UNIZINK

UNIZINK 50 gastro-resistant tablets

Important notes (mandatory information)

Unizink 50, enteric-coated tablets. Active ingredient: Zinc aspartate.

Indications

for the treatment of zinc deficiency conditions that cannot be corrected through diet.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Unizink 50, 50 mg enteric-coated tablets for children from 1 year of age and adults
Active ingredient: Zinc aspartate

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 need to read it again later.
• If you have any further questions, ask your doctor or pharmacist.
• If you notice any side effects, talk to 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 if you feel worse, contact your doctor.

What this package leaflet contains

1. WHAT IS UNIZINK 50 AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING UNIZINK 50?
3. HOW TO TAKE UNIZINK 50?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE UNIZINK 50?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS UNIZINK 50 AND WHAT IS IT USED FOR?

Mode of action:
Unizink 50 is a mineral supplement for the supply (substitution) of zinc in case of zinc deficiency.

Indications

For the treatment of zinc deficiency conditions that cannot be corrected through diet.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING UNIZINK 50?

Unizink 50 must not be taken:

• if you are allergic to zinc aspartate or any of the other ingredients of this medicine listed in section 6.
• if you suffer from severe kidney damage or acute kidney failure.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Unizink 50. In case of long-term intake of zinc, both the copper and zinc levels should be monitored.

Taking Unizink 50 together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Zinc reduces the absorption of tetracyclines (antibiotics). A time interval of at least 4 hours should be observed 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 Unizink 50 together with food

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

Pregnancy, breast-feeding and fertility

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.

Pregnancy and breast-feeding

In case of proven, clinically confirmed zinc deficiency, there is no restriction on taking Unizink 50 during pregnancy and breast-feeding within the therapeutic dose range.

Fertility

It is not known whether Unizink 50 has an effect on fertility.

Driving and using machines

No special precautions are required.

Unizink 50 contains sorbitol

Please only use Unizink 50 after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW TO TAKE UNIZINK 50?

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.

Adults

The recommended dose for adults as well as pregnant and breast-feeding women is 2 tablets daily.

Children between 1 and 10 years of age

Children between 1-10 years of age take 1 tablet daily

Children from 11 years of age

Children from 11 years of age take (depending on their body weight) 1-2 tablets daily.

The tablets should be taken whole and unchewed with liquid, preferably approx. 30-60 minutes before meals.

Duration of use

Unizink 50 is suitable for long-term use over several months in the recommended dose.

If you have taken more Unizink 50 than you should

Only in case of a greatly increased intake of Unizink 50 can symptoms of overdose occur, such as a metallic taste on the tongue, headache, diarrhoea and vomiting. In this case, Unizink 50 should be discontinued immediately.

If you forget to take Unizink 50

Do not take double the amount to make up for a forgotten dose.

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.

The frequency of the following side effects is not known

After prolonged use, Unizink 50 can cause a copper deficiency.

Reporting of side effects

If you notice 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, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW TO STORE UNIZINK 50?

Keep this medicine out of the reach of children. Do not store above 25°C. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you no longer use it. This helps to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Unizink 50 contains

The active ingredient is zinc bis-(hydrogen-DL-aspartate). 1 enteric-coated tablet contains 50 mg zinc bis-(hydrogen-DL-aspartate) (equivalent to 10 mg zinc). The other ingredients are: Microcrystalline cellulose, sorbitol, triethyl citrate, croscarmellose - sodium, talc, titanium dioxide, boeson VP, magnesium stearate, macrogol 6000, eudragit L 30 and E/L 12.5.

What Unizink 50 looks like and contents of the pack

Unizink 50 are white, round, coated tablets, which are packed in blisters of 10 tablets each. Unizink 50 is available in the following pack sizes: Packs of 20 enteric-coated tablets (N1), packs of 50 enteric-coated tablets (N2), packs of 100 enteric-coated tablets (N3) and hospital packs of 500 (10 x 50) enteric-coated tablets hospital packs of 1000 (10 x 100) enteric-coated tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Köhler Pharma GmbH
Neue Bergstraße 3-7
64665 Alsbach-Hähnlein
Phone: 0 62 57/506 529-0
Fax: 0 62 57/506 529-20

Pharmaceutical manufacturer

Dr. Franz Köhler Chemie GmbH
Werner-von-Siemens-Str. 14-28
64625 Bensheim

This package leaflet was last revised in December 2016.

Source: Information from the package leaflet
Status: 12/2017
Active ingredient: Zinc aspartate. Indications: for the treatment of zinc deficiency conditions that cannot be corrected through diet.