Each capsule contains:

Active ingredients:

- Diclofenac Sodium 50 mg.

- Thiamine nitrate (vit Bl) 50 mg.

- Pyridoxine HCL (vit BG} 50 mg.

- Cyanocobalmine (vit B12) 0.25 mg.

Pharmaceutical form: Capsule

Diclofenac is approved for the chronic symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. It's apparent accumulation in the synovial fluid provided a longer duration of action than would be expected from its plasma half-lifer because of its potent cyclooxygenase inhibitor activity the most side effects are Gestro Intestinal bleeding and ulceration. Diclofenac exerts its anti-inflammatory activity by the inhibition of cyclooxygenase and thus the inhibition of the formation of the prostaglandins, Diclofenac inhibit cyclooxygenase through reversible competitive inhibition, this drug bind to the active site of the enzyme and compets with the active substrate. Diclofenac's effectiveness reduced as it's concentration decreased. Diclofenac also has dual mechanism of action with regard to its analgesic efficacy. In addition to inhibiting cyclooxygenase activity, it also down-regulate on going hyperalgesia.

• Diclofenac is rapidly absorbed when given as oral solution, su11pository, or by intramuscular injection. It is absorbed more slowly when given as enteric-coated tablets especially when this dosag form is given with food. although orally administrated diclofenac is the most completely absorbed. It is subjectea to first pass metabolism so that only 50 to 60% of the drug reaches the systemic circulation in the unchanged form, diclofenac is also absorbed percutaneously. At therapeutic concentrations it is more than 99% bound to 11lasma proteins. Diclofenac Penetrates synovial fluid and has been detected in breast milk; the terminal plasma half-life is about 1 to 2 hours.

• Diclofenac is metabolized and then excreted in form of glucuronide and sulphate conjugates, mainly in urine but also in bile.

- Neuritis and neuralgia e.g. cervical syndrome lumbago, ishialgia.

- Painful degenerative forms of rheumatism of an inflammatory nature or activated by an inflammation, e.g.

*Arthrosis

*Chronic polyarthritis.

*Spondylitis.

*spondylitis ankylosans ( Bechterew's disease)

*Acute attacks of gout.

- Non-articular rheumatism. - Non-rheumatic inflammatory pain.

(Capsule should be swallowed whole, with some water, during or after meals) & dose adjusted by doctor depending on severity of the disease, the recommended dose is:

Adults: 1 capsule (1-3 times/ day).

Children over 6 years of age: 2 mg diclofenac per kg body weight distributed over several doses.

For children under 6 years of age: definitely to the excluded from therapy.

Arthineur should not be used in:

- Gastric or duodenal ulcer.

- Prophyria.

- Patients with hypersensitivity to any of the active or inactive constituent.

- Disturbance of liver function and of haematopoiesis.

- Patients sensitive to acetylsalicylic acid or other non-steroidal anti-inflammatory agents with symptoms of asthma attacks, skin reactions, or acute rhinitis, arthineur may only be used with certain precautions.

- Gastrointeinal disorders, such as nausea, diarrhea, slight gastrointesestinal bleeding and gastric & intestinal ulcers may develop, single cases of abdominal complains have been reported.

- Central nervous system disorders, such as headaches, excitation, irritability, insomnia, tiredness and dizziness in rare cases. There have been isolated cases of disturbed, sensibi11ty or vision, tinnitus and SP.asm.

- Hypersensitivity reactions such as rashes and pruritus, nave occasionally been observed, so have in rare case urticaria and loss of hair, in isolated cases hypersensitivity to light, eczema and server forms of skin reactions may occur in rare cases.

- With long term therapy: liver & kidney damage is to be expected only in rare cases.

- Rarely, tendency towards accumulation of water in the body e.g. peripheral oedema.

- Urticaria has been described after administration of vitamin B1.

- Concomittant use of Arthineur with digoxin or lithium may increase the serum concentration of digoxin or lithium.

- Arthineur may diminish the effect of diuretics and antihypertensive, concomitant use of arthenieur with KSparing diuretics may lead to hyperkalaemia.

- Administration of arthineure within 24 hours before or after a dose of methotrexate may increase the concentration of methotrexate.

- Arthinure must not be administered in the last trimester of Pregnancy, during lactation period or to infants.

- Although so far there have been no indications of any teratogenic effects, Arthineur should not be taken during the first and second trimester of pregnancy either.

- Careful medical monitoring is required in patients with history of gastric or intestinal ulcer, with gastrointestinal disorders, as well as in patients with liver or kidney damage, hypertension and/or heart failure and in elderly patients.

- If sever pain, in particular in the epigastric region and/or black discoloration of the feces should accur, the doctor should be informed immediately.

- In long term therapy blood count, liver values & renal function should be monitored regularly.

-when use arthineur the ability to drive or operate machinery is impaired this applies particularly in conjugation with alcohol.

-Arthinure should not be administered in children under age of 6.

- Arthinure should not indicate in vit B deficiency.

- A box of 10 capsules in a blister.

the drug should not be used after the expiry date.

Store below 30° c in dry place

Protect from moisture, keep of reach of children