AMBROTUS 15 mg /2 Ml Solution For Nebulization

Зміст інструкції

1. AMBROTUS 15mg/2ml solution for nebulisation
   1. What is AMBROTUS and what is it used for
   2. What you need to know before using AMBROTUS
   3. How to use AMBROTUS
2. Ambrotus solution for nebulization can be administered using various devices for
   1. Possible side effects
   2. How to store AMBROTUS
   3. Contents of the pack and other information
3. AMBROTUS 30 mg/10 ml syrup bottle 200 ml, 30 mg/10 ml syrup single-dose containers 10 ml
   1. What is AMBROTUS and what is it used for
   2. What you need to know before you take AMBROTUS
   3. How to take AMBROTUS
   4. Possible side effects
   5. How to store AMBROTUS
   6. Contents of the pack and other information

AMBROTUS 15mg/2ml solution for nebulisation

Ambroxol hydrochloride

Read this leaflet carefully before using this medicine because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What is AMBROTUS and what is it used for

Ambrotus contains ambroxol, an active ingredient that works by dissolving mucus and facilitating its
elimination.
AMBROTUS is used in adults and childrenfor the treatment of secretions in acute and chronic
bronchial and pulmonary diseases (i.e., in the presence of cough and in case of difficulty expelling
mucus from the bronchi because it is increased or thickened).

2. What you need to know before using AMBROTUS

Do not use AMBROTUS

• if you are allergic to ambroxol or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from severe liver or kidney problems (severe hepatic and/or renal impairment).

Warnings and precautions
Consult your doctor or pharmacist before using AMBROTUS.
Use this medicine with caution and inform your doctor:

• if you have or have had lesions of the stomach and/or intestines (peptic ulcer).

Cases of severe skin reactions associated with the administration of ambroxol have been reported. If
you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes,
genitals), stop using AMBROTUS and consult your doctor immediately.
These reactions may be symptoms of severe skin conditions characterized by
skin peeling and severe toxic skin reaction (Stevens-Johnson syndrome and
Toxic Epidermal Necrolysis).
In addition, in the initial phase of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis
(TEN), you may experience non-specific symptoms similar to those of the flu, such as
fever, chills, runny nose (rhinitis), cough and sore throat. Due to these misleading symptoms, it is
possible that you will start symptomatic treatment again with a therapy for cough and
cold.

Other medicines and AMBROTUS
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, following the administration of ambroxol, the concentrations of antibiotics
(amoxicillin, cefuroxime, erythromycin) in broncho-pulmonary secretions and in saliva are
increased.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy

• If you are in the first 3 monthsof pregnancy, the use of Ambrotus is notrecommended.
• Use AMBROTUS from the 4th to 9th month of pregnancy only as directed by your doctor.

Breastfeeding

• If you are breastfeeding, the use of AMBROTUS is notrecommended.

Fertility

• AMBROTUS has no effect on fertility.

Driving and operating machinery
Ambrotus does not affect the ability to drive vehicles and operate machinery.

3. How to use AMBROTUS

Use this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

Adults and children over 5 years of age:2-3 vials per day.

Children under 5 years of age:1-2 vials per day.
Caution: do not exceed the indicated doses without the advice of your doctor.

Ambrotus solution for nebulization can be administered using various devices for

inhalation.
Your doctor will tell you whether to dilute this medicine with saline solution (sodium chloride solution). The
dilution must be done in equal parts (same amount of medicine and saline solution).
Do not mix Ambrotus solution for nebulization with other solutions whose resulting mixture has
a pH greater than 6.3 (e.g. using Emser salts), as an increase in pH can cause
clouding of the solution.
Since inhalation itself can cause coughing, breathe normally during inhalation.
It is recommended to warm the solution to body temperature by holding the vial in your hands
before use.
If you suffer from asthma, use your usual bronchodilator (medicine used for the treatment
of asthma) before inhalation.
Consult your doctor if the disorder occurs repeatedly, if you have noticed any recent change
in its characteristics, or if the symptoms worsen or do not improve.

If you use more AMBROTUS than you should
In case of ingestion/accidental intake of an excessive dose of Ambrotus, immediately notify
your doctor or go to the nearest hospital.

