NALCROM Capsule Ref.[7204] Active ingredients: Cromoglicic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Contraindications

Nalcrom is contraindicated in patients with a known hypersensitivity to sodium cromoglicate or to any of the excipients.

Special warnings and precautions for use

None stated.

Interaction with other medicinal products and other forms of interaction

None known.

Pregnancy and lactation

As with all medication caution should be exercised especially during the first trimester of pregnancy. Cumulative experience with sodium cromoglicate suggests that it has no adverse effects on foetal development. It should only be used in pregnancy where there is a clear need.

It is not known whether sodium cromoglicate is excreted in the breast milk but on the basis of its physico-chemical properties this is considered unlikely. There is no information to suggest that the use of sodium cromoglicate has any undesirable effects on the baby.

Effects on ability to drive and use machines

None known.

Undesirable effects

Nausea, skin rashes and joint pains have been reported in a few cases.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Incompatibilities

None stated.

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