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SPC, UK: Aceclofenac 100 mg film-coated Tablets (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Accord Healthcare Limited
Διεύθυνση :
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, UK
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Name of the medicinal product

Aceclofenac 100 mg film-coated Tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 100 mg Aceclofenac. For a full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. White to off-white, round shaped, biconvex, film-coated tablet debossed with 100 on one side and plain on the other side.

Therapeutic indications

Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

Posology and method of administration

Aceclofenac film-coated tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid. To be taken preferably with or after food. When Aceclofenac was ...

Contraindications

Hypersensitivity to Aceclofenac or to any of the excipients. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). NSAIDS are contraindicated ...

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 (see section 4.4). Anti-hypertensives: ...

Fertility, pregnancy and lactation

Pregnancy Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of ...

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 the elderly, may occur (see section ...

Overdose

Symptoms Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal irritation, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, ...

Pharmacodynamic properties

ATC code: M01AB16 Aceclofenac is a non-steroidal agent with marked anti-inflammatory and analgesic properties. The mode of action of aceclofenac is largely based on the inhibition to prostaglandin synthesis. ...

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

Core Tablet: Cellulose microcrystalline Croscarmellose sodium Povidone K-30 Glyceryl palmitostearate Tablet coating: Hypromellose 15 cps Macrogol 400 Titanium dioxide (E171).

Incompatibilities

Not applicable.

Shelf life

4 years.

Special precautions for storage

Store below 25°C.

Nature and contents of container

Aceclofenac Tablets 100 mg are packed in aluminium -aluminium blister packs. The aluminium blister foil is soft temper, plain, one side bright, dull side lacquer laminated to 25 μm OPA, bright side lacquer ...

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Accord Healthcare Limited Sage House 319, Pinner Road North Harrow Middlesex HA1 4 HF United Kingdom

Marketing authorization number(s)

PL 20075/0350

Date of first authorization / renewal of the authorization

14/09/2011

Date of revision of the text

07/07/2012
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