INDOCID Suppositories (2018)
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Περιεχόμενα
Name of the medicinal product
Indocid Suppositories 100 mg.
Qualitative and quantitative composition
Indocid Suppositories contains 100 mg of indometacin. For the full list of excipients, see section 6.1.
Pharmaceutical form
Indocid is available in polyethylene glycol suppositories.
Therapeutic indications
Non-steroidal anti-inflammatory agent indicated for the active stages of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute musculoskeletal disorders, degenerative joint disease of the ...
Posology and method of administration
The dosage of indometacin should be carefully adjusted to suit the needs of the individual patient. Posology Adult One suppository to be inserted once or twice a day. One should be used at bedtime. If ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. History of peptic ulcer or active peptic ulcer. Recurrent history of gastro-intestinal lesions. Patients who ...
Special warnings and precautions for use
Indometacin may have a reversible inhibitory effect on womens ovulation. The use of indometacin may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties ...
Interaction with other medicinal products and other forms of interaction
Aspirin: the use of indometacin with aspirin or other salicylates is not recommended. Controlled clinical studies have shown no enhanced therapeutic effect, and one study showed a significant increase ...
Fertility, pregnancy and lactation
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of ...
Effects on ability to drive and use machines
Patients should be warned that they may experience dizziness, drowsiness, visual disturbances or headaches and if they do, should not drive or undertake activities requiring alertness.
Undesirable effects
CNS reactions: headaches, dizziness, light-headedness, depression, vertigo, and fatigue (including malaise and listlessness). Reactions reported infrequently include mental confusion, anxiety, syncope, ...
Overdose
Symptoms The following symptoms may be observed following overdosage: nausea, vomiting, intense headache, dizziness, mental confusion, disorientation, or lethargy. There have been reports of paraesthesia, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiinflammatory and Antirheumatic Products, Non-Steroids ATC code: M01AB01 Indometacin has anti-inflammatory, antipyretic, and analgesic effects, it is an inhibitor of prostaglandin ...
Pharmacokinetic properties
Indometacin is rapidly and almost completely absorbed on oral administration, and peak plasma levels are reached in ½ to 2 hours. Absorption is slowed but remains virtually complete when taken with food. ...
Preclinical safety data
Administration of indomethacin to experimental animals at doses of 0.1-1.94 times the maximum recommended human clinical dose (MRHD) resulted in: i) maternal toxicity and death, ii) increased pre- and ...
List of excipients
Butylhydroxyanisole Butylhydroxytoluene Ethylenediamine-tetracrotic acid Glycerol Polyethylene glycol 8000 Macrogol 4000 Purified water
Incompatibilities
None known.
Shelf life
Shelf life: 36 months.
Special precautions for storage
Do not store above 25°C. Keep in original package.
Nature and contents of container
10 capsules packed in polyvinylchloride (pvc) blister, laminate strip packaging.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
PL 39699/0015
Date of first authorization / renewal of the authorization
Date of first authorisation: 13 October 1981
Date of revision of the text
28 September 2018
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