Tardyferon 80mg, Iron, 90 Coated Tablets

1. NAME OF DRUG TARDYFERON 80mg, coated tablet.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION Iron: 80.000 mg In the form of ferrous sulphate 1.5 H2O: (256.300 mg) Per coated tablet. Dilutants: castor oil, saccharose. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet. 4. CLINICAL DATA

4.1. Therapeutic Indications - Anaemia due to iron deficiency. - Preventative treatment for iron deficiency for pregnant women when they do not have enough iron in their body.

4.2. Dosage and how to use Suitable for adults and children over the age of 6 years old. Orally. Curative treatment: From 6 years of age: 1 tablet per day. Children over 10 years & Adults: 1-2 tablets per day. Preventative treatment: Pregnant women: 1 tablet per day or every 2 days during the last two trimesters of pregnancy (from the 4th month). Swallow the tablet whole. Do not suck, chew or keep the tablet in your mouth. Take with a large glass of water before or during mealtimes depending on your digestive tolerance. Length of treatment: Long enough to treat the anaemia and restore the iron reserves fo adults (600mg for women and 1200mg for men). Anaemia due to iron deficiency: 3-6 months depending on reserves, can be prolonged if the cause of anaemia is unknown. Efficacy control is only necessary after at least 3 months of treatment: it must be concerned with the repair of anaemia (Hb, VGM) and restoration of iron stocks (serum iron and saturation of the siderophiline).

4.3. Contraindications Martial surcharge in particular normo or hypersidemic anaemia such as thalassemia, refractory anaemia, anaemia due to medullar insufficiency, · allergy to one of its components, · intestinal obstruction due to castor oil content.

4.4. Special warnings and side effects Cautions Hyposidemia associated with inflammatory syndromes is not sensitive to iron treatment. Iron treatment should, as far as possible, be associated with treatment of the cause. Due to the saccharose content in this medication it is not suitable for those with a fructose intolerance, glucose/galactose malabsorption syndrome or sucrase-isomaltase insufficiency. Due to castor oil content there is a risk of sensitisation for children less than 3 years. Due to the risk of dental colouration and oral ulceration, tablets should not be sucked, chewed or kept in the mouth but should be swallowed whole with a large glass of water. Precautions for use Tea consumption inhibits iron absorption.

4.5. Interactions with other drugs Combinations to avoid: + Iron (salts) (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) Decreased digestive absorption of cyclines (formation of complexes). Take the iron salts at different times from cyclines (2 hours). + Magnesium Trisilicate (anti-acids) Decreased digestive absorption of iron salts. Take the anti-acids at different times from iron salts (2 hours).

4.6. Pregnancy and breast feeding Pregnancy: Negative clinical data for a few thousand treated women seem to exclude a negative effect of ferrous sulphate. 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 drug whilst breast-feeding.

4.7. Effects on the ability to drive and operate machinery Not applicable.

4.8. Side effects The table below shows the side effects observed in 7 clinical studies; 1051 patients of which 649 patients taking Tardyferon. The side effects are listed according to the MedDRA organ system classification and listed below as: very common (³ 1/10), common (³ 1/100,