Zinc sulfate heptahydrate

package leaflet

NAME OF THE MEDICINAL PRODUCT
ZINCO SOLFATO IDI “200 mg tablets” – 30 tablets
A12CB01
Zinc sulfate monohydrate

COMPOSITION
Each tablet contains:
Active substance: Zinc sulfate monohydrate 124.8 mg
equivalent to 200 mg of Zinc sulfate heptahydrate
(corresponding to 45.5 mg of Zinc)
Excipients: Lactose, Rice starch, Magnesium stearate.

PHARMACEUTICAL FORM AND CONTENT
30 oral tablets.

THERAPEUTIC CATEGORY
Mineral supplements.

MARKETING AUTHORISATION HOLDER
IDI FARMACEUTICI srl - Via dei Castelli Romani 83/85 - POMEZIA (RM)

MANUFACTURER AND FINAL CONTROLLER
IDI FARMACEUTICI srl - Via dei Castelli Romani 83/85 - POMEZIA (RM)

THERAPEUTIC INDICATIONS
Treatment and prophylaxis of Zinc deficiency during pregnancy and lactation.
Enteropathic acrodermatitis.
Adjunctive therapy in the treatment of wounds and burns.
Adjunctive therapy in the treatment of acne vulgaris.

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients or to substances closely
related chemically.

PRECAUTIONS FOR USE
Dosage reduction has not been found necessary either in geriatric patients or in those with
impaired excretory organ function.

INTERACTIONS
The absorption of zinc sulfate is inhibited by concomitant food intake.
Therefore, the medicinal product should be taken on an empty stomach, with liquids, at least one hour before meals.

The concomitant administration of medicinal products containing cimetidine, ranitidine or inhibitors
of gastric secretion is not recommended, as they may significantly reduce zinc absorption.
Concomitant intake of iron supplements should be avoided, as iron interferes with intestinal zinc absorption.
Zinc sulfate may form complexes with tetracyclines. To avoid interference with the absorption of these substances, it is important to administer the products at least one hour apart.

SPECIAL WARNINGS
Although therapeutic doses of zinc sulfate have been administered for periods longer than one year
without any adverse effects emerging, prolonged administration of zinc compounds may lead to copper deficiency (hypocupremia). To avoid potential accumulation and toxicity due to zinc-induced hypocupremia, prolonged administration of zinc sulfate should be carried out with periodic monitoring of serum zinc levels. In enteropathic acrodermatitis, however, since zinc deficiency is mediated by a genetically-based defect in intestinal absorption of the trace element, toxic or accumulation phenomena are unlikely.
At therapeutic doses, no toxic effects on the fetus have been observed.
Since zinc is excreted in breast milk, the intake of zinc sulfate should be reserved for cases of confirmed zinc deficiency in the mother. Plasma zinc levels should be assessed weekly, and if levels are found to be below 20 µmol/l, breastfeeding may continue.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The product must be taken on an empty stomach, at least one hour before meals, with liquids.
For prophylaxis of deficiency during pregnancy and lactation: 1-2 tablets daily
For enteropathic acrodermatitis: 10 mg/kg/day
For treatment of wounds and burns: 2-3 tablets daily
For acne vulgaris: 2-4 tablets daily.
Dosage adjustment is not required in geriatric patients or in those with renal insufficiency.

OVERDOSAGE
Symptoms of overdose include lethargy, somnolence and increased serum levels of amylase and
lipase.
Overdose of zinc sulfate may cause erosions of the gastrointestinal tract.
In case of accidental or intentional overdose, gastric lavage and induction of vomiting are therefore contraindicated.
Instead, administration of milk, egg white, activated charcoal, or chelating agents such as EDTA is recommended.

UNDESIRABLE EFFECTS

package leaflet

The most common adverse effects are gastrointestinal disorders (nausea,
dyspepsia, abdominal pain, vomiting, diarrhoea, gastric irritation, gastritis) of mild to
moderate severity.
Following the instructions contained in this package leaflet reduces the risk of adverse
effects.
Inform your doctor or pharmacist if you experience any adverse effects not described
in this package leaflet.
EXPIRY DATE AND STORAGE
Expiry date: see the expiry date stated on the packaging. The shelf life refers to the product
in its original, unopened packaging, correctly stored.
Warning: do not use the product after the expiry date stated on the packaging.
Storage: No special storage instructions are required.
KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN.
Revision of the package leaflet by the Ministry of Health:
The present package leaflet can be read or listened to via the QR Code or at the following address: http://www.leafletidi.it/zincosolfato.