SALOFALK supp. 500 mg
SALOFALK supp. 500 mg.
Acute treatment and prevention of relapses (preventive treatment) in ulcerative colitis (chronic inflammatory bowel disease).
Treatment of acute disease Crohn (chronic inflammatory bowel disease).
When you must not take Salofalk 500?
You should not take Salofalk 500 for prior hypersensitivity to salicylic acid or any other acetysal ingredient
Severe impairment of hepatic or renal function
Active gastric or duodenal ulcer
Morbid bleeding tendency (bleeding diathesis)
When you take Salofalk 500?
Only after consultation with your doctor
These are cases where you can take Salofalk 500 only in conditions of a special medical supervision are described below.
Contact your doctor for further clarification. This also applies if you had any accidents in the past.
If you know you are allergic to preparations containing sulfasalazine (a substance akin to masalazina), then you can start treatment with Salofalk "500 only under careful medical supervision (see adverse reactions).
What you should know about the use during pregnancy and lactation?
In the first three months of pregnancy, Salofalk 500 should not be used unless strictly indicated necessity. Women who want to have children will have to wait to get pregnant at the stage when the disease requires treatment or when they receive the lowest possible dosage. If the disease allows treatment could cut the last 2-4 weeks of pregnancy. The experience with the use of mesalazine during lactation is insufficient. If treatment during this period is necessary, the infant should be weaned more that experimental studies have shown that small amounts of mesalazine pass into breast milk.
What you need to know about administering the product to infants and toddlers?
Salofalk 500 should not be used to treat infants and young children, as experience in this age group is insufficient.
What precautions must be observed?
Salofalk 500 should be used under medical supervision. Blood and urine tests before and during treatment should be performed under medical evaluation. As a guide recommended a check 14 days after the start of treatment and then another 2-3 times in 4-week intervals. If the results are normal, then it only takes one check per quarter, or immediately if additional disease symptoms. For assessment of renal function is recommended study of urea and creatinine in blood and urine sediment. It is possible that increased levels of methemoglobin. In case of poor lung function and asthma in particular need treatment with Salofalk ® 500 should be under close medical supervision.
Interactions with other drugs
What other drugs can affect the action of Salofalk ® 500 or themselves be affected by it?
Note that this information also applies to drugs that have been taken recently!
Coumarin-type anticoagulants (anti-coagulants). Possible potentiation of the anticoagulant effect (increased risk of bleeding in the gastrointestinal tract).
Sulfanilureini (medications that lower blood sugar). Possible strengthening effect descriptions.
Methotrexate (an agent that inhibits cell growth). Possible increase in toxic effects.
Probenecid / sulfinpiratson (drugs that facilitate the excretion of uric acid by the kidneys).
Possible reduction of the effects described.
Spiroiolakton / furosemide (drugs that have a diuretic effect).
Possible reduction of the diuretic effect.
Rifampicin (a medicine used to treat tuberculosis). Possible reduction of tuberculostatic effect.
Glucocorticoids (kortizonopodobni anti-inflammatory agents). Possible increase in adverse reactions from the stomach.
In one patient who received both mesalazine and a combination of azathioprine and 6-mercapto-purine (cytostatic agents) was observed pancytopenia (a reduction in all blood cells).
Tell your doctor about medicines you take CURRENTLY
Instructions on dosage, method and duration of use
Attach the following instructions unless your doctor has given you another prescription for Salofalk 500.
Carefully follow the directions for use, as otherwise Salofalk ® 500 can not act properly.
How and when to take Salofalk 500?
Treatment of acute flare of Crohn:
Depending on the clinical needs of the individual patient is assigned three times a day 1 to 3 Salofalk tablets 500 mg (equivalent to 1.5 to 4.5 g mesalazine daily).
For treatment of acute attacks of ulcerative colitis:
Depending on the clinical needs of the individual patient but to take 1 to 2 tablets Salofalk ® 500 mg 3 times daily (equivalent to 1.5 to 3.0 g mesalazine daily).
To prevent recurrence of ulcerative colitis: should be taken one tablet Salofalk ® 500 mg 3 times daily (equivalent to 1.5g mesalazine daily).
How and when to take Salofalk 500?
