Country: Malta
Language: English
Source: Medicines Authority
ACEMETACIN
Viatris Healthcare GmbH Lutticher Strasse 5 53842 Troisdorf, Germany
M01AB11
ACEMETACIN 60 mg
HARD CAPSULE
ACEMETACIN 60 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Authorised
2008-01-18
1 PACKAGE LEAFLET: INFORMATION FOR PATIENTS _ _ _ _ _Rantudil_ _® _ _forte _ _Rantudil forte, _ 60 mg hard capsule Acemetacin For use by adults READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE AS IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you notice any side effects please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4. CONTENTS OF THIS LEAFLET 1. What Rantudil forte is and what it is used for. 2. What you need to know before you take Rantudil forte _._ 3. How to take Rantudil forte. 4. Possible side effects. 5. How to store Rantudil forte _._ 6. Package contents and other information 1. WHAT _RANTUDIL FORTE_ IS AND WHAT IT IS USED FOR. _Rantudil forte _ is an anti-inflammatory and analgesic medication (non-steroidal anti- inflammatory/analgesic). THERAPEUTIC INDICATIONS FOR _RANTUDIL FORTE _ Symptomatic treatment of pain and inflammation in - acute inflammation of the joints (arthritis) including attacks of gout - chronic inflammation of the joints (arthritis), in particular in cases of rheumatoid arthritis (chronic polyarthritis) - Bechterew’s disease (ankylosing spondylitis) and other inflammatory rheumatic conditions of the spinal column - irritation caused by degenerative disorders of the joints and the spinal column (arthroses, spondylarthroses) - inflammatory soft-tissue rheumatism syndrome - painful swelling or inflammation following injuries. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _RANTUDIL FORTE._ DO NOT TAKE _RANTUDIL FORTE_ 2 - if you are allergic to acemetacin, indometacin or any of the other ingredients of this medicine listed in section 6; - if you have had an asthma attack, nasal swelling or skin reaction in the past after taking ac Read the complete document
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT _Rantudil_ _®_ _ forte _ _60 mg hard capsules _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 60 mg acemetacin. Other ingredients with known effects: Each hard capsule contains 73.9 mg lactose- monohydrate. For a full list of excipients, see section 6.1. 3. DOSAGE FORM_ _ Hard capsule; colour of the upper capsule shell is L 570 red (orange-brown), colour of the lower capsule shell is opaque yellow (yellow-beige); size 4. 4. CLINICAL PARTICULARS 4.1 AREA OF APPLICATION Symptomatic treatment of pain and inflammation in - acute arthritis (including attacks of gout) - chronic arthritis, in particular in cases of rheumatoid arthritis (chronic polyarthritis) - ankylosing spondylitis (Bechterew’s disease) and other inflammatory rheumatic conditions of the spinal column - irritation caused by osteoarthritis and spondylosis - inflammatory soft-tissue rheumatism syndrome - painful swelling or inflammation following injuries. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology with single and daily doses The dose of acemetacin depends on the severity of the disorder being treated. The recommended dose range for adults is between 60 and 180 mg of acemetacin per day, spread over 1 - 3 individual doses. Age: Single dose: Total daily dose (Capsules) (Capsules) Adults 1 1 - 3 (equivalent to 60 mg of acemetacin) (equivalent to 60 - 180 mg of acemetacin) Dosage in acute attacks of gout: The dose for acute attacks of gout is 180 mg of acemetacin a day until the symptoms subside. Page 2 of 13 Higher doses may be indicated if specifically prescribed by the doctor. Patients without pre- existing gastrointestinal damage can take 120 mg of acemetacin at the start of treatment followed by a further 60 mg of acemetacin every 6 hours; a maximum dose range of 300 mg of acemetacin per 24 hours is permitted. On the second day of treatment, the same dose may be taken if necessary; otherwise, the dose should be reduced. Method and duratio Read the complete document