Pemason Pharmaceuticals Limited
72 Agege Motor Road, Alakara, Mushin.
Tel: 01-81507361, 2663986, 234-8033018912, 08033054541

Brand Name



Dextel Ltd, A Dexon Company, Or-Akiva, P.O.B. 50, Hadera 38100, Israel.

Therapeutic Class

Non-steroidal anti-inflammatory drugs (NSAIDs), Systemic

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet 50 (NRN: 04-0928): Diclofenac Sodium 50 mg; reddish-brown tabs.

Pack size: 30's; 50's (in blisters).

Betaren 50

Tablet Retard (NRN: 04-3877): Diclofenac Sodium 100 mg; sustained-release pink tab.

Pack size: 10's (in blisters).



Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of Diclofenac sodium, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.


Betaren Dexcel is an anti-inflammatory analgesic.


Hypersensitivity to one of its ingredients, or to aspirin, salicylates and other NSAIDs. Do not use this medicine if you are pregnant (last trimester of pregnancy) or breastfeeding; if you suffer from ulcer, bloody stool or dark stool.


Current or history of dysfunction of the respiratory tract (e.g. asthma), the cardiovascular system, the liver (e.g. hepatic porphyria), the kidney/urinary tract, the gastrointestinal tract (e.g. ulcer), the blood system (e.g. coagulation etc.), nasal polyps, high blood pressure, lupus erythematosus, connective tissue disease.

Use of this drug in high doses may affect alertness. It is therefore advisable to take special care when driving or when operating dangerous machinery. Do not drink wine and/or alcoholic beverages during treatment with this drug.

Do not use this medicine frequently or for lengthy periods without consulting your physician. If this is necessary, it is recommended to perform blood and urine tests, liver and kidney functions tests during treatment. Inform your doctor if you are aware of any sensitivities to foods or drugs before taking this medicine. If you are planning to undergo surgery (including dental surgery) inform your physician that you are taking Betaren Dexcel. Also notify your physician if you are planning to undergo laboratory tests as this drug may affect the results.


Notify your doctor if you are using aspirin and salicylates, anticoagulants, antihypertensives and drugs for the heart, diuretics, lithium, probenecid (anti-gout), methotrexate (for cancer and psoriasis), antidiabetics, cyclosporin (for implants), digoxin (for the heart), quinolone antibiotics, valproic acid, other NSAIDs.

Adverse Effects

In addition to the desired effect of the drug, some side effects may appear such as constipation, diarrhea, nausea, vomiting, headache, dizziness, heartburn, minor abdominal pain, gas, sensitivity to sunlight (use special protection during exposure to sunlight). Antacids may be taken to relieve gastrointestinal side effects; if these effects worsen contact your physician.

Side effects requiring special attention: Fever, swelling of face, lips, legs and hands, severe abdominal pain, hypersensitivity (rash or skin irritation, breathing difficulties, swelling around the eyes), black or bloody stool, bloody urine, vision disturbances, decreased urination, sores in the mouth, vomiting blood, nasal bleeding, hearing disturbances, symptoms of meningitis e.g. severe headache, stiff muscles, severe and continuous nausea and vomiting, spinal ache (rare); discontinue treatment and contact your physician immediately.

Dosage & Administration

According to physician's instruction only. Do not exceed the recommended dosage. This drug is usually not intended for children and infants under 14 years old.

If you have forgotten to take a dose, take it as soon as you remember, but never take two doses together.

Directions for use: Do not chew. This drug should be taken with a small quantity of water with or right after meals.

Storage/Handling Recommendations

Store in a dry and cool place.

Review Date

2015-07-08 08:04:14