Properties
What is it?
FAXSAMIN 550mg film-coated tablets are taken orally. Active substance: Each film-coated tablet contains 550 mg of rifaximin. Excipients: Contains sodium starch glycolate, microcrystalline cellulose 200, colloidal silicon dioxide, magnesium stearate, glyceryl distearate, talc, hypromellose, titanium dioxide, propylene glycol, iron red oxide, disodium ethylenediaminetetraacetic acid. Read this instruction for use carefully before starting to use this medicine, as it contains important information for you. - Keep this patient information leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. - Tell your doctor that you are taking this medicine if you have to visit a doctor or hospital during the period of taking this medicine. - Follow the instructions in this leaflet exactly. Do not take the medicine in a higher or lower dose than recommended for you. Contents of this leaflet: 1. What is Faximin and what is it used for 2. What to consider before using Faximin 3. How to take Faximin 4. Possible side effects 5. Storage conditions for Faximin Headings are included 1. What is Faximin and what is it used for Faximin comes in blister packaging containing 42 pink, oval film-coated tablets. Each film-coated tablet contains 550 mg of rifaximin. Faximin contains rifaximin as the active substance. Faximin is an antibiotic that destroys bacteria that settle in the intestine and cause hepatic encephalopathy. Hepatic encephalopathy; In case of sudden or chronic liver failure, harmful substances that are not cleared by the liver enter the brain through the blood and cause disorders such as mental tension, aggressiveness, confusion, muscle disorders, difficulty speaking, and coma. Faximin is used in adult patients with liver disease to reduce the recurrence of episodes of overt hepatic encephalopathy. The medicine is used to treat chronic gastrointestinal disorders characterized by diarrhea, mainly abdominal pain, bloating, and changes in defecation frequency. Faximin can be used as monotherapy or in combination with a stool softener, which usually contains lactulose. See blog: Antibiotic for liver health - what do we need to know about Faximin? 2. What to consider before using Faximin Do not use Faximin if: · You are hypersensitive to rifaximin, other rifamycins (e.g., rifampicin or rifabutin) or any other excipients in the preparation (if you think you are allergic), · You have fever, · You have 8 or more episodes of irregular defecation in the last 24 hours, · You have ulcers, constipation, or intestinal obstruction, · Tell your doctor if you have impaired kidney function, · You have bloody stools and diarrhea with fever, · Rifaximin; Do not use with similar antibiotics (such as rifampicin or rifabutin). Caution is required when using Faximin in the following cases: If: · Your symptoms worsen during treatment, stop taking Faximin and consult your doctor. · Your urine may turn red during treatment with Faximin. This is normal. · Treatment with antibiotics containing rifaximin may cause diarrhea. This can continue for up to 1 month after stopping the medicine. If diarrhea develops during or after treatment with Faximin; stop taking Faximin and consult your doctor immediately. · If liver disease is severe; you need to be monitored by your doctor. · Your doctor will monitor changes in serum sodium and potassium concentrations. · Escherichia coli, a bacterium involved in rifaximin vitamin K synthesis. Your doctor will monitor your blood clotting status. · Rifaximin; take precautions when using drugs such as cyclosporine (immunosuppressant), verapamil (cardiovascular drug), amiodarone (heart rhythm regulator) simultaneously. If these precautions apply to you, or have applied to you at any time in the past, consult your doctor. Taking Faximin with food and drink: Taking the medicine with or without food does not change its effect. The medicine is taken orally with a glass of water. Pregnancy Before taking this medicine, consult your doctor or pharmacist. The harm of Faximin to the fetus is not known. Therefore, it should not be used during pregnancy. If pregnancy is detected during treatment, consult your doctor or pharmacist immediately. Breastfeeding Before taking this medicine, consult your doctor or pharmacist. It is not known whether rifaximin is excreted in breast milk. Therefore, Faximin should not be used during breastfeeding. Use of vehicles and machinery Generally, Faximin does not affect the ability to drive vehicles or operate machinery, but in some cases it may cause dizziness. If you feel dizzy, do not drive vehicles or operate machinery. Important information about some ingredients of Faximin If you are not hypersensitive to the substances in Faximin, no adverse effects are expected. Taking with other medicines Tell your doctor if you are taking the following medicines: -Antibiotics (medicines used to treat infections) -Warfarin (medicine for the prevention of blood clots) -Antiepileptic drugs (medicines for the treatment of epilepsy) -Antiarrhythmic drugs (medicines for the treatment of abnormal heart rhythm) -Cyclosporine (immunosuppressant) -Oral contraceptives (birth control pills) Tell your doctor or pharmacist about any prescription or over-the-counter medicines you are taking or have recently taken. 