Acodin 150 Iunior

Package Leaflet: Information for the User

ACODIN 150 Junior (7.5 mg + 50 mg)/5 ml, syrup
Dextromethorphan hydrobromide + Dexpanthenol

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Acodin 150 Junior and what is it used for
• 2. Important information before taking Acodin 150 Junior
• 3. How to take Acodin 150 Junior
• 4. Possible side effects
• 5. How to store Acodin 150 Junior
• 6. Contents of the pack and other information

1. What is Acodin 150 Junior and what is it used for

Acodin 150 Junior is available in the form of 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. In the applied doses, it does not have a suppressive effect on the function of the bronchial mucociliary apparatus (structure responsible for the transport of secreted mucus).
Dexpanthenol plays an important role in metabolism, including the regeneration of mucous membranes of the respiratory tract.
Acodin 150 Junior is used for the symptomatic treatment of dry cough of various origins (not associated with the accumulation of secretions in the respiratory tract).

2. Important information before taking Acodin 150 Junior

This medicine should always be taken according to the doctor's recommendation and in accordance with the indications contained in this patient leaflet. Do not exceed the recommended dosage. Cases of abuse of this medicine have been reported, also by children and adolescents.
Taking this medicine can lead to dependence. Therefore, treatment should be short-term.

When not to take Acodin 150 Junior:

• 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 in depression, Parkinson's disease) or has taken such medicines within the last 14 days (see also the section "Acodin 150 Junior 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 150 Junior, the patient should talk to their doctor, pharmacist, or nurse:

• if the patient is taking such medicines as certain antidepressants or antipsychotics, Acodin 150 Junior 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 gastrointestinal tract (e.g., nausea, vomiting, diarrhea).

Dextromethorphan, the active substance of Acodin 150 Junior, has addictive properties. The recommended treatment time should not be exceeded, as tolerance to dextromethorphan may develop, as well as psychological and physical dependence. 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 7 days or the disease is accompanied by fever, headache, or rash, the patient should consult a doctor.
• Do not use in patients with respiratory diseases associated with increased mucus production, e.g., 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 150 Junior with food, drink, and alcohol").

Acodin 150 Junior and other medicines

The patient should inform 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 150 Junior should not be taken simultaneously with the following medicines:

• monoamine oxidase inhibitors (some medicines used in depression, Parkinson's disease, such as iproniazid, selegiline, moclobemide), as well as within 14 days after the end of treatment with such medicines, as the risk of serotonin syndrome (a condition caused by excessive serotonin in the brain) increases. Concurrent administration 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 150 Junior and medicines that inhibit the CYP2D6 enzyme, which is responsible for the metabolism of dextromethorphan, may lead to an increase in dextromethorphan concentration. 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 150 Junior with food, drink, and alcohol

Acodin 150 Junior syrup can be taken with or without food.
Alcoholic beverages should not be consumed during treatment with dextromethorphan. Dextromethorphan enhances the inhibitory effect of alcohol on the central nervous system.

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 before taking this medicine.
This medicine should not be taken by breastfeeding women.

Driving and using machines

In therapeutic doses, the medicine does not cause impairment of psychophysical abilities, ability to drive vehicles, or operate machinery. When taken in doses higher than recommended, it has an inhibitory effect on the central nervous system.

Acodin 150 Junior contains sucrose and sodium benzoate

5 ml of the 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 the syrup.

3. How to take Acodin 150 Junior

This medicine should always be taken according to the doctor's recommendation or pharmacist's advice. In case of doubts, consult a doctor or pharmacist.
Children and adolescents
In case of overdose in children, severe side effects may occur, including neurological disorders. Caregivers should not give a dose larger than recommended.
The syrup bottle is equipped with a measuring cup for dosing the medicine.
Adults and children over 12 years of age:
10 ml of Acodin 150 Junior syrup up to 4 times a day.
Children between 6 and 12 years of age:
5 ml of Acodin 150 Junior syrup up to 4 times a day.
Acodin 150 Junior syrup can be taken with or without food.
If the patient feels that the effect of Acodin 150 Junior is too strong or too weak, they should consult their doctor.

Taking a higher dose of Acodin 150 Junior than recommended

If the patient takes a higher dose of Acodin 150 Junior 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 a doctor or go to the hospital.
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or pharmacist.

Missing a dose of Acodin 150 Junior

In case of missing a dose, the patient should take it as soon as possible.
Do not take a double dose to make up for the missed dose.
In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Acodin 150 Junior 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 respiratory tract and be life-threatening), bronchospasm, breathing difficulties, and anaphylactic reaction (a severe and life-threatening allergic reaction). In case of such symptoms, the patient should immediately consult a doctor;
• psychotic disorders, including hallucinations;
• involuntary movements, especially in children;
• neurological symptoms, including dizziness of peripheral or central origin, feeling of emptiness in the head, fatigue, 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
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, more information can be collected on the safety of the medicine.

5. How to store Acodin 150 Junior

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. The patient should ask their 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 150 Junior contains

• The active substances of the medicine are dextromethorphan hydrobromide and dexpanthenol. 5 ml of the syrup contains 7.5 mg of dextromethorphan hydrobromide and 50 mg of dexpanthenol.
• The other ingredients are: sodium carmellose, glycerol, sucrose, sodium benzoate, food caramel, citric acid, food raspberry flavor, purified water.

What Acodin 150 Junior looks like and contents of the pack

The pack contains 100 ml of the syrup.
A brown glass bottle containing 100 ml of the syrup with a child-resistant closure and a measuring cup, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:
STADA Arzneimittel AG
Stadastrasse 2-18
6118 Bad Vilbel
Germany
Manufacturer:

• 1. Sanofi-Aventis Sp. z o.o. in Warsaw, Branch in Rzeszów, Production and Distribution Plant in Rzeszów, ul. Lubelska 52, 35-233 Rzeszów
• 2. 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