Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Aceclofenac
EURODRUG LABORATORIES (M) SDN. BHD.
Aceclofenac
10 Tablets; 20 Tablets; 40 Tablets; 50 Tablets; 100 Tablets
Industrias Farmaceuticas Almirall, S.A. (IFA)
AIRTAL ® 100MG FILM-COATED TABLET Aceclofenac (100mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Airtal_ is used for 2. How _Airtal_ works 3. Before you use _Airtal_ 4. How to use _Airtal_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Airtal_ 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial Number WHAT _AIRTAL_ IS USED FOR Airtal is used to relieve pain and reduce redness and swelling (inflammation) in patients suffering from: Osteoarthritis - inflammation of the joints. This is a common condition in patients over the age of 50 and causes damage to the tissues and bones in the joints. Rheumatoid arthritis - long term inflammation of the joints caused by the body’s own immune system (autoimmune response). Ankylosing spondylitis - inflammation of the spine/backbone which can lead to the joints fusing together. HOW _AIRTAL_ WORKS Airtal belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). They have anti- inflammatory and painkiller properties causing a lowering of swelling, redness (inflammation) and pain. The medicine/active ingredient of Airtal is aceclofenac. Airtal works by blocking the production of hormone-like substances called prostaglandins. Prostaglandins have many functions in the body including an important role in both the way the body responds to inflammation and also the reabsorption of calcium in some diseases of the bone. BEFORE YOU USE _AIRTAL_ - _When you must not use it _ if you are allergic to aceclofenac or any of the other ingredients of this medicine (listed in section 6). if you are allergic to aspirin or any other NSAIDs (such as ibuprofen, naproxen or diclofenac). if you have taken aspirin or any other NSAIDs and experienced one of the following: - asthma attack causing tightness in the chest wheezing and difficulty breathing. - runny nose, itching and/or sneezing (irritation of the nose). - raised red circular patc Leggi il documento completo
AIRTAL ® 100 MG FILM-COATED TABLET NON STEROIDAL ANTI-INFLAMMATORY DRUG FORMULATION: Each Aceclofenac (Airtal ® ) Film-coated tablet contains: Aceclofenac ……………….……………………. 100mg Excipients: microcrystalline cellulose, croscarmellose sodium, glyceryl palmitostearate, povidone, hydroxypropyl methyl cellulose, polyoxyl 40 stearate and titanium dioxide. White circular biconvex film-coated tablets. INDICATION: Aceclofenac (Airtal ® ) is indicated for the relief of pain and inflammation in, osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. MECHANISM OF ACTION: Aceclofenac (Airtal ® ) is a non-steriodal agent with anti-inflammatory and analgesic properties. Its pharmacotherapeutic group is: Non-steroidal anti-inflammatory and anti-rheumatic products. Derivatives of acetic acid and related substances. (ATC Code: M01AB16). Aceclofenac’s mechanism of action is largely based on inhibiting prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cyclooxygenase, which is involved in producing prostaglandins. After oral administration, Aceclofenac is rapidly and completely absorbed as unaltered drug. Maximum plasma concentrations are reached approximately 1.25 to 3.00 hours after administration. Aceclofenac penetrates into the synovial fluid, where its concentrations reach approximately 57% of the plasma concentrations. The volume of distribution is approximately 25 L. The plasma half-life is around 4 hours. Aceclofenac shows high protein binding (>99%). Aceclofenac mainly circulates in the form of unaltered drug. The principal metabolite found in the plasma is 4’-hydroxyaceclofenac. Approximately two thirds of the dose administered is excreted through the urine, predominantly in the form of hydroxymetabolites. The results from preclinical studies performed with aceclofenac are congruent with those expected in non-steroidal anti- inflammatory drugs. The main target organ was the gastrointestinal tract. No unexpected findings were recorded. Aceclofenac was consi Leggi il documento completo