1. What this product is and what it is used for Ethionamide is used in combination with other antitituberculosis agents for the treatment of all forms of tuberculosis caused by Mycobacterium tuberculosis. Ethionamide is used as a second line antimycobacterial drug when resistance to or toxicity from first-line drugs has developed. 2. What you need to know before you use this product a.Do not take Ethionamide Tablets 250 mg: - if you are hypersensitive (allergic) to ethionamide or any of the other ingredients of Ethionamide Tablets (see section 6, What Ethionamide Tablets contains), - if you have severe liver disease. b.Take special care with Ethionamide Tablets 250 mg: Take Ethionamide Tablets always together with other antitituberculosis drugs, that your doctor or health care provider prescribes you. If you develop clinical symptoms suggesting an injury of the liver, such as loss of appetite, nausea, jaundice (yellowing of the skin and eye white), dark urine, discoloured stools, pain and tenderness in the upper right abdomen, tell your doctor immediately . If you experience rash or fever (possible signs of an allergic reaction), tell your doctor or health care provider immediately. Your doctor or health care provider will regularly monitor your blood sugar, your thyroid function and your visual acuity throughout therapy with Ethionamide because ethionamide may lead to alterations (see “Undesirable effects”). Your doctor may prescribe a certain vitamin, called pyridoxine, for you to be taken concomitantly with ethionamide. This medicine may reduce the risk of developing nerve damage. It is important that your doctor or health care provider knows about all your symptoms even when you think they are not related to tuberculosis infection. c.Taking other medicines Please tell your doctor, health care provider or pharmacist if you are taking or have recently any other medicines, including medicines obtained without prescription. These may affect the action of Ethionamide Tablets, or Ethionamide Tablets may affect their action. Ethionamide may interact with isoniazid and rifampicin and may make side effects worse: Ethionamide Tablets should not be taken with large amounts of alcohol. d.Taking Ethionamide Tablets with food and drink Ethionamide Tablets may be taken with or without food. Intake with food may reduce gastrointestinal side effects. e.Pregnancy and breast-feeding You should avoid becoming pregnant while on treatment with Ethionamide Tablets. If you become pregnant, or are planning to become pregnant, you must contact your doctor or health care provider to discuss the potential benefits and risks of your tuberculosis therapy to you and your child. It is not known whether ethionamide is excreted into human milk. If continuation of breast-feeding during ethionamide treatment is deemed necessary, your baby should be closely monitored for side effects of ethionamide. f.Driving and using machines Ethionamide may cause side effects such as drowsiness or headache, that can impair your ability to drive and to use machines. 3. How to use this product. Always take Ethionamide Tablets exactly as your doctor or health care provider told you. You should check with your doctor, health care provider or pharmacist if you are not sure. Your doctor will assign the dose of Ethionamide Tablets appropriate for you. The following information includes only the average doses of this medicine. If your prescribed dose is different, do not change it unless your doctor or health care provider tells you to do so. For adults the usual daily dose is two to four tablets (500 mg to 1 g daily), depending on body weight and tolerance. The daily dose can be taken either at a single occasion or split up in two doses over the day to improve tolerability. Ethionamide Tablets may be taken with or without food. Intake with food may improve gastrointestinal tolerability. Children: For children the dose must be determined by the doctor that prescribes the drug. Doses of 10-20 mg/kg of body weight per day have been recommended. The dose can be taken either at a single occasion or split up in two doses over the day to improve tolerability. If you have severe liver disease you must not take ethionamide. No dose adjustment is necessary if you have a kidney disease. a.If you take more Ethionamide Tablets 250 mg than you should If you have taken too many tablets or if someoneally swallows some, there is no immediate danger. However, you should contact your doctor, health care provider or the nearest hospital emergency department for further advice. b.If you forget to take Ethionamide Tablets 250 mg If you accidentally miss a dose and notice within 6 hours take the missed dose as soon as possible. Take the next regular dose as scheduled. If you notice later, then simply take your normal dose when the next one is due. Do not take a double dose to make up for forgotten individual doses. c.If you stop taking Ethionamide Tablets 250 mg Keep taking the medicine for as long as your doctor has told you, even if you are feeling better. If you stop the medicine too soon, your infection may not be completely cured. You should not stop treatment unless your doctor or health care provider tells you to. If you have any further questions on the use of this product, ask your doctor or health care provider or pharmacist. 4. Possible side effects Like all medicines, Ethionamide Tablets can cause side effects, although not everybody gets them. When treating tuberculosis, it is not always possible to differentiate between unwanted effects caused by Ethionamide Tablets, or those caused by any other medicines you may be taking at the same time. For this reason, it is important that you inform your doctor or health care provider of any change in your health. The most commonly reported side effects (greater than 1 in 10 patients treated) are stomach discomfort, abdominal pain, loss of appetite, vomiting, diarrhoea, nausea. The frequency depends on the dose and duration of therapy. Furthermore, increased serum transaminases have been reported very commonly. Other common side effects (greater than 1 in every 100 patients treated) are headache, dizziness, drowsiness, general weakness, feeling of pins and needles (paraesthesia), inflammation of the liver (hepatitis) and yellowing of the skin. The following side effects have been reported in patients treated with ethionamide. However, frequency estimates for these effects are not available: Decrease of platelets (blood cells important for blood clotting), metallic taste and sulfurous belching, increased salivation, taste disorders, a so called Pellagra-like syndrome (a condition presenting with diarrhoea, skin inflammation and impaired brain function, caused by a lack of Niacin, a certain vitamin), thyroid underfunction, raised sugar in the blood, psychotic reactions (hallucinations, abnormal thinking, personality changes), low blood pressure (especially after standing up), altered brain function and/or structure (encephalopathy), tingling in the limbs, altered sense of smell, rash (red, raised or itchy), urticaria, acne, sensitivity to light (photosensitivity), inflammation of mucous lining (cheeks, gums, tongue, lips, throat), hair loss, red or purple discolouration on the skin (purpurea), breast enlargement in male patients,menstrual disturbance, impotence, visual disturbance (blurred or double vision, complete or partial loss of vision), damage to the ear (eg dizziness, hearing loss, tinnitus), rash and fever. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or health care provider or pharmacist as soon as possible. 5. How to store this product Keep out of the reach and sight of children. Store below 300C , protect from light. Do not use Ethionamide Tablets after the expiry date which is stated on the after the expiry date. The expiry date refers to the last day of that month. Do not use Ethionamide Tablets if you notice discolouration or swelling of tablets. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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