Patient Information Leaflet

ZINCAS FORTE, 27 mg zinc ions, tablets
Zinci hydroaspartas
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always take this medicine exactly as described in this patient leaflet or as your doctor,
pharmacist, or nurse has told you.

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

Contents of the leaflet

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

1. What Zincas Forte is and what it is used for

Zincas Forte 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 production of sperm and egg cells). It reduces the body's susceptibility to infections and allergies. It affects the proper secretion of insulin by the pancreas.
Zinc deficiency may lead to disorders in the function of the skin, gastrointestinal system, nervous system, immune system, and skeletal system. Severe zinc deficiency may cause dwarfism and underdevelopment of sexual organs.
Indications:

supplementation of zinc deficiency in the body.

2. Information before using Zincas Forte

When not to use Zincas Forte

if the patient is allergic (hypersensitive) to zinc aspartate dihydrate or to any of the other ingredients of this medicine (listed in section 6),
if the patient has renal failure,
if the patient is being treated with antibiotics or other medicines (see section "Zincas Forte and other medicines").

Warnings and precautions
Administration of doses higher than recommended may cause diarrhoea.
Children
Zincas Forte must not be used in children under 15 years of age.
Zincas Forte and other medicines
You must tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take Zincas Forte together with the following medicines:

tetracycline antibiotics (e.g. doxycycline), as zinc reduces their absorption,
products containing acetylsalicylic acid,
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, as they reduce zinc absorption,
chelating agents, e.g. penicillamine – a medicine used, among others, in the treatment of lead or copper poisoning.

Taking Zincas Forte with food and drink
The medicine should be taken after a meal, with water (see section 3).
Do not take Zincas Forte simultaneously with dairy products (milk and its derivatives). These products reduce zinc absorption.
Pregnancy, breastfeeding and 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 Forte must not be used during pregnancy and breastfeeding.
Driving and operating machinery
There is no data available on harmful effects of Zincas Forte on the ability to drive and operate machinery.
Zincas Forte contains sucrose. One tablet contains 12.24 mg of sucrose. This should be taken into consideration in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to use Zincas Forte

This medicine should always be used exactly as described in the patient leaflet or
as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Use in adults and adolescents over 15 years of age
Recommended dose:
1 tablet per day.
Zincas Forte should be taken orally, after a meal, with water.
If symptoms do not improve after 30 days of treatment, consult a doctor.
Taking more medicine than recommended Zincas Forte
In case of taking more than the recommended dose, consult a doctor or pharmacist.
Symptoms of Zincas Forte poisoning may occur (listed in section 4).
Missed dose of Zincas Forte
If a dose is missed, take the medicine as soon as possible. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
No adverse effects 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 Forte may lead to copper deficiency and anaemia.

Reporting adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Zincas Forte

Keep the medicine out of sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect from light and moisture.
Do not use this medicine 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 Forte contains

The active substance is zinc hydrogen aspartate dihydrate. One tablet contains: 27 mg of zinc ions in the form of 150 mg of zinc hydrogen aspartate dihydrate.
Other ingredients are: potato starch, sucrose, talc, magnesium stearate, dextrin, sodium carboxymethyl starch (type C), microcrystalline cellulose.

What Zincas Forte looks like and contents of the pack
Zincas Forte is in the form of white, round, biconvex tablets.
Available pack: container containing 50 tablets in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Farmapol Pharmaceutical Company Farmapol Sp. z o.o.
ul. Święty Wojciech 29
61-749 Poznań
tel.: +48 61 852 63 53 e-mail: [email protected]
For more detailed information, please contact the representative of the Marketing Authorisation Holder.
Information for blind and partially sighted people: the leaflet content is available via free phone number: 0800 706 848.