Ambroxol Almus
Italy
Table of Contents
Package leaflet: Information for the patient
AMBROXOL ALMUS 15 mg/2 ml nebulising solution
Generic medicine
Please 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 instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days.
Contents of this leaflet:
- What AMBROXOL ALMUS is and what it is used for
- What you need to know before taking AMBROXOL ALMUS
- How to take AMBROXOL ALMUS
- Possible side effects
- How to store AMBROXOL ALMUS
- Contents of the pack and other information
1. What AMBROXOLO ALMUS is and what it is used for
This medicinal product contains the active substance ambroxol hydrochloride, which belongs to a group of medicines called "mucolytics", which help eliminate mucus from the respiratory tract, thereby 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 taking 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 have severe liver or kidney problems (severe hepatic and/or renal impairment).
Warnings and precautions
Talk to 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 condition called peptic ulcer.
Severe skin reactions have been reported with ambroxol administration. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking AMBROXOLO ALMUS and contact your doctor immediately.
Children
AMBROXOLO ALMUS, like all mucolytic medicines, may cause bronchial obstruction in children under 2 years of age. Indeed, 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
Inform 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, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Use of AMBROXOLO ALMUS is not recommended during pregnancy, especially during the first three months. If you are pregnant, take AMBROXOLO ALMUS only if absolutely necessary and under direct medical supervision.
Breastfeeding
Use of AMBROXOLO ALMUS is not recommended during breastfeeding. The drug, if taken, is excreted in breast milk and may cause adverse effects in the breastfed infant. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue therapy with AMBROXOLO ALMUS. Ask your doctor for advice.
Driving and using machines
AMBROXOLO ALMUS does not affect the ability to drive or use machinery.
3. How to take AMBROXOL ALMUS
Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Before inhalation, warm the nebulisation solution to body temperature.
You can use the solution with standard nebuliser devices, and you may dilute it with distilled water (in a 1:1 ratio).
Since deep inhalation of the aerosol may trigger coughing, it is recommended to breathe normally during inhalation.
If you suffer from asthma, it is advisable to take your usual asthma medication (bronchospasmolytics) before using this medicine by inhalation.
Use in adults and children above 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 AMBROXOL ALMUS than you should
No cases of overdose have been reported. Symptoms of overdose may correspond to the undesirable effects that may occur at the recommended doses (See section 4).
In case of accidental ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take AMBROXOL ALMUS
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 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 passing urine (dysuria);
- headache (cephalalgia);
- heartburn and of the oesophagus (pyrosis);
- digestive difficulties (dyspepsia);
- constipation (stipsis);
- nausea and vomiting;
- skin irritation (contact dermatitis);
- hypersensitivity reactions;
- rash, urticaria.
Not known (frequency cannot be estimated from the available data)
- bronchial obstruction (bronchial occlusion);
- anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues), and pruritus;
- 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 effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
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 AMBROXOL ALMUS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 AMBROXOLO ALMUS 15 mg/2 ml nebulising solution contains
- The active substance is ambroxol hydrochloride. Each vial contains 15 mg of ambroxol hydrochloride.
- The other components are: monobasic sodium phosphate dihydrate, dibasic sodium phosphate dihydrate, water for injections.
Description of the appearance of AMBROXOLO ALMUS and contents of the pack
Carton pack containing 10 glass vials of 2 ml solution.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Almus S.r.l. - Via Cesarea, 11/10 – 16121 Genoa
Manufacturer
Esseti Farmaceutici S.r.l. - Via Campobello 15 - 00040 Pomezia (Rome)
Patient information leaflet
AMBROXOL ALMUS 30 mg/10 ml syrup
Generic medicine
Please 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 instructed you.
- Keep this leaflet. You may need to read it again.
- If you would like more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days.
Contents of this leaflet:
- What AMBROXOL ALMUS is and what it is used for
- What you need to know before taking AMBROXOL ALMUS
- How to take AMBROXOL ALMUS
- Possible side effects
- How to store AMBROXOL ALMUS
- Contents of the pack and other information
1. What AMBROXOLO ALMUS is and what it is used for
This medicinal product contains the active substance ambroxol hydrochloride, which belongs to a group of medicines called "mucolytics", that facilitate the removal of mucus from the respiratory tract, thus promoting 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 taking AMBROXOL ALMUS
Do not take AMBROXOL ALMUS
- 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 (severe hepatic and/or renal impairment);
- if the person taking this medicine is a child under 2 years of age (see section “Children”).
