SULINDAC Tablets (2014)
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Περιεχόμενα
Name of the medicinal product
Sulindac 100 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 100 mg of sulindac. Excipients with known effect: Each tablet contains 18 mg of lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
8mm flat bevel-edged orange yellow tablet marked SD breakline 100 on one side and α on the reverse.
Therapeutic indications
8mm flat bevel-edged orange yellow tablet marked SD breakline 100 on one side and α on the reverse.
Posology and method of administration
Posology For oral administration. Sulindac should always be taken with fluids either with food or immediately after food and is normally taken twice a day. The usual adult dosage is 400 mg a day and doses ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. NSAIDS are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, ...
Special warnings and precautions for use
In all patients Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below). ...
Interaction with other medicinal products and other forms of interaction
Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects (see section 4.3). Anti-hypertensives: ...
Fertility, pregnancy and lactation
Sulindac has not been established as safe for use in pregnant or lactating women. Pregnancy Congenital abnormalities have been reported in association with NSAID administration in man; however, these are ...
Effects on ability to drive and use machines
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.
Undesirable effects
Gastrointestinal: The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in older people, may occur (see section ...
Overdose
Symptoms Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, stupor, drowsiness, dizziness, tinnitus, fainting, ...
Pharmacodynamic properties
Sulindac is a fluorinated indene with a structural resemblance to indometacin. It has analgesic, anti-inflammatory and antipyretic actions.
Pharmacokinetic properties
Sulindac is incompletely absorbed from the gastro-intestinal tract. It is metabolised by reversible reduction to the sulphide metabolite, which appears to be the biologically active form, and by irreversible ...
Preclinical safety data
There are no preclinical safety data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
List of excipients
The tablets contain: Lactose monohydrate Cellulose, microcrystalline Povidone Sodium starch glycolate Magnesium stearate Talc Quinolone yellow (E104)
Incompatibilities
None stated.
Shelf life
Shelf life: 5 years.
Special precautions for storage
Store below 25°C. Store in the original package in order to protect from light and moisture.
Nature and contents of container
Sulindac tablets are available either in PVC/aluminium foil blisters or polypropylene containers with polyethylene caps. The pack sizes available in both pack types are 5, 7, 10, 14, 15, 20, 21, 25, 28, ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL
Marketing authorization number(s)
PL 04569/0187
Date of first authorization / renewal of the authorization
Date of first authorisation: 17/11/1987 Date of latest renewal: 15/07/2005
Date of revision of the text
10/09/2014
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