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Rosemont Pharmaceuticals Limited

Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE

Telephone: +44 (0)113 244 1400
Fax: +44 (0)113 246 0738
WWW: http://www.rosemontpharma.com
Customer Care direct line: +44 (0)800 919 312

Out of Hours Telephone: +44 (0)7836 557 879
Out of Hours contact: pharmacovigilance@rosemontpharma.com

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Summary of Product Characteristics last updated on the eMC: 08/05/2008

SPC	Folicare 0.4mg/5ml Oral Solution

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
Administrative Data
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Folicare 0.4mg/5ml Oral Solution

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Folic Acid Ph. Eur 0.4mg/5ml

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3. PHARMACEUTICAL FORM

Oral Solution

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

To prevent first occurrence of neural tube defects.

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4.2 Posology and method of administration

For oral administration only

0.4mg daily prior to conception and until the twelfth week of pregnancy.

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4.3 Contraindications

Known hypersensitivity to Folic Acid or any of the excipients

Known hypersensitivity to hydroxybenzoate esters

Patients with folate dependent tumours.

Patients with malignant disease, unless megaloblastic anaemia due to folic acid deficiency

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4.4 Special warnings and precautions for use

Folic acid should not be used in monotherapy in patients with pernicious anaemia and other B₁₂ deficiency states as this may lead to sub-acute combined degeneration of the spinal cord

Excipients in the formulation

Methyl and propyl hydroxybenzoates are contained in this product which may cause allergic reactions (possibly delayed).

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4.5 Interaction with other medicinal products and other forms of interaction

Folic Acid has been observed to reduce plasma levels of anticonvulsants, particularly phenytoin and primidone and therefore patients should be carefully monitored by the physician and the anticonvulsant drug dose adjusted as necessary.

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4.6 Pregnancy and lactation

The product is indicated for use during pregnancy. Folic Acid is excreted in breast milk.

Folic Acid administered during early pregnancy has been shown to be beneficial in man.

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4.7 Effects on ability to drive and use machines

There are no known effects of this preparation on the ability to drive or use machines.

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4.8 Undesirable effects

Allergic reactions to Folic Acid have been reported. Mild gastro-intestinal upsets are rare but may occur. Morning sickness may occur in pregnancy but may be unrelated to the effects of Folic Acid.

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4.9 Overdose

No cases have been reported; but even extremely high doses are unlikely to cause harm to the recipient.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

After conversion into co-enzyme, Folic Acid is concerned in single carbon unit transfers in the synthesis of purines, pyrimidines and methionine.

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5.2 Pharmacokinetic properties

It is known that about 70 - 80% of a 2mg oral dose of Folic Acid is absorbed. Larger doses are probably equally well absorbed.

It is distributed into plasma and extra-cellular fluid. In plasma, folate is bound weakly to albumin.

About 70% of small doses (about 1mg) is retained, the rest is excreted in the urine. With a 5mg dose urinary excretion will be complete in about 5 hours.

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5.3 Preclinical safety data

Toxicity has been observed in rats given huge doses of folate but this is not found in man at the doses recommended.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Disodium Edetate, Methyl Hydroxybenzoate (E218), Ethyl Hydroxybenzoate (E214), Propyl Hydroxybenzoate (E216), Glycerol (E422), Mannitol (E421), Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate anhydrous (E339), Strawberry Flavour (containing propylene glycol E1520) and Purified Water

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6.2 Incompatibilities

None stated

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6.3 Shelf life

24 months - unopened

1 month - opened

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6.4 Special precautions for storage

Store below 25°C. Protect from light.

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6.5 Nature and contents of container

Amber (type III) glass bottles with capacities of 100ml, 150ml or 200ml

Closures are	a) Aluminium, EPE wadded, roll-on pilfer proof
	b) HDPE, child resistant EPE wadded, tamper evident
	c) HDPE, EPE wadded, tamper evident