BROXOL 15 мг/5 мл Сироп

Содержание инструкции

1. BROXOL 15 mg/5ml syrup, 30 mg granules for oral solution
   1. What is BROXOL and what is it used for
   2. What you need to know before taking BROXOL
   3. How to take BROXOL
   4. Possible side effects
   5. How to store BROXOL
   6. Contents of the pack and other information
2. BROXOL 0.75% solution for nebulization
   1. What BROXOL is and what it is used for
   2. What you need to know before you use BROXOL
   3. How to use BROXOL
   4. Possible side effects
   5. How to store BROXOL
   6. Contents of the pack and other information

BROXOL 15 mg/5ml syrup, 30 mg granules for oral solution

Ambroxol hydrochloride

Read this leaflet carefully before taking this medicine because 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 a few days.

Contents of this leaflet

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

1. What is BROXOL and what is it used for

This medicine contains ambroxol hydrochloride, an active ingredient belonging to a
group of medicines called “mucolytics”, which work by thinning the mucus in the
respiratory tract (catarrh).
BROXOL is indicated in patients who have cough and catarrh in bronchial and
pulmonary diseasesacute or that last for a long time (chronic).

2. What you need to know before taking BROXOL

Do not take BROXOL

• if you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver or kidney problems.

BROXOL should not be taken in children (see Children section in “Warnings and
precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking BROXOL. Take this medicine with
caution and tell your doctor if:

• you suffer from a stomach or intestinal problem called peptic ulcer;
• you have kidney problems (renal insufficiency);
• you suffer from diabetes mellitus or rare hereditary intolerances (fructose intolerance, glucose-galactose malabsorption, sucrase isomaltase deficiency), as BROXOL contains sucroseas an excipient.

Following the administration of ambroxol, cases of skin reactions
associated with severe diseases (multiforme erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis) have been reported.

If you develop a skin rash (including blisters or lesions of the mucous membranes such as mouth, throat,
nose, eyes and genitals), stop taking BROXOL and consult your doctor immediately.
In particular in the early stages of these diseases, you may experience symptoms similar to those
of the flu, such as fever, chills, cold (rhinitis), cough and sore throat.

Children
BROXOL should not be given to children.
BROXOL 15 mg/5ml syrup is contraindicated in children under 2 years of age, as
it can cause airway obstruction and prevent normal breathing. In fact, the ability to
clear mucus is limited in this age group, due to the physiological characteristics
of the respiratory tract.

Other medicines and BROXOL
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
After administration of ambroxol, the concentrations of antibiotics such as amoxicillin,
cefuroxime and erythromycin, in broncho-pulmonary secretions and in saliva are
increased.
BROXOL does not interfere with other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Pregnancy
The use of BROXOL during pregnancy is not recommended, especially during the first three
months. If you are pregnant, take BROXOL only if absolutely necessary and under the
direct supervision of your doctor.
Breastfeeding
The use of BROXOL during breastfeeding is not recommended.

Driving and operating machinery
There is no data available to establish the effects of BROXOL on the ability to drive vehicles and
operate machinery.

BROXOL 15 mg/5ml syrup contains methyl hydroxybenzoate, propyl hydroxybenzoate and
sucrose
This medicine contains methyl hydroxybenzoate and propyl hydroxybenzoate which may cause
allergic reactions (including delayed reactions).
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed
an intolerance to some sugars, contact him before taking this medicine.

BROXOL 30 mg granules for oral solution contains sucrose
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed
an intolerance to some sugars, contact him before taking this medicine.

3. How to take BROXOL

Take this medicine following exactly the instructions in this leaflet, or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Take BROXOL after meals and avoid taking it for prolonged periods.

BROXOL 15 mg/5ml syrup
Adults
The recommended dose is 10 ml (30 mg), three times a day.

Use in children over 5 years of age
The recommended dose is 3 ml (15 mg), four times a day.

Use in children from 2 to 5 years of age
The recommended dose is 2.5 ml (7.5 mg), three times a day.

