QUESTRAN Powder for oral suspension (2019)
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Περιεχόμενα
Name of the medicinal product
Questran Light 4g/sachet Powder for Oral Suspension.
Qualitative and quantitative composition
Each sachet contains 4g anhydrous colestyramine (a basic anion-exchange resin). Excipient with known effect: Questran Light contains 30mg of aspartame per sachet. For the full list of excipients, see section ...
Pharmaceutical form
Powder for oral administration.
Therapeutic indications
Questran Light is used for: Primary prevention of coronary heart disease in men between 35 and 59 years of age and with primary hypercholesterolaemia who have not responded to diet and other appropriate ...
Posology and method of administration
Posology Adults 1. For primary prevention of coronary heart disease and to reduce cholesterol: After initial introduction over a three to four week period, 3 to 6 Questran Light sachets per day, administered ...
Contraindications
Questran Light is contraindicated in patients who have shown hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In patients with complete biliary obstruction, since ...
Special warnings and precautions for use
Reduction of serum folate concentrations has been reported in children with familial hypercholesterolaemia. Supplementation with folic acid should be considered in these cases. Since Questran Light may ...
Interaction with other medicinal products and other forms of interaction
Questran Light may delay or reduce the absorption of certain drugs (such as digitalis, tetracycline, chlorothiazide, warfarin and thyroxine). The response to concomitant medication should be closely monitored ...
Pregnancy and lactation
The safety of colestyramine in pregnancy and lactation has not been established and the possibility of interference with absorption of fat soluble vitamins should be considered.
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Frequency categories are defined according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), ...
Overdose
One case of medication error experienced heartburn and nausea after taking colestyramine 27g three times a day for a week. The potential problem in overdosage would be obstruction of the gastrointestinal ...
Pharmacodynamic properties
Pharmacotherapeutic group: Bile acid sequestrants ATC code: C10AC01 Colestyramine resin absorbs and combines with the bile acids in the intestine to form an insoluble complex which is excreted in the faeces. ...
Pharmacokinetic properties
The colestyramine resin in Questran Light is not absorbed from the digestive tract.
Preclinical safety data
No further significant information.
List of excipients
Aspartame Citric acid anhydrous Colloidal anhydrous silica Orange juice flavour Propylene glycol alginate Xanthan gum
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Original packs containing 50 or 60 laminate sachets composed of paper, polyethylene and aluminium. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special instructions. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
Marketing authorization number(s)
PL 27041/0020
Date of first authorization / renewal of the authorization
25<sup>th</sup> July 1988 / 26<sup>th</sup> November 1998
Date of revision of the text
31/07/2019
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