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ETHAMBUTOL HYDROCHLORIDE 100 MG FILM-COATED TABLETS - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - ETHAMBUTOL HYDROCHLORIDE 100 MG FILM-COATED TABLETS

2. what you need to know before you take ethambutol tablets

Do not take Ethambutol Tablets

  • 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

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.

Warnings and precautions

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.

Other medicines and Ethambutol Tablets

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.

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

Ethambutol Tablets with food and drink

Ethambutol Tablets may be taken with or without food.

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 or pharmacist 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.

Important information about Ethambutol Tablets

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

3. how to take ethambutol tablets

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 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 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 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.

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

If you forget to take Ethambutol Tablets

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.

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 medicine, ask your doctor or pharmacist.

4. possible side effects

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

If you get any of 1he 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.

Other possible side effects include:

  • 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), Stevens-Johnson syndrome (a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and/or genitals)
  • 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.

Reporting of side effects

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: or search for “MHRA Yellow Card” in the Google Play or Apple App Store

Ireland

HPRA Pharmacovigilance

Earlsfort Terrace, IRL – Dublin 2

Tel: +353 1 6764971, Fax: +353 1 6762517

Website: , e-mail:.

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

5. how to store ethambutol tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine 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.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. contents of the pack and other information

What Ethambutol Tablets contain

  • The active substance is ethambutol hydrochloride. Each tablet contains either 100mg or 400mg of ethambutol hydrochloride.
  • The other ingredients are

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is Ethambutol Hydrochloride 100 mg used for?

Ethambutol Hydrochloride 100 mg is primarily used to treat tuberculosis (TB) by stopping the growth of bacteria that cause the infection.

How should I take Ethambutol Hydrochloride 100 mg tablets?

You should take Ethambutol Hydrochloride 100 mg tablets exactly as prescribed by your doctor, usually once daily, with or without food.

What are the common side effects of Ethambutol Hydrochloride?

Common side effects may include nausea, vomiting, loss of appetite, and dizziness. If you experience severe side effects, contact your healthcare provider immediately.

Can I drink alcohol while taking Ethambutol Hydrochloride?

It is advisable to avoid alcohol while taking Ethambutol as it may increase the risk of liver problems and worsen side effects.

Is it safe to use Ethambutol during pregnancy?

Ethambutol should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Always consult your doctor.

What should I do if I miss a dose of Ethambutol Hydrochloride?

If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double up.

How long will I need to take Ethambutol Hydrochloride?

The duration of treatment can vary, but it is typically several months. Your healthcare provider will determine the length based on your condition.

Can children take Ethambutol Hydrochloride 100 mg tablets?

Ethambutol can be prescribed for children; however, the dosage needs to be adjusted according to their weight and age. Always consult a pediatrician.

What happens if I overdose on Ethambutol Hydrochloride?

An overdose may lead to severe side effects such as vision changes or confusion. In case of overdose, seek immediate medical attention.

Can I stop taking Ethambutol once I feel better?

No, it is important to complete the full course of treatment even if you feel better to prevent the infection from returning or developing resistance.

What are some drug interactions with Ethambutol Hydrochloride?

Ethambutol may interact with other medications such as antacids or drugs that affect kidney function. Inform your doctor about all medicines you are taking.

Will Ethambutol affect my eyesight?

In rare cases, Ethambutol can cause vision problems like blurred vision or color vision changes. If you notice any visual disturbances, contact your healthcare provider immediately.

Is there any special dietary requirement while on Ethambutol?

There are no specific dietary restrictions; however, maintaining a balanced diet can help support your overall health during treatment.

Can I take other TB medications while on Ethambutol?

Yes, Ethambutol is often used in combination with other TB medications. Always follow your healthcare provider's instructions regarding combination therapy.

How effective is Ethambutol Hydrochloride in treating TB?

When taken correctly and consistently as part of a comprehensive treatment plan for TB, it has been shown to be effective in controlling and curing the infection.

What should I tell my doctor before starting Ethambutol Hydrochloride?

Inform your doctor about any allergies, existing medical conditions (especially liver or kidney disease), and all medications you are currently taking before starting treatment.

Are there any alternatives to Ethambutol for tuberculosis treatment?

Yes, there are alternative medications for tuberculosis treatment; however, your doctor will determine which one is best based on your specific situation.

What monitoring will I need while taking Ethambutol Hydrochloride?

Regular follow-ups may include monitoring liver function tests and eye exams to check for any side effects associated with the medication.

Can I exercise while taking Ethambutol Hydrochloride 100 mg tablets?

Generally, yes; however, listen to your body and consult with your healthcare provider if you're experiencing fatigue or other significant side effects.