Golasept chesty cough

Package leaflet: Information for the user

GOLASEPT COUGH WITH MUCUS 7.5 mg/ml nebulising solution

Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always use 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

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

AMBROXOLO PHARMENTIS contains the active substance ambroxol hydrochloride, which belongs to a group of medicines called mucolytics, used to help clear mucus from the airways.
AMBROXOLO PHARMENTIS is used to treat cough associated with phlegm (for example, in acute and chronic respiratory diseases).
Consult your doctor if you do not feel better or feel worse after a short period of treatment.

2. What you need to know before using AMBROXOLO PHARMENTIS

Do not use AMBROXOLO PHARMENTIS

• 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 disease.

Warnings and precautions
Talk to your doctor or pharmacist before using AMBROXOLO PHARMENTIS.
In particular, please consider the following:

• Take AMBROXOLO PHARMENTIS with caution if you have a lesion on the inner lining of the stomach (peptic ulcer).
• Serious skin reactions have been reported with ambroxol hydrochloride administration. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking ambroxol hydrochloride and contact your doctor immediately.
• If you experience non-specific symptoms resembling those of influenza, such as fever, malaise, rhinitis, cough, and sore throat, discontinue treatment with AMBROXOLO PHARMENTIS as a precaution and consult your doctor immediately.
• If you have mild to moderate kidney problems (mild to moderate renal impairment), AMBROXOLO PHARMENTIS should only be used after consulting your doctor.

Other medicines and AMBROXOLO PHARMENTIS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking antibiotics (amoxicillin, cefuroxime, erythromycin). The use of ambroxol increases antibiotic concentrations in respiratory secretions and saliva.
No interactions with other medicines have been reported.

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

Pregnancy
Ambroxol hydrochloride crosses the placental barrier; therefore, take AMBROXOLO PHARMENTIS only after consulting your doctor and carefully evaluating the benefit-risk ratio in your individual case.
As a precautionary measure, especially during the first three months of pregnancy, the use of AMBROXOLO PHARMENTIS is not recommended.

Breastfeeding
Ambroxol hydrochloride passes into breast milk. Although adverse effects in breastfed infants are not expected, the use of AMBROXOLO PHARMENTIS is not recommended during breastfeeding.

Driving and using machines
No studies have been conducted on the effects on the ability to drive vehicles or operate machinery; therefore, there is no evidence demonstrating an effect of AMBROXOLO PHARMENTIS on the ability to drive or operate machinery.

3. How to use AMBROXOL PHARMENTIS

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.
Nebuliser solution
Adults and children over 5 years of age:
The recommended dose is 2–3 ml of solution 1–2 times daily.
Children under 5 years of age:
The recommended dose is 2 ml of solution 1–2 times daily.
During inhalation, try to breathe normally, as deep breathing of the aerosol may cause coughing. Warm the solution to body temperature before inhalation.
If you suffer from asthma, take a medicine to reduce bronchial spasms (bronchospasmolytic) before inhalation.
The nebuliser solution can be administered using standard aerosol therapy devices.
It may also be diluted with an equal volume of distilled water (ratio 1:1).
Do not use GOLASEPT TOSSE GRASSA for prolonged treatments.
If you use more AMBROXOL PHARMENTIS than you should
No cases of overdose have been reported. Symptoms of an 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 emergency department.
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:
Common (may affect up to 1 in 10 people)

• Taste disturbances (dysgeusia);
• Loss of sensitivity (hypoesthesia) in the oral cavity;
• Nausea.

Uncommon (may affect up to 1 in 100 people)

• Vomiting
• Diarrhea
• Indigestion (dyspepsia)
• Abdominal pain
• Dry mouth

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

• Headache
• Runny nose (rhinorrhea)
• Heartburn (pyrosis)
• Constipation
• Skin rashes (rash), urticaria, contact dermatitis
• Hypersensitivity reactions
• Difficulty urinating (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 acute generalized 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, contact your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the website https://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 PHARMENTIS

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 product in its original, unopened packaging, properly stored.
Do not store above 25°C.
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 PHARMENTIS contains

• The active substance is ambroxol hydrochloride. One vial contains 15 mg of ambroxol hydrochloride.
• The other components are: monosodium phosphate dihydrate, disodium phosphate dihydrate, water for injectable preparations.

