Patient Information Leaflet

ACODIN Duo, (15 mg + 50 mg)/5 ml, syrup
Dextromethorphani hydrobromidum + Dexpanthenolum
Please read this leaflet carefully before using the medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents:

What Acodin Duo is and what it is used for
Important information before using Acodin Duo
How to use Acodin Duo
Possible side effects
How to store Acodin Duo
Contents of the pack and other information

1. What Acodin Duo is and what it is used for

Acodin Duo is available as a syrup and contains the active substances: dextromethorphan hydrobromide and dexpanthenol.
Dextromethorphan acts as a cough suppressant by directly affecting the central nervous system to suppress the cough reflex. At the recommended doses, it does not impair the function of the bronchial ciliary apparatus (the structure responsible for mucus clearance from the airways).
Dexpanthenol plays an important role in metabolism, including the regeneration of the respiratory mucosa.
Acodin Duo is indicated for the symptomatic treatment of dry cough of various origins (not associated with mucus accumulation in the respiratory tract).

2. Important information before using Acodin Duo

This medicine should always be used according to the doctor's recommendations and the instructions contained in this patient leaflet. Do not exceed the recommended dose. Cases of misuse of this medicine have been reported, including among children and adolescents.
Use of this medicine may lead to dependence. Therefore, treatment should be short-term.

When not to use Acodin Duo:

if the patient is allergic to dextromethorphan, dexpanthenol, or any of the other ingredients of this medicine (listed in section 6).
if the patient is currently taking medicines from the group of monoamine oxidase inhibitors (MAOIs) (some medicines used in depression, Parkinson's disease), or has taken such medicines within the last 14 days (see also section "Acodin Duo with other medicines").
if the patient has respiratory failure or there is a risk of its occurrence.
if the patient suffers from bronchial asthma.

Warnings and precautions
Before taking Acodin Duo, consult a doctor, pharmacist, or nurse:

if the patient is taking medicines such as certain antidepressants or antipsychotics, Acodin Duo may interact with them, causing changes in mental state (e.g. agitation, hallucinations, coma) and other symptoms such as body temperature above 38°C, increased heart rate, unstable blood pressure, as well as exaggerated reflex responses, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea).

Dextromethorphan, the active substance in Acodin Duo, has addictive properties. Do not exceed the recommended duration of treatment, as tolerance to dextromethorphan may develop, and psychological and physical dependence may occur. Particular caution is advised when using this product in adolescents and young adults, as well as in individuals with a history of misuse of medicinal products or psychoactive substances.

This medicine suppresses cough but does not eliminate its cause. If the cough does not subside within 7 days, or if the illness is accompanied by fever, headache, or rash, consult a doctor.
Do not use in patients with respiratory tract diseases associated with increased mucus secretion, e.g. in bronchitis.
In patients with renal or hepatic impairment, the dose should be reduced or the intervals between doses increased.
Dextromethorphan enhances the depressant effect of alcohol on the central nervous system (see section "Acodin Duo with food, drink, and alcohol").

Acodin Duo with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to use.
Acodin Duo should not be used simultaneously with the following medicines:

monoamine oxidase inhibitors (MAOIs) (some medicines used in depression, Parkinson's disease, such as iproniazid, selegiline, mocllobemide), or within 14 days after discontinuation of such treatment, due to increased risk of serotonin syndrome (a condition caused by excessive serotonin in the brain). Concurrent use of these medicines may cause symptoms affecting the central nervous system (dizziness, agitation, significant increase in body temperature, nausea, muscle tremors, elevated blood pressure).

Concurrent use of Acodin Duo and medicines that inhibit the CYP2D6 enzyme, responsible for dextromethorphan metabolism, may increase dextromethorphan concentration. These include fluoxetine, paroxetine, quinidine, terbinafine, amiodarone, flecainide, propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine, and thioridazine. This may lead to symptoms of overdose.

