FLAMARYX Tablet Ref.[51178] Active ingredients: Meloxicam

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2012  Publisher: Aurogen South Africa (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa

4.1. Therapeutic indications

FLAMARYX is indicated for the symptomatic treatment of:

  • Rheumatoid arthritis.
  • Painful osteoarthritis.
  • Ankylosing spondylitis.
  • Episodes of acute sciatica.

4.2. Posology and method of administration

Safety and efficacy in children under the age of 18 years has not been established.

The tablet should be taken with a glass of water and together with a meal.

Use the lowest effective dose for the shortest possible duration of treatment.

The dose of FLAMARYX in patients with end stage renal disease on haemodialysis should not be greater than 7,5 mg/day. (No dosage reduction is necessary in patients with mild to moderate renal impairment).

Adults

The maximum daily dose of FLAMARYX is 15 mg.

Acute sciatica: 7,5 mg once daily. If there is no improvement the dose can be increased to 15 mg a day.

Ankylosing spondylitis: 15 mg once daily.

Osteoarthritis: 7,5 mg once daily. Increase to 15 mg if necessary.

Rheumatoid arthritis: 15 mg once daily. Reduce dose if possible (provided therapeutic response is maintained).

4.9. Overdose

Symptoms of overdosage

(See “SIDE EFFECTS”).

Treatment of overdosage

Treatment is symptomatic and supportive as there is no known antidote. Absorption should ber educed by:

  • Activated charcoal if patient presents 1 to 2 hours after overdose
  • Cholestyramine
  • Gastric lavage if within 1 hour of overdose

6.4. Special precautions for storage

Store at or below 25°C. Do not remove the blister from the carton until required for use.

KEEP OUT OF THE REACH OF CHILDREN.

6.5. Nature and contents of container

FLAMARYX 7,5 mg:

Tablets are packed in 250 micron white opaque PVC coated with 60 gsm PVdC and printed aluminium foil with 7 gsm heat seal lacquer. 3 blisters containing 10 tablets each are packed into a printed cardboard carton.

Pack size: 30’s (3 × 10’s).

FLAMARYX 15 mg:

Tablets are packed in 250 micron white opaque PVC coated with 60 gsm PVdC and printed aluminium foil with 7 gsm heat seal lacquer. 3 blisters containing 10 tablets each are packed into a printed cardboard carton.

Pack size: 30’s (3 × 10’s).

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.