Ethambutol Teva

Package Leaflet: Information for the User

Ethambutol TEVA, 250 mg, Capsules

Ethambutol Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Ethambutol and what is it used for
• 2. Important information before taking Ethambutol
• 3. How to take Ethambutol
• 4. Possible side effects
• 5. How to store Ethambutol
• 6. Contents of the pack and other information

1. What is Ethambutol and what is it used for

Ethambutol is an anti-tuberculosis medicine. It inhibits the growth and causes the death of the bacteria that cause tuberculosis in humans and animals, as well as some atypical mycobacteria that cause mycobacteriosis.
Ethambutol is used in combination with other anti-tuberculosis medicines, as it causes rapid development of resistance when used alone.
Indications for use:
In combination with other anti-tuberculosis medicines:

• pulmonary and pleural tuberculosis (primary and secondary infections);
• extrapulmonary tuberculosis (meningitis, bone and joint, genitourinary, nerve root).

The medicine can only be used to treat tuberculosis caused by microorganisms sensitive to ethambutol.

2. Important information before taking Ethambutol

When not to take Ethambutol

• If you are allergic to ethambutol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If you have optic neuritis.
• If you have severe kidney failure.
• If you are unable to provide information about vision disturbances (e.g. in unconscious patients).
• In children under 13 years of age.
• In pregnant women.
• If you have ever experienced severe skin rash or peeling of the skin, blisters, or ulcers in the mouth after taking ethambutol.

Severe skin rash or peeling of the skin, blisters, or ulcers in the mouth.

Warnings and precautions

Before starting treatment with Ethambutol, discuss it with your doctor or pharmacist.
Before and during treatment with ethambutol, the doctor will recommend regular ophthalmological examinations: examination of the fundus, visual field, visual acuity, and color vision. The control examination should include each eye separately and both eyes together. If doses greater than 15 mg/kg are administered, eye examinations should be performed at least once a month. Special ophthalmological control, due to the more difficult subjective and objective assessment of vision disturbances during ethambutol therapy, the doctor will cover patients with eye diseases: cataracts, inflammation within the eyeball, diabetic retinopathy. The patient must remember to self-monitor visual acuity and color vision, and in case of any disturbances, stop treatment and consult a doctor.
Ethambutol may cause decreased visual acuity and color perception. These disturbances may be related to the dose used and the duration of treatment. They usually disappear if the medication is stopped immediately after they are observed. However, irreversible blindness has also been reported.
In children, the doctor will recommend regular ophthalmological examinations.
Ethambutol can harm the liver, and even fatal cases have been observed.
The doctor will recommend regular examinations of kidney, liver, and hematopoietic system function.
During treatment with ethambutol, acute gout attacks may occur.

When to exercise special caution when taking Ethambutol:

In connection with the use of Ethambutol, severe skin reactions have been reported, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). You should stop taking Ethambutol and immediately consult a doctor if you experience any symptoms associated with these severe skin reactions, described in section 4.

Children and adolescents

Ethambutol should not be given to children under 13 years of age, as its safety in this age group has not been established.

Patients with kidney function disorders

In patients with kidney function disorders, the medicine may accumulate in the body, so the doctor will adjust the dosage accordingly.

Elderly patients

Caution should be exercised when using this medicine in this age group. Usually, the doctor will start with the lowest doses in the recommended range, taking into account the higher frequency of liver, kidney, or heart function disorders, as well as other concomitant diseases or ongoing therapies.

Ethambutol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Aluminum hydroxide reduces the absorption of ethambutol from the gastrointestinal tract, so it is recommended to maintain a 4-hour interval between taking ethambutol and taking an antacid containing aluminum hydroxide.
Ethambutol may interact with phentolamine, causing a false-positive result in the test for pheochromocytoma.

Ethambutol with food and drink

The medicine can be taken independently of meals; it is recommended to drink it with a glass of water.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
The use of the medicine during pregnancy is contraindicated.
Ethambutol passes into breast milk, and breastfeeding is not recommended during treatment.

Driving and using machines

Due to the possibility of vision disturbances (decreased visual acuity, limited visual field, color vision disturbances) during treatment with ethambutol, you should not drive vehicles or operate machines.

3. How to take Ethambutol

Always take this medicine exactly as your doctor or pharmacist has told you.
In case of doubt, consult your doctor or pharmacist.
The doctor may use different treatment regimens for tuberculosis using ethambutol.
Ethambutol can be used simultaneously with other anti-tuberculosis medicines, such as cycloserine, ethionamide, pyrazinamide, and viomycin.
In combination therapy, ethambutol can also be used with isoniazid, aminosalicylic acid, and streptomycin.
The following are the usual dosages.

