Dexapini

Package Leaflet: Information for the Patient

DEXAPINI, (426 mg + 65 mg + 6.5 mg)/5 ml, Syrup

Pine extract fluid + Fennel tincture + Dextromethorphan hydrobromide

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 7 days or the patient feels worse, a doctor should be contacted.

Table of Contents of the Package Leaflet

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

1. What is Dexapini and what is it used for

Dexapini is a syrup containing dextromethorphan hydrobromide and auxiliary substances: pine fluid extract and fennel fruit tincture.
Dextromethorphan hydrobromide is a cough suppressant. Its action, lasting 6-8 hours, involves inhibiting the cough center in the central nervous system, thereby reducing the frequency of dry cough attacks.

Indications:

• dry cough in the course of upper respiratory tract inflammatory conditions, such as colds, flu, pharyngitis.

2. Important information before taking Dexapini

When not to take Dexapini

• if the patient is allergic to the active substances or to plants of the Apiaceae family (formerly Umbelliferae) (anise, caraway, celery, coriander, and dill), or to anethole, or to any of the other ingredients of this medicine (listed in section 6);
• in case of cough with a large amount of secretions;
• in patients with asthma;
• in patients with severe liver disease;
• in patients with respiratory failure or risk of its occurrence;
• if the patient is taking monoamine oxidase inhibitors (MAOIs) and for 14 days after discontinuation of MAOI treatment;
• in patients taking selective serotonin reuptake inhibitors (SSRIs);
• in patients taking mucolytic agents (thinning mucus in the respiratory tract).

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Warnings and precautions

Before starting treatment with Dexapini, the doctor or pharmacist should be consulted.
Taking this medicine may lead to dependence. Therefore, treatment should be short-term.
Particular caution should be exercised when taking Dexapini if the patient is taking buprenorphine (used to treat acute or chronic pain). Taking buprenorphine with Dexapini may lead to serotonin syndrome, a life-threatening condition (see "Dexapini and other medicines").
If the patient is taking such medicines as certain antidepressants or antipsychotics, Dexapini 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, and exaggerated reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
In case of chronic or persistent cough, a doctor should be consulted before taking the medicine. If symptoms persist for more than 7 days, the patient has a recurring cough or cough with accompanying fever, rash, or persistent headaches, a doctor or pharmacist should be consulted. These may be symptoms of a serious illness.
The recommended doses should not be exceeded.
Cases of abuse of dextromethorphan-containing medicines have been reported. Particular caution is recommended when administering this medicine to adolescents and young adults, as well as to patients with a history of drug or psychoactive substance abuse.
No separate studies have been conducted on the use of dextromethorphan hydrobromide in patients with renal or hepatic impairment.
Due to the intensive hepatic metabolism of dextromethorphan hydrobromide, caution should be exercised in patients with hepatic impairment.
Caution should be exercised in patients with slow CYP2D6 metabolism or those taking CYP2D6 inhibitors, due to the possibility of increased and (or) prolonged effects of dextromethorphan.

Children

Due to the content of dextromethorphan hydrobromide, the medicine may release histamine, so it should be used with caution in children with atopic diseases.
The medicine is not recommended for children under 4 years of age.
In children aged 4 to 6 years, the medicine should be administered after consulting a doctor, and the maximum daily dose should not be exceeded, which is 30 mg of dextromethorphan hydrobromide.

Dexapini and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient, as well as about medicines planned to be taken.
MAOIs
The medicine should not be taken by patients taking MAOIs and for 14 days after discontinuation of MAOI treatment, as serotonin syndrome (high fever, hypertension, arrhythmias) may occur. Serious adverse reactions, sometimes fatal, have been reported after taking dextromethorphan hydrobromide in patients receiving MAOIs.
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Antibiotics
Linezolid: serotonin syndrome has been observed during concomitant use with dextromethorphan hydrobromide.
CYP2D6 inhibitors
Concomitant use of strong CYP2D6 inhibitors may increase the concentration of dextromethorphan in the body to a level several times higher than normal. This increases the risk of toxic effects of dextromethorphan (agitation, disorientation, tremors, insomnia, diarrhea, and respiratory depression) and the development of serotonin syndrome. Strong CYP2D6 inhibitors include fluoxetine, paroxetine, quinidine, and terbinafine. In the case of concomitant use with quinidine, the concentration of dextromethorphan in the serum may increase up to 20 times, increasing the risk of adverse reactions from the central nervous system associated with the use of this medicine. Similar effects on dextromethorphan metabolism are also caused by amiodarone, flecainide, and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine, and thioridazine. In the case of concomitant use of CYP2D6 inhibitors and dextromethorphan, the patient should be monitored, and it may be necessary to reduce the dose of dextromethorphan.
Buprenorphine
Dextromethorphan should not be taken with buprenorphine without prior consultation with a doctor.
This medicine may interact with Dexapini and may cause the patient to experience symptoms such as involuntary, rhythmic muscle contractions, including those of the eye muscles, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, increased muscle tone, body temperature above 38°C. If the patient experiences such symptoms, a doctor should be consulted.
Due to the content of dextromethorphan hydrobromide, concomitant use of the medicine with alcohol or other medicines with a depressant effect on the central nervous system may enhance their depressant effect on the central nervous system and be toxic in relatively small doses.

