Vicks cough expectorant

Package leaflet: Information for the patient

Vicks Tosse Fluidificante 200 mg/15 ml Syrup

guaifenesin
Please read all of 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 told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, contact 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 after 7 days.

Contents of this leaflet:

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

1. What Vicks Cough Expectorant is and what it is used for

Vicks Cough Expectorant contains the active substance guaifenesin, which belongs to a group of
medicines called expectorants, capable of liquefying bronchial secretions and facilitating their expulsion.
Vicks Cough Expectorant is indicated as a mucolytic in acute and chronic conditions of the bronchial system.
Consult a doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before taking Vicks Cough Expectorant

Do not take Vicks Cough Expectorant

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Vicks Cough Expectorant.
Exercise particular caution and consult your doctor before taking Vicks Cough Expectorant if:

• you have chronic or persistent cough (lasting more than one week), such as that associated with asthma, smoking, chronic bronchitis, a lung disease called emphysema, or cough with excessive mucus, to avoid prolonged self-medication and masking of symptoms that may require more complex treatment;
• if you are due to undergo laboratory tests to measure levels of 5-hydroxyindoleacetic acid and vanillylmandelic acid. Vicks Cough Expectorant may cause a false-positive result.

Consult your doctor if symptoms persist for more than 7 days, if the condition recurs repeatedly, or if you have noticed any recent change in its characteristics.
Children
Vicks Cough Expectorant is not recommended in children under 2 years of age unless strictly deemed necessary by a doctor.
Other medicines and Vicks Cough Expectorant
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
There is insufficient data available to determine whether guaifenesin could potentially impair fertility.
Pregnancy
Take this medicine only if clearly needed and under medical supervision.
Breastfeeding
Take this medicine only if clearly needed and under medical supervision.
Driving and using machines
Vicks Cough Expectorant has a negligible effect on the ability to drive vehicles or operate machinery.
Vicks Cough Expectorant contains:

• Sucrose and invert sugar: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. This medicine contains 5.55 g of sucrose per dose (15 ml). This should be taken into account in patients with diabetes mellitus.
• Sodium: this medicine contains 27.9 mg of sodium (a main component of table salt) per dose (15 ml). This corresponds to 1.40% of the recommended maximum daily dietary intake for an adult.
• Ethanol: this medicine contains 5.256 vol% ethanol (alcohol), equivalent to approximately 597 mg per 15 ml of medicine. The amount in 15 ml of medicine is equivalent to less than 12 ml of beer or 5 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
• Propylene glycol: this medicine contains 1650 mg of propylene glycol per dose, equivalent to 1650 mg per 15 ml. If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment. If you have liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
• Sodium benzoate: this medicine contains 15 mg of sodium benzoate per dose (15 ml).

3. How to take Vicks Cough Expectorant

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.
Adults and adolescents over 12 years
The recommended dose is 15 ml
Children from 6 to 11 years
The recommended dose is 10 ml
Children from 2 to 5 years
The recommended dose is 5 ml
These doses may be repeated every 4 hours, up to 6 times a day.
Do not exceed the recommended doses.
Use the graduated dosing cup supplied in the package.
If no noticeable improvement occurs after a short period of treatment, consult your doctor.
If you take more Vicks Cough Expectorant than you should
In case of accidental ingestion or misuse of the medicine, contact your doctor or the nearest hospital.
If you take an excessive dose of Vicks Cough Expectorant, symptoms such as mental confusion, dizziness, and gastrointestinal disturbances may occur.
If you accidentally ingest a particularly high dose of Vicks Cough Expectorant, symptoms such as excitation, mental confusion, respiratory depression, nausea, and vomiting may occur.
Prolonged use of high doses of this medicine may increase the risk of developing calculi (renal or urinary).
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 everyone experiences them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

• abdominal discomfort, nausea, vomiting, diarrhoea, oedema (swelling) of the lips or tongue;
• hypersensitivity reactions with itching, skin redness and erythema.

If you experience any of the following side effects, stop taking the medicine and consult a doctor immediately:

• Frequency not known (frequency cannot be estimated from the available data):
• severe itching with skin rash or swelling of the skin;
• facial oedema (swelling);
• bronchospasm, breathing difficulties (dyspnoea), oedema (swelling) of the throat;
• dizziness, headache.

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 Vicks Cough Expectorant

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging 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 Vicks Cough Expectorant contains

• The active substance is guaifenesin. 1 ml of product contains 13.33 mg (1.333% w/v) of guaifenesin.
• The other components are: sucrose, sodium saccharin, propylene glycol, 96 per cent ethanol, sodium citrate, anhydrous citric acid, sodium carmellose, polyethylene oxide, honey/ginger flavour, verbena flavour, levomenthol, macrogol stearate, sodium benzoate, purified water.

Description of the appearance of Vicks Cough Expectorant and the contents of the pack
Syrup in opaque glass bottles of 120 ml and 180 ml, with child-resistant closure and a graduated dosing cup made of polypropylene.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Procter & Gamble S.r.l. - Viale Giorgio Ribotta 11 - 00144 Rome, Italy
Manufacturer
Procter & Gamble Manufacturing GmbH, Procter-&-Gamble Strasse 1, 64521 Gross-Gerau, Germany.