ETOPAN XL 400

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

ETODOLAC

Disponibbli minn:

TARO PHARMACEUTICAL INDUSTRIES LTD

Kodiċi ATC:

M01AB08

Għamla farmaċewtika:

TABLETS EXTENDED RELEASE

Kompożizzjoni:

ETODOLAC 400 MG

Rotta amministrattiva:

PER OS

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

TARO PHARMACEUTICAL INDUSTRIES LTD

Grupp terapewtiku:

ETODOLAC

Żona terapewtika:

ETODOLAC

Indikazzjonijiet terapewtiċi:

For the management of signs and symptoms of osteoarthrities and rheumatoid arthritis.

Data ta 'l-awtorizzazzjoni:

2021-06-30

Fuljett ta 'informazzjoni

Etopan PIL
_–_
_ final September 2023 _
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
ETOPAN XL
400
EXTENDED-
RELEASE
TABLETS
ETOPAN XL
600
EXTENDED-
RELEASE
TABLETS
ACTIVE INGREDIENT
AND ITS QUANTITY:
Each extended-
release tablet
contains:
etodolac 400 mg
ACTIVE INGREDIENT
AND ITS QUANTITY:
Each extended-
release tablet
contains:
etodolac 600 mg
Inactive ingredients and allergens
in this medicine: see
section 2 ‘Important information about
some of this medicine’s ingredients’, and section 6 ‘Additional
information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1
. WHAT IS THIS MEDICINE INTENDED FOR?
For the management of signs and symptoms of osteoarthritis and
rheumatoid arthritis.
THERAPEUTIC GROUP:
Non-steroidal anti-inflammatory drugs (NSAIDs).
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient (etodolac) or to
any of the other
ingredients in this medicine (see section 6).
•
You have SEVERE HEART FAILURE.
•
You have an ulcer (a peptic ulcer, a small lesion or hole in the
stomach or duodenum) or
bleeding in the stomach, or have had two or more episodes of ulcers,
stomach bleeding or
perforation.
•
You have had an ALLERGIC REACTION OR ASTHMATIC REACTION (wheezing,
itching or skin rash)
after taking aspirin, Etopan or another NSAID.
•
You have severe liver failure and kidney failure.
•
YOU ARE IN THE LAST TRIMESTER OF PREGNANCY.
•
You have previously had bleeding from the stomach or bowel due to
taking a NSAID.
Etopan PIL
_–_
_ final September 2023 _
2
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BE

Karatteristiċi tal-prodott

Etopan XL Physician Leaflet Notification September 2023
1
Physician’s Prescribing Information
Etopan XL 400
Etopan XL 600
Extended Release Tablets
1.
Name of the medicinal product
Etopan XL 400
Etopan XL 600
2.
Qualitative and quantitative composition
Each tablet of Etopan XL 400 mg contains 400 mg etodolac.
Each tablet of Etopan XL 600 mg contains 600 mg etodolac.
Excipients with known effect
Each Etopan XL 400 mg tablet contains 37.33 mg of lactose anhydrous.
Each Etopan XL 600 mg tablet contains 56 mg of lactose anhydrous.
For the full list of excipients, see section 6.1.
3.
Pharmaceutical form
Extended release tablets
Etopan XL 400: pink, round, bi-convex, film coated tablet. One side is
engraved with 'T400', other side is plain.
Etopan XL 600: gray, oval, bi-convex, film coated tablets. One side is
engraved with 'T600', other side is plain.
4.
Clinical particulars
4.1 Therapeutic indications
For the management of signs and symptoms of osteoarthritis and
rheumatoid arthritis.
4.2 Posology and method of administration
400 mg XL - One to two tablets twice daily but no more than three
tablets
a day.
600 mg XL - One tablet once or twice daily.
The total daily dose of Etopan XL should not exceed 1,200 mg.
As with other NSAIDs, the lowest dose and longest interval should be
sought for each patient. Therefore, after observing the response to
initial
therapy with Etopan XL, the dose and frequency should be adjusted to
suit individual patient’s needs (tolerance and response). In
responsive
patients, partial symptomatic relief of symptoms usually occurs within
1
Etopan XL Physician Leaflet Notification September 2023
2
or 2 weeks, although maximum effectiveness may occur only after
several weeks of therapy.
During long-term administration the dose of Etopan XL may be adjusted,
up or down, depending on the patient’s clinical response (maximum
dose
1200 mg/day).
As with other NSAIDs, Etopan XL is preferably taken after meals or
with
food or antacids to reduce gastrointestinal irritation, especially
during
chronic u