SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Histergan Syrup Paxidorm Syrup Boots Sleepeaze Syrup Dreemon Syrup

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Diphenhydramine Hydrochloride BP 10mg/5ml

3.    PHARMACEUTICAL FORM

Oral Syrup

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

When sold under the Histergan brand:

Treatment of allergic conditions e.g. hay fever, vasomotor rhinitis, stings, urticaria, angioneurotic oedema, drug sensitivity, contact dermatitis and photosensitivity.

When sold under Paxidorm, Boots Sleepeaze and Dreemon brands:

As a short term mild hypnotic.

4.2. Posology and method of administration

1) Treatment of allergic conditions when branded as Histergan

Adults and Children over 12 years: Two 5ml spoonfuls 3 or 4 times per day. Children up to 1 year: Half a 5ml spoonful three times per day.

Children 1 to 5 years: Half to One 5ml spoonful three times per day. Children 6 to 12 years: One 5ml spoonful three times per day.

Elderly: As for adults.

2) As a short term hypnotic, when branded as Paxidorm, Boots Sleepeaze and Dreemon

Adults: 10 to 25ml at bedtime, or after retiring when sleep is not readily achieved.

Children: Not recommended for children under the age of 16.

Elderly: As for adults.

4.3. Contra-indications

Known sensitivity to any of the ingredients and/or porphyria.

4.4. Special warnings and precautions for use

Avoid concurrent taking of alcohol.

Use with caution in prostatic hypertrophy, epilepsy, urinary retention, glaucoma and hepatic disease and CNS depression or hypotension in the elderly.

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

Diphenhydramine may potentiate hypnotics and anxiolytics. Diphenhydramine and beta-histamine are antagonistic.

4.6. Pregnancy and lactation

Safety in pregnancy and lactation has not been demonstrated.

4.7. Effects on ability to drive and use machines

May cause drowsiness. If affected do not drive or operate machinery.

4.8. Undesirable effects

Dryness of mouth, dizziness, nausea, difficulty in micturation, hypotension, rashes, headache, gastrointestinal disturbances, photosensitivity, blurred vision, palpitations, arrhythmias, psychomotor impairment, depression, confusion, sleep disturbances, tremor, convulsions, sweating, myalgia, paraesthesia, blood disorders, liver dysfunction and hair loss, extrapyramidal effects, and hypersensitivity and allergic reactions (including bronchospasm, angioedema and anaphylaxis), and rarely thrombocytopenia.

4.9. Overdose

Symptoms: Dizziness, hypotension, inco-ordination, nausea, diarrhoea, vomiting, dryness of mouth, difficulty in micturation and convulsions. CNS stimulation (Paradoxical) and hyperpyrexia in children.

Treatment: Gastric lavage in the conscious patient (emetics should not be given) and intensive symptomatic supportive therapy where necessary. External cooling and I.V. fluids may be required in children. Anticonvulsive therapy may be necessary.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Diphenhydramine has anti-histaminic, anti-cholinergic (anti-spasmodic), antitussive and sedative activity.

5.2. Pharmacokinetic properties

Diphenhydramine is a histamine H₁ receptor antagonist.

Peak plasma concentration is in about 2 hours after ingestion.

The main site of metabolism is the liver.

The first hepatic pass will remove about 50% of an oral dose before reaching the general circulation.

5.3. Preclinical safety data

Not applicable.

6.1 List of excipients

Sucrose, Sodium Saccharin, Glycerin, Nipasept, Butyl Hydroxybenzoate, Propylene Glycol, Essence Concentrate CA, Caramel E150, Deionized Water.

6.2.    Incompatibilities

Incompatible with barbiturates and iodo compounds in solution.

6.3.    Shelf life

36 months.

6.4.    Special precautions for storage

Store between 4°C and 25°C.

6.5.    Nature and contents of container

Amber glass bottles of 150ml and 100ml, white caps.

6.6.    Instructions for use/handling

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Norma Chemicals Ltd.

51-53 Stert Street Abingdon

Oxfordshire OX14 3JF

8.    MARKETING AUTHORISATION NUMBER

PL 00386/5001R

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

21 September 1989 / 14 June 1995

10 DATE OF REVISION OF THE TEXT

20/04/2009