Rantudil retard 90 mg Hard capsule Sustained-release

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ACEMETACIN

Available from:

MEDA Manufacturing GmBH D-51010 Cologne, Germany

ATC code:

M01AB11

INN (International Name):

ACEMETACIN 90 mg

Pharmaceutical form:

HARD CAPSULE PROLONGED-RELEASE CAPSULE

Composition:

ACEMETACIN 90 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2008-01-18

Patient Information leaflet

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1
PACKAGE LEAFLET: INFORMATION FOR PATIENTS
_ _
_ _
_Rantudil_
_® _
_retard _
_Rantudil retard, _
90 mg sustained-release 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 medication has been prescribed for you personally and may not be
passed on to third
parties. It may harm them, even if their symptoms are the same as
yours.
•
If you notice any side effects, contact your doctor or pharmacist.
This also applies to side
effects not listed in this leaflet. (see section 4)
CONTENTS OF THIS LEAFLET
1.
What
_Rantudil retard_
is and what it is used for.
2.
What you need to know before you take
_Rantudil retard._
3.
How to take
_Rantudil retard_
.
4.
Possible side effects.
5.
How to store
_Rantudil retard._
6.
Package contents and other information.
1.
WHAT _RANTUDIL RETARD_ IS AND WHAT IT IS USED FOR.
_Rantudil retard _
is an anti-inflammatory and analgesic medication (non-steroidal anti-
inflammatory/analgesic)
THERAPEUTIC INDICATIONS FOR _RANTUDIL RETARD _
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)
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2
-
inflammatory soft-tissue rheumatism syndrome
-
painful swelling or inflammation following injuries.
Due to the sustained release of the active substance acemetacin,
_Rantudil retard _
is not suitable as
an introductory treatment for disorders where rapid onset of action is
required.
2

Summary of Product characteristics

Page
1
of
16
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_Rantudil_
_®_
_ forte _
_60 mg hard capsules _
_Rantudil_
_®_
_ retard _
_90 mg hard capsule, sustained-release _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rantudil forte
Each hard capsule contains 60 mg acemetacin.
Other ingredients with known effects: Each hard capsule contains 73.9
mg
lactose- monohydrate.
_Rantudil retard _
Each sustained-release hard capsule contains 90 mg acemetacin.
Other ingredients with known effects: Each sustained-release hard
capsule contains
63.0 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
DOSAGE FORM_ _
_Rantudil forte _
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.
_Rantudil retard _
Sustained-release hard capsule; colour of the upper capsule shell is
opaque brown
(brown), colour of the lower capsule shell is opaque yellow
(yellow-beige); size 1.
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.
Page
2
of
16
For sustained-release hard capsule:
Due to the sustained release of the active substance acemetacin,
_Rantudil retard_
is not
suitable as an introductory treatment for disorders where rapid onset
of action is
required.
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.
_RANTUDIL FORTE, _6