Spasmomen | Adverse Reactions

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Adverse Reactions

Tabulated list of adverse reactions collected during clinical trials: The frequency of adverse reactions occurring in patients treated with otilonium bromide is classified as follows: Common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000). (See table.)

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During post-marketing surveillance, cases of skin hypersensitivity, including urticaria and angioedema, have been reported. Because these reactions are reported from a population of undefined size, their frequency cannot be defined based on the available data, therefore it is not known.
Reporting suspected adverse drug reactions: Reporting suspected adverse drug 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 according to the guidelines issued by the local health authority.

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Spasmomen Adverse Reactions

otilonium bromide

Manufacturer:

A. Menarini

Distributor:

Zuellig

Agencia Lei Va Hong

Marketer:

A. Menarini