You should take the tablets with plenty of fluid one hour before meals morning, noon and night.
It is important to take Salofalk ® tablets 500 regularly and consistently, because only in this way can achieve successful recovery.
How long should you take Salofalk 500?
The duration of treatment depends on the nature, severity and course of the disease. Your doctor will decide how long to continue treatment in your case
ERRORS IN HANDLING AND OVERDOSE
What should you do if you take more than the prescribed Salofalk tablets 500 mg?
Until now, no known cases of poisoning. Due to the specific properties of mesalazine in Salofalk ® 500 mg are not aware of any signs of poisoning, even after using higher doses. Since according to current knowledge reaching excessive level of drug in the blood is probably not impose any countermeasures. When in doubt, tell your doctor to decide what to do. If you take more tablets Salofalk 500, take the next dose as prescribed, not to reduce
What should you do if you have less Salofalk tablets 500 or you miss a dose?
Do not try to correct his mistake by taking more tablets next time and just go with the usual treatment dose. If you find out quickly that you miss a dose, you may take it away.
If you find that a short time before the next dose take only the prescribed dose of this administration not to duplicate it. You should always consult your doctor before you stop treatment because of side effects of Salofalk 500 or stop it before it is completed.
What side effects may occur during treatment with Salofalk 500 and what measures are recommended to deal with them?
Side effects affecting the gastrointestinal tract
Rarely reported abdominal discomfort, diarrhea, more gas, nausea and vomiting.
Side effects affecting the central nervous system
Occasionally during treatment with mesalazine were seen headache and dizziness.
Adverse hypersensitivity reactions: In rare cases possible hypersensitivity reactions are not dose-dependent and are common to salicylic acid and its derivatives (acetysal), such as allergic skin rash (exanthema), drug fever, spasm of the airways (bronchospasm ), inflammation of the membrane spanning heart and the heart muscle (myocarditis and pericarditis), acute inflammation of the pancreas (pancreatitis), and inflammation of the kidneys with impaired function (interstitial nephritis). Isolated cases of allergic inflammation with air sakcheta lung (allergic alveolitis) were observed.
In some cases the entire colon was sore (pankolit). In preparations of mesalazine with similar chemical structure is similar to the one observed lupus erythematosus syndrome with butterfly rash on your face.
Other side effects:
Muscle and joint pains (myalgias and arthralgias) are rare. Changes in the ratio of blood pigment (increased methemoglobin) can not be excluded because of the chemical structure of the active ingredient mesalazine product. In some cases, after the use of mesalazine-containing drugs, changes in blood picture characterized by a decrease in the number of red and white blood cells and platelets (aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leucopenia and thrombocytopenia). Rare cases of allergic inflammation of the liver (hepatitis), and such a change in liver srunktsiya (elevated transaminases).
Patients with known hypersensitivity to preparations containing sulfasalazine should begin treatment with Salofalk 500 mg under close medical supervision. If acute intolerance symptoms such as cramping, acute abdominal pain, fever, severe headache or rash, treatment should be stopped immediately! (See contraindications). In rare cases, surgery patients with partial small bowel removed with surgery or near the transition between the small and large intestines (ileocaecal valve) Salofalk tablets 500 mg are excreted in faeces suspended because of too accelerated passage through the intestines. If you are in this group of patients and have the same problem, consult your doctor.
Tell your doctor if you have side effects, especially if they are not listed in this leaflet!
INFORMATION ON THE EXPIRATION DATE
The expiry date is printed on MEDICINAL
on the blister and carton.
Do not use after this date!
Always allow storage of Salofalk tablets 500 mg of reach of children!
Enterosolventna One tablet contains:
Therapeutically active ingredient: 500 mg mesalazine (5-aminosalicylic acid)
Evdragit L, dibutyl phthalate, talc, aminootsetna acid, polyvinyl, pyrrolidone, sodium carbonate, calcium stearate, microcrystalline cellulose, colloidal silica, hydroxypropyl methylcellulose, Evdragit Well, macrogol 6000, coloring agents: titanium dioxide and yellow iron oxide.
Medicine is available on prescription prescription. Pharmacotherapeutic group:
For use in inflammatory bowel disease (protivovazpaligelen agent / agent intestinal)