VICKS COUGH SEDATIVE 1.33 MG/ML SYRUP 1 GLASS BOTTLE OF 180 ML WITH CHILD-RESISTANT CLOSURE AND DOSING GLASS

Name
Vicks Cough Sedative 1.33 mg/ml syrup
Dextromethorphan hydrobromide


What is it and what is it for?
Vicks Cough Sedative contains dextromethorphan hydrobromide , a substance that helps calm dry coughs.
Talk to your doctor if you do not feel better or if you feel worse after 5-7 days.


What you need to know before taking the medicine
This medicine can lead to addiction. Therefore, treatment should be short-term.
Do not take Vicks Cough Sedative
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
- during and for two weeks following therapy with drugs used against depression, called monoamine oxidase inhibitors (MAOIs);
- if you suffer from asthma, chronic obstructive pulmonary disease (COPD - chronic lung disease), pneumonia, breathing difficulties or respiratory depression;
- if you have cardiovascular disease or suffer from high blood pressure;
- if you suffer from hyperthyroidism (increased thyroid function);
- if you have diabetes;
- if you suffer from increased pressure inside the eye (glaucoma);
- if you suffer from urinary problems caused by an enlarged prostate or other obstructions of the genitals or urinary tract;
- if you have obstructions in your esophagus, stomach or intestines;
- if you suffer from serious liver disease;
- if you suffer from epilepsy;
- if you are pregnant, especially in the first trimester (see section "Pregnancy, breastfeeding and fertility");
- if you are breastfeeding (see section "Pregnancy, breastfeeding and fertility").
Do not give Vicks Cough Sedative to children under 12 years of age.

Talk to your doctor or pharmacist before taking Vicks Cough Sedative:
If you are taking medicines such as some antidepressants or antipsychotics: Vicks Cough Depressant may interact with these medicines and changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38℃, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) may occur.


Warnings and precautions
Talk to your doctor or pharmacist before taking Vicks Cough Sedative.
Take special care and ask your doctor for advice before taking Vicks Cough Sedative if :
- your kidney or liver function is impaired (especially if severely impaired);
- has a persistent, irritating cough with significant mucus production (phlegm) or accompanied by fever, rash, headache, nausea, and vomiting; has a reduced ability to metabolize certain drugs, with an increase in toxicity.
Be especially careful when using the medicine for a long time as habituation, tolerance and mental and physical dependence on the medicine may occur (see "Possible side effects").
Contact your doctor if you do not obtain appreciable results after a short period of treatment (5-7 days), if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may include:
Common (may affect up to 1 in 10 people)
• dizziness;
• nausea;
• vomit;
• gastrointestinal disorders of the stomach and intestine;
• reduction of appetite;
• fatigue.

Rare (may affect up to 1 in 1,000 people)
• skin rashes;
• drowsiness.

Very rare (may affect up to 1 in 10,000 people)
• Hallucinations.

Not known (frequency cannot be estimated from the available data)
• hypersensitivity reactions, including anaphylactic reaction;
• swelling of the face, hands and feet, eyes, lips, larynx and/or tongue (angioedema);
• hives;
• itching;
• rash;
• erythema;
• diabetes mellitus;
• psychosis;
• very high fever (hyperpyrexia).

Reporting of side effects
If you experience any side effects, including any 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/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.