UNISOM SLEEPGELS Capsule (2018)
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Περιεχόμενα
1. Name of the medicinal product
Unisom SleepGels 50mg capsules.
2. Qualitative and quantitative composition
Each liquid-filled blue, soft gelatine capsule is imprinted UNISOM and contains 50 mg of mdiphenhydramine hydrochloride. For full list of excipients, see section 6.1.
3. Pharmaceutical form
Liquid filled, blue soft gelatine capsules imprinted with the word UNISOM.
4.1. Therapeutic indications
A night time sleep aid for the short-term management of insomnia.
4.2. Posology and method of administration
Adults and children over 12 years of age. The dose is one softgel (50 mg) at bedtime if needed. Should sleeplessness persist for more than 7 to 10 nights further medical advice should be sought. Do not ...
4.3. Contraindications
Premature or newborn infants. Hypersensitivity to the drug. Asthma attack, narrow angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstructions, bladder neck obstruction, patients ...
4.4. Special warnings and precautions for use
Diphenhydramine has an atropine-like action, which should be considered. Use with caution in those with a history of asthma. Unisom should be used with caution in subjects with a history of hyper thyroidism, ...
4.5. Interaction with other medicinal products and other forms of interaction
Antidepressants, particularly of the tricyclic and monoamine oxidase inhibitor types may interact with diphenhydramine. MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. ...
4.6. Fertility, pregnancy and lactation
Pregnancy Category A. (Drugs which have been taken by a large number of pregnant women and women of child bearing age without increase in the frequency of malformations or other direct harmful effects ...
4.7. Effects on ability to drive and use machines
May have an additive effect when taken with alcohol and other CNS depressants. Avoid alcohol and do not drive a motor vehicle.
4.8. Undesirable effects
The most frequently reported adverse reactions are dizziness, dryness of mouth, nose or throat, nausea and nervousness. Other less frequently reported effects are vertigo, palpitation, blurring of vision, ...
4.9. Overdose
Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in children. Atropine-like signs and symptoms such as dry mouth, fixed ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antihistamines for systemic use <b>ATC code:</b> R06AA02 Diphenhydramine is an ethanolamine antihistamine with anticholinergic and sedative effects. The primary action ...
5.2. Pharmacokinetic properties
Absorption Diphenhydramine is well absorbed following oral administration with the drug appearing in plasma within 15 minutes. High first-pass metabolism in the liver appears to affect systemic availability ...
5.3. Preclinical safety data
Mutagenicity and Carcinogenicity Long-term animal studies to determine the mutagenic and carcinogenic potential of diphenhydramine have not been performed to date.
6.1. List of excipients
Each capsule contains diphenhydramine hydrochloride USP 50 mg with Macrogol 400, glycerol, gelatin, sorbitol, brilliant blue FCF, polyvinyl acetate phthalate, shellac, titanium dioxide, propylene glycol ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Unisom SleepGels have a three year shelf-life.
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
Blister pack of 10 capsules.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
Pharmaco (NZ) Ltd, 4 Fisher Crescent, Mt Wellington, Auckland 1060, Telephone: 09 377 3336
9. Date of first authorization / renewal of the authorization
12/2/1996
10. Date of revision of the text
30 Nov 2018
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