ETAPIAM 400 mg Film-Coated Tablets

Зміст інструкції

1. ETAPIAM 500 mg/3 ml injectable solution
   1. What is ETAPIAM and what is it used for
   2. What you need to know before you use ETAPIAM
   3. How to use ETAPIAM
   4. Possible side effects
   5. How to store ETAPIAM
   6. Contents of the pack and other information
2. ETAPIAM 400 mg film-coated tablets
   1. What is ETAPIAM and what is it used for
   2. What you need to know before you take ETAPIAM
   3. How to take ETAPIAM
   4. Possible side effects
   5. How to store ETAPIAM
   6. Contents of the pack and other information

ETAPIAM 500 mg/3 ml injectable solution

Ethambutol hydrochloride

Read this leaflet carefully before you use 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 their symptoms are the same as yours, as it could 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 ETAPIAM is and what it is used for
• 2. What you need to know before you use ETAPIAM
• 3. How to use ETAPIAM
• 4. Possible side effects
• 5. How to store ETAPIAM
• 6. Contents of the pack and other information

1. What is ETAPIAM and what is it used for

ETAPIAM contains the active ingredient ethambutol, belonging to the group of medicines
called antituberculars or antimycobacterials.
This medicine is used to treat tuberculosis, a bacterial infection that affects
mainly the lungs (pulmonary tuberculosis), always in association with other antimycobacterial drugs.

2. What you need to know before you use ETAPIAM

Do not use ETAPIAM

• if you are allergic (hypersensitive) to ethambutol or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from an eye inflammation (optic neuritis), unless your doctor advises you to use it anyway.
• 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 evaluate and report adverse effects in visual field or changes in vision (e.g. young children, unconscious patients).

Warnings and precautions
Talk to your doctor or pharmacist before using ETAPIAM.
Use this medicine with cautionand tell your doctor if the following conditions apply to you:

• if you have severe liver or kidney problems (liver or kidney damage);
• if you are depressed;
• if you suffer from vision problems (cataracts, eye inflammation, optic neuritis, diabetic retinopathy). The use of this medicine can cause vision problems. Before starting therapy, undergo an eye examination (specific ophthalmoscopic examinations: visual field and color differentiation). In case of prolonged treatment, you should undergo periodic eye examinations (monthly for daily dosages greater than 15 mg/Kg), liver and kidney function tests.

Children and adolescents
The use of this medicine is not recommended in people under the age of 13.

Other medicines and ETAPIAM
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Due to the effects on the renal excretion of uric acid, ethambutol may counteract
the action of uricosuric agents. No drug interaction effects between
ethambutol and other agents have been reported, but concomitant therapy with isoniazid and pyridoxine may
contribute to exacerbate the effects on uric acid excretion.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if
absolutely necessary and always under direct medical supervision.

Driving and using machines
Ethambutol can decrease visual acuity and color vision, which can affect
your ability to drive and use machines. Patients should undergo periodic
checks to assess the appearance of effects on vision.

3. How to use ETAPIAM

Use this medicine following the instructions of your doctor or pharmacist exactly.
If you have any doubts, consult your doctor or pharmacist.
This medicine will be administered to you either through a local infiltration or instillation
or by slow injection into a vein (intravenously) with an infusion (infusion) after
dilution (in 500 ml of physiological solution or glucose solution).
Adults
The recommended doseis:

• 200-400 mg at a time if administered with infiltrations or instillations;
• 25 mg per Kg of body weight, in a single daily dose if administered intravenously. Subsequently, the intravenous dose may be reduced to 15 mg per Kg of body weight per day and followed by oral administration of 1 ETAPIAM 400 mg tablet, approximately 8-10 hours after the infusion. If you have severe kidney problems (severe renal failure), your doctor may adjust the dose. Children The use of ETAPIAM is not recommended in children under 13 years of age, unless absolutely necessary. The recommended dose for children is 25-30 mg per Kg of body weight per day.

