Etapiam

Package leaflet: Information for the user

ETAPIAM 500 mg/3 ml injectable solution

Ethambutol hydrochloride
Please read all of this leaflet carefully before you start using this medicine because 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including 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 using 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 ETAPIAM is and what it is used for

ETAPIAM contains the active substance ethambutol, which belongs to a group of medicines called antituberculosis or antimycobacterial agents.
This medicine is used to treat tuberculosis, a bacterial infection that primarily affects the lungs (pulmonary tuberculosis), always in combination with other antimycobacterial drugs.

2. What you need to know before using 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 have inflammation of the eye (optic neuritis), unless your doctor otherwise advises its use;
• if you are a child under 13 years of age, as safe use has not been established;
• if you are a patient unable to assess or report visual side effects 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 caution and inform your doctor if any of the following apply to you:

• if you have severe liver or kidney problems (hepatic or renal impairment);
• if you are depressed;
• if you have pre-existing eye problems (cataracts, eye inflammation, optic neuritis, diabetic retinopathy). This medicine may cause vision problems. Before starting treatment, you should undergo an ophthalmological examination (specific ophthalmoscopic tests: visual field and color discrimination). If undergoing prolonged treatment, you must have regular vision check-ups (monthly for daily doses exceeding 15 mg/kg), as well as periodic monitoring of liver and kidney function.

Children and adolescents
The use of this medicine is not recommended in individuals under 13 years of age.
Other medicines and ETAPIAM
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Due to its effects on renal uric acid excretion, ethambutol may counteract the action of uricosuric agents. No pharmacological interaction effects between ethambutol and other agents have been reported; however, concomitant therapy with isoniazid and pyridoxine may contribute to exacerbating effects on uric acid excretion.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if strictly necessary and always under direct medical supervision.

Driving and using machines
Ethambutol may reduce visual acuity and color vision, which could affect your ability to drive or operate machinery. Patients should undergo regular check-ups to monitor for visual side effects.

3. How to use ETAPIAM

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
This medicine will be administered either by local infiltration or instillation, or by slow intravenous injection (intravenous infusion) following dilution (in 500 ml of physiological saline or glucose solution).

Adults
The recommended dose is:

• 200–400 mg at a time when administered by infiltration or instillation;
• 25 mg per kg of body weight, given once daily when administered intravenously. Subsequently, the intravenous dose may be reduced to 15 mg per kg body weight per day, followed by oral administration of 1 tablet of ETAPIAM 400 mg approximately 8–10 hours after the infusion.
  If you have severe kidney problems (severe renal impairment), 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 body weight per day.

If you use more ETAPIAM than you should
If you take an excessive dose of ETAPIAM, inform your doctor immediately or go to the nearest hospital emergency department.
In case of overdose, the following may occur: excessive weight loss, nausea, vomiting, gastrointestinal disturbances, abdominal pain, fever, headache (cephalalgia), dizziness, confusion, disorientation, and possible hallucinations. If you experience these symptoms, stop treatment immediately and induce vomiting to eliminate the medicine from your body.

If you forget to use ETAPIAM
Do not take a double dose to make up for the 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 everyone gets them.
If you notice any vision problems, stop treatment with this medicine and contact your doctor immediately. This medicine may cause decreased vision due to inflammation of the eyes (optic neuritis), which may depend on the dose and duration of treatment. This condition may resolve after stopping treatment. (See section Warnings and precautions).

The use of this medicine may also cause the following side effects:

• allergic reactions;
• skin irritations (dermatitis), erythema, pruritus;
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, potentially life-threatening);
• changes in blood cell counts (thrombocytopenia, leucopenia, neutropenia);
• joint pain;
• weight loss, nausea, vomiting;
• stomach and intestinal disturbances, abdominal pain;
• fever, headache (cephalalgia), dizziness;
• lymphadenopathy;
• mental confusion, disorientation, and possible hallucinations;
• numbness and tingling in the hands and feet;
• increased levels of uric acid in the blood (hyperuricaemia);
• liver function abnormalities;
• inflammation of the liver (hepatitis);
• increased transaminase levels (blood tests indicating liver disturbances);
• 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 combination with other antituberculosis drugs, the occurrence of these adverse effects may be due to combination therapy.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. Reporting side effects helps 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 stated on the packaging after "Expires".
The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ETAPIAM contains

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

Description of the appearance of ETAPIAM and package contents
Pack containing 10 vials of 3 ml solution.
Marketing Authorization Holder
PIAM FARMACEUTICI S.p.A. – Via Fieschi, 8 – 16121 Genoa – Italy.
Manufacturer
SAVIO INDUSTRIAL srl – Via E. Bazzano, 14 – 16019 Ronco Scrivia (GE) – Italy.

