SALOFALK rectal suspension 4 g. / 60 ml.

Salofalk 4 g / 60 mL
• Active ingredient: mesalazine therapeutically active substance is mesalazine.
One Salofalk rectal suspension (60 g suspension) contains: 4 g mesalazine
• Excipients: Carbomer. Potassium acetate. Potassium metabisulphite (E224). Sodium benzoate (E211). Sodium edetate (Ph. Eur), purified water, xanthan gum
Salofalk is available in packs containing 7 rectal suspensions.
1. What Salofalk and what are they used?
Contained in Salofalk mesalazine is inflammatory substance which is used in inflammatory bowel disease.

Salofalk is taken to treat:
• acute conditions of ulcerative colitis chronic inflammatory disease of the colon.
2. Before taking Salofalk
Do not take Salofalk:
• If you are hypersensitive to salicylic acid derivatives or to any of the ingredients
• If you have severe disorders of the liver and kidneys
• If you have an existing gastric or duodenal ulcers peptic ulcer
• If you have abnormally increased bleeding tendency to bleeding diathesis
Take special care with 4 g / 60 mL if it is known that you are allergic to products containing sulfasalazine, a substance similar to mesalazine. In this case, you can start treatment with 4 g / 60 mL only under careful medical supervision see pt. 4 "Possible side effects".
You should ask your doctor about it. This applies even when these statement apply to you in any moment of the past.
Additional Warnings
Salofalk should be taken under medical supervision. Blood samples differential count, liver function tests such as transaminases, serum creatinine and urine samples test papers sediment should be performed before and during treatment as determined by your doctor. It is recommended to make the samples 14 days after commencement of treatment and then another 2-3 times with an interval of 4 weeks. If the finding is normal enough control tests every three months.
If you develop additional disease symptoms should immediately carry out new tests. Salofalk should be used with caution if you have liver dysfunction. Do not take Salofalk if you have impaired renal function. If renal function deteriorates during treatment with Salofalk, you should consult your doctor as it may be caused by the drug. If you have pulmonary dysfunction, particularly bronchial asthma should be monitored during treatment with Salofalk.
• Children under 6 years
Children under 6 years should not take Salofalk as experience in this age group is insufficient.
Pregnancy
The experience gained so far with a limited number of women receive during pregnancy medicines containing mesalazine showed no adverse effects on pregnancy or the unborn or newborn children. However, during pregnancy Salofalk should be taken only on prescription, because only your doctor can make the necessary assessments of the risk - benefit.
Breastfeeding
Experience with the use of medicinal products containing mesalazine during lactation is limited.
Small amounts of the active substance pass into breast milk. Therefore, they can not exclude hypersensitivity reactions in nursing infants. Experience so far shows that in isolated cases, they manifest as diarrhea. If your baby get diarrhea while you are taking Salofalk and breast-feeding, you should consult with your doctor whether you should stop breastfeeding.
Important information about some of the ingredients of Salofalk enema.
Since the product contains sodium benzoate, it may cause hypersensitivity reactions in susceptible patients in the form of irritation of the skin, eyes and mucous membranes.
Because it contains potassium metabisulphite Salofalk enema may cause allergic reactions with anaphylactic symptoms and narrowing of the bronchi bronchospasm in susceptible people, especially those with asthma or a history of allergy.
Taking other medicines
• coumarin anticoagulants, drugs that inhibit blood clotting: possible potentiation of the anticoagulant effect increased risk of bleeding in the gastrointestinal tract. Glucocorticoid anti-inflammatory drugs, cortisone-like: possible increase in adverse reactions in the stomach
• sulfonylureas medicines that lower blood sugar: possible strengthening effect descriptions.
• Methotrexate agent, inhibiting cell growth, can increase the toxicity of methotrexate.
• Probenetsidsulfinpirazon (drugs that promote excretion of uric acid: possible weakening of the increased excretion of uric acid
• Spironolactone furosemide medicines that increase urine output: possible weakening of increased urine output of diuretic effect.
• Rifampicin drug to treat tuberculosis: possible weakening of anti-tuberculosis effect.
• If you are taking a medicine containing azothioprine or 6 merkantopurin, they can intensify the suppression of blood cell formation in bone marrow.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
3. How to use Salofalk enema
Always use Salofalk enema strictly in accordance with the instructions of your doctor. Ask your doctor or pharmacist if you are not quite sure. If you want to stop treatment with Salofalk enema eg temporary or permanent. Because of side effects previously always talk to your doctor.
Adults:
If you have acute signs of inflammation use one rectal suspension (60 g suspension equivalent to 4 g mesalazine daily in the gut once daily.
Children under 6 years
Do not use Salofalk in children under six years, because there is very little experience with this age group.
Children over 6 years and adolescents
Salofalk enemas are available in the following doses: 2 g / 30 mL and 4 g / 60 mL.
The recommended dose should be chosen on the basis of the severity and extent of disease in the colon and the body weight of the child adolescent.
