Vicks Meddex o smaku miodu na kashel suhi

Leaflet accompanying the packaging: patient information

Vicks MedDex honey-flavored cough syrup

20 mg/15 ml, syrup

Dextromethorphan hydrobromide
For adults and adolescents from 14 years of age

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 to 5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Vicks MedDex honey-flavored cough syrup and what is it used for
• 2. Important information before taking Vicks MedDex honey-flavored cough syrup
• 3. How to take Vicks MedDex honey-flavored cough syrup
• 4. Possible side effects
• 5. How to store Vicks MedDex honey-flavored cough syrup
• 6. Package contents and other information

1. What is Vicks MedDex honey-flavored cough syrup and what is it used for

Vicks MedDex honey-flavored cough syrup contains the active substance dextromethorphan hydrobromide and is a medicine used for the symptomatic treatment of dry, irritating, non-productive cough.
This medicine is indicated for use in adults and adolescents from 14 years of age.

2. Important information before taking Vicks MedDex honey-flavored cough syrup

dry cough

When not to take this medicine:

• if the patient is allergic to dextromethorphan hydrobromide or any of the other ingredients of this medicine (listed in section 6).
• if the patient has asthma, chronic obstructive pulmonary disease (chronic bronchitis and emphysema), pneumonia, respiratory depression, or breathing difficulties (respiratory failure).
• in children under 14 years of age.
• while taking certain mood-enhancing medicines (MAO inhibitors) or within 14 days of stopping MAO inhibitors.
• in patients with impaired liver function.

Warnings and precautions

If the patient has a cough with significant mucus production (with expectoration), they should only take this medicine after consulting a doctor and with special caution, as cough suppression may be undesirable in such circumstances.
Chronic cough may be an early symptom of asthma. This medicine is therefore not recommended for suppressing such a cough, especially in children.
Taking this medicine may lead to dependence. Therefore, treatment should be short-term.
In patients with a tendency to abuse medicines or become dependent on them, this medicine should be used under strict medical supervision.

Children

This medicine is contraindicated in children under 14 years of age.

Vicks MedDex honey-flavored cough syrup and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• In patients who have previously taken or are currently taking certain mood-enhancing medicines (antidepressants from the MAO inhibitor group), there is a possibility of affecting the central nervous system, which manifests as excitement and disorientation, high fever, and respiratory and circulatory disorders (so-called serotonin syndrome). Similar symptoms have also been observed during concurrent use of the antibiotic linezolid.
• Concomitant use with other medicines that suppress the central nervous system may lead to mutual enhancement of action.
• If this medicine is taken concurrently with expectorant medicines, there may be a dangerous accumulation of secretions due to weakened cough reflex.
• Concomitant use of medicines that inhibit cytochrome P450 2D6 in the liver, thereby inhibiting the metabolism of dextromethorphan, particularly amiodarone, quinidine, fluoxetine, haloperidol, paroxetine, propafenone, thioridazine, cimetidine, and ritonavir, may lead to increased dextromethorphan levels.
• Certain medicines (e.g., certain blood pressure-lowering medicines, known as ACE inhibitors) may cause cough. If such medicines are taken, the patient should consult their doctor before taking a cough-suppressing medicine.
• If the patient is taking certain antidepressant or antipsychotic medicines, Vicks MedDex honey-flavored cough syrup may interact with them, causing changes in mental state (e.g., excitement, hallucinations, coma) and other symptoms, such as body temperature above 38°C, increased heart rate, unstable blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Taking Vicks MedDex honey-flavored cough syrup with alcohol

Additional alcohol consumption should be avoided.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Taking the medicine during pregnancy and breastfeeding should only be done after very careful consideration by the doctor of the benefits and possible side effects (see also section 4 "Possible side effects") for the mother and child.

Driving and operating machinery

Even if taken as recommended, this medicine may cause moderate fatigue, which can change reactions so much that it impairs the ability to drive vehicles and operate machinery. This is especially true when consuming alcohol or taking other medicines that can impair reactions.

Vicks MedDex honey-flavored cough syrup contains sucrose and inverted sugar (honey).

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The dose of the medicine contains 5.55 g of sucrose. This should be taken into account in patients with diabetes.

Vicks MedDex honey-flavored cough syrup contains sodium.

The medicine contains 27.9 mg of sodium (the main component of table salt) in each dose (15 ml). This corresponds to 1.40% of the maximum recommended daily intake of sodium in the diet for adults.

