AMBROXOLO 30 mg /10 Ml Сироп

Содержание инструкции

1. AMBROXOLO ALMUS 15 mg/2 ml solution for nebulization
   1. What is AMBROXOLO ALMUS and what is it used for
   2. What you need to know before you take AMBROXOLO ALMUS
   3. How to take AMBROXOLO ALMUS
   4. Possible side effects
   5. How to store AMBROXOLO ALMUS
   6. Contents of the pack and other information
2. AMBROXOLO ALMUS 30 mg/10 ml syrup
   1. What is AMBROXOLO ALMUS and what is it used for
   2. What you need to know before you take AMBROXOLO ALMUS
   3. How to take AMBROXOLO ALMUS
   4. Possible side effects
   5. How to store AMBROXOLO ALMUS
   6. Contents of the pack and other information

AMBROXOLO ALMUS 15 mg/2 ml solution for nebulization

Generic medicine

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 a few days.

Contents of this leaflet:

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

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

This medicine contains the active ingredient ambroxol hydrochloride, which belongs to a group
of medicines called “mucolytics”, which facilitate the removal of mucus from the respiratory tract,
thus facilitating normal breathing.
AMBROXOLO ALMUS is indicated for the treatment of cough in diseases of the bronchi and lungs (acute and
chronic bronchopulmonary conditions).

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

Do not take AMBROXOLO ALMUS

• if you are allergic to ambroxol hydrochloride or to 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 taking AMBROXOLO ALMUS.
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 ALMUS and consult your doctor immediately.

Children
AMBROXOLO ALMUS, like all mucolytic medicines, can cause 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 AMBROXOLO ALMUS
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
AMBROXOLO ALMUS generally 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 AMBROXOLO ALMUS is not recommended during pregnancy, especially during the
first three months. If you are pregnant, take AMBROXOLO ALMUS only in cases of absolute
necessity and under the direct supervision of your doctor.

Breastfeeding
The use of AMBROXOLO ALMUS is not recommended during breastfeeding. The drug, if taken,
is secreted into breast milk, and may cause undesirable effects in the infant. Therefore, it is
necessary to decide whether to discontinue breastfeeding or the use of AMBROXOLO ALMUS. Ask
your doctor for advice.

Driving and operating machinery
AMBROXOLO ALMUS does not impair the ability to drive vehicles or operate machinery.

3. How to take AMBROXOLO ALMUS

Take this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Before inhalation, warm the solution to be nebulizedto body temperature.
You can use the solution with standard aerosol devices, and you can dilute it with
distilled water (in a 1:1 ratio).
Since deep aerosol breathing may trigger coughing, it is recommended to breathe
normally during inhalation.
If you suffer from asthma, it is recommended to take your usual asthma medications
(bronchodilators) before using this medicine via inhalation.

Use in adults and children over 5 years of age
The recommended dose is 2-3 vials per day.

Use in children up to 5 years of age
The recommended dose is 1-2 vials per day.

If you take more AMBROXOLO ALMUS 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).
If you accidentally take an excessive dose of this medicine, immediately inform
your doctor or go to the nearest hospital.

If you forget to take AMBROXOLO ALMUS
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:

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

• fatigue;
• dry mouth (xerostomia);
• increased mucus production, runny nose (rhinorrhea);
• difficulty in urination (dysuria);
• headache (cephalalgia);
• heartburn and esophagus burning (pyrosis);
• digestive difficulties (dyspepsia);
• constipation;
• nausea and vomiting;
• skin irritation (contact dermatitis);
• 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, mucosa 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, tell your doctor or pharmacist. 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 AMBROXOLO ALMUS

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. 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 ALMUS 15 mg/2 ml nebulizer solution contains

• The active substance is ambroxol hydrochloride. One vial 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 AMBROXOLO ALMUS and contents of the pack
Pack containing 10 glass vials of 2 ml solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Almus S.r.l. - Via Cesarea, 11/10 – 16121 Genova
Manufacturer
Esseti Farmaceutici S.r.l. - Via Campobello 15 - 00040 Pomezia (Roma)

AMBROXOLO ALMUS 30 mg/10 ml syrup

Generic medicine

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 a few days.

