Etodolac 2care4 200mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ETODOLAC

Available from:

2care4 Generics ApS Stenhuggervej 12-14, 6710 Esbjerg V, Denmark

ATC code:

M01AB08

INN (International Name):

ETODOLAC 200 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ETODOLAC 200 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2013-05-30

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ETODOLAC 2CARE4 200 MG FILM-COATED TABLETS
ETODOLAC 2CARE4 300 MG FILM-COATED TABLETS
ETODOLAC
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 Etodolac 2care4 is and what it is used for
2.
What you need to know before you take Etodolac 2care4
3.
How to take Etodolac 2care4
4.
Possible side effects
5.
How to store Etodolac 2care4
6.
Contents of the pack and other information
1.
WHAT ETODOLAC 2CARE4 IS AND WHAT IT IS USED FOR
Etodolac 2care4 is a pain-killing and anti-inflammatory agent. It
belongs to the group of non
steroid anti-inflammatory drugs (NSAIDs).
You can take Etodolac 2care4
•
For the treatment of rheumatic diseases
•
For the treatment of pain and swelling of joints and muscles
Your doctor may have given you Etodolac 2care4 for a different
disorder. Always follow your
doctor's orders.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ETODOLAC 2CARE4
DO NOT TAKE ETODOLAC 2CARE4
•
if you are allergic to etodolac or any of the other ingredients of
this medicine (listed in section
6);
•
if you have experienced bleeding from your stomach or intestines or
your intestines have been
perforated due to treatment with painkillers (NSAIDs);
•
if you have or have had gastric ulcer or gastric bleeding more than
once;
•
if you have a very bad liver or kidneys;
•
if you have a very bad heart;
•
if you have a low platelet count in your blood;
•
if you have previously had difficulty in breathing, asthma, hives or a
cold after treatm

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
ETODOLAC 2CARE4 200MG FILM-COATED TABLETS
ETODOLAC 2CARE4 300MG FILM-COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Etodolac 2care4 200mg film-coated tablets
Etodolac 2care4 300mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of etodolac
Each tablet contains 300mg of etodolac
Excipient(s) with known effect:
Each tablet contains 85 mg lactose monohydrate and 15mg sodium starch
glycolate.
Each tablet contains 127.5 mg lactose monohydrate and 22.5mg sodium
starch glycolate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatic diseases and other inflammatory disorders.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Symptoms should be treated at the lowest effective dose for the least
amount of time to
minimize adverse reactions of Etodolac 2care4 (see section 4.4).
ADULTS
200mg twice daily, if necessary increased to 200mg three times daily
or 300mg twice daily.
OLDER PEOPLE
Elderly patients often experience adverse reactions following the use
of NSAIDs, see section The
treatment should be initiated at the lowest effective dose.
_Paediatric population_
Etodolac 2care4 should not be used in children.
The safety and efficacy of etodolac in children have not been
established.
IMPAIRED RENAL FUNCTION
Caution should be exercised in patients with impaired renal function,
see section 4.4.
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Method of administration
For oral administration
The tablets must be taken with a glass of water.
4.3
CONTRAINDICATIONS
Etodolac 2care4 is contraindicated in:
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
A history of gastrointestinal bleeding or perforation in connection
with NSAID treatment.
•
Active or recurrent gastrointestinal ulcer or gastrointestinal
bleeding (i.e. two or several
individual episodes of diagnosed ulcer or bleeding).
•
Severe hepatic or renal failure (