Warnings and precautions
Talk to your doctor or pharmacist before taking AMBROXOL ALMUS.
Take this medicine with caution and inform your doctor if you suffer from a stomach or intestinal condition called peptic ulcer.
Severe skin reactions have been reported with ambroxol administration. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking AMBROXOL ALMUS and contact your doctor immediately.
Children
AMBROXOL ALMUS, like all mucolytic medicines, may cause bronchial obstruction in children under 2 years of age. Indeed, the ability to drain bronchial mucus is limited in this age group due to the physiological characteristics of the respiratory tract.
Therefore, it must not be used in children under 2 years of age (see section “Do not take AMBROXOL ALMUS”).
Other medicines and AMBROXOL ALMUS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
AMBROXOL ALMUS does not interfere with other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of AMBROXOL ALMUS is not recommended during pregnancy, especially during the first three months. If you are pregnant, take AMBROXOL ALMUS only if absolutely necessary and under direct medical supervision.
Breastfeeding
The use of AMBROXOL ALMUS is not recommended during breastfeeding. The drug, if taken, is excreted in breast milk and may cause adverse effects in the nursing infant. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue the use of AMBROXOL ALMUS. Consult your doctor.
Driving and using machines
AMBROXOL ALMUS does not affect the ability to drive vehicles or operate machinery.
AMBROXOL 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, consult 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, an alcohol, which may cause headache, gastrointestinal disturbances and diarrhoea.
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 AMBROXOL ALMUS
Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take AMBROXOL ALMUS after meals and avoid taking it for prolonged periods.
Use in adults
The recommended dose is 10 ml (30 mg) three times daily.
Use in children over 5 years of age
The recommended dose is 5 ml (15 mg) three times daily.
Use in children from 2 to 5 years of age
The recommended dose is 2.5 ml (7.5 mg) three times daily.
If you take more AMBROXOL ALMUS than you should
Cases of overdose have not been reported. Symptoms of overdose may be consistent with the adverse effects that may occur at the recommended doses (See section 4).
In case of accidental ingestion of an excessive dose of this medicine, inform your doctor immediately or go to the nearest hospital.
If you forget to take AMBROXOL ALMUS
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 everybody gets them.
The following side effects may occur:
Rare (may affect up to 1 in 1,000 people)
- tiredness;
- dry mouth (xerostomia);
- increased mucus production, runny nose (rhinorrhea);
- difficulty passing urine (dysuria);
- headache (cephalalgia);
- heartburn and of the oesophagus (pyrosis);
- digestive difficulties (dyspepsia);
- constipation (stipsis);
- nausea and vomiting;
- skin irritation (contact dermatitis);
- allergic reactions (especially skin rashes);
- hypersensitivity reactions;
- rash, urticaria.
Not known (frequency cannot be estimated from the available data)
- bronchial obstruction (bronchial occlusion);
- anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues), and pruritus;
- 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 AMBROXOL ALMUS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 AMBROXOLO ALMUS 30 mg/10 ml syrup contains:
Single-dose containers of 10 ml:
- The active substance is ambroxol hydrochloride. Each single-dose container contains 30 mg of ambroxol hydrochloride.
- The other components are: hydroxyethylcellulose, sorbitol 70%, glycerol, benzoic acid, cherry flavour, propylene glycol, tartaric acid, purified water.
200 ml bottle:
- The active substance is ambroxol hydrochloride. 100 ml of syrup contained in the bottle contains 300 mg of ambroxol hydrochloride.
- The other components are: hydroxyethylcellulose, sorbitol 70%, glycerol, benzoic acid, cherry flavour, propylene glycol, tartaric acid, purified water.
Description of the appearance of AMBROXOLO ALMUS and package contents
Single-dose containers of 10 ml:
Carton containing 20 single-dose containers of 10 ml syrup.
200 ml bottle:
Carton containing 1 glass bottle of 200 ml syrup. A dosing cup is included inside the packaging.
Marketing Authorization Holder and Manufacturers
Marketing Authorization Holder
Almus S.r.l. - Via Cesarea, 11/10 - 16121 Genoa
Manufacturers
Single-dose containers of 10 ml:
Special Product’s Line S.p.A. - Via Campobello, 15 - 00040 Pomezia (Rome)
200 ml bottle:
Special Product’s Line S.p.A. - Strada Paduni, 240 - 03012 Anagni (FR)