AMDOCIN Capsule Ref.[115178] Active ingredients: Indometacin

Posology

Adults

The recommended dosage is 25 mg to 200 mg daily divided in two to four equal doses. 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 AMDOCIN is 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 AMDOCIN, 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 AMDOCIN 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.

24 months.

Store at or below 25°C.

Protect from light and moisture.

Keep in original packaging until required for use.

KEEP OUT OF REACH OF CHILDREN.

Aluminium foil/PVC film blister strip of 15 capsules and a package insert in a printed carton.

4 Aluminium foil/PVC film blister strip of 21 capsules and a package insert in a printed carton.

Bottles containing 100, 500 and 1 000 capsules.

Not all pack sizes may be marketed.

No special requirements.