Acodin Duo with food, drink, and alcohol
Acodin Duo syrup can be taken with or without food.
Do not consume alcoholic beverages while taking dextromethorphan. Dextromethorphan enhances the depressant effect of alcohol on the central nervous system.

Use of Acodin Duo in children
Acodin Duo is not intended for use in children under 12 years of age. For patients aged 6 to 12 years, Acodin 150 Junior is available.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. This medicine should not be used in breastfeeding women.

Driving and operating machinery
At therapeutic doses, this medicine does not impair psycho-physical performance, ability to drive vehicles, or operate machinery. When used in doses higher than recommended, it exerts a depressant effect on the central nervous system.

Acodin Duo contains sucrose and sodium benzoate
5 ml of syrup contains 2.625 g of sucrose. This should be taken into account in patients with diabetes.
If a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains 12.5 mg of sodium benzoate in 5 ml of syrup.

3. How to use Acodin Duo

This medicine should always be taken exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The bottle of syrup is equipped with a measuring device for dosing the medicine.
Adults and children over 12 years of age:
5 ml of Acodin Duo syrup up to 4 times daily.
If the effect of Acodin Duo seems too strong or too weak, consult a doctor.
Taking more than the recommended dose of Acodin Duo
If a patient takes more than the recommended dose of Acodin Duo, the following symptoms may occur:
nausea and vomiting, involuntary muscle spasms, restlessness, confusion, drowsiness, disturbances
of consciousness, involuntary rapid eye movements, cardiac disorders (fast heartbeat), coordination
problems, psychosis with visual hallucinations, and increased excitability.
Other symptoms of severe overdose may include: coma, severe respiratory depression, and seizures.
If any of the above symptoms occur, seek immediate medical attention from a doctor or go to a hospital.
In case of taking more than the recommended dose of the medicine, contact a doctor or pharmacist immediately.
Missing a dose of Acodin Duo
If a dose is missed, take it as soon as possible.
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 experiences them.
The following adverse reactions have been reported since the medicine was placed on the market:
Very common (affects more than 1 in 10 people):

drowsiness, mild dizziness

Common (affects less than 1 in 10 people):

disorientation, fatigue

Rare (affects less than 1 in 1,000 people):

gastrointestinal disorders

Frequency unknown (frequency cannot be estimated from available data):

skin allergic reactions such as itchy rash, urticaria, fixed drug eruptions,
angioedema (swelling of the skin and mucous membranes, which may involve the airways and may then be life-threatening), bronchospasm, breathing difficulties, and anaphylactic reaction (severe, life-threatening allergic reaction). If any of these symptoms occur, seek immediate medical advice;
psychotic disorders, including hallucinations;
involuntary movements (dystonia), especially in children;
neurological symptoms, including peripheral or central dizziness, feeling of emptiness in the head, fatigue, slurred speech, and nystagmus.

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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Acodin Duo

No special storage instructions are required. Do not freeze.
Keep the medicine in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines must 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 package and other information

What Acodin Duo contains

The active substances in this medicine are dextromethorphan hydrobromide and dexpanthenol. 5 ml of syrup contains 15 mg of dextromethorphan hydrobromide and 50 mg of dexpanthenol.
Other ingredients are: sodium carmellose, glycerol, sucrose, sodium benzoate, food caramel, citric acid, raspberry flavouring, purified water.

What Acodin Duo looks like and contents of the pack
The pack contains 60 or 100 ml of syrup.
Brown glass bottle containing 60 or 100 ml of syrup with a child-resistant cap, supplied with a dosing device, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer:
Sanofi-Aventis Sp. z o.o. in Warsaw Branch in Rzeszów
Production and Distribution Plant for Medicinal Products in Rzeszów
ul. Lubelska 52, 35-233 Rzeszów
Poland

Unither Liquid Manufacturing
1-3 allee de la Neste
Z.I. d’En Sigal
31770 Colomiers
France