ZINKOROTAT POS

ZINCOROTATE POS gastro-resistant tablets

Important notes (mandatory information)

Zinkorotat-POS 40 mg gastro-resistant tablets. Areas of application: for the treatment of zinc deficiency conditions that cannot be remedied through nutrition.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Zinkorotat-POS 40 mg gastro-resistant tablets
Active ingredient: Zinc orotate x 2 H2O

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse, contact your doctor.

What this package leaflet contains

1. WHAT IS ZINKOROTAT–POS AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ZINKOROTAT–POS?
3. HOW SHOULD YOU TAKE ZINKOROTAT–POS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ZINKOROTAT–POS BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ZINKOROTAT-POS AND WHAT IS IT USED FOR?

Mode of action: Zinkorotat-POS is a medicine for the supply (substitution) of zinc in the event of zinc deficiency. Area of application: For the treatment of zinc deficiency conditions that cannot be remedied through nutrition.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ZINKOROTAT-POS?

Zinkorotat-POS must not be taken if you are allergic to zinc orotate or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Zinkorotat-POS. Special care should be taken when taking Zinkorotat-POS if the preparation is taken over a longer period of time and in high doses. In this case, copper should also be monitored in the laboratory in addition to zinc.

Taking Zinkorotat-POS together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines, even if they are non-prescription medicines. Zinc reduces the absorption of tetracyclines. A time interval of at least 4 hours should be maintained between taking these medicines. Chelating agents such as D-penicillamine, dimercaptopropanesulfonic acid (DMPS) or edetinic acid (EDTA) can reduce the absorption of zinc or increase its excretion. The absorption of ofloxacin and other quinolones is impaired by zinc. The simultaneous administration of iron, copper or calcium salts reduces the absorption of zinc.

Taking Zinkorotat-POS together with food

Foods with a high phytate content (e.g. cereal products, legumes, nuts) reduce the absorption of zinc.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. There are no restrictions on the use of Zinkorotat-POS during pregnancy and breast-feeding, provided that there is a zinc deficiency and the recommended dosage is not exceeded.

Driving and using machines

No special precautions are required.

3. HOW SHOULD YOU TAKE ZINKOROTAT-POS?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the recommended dose is:

• Adults: Adults take 1 Zinkorotat–POS tablet 3 times a day; for long-term use, adults take one tablet 2–3 times a day.
• Children over 12 years of age and adolescents: The same dosages apply to children over 12 years of age and adolescents as for adults.
• Children from 4 to 11 years of age: Children from 4 to 11 years of age take 1 tablet 2 times a day.

The tablets should be taken whole with a little liquid about half an hour before meals. Please talk to your doctor or pharmacist if you have the impression that the effect of Zinkorotat-POS is too strong or too weak.

If you have taken more Zinkorotat-POS than you should

Symptoms of overdose only occur at very high doses, which are many times higher than the recommended daily intake of zinc. Signs of zinc overdose include a metallic taste on the tongue, headache, fatigue, diarrhoea and vomiting. These symptoms subside quickly after the medication is discontinued.

If you forget to take Zinkorotat-POS

Do not take twice the amount if you have forgotten to take the previous dose, but continue with the normal intake rhythm.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Very rarely, stomach problems and/or diarrhoea may occur. Very rarely, allergic reactions may occur. Zinkorotat-POS can cause copper deficiency if taken over a long period of time.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD ZINKOROTAT-POS BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the side flap of the outer carton/blister. The expiry date refers to the last day of the month indicated. Storage conditions: Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Zinkorotat-POS contains

The active ingredient is: Zinc orotate x 2 H2O. 1 gastro-resistant tablet contains 40 mg zinc orotate x 2 H2O (equivalent to a pure zinc content of 6.3 mg zinc). The other ingredients are: Dextrose-maltose-saccharide mixture (92 : 3.5 : 4.5); corn starch; D-mannitol; calcium hydrogen phosphate dihydrate; microcrystalline cellulose; copovidone; crospovidone; magnesium stearate (Ph.Eur.); methacrylic acid-methyl methacrylate copolymer (1:1); methacrylic acid-ethyl acrylate copolymer-(1:1)-dispersion 30%; talc; triethyl citrate.

What Zinkorotat-POS looks like and contents of the pack

Zinkorotat-POS are white, round, coated tablets that are packed in blisters of 10 tablets each. Zinkorotat-POS is available in the following pack sizes: 20, 50, 100 and 500 (hospital pack) gastro-resistant tablets.

Pharmaceutical entrepreneur and manufacturer

URSAPHARM
Industriestraße
66129 Saarbrücken
Tel.: 06805/92 92 -0
Fax: 06805/92 92 -88
Internet: www.ursapharm.de
E-mail: info@ursapharm.de

This package leaflet was last revised in November 2014.

Source: Information from the package leaflet
Status: 12/2017
Areas of application: for the treatment of zinc deficiency conditions that cannot be remedied through nutrition.