البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ethambutol hydrochloride
Esteve Pharmaceuticals Ltd
J04AK02
Ethambutol hydrochloride
400mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010900; GTIN: 5039021008257
290.00 mm 150.00 mm READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. IN THIS LEAFLET 1. What Ethambutol Talets are and what they are used for 2. Before you take Ethambutol Tablets 3. How to take Ethambutol Tablets 4. Possible side effects 5. How to store Ethambutol Tablets 6. Further information 1. WHAT ETHAMBUTOL TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Ethambutol Tablets. Ethambutol belongs to a group of medicines called antituberculosis drugs and is used for the treatment and prevention of tuberculosis, an infectious disease mainly affecting the lungs. 2. BEFORE YOU TAKE ETHAMBUTOL TABLETS DO NOT TAKE ETHAMBUTOL TABLETS: - if you have sight problems. - if you are allergic (hypersensitive) to ethambutol hydrochloride or any of the other ingredients (see list under ‘What Ethambutol Tablets contain’ in section 6). Problems with your sight You should have your eyesight checked before taking these tablets. If you notice any changes to your vision whilst taking these tablets, YOU SHOULD STOP TAKING THEM AND NOTIFY YOUR DOCTOR IMMEDIATELY. In the majority of cases, any changes to vision will return to normal within a few weeks/months after stopping treatment, however, in rare cases, it may take longer for eyesight to recover or the changes may become permanent. Take special care with Ethambutol if you have a history of kidney problems. Before treatment with Ethambutol you should have your kidneys checked. If you develop symptoms suggestive of hepatitis (e.g. abdominal pain, fever, loss of appetite) or feel generally unwell, you may need your liver functions tested. TAKING OTHER MEDICIN اقرأ الوثيقة كاملة
OBJECT 1 ETHAMBUTOL 400 MG TABLETS Summary of Product Characteristics Updated 07-Oct-2022 | Esteve Pharmaceuticals (formerly Intrapharm Laboratories) • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Ethambutol 400 mg Tablets 2. Qualitative and quantitative composition Each film coated tablet contains 400mg Ethambutol Hydrochloride. For a full list of excipients see section 6.1. 3. Pharmaceutical form Film coated tablet. Smooth, grey, circular, biconvex film coated tablet, plain on both sides. 4. Clinical particulars 4.1 Therapeutic indications The primary treatment and re-treatment of tuberculosis and for prophylaxis in cases of inactive tuberculosis or large-tuberculinpositive reaction. Ethambutol should only be used in conjunction with other anti- tuberculous drugs to which the patient's organisms are susceptible. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration _Route of adminis اقرأ الوثيقة كاملة