Properties
What is it?
Active substance: Each 1 rectal suspension contains 4 g mesalazine as active substance. Excipients: Sodium benzoate (E211), disodium edetate, potassium metabisulfite (E224), potassium acetate, carbomer 974P, xanthan gum, purified water. 1. What is Cronizon and what is it used for The active substance of Cronizon is mesalazine and each rectal suspension contains 4 g of active substance. Cronizon is a preparation called "aminosalicylic acid and similar preparations" and belongs to the group of "anti-inflammatory drugs for the intestines". These preparations prevent inflammation in the large intestine. Cronizon is presented on the market as a round, white, accordion-shaped low-density polyethylene bottle with a blue 7-layer high-density polyethylene cap in a cardboard box. Cronizon is used for the following conditions: To treat acute (sudden onset) attacks of inflammation of the large intestine. This condition is known to doctors as ulcerative colitis. See blog: Cronizon – A Modern Treatment for Inflammatory Bowel Diseases 2. What you need to know before using Cronizon Do not use Cronizon if: - you are allergic to salicylic acid, salicylates such as aspirin, or any of the other ingredients of this preparation, - you have severe liver or kidney disease, - Warnings and precautions - if you have a history of lung problems, especially if you have bronchial asthma. - if you have a history of allergy to sulfasalazine, which is a related substance to mesalazine. - if you have liver function problems. - if you have kidney function problems. During treatment, your doctor may want to monitor you closely and you may need regular blood and urine tests. If these warnings apply to you due to existing conditions, including at any time in the past, please consult your doctor. Use of Cronizon with food and drink Interactions of Cronizon with food and drink are not known. Pregnancy If you are planning to become pregnant, consult your doctor or pharmacist before using this preparation. During pregnancy, Cronizon should only be used as directed by your doctor. If pregnancy occurs during treatment, consult your doctor or pharmacist immediately. Breastfeeding Consult your doctor or pharmacist before using this preparation. During breastfeeding, as the active substance and its metabolites may be excreted in breast milk, this preparation should only be used as directed by your doctor. Driving and operating machinery Effects on the ability to drive and operate machinery have not been observed. Important information about some of the excipients of Cronizon Cronizon contains 0.06 g of sodium benzoate. Therefore, it may cause mild irritation to the skin, eyes, and mucous membranes. Cronizon contains 0.2808 g of potassium metabisulfite. Therefore, it can rarely cause severe hypersensitivity reactions and bronchospasm. Other medicines and Cronizon Tell your doctor if you are taking or using any of the following medicines, as the effects of these medicines may change (interactions): azathioprine, 6-mercaptopurine or thioguanine (medicines used to treat immune system disorders). Some medicines that inhibit blood clotting (anticoagulants or blood thinners, e.g., warfarin) Treatment with Cronizon may still be appropriate for you. In such cases, the doctor will choose the best treatment for you. If you are currently taking or have recently taken any prescription or over-the-counter medicines, inform your doctor or pharmacist about them. 3. How to use Cronizon Always use this preparation exactly as directed by your doctor. If you are unsure about anything, ask your doctor. Instructions for proper use and dose/frequency of administration: Adults: Unless otherwise recommended, the contents of one bottle of rectal suspension (equivalent to 4 g mesalazine, 60 ml suspension per day) should be administered rectally once a day. Route and method of administration: Cronizon is administered rectally only into the rectum. It cannot be taken orally and swallowed. Before going to bed, the contents of the rectal suspension bottle should be administered rectally. The best results are achieved when the bowels are emptied before administering Cronizon. Before use, it must be shaken for at least 30 seconds to thoroughly mix the contents of the rectal suspension. Then remove the cap, hold the bottle upright so that the contents of the rectal suspension do not spill. The patient should lie on their left side, extending the left leg and bending the right leg towards the abdomen. Insert the applicator, lubricated for easy insertion, into the rectum, the bottle should be directed towards the navel. Lower the bottle slightly and then gently and evenly squeeze. After use, carefully remove the empty bottle applicator from the rectum. Continue lying in the same position for 30 minutes, the rectal suspension should