BROXOL 30 mg granules for oral solution
Adults:
1 sachet, three times a day.
Dissolve the contents of the sachet in about half a glass of water.

If you take more BROXOL than you should
In case of accidental intake of an excessive dose of this medicine, inform your
doctor immediately or go to the nearest hospital.
No cases of overdose have been reported. The symptoms of an overdose may
correspond to the undesirable effects that may occur at normal recommended doses
(see section 4 “Possible side effects”).

If you forget to take BROXOL
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.
The following side effects may occur:

Common(may affect up to 1 in 10 people):

• alterations of the sense of taste (dysgeusia);
• loss of sensitivity (hypoesthesia) of the oral cavity and pharynx;
• nausea.

Uncommon(may affect up to 1 in 100 people):

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

Rare(may affect up to 1 in 1000 people):

• hypersensitivity reactions;
• rash, urticaria.

Not known(frequency cannot be estimated from available data):

• allergic reactions, anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucous and submucous tissues) and itching;
• severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis);
• bronchial obstruction and difficulty breathing (bronchial obstruction);
• heartburn and esophageal burning (pyrosis);
• dry throat.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at:
http//www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BROXOL

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.
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 BROXOL 15 mg/5ml syrup contains

• The active ingredient is ambroxol hydrochloride; 100 ml of syrup contains 300 mg of ambroxol hydrochloride.
• The other ingredients are: sucrose, methylparaben (E218), propylparaben (E216), cherry flavour and purified water.

What BROXOL 30 mg granules for oral solution contains

• The active ingredient is ambroxol hydrochloride; each sachet contains 30 mg of ambroxol hydrochloride,
• The other ingredients are: sucrose, sodium saccharin and cherry flavour.

Description of the appearance of BROXOL and contents of the pack
BROXOL 15 mg/5ml syrup
Pack containing a 150 ml bottle of syrup.

BROXOL 30 mg granules for oral solution
Pack containing 30 sachets of granules.

Marketing Authorisation Holder and Manufacturers

Marketing Authorisation Holder
S.F. Group S.r.l., Via Tiburtina, 1143 – 00156 Roma

Manufacturers

BROXOL 15 mg/5ml syrup
Officina Farmaceutica FRANCIA FARMACEUTICI Industria Farmaco Biologica S.r.l., Via dei
Pestagalli,7 - Milano– Italia
Lisapharma S.p.A. - Via Licinio, 11 - Erba (CO) – Italia

BROXOL 30 mg granules for oral solution
Fine Foods & Pharmaceuticals NTM S.P.A. - Via Dell'Artigianato 8/10 Brembate (BG) – Italia

BROXOL 0.75% solution for nebulization

Ambroxol hydrochloride

Read this leaflet carefully before using this medicine as 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 to do.

• 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 get worse after a few days.

Contents of this leaflet

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

1. What BROXOL is and what it is used for

This medicine contains ambroxol hydrochloride, an active ingredient belonging to a
group of medicines called “mucolytics”, which work by fluidifying the mucus of the
respiratory tract (phlegm).
BROXOL is indicated in patients who have cough and phlegm in bronchial and
pulmonary diseasesthat are acute or that last for a long time (chronic).

2. What you need to know before you use BROXOL

Do not use BROXOL

• if you are allergic to ambroxol hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe problems with your liver or kidneys.

Warnings and precautions
Talk to your doctor or pharmacist before using BROXOL. Use this medicine with caution
and inform your doctor if:

• you suffer from a stomach or intestinal problem called peptic ulcer;
• you suffer from kidney problems (renal insufficiency);
• you suffer from an airway abnormality that causes excessive narrowing of the airways (airway hyperreactivity), as BROXOL contains benzalkonium chlorideas an excipient which may cause breathing difficulties (bronchospasm).

