Ambroxol Eg

Patient Information Leaflet

AMBROXOL EG 15 mg/5 ml Syrup, 30 mg/10 ml Syrup

Equivalent medicine
Please read all of 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 to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, contact your pharmacist.
• If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not notice improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

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

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

This medicinal product contains the active substance ambroxol hydrochloride, belonging to a group of medicines called mucolytics, used to facilitate the removal of mucus from the respiratory tract.
AMBROXOLO EG is indicated for the treatment of cough associated with bronchial and lung diseases (acute and chronic bronchopulmonary conditions).

2. What you need to know before taking AMBROXOL EG

Do not take AMBROXOL EG

• 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 EG.
Take this medicine with caution and inform your doctor:

• if you have a stomach or intestinal condition called peptic ulcer;
• if you have kidney problems (severe renal insufficiency).

Severe skin reactions have been reported with ambroxol administration.
In particular, during the initial phase of such diseases, you may experience influenza-like symptoms such as fever, pain, cold (rhinitis), cough and sore throat. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking AMBROXOL EG and contact your doctor immediately.
Children
AMBROXOL EG 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 EG
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking medicines such as amoxicillin, cefuroxime and erythromycin, antibiotics used to treat bacterial infections.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The use of AMBROXOL EG is not recommended during pregnancy, especially during the first three months. If you are pregnant, take AMBROXOL EG only when strictly necessary and under direct medical supervision.
Breastfeeding
The use of AMBROXOL EG is not recommended during breastfeeding.
Driving and using machines
There are no data available to determine the effects of ambroxol hydrochloride on the ability to drive vehicles or operate machinery.
AMBROXOL EG contains sorbitol, benzoic acid and propylene glycol
This medicine contains 350 mg of sorbitol per ml. Sorbitol is a source of fructose. If your doctor has informed you (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients are unable to metabolize fructose, consult your doctor before taking this medicine (or giving it to the child).
This medicine contains 2 mg of benzoic acid per ml.
This medicine contains 30 mg of propylene glycol per ml.

3. How to take AMBROXOL EG

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take AMBROXOL EG after meals and avoid prolonged use.

Adults
The recommended dose for adults 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 EG 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 overdose, contact your doctor immediately or go to the nearest hospital.

If you forget to take AMBROXOL EG
Do not take a double dose to make up for the forgotten dose.

If you have any questions 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.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

• altered sense of taste (dysgeusia);
• loss of sensation in the oral cavity and pharynx (hypoaesthesia);
• nausea.

Uncommon (may affect up to 1 in 100 people)

• vomiting, diarrhoea, digestive difficulties (dyspepsia), and abdominal pain;
• dry mouth.

Rare (may affect up to 1 in 1000 people)

• hypersensitivity reactions;
• headache (cephalalgia);
• increased mucus production, runny nose (rhinorrhoea);
• heartburn and oesophageal burning (pyrosis);
• constipation (stipsis);
• skin irritation (skin rash, urticaria, contact dermatitis);
• difficulty in passing urine (dysuria);
• fatigue.

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

• 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 generalised exanthematous pustulosis);
• bronchial obstruction (bronchial occlusion);
• dry throat.

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 EG

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 "Exp".
The expiry date refers to the last day of that month.
This medicine requires no 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. Contents of the pack and other information

What AMBROXOLO EG 15 mg/5 ml syrup contains

• The active substance is ambroxol hydrochloride. 100 ml of syrup contain 300 mg of ambroxol hydrochloride.
• The other components are: hydroxyethylcellulose, sorbitol 70% solution, glycerol (E422), benzoic acid (E210), black cherry flavour, propylene glycol (E1520), tartaric acid, purified water.

What AMBROXOLO EG 30 mg/10 ml syrup contains

• The active substance is ambroxol hydrochloride. Each single-dose container contains 30 mg of ambroxol hydrochloride.
• The other components are: hydroxyethylcellulose, sorbitol 70% solution, glycerol, benzoic acid, black cherry flavour, propylene glycol, tartaric acid, purified water.