Vicks MedDex honey-flavored cough syrup contains 5% v/v alcohol.

This medicine contains 592 mg of alcohol (ethanol) in each dose (15 ml). The amount of alcohol in each dose (15 ml) of this 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 cause noticeable effects.

Vicks MedDex honey-flavored cough syrup contains 850.50 mg of propylene glycol in each dose (15 ml).

Pregnant or breastfeeding women should not take this medicine without a doctor's recommendation.
The doctor may decide to perform additional tests on such patients.
Patients with liver or kidney disorders should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients.

Vicks MedDex honey-flavored cough syrup contains 15 mg of sodium benzoate in each dose (15 ml).

3. How to take Vicks MedDex honey-flavored cough syrup

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Unless otherwise advised by the doctor, the recommended dose is:

Adolescents over 14 years of age and adults

15 ml (according to the marking on the measuring cup), (which corresponds to 20 mg of dextromethorphan hydrobromide)
3 times a day, the maximum daily dose is 45 ml (which corresponds to 60 mg of dextromethorphan hydrobromide).

Use in children

This medicine is contraindicated in children under 14 years of age.

Method of administration

The medicine should be taken orally. Before use, the bottle should be shaken. To open the bottle, the cap should be pressed and turned in the direction indicated by the arrow.

Duration of treatment

This medicine should not be taken for more than 3 to 5 days without consulting a doctor.
If the patient thinks the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Vicks MedDex honey-flavored cough syrup than recommended

If the patient takes a higher dose of Vicks MedDex honey-flavored cough syrup than recommended, the following symptoms may occur: nausea and vomiting, involuntary muscle contractions, excitement, confusion, drowsiness, impaired consciousness, involuntary rapid eye movements, cardiac disorders (rapid heartbeat), coordination disorders, psychosis with visual hallucinations, and increased excitability, dizziness, low blood pressure, and increased muscle tension.
Other symptoms of a large overdose may include: coma, severe respiratory disorders, and convulsions.
If any of the above symptoms occur, the patient should immediately consult their doctor or go to the hospital.

Missing a dose of Vicks MedDex honey-flavored cough syrup

A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Allergic reactions, including anaphylactic reactions and (or) anaphylactic shock, oral and pharyngeal edema. After the first symptoms of an allergic reaction, DO NOTtake the medicine again. The patient should inform their doctor.
Moderate fatigue, dizziness.
Nausea, gastrointestinal problems, vomiting.

Rare (may affect up to 1 in 1000 people):

Skin rashes.

Very rare (may affect up to 1 in 10,000 people):

Drowsiness, hallucinations, development of dependence if the medicine is abused.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Vicks MedDex honey-flavored cough syrup

The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the label and carton after: "EXP". The expiry date refers to the last day of the month stated.
The medicine should not be stored at a temperature above 25°C.
Shelf life after first opening the bottle: 3 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Vicks MedDex honey-flavored cough syrup contains

The active substance of the medicine is dextromethorphan hydrobromide.
15 ml of syrup contains 20 mg of dextromethorphan hydrobromide.
The other ingredients are: sucrose, sodium saccharin, propylene glycol, ethanol 96%, sodium citrate dihydrate, citric acid, sodium caramel, macrogol, honey flavor L-166952 (containing propylene glycol, honey, honey flavor, caramel, disodium edetate (EDTA), purified water), menthoxypropanediol (TK 10), macrogol stearate, sodium benzoate (E 211), vitus flavor, purified water.

What Vicks MedDex honey-flavored cough syrup looks like and what the package contains

Yellow, viscous liquid with a honey flavor and aroma.
This medicine is available in brown glass bottles with a child-resistant polypropylene closure and a polypropylene measuring cup in a cardboard box.
Available package sizes:

• Syrup, bottle of 100 ml
• Syrup, bottle of 120 ml
• Syrup, bottle of 180 ml
• Syrup, bottle of 240 ml.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

WICK Pharma Zweigniederlassung der Procter & Gamble GmbH
Sulzbacher Strasse 40-50
D-65824 Schwalbach am Taunus
Germany

Manufacturer:

Procter & Gamble Manufacturing GmbH
Gross-Gerau Plant
Procter & Gamble Strasse 1
64521 Gross-Gerau
Germany

Date of last revision of the leaflet: 01/2022