Description of the appearance of AMBROXOLO PHARMENTIS and package contents
Nebulisation solution 7.5 mg/ml, 10 vials of 2 ml
Marketing Authorization Holder and Manufacturer
FARMAPRO S.r.l.
Via Valfrè, 4 – 10121 Turin (Italy)
Manufacturer
Doppel Farmaceutici s.r.l. – Via Volturno, 48 – Quinto De’ Stampi – 20089 Rozzano (Milan)
Package leaflet: information for the user
AMBROXOLO PHARMENTIS 3 mg/ml syrup
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always use 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 improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

1. What AMBROXOLO PHARMENTIS is and what it is used for
2. What you need to know before using AMBROXOLO PHARMENTIS
3. How to use AMBROXOLO PHARMENTIS
4. Possible side effects
5. How to store AMBROXOLO PHARMENTIS
6. Package contents and other information

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

AMBROXOLO PHARMENTIS 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 PHARMENTIS is used for the treatment of respiratory diseases associated with phlegm.
Consult your doctor if you do not feel better or feel worse after a short period of treatment.

2. What you need to know before using AMBROXOLO PHARMENTIS

Do not use AMBROXOLO PHARMENTIS

• 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 disease;
• in children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using AMBROXOLO PHARMENTIS.
In particular, consider the following:

• Take AMBROXOLO PHARMENTIS with caution if you have a lesion on the inner surface of the stomach (peptic ulcer).
• Serious skin reactions have been reported following administration of ambroxol hydrochloride. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking ambroxol hydrochloride and consult your doctor immediately.
• If you experience non-specific flu-like symptoms such as fever, malaise, rhinitis, cough, and sore throat, discontinue treatment with AMBROXOLO PHARMENTIS as a precaution and consult your doctor immediately.
• If you have kidney problems (mild, moderate or severe renal impairment), AMBROXOLO PHARMENTIS should only be used after consulting your doctor.

Children
Mucolytics may cause reduced respiratory function (bronchial obstruction) in children under 2 years of age. Indeed, the ability to clear mucus from the airways is limited in this age group.
These medicines must not be used in children under 2 years of age (see section "Do not use AMBROXOLO PHARMENTIS").

Other medicines and AMBROXOLO PHARMENTIS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking antibiotics (amoxicillin, cefuroxime, erythromycin). The use of ambroxol increases antibiotic concentrations in respiratory tract secretions and in saliva.
No interactions with other medicines have been reported.

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 using this medicine.

Pregnancy
Ambroxol hydrochloride crosses the placental barrier; therefore, take AMBROXOLO PHARMENTIS only after consulting your doctor and carefully evaluating the benefit-risk ratio in your individual case.
As a precautionary measure, especially during the first three months of pregnancy, the use of AMBROXOLO PHARMENTIS is not recommended.

Breastfeeding
Ambroxol hydrochloride passes into breast milk. Although no adverse effects are expected in breastfed infants, the use of AMBROXOLO PHARMENTIS is not recommended during breastfeeding.

Driving and using machines
No studies have been conducted on the effects on the ability to drive vehicles or operate machinery; therefore, there is no evidence demonstrating an effect of AMBROXOLO PHARMENTIS on the ability to drive vehicles or use machinery.

AMBROXOLO PHARMENTIS contains sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to use AMBROXOLO PHARMENTIS

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.

Adults:
The recommended dose is 10 ml (30 mg) three times a day.

Children over 5 years:
The recommended dose is 5 ml (15 mg) three times a day.

Children from 2 to 5 years:
The recommended dose is 2.5 ml (7.5 mg) three times a day.

Take the syrup after meals.

Use only for short-term treatment.

If you take more AMBROXOLO PHARMENTIS 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 emergency department.

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 serious side effects may occur:

Common (may affect up to 1 in 10 people)
‐ taste disturbances (dysgeusia);
‐ loss of sensation (hypoaesthesia) in the oral cavity;
‐ nausea.

Uncommon (may affect up to 1 in 100 people)

• Vomiting
• Diarrhea
• Indigestion (dyspepsia)
• Abdominal pain
• Dryness of the mouth

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

• Headache
• Runny nose (rhinorrhea)
• Heartburn (pyrosis)
• Constipation
• Skin rash, urticaria, contact dermatitis
• Hypersensitivity reactions
• Difficulty urinating (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 acute generalized 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, pharmacist or nurse. You can also report side effects directly via the national reporting system at the website
https://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 AMBROXOLUM PHARMENTIS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C.
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 PHARMENTIS contains

• The active substance is ambroxol hydrochloride. 100 ml of syrup contain 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 PHARMENTIS and package contents
AMBROXOLO PHARMENTIS is available as a syrup.
Pack size: 1 bottle of 200 ml with dosing syringe.
Marketing Authorization Holder and Manufacturer
Zeta Farmaceutici Spa
Via Mentana 38
36100 Vicenza
Italy
Manufacturer
Doppel Farmaceutici s.r.l. – Martiri delle Foibe, 1 – 29016 Corte Maggiore (Piacenza)