SECRETIL <3 mg/ml Syrup

Зміст інструкції

1. Secretil 3 mg/ml syrup, 7.5 mg nebulizer solution, 15 mg nebulizer solution, 22.5 mg nebulizer solution
   1. What is Secretil and what is it used for
   2. What you need to know before using Secretil
   3. How to use Secretil
   4. Possible side effects
   5. How to store Secretil
   6. Package contents and other information
2. Secretil 60 mg granules for oral solution in sachets
   1. What is Secretil and what is it used for
   2. What you need to know before using Secretil
   3. How to use Secretil
   4. Possible side effects
   5. How to store Secretil
   6. Contents of the pack and other information

Secretil 3 mg/ml syrup, 7.5 mg nebulizer solution, 15 mg nebulizer solution, 22.5 mg nebulizer solution

Ambroxol

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Secretil and what is it used for

Secretil contains the active ingredient ambroxol which belongs to the class of mucolytics used to
facilitate the elimination of mucus from the respiratory tract.
Secretil is used for the treatment of secretions in respiratory diseases
characterized by thick and viscous mucus.

2. What you need to know before using Secretil

Do not use Secretil

• 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 you are pregnant or during breastfeeding (see “Pregnancy and breastfeeding”); Secretil 3 mg/ml syrup should not be used in children under 2 years of age (see “Children”).

Warnings and precautions
Consult your doctor or pharmacist before using Secretil.
Pay particular attention 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 Secretil and consult your doctor immediately.
Solution for nebulizer:
Too deep inhalation of the aerosol can cause irritation cough: try to inhale
and exhale normally during inhalation.
If you are particularly sensitive, it is advisable to warm the solution to be inhaled to body
temperature before use.
If you suffer from bronchial asthma, it is advisable to use a medicine that dilates the airways
(bronchospasmolytic) before inhalation.

Children
Do not use Secretil 3 mg/ml syrup in children under 2 years of age, as mucolytics can
create obstruction of the airways (bronchi) in this age group and prevent normal
breathing (see “Do not use Secretil”).

Other medicines and Secretil
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, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use this medicine during the first three months of pregnancy; in the further period of
pregnancy and during breastfeeding, the medicine can only be used if absolutely
necessary and under the direct control of the doctor.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles or operate machinery.

Secretil syrup contains sorbitoland para-hydroxybenzoates
This medicine contains 0.875 mg of sorbitol per 2.5 ml dose, 1.75 mg per 5 ml dose and
3.5 mg per 10 ml dose. Sorbitol is a source of fructose. If your doctor has told you that you (or the
child) are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose
intolerance, a rare genetic disease in which patients cannot transform fructose, talk
to your doctor before you (or the child) take this medicine.
The syrup contains para-hydroxybenzoates which may cause allergic reactions (even
delayed).

Secretil 7.5mg/ml solution for nebulizer in 100 ml bottlecontains benzalkonium
chloride as a preservative.
This medicine contains 0.45 mg of benzalkonium chloride per minimum dose (1 inhalation with 2
ml of solution for inhalations) and 1.35 mg per maximum dose (2 inhalations with 3 ml of solution
for inhalations).
Benzalkonium chloride may cause wheezing and difficulty breathing (bronchospasm), especially if
you suffer from asthma.

3. How to use Secretil

Take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended doses are:

SECRETIL 3 mg/ml syrup
Children:

• from 2 to 5 years: 2.5 ml 3 times a day
• from 5 to 12 years: 5 ml 2-3 times a day
• over 12 years: 10 ml 2-3 times a day for the first 3 days, then 5 ml 3 times a day. Adults: 10 ml 3 times a day for the first 3 days, then 10 ml 2 times a day. Take the syrup preferably after meals. Use the measuring device with graduated markings of 10 ml, 5 ml and 2.5 ml, which you can find in the package, to take the correct dose.

SECRETIL 7.5 mg/ml solution for nebulizer
Adults and children over 5 years of age:
the recommended dose is 1-2 inhalations per day with 3 ml of nebulizer solution.
Children aged 5 years and under:
the recommended dose is 1-2 inhalations per day with 2 ml of nebulizer solution.
Do not exceed the recommended maximum daily dose.

SECRETIL 15 mg solution for nebulizer
Children aged 5 years and under:
the recommended dose is 1-2 inhalations per day with 2 ml of nebulizer solution,
corresponding to 1 vial.
Do not exceed the recommended maximum daily dose.

SECRETIL 22.5 mg solution for nebulizer
Adults and children over 5 years of age:
the recommended dose is 1-2 inhalations per day with 3 ml of nebulizer solution,
corresponding to 1 single-dose container.
Do not exceed the recommended maximum daily dose.

Method of administration
Distilled water can be added to the nebulizer solution in a 1:1 ratio to obtain
optimal humidification of the respiratory area.
Secretil can be administered with all modern inhalation devices.
If deemed necessary, oral formulations of Secretil may be associated with inhalations.

If you use more Secretil than you should
In case of accidental ingestion/intake of an excessive dose of Secretil, immediately
inform your doctor or go to the nearest hospital.
No cases of overdose with Secretil are known. Should this happen, the doctor
may resort to inducing vomiting and/or gastric lavage.

If you forget to use Secretil
Do not take a double dose to make up for a missed dose.

