ACECLOFENAC Film-coated tablet (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Aceclofenac 100 mg film-coated Tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 100 mg of aceclofenac. For a full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. White, round, biconvex film-coated tablets, 8 mm diameter.
Therapeutic indications
Aceclofenac 100 mg Film-coated Tablets is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults.
Posology and method of administration
Posology Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Adults The recommended dose is 200 mg daily, ...
Contraindications
Hypersensitivity to aceclofenac or to any of the excipients listed in section 6.1 Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). ...
Special warnings and precautions for use
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). The use of Aceclofenac ...
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, including GI bleeding ...
Fertility, pregnancy and lactation
There is no information on the use of aceclofenac during pregnancy. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. Data from epidemiological ...
Effects on ability to drive and use machines
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances or other central nervous system disorders are possible after taking NSAIDs. If affected, patients should not drive or ...
Undesirable effects
<u>Gastrointestinal:</u> The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see ...
Overdose
Management of acute poisoning with NSAIDs essentially consists of supportive and symptomatic measures. a) Symptoms Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal irritation, ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antiinflammatory and antirheumatic products, non-steroids, acetic acid derivatives and related substances <b>ATC code:</b> M01AB16 Aceclofenac is a non-steroidal agent ...
Pharmacokinetic properties
After oral administration, aceclofenac is rapidly and completely absorbed as unchanged drug. Peak plasma concentrations are reached approximately 1.25 to 3.00 hours following ingestion. Aceclofenac penetrates ...
Preclinical safety data
The results from preclinical studies conducted with aceclofenac are consistent with those expected for NSAIDs. The principal target organ was the gastro-intestinal tract. No unexpected findings were recorded. ...
List of excipients
<u>Core:</u> Microcrystalline cellulose (E460i) Croscarmellose sodium Copovidone Talc (E553b) Silica colloidal anhydrous Glicerol distearate <u>Film-coating Opadry O3A0280002:</u> HPMC 2910/Hypromellose ...
Incompatibilities
None known.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Aceclofenac 100 mg Film-Coated Tablets are packaged in Aluminium/aluminium blisters placed into cardboard boxes containing 20, 30, 40, 60, 90, 100 or 180 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
RIVOPHARM UK Ltd., 100 Bishopsgate, London, EC2N 4AG, United Kingdom
Marketing authorization number(s)
PL 33155/0029
Date of first authorization / renewal of the authorization
11/02/2015
Date of revision of the text
27/06/2023
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