Package leaflet: Information for the patient

CORYFIN COUGH EXPECTORANT 3 mg/ml syrup

ambroxol hydrochloride
Sugar-free
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

What CORYFIN COUGH EXPECTORANT is and what it is used for
What you need to know before taking CORYFIN COUGH EXPECTORANT
How to take CORYFIN COUGH EXPECTORANT
Possible side effects
How to store CORYFIN COUGH EXPECTORANT
Contents of the pack and other information

1. What CORYFIN COUGH EXPECTORANT is and what it is used for

CORYFIN COUGH EXPECTORANT contains ambroxol hydrochloride, a substance belonging to the group of medicines known as "mucolytics". It works by liquefying mucus secretions in the respiratory tract. By reducing mucus viscosity, these medicines facilitate its removal from the body.
CORYFIN COUGH EXPECTORANT is used in respiratory tract conditions affecting the bronchi and lungs, relieving symptoms caused by excess mucus.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking CORYFIN COUGH EXPECTORANT

Do not take CORYFIN COUGH EXPECTORANT

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have severe liver or kidney problems;
in children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking CORYFIN COUGH EXPECTORANT:

if you have a stomach ulcer (mucosal lesion);
if you have impaired kidney function;
during the first three months of pregnancy or if you are breastfeeding.

Severe skin reactions have been reported following administration of ambroxol.
Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis
Serious skin reactions (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis) have been reported with the use of this medicine. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking CORYFIN COUGH EXPECTORANT and consult your doctor immediately. These serious skin reactions are often preceded by flu-like symptoms such as fever, chills, cold, and sore throat. The rash may progress with the appearance of widespread blisters and skin peeling (see section 4 "Possible side effects").
Children
Do not give this medicine to children under 2 years of age, because their respiratory tracts are not yet fully developed and this medicine may cause bronchial obstruction, leading to breathing difficulties (see section 2 "Do not take CORYFIN COUGH EXPECTORANT").
Other medicines and CORYFIN COUGH EXPECTORANT
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking antibiotics such as amoxicillin, cefuroxime, or erythromycin.
CORYFIN COUGH EXPECTORANT with food and drinks
Never mix this syrup with other liquids, as there is a risk of forming suspended flakes known as "flocs".
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, especially during the first trimester, or if you are breastfeeding, do not take CORYFIN COUGH EXPECTORANT unless your doctor considers it necessary.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
CORYFIN COUGH EXPECTORANT contains:

sodium metabisulfite: may rarely cause severe hypersensitivity reactions and bronchospasm.
sorbitol: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine. It may have a mild laxative effect. The caloric value of sorbitol is 2.6 kcal/g.
methyl 4-hydroxybenzoate: may cause allergic reactions (including delayed reactions).
ethanol: This medicine contains 3.8% vol ethanol (alcohol), e.g. up to 300 mg per dose (10 ml), equivalent to 7.6 ml of beer or 3.1 ml of wine per dose. It may be harmful for alcoholics. This should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy. The doses indicated for children aged 2 to 5 years and children over 5 years contain small amounts of ethyl alcohol (ethanol), less than 100 mg per dose. For individuals engaged in sports, the use of medicines containing ethyl alcohol may lead to a positive result in anti-doping tests, depending on the alcohol concentration limits set by certain sports federations.

3. How to take CORYFIN COUGH EXPECTORANT

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Instructions for use

Warning: Do not exceed the recommended doses.
CORYFIN COUGH EXPECTORANT can be taken at any time of the day, regardless of meals.
Take this medicine only for short treatment periods. If symptoms recur frequently or if you have noticed any recent changes in their characteristics, consult your doctor.
To take the correct syrup dose, use the provided dosing cup.

Use in adults
The recommended dose is:

during the first days of treatment: 10 ml of syrup 3 times a day;
in subsequent days: 5 ml of syrup 3 times a day.

Use in children
In children from 2 to 5 years of age: the recommended dose is 2.5 ml of syrup 3 times a day;
In children over 5 years of age: the recommended dose is 3 ml of syrup 4 times a day.
If you take more CORYFIN COUGH EXPECTORANT than you should
In case of overdose or accidental ingestion of too much CORYFIN COUGH EXPECTORANT, contact your doctor immediately or go to the nearest hospital. Bring this leaflet and the medicine package with you, even if empty.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking this medicine and contact your doctor immediately if:

you experience difficulty breathing, swelling of the face and lips, tongue or other parts of the body. These may be symptoms of anaphylactic shock (a severe allergic reaction);
you experience any skin changes, for example mouth, throat, nose, genital or eye ulcers, conjunctivitis (red and swollen eyes), widespread blisters and skin peeling. These may be symptoms of serious skin reactions called "Stevens-Johnson syndrome" and "toxic epidermal necrolysis" (see section 2 "Warnings and precautions").

The following side effects have also been reported with the use of this medicine:
Common (may affect up to 1 in 10 people):

altered sense of taste (dysgeusia);
nausea;
reduced sensation in the mouth (oral hypoesthesia);
reduced sensation in the throat (pharyngeal hypoesthesia).

Uncommon (may affect up to 1 in 100 people):

vomiting, diarrhoea, indigestion (dyspepsia), abdominal pain, dry mouth.

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

hypersensitivity reactions;
rash, urticaria;
skin eruptions, sudden appearance of raised itchy wheals that may be pale, pink or clearly red (urticaria).

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

anaphylactic reactions including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and pruritus;
serious cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and generalised exanthematous pustulosis);
dry throat;
breathing difficulty due to excessive mucus production blocking the bronchi (bronchial obstruction). A burning sensation rising from the stomach to the throat (pyrosis) has also been reported with the use of this medicine.

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 website: 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 CORYFIN COUGH EXPECTORANT

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton after “Expiry”.
The expiry date refers to the last day of that month.
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 CORYFIN COUGH EXPECTORANT contains

The active substance is ambroxol hydrochloride. 100 ml of syrup contain 300 mg of ambroxol hydrochloride.
The other components are sorbitol liquid non-crystallizable (E420), glycerol, methyl parahydroxybenzoate (E218), benzoic acid (E210), sodium bisulfite (E222), licorice extract, raspberry flavour, ethanol 96 percent, purified water.

Description of the appearance of CORYFIN COUGH EXPECTORANT and contents of the pack
CORYFIN COUGH EXPECTORANT 3 mg/ml syrup is presented in a 200 ml bottle with screw cap. A dosing cup is included in the package to measure the correct dose of medicine.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)