Patient Information Leaflet: Information for the User

ACODIN, 15 mg, tablets
Dextromethorphani hydrobromidum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

Table of Contents

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

1. What Acodin is and what it is used for

Acodin is available as tablets and contains the active substance dextromethorphan.
Dextromethorphan acts as an antitussive; it suppresses the cough reflex by direct action on the central nervous system. At therapeutic doses, it does not depress respiratory function or impair ciliary activity in the bronchi (the structure responsible for mucus clearance).

Acodin is indicated for the temporary suppression of non-productive cough (so-called dry cough, not associated with mucus accumulation in the airways) of various origins:

colds,
post-infectious cough (e.g., chest injuries),
cough caused by inhalation of irritant substances.

2. Important information before using Acodin

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

When not to use 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 currently taking medicines from the group of monoamine oxidase inhibitors (some medicines used in depression, Parkinson's disease) or has taken such medicines within the last 14 days (see also section "Acodin with other medicines").
if the patient has respiratory failure or is at risk of developing it.
if the patient has bronchial asthma.
if the patient is breastfeeding.
if the patient has chronic obstructive pulmonary disease (COPD).
if the patient has pneumonia.
if the patient has experienced respiratory depression (slowed breathing).

Warnings and precautions
Before taking Acodin, talk to your 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. agitation, 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).
- if the patient has kidney or liver impairment. In such patients, doses should be reduced or the intervals between doses increased.
- if the patient has cough with significant mucus production (e.g. in patients with conditions such as bronchiectasis, cystic fibrosis), or in patients with neurological disorders associated with markedly weakened cough reflex (such as stroke, Parkinson's disease, and dementia).
- if the patient has mastocytosis, a rare condition involving abnormal accumulation of mast cells in tissues, use of Acodin should be avoided.

Dextromethorphan, the active substance in Acodin, has addictive properties. Do not exceed the recommended treatment duration, as tolerance to dextromethorphan may develop, and psychological and physical dependence may occur. Do not exceed the recommended dose or duration of treatment. Particular caution is advised 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.
This medicine suppresses cough but does not eliminate its cause. If cough persists for more than 3 days, recurs despite treatment, or if the illness is accompanied by fever, headache, or rash, consult a doctor.
Do not use in patients with respiratory diseases associated with increased mucus production, e.g. in bronchitis, bronchiectasis, or cystic fibrosis.
Dextromethorphan enhances the depressant effect of alcohol on the central nervous system (see section "Acodin with food, drink and alcohol").

Acodin with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Acodin should not be used simultaneously with the following medicines:

monoamine oxidase inhibitors (some medicines used in Parkinson's disease and depression, such as iproniazid, selegiline, moclobemide), or within 14 days after stopping such treatment, because of an increased risk of serotonin syndrome (a condition caused by excessive serotonin levels in the brain).

Concomitant use of these medicines may cause symptoms from the central nervous system (dizziness, agitation, significant increase in body temperature, nausea, muscle tremors, elevated blood pressure).
Concurrent use of Acodin 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.
In such cases, symptoms of overdose have been observed.
Concurrent use of Acodin and secretolytic medicines in patients with existing lung disease, such as cystic fibrosis or bronchiectasis, in whom excessive mucus secretion occurs, may lead to increased mucus retention due to weakened cough reflex.

Acodin with food, drink and alcohol
Food does not affect absorption of the medicine from the gastrointestinal tract.
The medicine may be taken with or without food.
Do not consume alcoholic beverages while taking dextromethorphan. Dextromethorphan enhances the effect of alcohol on the central nervous system.

Use of Acodin in children
Acodin tablets are not intended for use in children under 12 years of age.
The medicine may be used in adolescents aged 12 years and older.

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 her doctor or pharmacist before using this medicine.
High doses of dextromethorphan may cause respiratory depression in newborns, even if used for a short period. Use of Acodin during pregnancy should always be under medical supervision.
Acodin is contraindicated during breastfeeding, as respiratory depression in infants cannot be excluded.

Driving and operating machinery
Acodin, even when used as directed, may cause mild drowsiness or dizziness and may alter reaction time to an extent that impairs the ability to drive or operate machinery. This risk is increased if the medicine is taken together with alcohol. When used in doses higher than recommended, it has a depressant 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 certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Acodin

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Acodin 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: the daily dose must not exceed 120 mg
of dextromethorphan (8 tablets).
The maximum duration of treatment should not exceed 3 days. If there is no improvement after 3 days,
or if the patient feels worse, consult a doctor.
Acodin may be taken with food or independently of meals.
If the effect of Acodin seems too strong or too weak, consult a doctor.
Taking more Acodin than recommended
If more Acodin has been taken than recommended, seek immediate advice from a doctor or
pharmacist.
If a patient takes more Acodin than recommended, the following symptoms may occur:
nausea and vomiting, involuntary muscle spasms, agitation, confusion, drowsiness, disturbances
of consciousness, involuntary rapid eye movements, cardiac disorders (rapid heartbeat),
coordination disturbances, 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 or go to a hospital.
Missing a dose of Acodin
If a dose of Acodin is missed, take it as soon as possible,
except when it is almost time for the next dose. 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, dizziness.

Common (affects less than 1 in 10 people):

disorientation, fatigue;
gastrointestinal disturbances (nausea, vomiting, constipation).

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

drug dependence.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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

Store the medicine at a temperature below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
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 properly dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Acodin contains

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

What Acodin looks like and contents of the pack
The pack contains 10, 20 or 30 tablets in PVC/Aluminum blisters, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer:
STADA Arzneimittel AG
Stadastrasse 2-18
611118 Bad Vilbel
Germany