Ethambutol 400 mg 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. 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.

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

• 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).
• if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking ethambutol.

Warnings and precautions - Take special care with Ethambutol 400mg Tablets:

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 400mg Tablets treatment. Stop taking Ethambutol 400mg Tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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.

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.

Please tell your doctor or pharmacist if you are taking or have recently take any other medicines, including medicines obtained without a prescription

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor 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.

Prevention and first time treatment: The usual dose of ethambutol for adults for prevention of tuberculosis or for 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 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 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 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 labelled medicine bottle with you, whether there are any Ethambutol Tablets left or not.

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.

• Severe allergic reaction (e.g. difficulty in breathing, flushed appearance, agitation or an irregular heartbeat.) If this occurs, stop taking this medicine and contact your doctor immediately.
• Eye problems (e.g. colour blindness, loss of vision or visual acuity). If you notice any changes or problems with your sight, contact your doctor immediately.
• Kidney problems (lower back pain, pain or burning when passing urine, difficulty passing urine)
• Liver problems (which may result in pale stools, blood in your urine or yellowing of the skin and/or eyes).
• Skin and subcutaneous skin disorders
  Stop using Ethambutol 400mg 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).

Uncommon side effects (may affect up to 1 in 100 people)

• High levels of uric acid in the blood (hyperuricaemia)

Rare side effects (may affect up to 1 in 1,000 people)

• Thrombocytopenia (which may result in bruising, nosebleeds, pinpoint red spots, prolonged bleeding after injury)
• Minor allergic reactions such as rashes, itching and hives
• Muscle weakness and wasting, pain, numbness, pins and needles sensations

Very rare side effects (may affect up to 1 in 10,000 people)

• Blood disorders such as leucopenia and neutropenia
• Gout (a symptom of these conditions is joint inflammation), joint pains
• Headache, dizziness, disorientation
• Mental confusion, hallucinations
• Shortness of breath, chest pains, generally feeling unwell, fever
• Liver failure
• Blisters or peeling skin (inc. following exposure to sunlight)

Not known side effects (frequency cannot be estimated from the available data)

• Loss of appetite, feeling sick, being sick, stomach pain/upsets, diarrhoea

If you get any side effects, talk to your doctor or pharmacist. This includes any 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 or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient is ethambutol (as ethambutol hydrocloride). Each tablet contains 400mg of ethambutol.

Other ingredients are:

Tablet core: Microcrystaline cellulose, sodium starch glycolate, maize starch, povidone, colloidal anhydrous silica and magnesium stearate.

Tablet coating: Polydextrose, hydroxypropylmethylcellulose, polyethylene glycol 4000, purified water, titanium dioxide (E171), iron oxide yellow (E172) and iron oxide black (E172).

Ethambutol 400mg Tablets are round grey coated tablets, plain on both sides. The tablets are available in bottles of 56 tablets.