PATIENT INFORMATION LEAFLET

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1 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): Sorbitol (E420), methyl paraben sodium (E219), propyl paraben sodium (E217), citric acid monohydrate, vanilla flavor, glycerin, propylene glycol and deionised 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 FERIFER-40 is and what it is used for 2. Before you use FERIFER How to use FERIFER Possible side effects 5. How to store FERIFER-40 1 What FERIFER-40 is and what it is used for? FERIFER-40 is an oral solution presented in PET/PE spoons covered by aluminum, containing 40 mg of iron (as iron III polymaltose complex) in each spoon (5 ml). Each box contains 10 or 28 single-use spoons of 5 ml capacity. These presentations of 10 and 28 spoons are also packaged in a PVC separator It is used for treatment and prophylaxis of all the iron deficiencies which are originated from various causes, and iron deficiency anemia and treatment of iron deficiency in pregnancy, lactation and childhood. 2 Before you use FERIFER-40 Do not use FERIFER-40 in the following conditions: If; you are allergic (hypersensitive) to iron or any of the other ingredients of FERIFER-40 you have iron overload (hemochromatosis, hemosiderosis) you are allergic (hypersensitivity) to iron you have anemia not dependent on iron deficiency (such as hemolytic anemia) you have disturbances in iron utilization (lead anemia, sideroachrestic anemia) you have thalassemia disease Page 1 / 5

2 you have progressive and chronic joint inflammation you have conditions which that require continuous blood transfusion on a regular basis you are HIV-infected and your anemia due to iron deficiency is not clinically confirmed you have severe liver and kidney diseases TAKE SPECIAL CARE WITH FERIFER-40 in the following conditions: If; you have an allergic condition, you have stomach ulcer, use under supervision of your doctor. Dark discoloration of stool may occur during treatment with oral iron preparations; this is an expected condition which does not require any measures. This does not cause false results on fecal occult blood tests. Therefore, there is no need to stop treatment during the examination. It should be used with caution in diseases that disrupt the absorption of iron from bowels and alcoholism In cases of anemia due to various diseases or malignancy, supplemented iron is stored in the liver and utilized after curing the disease and cancer. Please consult your doctor, even if these statements were applicable to you at any time in the past. Using FERIFER-40 with food and drink: FERİFER-40 should be taken with or after meals. It should not be taken with milk. Also, it should not be taken with calcium-containing products and medicines. These should be taken at least 2 hours interval. Pregnancy: Ask your doctor or pharmacist for advice before taking the medicine. FERIFER-40 can be used as iron supplementation during pregnancy, if your doctor recommends. 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. FERIFER-40 can be used as iron supplementation during breastfeeding, if your doctor recommends. Iron is secreted into breast milk. The secretion does not vary by the mother s iron levels or the amount of dietary iron. Therefore, iron supplementation to a breastfeeding mother does not cause iron intoxication or does not eliminate already present iron deficiency in the infant. Effects on ability to drive and use machines It has no effect on ability to drive or use machines. Important information about some of the ingredients of FERIFER-40 If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking FERIFER-40 because it contains sorbitol Page 2 / 5

3 It may cause allergic reactions (possibly delayed type) because it contains methyl paraben sodium and propyl paraben sodium. Headache, nausea and diarrhea may occur because it contains glycerin. Because it contains propylene glycol, alcohol-like symptoms could occur If you are on a controlled sodium diet, please note that this medicinal product contains 1.27 mg sodium per each 5 ml. Using with other medicines FERIFER-40 has no interaction with other drugs It is known that vitamin C increases the iron 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 FERIFER-40 Instructions for appropriate method and dose/frequency of administration Unless recommended otherwise by your doctor, use with or after meals at the indicated doses In children: In adults: 1 spoon (5 ml) 1-2 times a day (5 ml) 1 spoon (5 ml) 2-3 times a day (5 ml) It should be used as long as recommended by your doctor. In order to fill up the body iron reserves, treatment should continue for at least one month more after iron deficiency symptons disappears. Route and method of administration: FERIFER-40 is only for oral use. FERIFER-40 is taken directly from the spoon. It can be taken by mixing with fruit and vegetable juices Different age groups: Use in children: Use in children is as given above. Use in elderly: Use in elderly patients is the same as in adults. Special populations: Kidney/Liber failure: Do not use FERIFER-40 in severe liver and kidney diseases. If you have the impression that the effect of FERIFER-40 is too strong or too weak, talk to your doctor or pharmacist. If you have used more FERIFER-40 than you should: If you may have taken more FERIFER-40 than you should, talk to a doctor or pharmacist. Page 3 / 5

4 Diarrhea, stomach ache and vomiting may occur with overdose, and metabolic acidosis, severe muscle spasms and coma may be seen in further cases. Accidental intake/swallowing of iron-containing products in children under 6 years of age results in fatal intoxications. Therefore keep these medicines out of reach of children. In cases of overdose, immediately contact your doctor or the National Toxicity Information Center (UZEM). If you forget to use FERIFER-40: Do not use a double dose to make up for a forgotten dose. Skip the forgotten dose, and take the next dose at the planned dose time. If you stop using FERIFER-40: None. 4 Possible side effects Like all medicines, side effects can occur in people sensitive to the contents of FERIFER-40. If any of the following occur stop using FERIFER-40 and IMMEDIATELY inform your doctor or go to the nearest emergency department: Difficulty in breathing, swelling in face, lips, tongue and throat, sudden onset of blood pressure decrease, generalized and severe redness, itching, hives (urticaria) These are all very serious side effects. If you have any of them, this means you have serious allergy to FERIFER-40. 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: Asthma 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: Dyspepsia Feeling of discomfort in abdomen Nausea, vomiting Heartburn Brackish water coming to your mouth Mild abdominal pain Itching, exanthema, rash, redness Headache Urine and stool discoloration Reversible discoloration of the teeth These are mild effects of FERIFER-40. Page 4 / 5

5 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 FERIFER-40 Keep in the original package and out of the reach and sight of children. Store in room temperature under 25 C. Each spoon is for single use only. The remaining solution should be discarded without being used Use in accordance with expiry date Do not use FERIFER-40 after the expiry date which is stated on the spoon or package. Do not use FERIFER-40 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 07/10/2016. Page 5 / 5

PATIENT INFORMATION LEAFLET

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):