Rantudil Forte 60mg Hard Capsule

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ACEMETACIN

Available from:

MEDA Manufacturing GmBH

ATC code:

M01AB11

INN (International Name):

ACEMETACIN

Pharmaceutical form:

HARD CAPSULE

Composition:

ACEMETACIN 60 milligram(s)

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2008-01-18

Patient Information leaflet

PIL0800101
1
02.02.2015
_Translation from the German Language _
PACKAGE LEAFLET: INFORMATION FOR THE USER
_Rantudil_
_®_
_forte _
_Rantudil forte_ Hard Capsules 60 mg
Active substance: Acemetacin
For use in adults.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
1.
What _Rantudil forte_ is 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 analgesic and anti-inflammatory drug
(non-steroidal antiphlogistic /
analgesic agent).
USES
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 case
of rheumatoid
arthritis (chronic polyarthritis),
-
Bechterew's disease (ankylosing spondylitis) and other inflammatory
rheumatic
conditions of the spinal column,
PIL0800101
2
02.02.2015
-
irritation caused by degenerative disorders of the joints and the
spinal column
(osteoarthritis, spondylosis),
-
inflammatory soft-tissue rheumatism syndrome,
-
painful swelling and/or inflammation following injuries.
2. WHAT YOU NEED BEFORE YOU TAKE _RANTUDIL FORTE_
_DO NOT TAKE RANTUDIL FORTE _
-
if you are allergic (hypersensitive) to the active substance
acemetacin, to indometacin or any
of the other ingredients of this medicinal product;
-
if you ever had a bad reaction (such as asthma attacks, n

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
_Rantudil_
_®_
_ forte _
_60 mg Hard capsule _
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Acemetacin
_Rantudil forte _
1 hard capsule contains 60 mg acemetacin
3.
PHARMACEUTICAL FORM
_Rantudil forte _
Hard capsule; colour of the upper capsule part is red (brown-orange =
L 570),
colour of the lower capsule part is yellow opaque; size 4
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of pain and inflammation in
-
acute arthritis (including attacks of gout),
-
chronic arthritis, in particular in case of rheumatoid arthritis
(chronic polyarthritis),
-
ankylosing spondylitis (Bechterew's disease) and other inflammatory
rheumatic
conditions of the spinal column,
-
irritation caused by osteoarthritis and/or spondylosis,
-
inflammatory soft-tissue rheumatism syndrome,
-
painful swelling and/or inflammation following injuries.
For sustained-release 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 correct dose of acemetacin depends on the severity of the disorder
being treated. The
recommended dose range for adults is between 60 and 180 mg acemetacin
per day, spread
over 1 -3 individual doses.
RANTUDIL FORTE 60 MG:
Age:
Single dose:
(Capsules)
Total daily dose
(Capsules)
Adults
1
(equivalent to
60 mg acemetacin)
1 - 3
(equivalent to
60 - 180 mg acemetacin)
Page
1
of
13
RANTUDIL RETARD 90 MG:
Age:
Single dose:
(Capsules)
Total daily dose
(Capsules)
Adults
1
(equivalent to
90 mg acemetacin)
1 - 2
(equivalent to
90 - 180 mg acemetacin)
Dosage in acute attacks of gout:
The usual recommended dose to treat acute attacks of gout - until the
symptoms subside - is
180 mg acemetacin per day.
Higher doses may be indicated if specifically prescribed by the
doctor. Patients without
pre-existing gastrointestinal damage can take 120 m