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1. Nytol Simply Sleep Hot Chocolate 50mg Powder For Oral Solution
2. Nytol Simply Sleep Hot Chocolate 50mg Powder For Oral Solution

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Nytol Simply Sleep Hot Chocolate 50mg Powder for Oral Solution

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

50mg Diphenhydramine Hydrochloride Ph. Eur. per sachet. For the full list of excipients see section 6.1.

3    PHARMACEUTICAL FORM

Powder for oral solution.

4    CLINICAL PARTICULARS

4.1 Therapeutic indications

An aid to the relief of temporary sleep disturbance.

4.2 Posology and method of administration

Method of Administration

Nytol Simply Sleep is for oral use only.

Posology

Adults aged 16 and over:

One sachet to be mixed with hot water and taken 20 minutes before going to bed, or as directed by a physician. Empty the contents of the sachet into a mug. Half-fill with very hot water and stir well. Add cold water as necessary.

Do not exceed the stated dose or frequency of dosing

Do not use continuously for more than two weeks without consulting a doctor.

Do not use in children under 16 years.

Nytol Simply Sleep is contraindicated in patients who are hypersensitive to diphenhydramine the active substance or any of the excipients listed in section 6.1, and in those with the following conditions: stenosing peptic ulcer, pyloroduodenal obstruction.

Nytol Simply Sleep should be used with caution in patients with myasthenia gravis, epilepsy or seizure disorders, narrow-angle glaucoma, prostatic hypertrophy, urinary retention, asthma, bronchitis and chronic obstructive pulmonary disease (COPD), moderate to severe hepatic impairment and moderate to severe renal impairment.

Tolerance may develop with continuous use. Do not take for more than two weeks without consulting a doctor. 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 antihistamines and cough and cold medicines.

Use with caution in the elderly, who are more likely to experience adverse effects. Avoid use in elderly patients with confusion.

Patients with rare hereditary problems of; fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Keep out of the sight and reach of children.

4.5 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.

4.6 Fertility, Pregnancy and lactation

Fertility

No known effect.

Pregnan

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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.

Breastfeeding

Diphenhydramine has been detected in breast milk, but the effect of this on breastfed infants is unknown. Nytol Simply Sleep is not recommended for use during lactation. Consult a doctor before use.

4.7 Effects on ability to drive and use machines

Diphenhydramine 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.

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

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

Antihistamines have been reported rarely to cause thrombocytopenia

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 MHRA Yellow Card Scheme. Website: 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 (ATC code RO6A A02) is an ethanolamine-derivative antihistamine. It is an antihistamine with anticholinergic and marked sedative effects. It acts by inhibiting the effects on H1-receptors.

Diphenhydramine is effective in reducing sleep onset (i.e., time to fall asleep) and increasing the depth and quality of sleep.

5.2 Pharmacokinetic properties

Absorption

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. 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.

Distribution

It is rapidly distributed throughout the whole body. Diphenhydramine is approx 80-85% bound to plasma proteins. It is positively correlated with the plasma drug concentration.

Biotransformation

Diphenhydramine is rapidly and almost completely metabolised. The drug is metabolised principally to diphenylmetoxyacetic acid and is also dealkylated.

Elimination

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

Skimmed milk powder Fat reduced cocoa powder

Milk chocolate powder (sugar, cocoa mass, whole milk powder, cocoa butter, skimmed milk powder)

Maltodextrin Chocolate flavour Silica colloidal anhydrous Golden syrup flavour Sucralose Carrageenan E 407

6.2 Incompatibilities

None known.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

Store in the original package below 30^oC.

6.5    Nature and contents of container

The product is packed in child-resistant laminate sachets comprising PET film/polythene/aluminium foil/polythene.

1, 2, 5, 6, 7, 10 or 14 sachets are packed into cartons.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Omega Pharma Ltd.

1^st Floor

32 Vauxhall Bridge Road