SALOFALK 250 mg. 100 tablets

Enteric tablets containing 250mg
(Active ingredient: mesalazine (5-aminosalicylic acid).

STOCK
An enteric tablet contains:
The therapeutically active ingredient: 250mg mesalazine (5-aminosalicylic acid)
Other ingredients:
Evdragit L, dibutyl phthalate, talc, aminoacetic acid, polyvinyl pirolidon.natriev carbonate, calcium stearate, microcrystalline cellulose, colloidal silica, hydroxypropyl methyl cellulose, Evdragit E, macrogol 6000, coloring agents, titanium dioxide and yellow iron oxide.
The drug is subject to medical prescription prescription

Pharmaco-therapeutic group:
For use in inflammatory bowel disease (anti-inflammatory agent / enteric agent)

INDICATIONS:
-Ultserozen Colitis (chronic inflammatory bowel disease), as well as for the treatment of acute / and prevention na.retsidivite.
- Crohn's Disease (a chronic inflammatory bowel disease), for the treatment of acute attacks.

CONTRAINDICATIONS:
When you should not take Salofalk 250
You should not take Salofalk 250 at:
- Pre-existing hypersensitivity to salicylic acid, acetysal or any other ingredient
- Severely impaired hepatic or renal function
- Active gastric or duodenal ulcers
- Disease increased bleeding (hemorrhagic diathesis);

When you take Salofalk 250
Only after consultation with your doctor These are cases where you can take Salofalk 250 only in terms of a special medical supervision are described below. Talk to your doctor about additional razyasneniya.Tova also applies if you had such incidents in the past.
If you know that you are hypersensitive to preparations containing sulfasalazine, a substance akin to mesalazine, then you can start treatment with 250 Salofalk only under careful medical supervision (see side effects).

What you need to know about the use during pregnancy and lactation
In the first three months of pregnancy, SalofaIk 250 should not be used unless strictly indicated neobhodimost.Zhenite who wish to have children will have to wait to become pregnant in the phase when the disease requires treatment or when they receive the lowest possible dose .If the disease allows treatment could be interrupted during the last 2-4 weeks of bremennostta.Za now experience using mesalazine during lactation is nedostatachen.Ako treatment during this period is essential, the infant should be weaned more so Experimental studies have shown that small amounts of mesalazine pass into breast milk.

What I need to know about administering the product to infants and young children
Salofalk 250 should not be used to treat infants and young detsaday as experience in this age group is insufficient.

PRECAUTIONS AND WARNINGS
What precautions must be observed
Salofalk250 must be used under medical supervision. The study of blood and urine tests before and during treatment should be carried out by medical indication pretsenka.Kato recommended a check 14 days after the start of treatment, and then another 2-3 times during the 4-week intervali.Ako results are normal / then it is sufficient one check per quarter, or immediately upon the occurrence of further disease simptomi.Za assessment of renal function is recommended study of urea and creatinine in the blood and sediment in urinata.Vazmozhno is raising the level of fines on methemo. In case of poor pulmonary function and asthma in particular need will treatment with Salofalk 250 be under close medical supervision.

Interactions with other drugs
What other medicines can affect the action of Salofalk® 250 or yourself to be influenced by it
Note that this information also applies to drugs that were accepted until recently!
-Antikoagulanti Of kumarinovtip (anti-clotting drugs) possible potentiation of the anticoagulant effects (increasing the risk of bleeding in the gastrointestinal tract)
-Sulfaiilureini (Medicines that lower blood sugar) possible strengthening effect descriptions.
-Metotreksat (Agent that inhibits cell growth) possible strengthening of its toxic effects.
-Probenecid / Sulfinpiratson (drugs that facilitate the excretion of uric acid by the kidneys)
Possible reduction effect described.
-Spironolakton / Furosemide (medicines that have a diuretic effect) possible reduction of the diuretic effect.
-Rifampitsin (Medicine to treat tuberculosis) possible reduction effect tuburkulostatichniya
-Glyukokortikoidi (Cortisone-like anti-inflammatory agents) possible increase in adverse reactions in the stomach.

