Myambutol 400 mg film-coated tablets

Introduction

Package Leaflet: Information for the Patient

Myambutol 400 mg Film-Coated Tablets

Etambutol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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. See section 4.

Contents of the pack and other information:

1. What is Myambutol and what is it used for
2. What you need to know before you take Myambutol
3. How to take Myambutol
4. Possible side effects
5. 5. Storage of Myambutol
6. Contents of the pack and further information

1. What is Myambutol and what is it used for

Myambutol belongs to a group of medicines called antituberculars and is indicated in children over 3 months and adults for the treatment of tuberculosis (a lung disease) in all its locations, pulmonary or extrapulmonary, within the usual therapeutic schemes, with two or three medications, depending on the clinical characteristics and in vitro sensitivity of the microorganism involved in tuberculosis.

The medications used differ depending on whether they are initial or retreatment treatments. In the latter case, Myambutol must be used in combination with medications to which the patient has not developed resistance.

2. What you need to know before you take Myambutol

Do not take Myambutol

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• if you have diabetic retinopathy or severe optic neuritis (eye diseases), unless your doctor indicates otherwise.
• if you have ever had a severe skin rash or skin peeling, blisters, or sores in the mouth after taking etambutol.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Myambutol.

• If you have any kidney disease, inform your doctor so that they can prescribe the most suitable dose for you.
• Before starting treatment with etambutol, an eye examination must be performed, and if you notice any changes in your vision while taking etambutol, inform your doctor immediately.
• Young children or patients with difficulty communicating should be closely monitored by parents or caregivers to detect any signs of vision changes. It is recommended to perform a routine eye examination when treating young children.
• Patients with high uric acid levels (gout) should be evaluated periodically during treatment with etambutol.
• Patients with a history of seizures or neurological problems should be strictly controlled during treatment with etambutol.
• Periodic monitoring of liver function tests is recommended in all patients.
• Severe skin reactions, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to treatment with Myambutol. Stop using Myambutol and consult a doctor immediately if you observe any symptoms related to these severe skin reactions described in section 4.

Other medicines and Myambutol

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, especially those used to treat gout, isoniazid, and pyridoxine.

If you are taking antacids, you should take Myambutol at least one hour before the antacid. In the case of antacids containing aluminum hydroxide, the time margin should be at least 4 hours since the administration of Myambutol.

Due to its effect on the renal excretion of uric acid, etambutol may alter the action of uricosuric agents (medicines used to treat gout).

Concomitant treatment with disulfiram (used to treat chronic alcoholism) may increase the risk of vision problems.

Etambutol should not be used in conjunction with BCG (tuberculosis vaccine)

The concomitant use of etambutol and ethionamide (tuberculosis medication) may potentiate adverse effects.

The concomitant use of etambutol and delamanid (tuberculosis medication) may produce an increase in the amount of etambutol in the body.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

This medicine may cause vision problems, dizziness, discomfort, confusion, hallucinations; you should not drive or operate machinery until you know how the treatment is tolerated.

Myambutol contains sucrose and sorbitol

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

This medicine contains 22.9 mg of sorbitol in each tablet.

3. How to take Myambutol

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of etambutol varies from person to person, depending on age, weight, and whether it is used for the treatment or prevention of tuberculosis. It should not be used as a single antitubercular agent but in combination with other medications to avoid the development of resistance.

Adults

• Primary and latent pulmonary or extrapulmonary tuberculosis

Myambutol will be administered in a single daily oral dose of 15 mg/kg (15-20 mg/kg); concomitantly administered medications will be administered at their recommended dosage intervals.

• Retreatment

During the first 60 days of treatment, Myambutol will be administered in a single daily oral dose of 25 mg/kg. Subsequently, the dose should be reduced to 15 mg/kg, maintaining concomitantly administered medications at their recommended dosage intervals.

Use in children

• Primary and retreatment pulmonary or extrapulmonary tuberculosis

Children < 3 months

There is insufficient data to establish a recommendation in children under three months.

Children ≥ 3 months

The usual dose is 20 mg/kg (15-25 mg/kg) per day. The maximum dose is recommended for the most severe forms of tuberculosis, such as tuberculous meningitis. The maximum daily dose should not exceed the recommended daily dose for adults.

• Latent tuberculosis treatment

Administer a single daily oral dose of 15 mg/kg, maintaining concomitantly administered medications at their recommended dosage intervals.

The elderly or patients with kidney problems may need blood tests to determine if a dose reduction is necessary.

Method of administration

• Myambutol tablets should be taken once a day, preferably in the morning before meals.
• The tablets should be swallowed whole with a glass of water; do not chew or crush the tablets.
• If you are unsure how many tablets to take or when to take them, ask your doctor or pharmacist.

If you take more Myambutol than you should

If you have taken more Myambutol than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: (91) 562 04 20, indicating the medicine and the amount ingested.

There is no specific antidote, but gastric lavage should be used if necessary.

If you forget to take Myambutol

Do not take a double dose to make up for forgotten doses

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.

The following side effects may be serious:

• Severe allergic reactions, with difficulty breathing, wheezing, flushing, agitation, or irregular heartbeat. If this happens, stop taking this medicine and consult your doctor immediately.
• Vision problems, including color blindness. In most cases, it will return to normal after stopping treatment. However, in exceptional circumstances, the problem may take longer to resolve or may be permanent. If you notice any changes or problems with your vision, contact your doctor immediately.
• Kidney problems. If you have lower back pain, pain, burning, or difficulty urinating, or blood in the urine, you should contact your doctor as soon as possible.
• Red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized rash, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Other possible side effects are:

Uncommon (may affect up to 1 in 100 people)

• Increased uric acid in the blood
• Decreased visual acuity, vision loss, color blindness, and/or visual defects, eye pain

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

• Numbness, tingling, weakness, burning, tremors
• Numbness and tingling in the limbs and joints
• Stomach problems, such as loss of appetite, discomfort, weight loss, gas, or stomach pain, vomiting, and diarrhea.
• Liver problems that can cause pale stools, dark urine, or yellowing of the skin or eyes.
• Abnormal liver function test results.
• Allergic reactions, including skin rash and itching

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

• Reduction in certain types of blood cells that can cause an increased risk of infection
• Reduction of blood platelets that can cause a purple rash, bruising, or bleeding.
• Severe allergic reactions in the skin with blistering of the skin, mouth, eyelids, and genitals, or skin peeling.
• Skin problems, including hard lumps (nodules) or red spots, often on the back of the arms and hands.
• Gout, whose signs are pain or inflammation in the joints (especially the big toe) with sensitivity and heat in the skin.
• Dizziness, vertigo, mental confusion, disorientation, headache, hallucinations
• Lung inflammation, respiratory problems
• Liver failure
• Kidney disorders
• Discomfort
• Joint pain
• Fever

Reporting of side effects

If you experience 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 through the Spanish Medicines and Health Products Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Myambutol

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Myambutol

• The active substance is etambutol. Each tablet contains 400 mg of etambutol hydrochloride
• The other ingredients are sucrose, gelatin, sorbitol (E420), magnesium stearate (E470b), stearic acid, polydextrose, hydroxypropyl methylcellulose, titanium dioxide (E171), polyethylene glycol 4000, black iron oxide (E172), yellow iron oxide (E172).

Appearance of the product and pack contents

Myambutol is a light gray, round, film-coated tablet packaged in PVC/Aluminum blisters. Each pack contains 100 film-coated tablets.

Marketing authorization holder and manufacturer

Teofarma S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene (PV)

Italy

Date of last revision of this leaflet: July 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.