Patient information leaflet: information for the patient

ETAPIAM 400 mg film-coated tablets

Ethambutol hydrochloride
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 ETAPIAM is and what it is used for

ETAPIAM contains the active substance ethambutol, which belongs to a group of medicines called antituberculosis or antimycobacterial agents.
This medicine is used to treat tuberculosis, a bacterial infection that mainly affects the lungs (pulmonary tuberculosis), always in combination with other antimycobacterial drugs.

2. What you need to know before taking 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 have inflammation of the eye (optic neuritis), unless your doctor otherwise advises its use;
• if you are a child under 13 years of age, as safe use has not been established;
• if you are a patient unable to assess or report adverse visual effects 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 caution and inform your doctor if any of the following apply to you:

• if you have severe liver or kidney problems (hepatic or renal impairment);
• if you are depressed;
• if you have existing eye problems (cataract, eye inflammation, optic neuritis, diabetic retinopathy). Use of this medicine may cause vision problems. Before starting treatment, undergo an ophthalmological examination (specific tests: ophthalmoscopy, visual field testing, and color discrimination). If undergoing prolonged treatment, you will need regular monitoring of vision (monthly, when daily doses exceed 15 mg/kg), as well as of liver and kidney function.

Children and adolescents
Use of this medicine is not recommended in individuals under 13 years of age.
Other medicines and ETAPIAM
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Due to its effects on renal excretion of uric acid, ethambutol may counteract the action of uricosuric agents. No pharmacological interactions between ethambutol and other agents have been reported, but concomitant therapy with isoniazid and pyridoxine may contribute to exacerbate effects on uric acid excretion.
The absorption of ethambutol is reduced by antacids containing aluminium hydroxide.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only if clearly necessary and always under direct medical supervision.
Driving and using machines
Ethambutol may reduce visual acuity and color vision, which could affect your ability to drive or operate machinery. Patients should undergo periodic checks to monitor for visual side effects.
ETAPIAM film-coated tablets contain lactose
This medicine contains monohydrate lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take ETAPIAM

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will adjust the dosage according to your individual needs.

Adults
The recommended dose is 15–25 mg per kg of body weight per day, given in 1–2 daily doses.
If you have severe kidney problems (severe renal impairment), your doctor may adjust the dose accordingly.

Children
ETAPIAM is not recommended for 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 take more ETAPIAM than you should
If you take an excessive dose of ETAPIAM, inform your doctor immediately or go to the nearest hospital emergency department.
Overdose symptoms may include: excessive weight loss, nausea, vomiting, gastrointestinal disturbances, abdominal pain, fever, headache (cephalalgia), dizziness, confusion, disorientation, and possible hallucinations. If you experience these symptoms, stop the treatment immediately 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 the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice any vision problems, stop treatment with this medicine and contact your doctor immediately. This medicine may cause decreased vision due to inflammation of the eyes (optic neuritis), which may be related to the dose and duration of treatment. This condition may resolve after discontinuation of treatment. (See section “Warnings and precautions”).

The use of this medicine may 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 blood cell counts (thrombocytopenia, leucopenia, neutropenia);
• joint pain;
• weight loss, nausea, vomiting;
• stomach and intestinal disturbances, abdominal pain;
• fever, headache (cephalalgia), dizziness;
• lymphadenopathy;
• mental confusion, disorientation, and possible hallucinations;
• numbness and tingling in the hands and feet;
• increased blood uric acid levels (hyperuricaemia);
• altered liver function;
• liver inflammation (hepatitis);
• increased transaminase levels (blood tests indicating liver disturbances);
• pulmonary infiltrates with or without eosinophilia;
• pneumonia;
• hepatotoxicity, including fatal outcomes;
• myocarditis and pericarditis;
• kidney inflammation (nephritis).

However, since ethambutol is normally used in combination with other antituberculosis drugs, the occurrence of these adverse effects may be attributed to the combination therapy.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. Reporting side effects helps 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 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ETAPIAM contains
ETAPIAM 400 mg film-coated tablets

• The active substance is ethambutol hydrochloride. Each tablet contains 400 mg of ethambutol.
• The other components are: polyvinylpyrrolidone, lactose, microcrystalline cellulose, magnesium stearate (vegetable source), 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 Authorization Holder
PIAM FARMACEUTICI S.p.A. – Via Fieschi, 8 – 16121 Genoa – Italy.
Manufacturer
FINE FOODS & Pharmaceuticals NTM S.p.A. – Via Follereau, 25 – 24027 Nembro (Bergamo).