• It is recommended mainly half of the adult dose to be given a body weight up to 40 kg, while the normal dose for adults with body weight over 40 kg.
Therefore children weighing up to 40 kg should use Salofalk 2 g / 30 mL enema daily during pressure.
• Children weighing more than 40 kg should be treated with Salofalk or 2 g / 30 mL or Salofalk 4 g / 60ml enemas depending on the degree of inflammation.
Best results are achieved if the colon is cleaned prior to administration of Salofalk enemas.
Desired therapeutic results can baka achieved only if Salofalk enemas administered regularly and consistently.
Route of administration:
Preparation:
• Shake the bottle for 30 seconds.
• Remove the cap from the applicator.
• Hold the bottle vertically.
Correct position for use of enemas: The patient should lie on his left side with left leg straight and right leg curled up. This posture facilitates the use of an enema and its effectiveness.
Use of enema:
• Insert the tip of the applicator deep into the rectum.
• The vial should be sloped down and then squeeze the contents slowly.
• Applicators empty vial is removed slowly from the rectum.
• The patient must remain lying in the same position for at least 30 minutes to allow the contents of the enema can be spread in the rectum.
• If possible, fluid enema should be allowed to operate at night.
The length of your treatment depends on the nature, severity and course of the disease.
Your doctor will tell you how much you should continue treatment in your individual case.
If you have the impression that the effect of Salofalk is too strong or too weak, talk to your doctor.
If you take more Salofalk dose?
If you have any doubts about your case, talk to your doctor what action to take next. So far no cases of poisoning. Due to the specific properties of mesalazine in Salofalk is not likely symptoms of poisoning even after high doses. Generally not necessary counter-measures, as it is found that they are not likely high concentrations in the blood. If you take more Salofalk than it should, next time take transcribed dose and do not decrease.
If you find that you forget to take a dose, you may take it immediately. If you remember shortly before the time for your next dose, take it as prescribed. Do not take a double dose.
Always consult your doctor before stopping with Salofalk even if you disconnect, for example due to adverse reactions.
4. Possible side effects
Like all medicines, Salofalk can cause side effects.
• Undesirable effects affecting gastrointestinal Rare> 0.01 - <0.1% abdominal pain, diarrhea, bloating, nausea and vomiting.
• Undesirable effects affecting the CNS rare> 0.01 - <0.1%: headache and dizziness
• Undesirable effects affecting the kidneys very rare <0.01%, impaired renal function, including acute and chronic inflammation of the connective tissue of the kidney interstitial nephritis and renal failure.
• Hypersensitivity reactions very rare <0.01%: Allergic skin rash exanthema, drug fever, spasmodic narrowing of the airway bronchospasm, inflammation of the heart lining and the heart muscle pericarditis, myocarditis, acute inflammation of the pancreas, pancreatitis, allergic inflammation in the lung bubbles allergic alveolitis, erythematosus syndrome lupus erythematosus, inflammation of the entire colon pankolit.
• Musculoskeletal disorders very rare <0.01%: muscle and joint pain, myalgia, arthralgia.
• Blood and lymphatic system disorders Very rare <0.01%: blood dyscrasias aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia.
• Hepatobiliary disorders very rare <0.01%: change the parameters of liver function elevated transaminases and parameters of cholestasis, inflammation of the liver hepatitis, inflammation of the liver associated with stagnation of bile> cholestatic hepatitis.
• Skin and skin structure very rare <0.01%: alopecia hair loss and baldness.
Notes:
If you have a known hypersensitivity to medicines containing sulfasalazine, you should start treatment with Salofalk under close medical supervision. If you are experiencing acute signs of intolerance such as cramping, acute abdominal pain, fever, headaches or skin rashes, stop treatment immediately see also section "Before you take Salofalk. If you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. Storing Salofalk
• Keep out of reach of children.
• Protect from light.
• Do not store above 25 ° C.
• Do not open the blister pack before using it.
• The expiry date of this medicine is printed on the bottle and carton. Do not use after pelvis and date.
Additional patient information
Your doctor has prescribed Salofalk gastro-resistant tablets because you are suffering from a chronic inflammatory bowel disease / ulcerative colitis or Crohn's disease /. Salofalk has a direct anti-inflammatory effect on the changes in the lining of the small intestine and colon caused by the disease.
This medicine has been proven to be effective and well tolerated. The goal of treatment is to remove your current symptoms. You can do this if you always take Salofalk carefully and regularly as directed by your doctor.
If you suffer from ulcerative colitis after acute inflammation and relief of symptoms should continue taking 4 g / 60 mL suppositories as directed by your doctor, if he thinks it necessary. This will prevent the recurrence of inflammatory symptoms and lead to an extension of the period without inflammation. Especially in ulcerative colitis Your reliable assistance in taking the tablets in this asymptomatic period is particularly important. So follow your doctor's advice and attended the meeting, which you appointed. Thus you will contribute to the disappearance of your symptoms and may help prevent their recurrence.