Vicks meddex honey flavor for dry cough

Patient Information Leaflet

Vicks MedDex Honey Flavour Cough Syrup for Dry Cough
20 mg/15 ml, syrup
Dextromethorphani hydrobromidum
For adults and adolescents aged 14 years and older
Please read this leaflet carefully before taking the medicine, as it contains important information for you.
Always take this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3 to 5 days, consult your doctor.

Table of contents:

1. What Vicks MedDex Honey Flavour Cough Syrup for Dry Cough is and what it is used for
2. Important information before taking Vicks MedDex Honey Flavour Cough Syrup for Dry Cough
3. How to take Vicks MedDex Honey Flavour Cough Syrup for Dry Cough
4. Possible side effects
5. How to store Vicks MedDex Honey Flavour Cough Syrup for Dry Cough
6. Contents of the pack and other information

1. What Vicks MedDex Honey Flavour Cough Syrup for Dry Cough is and what it is used for

Vicks MedDex Honey Flavour Cough Syrup for Dry Cough 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 aged 14 years and older.

2. Important information before using Vicks MedDex honey-flavoured cough syrup for dry cough

dry
When this medicine should not be used:

• 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 bronchial asthma, chronic obstructive pulmonary disease (chronic bronchitis and emphysema), pneumonia, respiratory depression (respiratory depression), or breathing disorders (respiratory insufficiency).
• in children under 14 years of age.
• during concomitant use of certain antidepressant medicines (MAO inhibitors) or within 14 days after discontinuation of MAO inhibitors.
• in patients with impaired liver function.

Warnings and precautions
If the patient has a cough producing a significant amount of mucus (productive cough), this medicine should be used only after consulting a doctor and according to medical advice, and with special caution, because suppressing the cough reflex in such circumstances may be undesirable.
Chronic cough may be an early symptom of bronchial asthma. Therefore, this medicine is contraindicated for suppressing such cough, especially in children.
Use of this medicine may lead to dependence. For this reason, treatment should be short-term only.
In patients with a tendency to drug abuse or drug dependence, this medicine should be used under strict medical supervision.

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

Vicks MedDex honey-flavoured cough syrup for dry cough and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.

• In patients previously or currently using certain antidepressant medicines (MAO inhibitors), there is a risk of effects on the central nervous system, manifesting as excitation and disorientation, high fever, and disturbances in respiratory and circulatory function (so-called serotonin syndrome). Similar symptoms have also been observed during concomitant use of the antibiotic linezolid.
• Concomitant use with other medicines that depress the central nervous system may result in mutual enhancement of effects.
• If this medicine is used simultaneously with expectorant medicines, dangerous accumulation of secretions may occur due to a weakened cough reflex.
• Concomitant use of medicines that inhibit cytochrome P450 2D6 enzyme system in the liver, thereby inhibiting dextromethorphan metabolism—particularly amiodarone, quinidine, fluoxetine, haloperidol, paroxetine, propafenone, thioridazine, cimetidine, and ritonavir—may lead to increased dextromethorphan concentrations.
• Some medicines (e.g. certain antihypertensive medicines known as angiotensin-converting enzyme inhibitors—ACE inhibitors) may cause cough. If such medicines are being used, consult a doctor before using a cough suppressant.
• If the patient is taking medicines such as certain antidepressants or antipsychotics, Vicks MedDex honey-flavoured cough syrup for dry cough may interact with them, causing changes in mental state (e.g. excitation, hallucinations, coma) and other symptoms such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflex responses, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).

Use of Vicks MedDex honey-flavoured cough syrup for dry cough with alcohol
Additional alcohol consumption should be avoided.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, is planning to become pregnant, or is breastfeeding, she should consult a doctor or pharmacist before using this medicine.
Use of this medicine during pregnancy and breastfeeding should only occur after careful consideration by a doctor of the benefits versus possible adverse effects (see also section 4 “Possible side effects”) for both mother and child.

