Ambroxol Tecnigen

Patient Information Leaflet: Instructions for the User

Ambroxol TecniGen 30 mg/10 ml syrup

Ambroxol
Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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 you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ambroxol TecniGen is and what it is used for

Ambroxol TecniGen contains the active substance ambroxol, which belongs to the class of mucolytics.
This medicine works by making mucus more fluid, thus facilitating its elimination from the
respiratory tract.
Ambroxol TecniGen is used for the treatment of secretions in diseases of the bronchi and lungs (acute and chronic bronchopulmonary conditions).

2. What you need to know before taking Ambroxol TecniGen

Do not take Ambroxol TecniGen

• if you are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver and/or kidney disease;
• if the patient is a child under 2 years of age (see “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ambroxol TecniGen.
Pay particular attention when using this medicine if you have stomach lesions (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 TecniGen and contact your doctor immediately.
This medicine is not contraindicated if you have celiac disease.
Children
Do not administer Ambroxol TecniGen syrup to children under 2 years of age, as mucolytics may cause airway obstruction (bronchial obstruction) in this age group. 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 Ambroxol TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Ambroxol TecniGen during pregnancy unless clearly indicated by your doctor (see “Do not take Ambroxol TecniGen”).
This medicine passes into breast milk. The use of Ambroxol TecniGen may cause adverse effects in the breastfed infant; therefore, you and your doctor must decide whether to discontinue breastfeeding or the treatment with the medicine.
Driving and using machines
Ambroxol TecniGen does not affect the ability to drive vehicles or operate machinery.
Ambroxol TecniGen contains sorbitol, glycerol and benzoic acid
The medicine contains sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine. In addition, due to the presence of sorbitol, it may have a mild laxative effect.
The medicine contains glycerol, which may be harmful at high doses and may cause headache, gastrointestinal disturbances and diarrhea. The medicine contains benzoic acid, which is mildly irritating to skin, eyes and mucous membranes, and may increase the risk of jaundice in newborns.

3. How to take Ambroxol TecniGen

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended doses are:
Adults: 10 ml (30 mg) three times daily.
Use in children
Children from 2 to 5 years: 2.5 ml (7.5 mg) three times daily.
Children over 5 years: 5 ml (15 mg) three times daily.
Take the syrup after meals.
Do not use this medicine for prolonged treatments.
If you take more Ambroxol TecniGen than you should
If you accidentally ingest or take an excessive dose of Ambroxol TecniGen, inform your doctor immediately or go to the nearest hospital.
Data regarding ambroxol overdose are limited. Symptoms of overdose correspond to the undesirable effects described in section “Possible side effects”.
If you forget to take Ambroxol TecniGen
Do not take a double dose to make up for the missed dose.
If you stop treatment with Ambroxol TecniGen
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Rare (may affect up to 1 in 1,000 patients)

• fatigue
• dry mouth
• increased mucus production, runny nose
• difficulty in passing urine
• headache
• heartburn and oesophagitis
• indigestion
• constipation
• nausea and vomiting
• contact dermatitis or other allergic reactions (especially skin rashes)
• hypersensitivity reactions
• rash, urticaria

Frequency not known (frequency cannot be estimated from the available data)

• airway obstruction (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).

Following the instructions provided in the package leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Ambroxol TecniGen

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. The expiry date applies to the product in its original, undamaged packaging, stored correctly.
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 Ambroxol TecniGen contains
Ambroxol TecniGen 30 mg/10 ml syrup, 200 ml bottle

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

Ambroxol TecniGen 30 mg/10 ml syrup, 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.

Description of the appearance of Ambroxol TecniGen and package contents
Ambroxol TecniGen is a syrup.
Bottle containing 200 ml of syrup
Carton containing 20 single-dose containers of 10 ml each

Marketing Authorization Holder
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 - Cinisello Balsamo (MI)

Manufacturer
Single-dose syrup
Special Product’s Line S.p.A. - Via Campobello 15 - 00040 Pomezia Rome
Syrup bottle
Special Product’s Line S.p.A. – Strada Paduni 240, 03012 Anagni (FR)

Package leaflet: Information for the user

Ambroxol TecniGen 15 mg/2 ml nebulizer solution

Ambroxol
Generic medicine
Please read this leaflet carefully before using this medicine, as 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 you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ambroxol TecniGen is and what it is used for

Ambroxol TecniGen contains the active substance ambroxol, which belongs to the class of mucolytics.
This medicinal product works by making mucus more fluid, thus facilitating its elimination from the respiratory tract.
Ambroxol TecniGen is used for the treatment of secretions in diseases of the bronchi and lungs (acute and chronic bronchopulmonary conditions).

