Ambroxol ABC
ItalyTable of Contents
Package leaflet: Information for the patient
AMBROXOLO ABC 30 mg tablets, suppositories
Ambroxol hydrochloride
Equivalent medicine
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What AMBROXOLO ABC is and what it is used for
- What you need to know before taking AMBROXOLO ABC
- How to take AMBROXOLO ABC
- Possible side effects
- How to store AMBROXOLO ABC
- Contents of the pack and other information
1. What AMBROXOLO ABC 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, used to facilitate the removal 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).
2. What you need to know before taking AMBROXOL ABC
Do not take AMBROXOL 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 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 ABC.
Take this medicine with caution and inform your doctor if
- you suffer from a stomach or intestinal condition called peptic ulcer.
Severe skin reactions associated with ambroxol administration have been reported. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking AMBROXOL ABC and contact your doctor immediately.
Children
AMBROXOL ABC must not be administered to children under 2 years of age, as it may obstruct the bronchi and interfere with normal breathing.
Other medicines and AMBROXOL 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, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of AMBROXOL ABC is not recommended during pregnancy, especially during the first three months. If you are pregnant, take AMBROXOL ABC only when strictly necessary and under direct medical supervision.
Breastfeeding
This medicine is excreted in breast milk; therefore, your doctor will decide whether to discontinue AMBROXOL ABC or to stop breastfeeding.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
AMBROXOL ABC 30 mg tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
3. How to take AMBROXOL ABC
Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
AMBROXOL ABC 30 mg tablets:
Take this medicine after meals, with a glass of water or other liquid.
In adults, the recommended dose is 1 tablet 3 times daily for the first 8–10 days.
Thereafter, the dose may be reduced to 1 tablet twice daily.
AMBROXOL ABC 30 mg suppositories (paediatric use):
In children weighing more than 15 kg and over 2 years of age, the recommended dose is 1 suppository, 1 or 2 times daily.
If you take more AMBROXOL ABC than you should
No cases of overdose have been reported. Symptoms of overdose may correspond to 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, contact your doctor immediately or go to the nearest hospital.
If you forget to take AMBROXOL ABC
Do not take a double dose to make up for the forgotten 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.
Rarely, the following side effects may occur:
- headache (cephalaea);
- dry mouth;
- nausea, vomiting, digestive difficulties (dyspepsia);
- increased mucus production, runny nose (rhinorrhea);
- heartburn and of the oesophagus (pyrosis);
- constipation;
- skin irritation (rash, contact dermatitis);
- difficulty in passing urine (dysuria);
- fatigue.
Rare (may affect up to 1 in 1,000 people):
- hypersensitivity reactions;
- rash, urticaria.
Not known (frequency cannot be estimated from the available data):
- bronchial obstruction;
- anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa, and submucosal tissues), and pruritus;
- severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and generalized acute 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 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 AMBROXOL ABC
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
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 ABC 30 mg tablets contain
- The active substance 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 substance is ambroxol hydrochloride. Each suppository contains 30 mg of ambroxol hydrochloride.
- The other ingredients are: semisynthetic triglycerides, colloidal silicon dioxide.
Description of the appearance of AMBROXOLO ABC and package contents
AMBROXOLO ABC 30 mg tablets:
Boxes of 20 tablets in blisters.
AMBROXOLO ABC 30 mg suppositories:
Pack containing 10 suppositories.
Marketing Authorization Holder
ABC FARMACEUTICI S.P.A. - Corso Vittorio Emanuele II, 72 – 10121 Turin
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)
Patient information leaflet: information for the patient
AMBROXOL ABC 30 mg granules for oral suspension, 15 mg granules for oral suspension, 15 mg/2 ml solution for nebulisation
Ambroxol hydrochloride
Equivalent 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, please contact your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice any improvement or if your symptoms worsen after a few days.
Contents of this leaflet:
- What AMBROXOL ABC is and what it is used for
- What you need to know before taking AMBROXOL ABC
- How to take AMBROXOL ABC
- Possible side effects
- How to store AMBROXOL ABC
- Contents of the pack and other information
1. What AMBROXOLO ABC is and what it is used for
This medicine contains the active substance ambroxol hydrochloride, which belongs to a group of medicines called mucolytics, used to help eliminate 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 to any of the other ingredients of this medicine (listed in section 6);
- if you have severe liver or kidney problems;
- if the person taking 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 condition called peptic ulcer;
- you suffer from asthma; in this case, take a bronchodilator medicine (bronchial spasmolytic) before using this medicine by inhalation. Since deep inhalation of aerosol may trigger coughing, try to breathe normally during inhalation. Serious skin reactions have been reported with ambroxol administration. If you develop a skin rash (including mucosal membrane lesions such as in the mouth, throat, nose, eyes, genitals), stop taking Ambroxolo ABC and contact your doctor immediately.
Warm the solution to body temperature before inhalation.
If you have bronchial asthma, take a bronchodilator medicine (bronchospasmolytic) before inhalation.
Children
AMBROXOLO ABC must not be administered to children under 2 years of age, as it may obstruct the bronchi and interfere with normal breathing.
Other medicines and AMBROXOLO ABC
Inform 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, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of AMBROXOLO ABC during pregnancy is not recommended, especially during the first three months. If you are pregnant, take AMBROXOLO ABC only if absolutely necessary and under direct medical supervision.
Breastfeeding
This medicine is excreted in breast milk; therefore, your doctor will decide whether to discontinue AMBROXOLO ABC or to stop breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
AMBROXOLO ABC oral suspension granules contain sucrose.
AMBROXOLO ABC 15 mg oral suspension granules contain 3.96 g of sucrose (sugar) per sachet.
AMBROXOLO ABC 30 mg oral suspension granules contain 7.9 g of sucrose (sugar) per sachet.
This should be taken into consideration in patients with diabetes mellitus.
If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.
3. How to take AMBROXOLO ABC
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.
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 daily.
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 daily.
AMBROXOLO ABC 15 mg/2 ml nebulising solution:
This medicine may be mixed in the nebuliser device with distilled water.
Use in adults and children over 5 years of age:
The recommended dose is 2–3 ml of nebulising solution, 1–2 times daily.
Use in children under 5 years of age:
The recommended dose is 2 ml of solution, 1–2 times daily.
To prevent coughing, breathe normally during inhalation of the nebulised solution.
If you are particularly sensitive, you may warm the nebulising solution to body temperature before inhalation.
You can inhale the solution using standard aerosol devices. The solution may also be diluted with an equal volume of distilled water (ratio 1:1).
If you take more AMBROXOLO ABC than you should
No overdose cases have been reported. Symptoms of overdose may correspond to the adverse effects that may occur at 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 AMBROXOLO ABC
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 will experience them.
Rarely, the following side effects may occur:
- headache (cephalalgia);
- dry mouth;
- nausea, vomiting, indigestion (dyspepsia);
- increased mucus production, runny nose (rhinorrhea);
- heartburn and oesophageal burning (pyrosis);
- constipation;
- skin irritation (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 the available data)
- bronchial obstruction;
- anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues), and pruritus;
- severe cutaneous 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 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 AMBROXOL ABC
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines 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 ABC 15 mg granules for oral suspension contains
- The active substance is ambroxol hydrochloride. Each sachet contains 15 mg of ambroxol hydrochloride.
- The other components are: orange flavour, pineapple flavour, sucrose.
What AMBROXOLO ABC 30 mg granules for oral suspension contains
- The active substance is ambroxol hydrochloride. Each sachet contains 30 mg of ambroxol hydrochloride.
- The other components are: orange flavour, pineapple flavour, sucrose.
What AMBROXOLO ABC 15 mg/2 ml nebulising solution contains
- The active substance is ambroxol hydrochloride. Each 2 ml vial contains 15 mg of ambroxol hydrochloride.
- The other components 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 nebulising solution
Pack containing 6 glass vials of 5 ml.
Marketing Authorization Holder
ABC FARMACEUTICI S.P.A. - Corso Vittorio Emanuele II, 72 – 10121 Turin
Manufacturers
AMBROXOLO ABC 15 mg/2 ml nebulising solution:
BIOLOGICI ITALIA LABORATORIES - Via Cavour No. 41-43 - Novate Milanese (MI)
BIOLAB - Via Buozzi 2 - 20090 Vimodrone (MI) (pyrogen testing)
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