Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ethambutol 400 mg Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ethambutol hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
The name of your medicine is Ethambutol Tablets. Ethambutol belongs to a group of medicines 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 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.
Jun 2024
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. Taking other medicines 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 Pregnancy and breast-feeding 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. Driving and using machines 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. 3.
How to take it
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 per day. 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. Keep taking your tablets for as long as your doctor directed, even if you feel better. Adults: 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. Children: Prevention: The usual dose of ethambutol for children for prevention of tuberculosis is 15mg per kg of body weight per day.
Jun 2024
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 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 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, this medicine can cause side effects, although not everybody gets them. If you get any of the following symptoms, tell your doctor immediately:
- 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). Other possible side effects include: 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 Jun 2024
- 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 Reporting of side effects 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. 5.
How to store it
Ethambutol Tablets
Keep out of the sight and reach of children. Do not use Ethambutol Tablets after the expiry date which is stated on the packaging after EXP. Store below 30oC in the original packaging to protect from moisture. 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 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). What Ethambutol Tablets look like and contents of the pack: Ethambutol 400mg Tablets are round grey coated tablets, plain on both sides. The tablets are available in bottles of 56 tablets. Marketing Authorisation Holder Esteve Pharmaceuticals Ltd, The Courtyard Barns, Choke Lane, Maidenhead, Berks SL6 6PT, UK. Manufacturer: Esteve Pharmaceuticals Ltd, The Courtyard Barns, Choke Lane Maidenhead, Berks, SL6 6PT, UK. This leaflet was last revised in June 2024.
Jun 2024
Frequently asked questions about Ethambutol 400 mg Tablets
How do I take Ethambutol 400 mg Tablets?
Ethambutol 400 mg Tablets comes as tablet containing 400mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Ethambutol 400 mg Tablets?
The active substance in Ethambutol 400 mg Tablets is ethambutol hydrochloride.
Are there equivalent medicines to Ethambutol 400 mg Tablets?
Medicines with the same active substance, strength and form include: Ethambutol 400 mg film-coated tablets, Ethambutol hydrochloride 400mg Film-coated tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ethambutol 400 mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ethambutol 400 mg Tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ethambutol hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
The primary treatment and re-treatment of tuberculosis and for prophylaxis in cases of inactive tuberculosis or large-tuberculinpositive reaction. Ethambutol should only be used in conjunction with other anti-tuberculous drugs to which the patient's organisms are susceptible.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2. Posology and method of administration
Route of administration:
Oral
Posology:
Recommended Dosage
The dosage of ethambutol must be adjusted according to the body weight of the patient.
This drug should not be used as a sole anti-tuberculosis agent, but should be given with at least one other antituberculosis drug to avoid development of resistant strains.
The usual daily dosage is 15-25mg/kg body weight given as a single dose.
Adults
For primary treatment and prophylaxis: Ethambutol should be administered in a single daily dose of 15mg/kg, concomitant drugs being maintained at their recommended dosage levels.
For re-treatment: For the first 60 days of treatment, ethambutol should be administered in a single daily dose of 25mg/kg. Thereafter the dosage should be reduced to 15mg/kg, concomitant drugs being maintained at their recommended dosage levels.
Children
For primary treatment and re-treatment: For the first 60 days of treatment, a single daily oral dose of 25mg/kg. Thereafter the dosage should be reduced to 15mg/kg, concomitant drugs being maintained at their recommended dosage levels.
For prophylaxis: A single daily oral dose of 15mg/kg, concomitant drugs being used at their recommended dosage levels
As children might be less likely or unable to report ocular toxicity, particular caution may be warranted (see section 4.4).
Elderly
As for adults. However, patients with decreased renal function may need to have the dosage adjusted as determined by blood levels of ethambutol.
4.3. Contraindications
Ethambutol is contraindicated in patients who are known to be hypersensitive to the active substance or any of the excipients.
Ethambutol is contraindicated in patients who have optic neuritis, or retrobulbar neuritis unless clinical judgement determines that the benefit outweighs the risk.
4.4. Special warnings and precautions for use
Renal function:
Toxic effects are more common if renal function is impaired.
Ocular toxicity:
Ethambutol may produce a unique type of visual impairment which is generally reversible and which appears to be due to optic neuritis and to be related to dose and duration of treatment.
Less than 1% of patients undergoing treatment with the higher dose regimen of 25mg/kg/day for two months, and 15mg/kg/day thereafter, have exhibited decrease in visual acuity. It is recommended that patients undergo a full ophthalmic examination before starting treatment. This should include visual acuity, colour vision, perimetry and ophthalmoscopy. Any change may be unilateral or bilateral and hence both eyes should be tested individually.
Routine ophthalmological examination for adults is not thereafter necessary, but patients should be informed of the importance of reporting any change in vision. Routine ophthalmological examinations may be considered desirable when treating young children.
Any negative effects on vision are generally reversible when administration of the drug is discontinued promptly and recovery of visual acuity has usually occurred over a period of weeks to months after the drug was discontinued. Patients have then received Ethambutol at lower dosages without toxicity.
In rare cases, recovery may be delayed for up to one year or more or the effects may be irreversible.
Hepatic impairment:
Liver function tests should be performed in patients who develop symptoms suggestive of hepatitis or who become generally unwell during treatment.
Other warnings:
Consideration should be given to current clinical guidance on the appropriate use of antituberculous drugs.
Skin and subcutaneous tissue disorders:
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported post-marketing in association with ethambutol treatment.
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
If signs and symptoms suggestive of these reactions appear, ethambutol should be withdrawn immediately and an alternative treatment considered (as appropriate).
If the patient has developed a serious reaction such as SJS, TEN or DRESS with the use of ethambutol, treatment with ethambutol must not be restarted in this patient at any time.
In children, the presentation of a rash can be mistaken for the underlying infection or an alternative infectious process, and physicians should consider the possibility of a reaction to ethambutol in children that develop symptoms of rash and fever during therapy with ethambutol.
4.5. Interaction with other medicinal products and other forms of interaction
Aluminium Hydroxide impairs the absorption of Ethambutol. Acid suppressing drugs or antacids that do not contain Aluminium Hydroxide should be used during Ethambutol therapy.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited data from the use of ethambutol in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown.
Ethambutol is not recommended during pregnancy and in women of childbearing potential unless the potential benefit to the mother is considered to outweigh any possible risks.
Breast-feeding
Ethambutol/metabolites have been identified in breastfed newborns/infants of treated women. There is insufficient information on the effects of ethambutol in newborns/infants.
Breast-feeding is not recommended during Ethambutol treatment unless the benefit of breast-feeding to the child is considered to outweigh any possible risks.
4.7. Effects on ability to drive and use machines
Patients who suffer from visual impairment during treatment with ethambutol should not drive or operate machinery.
Numbness, paraesthesia, dizziness, disorientation are also among possible side effects that may affect a patient's ability to drive or operate machinery, if affected, patients should not drive or operate machinery.
4.8. Undesirable effects
In this section, frequencies of undesirable effects are defined as follows: Frequency: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000), very rare (<1/10,000).
Blood & lymphatic system disorders:
Rare: Thrombocytopenia
Very rare: Leucopenia, neutropenia
Immune system disorders:
Very rare: Hypersensitivity, anaphylactoid reactions, (see also Skin and subcutaneous tissue disorders)
Metabolic & nutrition disorders:
Uncommon: Hyperuricaemia
Very rare: Gout
Nervous system disorders:
Rare: Peripheral neuropathy, numbness, paraesthesia of the extremities
Very rare: headache, dizziness, disorientation
Psychiatric disorders:
Very rare: mental confusion, hallucinations
Eye disorders:
Uncommon: Optic neuritis (decreased visual acuity, loss of vision, scotoma, colour blindness, visual disturbance, visual field defect, eye pain)
Respiratory, thoracic & mediastinal disorders:
Very rare: Pneumonitis, pulmonary infiltrates, with or without eosinophilia
Gastrointestinal disorders:
Gastrointestinal disorders such as anorexia, nausea, vomiting, abdominal pain and diarrhoea have been noted in patients on multiple drug anti-tuberculosis therapy including ethambutol although not in test patients receiving ethambutol as sole therapy.
Hepatobiliary disorders:
Hepatic reactions with hepatitis, jaundice, abnormal liver function test values, and very rarely, hepatic failure, have been reported in patients treated with multiple drug therapy including ethambutol. Liver function tests should be performed in patients who develop symptoms suggestive of hepatitis or who become generally unwell during treatment.
Skin & subcutaneous tissue disorders:
Rare: Rash, pruritus, urticaria
Very rare: photosensitive lichenoid eruptions, bullous dermatitis, Stevens-Johnson syndrome, epidermal necrolysis
not known: drug reaction with eosinophilia and systemic symptoms (DRESS) (see section 4.4)
Musculoskeletal and connective tissue disorders:
Very rare: Joint pains
Renal & urinary disorders:
Very rare: Interstitial nephritis
General disorders and administration site conditions:
Very rare: Malaise, pyrexia
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
Symptoms: Gastrointestinal disturbances, vomiting, fever, headache, anorexia, dizziness, hallucinations and/or visual disturbances.
Treatment: No specific antidote, but gastric lavage should be employed if necessary
💬 Ask about this leaflet
Ask anything about Ethambutol 400 mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.