PATIENT INFORMATION LEAFLET

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Roxanne Chambers
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1 ZINCO-K 15 mg/5 ml syrup For oral use PATIENT INFORMATION LEAFLET Active substance(s): Each 5 ml syrup (1 spoon) contains 15 mg of zinc as zinc sulphate heptahydrate. Excipient(s): Sorbitol (%70), maltitol, citric acid monohydrate, methyl paraben, glycerin, orange flavor, sunset yellow (E110) and deionized water. Read this PATIENT INFORMATION LEAFLET carefully before you start using this medicine, because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. If you go to a doctor or hospital during the use of this medicine, inform your doctor about this Follow the instructions in this leaflet exactly. Do not use higher or lower doses than the dose which was recommended for you. What is in this leaflet: 1. What ZINCO-K is and what it is used for 2. Before you use ZINCO-K 3. How to use ZINCO-K 4. Possible side effects 5. How to store ZINCO-K 1. What ZINCO-K is and what it is used for? ZINCO-K is a zinc-containing syrup and presented in PET/PE spoons (each spoon (5 ml) contains 15 mg zinc as zinc sulfate heptahydrate) closed with aluminum. Each box contains 20 or 28 spoons of 5 ml capacity. The presentation of 20 spoons is also packaged in a PVC separator. It is used for the treatment or prevention of zinc deficiency 2. Before you use ZINCO-K Do not use ZINCO-K in the following conditions If; You are allergic (hypersensitivity) to zinc salts or any of the other ingredients of ZINCO-K TAKE SPECIAL CARE WITH ZINCO-K in the following conditions Since there is not adequate studies in those with kidney and liver disease please consult your doctor if you have any such disease. Accumulation of zinc in the body may increase in kidney failure, therefore caution should be exercised in cases of renal insufficiency. Prolonged use may cause copper deficiency.

2 Please consult your doctor, even if these statements were applicable to you at any time in the past. Using ZINCO-K with food and drink Since concomitant intake of zinc with high-fiber food, whole meal bread or dairy products decrease the absorption of zinc, ZINCO-K should not be taken together with these types of food. Also food rich in phytic acid (inositol) (e.g. wheat bran, flaxseed, cereals, legumes) and coffee may decrease the absorption of zinc compounds. In order to ensure maximum absorption, zinc salts should not be orally taken with foods and drinks (except for water). Pregnancy Ask your doctor or pharmacist for advice before taking the medicine. Use under the supervision of your doctor during pregnancy, if necessary. If you notice that you are pregnant during treatment, please consult your doctor or pharmacist immediately. Breastfeeding Ask your doctor or pharmacist for advice before taking the medicine. Use under the supervision of your doctor if necessary during breastfeeding. Effects on ability to drive and use machines No studies have been carried to test its effects on the ability to drive or use machines. Important information about some of the excipients of ZINCO-K If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking ZINCO-K, because it contains sorbitol and maltitol. It contains less than 10 g of glycerin per each dose of 5 ml. No adverse effects associated with glycerin are expected because of its dose This medicinal product contains methyl paraben which may cause allergic reactions (possibly delayed). This medicinal product contains sunset yellow (E110) which may cause allergic reactions. Using with other medicines Concomitant intake of zinc salts with tetracyclines (a type of antibiotic) or penicillamine (an antiinflammatory agent) may reduce the efficacy of zinc; therefore a 3-hour interval should be allowed between the intake of these agents and zinc. High dose iron preparations should not be taken with zinc, as they may reduce zinc absorption. Zinc may reduce the absorption of fluoroquinolones (ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin), a class of antibiotics used for the treatment of diseases caused by bacteria. Calcium salts may reduce zinc absorption. Contraceptives may reduce plasma zinc levels. Food rich in bran or fiber as well as dairy products may reduce zinc absorption.

