FOLIC ACID COLONIS

For oral administration only. Adults (including the elderly): - In folate deficient megaloblastic anaemia: 5 mg daily for 4 months; up to 15 mg daily may be necessary for malabsorption states. - In drug-induced folate deficiency: 5 mg daily for 4 months; up to 15 mg daily may be necessary for malabsorption states.

- For prophylaxis in chronic haemolytic states: 5 mg every 1-7 days depending on underlying disease. - Prevention of neural tube defects for women planning a pregnancy and known to be at risk: 5 mg daily started before conception and continued throughout the first trimester.

- In established folate deficiency of pregnancy: 5 mg daily continued to term. 4 mg daily until 10 to 12 weeks after last menstrual period Paediatric population: - In folate deficient megaloblastic anaemia: Child 1-18 years, 5 mg daily for 4 months; maintenance, 5 mg every 1-7 days.

5 mg-5 mg once daily. Child 12-18 years, 5-10 mg once daily. The duration of the folic acid regimen has not been determined precisely in all patient populations, but it is recommended to administer the vitamin until the formation of new colonies of red blood cells is observed.

Depending on the etiological factor, diet improvement, removal of etiological factor, treatment of an inflammation may lead to cessation of treatment. In cases of haemolytic anaemia or in cases of concomitant drug intake, a longer treatment may be necessary in order to prevent occurrence of haematological disorders.

Method of administration A graduated oral syringe and a Press-In Bottle Adapter (PIBA) are provided with the product. 1. Open the bottle and at first use insert the Press-In Bottle Adapter (PIBA). 2. Insert the syringe into the PIBA and draw out the required volume from the inverted bottle.

3. Remove the filled syringe from the bottle in the upright position 4. Discharge the syringe contents into the mouth. Repeat steps 2 to 4 as needed to achieve the required dose. 5. Rinse the syringe and replace the cap on the bottle (PIBA remains in place).

Gastrointestinal disorders:

Loss of appetite, nausea, abdominal distension and flatulence.

Rare (≥ 1/10,000 to <1/1,000) Immune system disorders:

Allergic reactions such as erythema, rash, itching, urticaria, difficulty in breathing and anaphylactic reactions (including shock) 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. uk/yellowcard

If folic acid is used indiscriminately, there is a danger that patients with pernicious anaemia and other B12 deficiency states, despite a haematological remission, may develop irreparable neurological lesions. Therefore a full clinical diagnosis should be made before initiating treatment.

Folic acid is removed by haemodialysis. The therapeutic effect should be monitored by laboratory analysis and the diagnosis should be reassessed (specialist workup) in case the expected response fails to appear. Serum Potassium levels and iron/ferritin status should be controlled.

Cobalamin status needs to be established in all megaloblastic states (not only in pregnancy). Excipient warnings Folic acid Colonis 1 mg/ml oral solution contains sodium methyl parahydroxybenzoate (E219) and sodium • Sodium methyl parahydroxybenzoate (E219) may cause allergic reactions (possibly delayed).

• This medicine contains less than 1 mmol sodium (23 mg) per 1 ml that is to say essentially ‘sodium-free’.

Known hypersensitivity to folic acid. Known hypersensitivity to hydroxybenzoate esters. Folic acid should not be given alone in the treatment of Addisonian pernicious anaemia and other vitamin B12 deficiency states because it may precipitate the onset of subacute combined degeneration of the spinal cord.

In elderly people, a cobalamin absorption test should be done before long-term folate therapy. Folic acid given to patients for 3 months or longer has precipitated cobalamin neuropathy. No harm results from short courses of folic acid.

Folic acid should not be used in folate-dependent tumours or malignant disease unless megaloblastic anaemia owing to folate deficiency is an important complication.