QUINORIC Film coated tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Hydroxychloroquine Sulfate 200 mg Film–Coated Tablets. Quinoric 200mg Film-Coated Tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 200 mg Hydroxychloroquine Sulfate B.P. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film coated tablet (tablet). White, circular, biconvex film coated tablets embossed with BL on one face and 200 on the other.
Therapeutic indications
Adults Treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight. Paediatric Population Treatment of juvenile idiopathic ...
Posology and method of administration
Posology Adults (including the elderly) The minimum effective dose should be employed. This dose should not exceed 6.5 mg/kg/day (calculated from ideal body weight and not actual body weight) and will ...
Contraindications
Hypersensitivity to the active substance, 4-aminoquinoline compounds or to any of the excipients listed in section 6.1. Pre-existing maculopathy of the eye. Pregnancy (see section 4.6).
Special warnings and precautions for use
Retinopathy The occurrence of retinopathy is very uncommon if the recommended daily dose is not exceeded. The administration of doses in excess of the recommended maximum is likely to increase the risk ...
Interaction with other medicinal products and other forms of interaction
Digoxin Hydroxychloroquine sulfate has been reported to increase plasma digoxin levels: Serum digoxin levels should be closely monitored in patients receiving concomitant treatment. Anti-diabetics As hydroxychloroquine ...
Fertility, pregnancy and lactation
Pregnancy A moderate amount of data on pregnant women (between 300 – 1000 pregnancy outcomes), including prospective studies in long-term use with large exposure, have not observed a significant increased ...
Effects on ability to drive and use machines
Impaired visual accommodation soon after the start of treatment has been reported and patients should be warned regarding driving or operating machinery. If the condition is not self-limiting, it will ...
Undesirable effects
The following CIOMS frequency rating is used, when applicable: 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); Not known ...
Overdose
Overdose with the 4-aminoquinolines is dangerous particularly in infants, as little as 1-2g having proved fatal. Symptoms The symptoms of overdose may include headache, visual disturbances, cardiovascular ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antimalarials, Aminoquinolines ATC Code: P01BA02 Mechanism of action Antimalarial agents like chloroquine and hydroxychloroquine have several pharmacological actions which may ...
Pharmacokinetic properties
Absorption Following oral administration, hydroxychloroquine is rapidly and almost completely absorbed. In one study, mean peak plasma hydroxychloroquine concentrations following a single dose of 400mg ...
Preclinical safety data
Only limited preclinical data are available for hydroxychloroquine, therefore chloroquine data are considered due to the similarity of structure and pharmacological properties between the two products. ...
List of excipients
Maize starch Calcium hydrogen phosphate dihydrate Colloidal anhydrous silica Polysorbate 80 Purified talc Magnesium stearate Hypromellose Titanium dioxide Macrogol 6000
Incompatibilities
Not applicable.
Shelf life
<u>Containers:</u> 3 years. <u>Blisters:</u> 4 years.
Special precautions for storage
Store in the original package.
Nature and contents of container
Al/PVC blister, pack sizes of 30, 60 and 100 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Bristol Laboratories Ltd., Unit 3, Canalside, Northbridge Road, Berkhamsted, Herts, HP4 1EG, United Kingdom
Marketing authorization number(s)
PL 17907/0017
Date of first authorization / renewal of the authorization
Date of First Authorisation: 15<sup>th</sup> February 2007 Date of Renewal of Authorisation: 12<sup>th</sup> October 2011
Date of revision of the text
13 April 2022
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