Zincteral

Package Leaflet: Information for the User

ZINCTERAL, 45 mg, coated tablets

Zinc sulfate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Zincteral and what is it used for
• 2. Important information before taking Zincteral
• 3. How to take Zincteral
• 4. Possible side effects
• 5. How to store Zincteral
• 6. Contents of the pack and other information

1. What is Zincteral and what is it used for

Zincteral is a medicinal product in the form of coated tablets for oral administration, containing zinc ions as an active substance.
Zinc is one of the most important trace elements involved in cellular metabolism. It is a component of many enzymatic systems that regulate basic metabolic processes - it participates in protein synthesis and carbohydrate metabolism. It is essential for proper growth and reproduction. Zinc is absorbed in the duodenum and small intestine.
Indications for the use of Zincteral:

• Prevention and treatment of zinc deficiencies caused by improper nutrition.
• Malabsorption and zinc deficiencies accompanying conditions that disrupt zinc absorption or increase its loss.
• Supportive treatment in Wilson's disease.

2. Important information before taking Zincteral

When not to take Zincteral

• If the patient has been diagnosed with hypersensitivity (allergy) to zinc sulfate or zinc acetate or to any of the other ingredients of Zincteral.

Warnings and precautions

• Caution should be exercised if the patient is pregnant.
• Attention should be paid to the existing risk of copper deficiency during long-term use of zinc-containing medications; in case of doubts, consult a doctor.

Zincteral with other medicines

Tell your doctor about all the medicines you have taken recently, including those that are available without a prescription.

• Tetracyclines - zinc salts reduce the absorption of tetracyclines from the gastrointestinal tract (zinc salts should be taken at least 2 hours after taking tetracyclines).
• Copper preparations - high doses of zinc may inhibit copper absorption (zinc salts should be taken at least 2 hours after taking copper preparations).
• Thiazide diuretics - increase zinc excretion in the urine.
• High-fiber diet (e.g., bran), high-phosphorus diet (e.g., dairy products), whole grain bread, or phytates - reduce zinc absorption by binding it into non-absorbable complexes; such products can be consumed at least 2 hours after taking zinc salts.
• Folic acid - may slightly disrupt zinc absorption.
• Oral iron preparations - high doses of iron significantly reduce zinc absorption (zinc salts should be taken at least 2 hours after taking iron preparations).
• Penicillamine and other chelating agents - reduce zinc absorption (there should be at least a 2-hour interval between taking penicillamine and zinc salts).
• Complex nutritional preparations (e.g., multivitamin preparations with mineral compounds) - concurrent use of several zinc-containing preparations may lead to too high a concentration of zinc in the serum.
• Quinolones - zinc affects the reduced absorption of quinolone antibiotics (norfloxacin, ciprofloxacin) and fluoroquinolones (ofloxacin); zinc salts should be taken at least 2 hours after taking quinolones.

Zincteral with food and drink

The medicine is usually taken 1 hour before or 2 hours after a meal, as many food products may disrupt zinc absorption.
Food products containing phytic acid (e.g., whole grain bread) reduce zinc absorption and should be avoided after taking zinc-containing medications.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist.

Pregnancy

Zinc crosses the placental barrier. No studies have been conducted on the effect of usually administered doses of zinc salts on the course of pregnancy and fetal development. There are also no adequate animal studies.
The medicine may be used during pregnancy only in cases where, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding

Zinc passes into breast milk. No studies have been conducted on the effect of usually administered doses of zinc salts in breastfeeding women.
It is not recommended to use the medicine during breastfeeding.

Driving and using machines

The medicine does not affect psychophysical fitness, the ability to drive vehicles, and operate machinery.

Zincteral contains lactose monohydrate.

If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.

Zincteral contains azorubine, lake (E 122).

The medicine may cause allergic reactions.

3. How to take Zincteral

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Method of administration
The medicine is taken orally.
Adults
Usually 1 to 2 tablets per day.
Wilson's disease
In adults, usually 4 tablets per day in a 1-2-1 scheme, starting with a dose of 1 tablet per day, increasing every 3 days, according to the following dosing scheme:
0-1-0 - one tablet per day
1-1-0 - two tablets per day
1-1-1 - three tablets per day
1-2-1 - four tablets per day
Children and adolescents
In children over 4 years of age and adolescents, 1 tablet per day.
The medicine is usually taken 1 hour before or 2 hours after a meal, as many food products may disrupt zinc absorption. If symptoms of gastrointestinal irritation occur, the medicine can be taken directly before or during a meal, but then the absorption of the medicine may be lower.
Do not divide or chew the tablets.

Overdose of Zincteral

In case of taking a higher dose of Zincteral than recommended, an overdose may occur.
In case of taking a higher dose of the medicine than recommended, consult a doctor immediately.
Symptoms
Burning pain in the mouth and throat, watery or bloody diarrhea, painful defecation, belching, hypotension (dizziness); jaundice (yellowing of the eyes and skin); pulmonary edema (chest pain, difficulty breathing); vomiting. The following may also occur: hematuria, anuria, shock, seizures, hemolysis (red blood cell breakdown with hemoglobin release into the serum), fatigue.
Long-term use of zinc sulfate may cause copper deficiency.

Missed dose of Zincteral

In case of missing a dose of Zincteral, do not take a double dose to make up for the missed dose; take the next dose at the usual time.
If you feel that the effect of the medicine is too strong or too weak, consult a doctor.

4. Possible side effects

Like all medicines, Zincteral can cause side effects, although not everybody gets them.
After high doses of zinc, with an unknown frequency, gastrointestinal disorders (nausea, indigestion, heartburn), blood and lymphatic system disorders (blood morphology disorders), including leukopenia (reduced white blood cell count) manifested by: fever, chills, throat pain, neutropenia (reduced granulocyte count) manifested by: oral and throat ulcers, sideroblastic anemia (anemia caused by impaired red blood cell production) manifested by: fatigue, weakness. Headaches and metallic taste in the mouth may also occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zincteral

Keep the medicine out of the reach and sight of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zincteral contains

• The active substance of the medicine is zinc sulfate monohydrate in an amount equivalent to 45 mg of zinc ions.
• Other ingredients of the medicine are: potato starch, lactose monohydrate, povidone, talc, magnesium stearate. Coating: azorubine lake (E 122), polyethylene glycol, hydroxypropyl methylcellulose, titanium dioxide (E 171).

What Zincteral looks like and contents of the pack

Coated tablets, purple-pink, round, biconvex, with a uniform surface.
50 tablets (2 blisters of 25 each) in a cardboard box.
150 tablets (1 bottle containing 150 tablets) in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warszawa
tel.: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków

Date of approval of the leaflet: