Acodin Duo

Leaflet attached to the packaging: information for the user

ACODIN Duo, (15 mg + 50 mg)/5 ml, syrup

Dextromethorphan hydrobromide + Dexpanthenol

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

This medicine should always be used exactly as described in the patient leaflet or as directed by your 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 tell their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Acodin Duo and what is it used for
• 2. Important information before taking Acodin Duo
• 3. How to take Acodin Duo
• 4. Possible side effects
• 5. How to store Acodin Duo
• 6. Contents of the pack and other information

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

Acodin Duo is available as a syrup and contains the active substances: dextromethorphan hydrobromide and dexpanthenol.
Dextromethorphan acts as an antitussive, inhibiting the cough reflex by directly acting on the central nervous system. At the recommended doses, it does not have a depressant effect on the respiratory tract's ciliary function (structure responsible for transporting secreted mucus).
Dexpanthenol plays an essential role in metabolism, including the regeneration of mucous membranes in the respiratory tract.
Acodin Duo is used for the symptomatic treatment of dry cough of various origins (not associated with secretions in the respiratory tract).

2. Important information before taking Acodin Duo

This medicine should always be used exactly as directed by your doctor or pharmacist and in accordance with the instructions in this patient leaflet. Do not exceed the recommended dose. Cases of abuse of this medicine have been reported, including by children and adolescents.
Taking this medicine can lead to dependence. Therefore, treatment should be short-term.

When not to take 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 taking monoamine oxidase inhibitors (some medicines used for depression, Parkinson's disease) at the same time or has taken them within the last 14 days (see also the section "Acodin Duo and other medicines").
• if the patient has respiratory failure or is at risk of its occurrence.
• if the patient has asthma.

Warnings and precautions

Before taking Acodin Duo, you should talk to your doctor, pharmacist, or nurse:

• if the patient is taking certain antidepressant or antipsychotic medicines, Acodin Duo may interact with them, causing changes in mental status (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).

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

• The medicine suppresses cough but does not eliminate its cause. If the cough does not subside within 7 days or the disease is accompanied by fever, headache, or rash, you should contact your doctor.
• Do not use in patients with respiratory diseases associated with increased mucus production, such as bronchitis.
• In patients with renal or hepatic insufficiency, the dose of the medicine should be reduced or the intervals between doses increased.
• Dextromethorphan enhances the inhibitory effect of alcohol on the central nervous system (see the section "Acodin Duo with food, drinks, and alcohol").

Acodin Duo and other medicines

You should tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Acodin Duo should not be used at the same time as the following medicines:

• monoamine oxidase inhibitors (some medicines used for depression, Parkinson's disease, such as iproniazid, selegiline, moclobemide), as well as within 14 days after stopping treatment with such medicines, as the risk of serotonin syndrome (a condition caused by excessive serotonin in the brain) increases. Concomitant use of these medicines may cause symptoms from the central nervous system (dizziness, excitement, significant elevation of body temperature, nausea, muscle tremors, elevated blood pressure).

Concomitant use of Acodin Duo and medicines that inhibit the CYP2D6 enzyme, which is responsible for the metabolism of dextromethorphan, may lead to increased dextromethorphan concentrations. These medicines include fluoxetine, paroxetine, quinidine, and terbinafine, amiodarone, flecainide, propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine, and thioridazine.
As a result, symptoms of overdose have been observed.

Acodin Duo with food, drinks, and alcohol

Acodin Duo syrup can be taken with or without food.
You should not drink alcoholic beverages while taking dextromethorphan. Dextromethorphan enhances the inhibitory effect of alcohol on the central nervous system.

Using Acodin Duo in children

Acodin Duo is not intended for use in children under 12 years of age. For patients between 6 and 12 years old, Acodin 150 Junior is available.

Pregnancy, breastfeeding, and fertility

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 using this medicine. This medicine should not be used in breastfeeding women.

Driving and using machines

At therapeutic doses, the medicine does not cause impairment of psychophysical abilities, the ability to drive vehicles, or operate machinery. When used in doses higher than recommended, it has an inhibitory 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 the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains 12.5 mg of sodium benzoate in 5 ml of syrup.

3. How to take Acodin Duo

This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
The bottle of syrup is equipped with a measuring cup for dosing the medicine.
Adults and children over 12 years old:
5 ml of Acodin Duo syrup up to 4 times a day.
If you feel that the effect of Acodin Duo is too strong or too weak, you should consult your doctor.

Taking a higher dose of Acodin Duo than recommended

If the patient takes a higher dose of Acodin Duo 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.
Other symptoms of a large overdose may include: coma, severe respiratory disorders, and convulsions.
If any of the above symptoms occur, you should immediately consult a doctor or go to the hospital.
If you have taken a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Acodin Duo

If you miss a dose of the medicine, you should take it as soon as possible.
Do not take a double dose to make up for the missed dose.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After the medicine was placed on the market, the following side effects were reported:
Very common(more than 1 in 10 patients):

• drowsiness, mild dizziness

Common(less than 1 in 10 patients):

• disorientation, fatigue,

Rare(less than 1 in 1000 patients):

• gastrointestinal disorders

Frequency not known(frequency cannot be estimated from the available data):

• allergic skin reactions, such as rash with itching, urticaria, persistent drug eruptions,
• angioedema (swelling of the skin and mucous membranes, which can affect the airways and be life-threatening), bronchospasm, difficulty breathing, and anaphylactic reaction (a severe and life-threatening allergic reaction). If such symptoms occur, you should immediately consult a doctor;
• psychotic disorders, including hallucinations;
• involuntary movements (dystonia), especially in children;
• neurological symptoms, including dizziness of peripheral or central origin, feeling of emptiness in the head, fatigue, slurred speech, and oculogyric crisis.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Acodin Duo

There are no special precautions for storage. Do not freeze.
The medicine should be stored out of sight and reach 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 month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Acodin Duo contains

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

What Acodin Duo looks like and what the pack contains

The pack contains 60 or 100 ml of syrup.
A brown glass bottle containing 60 or 100 ml of syrup with a child-resistant closure, equipped with a measuring cup for dosing the medicine, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer:
Sanofi-Aventis Sp. z o.o. w Warszawie Oddział w Rzeszowie
Zakład Produkcji i Dystrybucji Leków w Rzeszowie
ul. Lubelska 52, 35-233 Rzeszów
Unither Liquid Manufacturing
1-3 allee de la Neste
Z.I. d’En Sigal
31770 Colomiers
France
Date of last revision of the leaflet:11/2021