ZINK-RATIOPHARM

ZINK-RATIOPHARM 25 mg effervescent tablets

Important notes (mandatory information)

Zink-ratiopharm 25 mg effervescent tablets. Areas of application: for the treatment of clinically confirmed zinc deficiency conditions, if they cannot be remedied through nutrition. Warning: 1 effervescent tablet contains 14.14 mmol (325 mg) of sodium.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Zink-ratiopharm 25 mg effervescent tablets
Active ingredient: zinc

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use 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.

What this package leaflet contains

1. WHAT IS ZINK-RATIOPHARM 25 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING ZINK-RATIOPHARM 25 MG?
3. HOW TO USE ZINK-RATIOPHARM 25 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ZINK-RATIOPHARM 25 MG?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ZINK-RATIOPHARM 25 MG AND WHAT IS IT USED FOR?

Zink-ratiopharm 25 mg is a mineral supplement. Zink-ratiopharm 25 mg is used to treat clinically confirmed zinc deficiency conditions, if they cannot be remedied through nutrition.

2. WHAT SHOULD YOU CONSIDER BEFORE USING ZINK-RATIOPHARM 25 MG?

Zink-ratiopharm 25 mg must not be used if you are allergic to zinc sulphate monohydrate or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or before using Zink-ratiopharm 25 mg.

• if you suffer from peptic stomach ulcers as well as acute renal failure or severe renal parenchymal damage.
• if you use Zink-ratiopharm 25 mg long-term; in case of long-term use of zinc, copper should also be monitored in the laboratory in addition to zinc.

Use of Zink-ratiopharm 25 mg with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Zinc reduces the absorption of antibiotics such as tetracyclines (e.g. doxycycline), ofloxacin or other quinolones (e.g. ciprofloxacin, norfloxacin). Due to the risk of reduced effectiveness against bacterial infections, a time interval of at least 4 hours should be maintained between taking zinc and tetracyclines or quinolones. D-penicillamine, dimercaptopropanesulfonic acid (DMPS), dimercaptosuccinic acid (DMSA) or ethylenediaminetetraacetic acid (EDTA) can reduce zinc absorption or increase excretion. The absorption of zinc can be reduced if zinc is taken at the same time as phosphates, iron, copper and calcium salts. Zinc preparations can reduce the absorption and storage of iron if taken at the same time as iron. Zinc can impair the absorption of copper.

Use of Zink-ratiopharm 25 mg with food and drink

Foods with a high phytic acid content, e.g. wholemeal bread, soybean sprouts and corn, reduce the absorption of zinc into the body and should therefore be avoided after taking zinc. There is evidence that coffee appears to hinder zinc resorption.

Pregnancy and breast-feeding

If your doctor has diagnosed you with a zinc deficiency, you can use the dose of Zink-ratiopharm 25 mg recommended by your doctor during pregnancy and breast-feeding.

Zink-ratiopharm 25 mg contains sodium

One effervescent tablet contains 14.14 mmol (325 mg) of sodium. If you need to follow a low-salt diet, you should take this into account.

3. HOW TO USE ZINK-RATIOPHARM 25 MG?

Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Adults and children over 12 years: ½-1 effervescent tablet daily (equivalent to 12.5 - 25 mg of zinc ions). The effervescent tablet can be divided into equal doses.

Method of administration

For oral use after dissolving. Please dissolve the effervescent tablet in half a glass of water and drink the glass completely, preferably after a meal.

Duration of use

The duration of treatment depends on the severity of the zinc deficiency. Please talk to your doctor or pharmacist if you have the impression that the effect of Zink-ratiopharm 25 mg is too strong or too weak.

If you have used more Zink-ratiopharm 25 mg than you should

Acute overdose is rare and only occurs after taking at least 1 g of zinc sulphate monohydrate; this corresponds to a quantity of 14 effervescent tablets of Zink-ratiopharm 25 mg. If you have taken too much Zink-ratiopharm 25 mg, please contact your doctor or pharmacist immediately.

If you have any further questions on the use of 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 categories are used as a basis for the frequency of 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.

In very rare cases, skin reactions (such as skin redness or itching) have been observed in connection with the ingestion or injection of zinc salts. Long-term use of zinc sulphate can lead to copper deficiency.

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

5. HOW TO STORE ZINK-RATIOPHARM 25 MG?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the foil strip. The expiry date refers to the last day of the month indicated. Do not store above 25°C. Store in the unopened original container to protect the contents from moisture.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Zink-ratiopharm 25 mg contains

The active ingredient is zinc sulphate monohydrate. Each effervescent tablet contains 69 mg of zinc sulphate monohydrate, equivalent to 25 mg of zinc. The other ingredients are: Anhydrous citric acid (Ph.Eur.), sodium hydrogen carbonate, sodium carbonate, mannitol (Ph.Eur.), sodium citrate x 2 H2O, saccharin sodium, sodium cyclamate, lemon flavour.

What Zink-ratiopharm 25 mg looks like and contents of the pack

Round, white effervescent tablet with a break notch. Zink-ratiopharm 25 mg is available in packs of 20 effervescent tablets.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This package leaflet was last revised in May 2016.

Source: Information from the package leaflet
Status: 01/2018
Areas of application: for the treatment of clinically confirmed zinc deficiency conditions, if they cannot be remedied through nutrition. Warning: 1 effervescent tablet contains 14.14 mmol (325 mg) of sodium.