Leaflet added to the packaging: information for the patient. Dafurag max, 100 mg, tablets Furaginum

Transcription

1 Leaflet added to the packaging: information for the patient Dafurag max, 100 mg, tablets Furaginum You should read the leaflet carefully before taking the medicine as it contains information important to the patient. - This medicine should be administered exactly in a way that is described in the leaflet or according to the doctor s or pharmacist orders. Keep this leaflet so that you can read it again if needs be. - If you need any advice or additional information, please ask the pharmacist. - If the patient experiences any side effects, including side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4. - If there is no improvement or the patient feels worse after 7-8 days, you should contact your doctor. Leaflet index 1. What is Dafurag max drug and what is it used for 2. Important information before taking Dafurag max drug 3. How to take Dafurag max drug 4. Possible side effects 5. How to store Dafurag max drug 6. Packaging contents and other information 1. What is Dafurag max drug and what is it used for Dafurag max is an antibacterial agent containing an active substance furaginum, a derivative of nitrofuran. Furaginum inhibits the growth of bacteria that cause urinary tract infections. Indication for use of Dafurag max is an infection of the lower urinary tract. If there is no improvement or the patient feels worse after 7-8 days, you should contact your doctor. 2. Important information before taking Dafurag max drug When not to take Dafurag max drug - if the patient is allergic to furaginum or any of the other ingredients of this medicine (listed in section 6) or to derivatives of nitrofuran; - in the first trimester of pregnancy; - in the full-term pregnancy (38 weeks) and labor, due to the risk of hemolytic anemia in the neonate (anemia associated with the breakdown of red blood cells); - in children and adolescents under 15 years of age; - if the patient suffers from severe renal insufficiency (oliguria, anuria); - if the patient suffers from recognized polyneuropathy, eg. diabetic (nerve damage caused by elevated sugar level in blood); - if the patient suffers from a glucose-6-phosphate dehydrogenase deficiency the drug may induce breakdown of red blood cells (hemolysis), which in turn may lead to the development of hemolytic anemia (anemia caused by excessive disintegration of blood cells). Warnings and precautions Before taking Dafurag max drug, it should be consulted with a doctor or pharmacist.

2 - If the patient suffers from kidney or liver functioning disorders, nervous system disorders, anemia, electrolyte imbalance, deficiency of vitamin from B group, folic acid deficiency or lung disease; - if the patient suffers from diabetes, because furagin can cause nerve damage. In patients treated with the nitrofuran derivatives, damage to peripheral nerves could be observed. This disorder, in severe cases, can be irreversible and fatal. Therefore Dafurag max drug s use should be discontinued if symptoms from nervous system occur (tingling, numbness, feeling of an electric current running through the body); - if the patient suffers from a fever, chills, cough, chest pain, shortness of breath. These may be signs of acute pulmonary reactions, which are sometimes observed in patients treated with derivatives of nitrofuran. In the event of the occurrence of such symptoms, treatment should be discontinued immediately. These symptoms usually subside quickly or very quickly after the discontinuation of the use of the drug. In case of chronic reactions, the intensity of symptoms and their reversibility after the discontinuation of the use of the drug depend on the length of the follow-up treatment after first side effects occurred. It is key to recognize, as soon as possible, the side effect and discontinue the treatment. Impaired lung functioning may be irreversible. Chronic reactions occurred in patients taking furaginum for longer than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may occur, especially in elderly patients; - If the drug is used long-term a blood test may be needed in order to check the number of white blood cells as well as the kidney and liver function. Effects on laboratory tests The drug can cause false positive results of determinations of glucose in the urine. Before taking the urine sample for such tests, please inform the medical stuff that you are taking Dafurag max. Children and adolescents Dafurag max drug should not be used in children and adolescents below 15 years of age. Dafurag max drug and other drugs One should tell the doctor or pharmacist about all the medicines taken by the patient now or recently, as well as drugs which patient plans to take. Caution should be exercised with the concomitant use of the following drugs: - quinolone derivatives (eg. nalidixic acid an antibiotic) furaginum may inhibit the antibacterial activity; - probenecid and sulfinpyrazone (used to treat gout) may reduce the effect of furaginum and increase its toxicity; - antibiotics and tetracycline, an aminoglycoside administered with furaginum strengthen its antibacterial activity; - chloramphenicol and ristomicin (antibiotics) enhance the toxic activity of furaginum; - antacids that contain magnesium trisilicate because they reduce the absorption of furaginum, which weakens its antibacterial activity; - atropine (an antispasmodic and mydriatic) may delay absorption of furaginum, but the overall amount of the substance absorbed does not change; - B group vitamins increase the absorption of nitrofuran derivatives. Dafurag max drug with food and water Dafurag max drug is best taken with meals containing protein as it increases the absorption of furaginum. Pregnancy, breast-feeding and effect on fertility If the patient is pregnant or breast-feeding, think she might be pregnant or is planning to have a baby, the patient should consult their doctor or pharmacist before taking this medicine. Pregnancy In the absence of clinical data on adverse effects of furaginum on the embryo or fetus, the drug should not be used in the first trimester of the pregnancy.

