Medicinal Products

DICLOFENAC SANDOZ 50 mg

Generic drug from Voltarene
Therapeutic class: Anti-inflammatories
Active ingredients: Diclofenac
laboratory: Sandoz

Gastroresistant tablet
Box of 30
All forms

Indication

They come from the anti-inflammatory activity of diclofenac, the importance of the manifestations of intolerance to which the drug gives rise and from its place in the range of anti-inflammatory products currently available.
IN ADULT AND CHILD FROM 15 YEARS, they are limited to:
- Long-term symptomatic treatment:
. chronic inflammatory rheumatism, including rheumatoid arthritis, ankylosing spondylitis or related syndromes, such as Fiessinger-Leroy-Reiter syndrome and psoriatic arthritis,
. some painful and disabling arthroses.
- Short-term symptomatic treatment of acute episodes of:
. abarticular rheumatism (acute painful shoulders, tendinitis, bursitis),
. microcrystalline arthritis,
. arthrosis,
. low back pain, severe radiculalgia.
- Treatment of essential dysmenorrhea after etiological assessment.
IN CHILDREN FROM 35 KG, (ABOUT 12 YEARS), the indication is limited to infantile inflammatory rheumatism.

Dosage DICLOFENAC SANDOZ 50 mg Gastroresistant tablet Box of 30

Administration mode :
Oral way.
The tablets are swallowed whole without chewing with a glass of water, preferably during the meal.
Dosage:
- Adult :
. Maintenance treatment (or from the outset in some patients) : 75 to 100 mg per day, that is: 3 tablets at 25 mg per day to 2 tablets at 50 mg in 2 or 3 doses.
. Treatment of acute flares : 150 mg for up to 7 days, ie 1 tablet at 50 mg, 3 times daily for 7 days.
In case of acute attack, it is advisable to take the tablets before meals.
. Essential dysmenorrhea : 100 mg daily in 2 doses, ie 1 tablet at 50 mg, morning and evening.
- Child from 35 kg to 50 kg (12 to 15 years): 2 to 3 mg / kg per day, to be divided into 2 or 3 doses.
As an indication: 1 tablet 50 mg, 2 to 3 times a day, or 100 to 150 mg per day.

Against indications

CONTRAINDICATED:
This medicine is contraindicated:
- history of allergy or asthma triggered by taking diclofenac or substances of similar activity such as other NSAIDs, aspirin,
- hypersensitivity to any of the excipients,
- evolving gastroduodenal ulcer,
- severe hepatocellular insufficiency,
- severe renal insufficiency,
- child under 35 kg (due to the inappropriate dosage of this medicine),
- from the 6th month of pregnancy: during the third trimester, all prostaglandin synthesis inhibitors may expose the fetus to cardiopulmonary toxicity (pulmonary arterial hypertension with premature closure of the ductus arteriosus), renal dysfunction up to at renal failure with oligoamnios; the mother and the child, at the end of pregnancy, to a possible lengthening of the bleeding time. As a consequence, apart from extremely limited obstetric use and which warrant specialized supervision, the prescription of NSAIDs is contraindicated from the 6th month.
Due to the presence of lactose, this drug is contraindicated in case of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
NOT RECOMMENDED :
- Breast-feeding: NSAIDs passing into breast milk, as a precaution, should be avoided in women who are breastfeeding.
- This drug is generally not recommended in combination with:
. oral anticoagulants,
. other NSAIDs (including high-dose salicylates),
. heparins (parenteral route),
. lithium,
. methotrexate (used at doses greater than 15 mg / week),
. ticlopidine.

Adverse effects Diclofenac Sandoz

- Gastrointestinal effects:
. Uncommon : at the start of treatment, nausea, vomiting, diarrhea, abdominal cramps, epigastric pain, dyspepsia, anorexia, belching.
. Rare : gastroduodenal ulcer, perforation or digestive hemorrhage. These are all the more frequent as the dosage used is high.
. Isolated cases : lower abdominal conditions such as nonspecific haemorrhagic colitis, exacerbation of ulcerative colitis. Pancreatitis has been reported, cases of constipation.
- Skin effects:
. Isolated cases : hair loss, photosensitization reactions.
. Very rare : occurrence of bullous dermatoses (Stevens-Johnson, Lyell syndrome) and erythroderma.
- Hypersensitivity reactions:
. dermatological : rash, urticaria, eczema.
. Respiratory : bronchospasm, hypersensitivity pneumonitis.
. others : isolated cases of vasculitis including allergic purpura, hypotension.
. general : very rare anaphylactic / anaphylactoid reactions, especially in subjects with allergy to aspirin.
- Effects on the Central Nervous System:
. Uncommon : Headache, dizziness or vertigo.
. Rarely : drowsiness.
. Isolated cases : convulsions, aseptic meningitis. Insomnia, irritability, asthenia, tremors have been reported.
Isolated cases of sensory disturbances: paresthesia, visual disturbances (visual blur, diplopia), tinnitus.
- Effects on the kidney:
. Rare peripheral edema.
. Isolated cases : acute renal failure, urinary abnormalities (hematuria, proteinuria), interstitial nephritis, nephrotic syndrome, papillary necrosis, hyperkalemia due to hyporeninism.
- Effects on the liver:
. Uncommon : increased serum transaminases.
. Rare hepatitis with or without jaundice.
. Isolated cases : fulminant hepatitis.
- Effects on the blood:
Very rarely : leukopenia, agranulocytosis, thrombocytopenia with or without purpura, bone marrow aplasia, hemolytic anemia.

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