Salofalk

Salofalk

mesalazine

Manufacturer:

Falk

Distributor:

DCH Auriga
Full Prescribing Info
Contents
Mesalazine.
Description
Each tablet also contains the following excipients: Sodium carbonate, eudragit L/dibutylphthalate, talcum, poly(vinyl-2-pyrrolidone), microcrystalline cellulose, carboxymethylcellulose sodium, glycine, calcium stearate, silica, hydroxypropylmethylcellulose, eudragit E, macrogol 6000, titanium dioxide (E171), yellow iron oxide (E172).
Each suppository also contains the following excipients: Hard fat, docusate sodium and cetyl alcohol.
The enema also contains the following excipients: Sodium benzoate (0.03 g), potassium metabisulfite (max. 0.14 g), disodium edetate, carbomer, potassium acetate, xanthan gum.
Indications/Uses
Tablet: Ulcerative colitis (treatment of acute attack, prevention of recurrence), Crohn's disease (treatment of acute attack).
Suppository: Ulcerative colitis, proctitis and inflammation of the anal canal.
Enema: Treatment of mild and moderate attacks of ulcerative colitis, above all those in the rectum and sigmoid colon.
Dosage/Direction for Use
Tablet: For treatment of inflammatory bowel diseases (Crohn's disease, ulcerative colitis), Salofalk 250- and 500-mg tablets are available.
With a dosage recommendation of mesalazine 1.5 g/day, 3 x two 250-mg tab can be taken. If the recommended dosage is mesalazine >1.5 g/day, Salofalk 500-mg tabs should be taken, if possible. Depending on the clinical requirements in the individual case, the following dosages are recommended: Crohn's Disease: Acute Attack: 1.5-4.5 g.
Ulcerative Colitis: Acute Attack: 1.5-3 g. Remission/Long-Term Treatment: 1.5 g.
The required number of tablets shall be taken 1 hr before meals in the morning, at midday and in the evening. The tablets shall be swallowed whole with sufficient liquid.
In patients with bowel resection of the ileocoecal region with resection of the ileocoecal valve, it was observed in rare cases that Salofalk 500-mg tabs were excreted undissolved with the faeces due to the too fast intestinal passage. In case of this observation, contact the physician.
Suppository: Insert one 500-mg supp into the anus in the morning, at midday and in the evening when acute signs of inflammation are present.
As soon as remission occurs, the dose should be reduced to one 250-mg supp 3 times daily to avoid recurrences.
Enema: Unless otherwise prescribed, the contents of 2 enemas (2 x 30-mL susp) is given once daily rectally before retiring. If there are problems to retain the large quantity of liquid, the enema may also be applied in 2 doses eg, during the night (after a bowel movement which discharges the 1st dose) or early in the morning.
The duration of Salofalk therapy is determined by the physician.
Treatment with Salofalk demands reliability and consistency from the side of the patient both on the acute inflammatory stage and during long-term therapy to enable therapeutic success.
Overdosage
Tablet: Even following ingestion at high dose, no symptoms of intoxication should be expected because of the substance-specific pharmacokinetic properties of mesalazine. Symptoms similar to those known in salicylate intoxication should be in principle occur. However, since higher absorption rates do not occur at high mesalazine doses, intoxication is unlikely.
Suppository/Enema: Owing to the biopharmaceutical properties of Salofalk suppository/enema and the substance-specific pharmacokinetic properties of mesalazine, only small amounts of the active principle are available for systemic action. For this reason, signs of intoxication are thus not to be reckoned with even when very high doses are taken. In principle, similar symptoms would have to occur to those which are familiar in salicylate intoxications: Mixed acidosis-alkalosis, hyperventilation, pulmonary oedema, dehydration by sweating and vomiting, hypoglycaemia.
Treatment: In Mixed Acidosis-Alkalosis: Restoration of the acid-base equilibrium in accordance with the situation, electrolyte substitution.
In dehydration by sweating and vomiting: Fluid administration.
In Hypoglycaemia: Glucose administration.
Contraindications
Hypersensitivity to salicylic acid and its derivatives, benzoates (for enema) or one of the other ingredients.
Bronchial asthmatics should not be treated with Salofalk enemas since sulphite contained in the enemas may cause hypersensitivity reactions.
Severe liver and kidney function disturbances; gastric and duodenal ulcers; haemorrhagic diathesis (predisposition to bleeding).