If you forget to use AMBROTUS
Do not use a double dose to make up for a missed dose.

If you stop the treatment with AMBROTUS
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur following the use of Ambrotus:

Common(may affect up to 1 in 10 people)

• nausea, taste alterations (dysgeusia) numbness of the mouth and tongue (oral hypoesthesia) and numbness of the throat (pharyngeal hypoesthesia);

Uncommon(may affect up to 1 in 100 people)

• vomiting, diarrhoea and abdominal pain, difficulty digesting (dyspepsia) dry mouth

Rare(may affect up to 1 in 1,000 people)

• hypersensitivity reactions, skin rash, appearance of red spots on the skin accompanied by itching (urticaria), dryness of the throat, difficulty in passing urine (dysuria), fatigue.

Not known(frequency cannot be estimated from available data)

• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and itching;
• serious skin adverse reactions (including erythema multiforme, Stevens Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis);
• heartburn (pyrosis);

These side effects are generally transient. When they occur, consult your doctor
or pharmacist.

Reporting of side effects
If you get any side effects, even 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 AMBROTUS

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.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater 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 AMBROTUS contains
One vial contains:

• the active ingredient is ambroxol hydrochloride. 2 ml of nebulizer solution contains 15 mg of ambroxol hydrochloride.
• The other ingredients are: monobasic sodium phosphate dihydrate, dibasic sodium phosphate dihydrate, water for injections.

Description of the appearance of AMBROTUS and contents of the pack
Ambrotus is presented as a nebulizer solution. It is available in a pack containing
10 vials of 2 ml.

Marketing Authorisation Holder
Epifarma S.r.l. - Via San Rocco, 6 – 85033 Episcopia (PZ)

Manufacturer
Esseti Farmaceutici S.r.l. -Via Campobello, 15 - 00071 Pomezia – Roma

AMBROTUS 30 mg/10 ml syrup bottle 200 ml, 30 mg/10 ml syrup single-dose containers 10 ml

Ambroxol hydrochloride

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 2 weeks of treatment.

Contents of this leaflet:

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

1. What is AMBROTUS and what is it used for

Ambrotus contains ambroxol, an active ingredient that works by dissolving mucus and facilitating its
elimination.
AMBROTUS is used in adults and children over 2 years of agefor the
treatment of secretions in acute and chronic bronchial and lung diseases (i.e. in
the presence of cough and in case of difficulty expelling mucus from the bronchi because it is increased or
thickened).

2. What you need to know before you take AMBROTUS

Do not take AMBROTUS

• if you are allergic to ambroxol or any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver or kidney problems;
• if the person who needs to take this medicine is a child under 2 years of age (See the “Children” section).

Warnings and precautions
Talk to your doctor or pharmacist before taking AMBROTUS.
Take this medicine with caution and inform your doctor:

• if you have or have had stomach and/or intestinal lesions (peptic ulcer).

Cases of severe skin reactions associated with the administration of ambroxol have been reported. If
you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes,
genitals), stop taking AMBROTUS and consult your doctor immediately.
These reactions may be symptoms of severe skin conditions characterized by
skin peeling and severe toxic skin reaction (Stevens-Johnson syndrome and
Toxic Epidermal Necrolysis).
In addition, in the early stages of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis
(TEN), you may experience non-specific symptoms similar to those of the flu, such as
fever, chills, runny nose (rhinitis), cough and sore throat. Due to these misleading symptoms, it is
possible to restart symptomatic treatment with a cough and cold therapy.

Children
Donot give this medicine to children under 2 years of age. Mucolytics may induce
bronchial obstruction in children under 2 years of age. In fact, the ability to drain
bronchial mucus is limited in this age group due to the physiological characteristics of the respiratory
tract.

Other medicines and AMBROTUS
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, following the administration of ambroxol, the concentrations of antibiotics
(amoxicillin, cefuroxime, erythromycin) in broncho-pulmonary secretions and saliva are
increased.