If you stop taking Secretil
Do not stop treatment before consulting your doctor.
If you have any questions about the use of this medicine, ask 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:

Rare: may affect up to 1 in 1,000 people

• hypersensitivity reactions
• rash, urticaria Frequency not known(the frequency cannot be estimated based on available data)
• airway obstruction (bronchial obstruction)
• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucous membranes and submucosal tissues) and itching
• severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis). In some cases, mild gastrointestinal disorders (nausea, diarrhoea) have been observed.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 Secretil

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. The expiry date refers to the last day of that month. This date applies 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. Package contents and other information

What Secretil contains
Secretil 3 mg/ml syrup

• The active ingredient is ambroxol hydrochloride. 1 ml of syrup contains 3 mg of ambroxol hydrochloride.
• The other ingredients are: sorbitol, glycerol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, raspberry essence, ammonium glycyrrhizinate, purified water.

Secretil 7.5 mg/ml solution for nebulizer in 100 ml bottle

• The active ingredient is ambroxol hydrochloride. 1 ml of solution contains 7.5 mg of ambroxol hydrochloride.
• The other ingredients are: benzalkonium chloride, purified water.

Secretil 15 mg sterile solution for nebulizer in 2 ml vials

• The active ingredient is ambroxol hydrochloride. 1 ml of solution contains 7.5 mg of ambroxol hydrochloride.
• The other ingredient is: water for injections.

Secretil 22.5 mg solution for nebulizer in 3 ml single-dose containers

• The active ingredient is ambroxol hydrochloride. 1 ml of solution contains 7.5 mg of ambroxol hydrochloride.
• The other ingredients are: sodium chloride, water for injections.

Description of the appearance of Secretil and contents of the pack
Secretil is available as syrup and solution for nebulizer.
Syrup: 200 ml bottle.
Solution for nebulizer: 100 ml bottle; 3 ml single-dose containers and 2 ml vials.

Marketing authorization holder
Savio Pharma Italia Srl– Via del Mare n. 36 Pomezia (RM)

Manufacturer
Syrup
ABC Farmaceutici SpA - Establishment: Canton Moretti, 29 – Località San Bernardo - 10015
IVREA (TO)

Solution for nebulizer in 2 ml vials and in 100 ml bottle
Istituto Biochimico Nazionale Savio S.r.l. – Via E. Bazzano n° 14 – Ronco Scrivia (GE)

Solution for nebulizer in 3 ml single-dose containers
Genetic S.p.a. – Contrada Canfora – 84084 Fisciano (SA)

Secretil 60 mg granules for oral solution in sachets

Ambroxol

Read this leaflet carefully before using 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Secretil and what is it used for

Secretil contains the active ingredient ambroxol, which belongs to the class of mucolytics used to
facilitate the elimination of mucus from the respiratory tract.
Secretil is used for the treatment of secretions in respiratory diseases
characterized by dense and viscous mucus.

2. What you need to know before using Secretil

Do not use Secretil

• 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;
• if you are pregnant or during breastfeeding (see “Pregnancy and breastfeeding”);

Secretil 60 mg granules for oral solution in sachets should not be used in children under
2 years of age (see “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before using Secretil.
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 Secretil and consult your doctor immediately.

Children
Do not use Secretil 60 mg granules for oral solution in sachets in children under 2 years of age,
because mucolytics can create obstruction of the airways (bronchi) in this age group and prevent
normal breathing (see “Do not use Secretil”).

Other medicines and Secretil
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, 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 this medicine during the first three months of pregnancy; in the further period of
pregnancy and during breastfeeding, the medicine can only be used if absolutely
necessary and under the direct control of the doctor.

Driving and operating machinery
This medicine does not alter the ability to drive vehicles or operate machinery.

Secretil granules for oral solution in sachets contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.

3. How to use Secretil

Use this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dosesare:

Secretil 60 mg granules for oral solution in sachet
Adults :2 sachets per day for the first 3 days (attack therapy). Afterwards, the dose may
be reduced to 1 sachet per day.
Dissolve the sachets in water and take the medicine preferably after meals.

If you use more Secretil than you should
In case of accidental ingestion/intake of an excessive dose of Secretil, immediately inform
your doctor or go to the nearest hospital.
No cases of overdose with Secretil are known. Should this happen, your doctor
may resort to inducing vomiting and/or gastric lavage.

If you forget to use Secretil
Do not use a double dose to make up for a missed dose.

If you stop using Secretil
Do not stop treatment before consulting your doctor.
If you have any doubts about the use of this medicine, ask 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:

Rare: may affect up to 1 in 1,000 people

• hypersensitivity reactions
• rash, urticaria Frequency not known(the frequency cannot be estimated based on available data)
• airway obstruction (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. Mild gastrointestinal disorders (nausea, diarrhea) have been observed in some cases.

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:
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 Secretil

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. The expiry date refers to the last day of that month. This date applies 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 Secretil contains
Secretil 60 mg granules for oral solution in sachet

• The active ingredient is ambroxol hydrochloride. Each sachet contains 60 mg of ambroxol hydrochloride.
• The other ingredients are: orange aroma powder, pineapple aroma powder, sucrose.

Description of the appearance of Secretil and contents of the pack
Secretil is presented as granules for oral solution: pack of 20 sachets of 60
mg.

Marketing Authorisation Holder
Savio Pharma Italia S.r.l. – Via del Mare n. 36 - Pomezia (RM)

Manufacturer
FINE FOODS NTM S.p.A. – Via dell’Artigianato n° 8/10 – Brembate (BG)