Pentasa granules prolonged action for oral use 1g sachets, 50pcs

Composition

of 1 pack. – mesalazine 1000 mg.

Auxiliary substances:

ethylcellulose-4 mg-15 mg,

povidone-50 mg

Pharmacological action

Mesalazine-5-aminosalicylic acid-is the active component of sulfasalazine. Pentasa® granules are microgranules of mesalazine coated with ethylcellulose. The therapeutic effect of mesalazine after oral use is more due to the local effect on inflamed intestinal tissue than to the systemic effect. The therapeutic effect of mesalazine is manifested by local contact with the affected intestinal mucosa. Mesalazine inhibits leukocyte chemotaxis, reduces the production of cytokines and leukotriene, and reduces the formation of free radicals in inflamed intestinal tissue. But the exact mechanism of action of mesalazine is not fully understood.

Indications

* Ulcerative colitis• Crohn’s disease

Use during pregnancy and lactation

Pentasa should only be used during pregnancy if the expected benefit to the mother outweighs the potential risk to the fetus. In the last 2-4 weeks of pregnancy, the drug should be discontinued. Mesalazine penetrates the placental barrier and is excreted in breast milk. Therefore, breast-feeding should be discontinued while taking Pentasa®.

Contraindications

* Hypersensitivity to salicylates and other components of the drug• Severe liver or kidney failure• Peptic ulcer of the stomach or duodenum• Hemorrhagic diathesis• Children under 6 years of agefif you have one of these diseases, be sure to consult your doctor before taking the drug.

With caution

With caution, the drug should be prescribed to patients with impaired lung function, in particular, with bronchial asthma. Caution should be exercised when prescribing Pentasa® to patients with mild to moderate renal/hepatic insufficiency, since a decrease in the rate of elimination and an increase in the systemic concentration of mesalazine increases the risk of kidney damage.

Side effects

Diarrhoea (3%), nausea (3%), abdominal pain (3%), headache (3%), vomiting (1%), and skin rashes (1%) are most common when Pentasa is used.

( * ) The mechanism of development of adverse reactions, presumably, is allergic in nature. If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Concomitant use of Pentasa with azathioprine or 6-mercaptopurine increases the risk of bone marrow suppression (leukopenia, thrombocytopenia, erythrocytopenia/anemia, or pancytopenia). Concomitant use of Pentasa and other drugs with nephrotoxicity, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and azathioprine, increases the risk of adverse reactions from the kidneys. It slows down the absorption of cyanocobalamin (vitamin B12), enhances the hypoglycemic effect of sulfonylurea derivatives, ulcerogenicity of glucocorticosteroids, toxicity of methotrexate, weakens the activity of furosemide, spironolactone, sulfonamides, rifampicin, probenecid and sulfinpyrazone, enhances the action of anticoagulants, increases the effectiveness of uricosuric drugs (tubular secretion blockers). With the simultaneous use of mesalazine and digoxin, digoxin absorption decreases.

How to take, course of use and dosage

Pellets are recommended to be taken after meals, without chewing. Pour the contents of one sachet on your tongue and wash it down with water or juice. Children over 6 years of age and teenagers:  the dosage is selected individually. The recommended dose during the acute period is 20-30 mg of mesalazine per kilogram of body weight per day in several doses, the maximum single dose is not more than 75 mg / kg, the maximum daily dose is not more than 4 g. The recommended maintenance dose is 20-30 mg/kg / day, the maximum daily dose is not more than 2 g. Children with a body weight of more than 40 kg are recommended toAdults:  the dosage is selected individually. The recommended dose during exacerbation is up to 4 g per day, divided into several doses, maintenance therapy is 2-4 g per day, divided into several doses. The duration of therapy is determined by the attending physician.

Overdose

Cases of overdose with Pentasa® are rare. There are no specific antidotes. It is recommended to flush the stomach and take measures to increase diuresis. In case of acidosis, alkalosis, dehydration, hyperventilation or pulmonary edema, it is necessary to restore the acid-base and water-electrolyte balance. If there are signs of hypoglycemia, you should take glucose.

Special instructions

In case of acute symptoms of intolerance to the drug (muscle spasms, abdominal pain, fever, severe headache and skin rashes) or signs of impaired liver and/or kidney function, Pentasa® should be discontinued. During the entire course of treatment with Pentasa®, the blood creatinine concentration should be regularly monitored.

Form of production

Granules of prolonged action for oral use are cylindrical, from light gray to light brown in color.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date.

Active ingredient

Mesalazine

Conditions of release from pharmacies

By prescription

Dosage form

long-acting tablets

Purpose

For adults as directed by your doctor

Indications

Colitis, Crohn ‘s Disease