If you use more ETAPIAM than you should
In case of taking an excessive dose of ETAPIAM, immediately inform your doctor
or go to the emergency room of the nearest hospital.
In case of overdose, the following may occur: excessive weight loss, nausea, vomiting,
gastrointestinal disorders, abdominal pain, fever, headache, dizziness,
mental confusion, disorientation and possible hallucinations. If you notice these symptoms
stop therapy and induce vomiting to eliminate the medicine from the body.

If you forget to use ETAPIAM
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice vision problems stop the treatmentwith this medicine and consult
your doctor immediately. This medicine can cause decreased vision, due to an
inflammation of the eyes (optic neuritis) which may depend on the dose and duration of
therapy. This condition may return to normal after discontinuation of the
treatment. (See section Warnings and precautions).
The use of this medicine can also cause the following side effects:

• allergic reactions;
• skin irritations (dermatitis), erythema, itching;
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, potentially life-threatening)
• changes in the number of blood cells (thrombocytopenia, leukopenia, neutropenia)
• joint pain;
• weight loss, nausea, vomiting;
• stomach and intestinal disorders, abdominal pain;
• fever, headache, dizziness;
• lymphadenopathy
• mental confusion, disorientation and possible hallucinations;
• numbness and tingling in the hands and feet;
• increased levels of uric acid in the blood (hyperuricemia);
• alteration of liver function.
• liver inflammation (hepatitis)
• increased transaminases (blood tests that indicate liver disorders)
• pulmonary infiltrates with or without eosinophilia
• pneumonia
• hepatotoxicity including fatal outcomes
• myocarditis, and pericarditis
• inflammation of the kidneys (nephritis) However, since ethambutol is normally used in association with other anti-tuberculosis drugs, the onset of these side effects may be attributed to the associated therapy. Reporting of side effectsIf you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. Reporting of side effects helps to provide more information on the safety of this medicine.”

5. How to store ETAPIAM

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 packaging after
“Expiry”.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ETAPIAM contains

• The active ingredient is etambutol hydrochloride. Each vial contains 500 mg of etambutol.
• The other component is water for injections.

Description of the appearance of ETAPIAM and contents of the pack
Pack containing 10 vials of 3 ml solution.

Marketing Authorisation Holder
PIAM FARMACEUTICI S.p.A. – Via Fieschi, 8 – 16121 Genova – Italy.

Manufacturer
SAVIO INDUSTRIAL srl – Via E. Bazzano, 14 – 16019 Ronco Scrivia (GE) – Italy.

ETAPIAM 400 mg film-coated tablets

Ethambutol hydrochloride

Read this leaflet carefully before you start 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 ETAPIAM is and what it is used for
• 2. What you need to know before you take ETAPIAM
• 3. How to take ETAPIAM
• 4. Possible side effects
• 5. How to store ETAPIAM
• 6. Contents of the pack and other information

1. What is ETAPIAM and what is it used for

ETAPIAM contains the active ingredient ethambutol, belonging to the group of medicines
called antituberculars or antimycobacterials.
This medicine is used to treat tuberculosis, a bacterial infection that affects
mainly the lungs (pulmonary tuberculosis), always in association with other antimycobacterial drugs.

2. What you need to know before you take ETAPIAM

Do not take ETAPIAM

• if you are allergic (hypersensitive) to ethambutol or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from inflammation of the eye (optic neuritis), unless your doctor advises you to use it anyway.
• if you are a child under 13 years of age as safe methods of use have not been established;
• if you are a patient who is unable to evaluate and report adverse effects in visual field or changes in vision (e.g. young children, unconscious patients).

Warnings and precautions
Talk to your doctor or pharmacist before taking ETAPIAM.
Take this medicine with cautionand tell your doctor if the following conditions apply to
you:

• if you have severe liver or kidney problems (hepatic or renal impairment);
• if you are depressed;
• if you have vision problems (cataracts, eye inflammation, optic neuritis, diabetic retinopathy). The use of this medicine can cause vision problems. Before starting therapy, undergo an eye examination (specific ophthalmoscopy, visual field and color differentiation tests). If treatment is prolonged, you should undergo periodic eye (monthly for daily doses greater than 15 mg/Kg), liver and kidney checks.

