MUCICLAR 15 mg /5 Ml Syrop

Treść ulotki

1. MUCICLAR 15 mg/2 ml solution for nebulisation
   1. What is MUCICLAR and what is it used for
   2. What you need to know before you take MUCICLAR
   3. How to take MUCICLAR
   4. Possible side effects
   5. How to store MUCICLAR
   6. Contents of the pack and other information
2. MUCICLAR 15 mg/5 ml syrup, 75 mg prolonged release capsules, 30 mg granules for oral solution
   1. What is MUCICLAR and what is it used for
   2. What you need to know before taking MUCICLAR
   3. How to take MUCICLAR
   4. Possible side effects
   5. How to store MUCICLAR
   6. Package contents and other information

MUCICLAR 15 mg/2 ml solution for nebulisation

Ambroxol hydrochloride
Equivalent medicine

Read this leaflet carefully before you start to take this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor or pharmacist
have told you to.

• Keep this leaflet. You may need to read it again.
• If you want any further information or advice, ask your pharmacist.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your symptoms do not improve or get worse after a few days.

Contents of this leaflet:

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

1. What is MUCICLAR and what is it used for

This medicine contains the active ingredient ambroxol hydrochloride, belonging to a group of medicines
called mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
MUCICLAR is indicated for the treatment of secretion in acute and
chronic diseases of the bronchi and lungs (in the presence of cough and phlegm).
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before you take MUCICLAR

Do not take MUCICLAR

• if you are allergic to ambroxol hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from severe liver or kidney problems. Warnings and precautionsConsult your doctor or pharmacist before taking MUCICLAR.

Take this medicine with caution and inform your doctor:

• if you suffer from a stomach or intestinal problem called peptic ulcer;
• if you suffer from kidney problems (renal insufficiency).

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 MUCICLAR and consult your doctor immediately.
In particular in the early stages of these diseases, you may experience symptoms similar to those of the flu,
such as fever, pain, cold (rhinitis), cough and sore throat.
If you develop skin or mucous membrane lesions, consult your doctor and discontinue treatment with
MUCICLAR.
During the administration of the solution for nebulization, cough due to irritation may occur, it is recommended to
breathe normally during inhalation. If you are particularly sensitive to this condition, it is recommended
to warm the solution to body temperature (37°C) before inhalation.
If you have asthma, it is advisable to take medicines for asthma therapy (bronchodilators) before
using this medicine by inhalation.

Other medicines and MUCICLAR
Inform your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Take this medicine with caution and inform your doctor if you are taking antibiotics such as amoxicillin,
cefuroxime and erythromycin.

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.
Pregnancy
The use of MUCICLAR is not recommended during pregnancy, especially during the first three months.
If you are pregnant, take MUCICLAR only in cases of absolute necessity and under the direct control
of the doctor.
Breastfeeding
The use of MUCICLAR is not recommended during breastfeeding.

Driving and operating machinery
No data are available to establish the effects on the ability to alter driving or operating
machinery.

3. How to take MUCICLAR

Take this medicine following exactly what is reported in this leaflet or the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine can be diluted with the same volume of distilled water to obtain optimal humidification of the air to be breathed.
The recommended dose for adults is 2-3 single-dose containers per day.

Use in children
The recommended dose is 1-2 single-dose containers per day.
Each single-dose container contains 2 ml corresponding to 15 mg of ambroxol.

If you take more MUCICLAR than you should
No cases of overdose have been reported. The symptoms of an overdose may correspond to the undesirable effects that may occur at the recommended doses (See paragraph 4).
In case of accidental intake of an excessive dose of this medicine, immediately inform your doctor or go to the nearest hospital.

If you forget to take MUCICLAR
Do not take a double dose to make up for the missed dose.
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.
The following side effects may occur:

Common(may affect up to 1 in 10 people)

• alterations of the sense of taste (dysgeusia);
• loss of sensitivity (hypoesthesia) of the oral cavity and pharynx;
• nausea.

