ETOPAN XL 500

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 500 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

1
Etopan XL Patient Leafletnotification-06.21
-
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)
1986
The medicine is dispensed in accordance with a doctor’s prescription
only
ETOPAN XL 600
DELAYED-RELEASE
TABLETS
ETOPAN XL 400
DELAYED-RELEASE
TABLETS
ACTIVE INGREDIENT AND ITS QUANTITY:
Each delayed-release tablet
contains: etodolac 600 mg
ACTIVE INGREDIENT AND ITS QUANTITY:
Each delayed-release tablet
contains: etodolac 400 mg
For the list of inactive ingredients, see section 2 under "Important
information about some of the
ingredients of the medicine" and section 6 “Additional
information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have any further
questions, ask your doctor or
pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others.
It may harm them, even if their illness appears to be similar.
This medicine is not recommended for children and infants.
1.
WHAT IS THIS MEDICINE INTENDED FOR?

For the treatment of symptoms of osteoarthritis and rheumatoid
arthritis.
THERAPEUTIC GROUP:
Non-steroidal anti-inflammatory drugs (NSAIDs)
2.
BEFORE USING THE MEDICINE
:
DO NOT TAKE THE MEDICINE IF:

you are hypersensitive (allergic) to the active ingredient (etodolac)
or any of the other
ingredients of this medicine (listed in section 6)

you are sensitive to other analgesics of the NSAID class, such as
aspirin or ibuprofen.

you are in the last trimester of pregnancy.

you have previously experienced shortness of breath, rhinitis
(congested or runny nose)
or urticaria (allergic skin reaction) after taking aspirin, ibuprofen
or another medicine of
the NSAID class.

you suffer from severe heart failure, hepatic failure or renal
failure.
2
Etopan XL Patient Leafletnotification-06.21

you have experienced gastrointestinal bleeding or perforation as a
result of taking
another NSAID.

you have a peptic ulcer (an ulcer

Karatteristiċi tal-prodott

Etopan XL 500 Physician Leaflet Notification Nov 2021
1
PHYSICIAN’S PRESCRIBING INFORMATION
ETOPAN XL 500
EXTENDED RELEASE TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Etopan XL 500 mg Extended Release Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Etopan XL 500 mg contains 500 mg etodolac.
Excipient with known effect
Each Etopan XL 500 mg tablet contains 46.67 mg of lactose anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Extended Release Tablets
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
500mg XL ‐ one tablet once or twice daily
The total daily dose of Etopan XL should not exceed 1,200mg.
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 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 use.
Etopan XL 500 Physician Leaflet Notification Nov 2021
2
However, for faster absorption when a rapid initial effect is
required, the first 1
or 2 doses may be taken 30 minutes before meals or at least 2 hours
after
meals. If an antacid is taken concurrently, an aluminum and
magnesium‐
containing formulation may be preferred. It is recommended to take
Etopan XL
tablets with a full glass of water and that the patient remains in an
upright
position for 15‐30 minutes after administrati