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PACKAGE LEAFLET: INFORMATION FORTHE USER

Ethambutol 100mg and 400mg Film-coated 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 gets 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 used for

2.    Before you take Ethambutol Tablets

3.    How to take Ethambutol Tablets

4.    Possible side effects

5.    Howto store Ethambutol Tablets

6.    Further information

Taking Ethambutol Tablets with food and drink

Ethambutol Tablets may be taken with or without food.

Pregnancy and breast-feeding

You should not take this medicine if you are pregnant, breast feeding or trying fora baby without consulting your doctor

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Ethambutol Tablets may cause visual disturbances that can impair your ability to drive and to use machines.

3. HOWTO TAKE ETHAMBUTOLTABLETS

1. WHAT ETHAMBUTOL TABLETS ARE AND WHAT THEY USED FOR

Ethambutol is an antibiotic (antibacterial medicine) for treating infections. It belongs to a group of antibiotics called antituberculosis drugs and used is used in combination with other antituberculosis agents to treat and prevent tuberculosis (TB), an infectious disease mainly affecting the lungs.

2. BEFORE YOU TAKE ETHAMBUTOL TABLETS

Do not take Ethambutol Tablets

•    if you are allergic (hypersensitive) to ethambutol hydrochloride or any of the other ingredients of Ethambutol Tablets (See “Ingredients”)

•    if you have poor vision or swelling of the optic nerve which results in blurring ofvision (optic neuritis)

Take special care with Ethambutol Tablets

•    if you have been treated for kidney problems

Before treatment with Ethambutol Tablets you doctor may send you for an eye test and if you notice any changes to your vision during your treatment you should immediately let your doctor know.

Taking other medicines

It is not known if Ethambutol Tablets interacts with other medicines. However, it is best to tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Always take Ethambutol Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The dose of Ethambutol Tablets will be decided by your doctor based on your age, body weight and whether it is being used for the treatment or prevention of tuberculosis. Elderly patients who have kidney problems may need blood tests so theirdoctor can prescribe them an appropriate dose.

Adults:

Prevention and treatment for the first time:

The usual dose of ethambutol for adults for the prevention of tuberculosis or first time treatment of tuberculosis is 15mg per kg of body weight per day.

Re-treatment:

The usually dose of ethambutol for adults in the re-treatment of tuberculosis is 25mg per kg of body weight per day for the first 60 days and then reducing to 15mg per kg of body weight per day for as long as the doctor considers it necessary.

Children:

Prevention:

The usually dose of ethambutol for children for the prevention of tuberculosis is 15mg per kg of body weight per day.

Treatment:

The usually dose of ethambutol for children for the treatment of tuberculosis is 25mg per kg of body weight per day for the first 60 days and then reducing to 15mg per kg of body weight per day for as long as the doctor considers it necessary.

Ethambutol Tablets will always be taken in combination with other antituberculosis medication; please make sure to follow the instructions within the supplied package leaflet(s).

If you take more Ethambutol Tablets than you should

If you have taken too many tablets or if someone accidentally swallows some, immediately contact your doctor, health care provider or the nearest hospital emergency department for further advice.

If you forget to take Ethambutol Tablets

If you miss a dose, just carry on with the next one as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Ethambutol Tablets

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.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If any side-effects get serious, or if you notice and side-effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE ETHAMBUTOL TABLETS

Keep out of the reach and sight of children.

Do not use Etambutol Tablets after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

Like all medicines, ethambutol can cause side effects, although not everybody gets them.

Very rarely you may experience a serious allergic reaction known as an anaphylactoid reaction which causes difficulty in breathing or irregular heart beats.

If you experience any of the above then stop taking the tablets straight away and tell your doctor immediately.

The following side effects have been reported in patients treated with ethambutol. However, frequency estimates for these effects are not available:

•    Changes in white blood cell count, reduction in blood platelets, which increases risk of bleeding orbruising,

•    Abnormal liver function, hepatitis and yellowing of the skin or eyes (jaundice)

•    Loss of appetite, nausea, vomiting, diarrhoea

•    Tingling or numbness in the hands or feet, muscle weakness and wasting, dizziness, headaches

•    Hypersensitivity, rash, itching, red patches often on the back of arms and hands, and blisters or peeling. Increased sensitivity to sunlight

•    High levels of uric acid in the blood, gout

•    Mental confusion, disorientation, hallucination

•    Inflammation of the lungs

•    General feeling of unwell, joint pains, fever

•    Inflammation of the kidney which can cause swollen ankles or high blood pressure

The most commonly reported serious side effects are visual changes due to inflammation of the optic nerve (optic neuritis). The frequency depends on the dose and duration of therapy. Typical initial signs include impairment of colour vision (red-green blindness) and constriction of visual field (central or peripheral scotoma). These changes are often reversible after discontinuation of treatment with ethambutol. If you notice any visual disturbance, please inform your doctor or health care provider immediately.

What Etambutol Tablets contains

•    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).

What Ethambutol Tablets looks like and contents of the pack

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.

Marketing Authorisation Holder

Morningside Healthcare Ltd 115 Narborough Road,

Leicester, LE3 0PAU.K.

Site responsible for batch release

Morningside Pharmaceuticals Ltd 5 Pavilion Way Loughborough.

LE11 5GW. U.K.

This leaflet was last approved in January 2011.