SALAZOPYRIN 500 mg. 100 tablets
SALAZOPYRIN EN represents a gastro-resistant coated tablets for oral administration. Each tablet contains drug sulfasalazine 500 mg and excipients - starch, magnesium stearate, anhydrous silica, cellulose acetate phthalate, propylene glycol, talc, polyethylene glycol 20000, carnauba wax, glyceryl monostearate self-emulsifying, white beeswax.
WHAT SALAZOPYRIN EN?
SALAZOPYRIN EN is used to treat inflammatory bowel disease and rheumatoid arthritis. The use of tablets specifically designed to dissolve in the intestine will reduce the incidence of side effects in the gastrointestinal tract. The colon sulfasalazine is split by the intestinal bacteria to sulfapyridine and 5-amino salicylic acid. Sulfasalazine and its metabolites have anti-inflammatory, immunosuppressive and anti-bacterial effects.
What is SALAZOPYRIN EN?
SALAZOPYRIN EN is used in the following cases:
• Rheumatoid arthritis
• Ulcerative colitis
• Alzheimer's disease (with localization in the colon)
WHAT YOU SHOULD KNOW BEFORE AND DURING TAKE SALAZOPYRIN EN?
Before initiation of therapy, and every second week during the first three months of its conduct must be assessed and regularly monitor liver function and blood counts (including differential count of white blood cells). Over the next three months control is every four weeks. Then liver function and blood count checked every three months.
Renal function should be assessed prior to and at regular intervals in the course of treatment.
Each of these tests to monitor your condition will be directed by your doctor.
When you must not take SALAZOPYRIN EN?
Do not use in children under 2 years.But should use this medicine if you have hypersensitivity to sulfonamides or salicylates, and if you have acute intermittent porphyria.
SALAZOPYRIN EN must be used with caution in patients with glucose-6-phosphate dehydrogenase deficiency (enzyme disease), as it can cause hemolytic anemia. Changes in blood counts due to folic acid deficiency can be brought into the normal range by folic acid or folinic acid (leucovorin), who will be appointed at the discretion of your doctor. Cases of yellow skin and body fluids. In severe reactions tell your doctor. It should stop the drug.
Can you use SALAZOPYRIN EN during pregnancy and lactation?
Experience shows that SALAZOPYRIN EN can be used in pregnancy. SALAZOPYRIN EN passes into breast milk, but the amount that is found there should not be a risk to healthy child. Caution is recommended in premature infants and children with neonatal jaundice.
Does SALAZOPYRIN EN your ability to drive or operate machinery?
It is believed that SALAZOPYRIN EN is safe and is unlikely to have an effect on the ability to drive and use machines.
HOW TO TAKE YOUR MEDICINE? (DOSAGE)
Your doctor will determine your dose individually according to response and tolerance to the drug. For patients not previously treated with SALAZOPYRIN EN is recommended to increase the dose gradually over the first 9 days. The tablets should be swallowed whole and not crushed or broken.
Adults, incl. sick elderly
Due to the favorable benefit-risk regarding treatment SALAZOPYRIN EN tablets can be started at the beginning of the treatment of rheumatoid arthritis. Therapy should be initiated at a lower dose - 2 tablets per day for 4 days in 4 days was increased to 3 tablets a day, and then 4 tablets per day (see. The table below). In some patients with intolerance to the intake of 4 tablets a day can be observed clinical improvement at lower doses. Experience has shown that the effect tends to occur in less than 4 weeks of treatment. If the patient does not respond satisfactorily to the therapy for 2-3 months, the daily dose may be increased up to 3 g. Concomitant treatment with analgesics and / or anti-inflammatory drugs are recommended at least until the effects become visible. SALAZOPYRIN EN was effective and well tolerated in long-term treatment.
Currently can not be given treatment recommendations yuvelinen rheumatoid arthritis (rheumatoid arthritis in childhood).
Inflammatory bowel disease (ulcerative colitis, Crohn's Kpoh) exacerbations (flare):
WHAT SIDE EFFECTS MAY occur in taking your medicine?
