Asda Sleep Aid
Sleep Aid Tablets
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Asda Sleep Aid Tablets
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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.
Oral administration only.
Adults (including the elderly) and children over 16 years of age :
Two tablets (50mg) 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.
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 hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction or bladder neck obstruction and porphyria.
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.
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.
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.
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.
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:
Immune system disorders:
Unknown: Hypersensitivity reactions including rash, urticaria, dyspnoea and angioedema
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
Unknown: blurred vision
Ear and labyrinth disorders:
Unknown: tachycardia, palpitations
Respiratory, thoracic and mediastinal disorders:
Unknown: thickening of bronchial secretions
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), antiemetic, 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.
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.
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 Maize starch Magnesium stearate
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 20pm aluminium foil 250pm/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.
Galpharm Healthcare Limited