Download Etopan XL 400600-Tab-PL.fh9

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Etodolac 600 mg
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Etodolac 400 mg
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Microcrystalline cellulose, Hydroxypropyl methylcellulose, Lactose anhydrous,
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PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
The dispensing of this medicine requires a doctor's prescription
Read this package insert carefully
in its entirety before using this medicine
The format of this leaflet was determined by the
Ministry of Health and its content was checked and approved
ETOPAN XL
400 mg
ETOPAN XL
600 mg
Extended-release tablets
Extended-release tablets
Composition:
Each extended-release tablet contains: Each extended-release tablet contains:
Etodolac 400 mg
Etodolac 600 mg
Inactive ingredients:
Microcrystalline cellulose, Hydroxypropyl methylcellulose, Lactose anhydrous,
Povidone, Opadry colour (pink or green or grey), Magnesium stearate
Each ETOPAN XL 400 mg tablet contains: 37.33 mg lactose.
Each ETOPAN XL 600 mg tablet contains: 56.00 mg lactose.
Therapeutic group: Nonsteroidal anti-inflammatory drugs (NSAIDs).
Therapeutic activity:
A nonsteroidal anti-inflammatory drug for the management of osteoarthritis and
rheumatoid arthritis symptoms.
When should the preparation not be used?
Do not use this medicine if you are sensitive to any of its ingredients or to other
drugs for the management of pain from the same group, including aspirin.
Do not use this medicine in late pregnancy.
Do not use this medicine if you suffer from severe allergic reactions, e.g. rash, or
from asthma in conjunction with nasal polyps due to using acetylsalicylic acid or
any other nonsteroidal anti-inflammatory drug.
Do not use this medicine if you suffer, or have suffered in the past, from active
peptic ulcer.
Do not use this medicine before or after bypass surgery.
Do not take this medicine without consulting a doctor before starting
treatment:
If you are pregnant or breastfeeding.
If you are suffering, or have suffered in the past, from impaired function of: the liver,
the kidney/urinary tract, the digestive system (e.g. ulcer), the blood system (e.g.
coagulation disorder), the respiratory system (e.g. asthma), the heart, from diabetes
mellitus, hypertension and from fluid retention problems.
How will this medicine affect your daily life?
Drinking wine, alcoholic beverages or smoking while under treatment with this
medicine may increase the risk of gastrointestinal ulceration.
Warnings:
The preparation contains lactose and may cause an allergic reaction in patients
sensitive to lactose.
NSAID medications may increase the risk of heart attack or stroke, especially in
patients with heart disease or after prolonged treatment. Use the lowest effective
dose for the shortest possible duration of treatment.
Before any surgical treatment, including dental surgery, inform your doctor that you
are using this medicine.
Inform your doctor if you are going to undergo laboratory tests because the use of
this drug may interfere with test results.
As with other preparations belonging to the group of nonsteroidal anti-inflammatory
drugs (NSAIDs), this preparation may increase the risk of gastric bleeding, especially
in the following cases: in people concomitantly taking blood thinners, steroids and
other NSAIDs, in prolonged use of the preparation and when consuming alcohol.
If you are sensitive to any type of food or medicine, inform your doctor before
commencing treatment with this medicine.
Caution is recommended in geriatric patients, who may develop adverse hepatic,
renal and gastrointestinal effects.
Drug interactions:
If you are taking another drug concomitantly, including non-prescription medicines
and nutritional supplements, or if you have just finished treatment with another
medicine, inform the attending doctor, in order to prevent hazards or lack of efficacy
arising from drug interactions. This is especially important for medicines belonging
to the following groups: aspirin or any other nonsteroidal anti-inflammatory drugs
(especially phenylbutazone), antihypertensives, anticoagulants (e.g. warfarin),
cyclosporin for organ transplants, digitalis glycosides, probenecid for gout, diuretics
(for example: furosemide), valproic acid for epilepsy, methotrexate for cancer or
psoriasis, lithium (for treatment of bipolar disorder), cephalosporin antibiotics,
corticosteroids.
Side effects:
In addition to the desired effect of the medicine, adverse reactions may occur during
the course of taking this medicine, for example: dizziness, headache, stomach ache,
bloating, nausea, diarrhea, constipation, vomiting, mouth sores, numbness and
pricking sensation in the limbs and hypersensitivity to light.
Effects that require special attention:
Fever and chills, muscle aches, skin rash, itching, depression, digestive problems,
blood in the stools or black stools, black vomit, acute abdominal spasms and pain,
heartburn, painful and urgent urinating, changes in vision, tinnitus (rare): stop
treatment and consult your doctor.
Change in the color of urine, palpitations, unusual bleeding or bruising, high blood
pressure and/or swelling of the legs (rare): stop treatment and refer to the doctor.
Allergic reaction such as swelling of the lips, tongue, throat and/or breathing difficulties:
stop treatment and refer to the doctor immediately.
In the event that you experience side effects not mentioned in this leaflet, or if there
is a change in your general health, consult your doctor immediately.
Dosage:
Dosage is according to doctor's instructions only.
Do not exceed a total daily dosage of 1200 mg.
This medicine is not usually recommended for administration to children and
infants.
This medicine is to be taken at specific time intervals as determined by the attending
doctor.
If you forget to take this medicine at the specified time, take the dose as soon as
you remember, but never take a double dose to compensate for a missed one!
Directions for use:
Do not chew, halve or crush! Swallow the medicine with a glass of water - do not
lie down for 30 minutes after taking the medicine.
Take the medicine with or after a meal.
How can you contribute to the success of the treatment?
Complete the full course of treatment as instructed by the doctor.
Even if there is an improvement in your health, do not discontinue use of this
medicine without consulting your doctor.
Avoid poisoning!
This medicine, and all other medicines, must be stored in a safe place out of the
reach of children and/or infants, to avoid poisoning.
If you have taken an overdose, or if a child has accidentally swallowed the medicine,
proceed immediately to a hospital emergency room and bring the package of the
medicine with you.
Do not induce vomiting unless explicitly instructed to do so by a doctor!
This medicine has been prescribed for the treatment of your ailment; in another
patient it may cause harm. Do not give this medicine to your relatives, neighbours
or friends.
Do not take medicines in the dark! Check the label and the dose each time you take
your medicine. Wear glasses if you need them.
Storage: Store in a cool and dry place (250C).
Even if kept in their original container and stored as recommended, medicines may
be kept for a limited period only. Please note the expiry date of the medicine! In
case of doubt, consult the pharmacist who dispensed the medicine to you.
Do not store different medications in the same package.
License number: ETOPAN XL 400 mg: 13003.30728
ETOPAN XL 600 mg: 12259.30274
Manufacturer:
Taro Pharmaceutical Industries Ltd., P.O.Box 10347, Haifa Bay 26110.