Some side effects are dose dependent and symptoms can often be alleviated by reducing the dose. About 75% of the adverse reactions occurred during the first 3 months of treatment, and 90% within six months.
More common side effects are:
Common: headache, fever, loss of appetite.
Blood: decrease in white blood cells, hemolytic anemia, changes in the shape of blood cells.
GI: abdominal pain, nausea, indigestion
Liver: elevated liver enzymes.
Skin: rash, hives, itching, redness.
Other: Reversible reduction in the number of spermatozoa. Induction of auto-antibodies.
Below lists the adverse reactions have been reported very rarely: Blood: abnormalities in red blood cell (eg. Hemolytic anemia, macrocytosis), cyanosis. Gastrointestinal tract: abdominal discomfort and pain.
Central nervous system: tinnitus and dizziness.
Renal function, protein or blood in the urine
Severe disease activity (after resolution of severe symptoms):
2-4 3-4pati tablets per day (3 g - 8 g per day).
Medium and low disease activity: 2 tablets 3-4 times daily.
40-60 mg / kg of body weight every 24 hours, divided into 3-6 doses.
Prevention of recurrence
Adults, incl. sick elderly
As a rule, in patients with ulcerative colitis in remission recommended maintenance dose of 2 tablets 2 (3) times a day for the purpose of docking of the symptoms. This dosage should be applied indefinitely, except in case of interruption due to adverse reactions.
In degradation, the dosage is increased by 2 (to 4) tablets 3-4 times daily.
20-30 mg / kg of body weight every 24 hours, divided into 3-6 doses.
What to morals, if you take more than your prescribed tablets?
The most characteristic events, if you take too much of the drug are nausea and vomiting. Overdose of SALAZOPYRIN EN unlikely to cause serious poisoning, except for patients with impaired renal function.
If you suspect that you have taken more than the prescribed dose as immediately contact your doctor or Ambulance (tel. 150).
They will take the appropriate therapy, which consists of gastric lavage as quickly as possible, abundantly intravenous fluids to maintain high diuresis, basifying with sodium bicarbonate. Should be considered a possible risk for the occurrence of oliguria and anuria. In anuria shown dialysis. In case of methemoglobinemia (cyanosis) applies slow intravenous infusion of methylene blue 1-2 mg / kg body weight. Otherwise symptomatic treatment. Possible volume blood transfusion in the presence of acute sulfahemoglobinemiya.
Below listed events are probably not dose-dependent:
Hematologic: suppression of bone marrow, e. reduction in the number or a change in the blood cells.
Gastrointestinal tract and liver: hepatitis, pancreatitis.
Central nervous system: peripheral neuropathy (it feels tingling, reduced sensitivity), aseptic meningitis.
Skin: rash, hives, redness of skin blistering (erythema multiforme / syndrome Stevens-Johnson), exfoliative dermatitis, peeling skin (syndrome Lyui) light sensitivity.
Lung: complications such as fibrosing alveolitis (change in the structure alveoli that make up the lungs) with difficulty in breathing, coughing, appearance of eosinophils (a type of white blood cell) and others.
Other reactions of hypersensitivity to: reduce the number of sperm with infertility has been described in men treated with sulfasalazine. Discontinuation of treatment resulted in a reversal of these effects.
If any of these or ANY OTHER SIDE EFFECTS WHEN USING SALAZOPYRIN EN, please tell your doctor.
Taking other medicines
Tell your doctor if you take other medicines.
There has been reduced absorption of digoxin (heart medicine) in concomitant with SALAZOPYRIN EN. It is possible that the occurrence of folate deficiency since SALAZOPYRIN EN inhibits absorption of folate. Particular care is needed in patients taking both mercaptopurine and SALAZOPYRIN EN.
HOW TO STORE YOUR MEDICINE?
No special storage conditions.
Keep out of reach of children.
Do not use SALAZOPYRIN EN after the expiry date stated on the packaging.
SALAZOPYRIN EN can be found in the package of 100 tablets.