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Nytol One A Night 50mg caplets (pack of 16) |
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Nytol One-A-Night Caplets are for people who suffer from disturbed sleep that would prefer to take one caplet to help relieve their temporary sleeplessness. One caplet contains the same dose as two original Nytol Caplets.
What do Nytol One-A-Night Caplets contain?
Nytol One-A-Night Caplets contain the active ingredient Diphenhydramine Hydrochloride. Diphenhydramine is a commonly used and trusted sedating antihistamine. Nytol can help you drift off to sleep and so helps you wake up feeling refreshed in the morning.
What is meant by natural sleep?
Nytol One-A-Night Caplets can help you gently drift off into a natural sleep. It won’t knock you out as you would be for a hospital operation.
Are Nytol One-A-Night Caplets the same as prescription sleeping pills?
No. Nytol One-A-Night Caplets are considered to have a good enough safety profile to allow them to be bought over the counter at your local pharmacy. Prescription sleeping pills must be prescribed by your doctor.
How and when should I use Nytol One-A-Night Caplets?
The recommended dosage of Nytol One-A-Night Caplets is one 50mg caplet, 20 minutes before you go to bed, unless otherwise directed by your doctor.
If after two weeks you’re still having trouble sleeping, you should consult your doctor as Nytol may not be an appropriate way to treat your problem.
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Nytol One-A-Night contains 50mg Diphenhydramine Hydrochloride BP per caplet
An aid to the relief of temporary sleep disturbance
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One caplet to be taken 20 minutes before going to bed, or as directed by a physician.
Not recommended for children under 16 years.
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.
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Contraindications
Nytol One-A-Night is contraindicated in patients who are hypersensitive to diphenhydramine and in those with the following conditions: asthma, narrow angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction or bladder neck obstruction.
Special warnings and precautions for use
Nytol One-A-Night should be used with caution in patients with myasthenia gravis or seizure disorders. Tolerance may develop with continuous use.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Interaction with other medicinal products and other forms of interaction
Diphenhydramine may potentiate the sedative effects of alcohol and other CNS depressants (e.g. tranquillizers, hypnotics and anxiolytics).
Monoamine oxidase inhibitors (MAOI) prolong and intensify the anticholinergic effects of diphenhydramine. The product should be used with caution with MAOIs or within 2 weeks of stopping an MAOI.
As diphenhydramine has some antimuscarinic activity, the effects of some anticholinergic 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 any of the above drugs unless directed by a doctor.
Pharmacodynamic properties
Diphenhydramine hydrochloride is the active ingredient in Nytol One-A-Night, it is an antihistamine with well known pharmacological activities. As with most of the older antihistamines, diphenhydramine hydrochloride has a pronounced sedative effect. Diphenhydramine hydrochloride has been formulated into Nytol One-A-Night, a caplet for use as an aid to the relief of temporary sleep disturbance.
Diphenhydramine is an ethanolamine-derivative antihistamine. It is an antihistamine with anticholinergic and marked sedative effects. It acts by inhibiting the effects on HI-receptors.
Diphenhydramine is effective in reducing sleep onset (i.e., time to fall asleep) and increasing the depth and quality of sleep.
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Pregnancy and lactation
Pregnancy
Diphenhydramine crosses the placenta. Because animal reproduction studies are not always predictive of human response and since there is inadequate experience with use of diphenhydramine in pregnant women, the potential risk for humans is unknown. 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
Diphenhydramine has been detected in breast milk, but the effect of this on breastfed infants is unknown. Nytol One-A-Night is not recommended for use during lactation in nursing mothers. Consult a doctor before use.
Effects on ability to drive and use machines
Nytol One-A-Night is a hypnotic and will produce drowsiness or sedation soon after the dose has been taken. It 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.
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
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
List of excipients
Anhydrous lactose
Stearic acid, powder
Microcrystalline cellulose
Silicon dioxide
Maize starch
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