Dexapini with food, drink, and alcohol

During treatment, it is not recommended to consume alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
The medicine should not be taken by pregnant or breastfeeding women.
There are no data on the effect on fertility.

Driving and using machines

Due to the possibility of drowsiness, caution should be exercised when driving vehicles and operating machines. The ethanol (alcohol) content in the medicine should also be taken into account, a single dose of 15 ml contains up to 1100 mg of ethanol, which corresponds to up to 27 ml of beer, 11.3 ml of wine.

Dexapini contains sucrose and ethanol

The medicine contains 4 g of sucrose in 5 ml of syrup. This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to certain sugars, a doctor should be consulted before taking the medicine.
The medicine contains up to 7% (m/v) ethanol (alcohol), i.e., up to 367 mg per dose (5 ml), which is equivalent to 9 ml of beer, 3.75 ml of wine per dose (5 ml).
The medicine contains up to 7% (m/v) ethanol (alcohol), i.e., up to 1100 mg per dose (15 ml), which is equivalent to 27 ml of beer, 11.3 ml of wine per dose (15 ml).
Harmful to people with alcoholism.
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This should be taken into account when administering the medicine to pregnant or breastfeeding women, children, and people at high risk, such as patients with liver disease or epilepsy.

3. How to take Dexapini

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
Oral administration.
Recommended dose:

• children from 6 to 11 years: 5 ml of syrup three times a day;
• adolescents from 12 years and adults: 15 ml of syrup three times a day.

Children and adolescents

In case of overdose in children, serious adverse reactions, including neurological disorders, may occur. Caregivers should not administer a dose larger than recommended.

Taking a higher dose of Dexapini than recommended

If the patient takes a higher dose of Dexapini than recommended, the following symptoms may occur:
nausea and vomiting, involuntary muscle contractions, agitation, 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, a doctor should be consulted immediately or the patient should go to the hospital.

Missing a dose of Dexapini

Missing a dose of the medicine does not have a significant impact on the course of treatment. Treatment should be continued with the previously used dosage. A double dose should not be taken to make up for the missed dose.

Stopping treatment with Dexapini

The medicine is intended for use in case of symptoms.
In case of any doubts related to the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (less than 1 in 1,000 people):

• drowsiness.

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

• allergic reactions from the skin and respiratory system;
• agitation, confusion;
• dizziness, convulsions;
• respiratory depression;
• vomiting, nausea, diarrhea;
• rash.

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Reporting side effects

If any side effects occur, including those not listed in this package leaflet, the doctor or pharmacist should be informed. 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.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Dexapini

The medicine should be stored in a tightly closed package, at a temperature not exceeding 25°C.
The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the package. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the package and other information

What Dexapini contains

• The active substances of the medicine are dextromethorphan hydrobromide, pine extract, and fennel tincture. 5 ml of syrup contains: dextromethorphan hydrobromide - 6.5 mg; pine fluid extract (DER 1:1.6), [extractant: ethanol 90% (V/V)] - 426 mg; fennel fruit tincture (DER 1:5), [extractant: ethanol 70% (V/V)] - 65 mg.
• Other ingredients of the medicine are: sucrose, phosphoric acid, calcium lactate pentahydrate, purified water. The medicine contains up to 7% (m/v) ethanol (alcohol).

What Dexapini looks like and what the package contains

A brown glass bottle with a polyethylene cap and a measuring cup in a cardboard box.
1 bottle of 115 ml

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

„Herbapol-Lublin” S.A.
ul. Diamentowa 25, 20-471 Lublin
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Date of the last update of the package leaflet:

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