Medicinal Products

DIPENTUM 500 mg

Generic drug of the therapeutic class: Gastro-Entero-Hepatology
Active ingredients: Olsalazine
laboratory: Ucb Pharma SA

Compressed
Box of 1 bottle of 60
All forms

Indication

Attack and maintenance treatment of ulcerative colitis, especially in case of allergy or intolerance to salazopyrine.

Dosage DIPENTUM 500 mg Tablet Box of 1 Bottle of 60

Oral way.

RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS

The tablets should be taken at regular intervals during the day immediately after meals.

In the adult

Attack treatment

3 to 4 tablets a day (1.5 to 2 g), in 3 to 4 regularly spaced doses.

It is advisable to start this treatment gradually (for example with two tablets) in order to improve its tolerance. The dose increase is slower, with lower doses and longer intervals, if digestive disorders occur.

In case of insufficient therapeutic response and in the absence of side effects, it is possible to increase the daily dose up to 3 g (6 tablets), without exceeding 1 g (2 tablets) per dose.

Maintenance treatment

1 tablet 2 times a day.

In children over 6 years of age (because of the risk of miscarriage)

Attack treatment

1 to 3 tablets daily depending on age and weight.

Maintenance treatment

1 tablet 2 times a day.

Against indications

Hypersensitivity to olsalazine, salicylates or any of the excipients.

· Severe renal or hepatic impairment.

Dipentum side effects

The most common side effects are diarrhea, which is usually transient, but may require a dose reduction or discontinuation if significant (approximately 5% of cases).

Other adverse reactions reported with olsalazine are presented below by organ class and by frequency estimation according to the following classification:

Very common (≥1 / 10) frequent (≥1 / 100 to <1/10); uncommon (≥1 / 1000 to <1/100); rare (≥1 / 10, 000 to <1/1000); very rare (<1 / 10, 000); not known (can not be estimated based on available data)

General disorders and administration site conditions

· Common: headache

· Uncommon: fever

Blood and lymphatic system disorders

· Uncommon: thrombocytopenia

· Not known: aplastic anemia, eosinophilia, haemolytic anemia, leukopenia, neutropenia, pancytopenia.

Gastrointestinal disorders

· Common: diarrhea, nausea

· Uncommon: vomiting, dyspepsia

· Not known: abdominal pain, pancreatitis

Hepatobiliary disorders

· Uncommon: increased liver enzymes

· Not known: hepatitis, increased bilirubin

Skin and subcutaneous tissue disorders

· Common: rash

· Uncommon: pruritus, alopecia, photosensitivity reactions, urticaria

· Not known: angioneurotic edema

Heart conditions

· Uncommon: tachycardia

· Not known: myocarditis (against indicating any reintroduction), palpitations, pericarditis

Renal and urinary disorders

· Not known: tubal-interstitial nephritis

Chest and mediastinal respiratory disorders

· Uncommon: dyspnea

· Not known: interstitial lung disease

Musculoskeletal and systemic disorders

· Common: arthralgia

· Uncommon: myalgia

Nervous system disorders

· Uncommon: dizziness, paresthesia

· Not known: Peripheral neuropathy

Psychiatric disorders

· Uncommon: depression

Eye disorders

Not known: blurred vision

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