PATIENT INFORMATION LEAFLET

Transcription

1 FERROZINC-G syrup, 100 ml For oral use PATIENT INFORMATION LEAFLET Active substance(s): Each 5 ml (1 spoon) syrup contains 40 mg iron (as ferrous gluconate) and 15 mg zinc (as zinc gluconate). Excipient(s): Sorbitol, sodium benzoate, fructose, sodium cyclamate, sodium chloride, sodium hydroxide, sodium acetate, citric acid, glycerin, neohesperidin DC, raspberry flavor 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 FERROZINC-G is and what it is used for 2. Before you use FERROZINC-G 3. How to use FERROZINC-G 4. Possible side effects 5. How to store FERROZINC-G 1 - What FERROZINC-G is and what it is used for? FERROZINC-G is a syrup containing 40 mg iron (as ferrous gluconate) and 15 mg zinc (as zinc gluconate) per each 5 ml and presented in a 100 ml amber colored glass bottle. FERROZINC-G is used in all the iron deficiencies which are originated from various causes and iron deficiency anemia and zinc deficiency seen with iron deficiency anemia 2 - Before you use FERROZINC-G Do not use FERROZINC-G in the following conditions If; You have iron absorbance (hemochromatosis) or iron accumulation (hemosiderosis) disorder; You have lead anemia or Mediterranean anemia; You have anemia not dependent on iron deficiency (megaloblastic anemia dependent on Vitamin B12 deficiency, hemolytic anemia); You receive regular blood transfusions; You are HIV-infected; Your iron deficiency is not clinically confirmed

2 TAKE SPECIAL CARE WITH FERROZINC-G in the following conditions If you had anemia not dependent on iron deficiency in your child, do not use without consulting your doctor. If you have stomach ulcer, use under supervision of your doctor During pregnancy do not use without consulting your doctor Please consult your doctor, even if these statements were applicable to you at any time in the past. Using FERROZINC-G with food and drink Do not use together with tea, coffee, milk, cheese, eggs as they decrease iron and zinc absorption. Take FERROZINC-G at least 1 hour before or 2 hours after the nutrition above. 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. As FERROZINC-G can pass into breast milk, use under the supervision of your doctor if necessary during breastfeeding. Effects on ability to drive and use machines There is no negative effect on ability to drive and use machines. Important information about some of the ingredients of FERROZINC-G If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking FERROZINC-G. If you are on a controlled sodium diet, please note that this medicinal product contains mg sodium per each 5 ml. Using with other medicines FERROZINC-G should be taken carefully with the following medicines; Antacids reducing stomach acid (magnesium trisilicate and carbonate) Certain painkillers (salicylates, phenylbutazone and oxyphenbutazone) Certain anti-inflammatory medicines (tetracycline) Medicines used in the treatment of certain rheumatic diseases (oral gold compounds taken orally) Please tell your doctor or pharmacist if you are taking or have recently taken any other prescription or nonprescription medicine. 3 - How to use FERROZINC-G Instructions for appropriate method and dose/frequency of administration: Unless recommended otherwise by your doctor, divide FERROZINC-G into 2-3 doses in children and use as follows.

3 Age of patients Amount to be given 6 12 months ml 1 3 years ml 4 8 years 3 5 ml 9 12 years ml years 5 10 ml In cases of severe iron deficiency anemia: Use 5 ml 4 times daily. Take same dosage until your doctor tells you your blood levels returned to normal in the blood analyses. Then continue taking 5 ml twice daily for 2 months. Take specified dosage unless recommended otherwise by your doctor. Route and method of administration: FERROZINC-G is only for oral use. Take at least 1 hour before or 2 hours after meals with a pipette. Different age groups: Use in elderly: No specific conditions regarding use of FERROZINC-G in elderly patients. Special populations: Kidney/Liver failure: Do not use FERROZINC-G in case of kidney and liver failure. If you have the impression that the effect of FERROZINC-G is too strong or too weak, talk to your doctor or pharmacist. If you have used more FERROZINC-G than you should: If you may have taken more FERROZINC-G than you should, talk to a doctor or pharmacist. These signs can be observed in case of FERROZINC-G overdose: drowsiness, nausea, vomiting, diarrhea, dizziness and hypotension. Accidental intake of iron-containing products at a dose of 60 mg / kg (7.5 ml/kg with a pipette) in children under 6 years of age results in fatal intoxications. Therefore keep these medicines out of reach of children. In cases of toxication, immediately contact your doctor or the National Toxicity Information Center (UZEM).. If you forget to use FERROZINC-G: Do not use a double dose to make up for a forgotten dose. Continue to take the recommended dose again according to the subsequent normal intake time. If you stop using FERROZINC-G: None. 4 - Possible side effects? Like all medicines, side effects can occur in people sensitive to the contents of FERROZINC-G. If any of the following occur stop using FERROZINC-G and IMMEDIATELY inform your doctor or go to the nearest emergency department: Swelling in face, tongue, throat

4 Trouble breathing, wheezing Excessive drop in blood pressure, dizziness, loss of balance Hives and itch, skin rash These are all very serious side effects. If you have any of them, this means you have serious allergy to FERROZINC-G. 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: Tar colored stool or light colored blood in the stool Vomiting with severe stomachache 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: Diarrhea Nausea Abdominal ache in stomach area Burning sensation in the stomach Bloating in the stomach Constipation Vomiting Darkening of stool color Dark coloring of the teeth These are mild effects of FERROZINC-G. 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. 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 FERROZINC-G 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 FERROZINC-G after the expiry date which is stated on the label or package. Do not use FERROZINC-G if you notice any damage to the product and/or package.

5 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 22/02/2017.