Ethambutol teva
Poland
Table of Contents
Package leaflet: Information for the user
Ethambutol TEVA, 250 mg, capsules
Ethambutoli hydrochloridum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents
- What Ethambutol is and what it is used for
- Important information before taking Ethambutol
- How to take Ethambutol
- Possible side effects
- How to store Ethambutol
- Contents of the pack and other information
1. What Ethambutol is and what it is used for
Ethambutol is an antituberculosis agent. It inhibits the multiplication and causes the death of mycobacteria causing tuberculosis in humans and animals, as well as certain atypical mycobacteria responsible for mycobacterioses.
Ethambutol is used in combination with other antituberculosis drugs, as monotherapy leads rapidly to the development of bacterial resistance.
Indications for use
In combination with other antituberculosis drugs:
- Pulmonary tuberculosis and pleural tuberculosis (primary and secondary infections);
- Extrapulmonary tuberculosis (meninges, bones and joints, genitourinary organs, nerve ganglia).
This medicine should only be used for the treatment of tuberculosis caused by microorganisms sensitive to ethambutol.
2. Important information before using Ethambutol
When not to use Ethambutol
- If the patient is allergic to ethambutol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- If the patient has optic neuritis.
- If the patient has severe renal insufficiency.
- If it is not possible to obtain information from the patient regarding visual disturbances (e.g. in unconscious patients).
- In children under 13 years of age.
- In pregnant women.
- If the patient has ever experienced, after taking ethambutol: severe skin rash, skin peeling, blisters, or oral mucosal ulcers.
Warnings and precautions
Before starting treatment with Ethambutol, discuss this with your doctor or pharmacist.
Before starting and during treatment with ethambutol, your doctor will recommend regular ophthalmological examinations: fundoscopy, visual fields, visual acuity, and color vision testing. Follow-up examinations should include each eye separately and both eyes together. If doses higher than 15 mg/kg body weight are administered, visual examinations should be performed at least once a month. Special ophthalmological monitoring is recommended for patients with eye disorders such as cataracts, intraocular inflammations, or diabetic retinopathy, due to the difficulty in assessing subjective and objective visual disturbances during ethambutol therapy. The patient must perform self-monitoring of visual acuity and color discrimination, and if any disturbances are noticed, treatment should be discontinued immediately and the patient should consult a doctor.
Ethambutol may cause decreased visual acuity and impaired color vision. These disturbances may be related to the dose used and duration of treatment. They usually resolve if the drug is discontinued promptly after onset. However, cases of irreversible blindness have also been reported.
Children should undergo regular ophthalmological monitoring as recommended by the doctor.
Ethambutol may have harmful effects on the liver, and fatal cases have been observed.
Your doctor will recommend periodic monitoring of kidney function, liver function, and hematological system.
Acute attacks of gout may occur during ethambutol treatment.
When to exercise special caution when using Ethambutol:
Serious skin reactions have been reported during treatment with Ethambutol, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Treatment with Ethambutol must be discontinued and immediate medical advice sought if any of the symptoms associated with these serious skin reactions, described in section 4, occur.
Children and adolescents
Ethambutol should not be given to children under 13 years of age, as safety and efficacy have not been established in this age group.
Patients with impaired renal function
In patients with impaired renal function, the drug may accumulate in the body; therefore, the doctor will adjust the dose accordingly.
Elderly patients
Caution should be exercised when administering Ethambutol to elderly patients. The doctor will usually start with the lowest recommended dose, taking into account the higher prevalence of impaired liver, kidney, or heart function, as well as other concomitant diseases or therapies.
Ethambutol and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines you plan to take.
Aluminium hydroxide reduces the gastrointestinal absorption of ethambutol; therefore, a 4-hour interval between taking ethambutol and an antacid containing aluminium hydroxide is recommended.
Ethambutol may interfere with phentolamine, leading to a false-positive result in tests for pheochromocytoma.
Ethambutol with food and drink
This medicine can be taken independently of meals; it is recommended to take it with a glass of water.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Use of this medicine during pregnancy is contraindicated.
Ethambutol passes into breast milk; breastfeeding is not recommended during treatment.
Driving and using machines
Due to the possibility of visual disturbances (reduced visual acuity, restricted visual fields, color vision disturbances) during ethambutol treatment, patients should not drive or operate machinery.
3. How to use Ethambutol Teva
This medicine should always be taken exactly as recommended by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Your doctor may use different anti-tuberculosis treatment regimens containing ethambutol.
Ethambutol may be used concomitantly with other anti-tuberculosis medicines such as: cycloserine,
ethionamide, pyrazinamide, viomycin.
