AMBROXOL 15 mg /2 Ml Roztwór Do Nebulizacji

Treść ulotki

1. Ambroxol TecniGen 30 mg/10 ml syrup
   1. What is Ambroxol TecniGen and what is it used for
   2. What you need to know before you take Ambroxol TecniGen
   3. How to take Ambroxol TecniGen
   4. Possible side effects
   5. How to store Ambroxol TecniGen
   6. Contents of the pack and other information
2. Ambroxol TecniGen 15 mg/2 ml solution for nebulization
   1. What is Ambroxol TecniGen and what is it used for
   2. What you need to know before using Ambroxol TecniGen
   3. How to use Ambroxol TecniGen
3. AMBROXOL TecniGen nebulizing solution (pH 5.0) must not be mixed with other
   1. Possible side effects
   2. How to store Ambroxol TecniGen
   3. Contents of the pack and other information

Ambroxol TecniGen 30 mg/10 ml syrup

Ambroxol
Equivalent medicine
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take Ambroxol TecniGen
• 3. How to take Ambroxol TecniGen
• 4. Possible side effects
• 5. How to store Ambroxol TecniGen
• 6. Contents of the pack and other information

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

Ambroxol TecniGen contains the active ingredient ambroxol, which belongs to the class of mucolytics.
This medicine works by making mucus more fluid and therefore more easily eliminated 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 you take 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 suffer from 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.
Be particularly careful with this medicine if you have stomach lesions (peptic ulcer).
Cases of severe skin reactions associated with the administration of ambroxol have been reported. If
you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes,
genitals), stop taking Ambroxol TecniGen and consult your doctor immediately.
The 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 induce blockage of the airways (bronchial obstruction) in this age group. In fact, the ability to drain bronchial mucus is limited in this age group, due to
the physiological characteristics of the airways.

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 are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice 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. Use of Ambroxol TecniGen may cause
undesirable effects in the infant, therefore it is necessary to decide with your doctor whether to discontinue
breastfeeding or 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 some
sugars, contact him before taking this medicine. Also, due to the presence of sorbitol, it may
have a mild laxative effect.
The medicine contains glycerol which can be dangerous at high doses and may cause headache,
gastric disturbances and diarrhoea. 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 following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
The recommended dosesare:
Adults: 10 ml (30 mg) three times a day.

Use in children
Children from 2 to 5 years: 2.5 ml (7.5 mg) 3 times a day.
Children over 5 years: 5 ml (15 mg) 3 times a day.
Take the syrup after meals.
Do not use this medicine for prolonged treatments.

If you use more Ambroxol TecniGen than you should
In case of ingestion/accidental intake of an excessive dose of Ambroxol TecniGen, immediately inform
your doctor or go to the nearest hospital.
Data relating to ambroxol overdose are limited. Symptoms of overdose
correspond to the undesirable effects described in the paragraph “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 taking Ambroxol TecniGen
If you have any doubts 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 everyone will experience them.

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

• fatigue
• dry mouth
• increased mucus production, runny nose
• difficulty in urination
• headache
• heartburn and esophageal burning
• 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 on the basis of available data)

• blockage of the airways (bronchial obstruction)
• Anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and itching
• Severe 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 effects, including those not listed in this leaflet, please
inform your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can
contribute to providing 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 which is stated on the packaging after “Exp”.
The expiry date refers to the last day of that month. The expiry date refers to the
product in intact packaging, correctly stored.
Do not dispose of any medicine in 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 Ambroxol TecniGen contains

Ambroxol TecniGen 30 mg/10 ml syrup 200 ml bottle

• The active ingredient is ambroxol hydrochloride. 100 ml contains 300 mg of ambroxol hydrochloride.
• The other ingredients are: hydroxyethylcellulose, sorbitol70%, glycerol, benzoic acid, cherry aroma, propylene glycol, tartaric acid, purified water.

Ambroxol TecniGen 30 mg/10 ml syrup single-dose containers of 10 ml

• The active ingredient is ambroxol hydrochloride. Each single-dose container contains 30 mg of ambroxol hydrochloride.
• The other ingredients are: hydroxyethylcellulose, sorbitol70%, glycerol, benzoic acid, cherry aroma, propylene glycol, tartaric acid, purified water.

Description of the appearance of Ambroxol TecniGen and contents of the pack
Ambroxol TecniGen is presented as a syrup.
Bottle containing 200 ml of syrup
Pack containing 20 single-dose containers of 10 ml

Marketing Authorisation 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 Roma

Bottle syrup
Special Product’s Line S.p.A. – Strada Paduni 240, 03012 Anagni (FR)

Ambroxol TecniGen 15 mg/2 ml solution for nebulization

Ambroxol
Generic medicine
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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell 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. Contents of the pack and other information

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

Ambroxol TecniGen contains the active ingredient ambroxol, which belongs to the class of mucolytics.
This medicine works by making mucus more fluid and therefore more easily eliminated 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 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 suffer from severe liver and/or kidney diseases.

Warnings and precautions
Talk to your doctor or pharmacist before using Ambroxol TecniGen.
Be particularly careful with this medicine if you have stomach lesions (peptic ulcer).
Cases of severe skin reactions associated with the administration of ambroxol have been reported. If
you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes,
genitals), stop taking Ambroxol TecniGen and consult 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 are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not use Ambroxol TecniGen during pregnancy unless clearly indicated by your
doctor (see “Do not use Ambroxol TecniGen”).
This medicine passes into breast milk. The use of Ambroxol TecniGen may cause
undesirable effects in the infant, therefore you should decide together with your doctor whether to
interrupt breastfeeding or treatment with the medicine.

Driving and operating machinery
Ambroxol TecniGen does not affect the ability to drive vehicles or operate machinery.

3. How to use Ambroxol TecniGen

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult
your doctor or pharmacist.
The recommended dosesare:
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 breathing of 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 medicine that
dilates the airways (bronchodilator) before inhalation.
The solution for nebulization can be administered using normal aerosol therapy devices. It can also be diluted in distilled water in a 1:1 ratio.
Instructions for use
To 1 vial of Ambroxol TecniGen you can add: beclometasone dipropionate 2 ml susp.
0.4%, betamethasone disodium phosphate 1 tablet of 0.5 mg or 1 vial of 1.5 mg, fenoterol drops 1
ml sol. 0.1%, ipratropium bromide 1 ml sol. 0.025%, salbutamol 1 tablet of 2 mg or 5 drops sol.
0.5%.
Incompatibilities

AMBROXOL TecniGen nebulizing solution (pH 5.0) must not be mixed with other

solutions with a pH greater than 6.3, because an increase in pH leads to the precipitation of the free base of ambroxol.

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

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

If you stop taking Ambroxol TecniGen
If you have any doubts 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.

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

• fatigue
• dry mouth
• increased mucus production, runny nose
• difficulty in urination
• headache
• heartburn and esophageal burning
• 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)

• blockage of the airways (bronchial obstruction)
• Anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and itching
• Severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after “Exp”.
The expiry date refers to the last day of that month. The expiry date refers to the
product in intact packaging, correctly stored.
Do not dispose of any medicine in 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 Ambroxol TecniGen contains

• The active ingredient is ambroxol hydrochloride. One 2 ml vial contains 15 mg of ambroxol hydrochloride.
• The other ingredients 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 presented as a solution for nebulisation.
Pack containing 10 vials of 2 ml

Marketing Authorisation 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 Roma