HISTERGAN Coated tablet (2017)
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Περιεχόμενα
1. Name of the medicinal product
<u>When sold as an antihistamine:</u> Histergan Tablets <u>When sold as a sleep aid:</u> Paxidorm Tablets 25mg Numark Night Time Sleep Aid Tablets NightAid Aspar Sleep Aid 25 mg Tablets Tor Generics Sleep ...
2. Qualitative and quantitative composition
Diphenhydramine Hydrochloride 25mg. <u>Excipients with known effects:</u> Lactose Sucrose For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pink sugar coated tablets.
4.1. Therapeutic indications
As an antihistamine Treatment of allergic conditions e.g. hay fever, vasomotor rhinitis, stings, urticaria, angioneurotic oedema, drug sensitivity, contact dermatitis and photosensitivity. As a sleep aid ...
4.2. Posology and method of administration
As an antihistamine Adults and Children over 12 years: 1 or 2 tablets three or four times per day. In severe or chronic conditions this may be increased at the discretion of a doctor, but not to exceed ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. <u>Contraindicated for use in patients with the following conditions:</u> stenosing peptic ulcer, pyloroduodenal ...
4.4. Special warnings and precautions for use
Diphenhydramine should be used with caution in patients with myasthenia gravis,epilepsy or seizure disorders, prostatic hypertrophy, urinary retention, narrow-angle glaucoma, asthma, bronchitis and chronic ...
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 (MAOIs) prolong and intensify the ...
4.6. 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 ...
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 ...
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 ...
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 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antihistamines for systemic use – diphenhydramine <b>ATC Code:</b> R06AA02 Diphenhydramine is an ethanolamine-derivative anti-histamine with anti-cholinergic (anti-spasmodic), ...
5.2. Pharmacokinetic properties
Diphenhydramine is a histamine H<sub>1</sub> receptor antagonist. The main site of metabolism is the liver. Absorption Diphenhydramine hydrochloride is rapidly absorbed following oral administration. Apparently ...
5.3. Preclinical safety data
Not applicable.
6.1. List of excipients
Lactose Corn starch Povidone Magnesium stearate Opaseal (polyvinyl acetate phthalate, ethyl acetate and stearic acid) Sucrose Calcium carbonate Talc Acacia Titanium dioxide E171 Opalux Pink AS 1537 (E127 ...
6.2. Incompatibilities
Incompatible with barbiturates and iodo compounds in solution.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
Blister packs of 8, 16 and 20 tablets.
6.6. Special precautions for disposal and other handling
None stated.
7. Marketing authorization holder
Norma Chemicals Ltd., 51-53 Stert Street, Abingdon, Oxfordshire OX14 3JF United Kingdom
8. Marketing authorization number(s)
PL 00386/5008R
9. Date of first authorization / renewal of the authorization
08 September 1989 / 14 June 1995
10. Date of revision of the text
13<sup>th</sup> October 2017
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