Fero-Grad Vitamin C 500, Iron 105mg, Vitamin C 500mg, 30 coated tablets

1. NAME OF DRUG FERO-GRAD VITAMIN C 500, coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ferrous sulphate: 325.00 mg Quantity of iron: 105.00 mg Ascorbic acid for direct compression*: 555.56 mg Quantity of ascorbic acid: 500.00 mg Per coated tablet. *Contains 90% of ascorbic acid and 10% of starch (cheat) and lactose monohydrate. One tablet contains 105mg of iron. Dilutant: lactose. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet. 4. CLINICAL DATA 4.1. Therapeutic Indications Anaemia by iron deficiency. Preventative treatment of iron deficiency for pregnant women. 4.2. Dosage and how to use Orally. To limit the side effects and due to the stimulant effect of vitamin C, it is recommended to take this medication in the morning on an empty stomach before breakfast. The time of the dose and the dose itself is adapted depending on your digestive tolerance. ONLY TO BE TAKEN BY ADULTS. Curative treatment: - For adults: 100-200 mg of metal iron per day (1-2 tablets per day). Preventative treatment: - For pregnant women: 1 tablet per day during the last two trimesters of pregnancy (from the 4th month). Length of treatment: 3-6 months should treat the anaemia and restore the iron reserves (adults- 1000mg). 4.3. Contraindications: Iron excess, in particular normal or hypersideremic anaemia such as thalassemie, refractory anaemia or anaemia due to medullar insufficiency. 4.4. Special warnings and side effects Special warnings: Hyposideremia with inflammatory syndromes is not noticeable with iron treatment. Iron treatment must be combined with a ethological treatment. · This drug contains lactose. This drug is not recommended for patients with a lactose intolerance. Precautions for use: Prevention of children having iron deficiency is based on the early introduction of a diverse diet. Tea consumption inhibits iron absorption. An efficacy test is useful after 3 months of treatment: it must be concerned with correcting anaemia (Hb, VGM) and restoring iron stocks (serum iron and siderophiline saturation). 4.5. Interactions with other drugs Combinations to avoid: + Iron (salts) via injection Lipothymia, or even shock attributed to the rapid release of iron from its complex form and saturation of siderophilin. Combinations to be aware of + Cyclines (orally) Decrease in digestive absorption of cyclines (formation of complex). Take iron salts at different times from cyclines (more than 2 hours apart). + Diphosphonates (orally) Decrease in diphosphonate absorption. Take iron salts at different times from disphosphonates (more than 2 hours apart). + Fluoroquinolones Decrease in the bioavailability of fluoroquinolones by chelation and by a non-specific effect on the absorption capacity of the digestive tract. Take iron salts at different times from fluroquinolones (more than 2 hours apart). + Penicillamine Decrease in digestive absorption of penicillamine. Take iron salts at different times from penicillamine (more than 2 hours apart). + Magensium Salts, oxides and hydroxides, alumunium and calcium Decrease in digestive absorption of iron salts. Take gastro-intestinal topics at different times from iron salts (more than 2 hours apart). + Thyroxine Decrease in digestive absorption of thyroxine and hypothyroxinemia. Take iron salts at different times from thyroxine (more than 2 hours apart). 4.6. Pregnancy and breast feeding Pregnancy: Negative clinical data for a few thousand treated women seem to exclude a detrimental effect of ferrous sulphate. Under normal conditions this medication can be prescribed during pregnancy. Breast feeding: The passage of ferrous sulphate in breast milk has not been evaluated, but given the nature of the molecule, it is possible to administer this medication in breastfeeding women. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects Possibility of stomach troubles: nausea, constipation or diarrhoea. Discolouration of faeces (black/grey). Allergic reactions: rash, urticaria and exceptional cases of anaphylactic shock. 4.9. Overdose In case of excessive intake of iron salts for children under 2 years: · Symptoms include severe irritation or necrosis of the digestive mucous membranes resulting in abdominal pain, vomiting, often bloody diarrhoea, shock with acute renal failure, hepatic impairment, and often convulsive coma. · At a distance from poisoning, digestive stenosis is possible. · Treatment should be initiated as soon as possible by gastric lavage with 1% sodium bicarbonate solution. · The use of a chelating agent is effective, the most specific being deferoxamine, mainly when the serum iron concentration is greater than 5 mg/ml. The state of shock, dehydration and the acid-base anomalies are treated in a conventional manner. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties ANTI-ANAEMIC. FERROUS SULPHATE TAKEN ORALLY. (B: blood and haematopoietic organs) Iron is an essential component of the body and it is important for the haemoglobin and the oxidation process for living tissue. 5.2. Pharmacokinetics properties Ferrous sulphate like all ferrous salts are weakly absorbed (10-20% per dose). It is kept in an inert and porous matrix, this inert matrix finds itself in the faeces. The absorption of ferrous sulphate is higher when the iron reserves are lower. it takes place in the duodenum in the jejunum part. 5.3. Preclinical safety data Not known. 6. PHARMACEUTICAL DATA 6.1. List of dilutants Acrylate copolymer and methyl metacrylate, magnesium stearate, povidone, macrogol 8000, microcrystalline cellulose, ethylcellulose (45 cps), macrogol 400, talc, hypromellose (15 cps), titanium dioxide (E171), quinoline yellow E104). 6.2. Incompatibilities Not applicable. 6.3. Shelf life 3 years. 6.4. Storage precautions No specific storage precautions. 6.5. Nature and contents of outside packaging Box of 30 tablets in blister packs (PVC/Alu). 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER TEOFARMA SRL Via F.lli cervi n° 8 27010 Valle Salimbene (PV) ITALY 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 311 879-4: Box of 30 tablets in blister packs (PVC/Alu). 9. START/RENEWEL DATE OF AUTHORISATION [To be completed by holder] 10. DATE OF UPDATE OF TEXT [To be completed by holder] 11. DOSIMETRY Not applicable. 12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION Not applicable. PRESCRIPTION AND DELIVERY CONDITIONS Drug not subjected to prescription.