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INDOCID Capsules (2018)

Αναφορές

Βιβλιογραφική αναφορά

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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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