Uncommon(may affect up to 1 in 100 people)

• vomiting, diarrhea, indigestion (dyspepsia) and abdominal pain;
• dry mouth.

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

• headache;
• increased mucus production, runny nose (rhinorrhea);
• heartburn and esophageal burning (pyrosis);
• constipation;
• skin irritation (rash, urticaria);
• difficulty in urination (dysuria);
• fatigue.
• Hypersensitivity reactions

Not known(frequency cannot be estimated from available data)

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

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 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 MUCICLAR

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 “Scad”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Once the aluminum sachet containing the single doses has been opened, the medicine must be
used within three months. After this period, any unused medicine must be discarded.
In case of using half a dose, the container can be resealed by pressing on the cap and must be
stored in a refrigerator (2-8°C) for a maximum of 12 hours. The remaining medicine must be discarded.
Do not dispose of any medicine in the 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 MUCICLAR contains

• The active ingredient is ambroxol hydrochloride. 1 single-dose vial (2ml) contains 15 mg of ambroxol hydrochloride.
• The other ingredients are: sodium chloride, water for injections. Description of the appearance of MUCICLAR and contents of the packPack containing 30 single-dose containers of 2 ml with a mark at a volume of 1 ml (half dose). The single-dose containers are divided into strips of 5 containers; each strip is inserted in an aluminum pouch.

Marketing authorisation holder
PIAM FARMACEUTICI S.P.A. - Via Fieschi, 8 - 16121 Genova

Manufacturer
Genetic S.p.A., Contrada Canfora, Fisciano (SA)

MUCICLAR 15 mg/5 ml syrup, 75 mg prolonged release capsules, 30 mg granules for oral solution

Ambroxol hydrochloride
Generic medicine

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor or pharmacist
has told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a few days.

Contents of this leaflet:

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

1. What is MUCICLAR and what is it used for

This medicine contains the active ingredient ambroxol hydrochloride, belonging to a group of medicines
called mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
MUCICLAR is indicated for the treatment of secretion in acute and
chronic diseases of the bronchi and lungs (in the presence of cough and phlegm).
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking MUCICLAR

Do not take MUCICLAR

• if you are allergic to ambroxol hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from severe liver or kidney problems.

MUCICLAR should not be given to children under 2 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking MUCICLAR.
Take this medicine with caution and inform your doctor:

• if you suffer from a stomach or intestinal problem called peptic ulcer;
• if you suffer from kidney problems (renal insufficiency).

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 MUCICLAR and consult your doctor immediately.
In particular in the early stages of these diseases, you may experience symptoms similar to those of the flu,
such as fever, pain, cold (rhinitis), cough and sore throat.
If you experience skin or mucous membrane lesions, consult your doctor and stop treatment with
MUCICLAR.

Children
MUCICLAR 15 mg/5 ml syrup, MUCICLAR 75 mg prolonged-release capsules and MUCICLAR 30 mg
granules for oral solution should not be given to children under 2 years of age, as they may induce
bronchial obstruction and prevent normal breathing due to the limited
ability of children to eliminate secretions.

Other medicines and MUCICLAR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Take this medicine with caution and inform your doctor if you are taking antibiotics such as amoxicillin,
cefuroxime and erythromycin.

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.
Pregnancy
The use of MUCICLAR during pregnancy is not recommended, especially during the first three months. If you
are pregnant, take MUCICLAR only if absolutely necessary and under the direct supervision of
your doctor.
Breastfeeding
The use of MUCICLAR during breastfeeding is not recommended.

Driving and operating machinery
No data are available to establish the effects on the ability to alter driving or operating
machinery.

MUCICLAR 15 mg/5 ml syrup contains sorbitol, glycerol, para-hydroxybenzoates and alcohol.
This medicine contains sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, contact
him before taking this medicine.
This medicine contains glycerol which can cause headache, stomach upset and diarrhoea.
This medicine contains para-hydroxybenzoates (methyl p-hydroxybenzoate, propyl p-hydroxybenzoate) which
can cause allergic reactions (even delayed).
This medicine contains 3 vol % ethanol (alcohol), e.g. up to 300 mg per dose, equivalent to 6 ml of
beer, 2.5 ml of wine per dose. It may be harmful to alcoholics. To be considered in pregnant or breastfeeding
women, children and high-risk groups such as people with liver disease or epilepsy.

