MIAMBUTOL 400 mg Film-Coated Tablets

Зміст інструкції

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

MIAMBUTOL

400 mg tablets

Ethambutol dihydrochloride

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is MIAMBUTOL and what is it used for

MIAMBUTOL belongs to the family of antituberculosis drugs, medicines used for the treatment of
tuberculosis (an infectious disease caused by certain mycobacteria).
It is indicated for the treatment of tuberculosis infections in association with other specific medicines.
It is particularly indicated in the treatment of pulmonary tuberculosis due to mycobacteria
resistant to other medicines, already used for initial treatment.

2. What you need to know before taking MIAMBUTOL

Do not take MIAMBUTOL:

• if you are allergic to etambutol dihydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if you have inflammation of the optic nerve (optic neuritis), unless otherwise advised by your doctor,
• if you are a child under 13 years of age as safe usage methods have not been established
• if you are a patient who is unable to notice visual side effects or changes in vision (e.g. young children, unconscious patients).

Warnings and precautions
Talk to your doctor or pharmacist before taking MIAMBUTOL.

Tell your doctor:

• if you suffer from kidney failure. Your doctor may decide to reduce the dose as this medicine is eliminated mainly by the kidneys.
• if your visual acuity decreases. Changes in visual acuity (ability to see) may affect one or both eyes. Consequently, the eyes must be examined individually and together. Measurements of visual acuity must be performed before the start of treatment and periodically during treatment (once a month in case of daily doses greater than 15 mg/kg). Since the medicine may have negative effects on vision, an objective examination (i.e. an ophthalmological specialist visit) should include a series of tests (e.g. ophthalmoscopy, visual field control and color differentiation). In patients who present with visual impairments such as cataracts, recurrent inflammatory conditions at the ocular level, optic neuritis (inflammation of the optic nerve), diabetic retinopathy (retinal suffering), it is more difficult to assess changes in visual acuity. In this case, it is necessary to verify that changes in visual ability are not due to pre-existing pathological conditions (diseases). In these patients, the benefit-risk ratio should be considered from the moment the assessment of visual acuity becomes difficult. If a precise assessment confirms the importance of visual impairment and reveals no other causes, your doctor will stop treatment with MIAMBUTOL and re-examine you periodically. A progressive decrease in visual acuity during treatment should be considered a consequence of treatment with MIAMBUTOL. Patients who report visual disturbances during treatment with MIAMBUTOL may experience visual symptoms before or at the same time as a decrease in visual acuity; patients undergoing MIAMBUTOL therapy should periodically report to their doctor if they experience blurred vision or other subjective ocular symptoms.
• Etambutol dihydrochloride, MIAMBUTOL, can reduce the renal elimination of urates such as uric acid and may cause hyperuricemia, i.e. an increase in the concentration of uric acid in the blood. Acute attacks of gout, a disease due to increased uric acid in the blood, have been reported.
• During treatment with MIAMBUTOL, the function of the liver, kidneys, vision and the ratio between the various elements of the blood, such as red blood cells, white blood cells and platelets, must be checked periodically, as with any potent medicine.
• MIAMBUTOL can cause a decrease in visual acuity that appears to be due to optic/retrobulbar neuritis (inflammation of the optic nerve/behind the eyeball). This effect is related to dose and duration of treatment. The effect is generally reversible when the medicine is stopped quickly. However, cases of irreversible blindness have been reported. During visual acuity examination, it is recommended to wear corrective glasses if the patient already used them before starting treatment with MIAMBUTOL.

It is possible that, in the context of prolonged therapy for 1 or 2 years, disturbances in the passage of light rays through the eye, such as myopia and presbyopia, may develop, which the examining doctor will correct to avoid falsifying the results of the examination. Patients who record visual disturbances during therapy with MIAMBUTOL may experience subjective visual symptoms before or at the same time as a decrease in visual acuity; you will be asked periodically during treatment with MIAMBUTOL if you experience blurred vision or other subjective ocular symptoms. Restoration of visual acuity generally occurs within a period ranging from one week to a few months after stopping the medicine. Some patients have been retreated with etambutol dihydrochloride after recovery without a recurrence of visual acuity loss.

• Cases of hepatic toxicity, including fatal ones, have been reported. Periodic liver function tests must be performed.

Children and adolescents
MIAMBUTOL is not recommended for children under 13 years of age and the use of this product should be limited to a real need and under direct medical supervision.

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

• MIAMBUTOL can be used in combination with other anti-tuberculosis medicines.
• MIAMBUTOL may counteract the action of uricosuric agents (which promote urinary elimination of uric acid) due to the effects of MIAMBUTOL on the renal elimination of uric acid.
• No interactions between MIAMBUTOL and other drugs have been reported, but concomitant therapy with isoniazid and pyridoxine, drugs that can be used in tuberculosis therapy, may contribute to increased elimination of uric acid.
• Antacids containing aluminum hydroxide decrease the effectiveness of MIAMBUTOL.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

• The product should not be administered to pregnant women unless in case of real necessity and under the direct supervision of a doctor. MIAMBUTOL crosses the placental barrier. Ocular abnormalities have been reported in newborns born to women undergoing tuberculosis therapy including etambutol dihydrochloride.
• MIAMBUTOL is excreted in breast milk, therefore the use of this medicine during breastfeeding is not recommended unless the expected benefit for the mother is greater than the potential risk to the infant.

