Ethambutol hydrochloride 400mg Film-coated tablets

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any serious side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

1. What Ethambutol Tablets are and what they are used for
2. What you need to know before you take Ethambutol Tablets
3. How to take Ethambutol Tablets
4. Possible side effects
5. How to store Ethambutol Tablets
6. Contents of the pack and other information

• if you are allergic to ethambutol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you have sight problems.
• If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking ethambutol.

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 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.

Talk to your doctor or pharmacist before taking Ethambutol Tablets

• 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.
• Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Ethambutol Tablet treatment. Stop taking Ethambutol Tablet and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

You should not take ethambutol tablets at the same time as antacid medicine containing aluminium hydroxide (used to treat heartburn and indigestion) as this can make ethambutol less effective.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Ethambutol Tablets may be taken with or without food.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Ethambutol occasionally causes sight problems and may present symptoms which affect the ability to drive or use machinery (e.g. numbness or paraesthesia (abnormal sensation like pins and needles} of the furthest parts of your body, disorientation). After taking your medicine you should not drive or use machinery until you know how ethambutol affects you.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Prevention and treatment for the first time:

The usual dose of ethambutol for adults for prevention of tuberculosis or first time treatment of 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 it necessary.

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 it necessary.

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 to take the carton and blister pack with you, whether there are any Ethambutol Tablets left or not.

If you forget to take 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 carry on taking the rest of your tablets as usual. Do not take a double dose to make up for a forgotten dose.

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.

Stop using Ethambutol Tablets and tell your doctor immediately if you notice any of the following symptoms:

• reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• High levels of uric acid in the blood (hyperuricaemia) and gout (a symptom of these conditions is joint inflammation)
• Thrombocytopenia (which may result in bruising, nosebleeds, pinpoint red spots, prolonged bleeding after injury) and other blood disorders such as leucopenia and neutropenia
• Minor allergic reactions such as rashes, itching and hives
• Muscle weakness and wasting, pain, numbness, pins and needles sensations
• Headache, dizziness, disorientation
• Mental confusion, hallucinations
• Generally feeling unwell, fever
• Shortness of breath, chest pains
• Blisters or peeling skin (Inc. following exposure to sunlight)
• Kidney problems (lower back pain, pain or burning when passing urine, difficulty passing urine)
• Other potential unwanted effects include loss of appetite, feeling sick, being sick, stomach pain/upsets, diarrhoea and liver problems (which may result in pale stools, blood in your urine or yellowing of the skin and/or eyes).

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.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

UK

The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for “MHRA Yellow Card” in the Google Play or Apple App Store

Ireland

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is ethambutol hydrochloride.
  Each tablet contains either 100mg or 400mg of ethambutol hydrochloride.
• The other ingredients are
  Core Tablet:
  Magnesium stearate, maize starch, microcrystalline cellulose, povidone, silica colloidal anhydrous, sodium starch glycolate.
  Film Coating:
  Hypromellose 15cP, polydextrose, polyethylene glycol 4000, titanium dioxide.
  The tablets also contain the following colourants:
  100mg - Iron oxide yellow (E172).
  400mg- Iron oxide black (E172), iron oxide yellow (E172).

Ethambutol 100mg Tablets are yellow, circular biconvex film-coated tablets, plain on both sides. Ethambutol 400mg Tablets are grey circular biconvex film-coated tablets, plain on both sides. Both tablets are supplied in blister packs of 10, 14, 20, 28, 30, 56, 60, 84, 90 and 112 tablets.

Not all pack sizes may be marketed.

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