HAYLEVE Tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Hayleve. Chlorphenamine Maleate 4 mg.
2. Qualitative and quantitative composition
Each tablet contains chlorphenamine maleate 4 mg. <u>Excipient with known effect:</u> also contains lactose. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. The tablet can be divided into equal doses. Biconvex pale yellow scored (*). Odourless. (*) Score is in the form of a cross break-line.
4.1. Therapeutic indications
The tablets are indicated for symptomatic control of all allergic conditions responsive to antihistamines, including urticaria, hayfever, food allergy, drug and serum reactions, insect bites, vasomotor ...
4.2. Posology and method of administration
Oral Administration only. Do not exceed the stated dose or frequency of dosing. Adults and children over 12 years 1 tablet four to six hourly. Maximum daily dose: 6 tablets (24 mg) in any 24 hours. Elderly ...
4.3. Contraindications
The tablets are contra-indicated in patients who are hypersensitive to antihistamines or to any of the tablet ingredients. The anticholinergic properties of chlorphenamine are intensified by monoamine ...
4.4. Special warnings and precautions for use
Chlorphenamine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intra-ocular pressure including glaucoma ; prostatic hypertrophy; hepatic impairment, ...
4.5. Interaction with other medicinal products and other forms of interaction
Concurrent use of chlorphenamine and hypnotics or anxiolytics may cause an increase in sedative effects, therefore medical advice should be sought before taking chlorphenamine concurrently with these medicines. ...
4.6. Pregnancy and lactation
Pregnancy There are no adequate data from the use of chlorphenamine maleate in pregnant women. The potential risk for human is unknown. Use during the third trimester may result in reactions in the newborn ...
4.7. Effects on ability to drive and use machines
The anticholinergic properties of chlorphenamine may causes drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patients ability to drive and use 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 trails and which are ...
4.9. Overdose
Symptoms and signs The estimated lethal dose of chlorphenamine is 25 to 50 mg/kg bodyweight. Symptoms and signs include sedation, paradoxic stimulation of the CNS, toxic psychosis, apnoea, convulsions, ...
5.1. Pharmacodynamic properties
<b>ATC Code:</b> R06AB04 Chlorphenamine is a potent antihistamine (H<sub>1</sub>-antagonist). Antihistamines diminish or abolish the actions of histamine in the body by competitive reversible blockade ...
5.2. Pharmacokinetic properties
Chlorphenamine is well absorbed from the gastro-intestinal tract, following oral administration. The effects develop within 30 minutes, are maximal within 1 to 2 hours and last 4 to 6 hours. The plasma ...
5.3. Preclinical safety data
No additional data of relevance.
6.1. List of excipients
Lactose Maize starch Povidone K25 Quinoline yellow E104 Magnesium stearate Sodium starch glycollate
6.2. Incompatibilities
Chlorphenamine is incompatible with alkaline substances which precipitate Chlorphenamine Base.
6.3. Shelf life
<u>Plastic containers:</u> 36 months. <u>Blister-packs:</u> 36 months.
6.4. Special precautions for storage
Keep containers well closed. Protect from light. Store below 25°C.
6.5. Nature and contents of container
High density polystyrene with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polyurethane or polythene inserts. <u>Pack sizes:</u> 100, 500 and 1,000. PVC/Aluminium ...
6.6. Special precautions for disposal and other handling
No special instructions.
7. Marketing authorization holder
Chelonia Healthcare Limited, 11 Boumpoulinas Street, 3rd Floor, 1060 Nicosia, Cyprus
8. Marketing authorization number(s)
PL 33414/0140
9. Date of first authorization / renewal of the authorization
19 July 2000
10. Date of revision of the text
15/06/2020
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