ACRIVASTINE

Posology Adults and children 12 years – 65 years:

One 8 mg capsule, as necessary up to three times a day.

Use in the Elderly (over 65):

As yet, no specific studies have been carried out in the elderly. Until further information is available, Acrivastine should not be given to elderly patients. Paediatric population The safety and efficacy of Acrivastine in children under 12 years of age has not yet been established.

Renal dysfunction This product is contraindicated in patients with severe renal impairment. Method of Administration For oral use.

The safety of acrivastine is based on available data from 10 placebo-controlled clinical trials with a total population of 373 treated subjects, where adverse events reported by ≥1% were assessed. Additionally, adverse drug reactions (ADRs) identified during post-marketing experience are included.

The frequencies are provided according to the following convention:

Very common ≥1/10, Common ≥1/100 and < 1/10, Uncommon ≥1/1,000 and <1/100, Rare ≥1/10,000 and <1/1,000, Very rare <1/10,000, Not known (cannot be estimated from the available data). ADRs identified are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available or 2) when incidence is unavailable, frequency category is listed as Not known.

Adverse Drug Reactions Identified During Post-Marketing Experience with Acrivastine Frequency Category Estimated from Clinical Trials or Epidemiology Studies SOC Frequency category Adverse Event Preferred term Immune System Disorders Not known Hypersensitivity (including Dyspnoea and face swelling) Nervous system disorders Very common Somnolence Common Dizziness Gastrointestinal Disorders Common Dry Mouth Skin and Subcutaneous Tissue Disorders Not Known Rash 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Concomitant administration of acrivastine with CNS depressants, including alcohol, sedatives, and tranquilizers, may produce additional impairment in mental alertness in some individuals. Patients with renal impairment should consult with a physician before use.

8). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. Renal excretion is the principal route of elimination of acrivastine. Until specific studies have been carried out acrivastine should not be given to patients with significant renal impairment.