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Physician's Prescribing Information Etopan XL 400 and 600 MG Extended Release Tablets
Physician's Prescribing Information Etopan XL 400 and 600 MG Extended Release Tablets
3. Pharmaceutical form
Extended Release Tablets
4. Clinical particulars
5.
4.1 Therapeutic indications
For the management of signs and symptoms of osteoarthritis and
rheumatoid arthritis.
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. 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
4.3 Contraindications
• Hypersensitivity to etodolac or to any of the excipients.
NSAIDs are contraindicated in patients who have previously shown
hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria)
in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory
drugs.
• History of gastrointestinal bleeding or perforation, related to previous
NSAID's therapy.
• Active or history of recurrent peptic ulcer/haemorrhage (two or more
distinctepisodes of proven ulceration or bleeding).
• Severe heart failure, hepatic failure and renal failure (see section 4.4).
• During the last trimester of pregnancy (see section 4.6).
4.9 Overdose
a) Symptoms
Symptoms include headache, nausea, vomiting, epigastric pain,
gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation,
coma, drowsiness, dizziness, tinnitus, fainting, and occasionally
convulsions. In cases of significant poisoning acuterenal failure and liver
damage are possible.
b) Therapeutic measure
Patients should be treated symptomatically as required.
Within one hour of ingestion of a potentially toxic amount, activated
charcoal should be considered. Alternatively, in adults,gastric lavage
should be considered within one hour of ingestion of a potentially life-
threatening overdose.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of
potentially toxic amounts.
Frequent or prolonged convulsions should be treated with intravenous
diazepam. Other measures may be indicated by thepatient's clinical
condition.
6. Pharmacological properties
5.1 Pharmacodynamic properties
ATC code: M01A B08
7. Pharmaceutical particulars
6.1 List of excipients
Microcrystalline cellulose, Hypromellose, Lactose anhydrous, Povidone,
Magnesium stearate, Polydextrose, Titanium Dioxide, Triacetin,
Macrogol, FD&C Red #40 Aluminum Lake (E129), FD&C Yellow #6
Aluminum Lake (E110), FD&C Blue #2 Aluminum Lake (E132), black iron
oxide (E172) and yellow iron oxide (E172)
6.2 Incompatibilities
The content of this leaflet was approved by the Ministry of Health in June
2013 and updated according to the guidelines of the Ministry of Health in
April 2018.