Clarinase

Clarinase Adverse Reactions

loratadine + pseudoephedrine

Manufacturer:

Bayer

Distributor:

Zuellig
/
Four Star
Full Prescribing Info
Adverse Reactions
Repetab: Tabulated list of adverse reactions: The following adverse reactions reported during clinical trials in excess of placebo for 5 mg/120 mg prolonged-release tablets are listed in the following table by System Organ Class. Frequencies are defined as very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1000, < 1/100); rare (> 1/10,000, < 1/1000); very rare (< 1/10,000); and not known (cannot be estimated from the available data). (See Table 1.)

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Other adverse reactions reported during the post-marketing period are listed in the following table. (See Table 2.)

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Other adverse reactions that were only reported for loratadine in clinical trials and during the post-marketing period include increased appetite, rash and gastritis.
From post-marketing experience, isolated cases of acute generalized exanthematous pustulosis (AGEP), a form of severe skin reaction, have been reported with pseudoephedrine-containing products.
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.
ER tab: Tabulated list of adverse reactions: The following adverse reactions reported during clinical trials in excess of placebo for 10 mg/240 mg extended-release tablets are listed in the following table by System Organ Class. Frequencies are defined as very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1000, < 1/100); rare (> 1/10,000, < 1/1000); very rare (< 1/10,000); and not known (cannot be estimated from the available data). (See Table 3.)

Click on icon to see table/diagram/image

Other adverse reactions reported during the post-marketing period are listed in the following table. (See Table 4.)

Click on icon to see table/diagram/image

Other adverse reactions that were only reported for loratadine in clinical trials and during the post-marketing period include increased appetite, rash and gastritis.
From post-marketing experience, isolated cases of acute generalized exanthematous pustulosis (AGEP), a form of severe skin reaction, have been reported with pseudoephedrine-containing products.
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.
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