Benadryl Allergy Relief

1. Name Of The Medicinal Product

Benadryl Allergy Relief

2. Qualitative And Quantitative Composition

Benadryl Allergy Relief contains 8 mg Acrivastine per capsule.

3. Pharmaceutical Form

Capsules

4. Clinical Particulars

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

Adults and children 12 years – 65 years:

Oral. 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, Benadryl Allergy Relief should not be given to elderly patients.

4.3 Contraindications

Benadryl Allergy Relief is contraindicated in individuals with known hypersensitivity to acrivastine or triprolidine. 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 significant renal impairment.

4.4 Special Warnings And Precautions For Use

The following statements will appear on the pack:

Do not store above 30°C. Store in the original package. Keep out of the reach and sight of children.

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 Pregnancy And Lactation

No information is available on the effects of administration of Benadryl Allergy Relief during human pregnancy or lactation. Acrivastine, like most medicines, 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/nursing infant.

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

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

Most patients do not experience drowsiness with Benadryl Allergy Relief. Nevertheless, as there is individual variation in response to all medication, it is sensible to caution all patients about engaging 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

Reports of drowsiness directly attributable to Benadryl Allergy Relief are extremely rare. Indeed for the great majority of patients, treatment with Benadryl Allergy Relief is not associated with clinically significant anticholinergic or sedative side effects.

4.9 Overdose

There is no experience of overdosage with Benadryl Allergy Relief. Appropriate supportive therapy, including gastric lavage should be initiated if indicated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Acrivastine provides symptomatic relief in conditions believed to depend wholly or partly upon the triggered release of histamine.

It is a potent competitive histamine H₁ antagonist which lacks significant anti-cholinergic effects, and has a low potential to penetrate the central nervous system.

After oral administration of a single dose of 8 mg acrivastine to adults, the onset of actions, as determined by the ability to antagonise histamine induced weals and flares in the skin, is 15 minutes. Peak effects occur at 2 hours, and although activity declines slowly thereafter, significant inhibition of histamine induced weals and flares still occur 8 hours after dose.

In patients, relief from the symptoms of allergic rhinitis is apparent within 1 hour after the systemic administration of the drug.

5.2 Pharmacokinetic Properties

Acrivastine is well absorbed from the gut. In healthy adult volunteers, the peak plasma concentration (Cmax) is approximately 150 NG/ML, occurring at about 1.5 hours (Tmax) after the administration of 8 mg acrivastine. The plasma half-life is approximately 1.5 hours. In multiple dose studies over 6 days, no accumulation of acrivastine was observed. Renal excretion is the principal route of elimination of acrivastine.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose

Sodium starch glycollate

Magnesium stearate

The capsule shell contains the following constituents:

Gelatin

Purified water

Titanium dioxide

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 30°C. Store in the original package.

6.5 Nature And Contents Of Container

PVC/aluminium foil blister packs – 9 12, 21 capsules.

6.6 Special Precautions For Disposal And Other Handling

None applicable.

Administrative Data

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0128

9. Date Of First Authorisation/Renewal Of The Authorisation

8^th March 2005

10. Date Of Revision Of The Text

14 March 2008