AMBROXOLO 30 mg Tabletka Powlekana

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1. AMBROXOLO ABC 30 mg tablets, suppositories
   1. What is AMBROXOLO ABC and what is it used for
   2. What you need to know before you take AMBROXOLO ABC
   3. How to take AMBROXOLO ABC
   4. Possible side effects
   5. How to store AMBROXOLO ABC
   6. Contents of the pack and other information
2. AMBROXOLO ABC 30 mg granules for oral suspension, 15 mg granules for oral suspension, 15 mg/2 ml solution for nebulisation
   1. What is AMBROXOLO ABC and what is it used for
   2. What you need to know before taking AMBROXOLO ABC
   3. How to take AMBROXOLO ABC
   4. Possible side effects
   5. How to store AMBROXOLO ABC
   6. Contents of the pack and other information

AMBROXOLO ABC 30 mg tablets, suppositories

Ambroxol hydrochloride

Generic medicine

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 any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is AMBROXOLO ABC and what is it used for

This medicine contains the active ingredient ambroxol hydrochloride, belonging to a group of medicines
called mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
AMBROXOLO ABC is indicated for the treatment of secretions in acute and chronic bronchial and lung
diseases (in the presence of cough and phlegm).

2. What you need to know before you take AMBROXOLO ABC

Do not take AMBROXOLO ABC

• 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 liver or kidney problems;
• if the person who needs to take this medicine is a child under 2 years of age (See section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before taking AMBROXOLO ABC.
Take this medicine with caution and inform your doctor if

• you suffer from a stomach or intestinal problem called 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 Ambroxolo ABC and consult your doctor immediately.

Children
AMBROXOLO ABC should not be given to children under 2 years of age, as it may
obstruct the bronchi and prevent normal breathing.

Other medicines and AMBROXOLO ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
No interactions with other medicines are known.

Pregnancy and breastfeeding
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
The use of AMBROXOLO ABC is not recommended during pregnancy, especially during the first three
months. If you are pregnant, take AMBROXOLO ABC only if absolutely necessary and under the
direct supervision of your doctor.
Breastfeeding
This medicine is excreted in breast milk, therefore your doctor will assess whether to discontinue or not
taking AMBROXOLO ABC or to discontinue breastfeeding.

Driving and using machines
This medicine does not impair the ability to drive vehicles or operate machinery.

AMBROXOLO ABC 30 mg tablets contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this
medicine.

3. How to take AMBROXOLO ABC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

AMBROXOLO ABC 30 mg tablets:
Take this medicine after meals, with some water or other liquids.
In adults, the recommended dose is 1 tablet 3 times a day for the first 8-10 days.
Afterwards the dose may be reduced to 1 tablet 2 times a day.

AMBROXOLO ABC 30 mg suppositories (pediatric use):
In children weighing more than 15 kg and over 2 years of age, the recommended dose is 1 suppository, 1
or 2 times a day.

If you take more AMBROXOLO ABC than you should
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).
In case of accidental intake of an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.

If you forget to take AMBROXOLO ABC
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.

Rarelythe following side effects may occur:

• headache;
• dry mouth;
• nausea, vomiting, indigestion (dyspepsia);
• increased mucus production, runny nose (rhinorrhea);
• heartburn and esophagus burning (pyrosis);
• constipation;
• skin irritation (skin rash, contact dermatitis);
• difficulty in urination (dysuria);
• fatigue.

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

• hypersensitivity reactions;
• rash, urticaria.

Not known(frequency cannot be estimated from available data)

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://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 AMBROXOLO ABC

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 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 AMBROXOLO ABC 30 mg tablets contain

• The active ingredient is ambroxol hydrochloride. Each tablet contains 30 mg of ambroxol hydrochloride.
• The other ingredients are: lactose, starch, polyvinylpyrrolidone, magnesium stearate.

What AMBROXOLO ABC 30 mg suppositories contain

• The active ingredient is ambroxol hydrochloride. Each suppository contains 30 mg of ambroxol hydrochloride.
• The other ingredients are: semi-synthetic triglycerides, colloidal silica.

Description of the appearance of AMBROXOLO ABC and contents of the pack
AMBROXOLO ABC 30 mg tablets:
Boxes of 20 tablets in blisters.
AMBROXOLO ABC 30 mg suppositories
Pack containing 10 suppositories.

Marketing Authorisation Holder
ABC FARMACEUTICI S.P.A. - Corso Vittorio Emanuele II, 72 – 10121 Torino

Manufacturers
AMBROXOLO ABC 30 mg suppositories:
LAMP S.PROSPERO S.p.A. - Via della Pace n° 25/A- S.Prospero (MO)
AMBROXOLO ABC 30 mg tablets:
ABC FARMACEUTICI S.p.A - Canton Moretti, 29 - 10090 San Bernardo d’Ivrea (TO)

AMBROXOLO ABC 30 mg granules for oral suspension, 15 mg granules for oral suspension, 15 mg/2 ml solution for nebulisation

Ambroxol hydrochloride

Generic medicine

Read this leaflet carefully before you start 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 you feel worse after a few days.

