Rantudil Forte 60mg Hard Capsule

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland

ATC code:

M01AB11

INN (International Name):

ACEMETACIN 60 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

ACEMETACIN 60 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2008-01-18

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_RANTUDIL FORTE, _60 MG HARD CAPSULE
Acemetacin
For use by adults
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE 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 signs of illness are the same as yours.
-
If you notice any side effects, talk to your doctor or pharmacist.
This includes any possible
side effects not listed in this leaflet. See Section 4.
WHAT IS IN 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.
Contents of the pack 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 _
-
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
2
acetylsalicylic acid or other non-ste

Summary of Product characteristics

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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.
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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