Boots Sleepeaze

Sleep Aid Tablets

Sleepeaze 25mg Tablets

Asda Sleep Aid Tablets

Numark Night Time Sleep Aid 25mg Tablets

Superdrug Sleep Aid 25mg Tablets

Morrisons Sleep Aid 25mg Tablets

Sainsbury's Sleep Aid 25mg Tablets

Vantage Sleep Aid 25mg Tablets

Diphenhydramine Hydrochloride BP 25mg.

Tablets for oral administration.

A symptomatic aid to the relief of temporary sleep disturbance.

Adults(including the elderly) and children over 16 years of age:

Two tablets (50 mg) twenty minutes before going to bed.

Children under 16 years of age:

Not recommended for use.

Contra-indicated in patients who are hypersensitive to diphenhydramine or to any ingredients of the tablets, and in those with the following conditions: asthma, narrow angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction or bladder neck obstruction and porphyria.

Caution is required if administered to patients with hepatic disease.

Caution should be exercised in patients with glaucoma and urinary retention.

Should be used with caution in patients with myasthenia gravis or seizure disorders, bronchitis or chronic obstructive pulmonary disease (COPD).

Tolerance may develop with continuous use.

Side effects are more likely to occur in the elderly.

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

Diphenhydramine may exacerbate tinnitus in existing tinnitus sufferers.

Diphenhydramine has a major influence on the ability to drive and use machines. It is a hypnotic and will produce drowsiness or sedation soon after the dose has been taken.

Diphenhydramine may also cause dizziness, blurred vision, cognitive and psychomotor impairment. These can seriously affect the patient's ability to drive and use machines. If affected do not drive or operate machinery.

The patient should be warned not to drive or operate machinery within 8 hours of ingestion.

Specific estimation of the frequency of adverse events for OTC products is inherently difficult (particularly numerator data). Adverse reactions which have been observed in clinical trials and which are considered to be common (occurring in> 1/100 to < 1/10) or very common (occurring in> 1/10) are listed below by MedDRA System Organ Class. The frequency of other adverse reactions identified during post-marketing use is unknown, but these reactions are likely to be uncommon (occurring in> 1/1,000 to <1/100) or rare (occurring in < 1/1,000).

General disorders and administration site conditions:

Common: fatigue

Immune system disorders:

Unknown: Hypersensitivity reactions including rash, urticaria, dyspnoea and angioedema

Psychiatric disorders*:

Unknown: confusion, paradoxical excitation (e.g. increased energy, restlessness, nervousness)

* The elderly are more prone to confusion and paradoxical excitation.

Nervous system disorders:

Common: sedation, drowsiness, disturbance in attention, unsteadiness, dizziness,

Unknown: convulsions, headache, paraesthesia, dyskinesias

Eye disorders:

Unknown: blurred vision

Ear and labyrinth disorders:

Unknown: tinnitus

Cardiac disorders:

Unknown: tachycardia, palpitations

Respiratory, thoracic and mediastinal disorders:

Unknown: thickening of bronchial secretions

Gastrointestinal disorders:

Common: dry mouth

Unknown: gastrointestinal disturbance including nausea, vomiting

Musculoskeletal and connective tissue disorders:

Unknown: muscle twitching

Renal and urinary disorders:

Unknown: urinary difficulty, urinary retention

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.

Overdose is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include mydriasis, fever, flushing, agitation, tremor, dystonic reactions, hallucinations and ECG changes. Large overdose may cause rhabdomyolysis, convulsions, delirium, toxic psychosis, arrhythmias, coma and cardiovascular collapse.

Treatment should be supportive and directed towards specific symptoms. Convulsions and marked CNS stimulation should be treated with parenteral diazepam.

Diphenhydramine hydrochloride has anti-histaminic (H₁- receptor), anti-emetic, anti-vertigo and sedative and hypnotic properties.

Anti-histamine action occurs by blocking the spasmogenic and congestive effects of histamine by competing with histamine for H₁ receptor sites on effector cells, preventing but not reversing responses mediated by histamine alone.

Anti-emetic action is by inhibition in medullary chemoreceptor trigger zone.

Anti-vertigo action is by central antimuscarinic effect on the vestibular apparatus and the integrative vomiting centre and medullary chemoreceptor trigger zone of the mid brain.

The exact mechanism for CNS depressant action is not known, but it is thought to cause indirect reduction of stimuli to the brain stem reticular formation.

Following oral administration, the drug is well absorbed from gastro-intestinal tract. It is highly bound to plasma proteins and is metabolised by the liver. Onset of action is 20 minutes and duration of effect being 4-6 hours. It is eliminated by the kidneys slowly, mainly as inactive as metabolites.

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain

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

Lactose BP

Maize starch BP

Magnesium stearate BP

Not applicable.

3 years in tablet containers.

3 years in blister packs.

Blister packaging - Do not store above 25°C. Store in the original package. Keep container in outer carton.

Tablet containers - Do not store above 25°C. Store in original container. Keep the container tightly closed.

Polypropylene containers with polyethylene child resistant closures, containing 20 tablets.

Blister strips comprised of 20µ m aluminium foil 250µ m/PVC enclosed in a carton containing 6, 8, 10, 12, 16, or 20 tablets.

Aluminium /PVC/PVDC blister strips enclosed in a cardboard outer containing 6, 8, 10, 12, 16, or 20 tablets.

Not applicable.

Galpharm Healthcare Limited

Wrafton,

Braunton,

Devon,

EX33 2DL,

United Kingdom.

PL 16028/0014

23^rd September 1997

05^th )