BENADRYL ALLERGY RELIEF PLUS DECONGESTANT

Posology Adults and children 12 years and over:

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

Children under 12 years:

This product is not currently recommended for use in children under 12 years of age.

Elderly:

This product is not currently recommended for use in the elderly.

Hepatic dysfunction:

Caution should be exercised when administering Benadryl Allergy Relief Plus Decongestant Capsules to patients with severe hepatic impairment.

Renal dysfunction:

Caution should be exercised when administering Benadryl Allergy Relief Plus Decongestant Capsules to patients with moderate renal impairment. Method of administration For oral use.

Placebo-controlled studies with sufficient adverse event data were not available for the combination of acrivastine and pseudoephedrine. No adverse drug reactions have been identified during post-marketing experience with the combination product acrivastine/pseudoephedrine.

Adverse drug reactions identified during clinical trials and post-marketing experience with acrivastine or pseudoephedrine as single ingredient products are listed below by System Organ Class (SOC).

The frequencies are defined in accordance with current guidance, as:

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 are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’.

4) Psychomotor hyperactivity* Tremor* Eye Disorders Not known Ischaemic optic neuropathy Cardiac Disorders Not Known Dysrhythmias* Myocardial infarction/myocardial ischaemia* Palpitations#* Tachycardia* Vascular Disorders Not known Hypertension* Common Dry mouth* Nausea* Gastrointestinal Disorders Not Known Not Known Ischaemic colitis* Vomiting* Skin and Subcutaneous Tissue Disorders Not Known Angioedema* Pruritus* Rash#* Severe skin reactions, including acute generalised exanthematous pustulosis (AGEP)* Renal and Urinary Disorders Not Known Dysuria* Urinary retention in men* in whom prostatic enlargement could have been an important predisposing factor # Associated with Acrivastine * Associated with Pseudoephedrine 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.

It is usual to advise patients not to undertake tasks requiring mental alertness whilst under the influence of alcohol or other CNS depressants including sedatives and tranquilizers. Concomitant administration of this product may, in some individuals, produce additional impairment.

Although pseudoephedrine has virtually no pressor effects in patients with normal blood pressure, this product should be used with caution in patients taking antihypertensive agents, tricyclic antidepressants or other sympathomimetic agents such as decongestants, appetite suppressants or amphetamine-like psychostimulants.

The effects of a single dose on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment. Patients with difficulty in urination and/or enlargement of the prostate, or patients with thyroid disease who are receiving thyroid hormones, decreased kidney function should not take pseudoephedrine unless directed by a physician.

Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment, or occlusive vascular disease. 8). If any of the following occur, this product should be stopped: • Hallucinations • Restlessness • Sleep disturbances Severe Skin reactions: Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine- containing products.

This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities.

Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of this medicine should be discontinued, and appropriate measures taken if needed.

1. 5) - Concomitant use of other sympathomimetic decongestants. - Diabetes mellitus - Phaeochromocytoma - Closed angle glaucoma - Hyperthyroidism - Severe acute or chronic kidney disease/renal failure The concomitant use of a pseudoephedrine-containing product and monoamine oxidase inhibitors may cause a rise in blood pressure and/or hypertensive crisis.

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