INDOCID Capsules (2018)
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Περιεχόμενα
Name of the medicinal product
Indocid Capsules 25 mg.
Qualitative and quantitative composition
Indocid Capsules 25 mg contain 25 mg of indometacin. For the full list of excipients, see section 6.1.
Pharmaceutical form
Indocid Capsules 25 mg are ivory, opaque capsules marked MSD 25.
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 Dosage in dysmenorrhoea: Up to 75 mg a day, starting with onset of cramps or bleeding, and continuing ...
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. In patients ...
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 indometacin to experimental animals at doses of 0.1-1.94 times the MRHD resulted in: i) maternal toxicity and death, ii) increased pre- and post-implantation loss. iii) increased embryotoxicity, ...
List of excipients
Colloidal silicon dioxide Lactose Liquid lecithin concentrate Magnesium stearate E572 Capsule shells: Gelatin Titanium dioxide E171 Yellow ferric oxide E172
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
Indometacin Capsules 25 mg: high density bottles with high density polyethylene cap-to-cap closures containing 100 or 500 capsules. Opaque 250 micron PVC blisters with 20 micron aluminium lid. Each blister ...
Special precautions for disposal and other handling
Indometacin Capsules should always be taken with food or an antacid.
Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
PL 39699/012
Date of first authorization / renewal of the authorization
Date of first authorisation: 12 June 1981
Date of revision of the text
28 September 2018
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