Diclofenac-50

Diclofénac-50

COMPOSITION

Each film coated tablet contains :

• Diclofenac (INN) sodium…………………………………………: 50 mg
• Excipients : qsp…………………………………..: one film coated tablet.

THEARAPEUTIC PROPERTIES

• Analgesic, antipyretic, anti-inflammatory,
• Short-term inhibition of platelet functions.

INDICATIONS

• Long-term symptomatic treatment of: chronic inflammatory rheumatism, particularly rheumatoid arthritis and ankylosing spondylitis; certain painful and disabling osteoarthritis.
• Short-term symptomatic treatment of acute flare-ups of non-articular rheumatism (acute painful shoulders, tendinitis, bursitis), microcrystalline arthritis, osteoarthritis, low back pain, severe radicular pain.

–        Treatment of primary dysmenorrhea, after etiological assessment.

CONTREAINDICATIONS

• History of allergy or asthma triggered by diclofenac use.
• Hypersensitivity to any of the components.
• Active gastroduodenal ulcer.
• Severe hepatic impairment.
• Severe renal impairment.
• Child weighing less than 35 kg.
• Pregnant woman (from the 6th month): see Pregnancy and Breastfeeding.

IN CASE OF DOUBT, IT IS NECESSARY TO CONSULT YOUR DOCTOR OR PHARMACIST.

PRECAUTION AND WARNING

– Diclofenac will be administered with caution and under special supervision in individuals with a history of digestive issues (gastroduodenal ulcer, ulcerative colitis, Crohn’s disease).

– At the beginning of treatment, careful monitoring of urine output and renal function is necessary in individuals with chronic heart, liver, and kidney failure.

– During prolonged treatment, it is recommended to monitor blood counts and liver and renal functions.

SIDE EFFECTS

– Rare for gastroduodenal  : at the start of treatment, nausea, vomiting, diarrhea, abdominal cramps, epigastric pain, dyspepsia, anorexia, belching.

– Isolated cases: hair loss, photosensitivity reactions.

– Dermatological: skin rash, urticaria, eczema.

– Rare for nervous central system  : headaches, dizziness, or vertigo.

DOSAGE

Children:

• For 35 kg, approximately 12 years old): Inflammatory rheumatism: 2 to 3 mg/kg/day, divided into 2 or 3 doses
• For 35 to 50 kg (approximately 12 to 15 years old): 1 film coated tablet of 50 mg 2 to 3 times per day, 100 to 150 mg per day.

Adult:

• Maintenance treatment (or initially for certain patients): 75 to 100 mg per day, or 2 film coated tablets of 50 mg in 2 doses.

• Treatment of acute flare-ups: 150 mg for a maximum of 7 days, or 1 film coated tablet of 50 mg 3 times per day.

• Primary dysmenorrhea: 100 mg per day in 2 doses, or 1 film coated tablet of 50 mg morning and evening. Preferably taken with meals.

Conservation :

• – Store below 30^oC, avoid light and humidity
• Keep out of reach and sight of children.
• Do not use after expiry date.