Driving and operating machinery
Even when used as directed, this medicine may cause moderate fatigue, which may affect reactions to such an extent that it impairs the ability to drive or operate machinery. This effect is particularly pronounced when alcohol is consumed concomitantly or when other medicines affecting reactions are used.

Vicks MedDex honey-flavoured cough syrup for dry cough contains sucrose and invert sugar (honey).
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Each dose contains 5.55 g of sucrose. This should be taken into account in patients with diabetes.

Vicks MedDex honey-flavoured cough syrup for dry cough contains sodium.
The medicine contains 27.9 mg of sodium (main component of table salt) in each dose (15 ml). This corresponds to 1.40% of the maximum recommended daily dietary sodium intake for adults.

Vicks MedDex honey-flavoured cough syrup for dry cough 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-flavoured cough syrup for dry cough contains 850.50 mg of propylene glycol in each dose (15 ml).
Women who are pregnant or breastfeeding should not take this medicine without medical advice.
The doctor may decide to perform additional tests in such patients.
Patients with impaired liver or kidney function should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.

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

3. How to use Vicks MedDex honey-flavoured cough syrup for dry cough

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Unless otherwise prescribed by a doctor, the usual recommended dose is:
Adolescents over 14 years of age and adults
15 ml (as indicated on the measuring device), (equivalent to 20 mg of dextromethorphan hydrobromide)
3 times daily. The maximum daily dose is 45 ml (equivalent 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. Shake the bottle before use. To open the bottle, press down on the cap while turning it in the direction indicated by the arrow.
Duration of treatment
This medicine should not be used for longer than 3 to 5 days without medical advice.
If the patient feels that the effect of the medicine is too strong or too weak, they should contact a
doctor or pharmacist.
Taking more Vicks MedDex honey-flavoured cough syrup for dry cough than recommended
If a patient takes more than the recommended dose of Vicks MedDex honey-flavoured cough syrup for dry cough, the following symptoms may occur: nausea and vomiting, involuntary muscle spasms, excitation, confusion, drowsiness, disturbances of consciousness, involuntary rapid eye movements, cardiac disorders (fast heartbeat), coordination disturbances, psychosis with visual hallucinations, increased excitability, dizziness, low blood pressure, and increased muscle tension.
Other symptoms of severe overdose may include coma, severe respiratory depression, and seizures.
If any of the above symptoms occur, seek immediate medical attention or go to hospital.
Missed dose of Vicks MedDex honey-flavoured cough syrup for dry cough
Do not take a double dose to make up for a missed dose.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Uncommon (may affect less than 1 in 100 people):
Hypersensitivity reactions, including anaphylactic reactions and (or) anaphylactic shock, swelling of the mouth and throat. If the first signs of hypersensitivity reaction occur, the medicine MUST NOT be taken again. Inform your doctor immediately.
Moderate fatigue, dizziness.
Nausea, gastrointestinal disturbances, vomiting.
Rare (may affect less than 1 in 1,000 people):
Skin rashes.
Very rare (may affect less than 1 in 10,000 people):
Somnolence, hallucinations, development of dependence if the medicine is misused.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Vicks MedDex honey flavour cough syrup

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following:
"EXP". The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Use within 3 months after first opening the bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Vicks MedDex honey-flavoured cough syrup for dry cough contains
The active substance is dextromethorphan hydrobromide.
20 mg of dextromethorphan hydrobromide is contained in 15 ml of syrup.
The other ingredients are: sucrose, sodium saccharin, propylene glycol, ethanol 96%, disodium citrate dihydrate, citric acid, sodium carmellose, macrogol, honey flavour L-166952 (containing propylene glycol, honey, honey flavouring, caramel, disodium edetate (EDTA), purified water), menthoxypropanediol (TK 10), polyoxyl 40 stearate, sodium benzoate (E 211), aniseed flavouring, purified water.

What Vicks MedDex honey-flavoured cough syrup for dry cough looks like and contents of the pack
Yellow, viscous liquid with a honey flavour and aroma.
This medicine is available in amber glass bottles with a child-resistant polypropylene closure and a polypropylene dosing cup, packed in a cardboard box.

Pack sizes available:

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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