Secretil

Package leaflet: Information for the user

Secretil 60 mg oral solution granules in sachet

Ambroxol
Please read all of this leaflet carefully before you take 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, 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 taking Secretil
3. How to take Secretil
4. Possible side effects
5. How to store Secretil
6. Contents of the pack and other information

1. What Secretil is and what it is used for

Secretil contains the active substance ambroxol, which belongs to the class of mucolytic agents 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 have severe liver and/or kidney disease;
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding");

Secretil 60 mg oral solution granules in sachet must not be used in children under 2 years of age
(see "Children").
Warnings and precautions
Talk to your doctor or pharmacist before using Secretil.
Take particular care with this medicine if you have stomach lesions (peptic ulcer).
Serious skin reactions have been reported in association with ambroxol administration. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Secretil and contact your doctor immediately.
Children
Do not use Secretil 60 mg oral solution granules in sachet in children under 2 years of age, as mucolytics may cause airway obstruction (bronchi) in this age group and impair 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, think you might be 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; during the later stages of pregnancy and while breastfeeding, the medicine may be used only if clearly necessary and under direct medical supervision.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Secretil oral solution granules in sachet contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Secretil

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
physician or pharmacist.
Unless otherwise prescribed by your doctor, the recommended doses are:
Secretil 60 mg oral granules for oral solution in sachets
Adults: 2 sachets per day for the first 3 days (initial treatment). 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 take more Secretil than you should
In case of accidental ingestion/overdose of Secretil, contact your doctor immediately or go to the nearest hospital.
There are no known cases of overdose with Secretil. If an overdose occurs, the doctor may induce vomiting and/or perform gastric lavage.

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

If you stop using Secretil
Do not stop treatment before consulting your doctor.

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 may 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 (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 generalized acute exanthematous pustulosis). Mild gastrointestinal disturbances (such as nausea, diarrhoea) have been observed in some cases.

Following the instructions contained 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: 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 stated on the packaging. The expiry date refers to the last day of that month. This date applies to the product in its original, undamaged packaging and correctly stored.
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 Secretil contains
Secretil 60 mg granules for oral solution in sachet

• The active substance is ambroxol hydrochloride. Each sachet contains 60 mg of ambroxol hydrochloride.
• The other components are: orange flavour powder, pineapple flavour powder, sucrose.

Description of the appearance of Secretil and package contents
Secretil is presented as granules for oral solution: pack of 20 sachets of 60 mg.
Marketing Authorization Holder
I.B.N. Savio 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)

Patient Information Leaflet: Information for the user

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

Ambroxol
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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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. Package contents and other information

1. What Secretil is and what it is used for

Secretil contains the active substance 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 have severe liver and/or kidney disease;
• if you are pregnant or during breastfeeding (see "Pregnancy and breastfeeding"); Secretil 3 mg/ml syrup must not be used in children under 2 years of age (see "Children").

Warnings and precautions
Talk to your doctor or pharmacist before using Secretil.
Take particular care with this medicine if you have stomach lesions (peptic ulcer).
Severe skin reactions associated with ambroxol administration 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 contact your doctor immediately.
Nebulizer solution:
Too deep inhalation of aerosols may cause irritation-induced coughing: 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 bronchodilator medicine before inhalation.

Children
Do not use Secretil 3 mg/ml syrup in children under 2 years of age, as mucolytics may cause obstruction of the airways (bronchi) in this age group and interfere with normal breathing (see "Do not use Secretil").

Other medicines and Secretil
Inform 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, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use this medicine during the first three months of pregnancy; during later stages of pregnancy and while breastfeeding, the medicine should only be used if clearly necessary and under direct medical supervision.

Driving and using machines
This medicine does not impair the ability to drive or use machinery.

Secretil syrup contains sorbitol and 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 informed you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine.
The syrup contains para-hydroxybenzoates which may cause allergic reactions (including delayed reactions).

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

3. How to use Secretil

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.

Recommended doses
Secretil 3 mg/ml syrup
Children:

• from 2 to 5 years: 2.5 ml three times a day
• from 5 to 12 years: 5 ml two to three times a day
• over 12 years: 10 ml two to three times a day for the first 3 days, then 5 ml three times a day
  Adults: 10 ml three times a day for the first 3 days, then 10 ml twice a day

Take the syrup preferably after meals. Use the graduated measuring cup provided in the package, with markings at 10 ml, 5 ml and 2.5 ml, to ensure 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 using 3 ml of solution for nebulizer.
Children aged 5 years and younger: the recommended dose is 1–2 inhalations per day using 2 ml of solution for nebulizer.
Do not exceed the maximum recommended daily dose.

SECRETIL 15 mg solution for nebulizer
Children aged 5 years and younger: the recommended dose is 1–2 inhalations per day using 2 ml of solution for nebulizer, corresponding to 1 vial.
Do not exceed the maximum recommended 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 using 3 ml of solution for nebulizer, corresponding to 1 single-dose container.
Do not exceed the maximum recommended daily dose.

Method of administration
Distilled water may be added to the solution for nebulizer in a 1:1 ratio to achieve optimal humidification of the respiratory tract.
Secretil can be administered using any modern inhalation device.
If considered necessary, oral formulations of Secretil may be used in combination with inhalations.

If you take more Secretil than you should
In case of accidental ingestion/overdose of Secretil, contact your doctor immediately or go to the nearest hospital.
There are no known cases of overdose with Secretil. If overdose occurs, the doctor may induce vomiting and/or perform gastric lavage.

If you forget to use Secretil
Do not take 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 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:
Rare: may affect up to 1 in 1,000 people

• 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 generalized acute exanthematous pustulosis). Mild gastrointestinal disturbances (such as nausea, diarrhea) have been observed in some cases. Adhering to the instructions provided 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, please inform 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 Secretil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. This date applies to the product in its original, undamaged packaging and properly stored.
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 Secretil Contains
Secretil 3 mg/ml syrup

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

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

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

Secretil 15 mg sterile solution for nebuliser in 2 ml vials

• The active substance is ambroxol hydrochloride. Each 1 ml of solution contains 7.5 mg of ambroxol hydrochloride.
• The other component is: water for injectable preparations.

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

• The active substance is ambroxol hydrochloride. Each 1 ml of solution contains 7.5 mg of ambroxol hydrochloride.
• The other components are: sodium chloride, water for injectable preparations.

Description of the Appearance of Secretil and Pack Contents
Secretil is available as syrup and solution for nebulisation.
Syrup: 200 ml bottle.
Solution for nebulisation: 100 ml bottle; single-dose containers of 3 ml; vials of 2 ml.

Marketing Authorisation Holder
I.B.N. Savio Srl – Via del Mare n. 36, Pomezia (RM)

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

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

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