In multi-drug combination therapy, ethambutol may also be used together with isoniazid,
aminosalicylic acid, and streptomycin.
The following dosage recommendations are generally used.
Use in adults and children above 13 years of age
Initial treatment – in patients who have not previously been treated with anti-tuberculosis medicines
15 to 25 mg/kg body weight once daily.
In these patients, the following regimens are most commonly used: ethambutol + isoniazid, or
ethambutol + isoniazid + streptomycin.
Retreatment – in patients who have previously received anti-tuberculosis treatment
20 to 25 mg/kg body weight once daily, in combination with at least one other tuberculostatic agent to which the organisms have been shown to be sensitive in vitro. After 60 days, the dose should be reduced to 15 mg/kg body weight once daily.
Intermittent therapy
50 mg/kg body weight once daily, administered as a single dose once or twice weekly.
Use in patients with renal impairment
Since the kidneys are the main route of elimination for ethambutol, the doctor will adjust the dosage as follows:
| Glomerular filtration rate (GFR) <50 | Dose in mg/kg b.w. | Interval between doses |
| >25 ml/min | 15-25 | every 24-36 hours |
| 10-25 ml/min | 7.5-15 | every 48 hours |
| <10 ml/min or dialysed patients | 5 | every 48 hours |
Duration of treatment
The full course of treatment should last at least 9 months.
Use of a higher than recommended dose of Ethambutol Teva
If a higher than recommended dose of the medicine is taken, consult a doctor or pharmacist immediately.
In case of overdose, the doctor may recommend inducing vomiting, administering purgatives, gastric lavage, and in severe clinical conditions – peritoneal dialysis or hemodialysis.
Missed dose of Ethambutol Teva
A missed dose should be taken as soon as possible. If the next dose is due in approximately 2 hours, wait and take the medicine at the scheduled time.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Ethambutol Teva
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Serious adverse reactions
If the patient notices any of the following symptoms, they should stop taking
Ethambutol Teva and immediately inform their doctor:
- Red, flat, disc-shaped or round spots on the trunk, often with blisters in the centre, peeling skin, mouth ulcers, throat, nose, genital organs and eyes (Stevens-Johnson syndrome or toxic epidermal necrolysis) (very rare)
- Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (frequency not known)
- Visual disturbances and colour vision defects (rare)
- Severe, life-threatening allergic reactions (including shock), with facial and skin swelling, itchy rash, low blood pressure and breathing difficulties (anaphylactic reactions) (frequency not known)
- Liver damage (including fatal cases) (frequency not known).
Other adverse reactions
Uncommon (in 1 out of 1,000 patients)
Headaches and dizziness; confusion; nausea, vomiting, diarrhoea, abdominal pain, loss of appetite – anorexia; joint pain and swelling.
Rare (in 1 to 10 out of 10,000 patients)
Fever, chills, malaise; disorientation, hallucinations; numbness and tingling in the limbs due to peripheral neuritis; skin rashes, itching; unilateral or bilateral retrobulbar optic neuritis (reduced visual acuity, colour vision disturbances, presence of central or peripheral scotoma, visual field defects).
Visual disturbances depend on the dose, duration of treatment and coexisting eye diseases. In such cases, the doctor will recommend discontinuation of ethambutol treatment. Visual changes are usually transient and resolve within a few weeks after stopping treatment; in severe cases, resolution may take several months. In exceptional cases, ocular changes may be irreversible due to optic nerve atrophy.
Very rare (less than 1 in 10,000 patients, including isolated cases)
Dermatitis (sometimes with red spots, nodules and scaling), photosensitivity reactions; gout, increased serum uric acid concentration, 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 petechial rash, bruising, prolonged bleeding time after minor injuries), leukopenia, including neutropenia; lymphadenopathy; transient liver function abnormalities, sometimes with jaundice (manifested by pale stools and yellowing of the whites of the eyes), increased liver enzyme activity (aspartate aminotransferase and alanine aminotransferase), hepatitis.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Ethambutol Teva
Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the stated month.
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. Contents of the pack and other information
What Ethambutol contains
- The active substance is ethambutol hydrochloride. One capsule contains 250 mg of ethambutol hydrochloride.
- 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
Colourless blisters made of Aluminium/PVC foil, in a cardboard box. The pack contains 90 capsules.
Polyethylene bag in a polypropylene container. The pack contains 250 capsules.
HDPE container with LDPE cap in a cardboard carton. The pack contains 250 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53 Street
00-113 Warsaw
Tel.: (22) 345 93 00
Manufacturer
Teva Operations Poland Sp. z o.o.
Mogilska 80 Street
31-546 Kraków