Zinkorot

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Zinkorot

25 mg Zn, tablets
(Zinci orotas dihydricus)

You should carefully read the contents of the leaflet before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken in accordance with the description in the patient information leaflet, as directed by a doctor
or pharmacist.

• You should keep this leaflet, so that you can read it again if necessary.
• You should consult a pharmacist if advice or additional information is needed.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4
• If after 14 days there is no improvement or the patient feels worse, you should contact a doctor.

Table of contents of the leaflet:

• 1. What is Zinkorot and what is it used for.
• 2. Important information before using Zinkorot.
• 3. How to use Zinkorot.
• 4. Possible side effects.
• 5. How to store Zinkorot.
• 6. Contents of the package and other information.

1. What is Zinkorot and what is it used for

Zinkorot is a zinc supplement used in the case of a deficiency of this element in the body,
if it cannot be supplemented with a normal diet.
Zinc plays an important role in the following systems and physiological processes:

• immune system;
• maintaining skin integrity;
• wound healing;
• taste and smell perception;
• thyroid function;
• growth and development processes;
• testicular maturation;
• nervous system function;
• insulin action (a hormone regulating glucose metabolism).

Zinc affects brain development and physiology, so a deficiency or excess of zinc
causes developmental disorders of the central nervous system, changes in behavior, and
neurological diseases.

2. Important information before using Zinkorot

When not to use Zinkorot

• if the patient is allergic to zinc orotate or any of the other ingredients of this medicine (listed in section 6).

Children and adolescents
Zinkorot should not be used in children under 6 years of age.
For this group of patients, other zinc-containing medicines, e.g. in liquid form, are more suitable.

When to exercise special caution when using Zinkorot

Zinc may affect copper absorption. In the case of long-term use of Zinkorot, the doctor will recommend a copper level test in the blood.

Other medicines and Zinkorot

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken,
including those that are available without a prescription.
Chelating agents (used to remove heavy metals from the body) such as D-penicillamine,
dimercaptopropanesulfonic acid (DMPS), dimercaptosuccinic acid (DMSA), or ethylenediaminetetraacetic acid (EDTA) may worsen zinc absorption or increase its excretion from the body.
Concomitant use of iron, copper, and calcium salts may decrease zinc absorption.
High doses of zinc may decrease copper and iron absorption.
Zinc impairs the absorption of tetracyclines, ofloxacin, and other quinolones (antibiotics, e.g.
norfloxacin, ciprofloxacin). Therefore, you should maintain at least a 3-hour interval
between taking zinc and the above-mentioned medicines.

Zinkorot with food and drink

Foods with a high phytate content (e.g. cereal products, vegetables, nuts) reduce
zinc absorption. Coffee may also inhibit zinc absorption.

Pregnancy, breastfeeding, and fertility

Before using any medicine, you should consult a doctor.
In pregnancy and breastfeeding, or if you suspect you are pregnant, or plan to become pregnant, you should consult a doctor or pharmacist before using this medicine.
Pregnancy:
Zinkorot should not be used during pregnancy, unless a doctor recommends otherwise.
Breastfeeding:
This medicine is not recommended for use in breastfeeding women.

Driving and using machines

No effect of Zinkorot on the ability to drive and use machines has been observed.
However, you should exercise special caution in the case of using a higher dose of Zinkorot than recommended. Using a higher dose than recommended may cause nausea and vomiting,
drowsiness, headache, and dizziness, which may impair the ability to drive and use machines.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free”.

3. How to use Zinkorot

This medicine should always be taken in accordance with the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Zinkorot should be taken orally with a sufficient amount of liquid (e.g. a glass of water). Do not take it directly before or after a meal. The tablet can be divided into halves.
Zinkorot should not be taken with meals.
Usually used doses:

Adults and adolescents (12-17 years)

The recommended dose is 12.5 to 25 mg of zinc (= ½ - 1 tablet of Zinkorot) per day.

Use in children

In children aged 6 to 11 years, the recommended daily dose is 12.5 mg of zinc (= ½ tablet of Zinkorot).
The medicine can be used in children provided that they can swallow the tablet safely.

Children under 6 years

Zinkorot should not be used in children under 6 years of age. For this group of patients, other pharmaceutical forms of zinc (e.g. in liquid form) may be more suitable.

Duration of treatment

The duration of treatment depends on the response to treatment. You should consult a doctor or pharmacist.

Taking a higher dose of Zinkorot than recommended

In the case of taking a higher dose of the medicine than recommended, you should contact a doctor
or pharmacist.
Overdose symptoms:
gastrointestinal disorders, metallic taste on the tongue, abdominal pain, nausea, vomiting,
drowsiness, headache, and dizziness.

Missing a dose of Zinkorot

In the case of missing a dose of Zinkorot, you should take the dose
as soon as possible, unless it is almost time for the next dose.
In this case, you should skip the missed dose and take the next dose at the right time.
You should not take a double dose to make up for the missed dose.

Stopping the use of Zinkorot

No side effects have been reported when stopping the use of Zinkorot.
In case of any further doubts regarding the use of the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop using Zinkorot and seek medical help immediately if you experience the following symptoms:

• breathing difficulties;
• throat swelling;
• swelling of the lips, tongue, or face;
• rash or urticaria.

Very rare:at the beginning of treatment, zinc salts may cause abdominal pain, nausea,
indigestion, and diarrhea. These symptoms occur more frequently if zinc is taken on an empty
stomach. The symptoms disappear quickly after stopping the use of the medicine.
In the case of long-term use of Zinkorot, the doctor will recommend a copper level test in the blood,
since long-term use of zinc reduces copper absorption. Long-term use of Zinkorot also reduces iron absorption.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Zinkorot

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging after the words EXP.
The expiry date refers to the last day of the given month.
No special precautions for storage of the medicinal product are necessary.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Zinkorot contains

• The active substance of the medicine is zinc (25 mg) in the form of zinc orotate dihydrate (157.36 mg).
• The other ingredients are: colloidal silica, microcrystalline cellulose, povidone K-30, sodium croscarmellose, talc, magnesium stearate. The medicine is considered sodium-free (see section 2).

What Zinkorot looks like and what the package contains

Zinkorot is a white, flat tablet with rounded edges and a dividing line on one side,
packaged in blisters and cardboard boxes.
Packaging of 20, 50, and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 24
71034 Böblingen
Germany

Manufacturer

Wörwag Pharma Production GmbH & Co. KG
Gewerbeallee 1
82343 Pöcking
Germany
Wörwag Pharma Operations Sp. z o.o.
ul. gen. Mariana Langiewicza 58,
95-050 Konstantynów Łódzki,
Poland
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
Woerwag Pharma Polska Sp. z o.o.
ul. Józefa Piusa Dziekońskiego 1
00-728 Warsaw
tel. (+48) 22 863 72 81
fax (+48) 22 877 13 70

Date of the last revision of the leaflet: May 2024