Nelpharm Diclofenac Sodium and Paracetamol Caplet

NELPHARM
DICLOFENAC SODIUM + PARACETAMOL

 

COMPOSITION

Each caplet contains:

Diclofenac Sodium 50mg

Paracetamol 500mg

 

PHARMACOLOGICAL CLASSIFICATION

Analgesic, Anti-inflammatory.

 

PHARMACOLOGICAL ACTION

Diclofenac exerts its actions analgesic and inflammatory through the synthesis of prostaglandins, substances that carry out an important action in the development of the pain, the inflammation and the fever.

 

INDICATIONS

Management of primary dysmenorrhoea, prompt pain relief, Non-articular Rheumatoid conditions, Rheumatoid or Osteoarthritis, Cervical Spondylosis, Infective Inflammation & dental conditions, Pain, Fever as associated with inflammation.

 

CONTRA-INDICATIONS

Sensitivity to paracetamol. Severe liver function impairment.
Diclofenac sodium is contraindicated in patients with known hypersensitivity to diclofenac and in patients who respond to aspirin and aspirin-type drugs with sensitivity reactions like asthma, acute rhinitis and urticaria. Diclofenac sodium is absolutely contra-indicated in patients with peptic ulceration or a history of such ulceration, and should be used with caution in patients with renal or hepatic insufficiency.

 

WARNINGS

Dosage in excess of those recommended can cause severe liver damage. Prolonged excessive use may cause irreversible kidney damage. Patients suffering from liver or kidney disease should only take Paracetamol under medical supervision. Consult your doctor if no relief is obtained from the recommended dosage. Do not use continuously for more than 10 days without consulting your doctor.

 

DOSAGE AND DIRECTIONS FOR USE

Usual Adult dose: 1 Tablet every 8 or 12 hours or as directed by your physician. The maximum recommended daily dosage is 3 tablets. The product is not recommended for use in children. Do not use continuously for more than ten (10) days without consulting your doctor.

 

SIDE-EFFECTS AND SPECIAL PRECAUTIONS

Skin rashes and other allergic reactions may occur occasionally. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by drug fever and mucosal lesions. The use of paracetamol has been associated with the occurrence of neutropenia, thrombocytopenia, pancytopenia and leucopoenia. The dose should be reduced in renal functional impairment.

Paracetamol should be given with care to patients with impaired kidney or liver function.

Paracetamol should be given with care to patients taking other drugs that affect the liver. In view of the product’s inherent potential to cause fluid retention, heart failure maybe precipitated in some compromised patients.

 

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

For symptoms of over dosage see Side-Effects and Special Precautions. Treatment is supportive and symptomatic.

 

PRESENTATION

10 caplets in a blister, 1 blister in a box.

10 caplets in a blister, 2 blister in a box.

10 caplets in a blister, 10 blister in a box.

 

STORAGE INSTRUCTIONS

KEEP OUT OF REACH OF CHILDREN.

STORE IN A COOL DRY PLACE BELOW 30°C, PROTECT FROM LIGHT.

 

SHELF VALIDITY

3 YEARS

 

MANUFACTURED BY

Jiangsu Ruinian Qianjin Pharmaceutical Co., Ltd.

Chuanbu Village, Yixing Economic Development Zone,

Jiangsu Province, China

 

Marketed by

Nelpharm Nigeria Ltd

13 Okunfolami Street, Anthony Village, Lagos, Nigeria

 

NAFDAC REG. NO.: B4-3030

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