Boots Sleepeaze 50mg Tablets

1. Name Of The Medicinal Product

Extra Strength Sleep Aid

Maximum Strength Nightcalm

Sleepeaze 50mg Tablets

Unichem Sleep Aid 50mg Tablets

Lloyds Pharmacy Extra Strength Sleep Aid Tablets

Co-op Sleep Aid 50mg Tablets

Numark Night Time Sleep Aid 50mg Tablets

Vantage Sleep Aid 50mg Tablets

Tesco Extra Strength Sleep Aid 50mg Tablets

Superdrug One-A-Night Sleep Aid 50mg Tablets

Galpharm One a Night Nightcalm 50mg Tablets

2. Qualitative And Quantitative Composition

Diphenhydramine Hydrochloride BP 50 mg.

3. Pharmaceutical Form

Tablets for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

A symptomatic aid to the relief of temporary sleep disturbance.

4.2 Posology And Method Of Administration

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

One tablet twenty minutes before going to bed.

Children under 16 years of age:

Not recommended for use.

4.3 Contraindications

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.

4.4 Special Warnings And Precautions For Use

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. Tolerance may develop with continuous use.

Side effects are more likely to occur in the elderly.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Diphenhydramine has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquillizers and tricyclic antidepressants) resulting in increased antimuscarinic and sedative effects. Monoamine oxidase (MAO) inhibitors prolong and intensify the anticholinergic effects of Diphenhydramine.

Diphenhydramine should not be used in patients receiving one of these drugs unless directed by a doctor.

4.6 Pregnancy And Lactation

Risk benefit must be considered before administration in pregnancy. Diphenhydramine crosses the placental barrier and has been reported to cause jaundice and extrapyramidal symptoms in infants whose mothers received the drug during pregnancy. Drug therapy, therefore, should be discontinued one to two weeks prior to delivery to avoid these effects in the neonate.

If administered during breast feeding there is an increased risk of adverse effects of antihistamine, such as unusual excitation or irritability in infants.

4.7 Effects On Ability To Drive And Use Machines

This product is a hypnotic and will produce drowsiness or sedation soon after the dose has been taken. This will affect the ability to drive and use machines; the patient should be warned not to drive or operate machinery within 8 hours of ingestion.

4.8 Undesirable Effects

Side effects that have occurred with diphenhydramine include blurred vision, dizziness, drowsiness and grogginess. These effects are mild and wear off about 8 hours after taking the medication. Dryness of mouth, nausea and nervousness have also been reported with diphenhydramine. The antihistamines have been reported rarely to cause thrombocytopenia.

Other side effects reported include headache, psychomotor impairment, antimuscarinic effects, gastrointestinal disturbances, hypotension, palpitations, arrhythmias, hypersensitivity reactions (including bronchospasm, angioedema and anaphylaxis), rashes, photosensitivity reactions, extrapyramidal effects, confusion, depression, blood disorders, liver dysfunction, sleep disturbances, tremors, convulsions, sweating, myalgia, paresthesia and hair loss.

4.9 Overdose

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

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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 to 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.

5.2 Pharmacokinetic Properties

Following oral administration, the drug is well absorbed from the 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 metabolites.

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 BP

Maize Starch BP

Magnesium Stearate BP

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years in tablet containers.

2 years in blister packs.

6.4 Special Precautions For Storage

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 the original container. Keep container tightly closed.

6.5 Nature And Contents Of Container

Polypropylene containers with polyethylene tamper-evident lids, containing 16, 20, 50, 100, 250, 500 or 1000 tablets.

Blister strips comprised of 20µm aluminium foil 250µm/PVC enclosed in a carton containing 6, 8, 10, 12, 14, 16, 20, 24 or 30 tablets.

Aluminium/PVC/PVDC blister strips enclosed in a cardboard outer 6, 8, 10, 12, 14, 16, 20, 24 or 30 tablets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Galpharm Healthcare Limited

Hugh House

Galpharm Way

Upper Cliffe Road

Dodworth Business Park

Dodworth

South Yorkshire

S75 3SP

8. Marketing Authorisation Number(S)

PL 16028/0010

9. Date Of First Authorisation/Renewal Of The Authorisation

15/2/07

10. Date Of Revision Of The Text

April 2007