MYAMBUTOL TABLETS 400MG

Active substance: ETHAMBUTOL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Myambutol 400mg 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.
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 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 Myambutol Tablets are and what they are used for
2. Before you take Myambutol Tablets
3. How to take Myambutol tablets
4. Possible side-effects
5. How to store Myambutol Tablets
6. Further information

1. WHAT MYAMBUTOL TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Myambutol 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 MYAMBUTOL TABLETS
Do not take Myambutol Tablets:



if you have sight problems
if you are allergic (hypersensitive) to ethambutol hydrochloride or to any of the ingredients (see list
under ‘What Myambutol Tablets contain’)

Problems with your sight
You should have your eyesight checked before taking these tablets, and if you notice any changes in 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. Befofe 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 Myambutol 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 MYAMBUTOL TABLETS
Always take Myambutol 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.

Myambutol 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.

1
Created 24/01/2013



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 Myambutol Tablets than you should
If you have taken an overdose of Myambutol 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 Myambutol Tablets left or not.

If you forget to take Myambutol 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 the 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 anaphylactic 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 hyperglycemia, 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 on bruising, nosebleeds, pinpoint red spots,
prolonged bleeding after injury), other blood disorders, leucopenia and neutropenia; allergic reactions,
pain or swelling or 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.

5. HOW TO STORE MYAMBUTOL TABLETS
Keep out of the reach and sight of children.
Do not take Myambutol Tablets after the expiry date which is printed on the pack. The expiry date refers to the
last day of the month.
Myambutol Tablets should be kept in the original package, in a safe, dry place at room temperature (below
25°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 Myambutol Tablets contain
The active substance in the Myambutol Tablets is ethambutol hydrochloride.
Other ingredients are: gelatin 125 bloom; sucrose; sorbitol solution 70%; magnesium stearate; stearic acid;
Opadry-GM-27600 grey (polydextrose, hydropropylmethylcellulose, polyethylene glycol 4000, titanium dioxide
(E171) iron oxide yellow (E172), iron oxide black(E172)) deionised water

What Myambutol Tablets look like and the contents of the pack
Myambutol Tablets 400mg are grey coated tablets.

Each bottle contains 56 tablets

2
Created 24/01/2013

POM
PL 17225/0005

Myambutol Tablets 400mg

Marketing Authorisation Holder
Genus Pharmaceuticals, Park View House, 65 London Road, Newbury, Berkshire, RG14 1JN, UK

Manufacturer
Custom Pharmaceuticals Limited, Conway Street, Hove, East Sussex, BN3 3LW, UK
This leaflet was last approved in March 2010

3
Created 24/01/2013

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)