QUININE SULFATE Film-coated tablet (2022)
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Περιεχόμενα
Name of the medicinal product
Quinine Sulfate 200mg Tablets.
Qualitative and quantitative composition
Each tablet contains quinine sulfate 200mg. <u>Excipient(s) with known effect:</u> Lactose Sodium less than 1 mmol sodium (23 mg) per tablet. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. A white, biconvex film-coated tablet, plain on both sides.
Therapeutic indications
For the treatment of chloroquine resistant falciparum malaria in adults and children aged 5 years or older (and ≥20kg). Treatment and prevention of nocturnal leg cramps in adults and the elderly, when ...
Posology and method of administration
Posology Treatment of chloroquine resistant falciparum malaria Adults (including the elderly) and children aged 12 years and over 600mg of quinine sulfate given every 8 hours for 7 days. The dose may depend ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Tinnitus. Optic neuritis. Haemoglobinuria. Myasthenia gravis (quinine may cause severe respiratory distress and ...
Special warnings and precautions for use
Chinchonism Administration of quinine may give rise to cinchonism, which is generally more severe in overdose, but may also occur in normal therapeutic doses. Patients should be warned not to exceed the ...
Interaction with other medicinal products and other forms of interaction
Effect of other drugs on quinine CYP3A4 substrate Quinine is metabolised via hepatic oxidative cytochrome P450 pathways, predominantly by CYP3A4. There is the potential for increased quinine toxicity with ...
Fertility, pregnancy and lactation
Pregnancy Quinine may cause congenital abnormalities of the CNS and extremities. Following administration of large doses during pregnancy, phototoxicity and deafness have been reported in neonates. Quinine ...
Effects on ability to drive and use machines
Quinine may cause visual disturbances and vertigo, hence patients should be advised that if affected they should not drive or operate machinery.
Undesirable effects
Cinchonism is more common in overdose, but may occur even after normal doses of quinine. In its mild form symptoms include tinnitus, impaired hearing, rashes, headache, nausea and disturbed vision. In ...
Overdose
Symptoms Quinine overdosage may lead to serious side effects including irreversible visual loss and can be fatal. In acute overdosage, symptoms of cinchonism may occur, including convulsions, nausea, vomiting, ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antimalarials, Methanolquinolines <b>ATC Code:</b> P01BC01 Quinine is a cinchona alkaloid and a 4-methanolquinoline antimalarial agent which is a rapidly acting blood ...
Pharmacokinetic properties
The pharmacokinetics of quinine are altered significantly by malaria infection, the major effects being reductions in both its apparent volume of distribution and its clearance. Absorption Quinine is rapidly ...
Preclinical safety data
No data of relevance to the prescriber, which is additional to that included in other sections of the SPC.
List of excipients
Lactose Microcrystalline cellulose Maize starch Colloidal anhydrous silica Purified talc Magnesium stearate Sodium starch glycollate <u>Coating Components/Tablet:</u> Methylhydroxypropylcellulose Opadry ...
Incompatibilities
Not applicable.
Shelf life
36 months.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC (250µm)/aluminium (25µm) foil blisters. <u>Pack sizes:</u> 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250 and 500. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Strides Pharma UK Ltd, Unit 4 Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD18 9SS
Marketing authorization number(s)
PL 13606/0200
Date of first authorization / renewal of the authorization
25/10/2016
Date of revision of the text
19/07/2022
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