4.1. Therapeutic indications

1. As a therapeutic nutritional adjunct where the intake of vitamins and minerals is suboptimal, e.g. in the presence of organic disease such as malignancy and immune deficiency syndromes, such as AIDS.

2. As a therapeutic nutritional adjunct in conditions where the absorption of vitamins and minerals is suboptimal, e.g. malabsorption, inflammatory bowel disease and fistulae, short bowel syndrome and Crohn's disease, and where concurrent medication decreases vitamin and mineral absorption.

3. As a therapeutic nutritional adjunct in convalescence from illness, e.g. where anorexia or cachexia exists and following chemo- or radio-therapy.

4. As a therapeutic nutritional adjunct in convalescence from surgery, e.g. where nutritional intake continues to be inadequate.

5. As a therapeutic nutritional adjunct for patients on special or restricted diets, e.g. in renal diets and where several food groups are restricted in therapeutic weight reducing diets.

6. As a therapeutic nutritional adjunct where food intolerance exists, e.g. exclusion diets.

7. As an adjunct in synthetic diets, e.g. in phenylketonuria, galactosaemia and ketogenic diets.

4.2. Posology and method of administration

Adults and the Elderly

One capsule daily, preferably taken one hour after meals. Do not exceed the stated dose. The capsule should be swallowed whole with water.

Children under 12 years of age

Forceval Capsules are not recommended for this age group.

4.3. Contraindications

Hypercalcaemia, haemochromatosis and other iron storage disorders.

Hypersensitivity to the active substance(s) or to any of the excipients.

Forceval capsules contain soya bean oil. Patients allergic to peanut or soya should not take this medicine.

4.4. Special warnings and precautions for use

Whilst taking Forceval Capsules both protein and energy are also required to provide complete nutrition in the daily diet. No other vitamins, minerals or supplements with or without vitamin A should be taken with this preparation except under medical supervision.

Do not take Forceval Capsules on an empty stomach. Do not exceed the stated dose. Keep out of the reach of children. If symptoms persist, consult your doctor.

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

This medicine contains E123 (amaranth) and E124 (ponceau 4R red) which may cause allergic reactions.

Evidence from Randomised Control Trials suggests that high doses (20-30 mg/day) b-carotene intake may increase the risk of lung cancer in current smokers and those previously exposed to asbestos. This high-risk population should consider the potential risks and benefits of Forceval Capsules, which contain 4.5mg per recommended daily dose, before use.

Patients with thyroid disorders should seek medical advice before taking Forceval Capsules. An allowance should be made for vitamins or minerals obtained from other sources.

4.5. Interaction with other medicinal products and other forms of interaction

Folic acid can reduce the plasma concentration of phenytoin. Oral iron and zinc sulfate reduce the absorption of tetracyclines.

4.6. Pregnancy and lactation

Forceval Capsules may be administered during pregnancy and lactation at the recommendation of the physician.

4.7. Effects on ability to drive and use machines

None anticipated.

4.8. Undesirable effects

Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

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

Not known: cannot be estimated from the available data

Immune system disorders

Not known:

Hypersensitivity reaction (such as rash)

Gastrointestinal disorders

Not known:

Gastrointestinal disturbances (such as nausea, vomiting and abdominal pain)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

No cases of overdosage due to Forceval therapy have been reported. Any symptoms which may be observed due to the ingestion of large quantities of Forceval capsules will be due to the fat soluble vitamin content. If iron overdosage is suspected, symptoms may include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycaemia and metabolic acidosis may also occur. Treatment should be implemented immediately. In severe cases, after a latent phase, relapse may occur after 24 - 48 hours, manifest by hypotension coma and hepatocellular necrosis and renal failure.

Treatment

The following steps are recommended to minimise or prevent further absorption of the medication:

1. Administer an emetic.

2. Gastric lavage may be necessary to remove drug already released into the stomach. This should be undertaken using desferrioxamine solution (2 g/l). Desferrioxamine 5 g in 50 - 100 ml water should be introduced into the stomach following gastric emptying. Keep the patient under constant surveillance to detect possible aspiration of vomitus; maintain suction apparatus and standby emergency oxygen in case of need.

3. A drink of mannitol or sorbitol should be given to induce small bowel emptying.

4. Severe poisoning: in the presence of shock and/or coma with high serum iron levels (>142 μmol/l) immediate supportive measures plus i.v. infusion of desferrioxamine should be instituted. The recommended dose of desferrioxamine is 5 mg/kg/h by slow i.v. infusion up to a maximum of 80 mg/kg/24 hours. Warning: hypotension may occur if the infusion rate is too rapid.

5. Less severe poisoning: i.m. desferrioxamine 50 mg/kg up to a maximum dose of 4 g should be given.

6. Serum iron levels should be monitored throughout.

7. Any fluid or electrolyte imbalance should be corrected.