Contents of this leaflet:

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

1. What is AMBROXOLO ABC and what is it used for

This medicine contains the active ingredient ambroxol hydrochloride, belonging to a group of medicines
called mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
AMBROXOLO ABC is indicated for the treatment of secretions in acute and chronic diseases of the bronchi and lungs
(in the presence of cough and phlegm).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment

2. What you need to know before taking AMBROXOLO ABC

Do not take AMBROXOLO ABC

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

Warnings and precautions
Talk to your doctor or pharmacist before taking AMBROXOLO ABC.
Take this medicine with caution and inform your doctor if

• you suffer from a stomach or intestinal problem called peptic ulcer;
• you suffer from asthma; in this case, take a bronchodilator medicine (bronchospasmolytic) before using this medicine via inhalation. As a deep breath of aerosol may cause coughing, try to breathe normally during inhalation. 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 Ambroxolo ABC and consult your doctor immediately.

Warm the solution to body temperature before inhalation.
If you have bronchial asthma, take a bronchodilator (bronchospasmolytic) medicine before
inhalation.

Children
AMBROXOLO ABC should not be given to children under 2 years of age, as it may
obstruct the bronchi and prevent normal breathing.

Other medicines and AMBROXOLO ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
No interactions with other medicines are known.

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 AMBROXOLO ABC is not recommended during pregnancy, especially during the first three
months. If you are pregnant, take AMBROXOLO ABC only if absolutely necessary and under the
direct supervision of your doctor.
Breastfeeding
This medicine is excreted in breast milk, therefore your doctor will assess whether to discontinue or not
taking AMBROXOLO ABC or discontinue breastfeeding.

Driving and using machines
This medicine does not impair the ability to drive vehicles or operate machinery.

AMBROXOLO ABC oral suspension granules contains sucrose.
AMBROXOLO ABC 15 mg oral suspension granules contains 3.96 g of sucrose (sugar) per
sachet.
AMBROXOLO ABC 30 mg oral suspension granules contains 7.9 g of sucrose (sugar) per
sachet.
This should be taken into consideration in people with diabetes mellitus.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.

3. How to take AMBROXOLO ABC

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.
Do not use AMBROXOLO ABC for prolonged treatments.

AMBROXOLO ABC 30 mg granules for oral suspension:
In adults, the recommended dose is 1 sachet 2 or 3 times a day.

AMBROXOLO ABC 15 mg granules for oral suspension:
In children over 2 years of age, the recommended dose is 1 sachet 2 or 3 times a day.

AMBROXOLO ABC 15 mg/2 ml solution for nebulisation:
This medicine can be mixed in the delivery device with distilled water.

Use in adults and children over 5 years of age:
the recommended dose is 2-3 ml of solution for nebulisation, 1-2 times a day.

Use in children under 5 years of age:
the recommended dose is 2 ml of solution, 1-2 times a day.
To avoid coughing, breathe normally during inhalation of the solution for nebulisation.
If you are particularly sensitive, you can warm the solution for nebulisation to body temperature before
inhalation.
You can inhale the solution using standard aerosol devices. You can also dilute the solution with an
equal volume of distilled water (1:1 ratio).

If you take more AMBROXOLO ABC than you should
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).
In case of accidental intake of an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.

If you forget to take AMBROXOLO ABC
Do not take a double dose to make up for a missed dose.
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.

Rarelythe following side effects can occur):

• headache;
• dry mouth;
• nausea, vomiting, digestive difficulties (dyspepsia);
• increased mucus production, runny nose (rhinorrhea);
• heartburn and esophageal burning (pyrosis);
• constipation;
• skin irritation (skin rash, contact dermatitis);
• difficulty in urination (dysuria);
• fatigue.

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

• hypersensitivity reactions;
• rash, urticaria.

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

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system
at https://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 AMBROXOLO ABC

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 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 AMBROXOLO ABC 15 mg granules for oral suspension contains

• The active ingredient is ambroxol hydrochloride. Each sachet contains 15 mg of ambroxol hydrochloride.
• The other ingredients are: orange flavour, pineapple flavour, sucrose.

What AMBROXOLO ABC 30 mg granules for oral suspension contains

• The active ingredient is ambroxol hydrochloride. Each sachet contains 30 mg of ambroxol hydrochloride.
• The other ingredients are: orange flavour, pineapple flavour, sucrose.

What AMBROXOLO ABC 15 mg/2 ml solution for nebulisation contains

• The active ingredient is ambroxol hydrochloride. Each 2 ml vial contains 15 mg of ambroxol hydrochloride.
• The other ingredients are: distilled water.

Description of the appearance of AMBROXOLO ABC and contents of the pack
AMBROXOLO ABC 15 mg granules for oral suspension
Pack containing 20 sachets.
AMBROXOLO ABC 30 mg granules for oral suspension
Pack containing 20 sachets.
AMBROXOLO ABC 15 mg/2 ml solution for nebulisation
Pack containing 6 glass vials of 5 ml.

Marketing Authorisation Holder
ABC FARMACEUTICI S.P.A. - Corso Vittorio Emanuele II, 72 – 10121 Torino

Manufacturers
AMBROXOLO ABC 15 mg/2 ml solution for nebulisation:
BIOLOGICI ITALIA LABORATORIES - Via Cavour N.41-43 - Novate Milanese (MI)
BIOLAB - Via Buozzi 2 - 20090 Vimodrone (MI) (pyrogen controls)
AMBROXOLO ABC 15 mg granules for oral suspension and AMBROXOLO ABC 30 mg granules for
oral suspension:
LA.FA.RE. S.r.l. - Via Benedetto Cozzolino, 77 - 80056 Ercolano - NA