Medicinal Products

PENTASA 1 g / 100 ml

Generic drug of the therapeutic class: Gastro-Entero-Hepatology
active ingredients: Mesalazine
laboratory: Ferring Sas

Rectal suspension
box of 5 bottles of 100 ml
All forms

Indication

· In monotherapy: low forms (not exceeding the left colic angle) of ulcerative colitis in mild or moderate thrust.

· In combination with other treatments for ulcerative colitis (oral salazosulfapyridine, oral or local corticosteroids): forms that are recurrent or resistant to these treatments.

Dosage PENTASA 1 g / 100 ml rectal suspension box of 5 vials of 100 ml

· In monotherapy: low forms (not exceeding the left colic angle) of ulcerative colitis in mild or moderate thrust.

· In combination with other treatments for ulcerative colitis (oral salazosulfapyridine, oral or local corticosteroids): forms that are recurrent or resistant to these treatments.

Against indications

· Known hypersensitivity to salicylates.

· Hypersensitivity to the active substance or to any of the excipients listed under Composition .

· Severe renal insufficiency and / or severe hepatic impairment.

Pentasa side effects

The following adverse reactions have been reported at frequencies corresponding to: common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10 000), <1/1000), very rare (<1 / 10, 000), not known (can not be estimated from the available data).

Difficulty keeping the enema, itching or painful bowel movements may occur while taking this medication.

Adverse reactions reported during clinical and post-marketing studies are described below:

MedDRA System Organ Classification (SOC)

Frequent (≥1 / 100, ≤1 / 10)

Uncommon (≥1 / 1, 000, <1/100)

Rare (≥1 / 10, 000, <1/1000)

Very rare (<1 / 10, 000)

Blood and lymphatic system disorders

Achievements of different blood lines (aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia), eosinophilia (due to an allergic reaction)

Immune system disorders

Pancolitis, hypersensitivity reactions (including allergy, exanthema, lupus erythematosus syndrome), drug-induced fever

Nervous system disorders

Dizziness, headache

Peripheral neuropathy

Heart conditions

Myocarditis and pericarditis

Respiratory, thoracic and mediastinal disorders

Allergic reactions and pulmonary fibrosis (including dyspnea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, interstitial lung disease, pulmonary infiltration, pneumonia)

Gastrointestinal disorders

Diarrhea, abdominal pain, nausea, vomiting, flatulence, increased amylase

Acute pancreatitis

investigations

Deterioration of liver function tests (increased transaminases and increased cholestasis parameters)

Hepatobiliary disorders

Hepatitis, cholestatic hepatitis

Affection of skin and subcutaneous tissue

Rash (including urticaria, rash erythematosus)

Alopecia

Musculoskeletal and systemic disorders

Myalgia, arthralgia

Renal and urinary disorders

Impairment of renal function including acute and chronic interstitial nephritis, and renal failure, nephrotic syndrome, discoloration of urine

General disorders and administration site conditions

Abdominal distension (only with the rectal form).

Anal discomfort, irritation at the site of application, tenesmus (only with rectal form)

Disorders of reproductive organs and breast

Oligospermia (reversible)

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers. Website: www.ansm.sante.fr.

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