NALCROM Capsule (2015)
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Περιεχόμενα
Name of the medicinal product
Nalcrom 100mg Capsules.
Qualitative and quantitative composition
The active component per capsule is: Sodium Cromoglicate 100.0mg. For a full list of excipients, see section 6.1.
Pharmaceutical form
Capsule. Hard gelatin capsule with a clear cap and body, marked SODIUM CROMOGLICATE 100 mg in black and containing a white powder.
Therapeutic indications
Nalcrom is indicated for food allergy (where adequate investigations have been performed to determine sensitivity to one or more ingested allergens) in conjunction with restriction of main causative allergens. ...
Posology and method of administration
Nalcrom must be administered orally. Adults (including the elderly) Initial dose: 2 capsules four times daily before meals. Children (2-14 years) Initial dose: 1 capsule four times daily before meals. ...
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. ...
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. ...
Overdose
As Nalcrom is only absorbed to a minimum extent, no action other than medical supervision should be necessary.
Pharmacodynamic properties
Pharmacotherapeutic group: Antiallergic agents, excluding corticosteroids ATC Code: A07EB01 Sodium cromoglicate inhibits the release from mast cells of mediators of the allergic reaction. In gastrointestinal ...
Pharmacokinetic properties
Not applicable.
Preclinical safety data
Animal studies have shown that sodium cromoglicate has a very low order of local or systemic toxicity.
List of excipients
Purified water No 2 hard gelatin capsules Black ink containing: Water Ethyl alcohol Iso-propyl alcohol Propylene alcohol N-butyl alcohol Shellac Ammonium hydroxide Potassium hydroxide Iron oxide black ...
Incompatibilities
None stated.
Shelf life
36 months.
Special precautions for storage
Store below 25°C. Store in a dry place. Keep the bottle tightly closed in order to protect from moisture.
Nature and contents of container
An aluminium can with aluminium screw cap containing 100 capsules or an HDPE bottle with screw cap containing 100 capsules.
Special precautions for disposal and other handling
Instructions for use are supplied with each pack.
Marketing authorization holder
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
Marketing authorization number(s)
PL 04425/0370
Date of first authorization / renewal of the authorization
1<sup>st</sup> May 2005
Date of revision of the text
8 October 2015
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