ADVERSE REACTIONS SECTION.

ADVERSE REACTIONSThe majority of side effects observed have been reversible and of minor nature and include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea), rash, ruber, urticaria, symptoms of enuresis, headache, dizziness, and drowsiness. To report suspected adverse reactions, call 1-800-FDA-1088.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONSPatients with allergy to these drugs or other analogues (diclofenac). Patients with asthma. Like NSAIDS, acetylsalicylic acid and other drugs which inhibit prostagladin-synthesis may precipitate attacks of asthma, acute rhinitis or urticaria. Patients with active peptic ulcer.

DESCRIPTION SECTION.

DESCRIPTIONWhite, oblong, film-coated tablet, engraved with UT on one side and CL CR on the other side.

DOSAGE & ADMINISTRATION SECTION.

Dosage and AdministrationAdults: The recommended dose is 200 mg daily, taken as one dose (every 24 hours). However, the dose and dose frequency of CLANZA CR can be modified under the supervison of physician or pharmacist.

DRUG INTERACTIONS SECTION.

DRUG INTERACTIONSThere has been no drug interactions reported, but close monitoring of patients on combination with lithium and digoxin, oral antidiabetic agents, anticoagulants, diuretics, and other analgesics.

GENERAL PRECAUTIONS SECTION.

GENERAL PRECAUTIONSPatients suffering from dizziness, vertigo, or other central nervous system disorders while taking NSAIDS should refrain from driving or handling dangerous machinery.

HOW SUPPLIED SECTION.

PACKAGE10 Blister Packs with 10 Tablets in each Blister Pack.

INDICATIONS & USAGE SECTION.

INDICATIONSCLANZA CR is indicated for Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and periarthritis of scapulohumerous, lumbago, ischiadynia, pain caused by nonaticular rheutism.

OVERDOSAGE SECTION.

OVERDOSAGEThere are no human data available on the consequences of CLANZA CR overdosage. If overdosage is observed, therapeutic measures should be taken according to symptoms; supportive and symptomatic treatment should be given for complications such as hypotension, gastro-intestinal irritation, respiratory depression, and convulsions.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

label test Clanza Package Label.

PEDIATRIC USE SECTION.

USE IN CHILDRENThe dosage and indication is not established yet for children with less than years old.

PRECAUTIONS SECTION.

CAUTIONSPatients with symptoms indicative of gastro-intestinal disorders, with history of gastroulceration. Patients with severe hepatic impairment or cardiac or renal impairment. Patients under the medication of diuretics. Patients in recovery after surgical treatment.

PREGNANCY SECTION.

USE IN PREGNANCY AND NURSING MOTHERSSince there is no information on the safe use of CLANZA CR during pregnancy and lactation, the use of CLANZA CR should therefore be avoided in pregnancy and lactation.

SPL PATIENT PACKAGE INSERT SECTION.

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STORAGE AND HANDLING SECTION.

STORAGEPreserve in tight containers. Store at room temperature not exceeding 30oC.SHELF LIFEThree (3) years from manufacturing date. Do not exceed the expiry date for use printed on the box.