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Βιβλιογραφική αναφορά

Προτάσεις

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

Εκδότης

Εκδότης Accord Healthcare Limited
Διεύθυνση Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, UK
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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 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” ...

Therapeutic indications

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

Posology and method of administration

Aceclofenac film-coated tablets are supplied for oral administration and should be swallowed whole with ...

Contraindications

Hypersensitivity to Aceclofenac or to any of the excipients. Active, or history of recurrent peptic ulcer/haemorrhage ...

Special warnings and precautions for use

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary ...

Interaction with other medicinal products and other forms of interaction

Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more ...

Fertility, pregnancy and lactation

Pregnancy Congenital abnormalities have been reported in association with NSAID administration in man; ...

Effects on ability to drive and use machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after ...

Undesirable effects

Gastrointestinal The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, ...

Overdose

Symptoms Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal irritation, gastrointestinal ...

Pharmacodynamic properties

ATC code: M01AB16 Aceclofenac is a non-steroidal agent with marked anti-inflammatory and analgesic properties. ...

Pharmacokinetic properties

After oral administration, aceclofenac is rapidly and completely absorbed as unchanged drug. Peak plasma ...

Preclinical safety data

The results from preclinical studies conducted with aceclofenac are consistent with those expected for ...

List of excipients

Core Tablet: Cellulose microcrystalline Croscarmellose sodium Povidone K-30 Glyceryl palmitostearate ...

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 ...

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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.