Tell your doctor about medicines you are taking CURRENTLY

INSTRUCTIONS FOR CONSUMPTION, AND METHOD OF USE
Apply the following instructions unless your doctor gave you another prescription for Salofalk 250.
Carefully follow directions for use, as otherwise Salofalk © 250 can not act properly!
The following dosages are recommended depending on the clinical needs of the individual case:
Daily dose of mesalazine in Crohn's disease and ulcerative colitis, acute attack; recurrence; chronic treatment l.5-4.5g: I.5-3.0g; 1.5g
In addition Salofalk 250 (containing 250mg mesalazine), Salofalk® 500 tablets (containing 500mg mesalazine) are also available for the treatment of chronic inflammatory bowel diseases (Crohn's disease and ulcerative colitis) .When recommended daily dose mesalazine exceeds 1.5g / have be used Salofalk® 500 tablets possibly.
How often and how many tablets Salofalk® 250 should take
At a daily dose of 1.5g, Bne should take 3 times 2 tablets Salofalk © 250.

How and when to take Salofalk 250
Tablets should be taken morning, noon and night, I hour before meals with plenty of fluids.
It is important to take Salofalk 250 tablets regularly and consistently, because only in this way can achieve successful recovery.

How long should you take Salofalk 250
The duration of treatment depends on the nature / severity and course of the disease.
Your doctor will decide how long to continue the treatment in your case.

ERRORS IN HANDLING AND OVERDOSE
What should be done if you take more than the prescribed tablets Salofalk
Until now there are no known cases of otravyane.Blagodarenie the specific qualities of mesalazine in Salofalk 250 not aware of any signs of poisoning even after using high doses .Because according to present knowledge reaching excessively high level of drug in the blood is not likely not impose any kontramerki.V case of doubt, inform your doctor to decide what to do.
If you take more tablets Salofalk 250, take the next dose as prescribed without reducing them.

What to do if you take fewer tablets Salofalk 250 or you miss a dose
Do not attempt to repair his error by taking more tablets next time, just continue treatment with usual doza.Ako find out fast that you miss a dose, you may take it immediately.
In case you find this short time before taking the next dose to take only the prescribed dose of this administration without duplicate it.
What should you do if you interrupt treatment or want to complete before it is completed
You should always consult your doctor before you discontinue treatment due to adverse reactions with Salofalk 250 or stop it before it is completed.

SIDE EFFECTS
What side effects may occur during treatment with Salofalk 250 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.
Adverse reactions affecting the central nervous system
In some cases, during the treatment with mesalazine were observed headache and dizziness.
Adverse reactions of hypersensitivity:
In rare cases are possible reactions of hypersensitivity, which do not depend on the dose and are common to salicylic acid and its derivatives (acetysal), such as allergic skin rash (exanthema) lekarstvenatreska, spasm of the airways (bronchospasm), inflammation of the female heart skin and the heart muscle (myocarditis and pericarditis), acute inflammation of the pancreas (pancreatitis), inflammation and kidney dysfunction with them (interstitial nephritis).
Single cases of allergic inflammation of the air sacs of the lung (allergic alveolitis) were nablyudavani.V some cases the entire colon was sore (pankolit) .For preparations of mesalazine with a similar chemical structure is similar to the one observed lupus erythematosus syndrome with butterfly rash on the face.
Other adverse reactions:
Muscle and joint pain (myalgia and arthralgia) are rare. Changes in the ratio of the blood pigment (povisheio level of methemoglobin) can not be excluded due to the chemical structure of the active ingredient of-mesalazine.
In some cases, after using mesalazine-containing drugs have been observed changes in blood picture .harakterizirashti the reduced number of red and white blood cells and platelets (aplastic анемия,агранулоцитоза,панцитопения,неутропения,левкопения or thrombocytopenia) .There are isolated reports of allergic inflammation of the liver (hepatitis) and those for changes in your liver function (elevated transaminases).

Warnings:
Patients with known hypersensitivity to preparations containing sulfasalazine should start treatment with Salofalk 250 only under close medical nablyudenie.Pri onset of acute symptoms of intolerance such as cramping, acute abdominal pain, fever, severe headache and rash, therapy should be stopped immediately! (see also contraindications).
In rare cases, surgery patients with partial small bowel removed or operation near the transition between the small and large intestine (ileocecal valve) tablets Salofalk  250 separate suspended with izprazhieniyata because too accelerated passage through chervata.Ako you from this group sick and have the same problem.posavetvayte your doctor.
Tell your doctor if you have side effects, especially if they are not listed in this leaflet!

INFORMATION ON THE SHELF LIFE
The expiry date of the medicines is printed on the blister and kutiyata.Ne use after this date!

STORAGE
Always provide storage Salofalk 250 tablets of reach of children!