Description of the appearance of AMBROXOLO EG and contents of the pack
AMBROXOLO EG 15 mg/5 ml syrup: pack containing 1 bottle of 200 ml in a printed carton.
AMBROXOLO EG 30 mg/10 ml syrup: pack containing 20 single-dose containers of 10 ml.
Marketing Authorization Holder
EG S.p.A. – Via Pavia, 6 – 20136 Milan
Manufacturer
Special Product Line S.p.A. Via Campobello 15 - 00040 Pomezia – Rome (30 mg/10 ml Syrup)
Special Product Line S.p.A. Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR) (15 mg/5 ml Syrup)

Package leaflet: information for the patient

AMBROXOL EG 15 mg/2 ml Nebulizer Solution

Generic medicine
Please read this leaflet carefully before using 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 need further 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:

1. What AMBROXOL EG is and what it is used for
2. What you need to know before taking AMBROXOL EG
3. How to take AMBROXOL EG
4. Possible side effects
5. How to store AMBROXOL EG
6. Package contents and other information

1. What AMBROXOL EG 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 help eliminate mucus from the respiratory tract.
AMBROXOL EG is indicated for the treatment of cough associated with bronchial and lung diseases (acute and chronic bronchopulmonary conditions).

2. What you need to know before taking AMBROXOLO EG

Do not take AMBROXOLO EG

• 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 EG.
Take this medicine with caution and inform your doctor:

• if you have a stomach or intestinal condition called peptic ulcer;
• if you have kidney problems (severe renal failure).

Severe skin reactions have been reported following administration of ambroxol.
In particular, during the initial phase of such diseases, you may experience influenza-like symptoms,
such as fever, pain, cold symptoms (rhinitis), cough and sore throat. If you develop a skin rash (including lesions
of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking AMBROXOLO EG and
seek immediate medical advice.

Other medicines and AMBROXOLO EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Take this medicine with caution and inform your doctor if you are taking medicines such as amoxicillin,
cefuroxime and erythromycin, antibiotics used to treat bacterial infections.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The use of AMBROXOLO EG is not recommended during pregnancy, especially during the first three months. If you are pregnant, take AMBROXOLO EG only when strictly necessary and under direct medical supervision.

Breastfeeding
The use of AMBROXOLO EG is not recommended during breastfeeding.

Driving and using machines
There are no data available to determine the effects of ambroxol hydrochloride on the ability to drive vehicles or operate machinery.

3. How to take AMBROXOL EG

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
It is recommended to warm the solution for nebulization to body temperature before inhalation.
Breathe normally during inhalation, as deep inhalation of the aerosol may trigger coughing.
If you suffer from asthma, take a medicine to reduce bronchial spasms (a bronchospasmolytic) before inhalation.
The solution for nebulization can be administered using standard nebulization devices. It may also be diluted with distilled water in a 1:1 ratio.

Use in adults and children over 5 years of age
The recommended dose is 2–3 vials (30–45 mg) per day.

Use in children up to 5 years of age
The recommended dose is 1–2 vials (15–30 mg) per day.

If you take more AMBROXOL EG than you should
No cases of overdose have been reported. Symptoms of overdose may be consistent with the adverse reactions
observed at 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 EG
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur:
Common (may affect up to 1 in 10 people)

• disturbances in taste sensation (dysgeusia);
• loss of sensitivity in the oral cavity and pharynx (hypoaesthesia);
• nausea.

Uncommon (may affect up to 1 in 100 people)

• vomiting, diarrhoea, digestive difficulties (dyspepsia), and abdominal pain;
• dry mouth.

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

• hypersensitivity reactions;
• headache (cephalalgia);
• increased mucus production, runny nose (rhinorrhoea);
• heartburn and oesophageal burning (pyrosis);
• constipation (stipsis);
• skin irritation (rash, urticaria, contact dermatitis);
• difficulty in passing urine (dysuria);
• fatigue.

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

• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa, and submucosal tissues), and pruritus;
• serious cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and generalized acute exanthematous pustulosis);
• dry throat.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store AMBROXOLUM EG

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 “Exp”.
The expiry date refers to the last day of that month.
This medicine requires no 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. Pack contents and other information

What AMBROXOLO EG 15 mg/2 ml nebulising solution contains

• The active substance is ambroxol hydrochloride. One vial (2 ml) of nebulising solution 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 EG and pack contents
Pack containing 10 vials of 2 ml.
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 – 20136 Milan
Manufacturer
Esseti Farmaceutici S.r.l., Via Campobello 15 - 00071 Pomezia - Rome