MUCICLAR 75 mg prolonged-release capsules and MUCICLAR 30 mg granules for oral solution
contain sucrose.
These medicines contain sucrose. If your doctor has diagnosed you with an intolerance to certain
sugars, contact him before taking these medicines.

3. How to take MUCICLAR

Take this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Muciclar 15 mg/5 ml syrup
The recommended dose for adults is 5-10 ml (5 ml of syrup corresponds to 15 mg of ambroxol), 3
times a day.

Use in children over 2 years of age
The recommended dose is 5 ml, 2-3 times a day.

Muciclar 75 mg prolonged-release capsules
The recommended dose for adults is 2 capsules in a single administration to be taken after breakfast
for the first 8 days and then 1 capsule until the end of treatment.

Muciclar 30 mg granules for oral solution
The recommended dose for adults is 1 sachet 2-3 times a day.

If you take more MUCICLAR than you should
No cases of overdose have been reported. The symptoms of an overdose may correspond to the
undesirable effects that may occur at the recommended doses (See section 4).
In case of accidental intake of an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.

If you forget to take MUCICLAR
Do not take a double dose to make up for a missed dose.
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:

Common(may affect up to 1 in 10 people)

• alterations of the sense of taste (dysgeusia);
• loss of sensitivity (hypoesthesia) of the oral cavity and pharynx;
• nausea.

Uncommon(may affect up to 1 in 100 people)

• vomiting, diarrhea, indigestion (dyspepsia) and abdominal pain;
• dry mouth.

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

• headache;
• increased mucus production, runny nose (rhinorrhea);
• heartburn and esophageal burning (pyrosis);
• constipation;
• skin irritation (rash, urticaria);
• difficulty in urination (dysuria);
• fatigue.
• Hypersensitivity reactions

Not known(frequency cannot be estimated from available data)

• 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)
• bronchial obstruction;
• dry throat.

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
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 MUCICLAR

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.
Store the syrup, capsules and oral solution granules at a temperature not exceeding
25°C.
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 MUCICLAR 15 mg/5 ml syrup contains

• The active ingredient is ambroxol hydrochloride. 100 ml of syrup contains 300 mg of ambroxol hydrochloride.
• The other ingredients are: sorbitol solution, glycerol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, hydroxyethylcellulose, alcohol, saccharin, raspberry essence, purified water.

What MUCICLAR 75 mg prolonged-release capsules contain

• The active ingredient is ambroxol hydrochloride. 1 capsule contains 75 mg of ambroxol hydrochloride.
• The other ingredients are: sucrose, starch, natural and artificial resins, talc, polyvinylpyrrolidone.

What MUCICLAR 30 mg granules for oral solution contain

• The active ingredient is ambroxol hydrochloride. 1 sachet contains 30 mg of ambroxol hydrochloride.
• The other ingredients are: sucrose, orange aroma, pineapple aroma.

Description of the appearance of MUCICLAR and package contents
MUCICLAR 15 mg/5 ml syrup: pack containing 1 bottle of 200 ml. The package includes a
measuring cup with markings at volumes of 2.5 ml, 5 ml, 10 ml.
MUCICLAR 75 mg prolonged-release capsules: pack containing 20 capsules.
MUCICLAR 30 mg granules for oral solution: pack containing 30 sachets.

Marketing authorisation holder
PIAM FARMACEUTICI S.P.A. - Via Fieschi, 8 - 16121 Genoa

Manufacturers
Genetic S.p.A., Contrada Canfora, Fisciano (SA) (15 mg/5 ml syrup)
Fine Foods NTM S.p.A. Via dell’Artigianato 8/10 - Brembate (BG) (30 mg granules for oral solution)
I.B.N. SAVIO S.r.l. – Ronco Scrivia - Genoa (75 mg prolonged-release capsules)