Salofalk 500 Mg Tablet

Description

SALOFALK 500 MG TABLET

Description :

Each tablet contains mesalazine (5-aminosalicylic acid) 500 mg.

Each sachet of 1.5-g granules contains mesalazine 1.5 g.

Each suppository contains mesalazine 250 mg.

Inactive Ingredients/Excipients: Tablet: Calcium stearate, croscarmellose sodium, basic butylated methylacrylate copolymer (=Eudragit E), methacrylic acid-methyl methacrylate copolymer (1:1) (=Eudragit L), glycine, colloidal silica anhydrous, hypromellose, macrogol 6000, microcrystalline cellulose, sodium carbonate anhydrous, povidone K25, talc, coloring agents: titanium dioxide (E 171), iron oxide hydrate (E 172).

Sachet: Aspartame (E 951), carmellose Na, citric acid, anhydrous colloidal silica, hypromellose, magnesium stearate, methacrylic acid-methyl methacrylate copolymer (1:1), (MW: Approx 135,000), (Eudragit L 100), methylcellulose, microcrystalline cellulose, polyacrylate dispersion 40% (Eudragit NE 40 D containing 2% nonoxynol 100), povidone K 25, simeticone, sorbic acid (Ph.Eur.), talc, titanium dioxide (E 171), triethyl citrate, vanilla custard flavouring (containing propylene glycol).

Each mL of enema also contains sodium benzoate, potassium metabisulfite, disodium edetate, carbomer, potassium acetate and xanthan gum.

Mesalazine is 5-aminosalicylic acid.

Suppository: Hard fat.

Indications / Uses

Tablet: Treatment of acute attacks or to prevent relapse of ulcerative colitis and proctitis. Treatment of acute attack of Crohn’s disease.

Granules: Treatment of acute episodes and the maintenance of remission of ulcerative colitis.

Enema: Treatment of acute episodes and maintenance of remission of ulcerative colitis that is limited to the rectum.

Suppository: Treatment of acute episodes and prevention of further episodes (recurrence) of a chronic inflammatory disease limited to the rectum (back passage) known by doctors as ulcerative colitis.

Administration

Should be taken on an empty stomach: Take 1 hr before meals. Swallow whole, do not chew/crush.

Contraindications

Hypersensitivity to salicylic acid, salicylates and its derivatives or any of the ingredients. Severe hepatic and renal diseases/impairment.

Tablet/Enema/Suppository: Salofalk suppositories should not be used in babies and infants. It should not be used in the case of pathological propensity to bleeding.

Enema: Bronchial asthmatics should not be treated with Salofalk 4-g enemas since sulfite contained in the enemas may cause hypersensitivity reactions.

Special Precautions

Tablet: Blood tests (differential blood count; liver function parameters such as transaminases; serum creatinine) and urine status (dip sticks/sediments) should be checked before and during treatment, at the discretion of the doctor. As a guideline, controls are recommended 14 days after starting treatment, then a further two to three times at intervals of 4 weeks.

If the findings are normal, follow-up tests are required every three months. If additional symptoms develop, tests must be performed immediately. The recommended kidney function tests are serum urea (BUN) and creatinine assay as well as urine sediment test.

Caution is recommended in patients with impaired hepatic function.

Salofalk 500 mg enteric coated tablets should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered, if renal function deteriorates during treatment.

In patients with pulmonary function disturbances, in particular asthma, close medical supervision is necessary during treatment with drugs containing mesalazine.

Treatment with Salofalk 500 mg Enteric-coated tablet should only be started under medical supervision in patients with known hypersensitivity to preparations containing sulphasalazine. If acute signs of intolerability e.g. cramps, acute abdominal pain, fever, severe headache and skin rash occur, treatment must be withdrawn immediately.

Enema: Salofalk should be taken under medical supervision. A blood count and urine status should be performed at the attending physician’s discretion during treatment. As a general guideline, tests are recommended 14 days after beginning of treatment and then another 2-3 times at 4-weekly intervals.

If the findings are normal, follow-up tests are required every 3 months or if additional signs of illness occur. The recommended kidney function tests are serum urea (BUN) and creatinine assays as well as urine sediment tests.

Patients should be monitored for elevated methemoglobin values.

In patients with pulmonary function disturbances, in particular asthma, close medical supervision is necessary during treatment with drugs containing mesalazine (5-aminosalicylic acid).

Treatment with Salofalk should only be started under medical supervision in patients with known hypersensitivity to preparations containing sulfasalazine. If acute signs of intolerability eg, cramps, acute abdominal pain, fever, severe headache and skin rash occur, treatment must be withdrawn immediately.