SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Extra Strength Sleep Aid Sleepeaze 50mg Tablets

Lloyds Pharmacy Extra Strength Sleep Aid Tablets Numark Night Time Sleep Aid 50mg Tablets Vantage Sleep Aid 50mg Tablets Superdrug One-A-Night Sleep Aid 50mg Tablets Galpharm One a Night Nightcalm 50mg Tablets Morrisons One-A-Night Sleep Aid 50mg Tablets Sainsbury’s One-A-Night Sleep Aid 50mg Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Diphenydramine Hydrochloride BP 50mg (2-benzhydryloxyethyldimethylamine hydrochloride)

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

Oral administration only.

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

One tablet twenty minutes before going to bed.

Children under 16years of age: Not recommended for use.

Do not exceed the stated dose or frequency of dosing.

4.3    Contraindications

Contraindicated 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 hypertrphy, stensing 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 and moderate to severe renal impairment.

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

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

Tolerance may develop with continuous use. Seek medical advice if sleeplessness persists, as insomnia may be a symptom of serious underlying medical illness.

May increase the effects of alcohol, therefore alcohol should be avoided. Avoid use of other antihistamine-containing preparations, including topical antihistamine and cough and cold medicines.

Side effects are more likely to occur in the elderly. Avoid use in elderly patients with confusion.

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.

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. The product should be used with caution with monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping an MAOI.

As Diphenhydramine has some antimuscarinic activity, the effects of antiocholinergic drugs (e.g. atropine, tricyclic antidepressants) may be potentiated therefore medical advice should be sought before taking Diphenhydramine with such medicines.

Diphenhydramine is an inhibitor of the cytochrome P450 isoenzyme CYP2D6. Therefore, there may be a potential for interaction with drugs which are primarily metabolised by CYP2D6, such as metoprolol and venlafaxine.

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

4.6 Fertility, pregnancy and lactation Pregnancy

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.

Use of sedating antihistamines during the third trimester may result in reactions in the newborn or premature neonates. This drug is not recommended during pregnancy. Consult a doctor before use.

Lactation

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

Diphenhydramine hydrochloride is not recommended for use during lactation in nursing mothers. Consult a doctor before use.

4.7 Effects on ability to drive and use machines

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.

4.8 Undesirable effects

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.

4.9 Overdose

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.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

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

Anti-histaminic 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

Diphenhydramine hydrochloride is rapidly absorbed following oral administration. Apparently it undergoes first-pass metabolism in the liver and only about 40-60% of an oral dose reaches systematic circulation as unchanged Diphenhydramine.

It is rapidly distributed throughout the whole body. Peak plasma concentrations are attained within 1-4 hours. The sedative effect also appears to be maximal within 1-3 hours after administration of a single dose.

It is positively correlated with the plasma drug concentration. Diphenhydramine is approximately 80-85% bound to plasma proteins. Diphenhydramine is rapidly and almost completely metabolised. The drug is metabolised principally to Diphenylmetoxyacetic acid and is also dealkylated.

The metabolites are conjugated with glycine and glutamine and excreted in urine. Only about 1% of a single dose is excreted unchanged in urine.

The elimination half-life ranges from 2.4-9.3 hours in healthy adults. The terminal elimination half-life is prolonged in liver cirrhosis.

5.3    Preclinical safety data

None stated

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Lactose Maize starch Magnesium stearate

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

3 years in tablet containers.

3 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.

250pm PVC/20pm aluminium foil blister strips enclosed in an outer carton containing 6, 8, 10, 12, 14, 16, 20, 24 or 30 tablets.

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

6.6    Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Galpharm Healthcare Limited

Wrafton

Braunton

Devon

EX33 2DL

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 16028/0010

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

27/06/1995    /    15/02/2007

DATE OF REVISION OF THE TEXT

20/11/2015

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