3 Due to the risk of causing hemolytic anemia in the fetus, caution should be exercised in case of women in their third trimester of pregnancy. The patient, in consultation with a doctor, should perform regular blood count test (hemoglobin and iron concentration, as well as the number of red blood cells erythrocytes). Breast-feeding The drug penetrates to the milk and therefore should not be used during the breast-feeding period. Fertility Clinical studies have shown that derivatives of nitrofuran have a negative impact on the function of the testicles. They may cause decrease in sperm motility, reduce the secretion of sperm and lead to pathological changes in the sperm morphology. Driving and using machines There is no data on the impact of furaginum on ability to drive and use machines. If you experience dizziness, drowsiness and blurred vision, do not drive or operate machinery. Dafurag max drug contains lactose Each tablet of Dafurag max contains 118 mg of lactose. If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the drug. 3. How to take Dafurag max drug This medicine should be taken exactly as it is described in the leaflet, or according to the doctor s or pharmacist s orders. Administer the drug orally, preferably with meals containing protein. Recommended dose Adults and adolescents over 15 years of age The first day of treatment: 1 tablet 4 times a day; Next days of treatment: 1 tablet 3 times a day. The drug should be use for 7-8 days. If symptoms worsen or these is no improvement after 7-8 days, you should consult a doctor. Use in children and adolescents Dafurag max drug should not be used in children and adolescents below 15 years of age. Taking more than the recommended dose of Dafurag max drug Due to the elimination of the drug from the body by the kidneys, patients with renal impairment may experience overdose symptoms, such as headaches, dizziness, allergic reactions, nausea, anemia. If you experience these symptoms, you should immediately contact your doctor. Forgetting to take Dafurag max drug Do not take a double dose to make up for a missed dose. If you have any further questions on the medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately or report to the nearest hospital if you experience: - angioedema (severe allergic reaction sudden swelling of the face, extremities or joints without itching and pain). Swelling of the head and neck may cause difficulty in swallowing and breathing.

4 Following side effects can occur Often (occur in 1 to 10 people in 100): - nausea, flatulence; - headaches. Rarely (occur in 1 out of 10 people in ): - anaphylactic reactions (sudden allergic reactions, local or systemic); - severe skin reactions (exfoliative dermatitis, erythema multiforme red-blueish spots on the skin and (or) mucous membranes, sometimes with blisters, fever and join pain, Stevens- Johnson syndrome the presence of blisters on the skin and (or) mucous membranes, which for painful wounds after cracking, often accompanied by fever, muscle and joint pain); - symptoms of drug-induced hepatitis, cholestatic jaundice (caused by an obstacle in the outflow of bile), liver necrosis (usually during long-term treatment). Occurrence level not known: - itching, rash (itchy, red bumps on the skin), urticaria (pale pink, itchy bumps on the skin)l - dizziness; - drowsiness; - blurred vision; - damage to the peripheral nerves (including acute or irreversible progress, especially in patients with impaired renal function, anemia, diabetes, electrolyte disturbances or deficiency of vitamin B); - acute, subacute and chronic hypersensitivity reactions to derivatives of nitrofuran on the respiratory system. Chronic reactions occurred in patients taking the drug for longer than 6 months. Acute hypersensitivity reactions regarding respiratory system manifested through fever, chills, cough, chest pain, effusion to pleural cavity. Most commonly, the following symptoms subsided quickly or very quickly after the discontinuation of the use of the drug: - vomiting; - constipation, diarrhea; - symptoms of indigestion, abdominal pain; - inflammation of the salivary glands; - inflammation of the pancreas; - pseudomembranous colitis (acute diarrheic of small intestine or colon); - alopecia; - microbial infections resistant to furaginum; - fever; - chills; - bad mood; - blueish skin color with a chocolate-brown hue; - megaloblastic anemia (resulting from the deficiency of vitamin B12 or folate deficiency), or hemolytic anemia (caused by the rapid disintegration of red blood cells) might occur in individuals with glucose-6-phosphae dehydrogenase deficiency. Reporting adverse effects If you experience any side effects, including any possible side effects not listed in this leaflet, please consult your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Side Effects of Medicinal Products Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Al. Jerozolimskie 181C, Warszawa tel.: faks.: ndl@urpl.gov.pl Thanks to reporting side effects more information can be gathered on the safety of the medicine usage. 5. How to store Dafurag max drug Medicine needs to be kept out of sight and reach of children.

5 Keep at temperatures below 25 C. Store in the original package in order to protect from moisture. Do not use this medicine after the expiry date stated on the blister and carton after: expiry date (Exp). The expiry date refers to the last day of the given month. Batch number (Lot). Medicines should not be disposed of via sewage system or household waste. Ask your pharmacist how to disposes of medicines which are no longer used. These actions will help to protect the environment. 6. Packaging contents and other information What does Dafurag max drug contain - the active substance is furaginum. 1 tablet contains 100 mg of furaginum. - other ingredients are: mannitol; lactose monohydrate; talc; colloidal anhydrous silica; sodium carboxymethyl starch (type A); magnesium stearate. How Dafurag max drug looks like and what does the packaging contain The drug has a form of an elongated, oval-shaped double-sided convex tablets, yellow coloured. The tablets are packaged in blisters and a cardboard box. Packaging: 15 or 30 tablets. Marketing Authorization Holder and manufacturer Aflofarm Farmacja Polska Sp. z o.o. ul. Partyzancka 133/ Pabianice tel. (42) Date of leaflet s last revision: