SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Slow Fe Tablets 160mg

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

One Slow Fe tablet contains 160.0 mg of ferrous sulphate (equivalent to 50 mg of elemental iron).

Excipient with known effect: Lactose For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Slow release tablet.

Round, biconvex, greenish white film coated impressed CG 503 on one side/plain on the other.

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

As a haematinic for the treatment of, or for the prophylaxis of iron deficiency anaemia, including that associated with post-gastrectomy and other malabsorption syndromes.

4.2    Posology and method of administration Adults

For prophylaxis, one tablet daily.

For treatment of iron deficiency anaemia, two tablets daily.

Paedatric population

For treatment, one tablet daily for children over the age of six years.

Method of administration:

The tablets should be swallowed whole, with fluid and may be taken at any time of the day.

For optimal iron absorption, avoid taking the tablets with beverages such as tea or coffee (see section 4.5).

4.3    Contraindications

Iron therapy is contraindicated in patients:

•    with known hypersensitivity to ferrous sulphate or to any of the excipients listed in Section 6.1.

•    with haemochromatosis, haemosiderosis and haemolytic anaemia

•    receiving repeated blood transfusions

•    with anaemias not resulting from iron deficiency unless iron deficiency is also present

Oral and parenteral iron therapy should not be used together.

4.4    Special warnings and precautions for use

As with all iron preparations, Slow Fe should be used with care in patients with known or suspected gastrointestinal diseases, such as inflammatory bowel disease, gastrointestinal strictures or diverticulae.

Slow Fe contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Important warning: Contains iron. Keep out of reach and sight of children, as overdose may be fatal.

4.5 Interaction with other medicinal products and other forms of interaction

Concurrent administration of antacids may reduce absorption of iron preparations. Iron chelates with tetracyclines and absorption of both agents may be impaired, iron may reduce the absorption or penicillamine and zinc salts.

•    Iron compounds interact with fluoroquinolone antibiotics, causing their serum antibacterial levels become subtherapeutic. The extent of this interaction in descending order is as follows: norfloxacin, levofloxacin, ciprofloxacin, moxifloxacin, gatifloxacin, ofloxacin/sparfloxacin and lomefloxacin.

•    Bone marrow depression provoked by chloramphenicol can oppose the treatment of anaemias with iron compounds.

•    Ferrous sulphate markedly reduces the absorption of cefdinir, producing a poorly absorbed complex.

•    Iron compounds may reduce the antihypertensive effects of methyldopa, and may reduce the bioavailability of levodopa and carbidopa, possibly reducing the control of Parkinson disease.

•    The oral absorption of bisphosphonates is reduced by iron preparations.

•    Ferrous sulphate causes a reduction in the effects of levothyroxine in patients treated for hypothyroidism.

•    Reduced iron absorption has been reported with beverages high in polyphenolics such as coffee and tea.

4.6 Fertility, pregnancy and lactation

Pregnancy

Slow Fe can be used in the iron deficiency anaemia of pregnancy, with or without additional folic acid, as appropriate.

Breastfeeding

Supplemental iron is either not excreted in breast milk or is not absorbed by the infant. It gives very low levels in the infant with no apparent effect. Slow Fe can therefore be used at therapeutic doses in case of iron deficiency anemia during lactation, with or without folic acid, as appropriate.

4.7 Effects on ability to drive and use machines

Slow Fe has no or negligible influence on the ability to drive and use machines.

4.8    Undesirable effects

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (> 1/10); common (> 1/100 to < 1/10); uncommon (> 1/1,000 to < 1/100); rare (> 1/10,000 to < 1/1,000); very rare (< 1/10,000), or not known (can not to be estimated from available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Gastrointestinal disorders

Common:    Nausea, constipation, abdominal discomfort/pain, diarrhoea.

Uncommon:    Faeces discoloured, vomiting

Immune system disorders

Rare: Hypersensitivity reactions (such as rash, erythema, pruritus, urticaria and swelling of face).

4.9    Overdose Symptoms

Include abdominal pain, nausea and vomiting, diarrhoea and haematemesis.

Treatment

Gastric lavage or emesis should be carried out immediately. To chelate excess free iron in the gastro-intestinal tract, 5g desferrioxamine dissolved in 50ml water should be introduced into the stomach. To chelate excess free iron in the blood, desferrioxamine may be given parenterally; depending on the patients condition, 1g desferrioxamine given every 3 hours intramuscularly may be appropriate.

5. PHARMACOLOGICAL PARTICULARS

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: iron preparations;

ATC code: B03AA07 ferrous sulphate.

Slow-Fe incorporates iron (ferrous sulphate) in a slow release preparation. It provides a source of iron which is an essential constituent of the body. Iron is necessary for haemoglobin formation and for the oxidative processes of living tissues. Deficiency of iron in the body causes_microcytic hypochromic_anaemia which may be treatable with an iron supplement such as Slow-Fe.

5.2    Pharmacokinetic properties Absorption

Iron is a dietary requirement. Iron is irregularly and incompletely absorbed from the gastrointestinal tract, the main sites of absorption being the duodenum and jejunum; only about 5% - 10% of the iron ingested with food is absorbed. Absorption is increased in conditions of deficiency and decreased when body stores are overloaded. Absorption is aided by the acid secretion of the stomach and by some dietary acids (such as ascorbic acid) and occurs more readily when the iron is in the ferrous state or is part of the haem complex (haem-iron).

In healthy men and non-menstruating women absorption of 1mg/day is required, in menstruating women this rises to 2mg/day and in pregnancy/lactation 3mg/day is required.

There is no significant difference between the absorption of iron from ferrous sulphate tablets and from Slow Fe in healthy persons, in anaemia, following gastrectomy, or in coeliac disease.

Distribution and Metabolism

Most absorbed iron is bound to transferrin and transported to the bone marrow, where it is incorporated into hemoglobin; the remainder is contained within the storage forms, ferritin or hemosiderin, or as myoglobin, with smaller amounts occurring in haem-containing enzymes or in plasma bound to transferrin.

Elimination

Only very small amounts of iron are excreted, as the majority released after the destruction of the hemoglobin molecule is re-used. This conservation of body iron and lack of an excretory mechanism for excess iron is the reason for the development of iron overload with excessive iron therapy or repeated transfusions.

Apart from haemorrhage, iron is lost from the body in: urine, hair, nails, skin and sweat.

In therapy, haemoglobin levels return to normal after about 10 weeks. 3 to 6 months are required to replenish body stores.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.

6.    PHARMACEUTICAL PARTICULARS

6.1    List o excipients

Lactose BP

Hydroxypropylmethylcellulose 50 CPS EP

Cetrostearyl alcohol BP

Magnesium Stearate BP

Hydroxypropylmethylcellulose 3CPS EP

Purified talc special EP

Polysorbate 80 USP

Titanium dioxide (E171) BP

Yellow iron oxide 17268 (E172) HSE

FD&C Blue No. 2 al lake (E132) HSE

Purified water

Methyline chloride

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Protect from moisture.

Nature and contents of container

PVC blister packs in cardboard carton, containing either 28 or 150 tablets.

6.6 Instructions for use and handling

None.

7 MARKETING AUTHORISATION HOLDER

Novartis Consumer Health UK Ltd

T/A Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL 00030/0181

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

28^th July 2000

10 DATE OF REVISION OF THE TEXT

17/10/2012