Use in adults and children over 13 years of age
Initial treatment – in patients who have not been previously treated with anti-tuberculosis medicines
From 15 to 25 mg/kg body weight per day in a single dose.
In these patients, the most commonly used regimens are: ethambutol + isoniazid or ethambutol + isoniazid + streptomycin.
Retreatment – in patients who have been previously treated with anti-tuberculosis medicines
From 20 to 25 mg/kg body weight per day in a single dose, in combination with at least one tuberculostatic medicine to which the bacteria are sensitive in vitro. After 60 days, the dose should be reduced to 15 mg/kg body weight per day in a single dose.
Intermittent treatment
50 mg/kg body weight per day in a single dose, 1 or 2 times a week.
Use in patients with kidney function disorders
Since the kidneys are the main route of elimination of ethambutol, the doctor will adjust the dosage as follows:

Duration of treatment
The full treatment period should last at least 9 months.

If you take more Ethambutol than you should

If you have taken more than the recommended dose, consult your doctor or pharmacist immediately.
In case of overdose, the doctor may recommend inducing vomiting, administering laxatives, gastric lavage, or in severe clinical conditions – peritoneal dialysis or hemodialysis.

If you forget to take Ethambutol

Take the missed dose as soon as possible. If it is almost time for the next dose, wait and take the medicine at the scheduled time.
Do not take a double dose to make up for the missed dose.

If you stop taking Ethambutol

If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Severe side effects

If you experience any of the following symptoms, stop taking Ethambutol immediately and inform your doctor:

• red, flat, plate-like, or round patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis) (very rare)
• widespread rash, high body temperature, and swollen lymph nodes (DRESS or hypersensitivity syndrome) (frequency not known)
• vision disturbances and color vision disturbances (rare)
• severe allergic reactions that can be life-threatening (including anaphylaxis) with facial and skin edema, itching rash, low blood pressure, and difficulty breathing (anaphylactic reactions) (frequency not known)
• liver damage (including fatal cases) (frequency not known)

Other side effects

Uncommon (in 1 in 1,000 patients)

Headache and dizziness; confusion; nausea, vomiting, diarrhea, abdominal pain, appetite disturbances – anorexia; joint pain and swelling.

Rare (in 1 to 10 in 10,000 patients)

Fever, chills, malaise; feeling of disorientation, hallucinations; numbness and tingling of limbs due to peripheral nerve inflammation; skin rashes, itching; extraocular optic neuritis (unilateral or bilateral) (decreased visual acuity, color vision disturbances, presence of a central or peripheral scotoma, limited visual field). The occurrence of vision disturbances depends on the dose, duration of treatment, and concomitant eye diseases. In such cases, the doctor will recommend stopping treatment with ethambutol. Changes in the visual organ are usually reversible, disappearing within a few weeks after discontinuation of treatment, in severe cases – within a few months. In exceptional cases, changes in the eyeball may be irreversible due to optic nerve atrophy.

Very rare (less than 1 in 10,000 patients, including single cases)

Skin inflammation (sometimes with red spots, nodules, and peeling), photosensitivity reactions; gout, increased uric acid levels in serum, interstitial nephritis.

Frequency not known (cannot be estimated from available data)

Hypersensitivity reactions (including skin reactions, allergic hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis), eosinophilia (increased granulocyte count in blood); pulmonary infiltrates with or without eosinophilia; thrombocytopenia (which may result in: petechiae, bruising, prolonged bleeding after cuts), decreased white blood cell count, including neutropenia; lymphadenopathy; transient liver function disturbances, sometimes with jaundice (manifested by pale stools, yellowing of the whites of the eyes), increased liver enzyme activity (aspartate aminotransferase and alanine aminotransferase), hepatitis.
If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ethambutol

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton after: Expiry Date (EXP). The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ethambutol contains

• The active substance is ethambutol hydrochloride. One capsule contains 250 mg of ethambutol hydrochloride.
• The other ingredients are: capsule filling: talc, magnesium stearate; hard gelatin capsule: titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), gelatin.

What Ethambutol looks like and contents of the pack

Colorless blisters of aluminum/PVC film, in a cardboard box. The pack contains 90 capsules
Polyethylene bag in a polypropylene container. The pack contains 250 capsules.
HDPE container with an LDPE cap, in a cardboard box. The pack contains 250 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
phone: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow

Date of last revision of the leaflet: