4.1. Therapeutic indications

Benadryl Allergy Relief is indicated for the symptomatic relief of allergic rhinitis, including hay fever. Benadryl Allergy Relief is also indicated for chronic idiopathic urticaria.

4.2. Posology and method of administration

Posology

Adults and children 12 years – 65 years:

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

Elderly

As yet, no specific studies have been carried out in the elderly. Until further information is available, Benadryl Allergy Relief should not be given to elderly patients.

Paediatric population

The safety and efficacy of Benadryl Allergy Relief 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.

4.3. Contraindications

Hypersensitivity to acrivastine, triprolidine or to any of the excipients listed in section 6.1. Renal excretion is the principal route of elimination of acrivastine. Until specific studies have been carried out Benadryl Allergy Relief should not be given to patients with severe renal impairment.

4.4. Special warnings and precautions for use

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.

This product may cause drowsiness (see section 4.8).

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

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.

4.5. Interaction with other medicinal products and other forms of interaction

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

There are no data to demonstrate an interaction between acrivastine and ketoconazole, erythromycin or grapefruit juice. However, due to known interactions between these compounds and other non-sedating antihistamines, caution is advised.

4.6. Fertility, pregnancy and lactation

Acrivastine should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs any possible risk to the developing foetus or nursing infant.

Fertility

Systemic administration of acrivastine in animal reproductive studies did not produce embryotoxic or teratogenic effects and did not impair fertility.

Pregnancy

There are no adequate and well-controlled studies in pregnant women.

Lactation

There is no information on the levels of acrivastine which may appear in human breast milk after administration of Benadryl Allergy Relief.

4.7. Effects on ability to drive and use machines

Acrivastine may cause dizziness and somnolence. As there is individual variation in response to all medication, it is sensible to caution all patients about engaging in activities requiring mental alertness, such as driving a car or operating machinery, until patients are familiar with their own response to the drug.

4.8. Undesirable effects

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 Drug Reaction (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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Symptoms

Drowsiness, restlessness, hyperactivity and tachycardia have been reported in overdose.

When the recommended therapeutic dose has been exceeded, acrivastine has been found to impair the ability to drive. This effect is related to the amount of acrivastine taken beyond the recommended maximum daily dosage.

Management

Appropriate supportive therapy, including activated charcoal should be initiated if indicated.