Ziloxicum 60mg Capsules Hard

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

ACEMETACIN

Beszerezhető a:

Drossapharm GMBH Wallbrunnstrasse 24 79539 Lörrach, Germany

ATC-kód:

M01AB11

INN (nemzetközi neve):

ACEMETACIN 60 mg

Gyógyszerészeti forma:

HARD CAPSULE

Összetétel:

ACEMETACIN 60 mg

Recept típusa:

POM

Terápiás terület:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Engedélyezési státusz:

Authorised

Engedély dátuma:

2014-06-17

Betegtájékoztató

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZILOXICUM 60 MG CAPSULES, HARD
acemetacin
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 get 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 Ziloxicum 60 mg is and what it is used for
2.
What you need to know before you take Ziloxicum 60 mg
3.
How to take Ziloxicum 60 mg
4.
Possible side effects
5.
How to store Ziloxicum 60 mg
6.
Contents of the pack and other information
1.
WHAT ZILOXICUM 60 MG IS AND WHAT IT IS USED FOR
Ziloxicum 60 mg is a medicine for the relief of inflammation and pain,
and belongs to the group of
the so-called non-steroidal anti-inflammatory medicinal products
(NSAIDs).
Ziloxicum 60 mg is used for the syptomatic treatment of pain and
inflammation in patients suffering
from
•
acute arthritis (including gout)
•
chronic arthritis, particularly in rheumatoid arthritis (chronic
polyarthritis)
•
ankylosing spondylitis (Bechterew’s Disease) and other inflammatory
rheumatic spinal
disorders
•
osteoarthritis
•
soft tissue inflammatory rheumatic disorders
•
painful inflammation and swelling due to trauma
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZILOXICUM 60 MG
DO NOT TAKE ZILOXICUM 60 MG
•
if you are allergic to acemetacin, indometacin or any of the other
ingredients of this medicine
(listed in section 6).
•
if you have a history of wheezing or asthma attacks, swelling of the
nasal mucosa ,
angioedema or hives in response to acetylsalicylic acid or other
NSAIDs.
•
if you suffer from unexplained disturbance of formation of blood
cells.
•
if you suffer from active pep

Termékjellemzők

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ziloxicum 60 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard contains 60 mg acemetacin.
Excipients with known effects:
55 mg lactose (as monohydrate) per capsule, hard
0,022 mg Azorubine (E122) per capsule, hard
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Hard gelatine capsule, size 4 (14.3 mm x 5,3 mm) with an
ivory-coloured opaque body and a violet
opaque cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of pain and inflammation in
•
acute arthritis (including gout)
•
chronic arthritis, particularly in rheumatoid arthritis (chronic
polyarthritis)
•
ankylosing
spondylitis
(Bechterew’s
Disease)
and
other
inflammatory
rheumatic
spinal
disorders
•
osteoarthritis
•
soft tissue inflammatory rheumatic disorders
•
painful inflammation and swelling due to trauma
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology with single and daily doses:
Acemetacin is dosed according to the severity of the disease.
ADULTS:
The recommended dose range is between 60 and 180 mg per day divided
into 1 – 3 three single doses.
_ _
Age:
Single-dose:
Daily dose
Adults
60 mg Acemetacin
60 - 180 mg Acemetacin
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The physician should decide on the duration of treatment.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control the symptoms (see section 4.4).
Treatment of rheumatic diseases may require intake of Ziloxicum over a
longer period.
ACUTE GOUT:
For the treatment of acute gout a daily dose of 180 mg is recommended
until symptoms subside.
Higher doses may occasionally be required for the first 24 to 48
hours. Treatment with a daily dose
higher than 180 mg should only occur under the close supervision of
the prescribing physician.
_ _
ELDERLY:
The elderly are at increased risk of the serious consequences of
adverse reactions. If an NSAID is
considered necessary, the lowe