TAVEGIL Tablet (2019)
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Περιεχόμενα
1. Name of the medicinal product
TAVEGIL TABLETS.
2. Qualitative and quantitative composition
Clemastine hydrogen fumarate 1.34mg (equivalent to clemastine base 1mg). For excipients see 6.1.
3. Pharmaceutical form
White, uncoated, round, 7 mm in diameter with beveled edges, smooth on one side and marked with OT and scored with a single breakline on the other.
4.1. Therapeutic indications
Allergic rhinitis, including hay fever and perennial rhinitis, vasomotor rhinitis. Allergic dermatoses, including pruritus, atopic eczema and contact dermatitis. Urticaria. Angioneurotic oedema, drug allergy. ...
4.2. Posology and method of administration
Adults 1mg clemastine base (one tablet) night and morning. In individual cases the dose may be increased to 6mg clemastine base daily if necessary (six tablets). Children <u>1 to 3 years:</u> 250 microgrammes ...
4.3. Contraindications
TAVEGIL is contraindicated in patients with a known hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients. TAVEGIL should not be given to porphyric patients. ...
4.4. Special warnings and precautions for use
Antihistamines should be used with caution in patients with: narrow-angle glaucoma stenosing peptic ulcer pyloroduodenal obstruction prostatic hypertrophy with urinary retention and bladder neck obstruction. ...
4.5. Interaction with other medicinal products and other forms of interaction
Antihistamines potentiate the sedative effects of Central Nervous System (CNS) depressants including hypnotics, monoamine-oxidase inhibitors (MAOIs), antidepressants, anxiolytics, opioid analgesics and ...
4.6. Pregnancy and lactation
TAVEGIL should not be given during pregnancy and breast-feeding.
4.7. Effects on ability to drive and use machines
TAVEGYL has moderate influence on the ability to drive and use machines, due to the antihistamine sedative effect of clemastine, however, patients should be warned not to take charge of vehicles or machinery ...
4.8. Undesirable effects
Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) ...
4.9. Overdose
Symptoms The effects of antihistamine overdose may vary from CNS depression to stimulation such as depressed level of consciousness, excitability, hallucinations, or convulsions. Anticholinergic symptoms ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antihistamines: H1-receptor <b>ATC code:</b> R06AA04 Mechanism of action and pharmacodynamic effects TAVEGIL (clemastine) is an H<sub>1</sub>-receptor antagonist. It belongs ...
5.2. Pharmacokinetic properties
Absorption Following oral administration TAVEGIL (clemastine) is almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are attained within 2-4 hours. The antihistaminic ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction at therapeutically ...
6.1. List of excipients
Lactose monohydrate Povidone Maize starch Talc (acid washed) Magnesium stearate
6.2. Incompatibilities
None known.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
PVC/PVDC blister pack (50 or 60 tablets).
6.6. Special precautions for disposal and other handling
None.
7. Marketing authorization holder
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
8. Marketing authorization number(s)
PL 44673/0179
9. Date of first authorization / renewal of the authorization
08 June 2000
10. Date of revision of the text
11<sup>th</sup> February 2019
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