Driving and operating machinery
Etambutol dihydrochloride can decrease visual acuity and color vision, which may affect the ability to drive and operate machinery.
Patients should undergo periodic checks to assess the onset of effects on vision.

MIAMBUTOL contains sucrose and sorbitol
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
It may be harmful to your teeth.

3. How to take MIAMBUTOL

Dosage and method of administration
Both for initial treatment and for retreatment of tuberculosis processes, MIAMBUTOL can
be administered as a single dose within 24 hours or in divided doses.
The recommended dose is 25 mg/kg per day for three months (in some cases this dosage has been
extended up to 6 months) and 15 mg per kg per day in the subsequent period until, that is,
deemed appropriate by the attending physician. The table below provides indicative doses in
relation to the patient's weight.
The ability to perfectly divide the tablets in half to obtain a 200 mg dosage,
will allow the doctor to adopt the most appropriate administration methods for each patient.
In patients with renal insufficiency: the doctor will appropriately reduce the doses based on
drug levels in the blood, as etambutol hydrochloride is mainly eliminated
by the kidneys.
Since the product is intended for long-term treatment, strictly adhere to the
instructions of the attending physician.

If you take more MIAMBUTOL than you should
In case of overdose, discontinue therapy and immediately notify the attending physician.
In cases of overdose, the following may occur: anorexia, (loss of appetite), nausea, vomiting,
gastrointestinal disturbances, abdominal pain, fever, headache, dizziness, mental confusion,
disorientation and possible hallucinations.

If you forget to take MIAMBUTOL

Resume initial treatment as soon as possible.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Visual acuity impairment: ethambutol hydrochloride can determine a reduction in visual
acuity, including irreversible blindness, which appears to be due to optic neuritis (inflammation of the optic
nerve). This effect can be related to the dose and duration of treatment. This effect
is generally reversible when the administration of the drug is promptly
interrupted. In rare cases, recovery may be delayed by a year or more.
Optic neuropathy, including optic neuritis or retrobulbar neuritis (inflammation of the optic
nerve or inflammation behind the eyeball) that occurs in association with therapy
with ethambutol hydrochloride may be characterized by one or more of the following events:

• reduction in visual acuity,
• scotomas (area of partial or complete blindness in an area of vision, with the appearance of blind, dark or colored spots, fixed or scintillating)
• color blindness and/or visual field defects,
• congenital anomalies of the visual system,
• blindness. These events have also been reported in the absence of a diagnosis of optic or retrobulbar neuritis (inflammation of the optic nerve or inflammation behind the eyeball).

Consult your doctor if you experience visual acuity impairment (see section Warnings and
precautions).
So far, the following have been reported as side effects:

• hypersensitivity, anaphylactic/anaphylactoid reaction (rapid-onset allergic reaction, including shock with fatal outcome), hypersensitivity syndrome characterized by skin reactions (such as rash, i.e. skin eruptions of various kinds, such as spots, red patches) and exfoliative dermatitis (redness and scaling of the skin),
• eosinophilia (increase in a type of white blood cell) and one or more of the following elements: hepatitis, pneumonia, nephritis, myocarditis and pericarditis (inflammation of the liver, kidneys, myocardium and pericardium, respectively). There may also be: fever, lymphadenopathy (enlargement of the lymph glands), pulmonary infiltrates (presence of thickened areas in the lungs) with or without eosinophilia, thrombocytopenia (decrease in the number of platelets in the blood), leukopenia (decrease in the number of white blood cells), neutropenia (decrease in the number of neutrophils), dermatitis, rash, Stevens-Johnson syndrome (characterized by skin redness, fever, inflammation), toxic epidermal necrolysis (almost total destruction of the skin due to death of skin cells with a generalized toxic state), itching, joint pain, anorexia (loss of appetite), nausea, vomiting, gastrointestinal disorders, liver toxicity (including with fatal outcome), increased blood levels of certain proteins originating from the liver, expression of its damage such as aspartate aminotransferase, and alanine aminotransferase, abdominal pain, fever, headache, dizziness, hypoesthesia (reduction in sensitivity), paresthesia (sensory disturbances), mental confusion, disorientation and possible hallucinations.

Cases of:

• numbness and tingling in the extremities,
• hyperuricemia (increased uric acid in the blood) and acute gout attacks

have also been reported, even more rarely.

However, since ethambutol hydrochloride is normally used in association with other anti-tuberculosis drugs,
the onset of these side effects may be attributable to the combined therapy.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly
through the national reporting system at www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store MIAMBUTOL

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad”.
The expiry date refers to the last day of that month.
for the product in intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What MIAMBUTOL contains
The active ingredient is: Ethambutol dihydrochloride.
The other ingredients are: Sucrose, gelatin, sorbitol, magnesium stearate, stearic acid, lacquer,
titanium dioxide, talc.

Description of the appearance of MIAMBUTOL and contents of the pack
Miambutol 400 mg is presented in a pack containing 20 tablets in a bottle.

Marketing Authorisation Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)

Manufacturer:
TEOFARMA S.r.l.
Viale Certosa, 8/A
27100 Pavia