is therefore considered safe for individuals with celiac disease.

This medicine contains lactose. Patients with galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption (rare hereditary disorders) should not take this medicine.

Pregnancy and Breastfeeding:

Pregnancy

In acrodermatitis enteropathica, zinc administration is essential and must be continued during pregnancy.

In the case of acne during the first trimester, based on available data, it is preferable, as a precautionary measure, to avoid using RUBOZINC 15 mg capsules. Indeed, while clinical data are reassuring, they are still limited, and animal data are not relevant (see section Preclinical safety data).

In the 2nd and 3rd trimesters, the use of RUBOZINC 15 mg capsules is possible, but the dosage will take into account other possible sources of zinc (especially "multivitamin and trace element" supplements).

Breastfeeding

In acrodermatitis enteropathica, zinc administration is essential and must be continued during breastfeeding.

In cases of acne, the use of RUBOZINC 15 mg capsules in breastfeeding women is possible, but the dosage should take into account any other potential sources of zinc (particularly "multivitamin and trace element" supplements). To date, no adverse effects have been reported in children whose mothers received doses of 30 mg or less of elemental zinc during breastfeeding.

Effects on ability to drive vehicles and use machines: RUBOZINC 15 mg capsules have no effect on the ability to drive vehicles or use machines.