Composition: 

Each coated tablet contains 100 mg Aceclofenac.

 

Properties:

• Aceclofenac is a new synthetic non-steroidal product which has an important anti-rheumatic, analgesic, and anti-inflammatory activity.
• It inhibits the synthesis of prostaglandines, main mediators of inflammatory processes.

 

Indications:

• Aceclotic is indicated for the treatment of pain of different aetiology such as: odontalgia,

post- traumatic tumefaction, lumbosciatica, myalgia, post-episiotomiae pain, post-labour pain, primary dysmenorrhoea and extra-articular rheumatism.

• Due to its anti-inflammatory activity it is also indicated in chronic treatment of inflammatory cases such as: rheumatoid arthritis, ankylopietic spondylitis, arthrosis and scapulohumeral periarthritis.

 

Contraidications:

-      This drug should not be taken if the patient is allergic to Aceclofenac or to drug of the same group (Diclofenac).

-      As with other anti-inflammatory non-steroidal agents, it is contraindicated in asthmatic patients in which Acetylsalicylic acid and other inhibitory agents of synthetase prostaglandine cause access of asthma, urticaria or acute rhinitis.

-      It should not be used in patients suffering from gastroduodenal ulcer in active phase.

 

Side effects:

• The reported side effects have usually been slight and transitory: epigastric pain, stomach-ache, vomiting, nausea, and sensation of fullness, occasionally skin rash, oedemas, and rarely urticaria.
• Occasionally may arise headache, sensation of tiredness, drowsiness or dizziness as well as an increase of nocturnal diuresis.

 

Precautions:

-      Patients suffering from gastrointestinal troubles or with a history of peptic ulcer should be kept under close observation.

-      It should be used with special care in elderly patients or in patients under treatment with diuretics and/or in convalescent patients after surgical operations, as well as in patients under the effects of a server hepatic, cardiac or renal lesion.

 

Warnings:

-       Though the present  data are insufficient, it is recommended not to use this drug during pregnancy or breast-feeding.

-       As a measure of prudence, patients must refrain from driving or handling dangerous machinery, and must avoid situations requiring a special state of alertness.

-       This drug is not to be taken in children under 7 years.

 

Drug Interactions:

Although there are no data concerning the interactions of this drug with others, it is convenient to inform the doctor if the patient is under treatment with other medicaments, especially if they contain lithium, digoxine, anticoagulants, oral administration antidiabetics, diuretics or any other anti-pain drug.

 

Dosage and administration:

-       Treatment (number of tablets, number of intakes, and duration) should be established by the doctor.

-       It is important that the patient follows doctor’s instructions.

-       Generally, the daily dose is of two tablets (200mg/ day) divided into two intakes,

1 tablet every 12 hours.

 

Overdose:

• In case of a massive accidental intake, the patient should be treated according to symptoms, giving him medication against gastrointestinal irritation, hypotension, respiratory depression, and convulsions.

 

Package:

Box contains 20 coated tablets.