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Sodium Cromoglicate Abbreviated Prescribing Information

Abbreviated Prescribing Information: Sodium cromoglicate 100 mg/5ml oral solution Consult Summary of Product Characteristics before prescribing. Presentation: Clear colourless solution. Free from any visible particles, containing 100mg sodium cromoglicate in each 5ml ampoule. Therapeutic Indications: Prophylactic treatment of allergic symptoms caused by components of the feed, if these components cannot be avoided. Posology and Method of Administration: For oral use. Take 15 minutes before the meal. 3 times before the meal and 1 time before bedtime in case of 4x daily dose. Adults: Drink the content of 2 ampoules of 5ml (4 x day). Paediatric population: Drink the content of an ampoule of 5ml (4 x day). There is insufficient data to assess potential harmfulness in children below 2 years of age. If an unsatisfactory result is achieved within 2-3 weeks, the dosage may be increased up to a maximum of 40 mg/kg/day. Try to decrease the dosage, if a satisfactory result has been achieved. If feed allergy already occurs in the mouth, rinse the mouth with the oral solution prior to swallowing. Contra-indications: Hypersensitivity to the active substance. Excipient warnings: None. Drug interactions: No interaction studies have been performed. Special Warnings and Precautions for use: Do not use in patients with a medical history of anaphylactic shock or other life-threatening reactions to food. Fertility, Pregnancy and Lactation: There are no or limited amount of data from the use in pregnant women. Not recommended during first trimester of pregnancy and in women of childbearing potential not using contraception. No effects on the breastfed newborn/infant are anticipated and therefore can be used during breast-feeding. There are no data indicating a harmful effect on fertility. Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machines have been performed. An effect is unlikely. Undesirable Effects: Rarely: Nausea, vomit, diarrhoea, stomach complaints, skin rash, joint pain. Very rarely: Hypersensitivity reactions. Overdose: No cases of overdose have been reported. Shelf Life and storage: 3 year, does not require any special storage conditions. Legal Category: POM. Pack Size and NHS Price: 5ml ampoule of LDPE Blow fill seal container with twist off cap. 96 ampoules – £121.86 Marketing Authorisation Number: PL 25298/0146. Marketing Authorisation Holder: Brown & Burk UK Ltd, 5, Marryat Close, Hounslow West, Middlesex, TW4 5DQ, United Kingdom Date of Preparation: May 2021

Adverse Drug Events

Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400