Acodin

Leaflet attached to the packaging: information for the user

ACODIN, 15 mg, tablets

Dextromethorphan hydrobromide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

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

Table of contents of the leaflet

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

1. What is Acodin and what is it used for

Acodin is available in tablet form and contains the active substance dextromethorphan. Dextromethorphan has an antitussive effect; it suppresses the cough reflex by acting directly on the central nervous system. At therapeutic doses, it does not have a suppressive effect on respiratory function and the action of the bronchial mucosa (structure responsible for transporting secreted mucus). Acodin is used for periodic suppression of non-productive cough (so-called dry cough, not associated with the accumulation of secretions in the airways) of various origins:

• colds,
• pleuritic cough (e.g., chest injuries),
• cough caused by inhaling irritating substances.

2. Important information before taking Acodin

This medicine should always be taken in accordance with the doctor's instructions and the indications contained in this patient leaflet. Do not exceed the recommended dose and duration of treatment. 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:

• if the patient is allergic to dextromethorphan or any of the other ingredients of this medicine (listed in section 6).
• if the patient is taking monoamine oxidase inhibitors (some medicines used in depression, Parkinson's disease) or has taken such medicines within the last 14 days (see also "Acodin and other medicines").
• if the patient has respiratory failure or is at risk of its occurrence.
• if the patient has asthma.
• if the patient is breastfeeding.
• if the patient has chronic obstructive pulmonary disease.
• if the patient has pneumonia.
• if the patient has experienced respiratory depression (slowed breathing).

Warnings and precautions

Before taking Acodin, the patient should talk to their doctor, pharmacist, or nurse:

• if the patient is taking certain antidepressant or antipsychotic medicines, Acodin 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, as well as exaggerated reflexes, muscle stiffness, lack of coordination, and (or) symptoms related to the digestive system (e.g., nausea, vomiting, diarrhea).
• if the patient has kidney or liver failure. In such patients, the dose of the medicine should be reduced or the intervals between doses increased.
• if the patient has a cough with significant mucus production (e.g., in patients with diseases such as bronchiectasis, cystic fibrosis) or in patients with neurological diseases associated with significantly weakened cough reflex (such as stroke, Parkinson's disease, and dementia).
• if the patient has mastocytosis, a rare disease associated with abnormal accumulation of mast cells (mastocytes) in tissues, they should avoid taking Acodin.

Dextromethorphan, the active substance of Acodin, has addictive properties. The recommended treatment time should not be exceeded, as tolerance to dextromethorphan may develop, as well as psychological and physical dependence. The recommended dose and treatment time should not be exceeded. Particular caution is recommended when using this product in adolescents and young adults, as well as in individuals with a history of abuse of medicinal products or psychoactive substances. The medicine suppresses cough but does not eliminate its cause. If the cough does not subside within 3 days or recurs despite taking the medicine, or if the disease is accompanied by fever, headache, or rash, the patient should contact their doctor. The medicine should not be taken by patients with respiratory diseases associated with increased mucus production, such as bronchitis, bronchiectasis, or cystic fibrosis. Dextromethorphan enhances the inhibitory effect of alcohol on the central nervous system (see "Acodin with food, drink, and alcohol").

Acodin 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. Acodin should not be taken simultaneously with the following medicines:

• monoamine oxidase inhibitors (some medicines used in Parkinson's disease, depression, 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 administration of these medicines may cause symptoms from the central nervous system (dizziness, excitement, significant increase in body temperature, nausea, muscle tremors, increased blood pressure). Concomitant use of Acodin and medicines that inhibit the CYP2D6 enzyme, which is responsible for the metabolism of dextromethorphan, may increase the concentration of dextromethorphan. 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. Concomitant use of Acodin and expectorant medicines in patients with existing lung disease, such as cystic fibrosis and bronchiectasis, in whom there is excessive mucus production, may lead to increased mucus accumulation.

Acodin with food, drink, and alcohol

Food does not affect the absorption of the medicine from the gastrointestinal tract. The medicine can be taken with or without food. The patient should not drink alcoholic beverages while taking dextromethorphan. Dextromethorphan enhances the effect of alcohol on the central nervous system.

Using Acodin in children

Acodin in tablet form is not intended for use in children under 12 years of age. The medicine can be used in adolescents over 12 years of age.

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 taking this medicine. High doses of dextromethorphan may cause respiratory depression in newborns, even if taken for a short time. The use of Acodin during pregnancy should always be under medical supervision. Acodin is contraindicated during breastfeeding, as it cannot be excluded that respiratory depression may occur in infants.

Driving and operating machinery

Acodin, even if taken as directed, may cause mild drowsiness or dizziness and alter reaction time to the extent that the ability to drive vehicles or operate machinery is impaired. This risk increases if the medicine is taken in combination with alcohol. When taken in doses higher than recommended, it has a suppressive effect on the central nervous system.

Acodin contains lactose

Each tablet contains 10 mg of lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Acodin

This medicine should always be taken in accordance with the doctor's or pharmacist's instructions. In case of doubt, the patient should consult their doctor or pharmacist. The medicine is taken orally. Adults and adolescents over 12 years of age: 15 mg (1 tablet) every 4 hours or 30 mg (2 tablets) every 6-8 hours. Adults and adolescents over 12 years of age:do not exceed the daily dose of 120 mg of dextromethorphan (8 tablets). The maximum treatment duration should not exceed 3 days. If after 3 days there is no improvement or the patient feels worse, they should contact their doctor. Acodin can be taken with or without food. If the patient feels that the effect of Acodin is too strong or too weak, they should consult their doctor.

Taking a higher dose of Acodin than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist. If the patient takes a higher dose of Acodin 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. In case of any of the above symptoms, the patient should immediately consult their doctor or go to the hospital.

Missing a dose of Acodin

In case of missing a dose, the patient should take it as soon as possible, unless it is close to the time of the next dose. The patient should not take a double dose to make up for the missed dose. In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Acodin 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, dizziness.

Common(less than 1 in 10 patients):

• -disorientation, fatigue;
• -gastrointestinal disorders (nausea, vomiting, constipation).

Very rare(less than 1 in 10,000 patients):

• addiction to medicines.

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

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

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the patient should inform their 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, Tel.: +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, more information can be collected on the safety of the medicine.

5. How to store Acodin

Store the medicine at a temperature below 25°C. Store the medicine 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. 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 Acodin contains

• The active substance of Acodin is dextromethorphan hydrobromide. Each tablet contains 15 mg of dextromethorphan hydrobromide.
• The other ingredients are: microcrystalline cellulose, lactose, potato starch, povidone 90F, sodium lauryl sulfate, talc, magnesium stearate.

What Acodin looks like and what the package contains

The package contains 10, 20, or 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder: STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany. Manufacturer: Opella Healthcare Poland Sp. z o.o., Branch in Rzeszów, ul. Lubelska 52, 35-233 Rzeszów.

Date of last revision of the leaflet: 03/2022