PALUDRINE Tablet (2016)
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Περιεχόμενα
Name of the medicinal product
Paludrine 100 mg tablets.
Qualitative and quantitative composition
Proguanil hydrochloride 100 mg. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Scored, uncoated white tablet. The tablet can be divided into equal halves.
Therapeutic indications
Paludrine is an effective antimalarial agent. It is recommended for the prevention and suppression of malaria.
Posology and method of administration
Oral use. Non-immune subjects entering a malarious area are advised to begin treatment with Paludrine 1 week before, or if this is not possible, then at least 2 days before entering the malarious area. ...
Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Special warnings and precautions for use
Renal Impairment Haematological changes in patients with severe renal impairment have been reported (see section 4.8). Paludrine should be used with caution in patients with severe renal impairment (See ...
Interaction with other medicinal products and other forms of interaction
Antacids Antacids may reduce the absorption of proguanil, so should be taken at least 2-3 hours apart. Anticoagulants Proguanil can potentiate the anticoagulant effect of warfarin and related anticoagulants ...
Pregnancy and lactation
Pregnancy There are limited data available from the use of proguanil in pregnant women. Paludrine should not be used during pregnancy unless, in the judgement of the physician, potential benefit outweighs ...
Effects on ability to drive and use machines
There is no evidence to suggest that Paludrine causes sedation or is likely to affect concentration.
Undesirable effects
Undesirable effects are listed by MedDRA System Organ Classes. Assessment of undesirable effects is based on the following frequency groupings: Very common: ≥1/10 Common: ≥1/100 to <1/10 Uncommon: ≥1/1,000 ...
Overdose
The following effects have been reported in cases of overdosage: Haematuria, renal irritation, epigastric discomfort and vomiting. There is no specific antidote and symptoms should be treated as they arise. ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antiprotozoals, Antimalarials <b>ATC code:</b> P01BB01 Proguanil is an antimalarial drug and dihydrofolate reductase inhibitor. It acts like the other antifolate antimalarials ...
Pharmacokinetic properties
Absorption Rapid, reaching a peak at 3 to 4 hours. The active metabolite (cycloguanil) peaks somewhat later (4 to 9 hours). Half-life The half-life of proguanil is 14 to 20 hours, whilst cycloguanil has ...
Preclinical safety data
Proguanil is a drug on which extensive clinical experience has been obtained. All relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.
List of excipients
Calcium carbonate Gelatin Magnesium stearate (E572) Maize starch
Incompatibilities
None known.
Shelf life
5 years.
Special precautions for storage
Store below 30°C.
Nature and contents of container
HDPE bottles (100) and blister packs (98).
Special precautions for disposal and other handling
Use as directed by the prescriber.
Marketing authorization holder
Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, United Kingdom
Marketing authorization number(s)
PL 16853/0144
Date of first authorization / renewal of the authorization
24/10/2005
Date of revision of the text
07/12/2016
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