be evenly distributed. The best results are achieved when the rectal suspension acts overnight. Duration of treatment: To achieve the desired therapeutic effect, Cronizon should be used regularly and continuously. The doctor will determine the duration of use of this preparation based on your condition. The duration of treatment depends on the condition of your disease. Different age groups: Use in children: There is little experience and documentation that Cronizon affects children. Use in the elderly: The dose/frequency recommendations for adults given in the previous section also apply to the elderly. Duration of treatment The duration of use of the preparation depends on your condition. The doctor will decide how long you should continue to use the preparation. It is important that treatment with Cronizon is continued regularly and continuously, as only in this way will the desired therapeutic effect be achieved. If you think that the effect of Cronizon is too strong or too weak, consult your doctor. Use in special cases: Renal/hepatic insufficiency Use with caution in patients with liver dysfunction. Not recommended for use in patients with impaired kidney function. If kidney function deteriorates during treatment, the nephrotoxicity (kidney poisoning) caused by the active substance mesalazine should be considered. Not for use in patients with acute renal and hepatic failure. If you have the impression that the effect of Cronizon is too strong or too weak, consult your doctor or pharmacist. If you have used more Cronizon than you should have used at once, do not reduce the next dose, use the dose that is needed. If you have used more Cronizon than you should have used, consult your doctor or pharmacist. If you forget to use Cronizon If you forget to take a dose, do not use extra Cronizon next time, continue to use the prescribed dose. Do not take a double dose to compensate for missed doses. If you stop using Cronizon Do not stop using this product without your doctor's advice. If you have any further questions about the use of this preparation, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, but not everyone gets them. If any reaction develops, stop using Cronizon and inform your doctor immediately or go to the nearest emergency medical department: All medicines can cause allergic reactions, however, serious allergic reactions are very rare: - allergic skin rash - fever - difficulty breathing If there is a sudden deterioration in your general health, especially with fever and/or sore throat and mouth, stop using the preparation and contact your doctor immediately. These symptoms, very rarely, can be caused by a decrease in the number of white blood cells in the blood (a condition called agranulocytosis), which can lead to a serious infection. A blood test can confirm whether these symptoms are caused by the effect of this preparation on the blood. All these effects are very serious side effects. If you have any of these symptoms, you have a serious allergy to Cronizon. You may need urgent medical attention or hospitalization. All these very serious side effects are rare. Patients have reported the following symptoms during the use of mesalazine: Rare side effects (occurring in less than 1 in 1,000 patients) - abdominal pain, diarrhea, gas, nausea and vomiting - headache, dizziness Very rare side effects (occurring in less than 1 in 10,000 patients) - changes in kidney function, sometimes swelling of the extremities or flank pain - severe abdominal pain acute inflammation of the pancreas shortness of breath, cough, difficulty breathing, shadow on the lungs on X-ray allergic and/or inflammatory lung conditions - severe diarrhea and abdominal pain due to an allergic reaction to this preparation - skin rash or inflammation - muscle and joint pain - jaundice or abdominal pain due to liver and bile duct disorders - hair loss and baldness - numbness and tingling in the hands and feet (peripheral neuropathy) - reversible decrease in sperm production If any side effect occurs that is not listed in these instructions for use, consult your doctor or pharmacist. Reporting of side effects If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. 5. How to store Cronizon Keep Cronizon out of the reach of children and in its original packaging. Store at room temperature up to 25°C. Store in the original packaging, protected from light. Use within the expiry period indicated on the packaging. Do not use Cronizon after the expiry date indicated on the packaging. Do not use Cronizon if you notice any damage to the product and/or its packaging. Do not dispose of expired or unused medicines! Hand them over to the collection system established by the Ministry of Environment and Urbanization. Dispensing category: Pharmaceutical product group III, available without prescription.
