ARTHREXIN Capsule Ref.[50339] Active ingredients: Indometacin

Posology

Adults

The recommended dosage of ARTHREXIN is 50 mg to 200 mg daily in divided doses, individually adjusted to the patient’s response and tolerability to the medicine. Undesirable effects may be minimised by taking the lowest effective dose for the shortest possible duration of treatment (see section 4.4), consistent with individual patient treatment goals, starting with a low dose.

A loading dose of ARTHREXIN not necessary. In chronic rheumatic disorders, initiating therapy with low doses, increasing gradually when necessary, and continuing for an adequate period (up to one month is recommended), will produce maximum benefit and minimise adverse reactions.

In chronic conditions start the treatment with a low dosage, increasing as required. In chronic musculoskeletal and joint disorders, the usual initial dose is 25 mg two or three times daily with food, increased, if required, by 25 mg to 50 mg daily at weekly intervals, up to 150 mg to 200 mg daily in divided doses.

In patients with persistent night pain and/or morning stiffness, a dose of up to 100 mg at bedtime may be helpful in affording relief. A dosage of 200 mg per day should not be exceeded.

In acute periarticular disorders and in low back pain 50 mg may be given two or three times daily for about 10 days. In the treatment of gouty arthritis, the recommended daily dosage of 150 mg to 200 mg in divided doses, until symptoms and signs subside.

In primary dysmenorrhoea, the recommended dosage is 75 mg daily as a single or divided dose, starting at the onset of cramps and bleeding and continuing for as long as symptoms usually last. The total combined daily dose by mouth should not generally exceed 200 mg.

Paediatric population

The safety and efficacy of indomethacin, as in ARTHREXIN, in children has not been established (see section 4.4).

Method of administration

For oral administration.

To minimise or reduce the possibility of gastrointestinal disturbances, it is recommended that ARTHREXIN be taken with food, milk or an antacid.

Symptoms

Symptoms include headache, nausea, vomiting, dyspepsia, epigastric pain, ulceration and/or gastrointestinal bleeding, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, occasionally convulsions, abdominal pain, anorexia, restlessness and agitation, vertigo and, gastrointestinal irritation resulting in, peptic ulceration often with bleeding and acute pancreatitis. In cases of significant poisoning, kidney injury (acute kidney failure) and liver damage are possible.

Treatment

In acute poisoning, the stomach should be emptied by inducing emesis or by aspiration and lavage.

Blood-electrolyte balance should be maintained.

Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Good urine output should be ensured. Renal and liver function should be closely monitored. Patients should be observed for at least four hours after ingestion of potentially toxic amounts. Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patient’s clinical condition.

Treatment is supportive and symptomatic.

ARTHREXIN 25: 60 months in securitainers, amber PVC Xactics, PVC blisters, Tins and in PP Hinge-lid vials. 24 month shelf life is inferred for the product packed in polyethylene minigrip and metallised patient ready packs.

ARTHREXIN-50: 24 months.

Store at or below 25°C.

Protect from light and moisture.

Keep in original packaging until required for use.

ARTHREXIN 25

100 capsules are packed in a white cylindrical polypropylene container and sealed with a white round, flat topped linear low density polyethylene snap-on cap with a tamper evident seal.

500 capsules are packed in a white polypropylene container and sealed with a white low density polyethylene snap-on cap together with a silica gel sachet.

1000 capsules are packed in an amber polyvinylchloride container and sealed with a white round flat-topped, high-density polyethylene crab claw cap together with a silica gel sachet.

15 or 84 capsules are packed in a metallised polyester, laminant and opaque white linear low density polyethylene patient ready lay flat pack. The lay flat is then sealed with a clear zip and overwrapped with a clear, low density polyethylene bag.

ARTHREXIN-50

30 or 100 capsules are packed in a white cylindrical polypropylene container and sealed with a white linear low-density polyethylene cap together with a foam insert. 500 capsules are packed in an amber polyvinylchloride container and sealed with a white high-density polyethylene pilfer proof screw cap together with a silica gel sachet.

1000 capsules are packed in a clear polyethylene bag, inside a white round polypropylene bucket and sealed with a white high density polyethylene lid together with silica gel sachets.

Not all packs or pack sizes may be marketed.

No special requirements.