Following the administration of ambroxol, cases of skin reactions
associated with serious illnesses ( erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis) have been reported.
If you develop a skin rash (including blisters or lesions of the mucous membranes such as mouth, throat,
nose, eyes and genitals), stop taking BROXOL and consult your doctor immediately.
In particular, in the early stages of these diseases, you may experience symptoms similar to those
of the flu, such as fever, chills, cold (rhinitis), cough and sore throat.

Other medicines and BROXOL
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
After administration of ambroxol, the concentrations of antibiotics such as amoxicillin,
cefuroxime and erythromycin, in broncho-pulmonary secretions and in saliva are
increased.
BROXOL does not interfere with other medicines.

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 taking
this medicine.
Pregnancy
The use of BROXOL is not recommended during pregnancy, especially during the first three
months. If you are pregnant, take BROXOL only in cases of absolute necessity and under the
direct supervision of your doctor.
Breastfeeding
The use of BROXOL is not recommended during breastfeeding.

Driving and using machines
No data are available to establish the effects of BROXOL on the ability to drive vehicles and
operate machinery.

BROXOL 0.75% solution for nebulization contains benzalkonium chloride
This medicine contains benzalkonium chloride as a preservative. Following inhalation,
this preservative may cause bronchospasm.

3. How to use BROXOL

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Avoid using BROXOL for prolonged periods

Adults
The recommended dose is 2-3 ml of solution, 1-2 times a day.

Use in children over 5 years of age
The recommended dose is 2-3 ml of solution, 1-2 times a day.

Use in children under 5 years of age
The recommended dose is 1-2 ml of solution, 1-2 times a day.
Method of administration
You can inhale the solution using standard nebulizer devices. Warm the solution to
body temperature before inhalation. You can also dilute the solution with an equal
volume of distilled water or saline solution (1:1 ratio).
As deep breathing of aerosol may cause coughing, try to breathe
normally during inhalation.
If you suffer from bronchial asthma, take a bronchodilator
medicine (bronchospasmolytic) before inhalation.
Broxol 0.75% solution for nebulization must not be mixed with chromoglycic acid (
used for the prevention of asthma and allergic rhinitis), or with other solutions whose
resulting mixture has a pH greater than 6.3, such as alkaline solutions for
nebulization (Emser salts); as an increase in pH leads to clouding of the
solution.

If you take more BROXOL than you should
In case of accidental intake of an excessive dose of this medicine, inform
your doctor immediately or go to the nearest hospital.
No cases of overdose have been reported. The symptoms of an overdose may
correspond to the undesirable effects that may occur at the recommended doses (See
section 4 “Possible side effects”).

If you forget to take BROXOL
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.
The following side effects may occur:

Common(may affect up to 1 in 10 people):

• alterations of the sense of taste (dysgeusia);
• loss of sensitivity (hypoesthesia) of the oral cavity and pharynx;
• nausea.

Uncommon(may affect up to 1 in 100 people):

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

Rare(may affect up to 1 in 1000 people):

• hypersensitivity reactions;
• rash, urticaria.

Not known(frequency cannot be estimated based on available data):

• allergic reactions, anaphylactic reactions, including anaphylactic shock, angioedema

(rapid swelling of the skin, subcutaneous tissues, mucosa and
submucosal tissues) and pruritus;

• severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis);
• heartburn and esophageal burning (pyrosis);
• dry throat.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at:
http//www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BROXOL

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.
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 BROXOL 0.75% solution for nebulisation contains

• The active ingredient is ambroxol hydrochloride; 100 ml of solution contains 750 mg of ambroxol hydrochloride.
• The other ingredients are: citric acid monohydrate, disodium phosphate, sodium chloride, benzalkonium chloride and purified water.

Description of the appearance of BROXOL and contents of the pack
BROXOL 0.75% solution for nebulisation
Pack containing a 40 ml bottle of solution for nebulisation.

Marketing Authorisation Holder and Manufacturers

Marketing Authorisation Holder
S.F. Group S.r.l., Via Tiburtina, 1143 – 00156 Rome

Manufacturer
Special Product's Line S.p.A , Strada Paduni, 240 – 03012 Anagni (FR) - Italy