2. What you should know before using Ambroxol TecniGen

Do not use Ambroxol TecniGen

• if you are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver and/or kidney disease.

Warnings and precautions
Talk to your doctor or pharmacist before using Ambroxol TecniGen.
Take particular care with this medicine if you have stomach lesions (peptic ulcer).
Severe skin reactions have been reported following ambroxol administration. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Ambroxol TecniGen and contact your doctor immediately.
Other medicines and Ambroxol TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use Ambroxol TecniGen during pregnancy unless clearly advised by your doctor (see "Do not use Ambroxol TecniGen").
This medicine passes into breast milk. The use of Ambroxol TecniGen may cause adverse effects in breastfed infants; therefore, you and your doctor must decide whether to discontinue breastfeeding or to discontinue treatment with the medicine.
Driving and using machines
Ambroxol TecniGen does not affect the ability to drive or operate machinery.

3. How to use Ambroxol TecniGen

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended doses are:
Adults: 2–3 vials per day.
Use in children
Children up to 5 years: 1–2 vials per day.
Children over 5 years: 2–3 vials per day.
Deep inhalation of the aerosol may cause coughing; try to breathe normally during inhalation.
Warm the solution to body temperature before inhalation.
If you suffer from bronchial asthma, it is recommended to use a bronchodilator (bronchospasmolytic) before inhalation.
The solution for nebulization can be administered using standard aerosol therapy devices. It may also be diluted with distilled water in a 1:1 ratio.

Instructions for use
To 1 vial of Ambroxol TecniGen, the following may be added: beclometasone dipropionate 2 ml suspension 0.4%, betamethasone disodium phosphate 1 tablet 0.5 mg or 1 vial 1.5 mg, fenoterol drops 1 ml solution 0.1%, ipratropium bromide 1 ml solution 0.025%, salbutamol 1 tablet 2 mg or 5 drops solution 0.5%.

Incompatibilities
AMBROXOL TecniGen nebulizing solution (pH 5.0) must not be mixed with other solutions with a pH greater than 6.3, as an increase in pH causes precipitation of the free base of ambroxol.

If you use more Ambroxol TecniGen than you should
In case of accidental ingestion/overdose of Ambroxol TecniGen, inform your doctor immediately or go to the nearest hospital.
Data regarding ambroxol overdose are limited. Symptoms of overdose correspond to the adverse reactions described in the section “Possible side effects”.

If you forget to use Ambroxol TecniGen
Do not use a double dose to make up for the missed dose.

If you stop using Ambroxol TecniGen
If you have any doubts about using 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.
Rare (may affect up to 1 in 1,000 patients)

• fatigue
• dry mouth
• increased mucus production, runny nose
• difficulty in passing urine
• headache
• heartburn and oesophagitis
• indigestion
• constipation
• nausea and vomiting
• contact dermatitis or other allergic reactions (especially skin rashes)
• hypersensitivity reactions
• rash, urticaria

Frequency not known (frequency cannot be estimated from the available data)

• airway obstruction (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).

Following the instructions in this leaflet reduces the risk of side effects.
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 TecniGen

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. The expiry date applies to the product in its original, unopened packaging, stored correctly.
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 Ambroxol TecniGen contains

• The active substance is ambroxol hydrochloride. Each 2 ml ampoule 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 Ambroxol TecniGen and contents of the pack
Ambroxol TecniGen is a solution for nebulization.
Carton pack containing 10 ampoules of 2 ml.

Marketing Authorization Holder
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 - Cinisello Balsamo (MI)

Manufacturer
Special Product’s Line S.p.A. - Via Campobello 15 - 00040 Pomezia Rome