Package leaflet: Information for the user

ZINCAS
5.5 mg zinc ions, tablets
Zinci hydroaspartas
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed
by your doctor, pharmacist, or nurse.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement or if you feel worse after 30 days, you should consult your doctor.

Leaflet contents

What Zincas is and what it is used for
What you need to know before taking Zincas
How to take Zincas
Possible side effects
How to store Zincas
Contents of the pack and other information

1. What Zincas is and what it is used for

Zincas is a medicinal product containing zinc.
Zinc is a trace element. It regulates the production of growth hormone and sex hormones (it is essential for the formation of sperm and oocytes). It reduces the body's susceptibility to infections and allergies. It influences the proper secretion of insulin by the pancreas.
Zinc deficiency causes disorders in the functioning of the skin, gastrointestinal system, nervous system, immune system, and skeletal system. Severe zinc deficiency may lead to dwarfism and underdevelopment of sexual organs.
Indications:

supplementation in cases of zinc deficiency in the body.

2. Important information before using Zincas

When not to use Zincas

if the patient is allergic to the active substance or to any of the other ingredients of the medicine (listed in section 6);
if the patient has renal insufficiency;
if the patient is being treated with antibiotics or other medicines (listed in section "Zincas and other medicines").

Warnings and precautions
Administration of a dose higher than recommended may cause diarrhoea.
Children
Do not use a dose higher than recommended.
Zincas and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, and any medicines the patient plans to take.
Do not take Zincas together with the following medicines:

tetracycline antibiotics (e.g. doxycycline), because zinc reduces their absorption;
medicines containing acetylsalicylic acid (e.g. aspirin, polopiryna);
painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, indomethacin;
diuretics (medicines that increase urine production), e.g. hydrochlorothiazide;
corticosteroids, known as steroids, e.g. hydrocortisone;
medicines and dietary supplements containing calcium, iron, or copper, because they reduce zinc absorption;
chelating agents, e.g. penicillamine – a medicine used, among others, in the treatment of lead or copper poisoning.

Taking Zincas with food and drink
Take the medicine after a meal, with water.
Do not take Zincas at the same time as dairy products (milk and milk products), because these reduce zinc absorption.
Pregnancy and breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. Zincas should not be used during pregnancy or breastfeeding.
Driving and operating machinery
Zincas has no influence on the ability to drive or operate machinery.
Zincas contains sucrose. One tablet contains 30 mg of sucrose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Zincas contains quinoline yellow, which may cause allergic reactions.
Zincas contains sodium. The medicine contains less than 1 mmol (23 mg) of sodium per maximum recommended dose (3 tablets), meaning the medicine is considered "sodium-free".

3. How to use Zincas

This medicine should always be taken exactly as described in this patient information leaflet or as
advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The usual dose is:
Age Dose Frequency
Children up to 5 years of age 1 tablet once daily
Children from 5 to 15 years of age 1 tablet twice daily
Adults and adolescents over 15 years of age 1 tablet three times daily
The medicine should be taken orally, after a meal, with water.
Whole tablets must not be given to young children. The tablet may be crushed, dissolved in a small
amount of water, and administered to the child for swallowing.
If symptoms persist beyond 30 days of using the medicine, consult your doctor.
Taking more Zincas than recommended
If you take more than the recommended dose, consult your doctor or pharmacist immediately.
Symptoms of overdose (listed in section 4) may occur.
If you miss a dose of Zincas
Do not take a double dose to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
No adverse reactions have been observed when the medicine is used according to the recommended dosage.
Higher doses of the medicine may cause adverse symptoms such as nausea,
abdominal pain, diarrhoea, metallic taste in the mouth, headache.
Prolonged use of Zincas may lead to copper deficiency and anaemia.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301,
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Zincas

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Store in the original packaging to protect from light and moisture.
Do not use Zincas after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Zincas contains

The active substance is zinc hydrogen aspartate dihydrate. One tablet contains: 5.5 mg of zinc ions in the form of 31 mg of zinc hydrogen aspartate dihydrate.
Other ingredients are: potato starch, sucrose, talc, magnesium stearate, dextrin,
sodium carboxymethyl starch (type C), microcrystalline cellulose, quinoline yellow (E 104).

What Zincas looks like and contents of the pack
Zincas is a yellow, round, biconvex tablet.
Available pack: container containing 50 tablets in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Farmapol Sp. z o.o. Pharmaceutical Company
ul. Święty Wojciech 29
61-749 Poznań
tel.: +48 61 852 63 53
e-mail: [email protected]

For further information about this medicine, please contact the representative of the Marketing Authorisation Holder.

Information for blind and visually impaired persons: the package leaflet content is available free of charge by calling the telephone number: 0800 706 848.