Contents of this leaflet:

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

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

This medicine contains the active ingredient ambroxol hydrochloride, which belongs to a group
of medicines called “mucolytics”, which facilitate the removal of mucus from the respiratory tract,
thus facilitating normal breathing.

AMBROXOLO ALMUSis indicated for the treatment of cough in diseases of the bronchi and lungs (acute and
chronic bronchopulmonary conditions).

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

Do not take AMBROXOLO ALMUS

• if you are allergic to ambroxol hydrochloride or to 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);
• if the person who is to take this medicine is a child under 2 years of age (See section “Children”).

Warnings and precautions
Consult your doctor or pharmacist before taking AMBROXOLO ALMUS.
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 ALMUS and consult your doctor immediately.

Children
AMBROXOLO ALMUS, like all mucolytic medicines, can 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.
They should therefore not be used in children under 2 years of age (see section “Do not
take AMBROXOLO ALMUS”).

Other medicines and AMBROXOLO ALMUS
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
AMBROXOLO ALMUS does not interfere with other medicines.

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 ALMUS is not recommended during pregnancy, especially during the
first three months. If you are pregnant, take AMBROXOLO ALMUS only in cases of absolute
necessity and under the direct supervision of your doctor.

Breastfeeding
The use of AMBROXOLO ALMUS is not recommended during breastfeeding. The drug, if taken,
is secreted in breast milk, and may cause adverse effects in the infant. Therefore, it is
necessary to decide whether to discontinue breastfeeding or the use of AMBROXOLO ALMUS. Ask
your doctor for advice.

Driving and operating machinery
AMBROXOLO ALMUS does not impair the ability to drive vehicles or operate machinery.

AMBROXOLO ALMUS contains sorbitol, glycerol and benzoic acid
This medicine contains sorbitol, a type of sugar. If your doctor has diagnosed you with an
intolerance to certain sugars, contact him before taking this medicine. It may have a mild
laxative effect. The caloric value of sorbitol is 2.6 kcal/g.
This medicine contains glycerol, a type of alcohol, which can cause headache, stomach
upset and diarrhea.
This medicine also contains benzoic acid, a mild irritant to skin, eyes and mucous membranes.
It may increase the risk of jaundice in newborns.

3. How to take AMBROXOLO ALMUS

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 AMBROXOLO ALMUS after meals and avoid taking it for prolonged periods.

Use in adults
The recommended dose is 10 ml (30 mg) 3 times a day.

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

Use in children from 2 to 5 years of age
The recommended dose is 2.5 ml (7.5 mg) 3 times a day.

If you take more AMBROXOLO ALMUS 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 ALMUS
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:

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

• fatigue;
• dry mouth (xerostomia);
• increased mucus production, runny nose (rhinorrhea);
• difficulty in urination (dysuria);
• headache (cephalalgia);
• heartburn and esophagus burning (pyrosis);
• digestive difficulties (dyspepsia);
• constipation;
• nausea and vomiting;
• skin irritation (contact dermatitis);
• allergic reactions (especially skin rashes);
• hypersensitivity reactions;
• rash, urticaria.

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

• bronchial obstruction (bronchial obstruction);
• 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).

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
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 AMBROXOLO ALMUS

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. 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 ALMUS 30mg/10 ml syrup contains:

Single-dose containers of 10 ml:

• The active ingredient is ambroxol hydrochloride. Each single-dose 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.

200 ml bottle:

• The active ingredient is ambroxol hydrochloride. 100 ml of syrup contained in the bottle, contains 300 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 AMBROXOLO ALMUS and contents of the pack

Single-dose containers of 10 ml:
Pack containing 20 single-dose containers of 10 ml of syrup.

200 ml bottle:
Pack containing 1 glass bottle of 200 ml of syrup. Inside the pack there is
a measuring cup.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder
Almus S.r.l. - Via Cesarea, 11/10 - 16121 Genova
Manufacturers

Single-dose containers of 10 ml:
Special Product’s Line S.p.A. - Via Campobello, 15 - 00040 Pomezia (Roma)

200 ml bottle:
Special Product’s Line S.p.A - Strada Paduni, 240 - 03012 Anagni (FR)