Ethambutol Tablets 100mg
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GENUS PHARMACEUTICALS
Ethambutol
Tablets 100mg
Each tablet contains 100mg Ethambutol Hydrochloride BP
56 tablets
PIP 107 5951
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Ethambutol Tablets 100mg also contain E104. To betaken by mouth. Use as directed by your doctor. | |
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Keep out of the sight and reach of children. Store at room temperature (15-30°C) in the original pack. | |
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MA holder: Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK. | |
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* Trademark | |
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POM | |
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PL 17225/0004 PM/01/863 |
PACKAGE LEAFLET: INFORMATION FOR THE USER Ethambutol 100mg Tablets Ethambutol Hydrochloride
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.
- Ihis 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 any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Ethambutol Tablets 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 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 to any of the ingredients (see list under ‘What Ethambutol Tablets contain')
Problems with your sight
You should have your eyesight checked before taking these tablets, and if you notice any changes to your vision whilst taking these tablets, you should notify your doctor immediately.
Take special care with Ethambutol if you have a history of kidney problems. Before treatment with Ethambutol you should have your kidneys checked.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
You should not take this medicine if you are pregnant, breast-feeding or trying for a baby without consulting your doctor first.
Driving and using machines
Ethambutol occasionally causes sight problems and numbness or paraesthesia (abnormal sensation) of the furthest parts of your body. After taking your medicine you should not drive or use machinery, until you know how ethambutol affects you.
Important information about the ingredients of Ethambutol Tablets.
This medicine contains sucrose and sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE ETHAMBUTOL TABLETS
Always take Ethambutol Tablets exactly as your doctor has told you to. You
should check with your doctor or pharmacist if you are not sure.
• The dosage of ethambutol varies from person to person depending on your age, how much you weigh and whether it is being used for the treatment or for the prevention of tuberculosis. • Patients who have kidney problems may need blood tests so that their doctor can reduce the dose in some cases. • Ethambutol Tablets should be taken once daily. • They should be
swallowed whole with a drink of water; do not chew or crush the tablets.
• If you are not sure how many tablets to take, or when to take them, ask
your pharmacist.
Adults:
• Prevention and first time treatment: The usual dose of ethambutol for adults for prevention of tuberculosis or for first time treatment for tuberculosis is 15mg per kg of body weight per day.
• Second time (or subsequent) treatment: The usual dose of ethambutol for adults for second time (or subsequent) treatment of tuberculosis is 25mg per kg of body weight per day for the first 60 days, reducing to 15mg per kg of body weight per day for as long as the doctor considers necessary.
Children:
• Prevention: The usual dose of ethambutol for children for prevention of tuberculosis is 15mg per kg of body weight per day.
• First, second time (or subsequent) treatment: The usual dose of ethambutol for children for first time treatment, second time treatment or subsequent treatment of tuberculosis is 25mg per kg of body weight per day for the first 60 days, reducing to 15mg per kg of body weight per day for as long as the doctor considers necessary.
If you take more Ethambutol Tablets than you should If you have taken an overdose of Ethambutol Tablets (that is more than the doctor has told you to) get medical help immediately, either by calling your doctor or going to the nearest hospital casualty department. Remember
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to take the labelled medicine bottle with you, whether there are any Ethambutol Tablets left or not. If you forget to take Ethambutol tablets If you forget to take a tablet you should take it as soon as you remember. However, if this is within 2 hours of your next dose you should skip the missed tablet and carry on taking the rest of your tablets as usual. Do not take a double dose to make up for a forgotten tablet. 4. POSSIBLE SIDE-EFFECTS Like all medicines, ethambutol can cause side-effects although not everybody gets them. Very rare is a severe allergic reaction known as an anaphylactoid reaction, |
which is characterised by difficulty in breathing, a flushed appearance, agitation or an irregular heartbeat. If this occurs, stop taking this medicine and contact your doctor immediately. If you notice any changes or problems with your sight, contact your doctor immediately. • Ethambutol has occasionally caused sight problems. In the majority of cases these will return to normal after stopping treatment. However in rare circumstances, the problem may take longer to heal or become permanent. • Ethambutol can cause gout and hyperuricaemia, a condition similar to gout. • Ethambutol can cause muscle weakness and wasting, pain, numbness, pins and needles sensations, rashes, itching, and hives. • Ethambutol can cause thrombocytopenia (which may result in bruising, |
nosebleeds, pinpoint red spots, prolonged bleeding after injury), other blood disorders leucopenia and neutropenia; allergic reactions, pain or swelling of joints, headache, dizziness, mental confusion, disorientation, hallucinations, generally feeling unwell, shortness of breath, chest pains, blisters or peeling, blistering following exposure to sunlight; a condition known as Stevens Johnson syndrome (ulceration, angina, mouth sores, joint aches, fever); kidney problems (lower back pain, pain or burning when passing urine, difficulty passing urine). • Other unwanted effects include loss of appetite, feeling sick, being sick, stomach pain and upsets; liver problems which may result in pale stools, blood in your urine, or make your skin or eyes look yellow. If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist. |
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE ETHAMBUTOL TABLETS Keep out of the sight and reach of children. Do not take Ethambutol Tablets after the expiry date which is printed on the pack. The expiry date refers to the last day of that month. Ethambutol Tablets should be kept in the original package, in a safe, dry place at room temperature (between 15 to 30°C). Return any unused tablets to your |
pharmacist. 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 protect the environment. 6. FURTHER INFORMATION What Ethambutol Tablets contain The active substance in Ethambutol Tablets is ethambutol hydrochloride. Other ingredients are: gelatin 125 bloom; sucrose; sorbitol solution 70% (non-crystallising); quinoline yellow (E104); magnesium stearate; stearic acid; shellac solution 40%; colorcon opaglos regular (containing shellac; polyvinylpyrrolidone; acetylated monoglyceride; industrial methylated spirits); and talc. |
What Ethambutol Tablets look like and the contents of the pack Ethambutol Tablets 100mg are slightly mottled yellow coated tablets. Each bottle contains 56 tablets. | POM | PL 17225/0004 Ethambutol Tablets 100mg Marketing Authorisation Holder: Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK. Manufacturer: Custom Pharmaceuticals Limited, Conway Street, Hove, East Sussex BN3 3LW, UK. This leaflet was last revised in September 2014 |
GENUS PHARMACEUTICALS Ethambutol Tablets 100mg Each tablet contains 100mg Ethambutol Hydrochloride BP 56 tablets _IUI_ |
Ethambutol Tablets 100mg also contain E104. To be taken by mouth. Use as directed by your doctor. Keep out of the sight and reach of children. Store at room temperature (15-30°C) in the original pack. MA holder: Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK. ^Trademark 25174501 POM PL 17225/0004 PM/01/863 |