SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Calcium Folinate 15mg Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 19.1mg of calcium folinate (as pentahydrate) equivalent to 15mg calcium folinate

For excipients, see 6.1

3    PHARMACEUTICAL FORM

Tablet.

A standard convex tablet, almost white to cream with slight speckling

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

To diminish the toxicity and counteract the action of folic acid antagonists such as methotrexate in cytotoxic therapy. Known as leucovorin rescue.

Amelioration of the blood picture in some megaloblastic anaemias due to folate deficiency.

4.2    Posology and method of administration

For oral administration Calcium Folinate Rescue :

Adults and Children :

In general up to 120mg in divided doses over 12 - 24 hours by intramuscular injection, bolus intravenous injection, or intravenous infusion in 0.9% w/v sodium chloride solution followed by 12 - 15mg intramuscularly or 15mg orally, every six hours for the next 48 hours.

Calcium Folinate should not be given simultaneously with methotrexate as it may reduce or suppress its anti-neoplastic activity. It is recommended that administration should commence within the first 24 hours following methotrexate.

In overdose situations or when the half-life of methotrexate is increased (e.g. renal function impairment or pleural or peritoneal effusions) it is important that Calcium Folinate be given until the blood concentration of methotrexate declines to non-toxic concentrations. In these cases, doses of Calcium Folinate equal to or greater than those of methotrexate should be given.

Foliate deficiency :

Adults: 15mg (one tablet) per day Children up to 12 years: 0.25mg/kg/day

4.3    Contraindications

Known hypersensitivity to the preparation

4.4    Special warnings and precautions for use

High dose methotrexate therapy together with leucovorin rescue should only be carried out under the direction of physicians experienced in antitumour chemotherapy.

Calcium Folinate should not be used in the treatment of pernicious anaemia or megaloblastic anaemias due to the lack of where vitamin B_i2 is deficient.

Lactose

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

4.5    Interaction with other medicinal products and other forms of interaction

Potential interactions between folinic acid and antiepileptics may occur; the plasma concentrations of phenobarbital, phenytoin and primidone may possibly be reduced, increasing the frequency of seizures in susceptible patients.

4.6    Pregnancy and lactation

Caution should be exercised in pregnancy and lactation

4.7    Effects on ability to drive and    use machines

None known

4.8    Undesirable effects

Adverse reactions to calcium folinate are rare, but following intravenous or intramuscular administration, occasional pyrexial reactions have been reported.

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 special instructions

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

ATC Code: V03A F03 Detoxifying agents for antineoplastic treatment Calcium Folinate is used in conjunction with methotrexate to reduce the toxicity of the methotrexate, it is also administered in megaloblastic anaemia.

5.2    Pharmacokinetic properties

Calcium Folinate is readily soluble, folinic acid is absorbed by the proximal portion of the small intestine. It is rapidly distributed in tissues.

5.3    Preclinical safety data

Preclinical information has not been included because the safety profile of calcium folinate has been established after many years of clinical use. Please refer to section 4.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Lactose monohydrate Maize starch

Pregelatinised maize starch Magnesium stearate (E572)

6.2    Incompatibilities

Not applicable

6.3    Shelf life

36 months

6.4    Special precautions for storage

Do not store above 25°C Store in original container

6.5    Nature and contents of container

Aluminium blister strips in packs of 10 tablets.

6.6    Special precautions for disposal

Not applicable

MARKETING AUTHORISATION HOLDER

TEVA UK Limited,

Brampton Road, Hampden Park Eastbourne, East Sussex, BN22 9AG

8    MARKETING AUTHORISATION NUMBER

PL 00289/0468

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

18/05/1998 / 04/06/2004

10    DATE OF REVISION OF THE TEXT

03/03/2016