Children and adolescents
The use of this medicine is not recommended in people under the age of 13.

Other medicines and ETAPIAM
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Due to the effects on the renal excretion of uric acid, ethambutol may counteract
the action of uricosuric agents. No drug interaction effects between
ethambutol and other agents have been reported, but concomitant therapy with isoniazid and pyridoxine may
contribute to exacerbate the effects on uric acid excretion
The absorption of ethambutol is decreased by antacids containing aluminum hydroxide

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
If you are pregnant, or if you are breastfeeding, take this medicine only if
absolutely necessary and always under direct medical supervision.

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

ETAPIAM coated tablets contains lactose
This medicine contains lactose monohydrate. If your doctor has diagnosed you with an
intolerance to certain sugars, contact him before taking this medicine.

3. How to take ETAPIAM

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The doctor will adjust the dosage according to your needs.
Adults
The recommended doseis 15-25 mg per Kg of body weight per day, in 1-2 intakes
daily.
If you have severe kidney problems (severe renal insufficiency) your doctor may modify the dose.
Children
ETAPIAM is not recommended in children under 13 years of age, unless in case of
absolute necessity.
The recommended dose for children is 25-30 mg per Kg of body weight per day.

If you take more ETAPIAM than you should
In case of taking an excessive dose of ETAPIAM, immediately inform your doctor
or go to the emergency room of the nearest hospital.
In case of overdose, the following may occur: excessive weight loss, nausea, vomiting,
gastrointestinal disorders, abdominal pain, fever, headache, dizziness,
mental confusion, disorientation and possible hallucinations. If you notice these symptoms
stop therapy and induce vomiting to eliminate the medicine from the body.

If you forget to take ETAPIAM
Do not take a double dose to make up for a missed dose.
If you have any doubts about 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 notice vision problems stop the treatmentwith this medicine and contact your
doctor immediately. This medicine can cause decreased vision, due to an
inflammation of the eyes (optic neuritis) which may depend on the dose and duration of
therapy. This condition may return to normal after stopping the
treatment. (See section “Warnings and precautions”).
The use of this medicine can also cause the following side effects:

• allergic reactions;
• skin irritations (dermatitis), erythema, itching; severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, potentially life-threatening)
• changes in the number of blood cells (thrombocytopenia, leukopenia, neutropenia)
• joint pain;
• weight loss, nausea, vomiting;
• stomach and intestinal disorders, abdominal pain;
• fever, headache, dizziness;
• lymphadenopathy
• mental confusion, disorientation and possible hallucinations;
• numbness and tingling in the hands and feet;
• increased levels of uric acid in the blood (hyperuricemia);
• alteration of liver function
• liver inflammation (hepatitis)
• increased transaminases (blood tests that indicate liver disorders)
• pulmonary infiltrates with or without eosinophilia
• pneumonia
• hepatotoxicity including fatal outcomes
• myocarditis, and pericarditis
• inflammation of the kidneys (nephritis) However, since ethambutol is normally used in association with other anti-tuberculosis drugs, the onset of these side effects may be attributed to the associated therapy. Reporting of side effectsIf you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. Reporting of side effects helps to provide more information on the safety of this medicine.”

5. How to store ETAPIAM

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 packaging after
“Exp”.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ETAPIAM contains
ETAPIAM 400 mg film-coated tablets

• The active ingredient is ethambutol hydrochloride. Each tablet contains 400 mg of ethambutol.
• The other ingredients are: polyvinylpyrrolidone, lactose, microcrystalline cellulose, vegetable magnesium stearate, talc, anhydrous silica, titanium dioxide, hydroxypropylcellulose, polyethylene glycol 4000, polyethylene glycol 6000.

Description of the appearance of ETAPIAM and contents of the pack
Pack containing 50 film-coated tablets of 400 mg.

Marketing Authorisation Holder
PIAM FARMACEUTICI S.p.A. – Via Fieschi, 8 – 16121 Genova – Italy.

Manufacturer
FINE FOODS & Pharmaceuticals NTM S.p.A. – Via Follereau, 25 – 24027 Nembro
(Bergamo).