3. How to take Faximin Instructions on the proper use of the medicine and dosage/frequency of administration: Always take Faximin exactly as prescribed by your doctor. If you are unsure, ask your doctor or pharmacist. Recommended dose: The recommended dose of Faximin is two tablets per day. After 6 months of starting use, your doctor will assess whether to continue your treatment. Faximin is used three times a day for 14 days to treat chronic gastrointestinal disorders characterized by diarrhea, mainly abdominal pain, bloating, and changes in intestinal structure. In case of recurrence of symptoms, your doctor may prescribe repeat treatment. Method of administration: Remove the film-coated tablet from the blister and swallow the tablet whole with a glass of water. Different age groups: Use in children: The use of the medicine is not recommended for children under 18 years of age, as the efficacy and safety of the medicine in children and adolescents under 18 years of age have not been established. Use in the elderly: Experience with rifaximin treatment in the elderly is limited. Special cases: Use in special cases is not described. If you think that the effect of Faximin is too strong or too weak, consult your doctor or pharmacist. If you have taken more Faximin than you should: Contact your doctor or pharmacist if you have taken too high a dose of Faximin. If you forget to take a dose of Faximin: Take the missed dose as soon as you remember, and then take the next dose at the usual time. Do not take a double dose to make up for a missed dose. Side effects that may develop after stopping treatment with Faximin: If you stop taking Faximin before completing treatment, your symptoms may worsen. 4. Possible side effects Like all medicines, side effects can occur in individuals who are sensitive to the substances in Faximin. The gastrointestinal side effects listed below may occur as a result of taking Faximin. The side effects of the medicine are classified into the following categories: Very common: Affects at least 1 in 10 patients. Common: Affects less than 1 in 10 patients, but more than 1 in 100 patients. Uncommon: Affects less than 1 in 100 patients, but more than 1 in 1000 patients. Rare: May affect less than 1 in 1000 patients, but more than 1 in 10,000 patients. Very rare: Affects less than 1 in 10,000 patients. Unknown: Frequency cannot be estimated from the available data. Stop taking Faximin and inform your doctor immediately or go to the emergency department of the nearest hospital if any of the following occur: Common: · Depression · Dizziness, headache · Shortness of breath · Upper abdominal pain, abdominal bloating, diarrhea, nausea, vomiting, ascites · Itching, rash · Muscle spasms, arthralgia · Peripheral edema Uncommon: · Clostridium infection, urinary tract infection, candidiasis · Anemia · Anorexia, hyperkalemia (high potassium levels) · Confusion, anxiety, insomnia, excessive desire to sleep (hypersomnia) · Balance disorder, memory loss (amnesia), seizure (convulsion), attention disorder, decreased sensitivity of nerves (hypoesthesia), memory impairment · Hot flashes · Accumulation of fluid in the lung lining (pleural effusion) · Abdominal pain, varicose bleeding, dry mouth, discomfort in the stomach area · Muscle pain (myalgia) · Painful urination (dysuria), frequent urination (pollakiuria) · Swelling, fever · Falls Rare: · Pneumonia, cellulitis, upper respiratory tract infection, chills · Fluid loss · High and low blood pressure · Chronic obstructive pulmonary disease · Constipation · Back pain · Protein in urine · Weakness (asthenia) · Confusion, procedural pain Unknown frequency: · Decrease in platelet count (thrombocytopenia) · Hypersensitivity reactions, swelling, hypersensitivity · Pre-syncope (feeling of impending fainting), syncope · Pathological results of liver function tests · Inflammatory skin disease (dermatitis), skin rash (eczema) · Pathological international normalized ratio values With prolonged therapy at high doses or damage to the intestinal inner layer, a small dose (less than 1%) of the drug may be absorbed and the urine may turn reddish. Tell your doctor or pharmacist if you experience any side effects not listed in this leaflet. 5. Storage conditions for Faximin Store Faximin out of reach of children, in its original packaging. Store at room temperature below 25°C, in the original packaging. Use the medicine within its expiry date. Do not use Faximin after the expiry date indicated on the packaging. Do not use Faximin if you notice any signs of damage to the medicine and/or its packaging. Do not discard expired or unused medicines! Hand them over to a collection facility designated by the Ministry of Environment and Urbanization. Dispensing regime: Pharmaceutical product group - II, dispensed with prescription form №3