Mucosolvan with food and drink
You can use Ambrotus both on an empty stomach and with food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy

• If you are in the first 3 months of pregnancy, the use of AMBROTUS is not recommended.
• Take Ambrotus from the 4th to the 9th monthof pregnancy only as directed by your doctor.

Breastfeeding

• If you are breastfeeding, the use of AMBROTUS is notrecommended.

Fertility

• Ambrotus has no effect on fertility.

Driving and using machines
Ambrotus does not affect the ability to drive vehicles and use machines.

AMBROTUS contains sorbitol, benzoic acid and propylene glycol
This medicine contains 350 mg of sorbitolper ml. Sorbitol is a source of fructose. If
your doctor has told you that you (or your child) are intolerant to certain sugars, or if you have a diagnosis of
hereditary fructose intolerance, a rare genetic disease in which patients cannot
metabolize fructose, talk to your doctor before you (or your child) take this medicine.
It may cause gastrointestinal problems and have a mild laxative effect.
This medicine contains 2 mg of benzoic acidper ml.
This medicine contains 30 mg of propylene glycolper ml.

3. How to take AMBROTUS

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

Adults:10 ml 3 times a day.

Children over 5 years of age:5 ml 3 times a day.

Children from 2 to 5 years of age:2.5 ml 3 times a day.
Caution: do not exceed the indicated doses without the advice of your doctor.
Consult your doctor if the disorder occurs repeatedly, if you have noticed any recent change in its characteristics or if the symptoms worsen or do not improve anyway.

If you take more AMBROTUS than you should
In case of accidental ingestion/intake of an excessive dose of Ambrotus, immediately inform your doctor or go to the nearest hospital.

If you forget to take AMBROTUS
Do not take a double dose to compensate for forgetting the dose.

If you stop treatment with Ambrotus
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur following the use of Ambrotus:

Common(may affect up to 1 in 10 people)

• nausea, taste alteration (dysgeusia) numbness of the mouth and tongue (oral hypoesthesia), numbness of the throat (pharyngeal hypoesthesia);

Uncommon(may affect up to 1 in 100 people)

• vomiting, diarrhea and abdominal pain, indigestion (dyspepsia) dry mouth.

Rare(may affect up to 1 in 1,000 people)

• hypersensitivity reactions, skin rash, appearance of red spots on the skin accompanied by itching (urticaria), dry throat difficulty in passing urine (dysuria), fatigue.

Not known(frequency cannot be estimated from available data)

• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and itching;
• severe skin adverse reactions (including erythema multiforme, Stevens Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis);
• bronchial obstruction (bronchial obstruction);
• heartburn (pyrosis);

These side effects are generally transient. When they occur, consult your doctor
or pharmacist.

Reporting of side effects
If you get any side effects, even 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 AMBROTUS

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.
This medicine does not require any particular storage conditions.
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 AMBROTUS 30mg/10ml syrup 200 ml bottle contains

• The active ingredient is ambroxol hydrochloride. 100 ml of syrup contains 300 mg of ambroxol hydrochloride.
• The other ingredients are: hydroxyethylcellulose, sorbitol 70%, glycerol, benzoic acid, cherry aroma, propylene glycol, tartaric acid, purified water.

What AMBROTUS 30mg/10ml syrup single-dose containers of 10 ml contains

• The active ingredient is ambroxol hydrochloride. One container contains 30 mg of ambroxol hydrochloride.
• The other ingredients are: hydroxyethylcellulose, sorbitol 70%, glycerol, benzoic acid, cherry aroma, propylene glycol, tartaric acid, purified water.

Description of the appearance of AMBROTUS and contents of the pack
Ambrotus is available in syrup form. It is available in a pack containing 1 bottle of
200 ml and a measuring cup, and in a pack containing 20 single-dose containers of 10 ml.

Marketing Authorisation Holder
EPIFARMA S.r.l. - Via San Rocco, 6 – 85033 Episcopia (PZ)

Manufacturer
AMBROTUS 30 mg/10 ml syrup 200 ml bottle:
Special Product Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 - Anagni (FR)

AMBROTUS 30 mg/10 ml syrup single-dose containers 10 ml:
Esseti Farmaceutici S.r.l. -Via Campobello, 15 - 00071 Pomezia – Roma