3 Penicillamine and trientin (agents used for the treatment of excessive copper accumulation in the body, or Wilson s disease) may reduce zinc absorption; also zinc may reduce the absorption of these two agents. Antacids (agents reducing gastric acidity) may reduce the rate and extent of zinc sulfate absorption. Please tell your doctor or pharmacist if you are taking or have recently taken any other prescription or nonprescription medicine. 3. How to use ZINCO-K? Instructions for appropriate method and dose/frequency of administration: ZINCO-K can be used before, after, or during the meals in adults. Unless recommended otherwise by your doctor, use as specified below. Age Elementary zinc (mg) Tolerated dose (mg) 9-13 years years years adults Spoon Route and method of administration: ZINCO-K is only for oral use. Drink directly from the spoon. Different age groups: Use in children: Use in children is as described above. Use in elderly: The safety and efficacy of ZINCO-K in elderly have not been tested. Special populations: Kidney/liver failure: The safety and efficacy of ZINCO-K in patients with kidney or liver failure have not been tested. Accumulation of zinc in the body may increase in kidney failure, therefore caution should be exercised in cases of renal insufficiency. If you have the impression that the effect of ZINCO-K is too strong or too weak, talk to your doctor or pharmacist. If you have used more ZINCO-K than you should: If you may have taken more ZINCO-K than you should, talk to a doctor or pharmacist. In cases of overdose, symptoms such as low blood pressure, dizziness, drowsiness and vomiting may occur. If you forget to use ZINCO-K: Do not use a double dose to make up for a forgotten dose.

4 If you stop using ZINCO-K: Do not stop the treatment with ZINCO-K without consulting your doctor. 4. Possible side effects? Like all medicines, side effects can occur in people sensitive to the contents of ZINCO-K. Side effects are classified as follows: Very common (may be seen at least 1 in 10 patients) Common (may be seen less than one in 10 patients but more than one in 100 patients) Uncommon (may be seen less than one in 100 patients but more than one in 1000 patients) Rare (may be seen less than one in 1000 patients but more than one in patients) Very rare (may be seen less than one in patients) Unknown (it cannot be estimated from the available data). If any of the following occur stop using ZINCO-K and IMMEDIATELY inform your doctor or go to the nearest emergency department. Hypersensitivity reaction (difficulty in breathing and swallowing, swelling in the hands/feet, face/lips, rash, faintness etc.) These are all very serious side effects. If you have any of them, this means you have serious allergy to ZINCO-K. You may need emergency medical care or hospitalization. These very serious side effects occur very rarely. If you notice any of the following immediately inform your doctor or go to the nearest emergency department: Low blood pressure (hypotension), irregular heartbeat (arrhythmias) These are all serious side effects. They may require emergency medical treatment. These serious side effects occur very rarely. If you notice any of the following, inform your doctor: Vomiting Changes in blood count parameters (neutropenia, leukopenia, anemia) Nausea Abdominal pain Dyspepsia Headache Nervousness, drowsiness Paresthesia, Gastric sensitivity Inflammation of the gastric mucosa (gastritis) Dizziness Diarrhea These are mild effects of ZINCO-K. These side effects disappear when the dose is reduced or treatment is discontinued. If you notice any side effects not mentioned in this leaflet inform your doctor or pharmacist.

5 Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via clicking Reporting of Drug Side Effects icon on the website or Turkish Pharmacovigilance Center (TUFAM) by calling the phone number for side effects reporting line. By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store ZINCO-K Keep in the original package and out of the reach and sight of children. Store in room temperature under 25 C. Use in accordance with expiry date. Do not use ZINCO-K after the expiry date which is stated on the package. Do not use ZINCO-K if you notice any damage to the product and/or package. Marketing Authorization Holder: Berko İlaç ve Kimya San. A.Ş. Yenişehir Mah. Özgür Sok. No: Ataşehir/İstanbul (Pbx) (Fax) info@berko.com.tr Manufacturer: Berko İlaç ve Kimya San. A.Ş. Adil Mah. Yörükler Sok. No: 2 Sultanbeyli/İstanbul (Pbx) (Fax) This patient information leaflet was approved on 12/10/2016.

PATIENT INFORMATION LEAFLET

FERIFER-40 Oral Solution, 40 mg/5 ml For oral use. PATIENT INFORMATION LEAFLET Active substance(s): Each one spoon solution (5 ml) contains 40 mg of iron (as iron III polymaltose complex). Excipient(s):