Use in pregnancy & lactation: In the first 3 months of pregnancy, mesalazine should only be used if strictly indicated. Wherever possible, women wishing to have children should wait for a phase when as little as possible or no medication is required before beginning pregnancy. If the individual's condition allows, treatment should be interrupted in the last 2-4 weeks of pregnancy. As yet there is insufficient experience with the medicament during breastfeeding. If treatment becomes necessary during lactation, the child should be weaned.
Use in children: Salofalk should not be used to treat infants and small children because of insufficient experience with this age group.
Special Precautions
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, it is recommended to conduct tests 14 days after beginning 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 methaemoglobin values.
In patients with pulmonary function disturbances, in particular asthma, close medical supervision is necessary during treatment with drugs containing mesalazine.
Treatment with Salofalk should only be started under medical supervision in patients with known hypersensitivity to preparations containing sulphasalazine. If acute signs of intolerability eg, cramps, acute abdominal pain, fever, severe headache and skin rash occur, treatment must be withdrawn immediately.
In isolated cases, hypersensitivity reactions principally in the form of respiratory problems may also be experienced by non-asthmatics due to potassium sulphite content of the enema.
Use In Pregnancy & Lactation
n the first 3 months of pregnancy, mesalazine should only be used if strictly indicated. Wherever possible, women wishing to have children should wait for a phase when as little as possible or no medication is required before beginning pregnancy. If the individual's condition allows, treatment should be interrupted in the last 2-4 weeks of pregnancy. As yet there is insufficient experience with the medicament during breastfeeding. If treatment becomes necessary during lactation, the child should be weaned.
Side Effects
Gastrointestinal: Abdominal discomfort, diarrhoea, flatulence, nausea and vomiting have been reported rarely.
Central Nervous System: In isolated cases under treatment with mesalazine, central nervous phenomena eg, headache and dizziness have been observed.
Hypersensitivity Reactions: Hypersensitivity reactions that are not dose-dependent and are common to salicylic acid and its derivatives eg, allergic rash, drug fever, bronchospasm, peri- and myocarditis, acute pancreatitis and interstitial nephritis are possible in rare cases.
Sporadic cases of allergic alveolitis have been observed during treatment with mesalazine. In isolated cases, pancolitis may occur.
Under certain conditions, some drugs with a similar chemical structure to mesalazine may cause a lupus erythematosus-like syndrome. Thus, the onset of this syndrome cannot be ruled out under treatment with Salofalk.
Others: Myalgia and arthralgia have been observed rarely.
Elevated methaemoglobin levels cannot be excluded on account of the chemical structure of the active constituent.
In isolated cases, changes in the blood count (aplastic anaemia, agranulocytosis, pancytopaenia, neutropaenia, leukopaenia, thrombocytopaenia) have been reported after the use of drugs containing mesalazine.
There have been occasional reports of inflammation of the liver (hepatitis). In rare cases, changes in liver function parameters (elevated transaminase levels) occur.
Drug Interactions
Interactions may occur if the following drugs are given at the same time as Salofalk.
Anticoagulants: Possible potentiation of the anticoagulative action (increased risk of bleeding in the gastrointestinal tract).
Glucocorticoids: Possible increase in gastric side effects.
Sulphonylureas: Possible potentiation of the hypoglycaemic effect.
Methotrexate: Possible increase of the methotrexate toxicity.
Probenecid/Sulphinpyrazone: Possible reduction in uricosuric effects.
Spironolactone/Furosemide: Possible reduction in diuretic effects.
Rifampicin: Possible reduction in tuberculostatic effects.
Pancytopaenia occurred in one case under mesalazine in combination with mercaptopurine.
Storage
Do not store at temperatures above 25°C (77°F). Protect the suppository/enema from light.
Shelf-Life: Tablet: 3 years.
ATC Classification
A07EC02 - mesalazine ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.
Presentation/Packing
Tab 250 mg x 100's. 500 mg (butter-yellow to ochre, lustreless with smooth surface) x 100's. Supp 250 mg x 30's. 500 mg x 30's. Enema 2 g/30 mL x 7's.
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