Dexapico

Package Leaflet: Information for the Patient

DexaPico (1625 mg + 6.5 mg)/5ml, Syrup

Tiliae flos extractum aquosum + 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 advised by a doctor or pharmacist.

• Keep this package 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 package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

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

1. What is DexaPico and what is it used for

DexaPico is a syrup containing dextromethorphan hydrobromide and a linden flower extract.
DexaPico 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.
The linden flower extract soothes irritations of the upper respiratory tract caused by coughing.

Indications:

In cases of persistent, dry cough of various origins, not associated with the accumulation of secretions in the respiratory tract.

2. Important information before taking DexaPico

When not to take DexaPico

• if the patient is allergic to linden flower or dextromethorphan hydrobromide, or any of the other ingredients of this medicine (listed in section 6);
• in case of cough with a large amount of secretion;
• 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 their discontinuation;
• in patients taking selective serotonin reuptake inhibitors (SSRIs);
• in patients taking mucolytic agents (thinning mucus in the respiratory tract).

Warnings and precautions

Before starting treatment with DexaPico, the patient should discuss it with their doctor or pharmacist.
Taking this product may lead to dependence. Therefore, treatment should be short-term.
Particular caution should be exercised when taking DexaPico if the patient is taking buprenorphine (used to treat acute or chronic pain). Taking buprenorphine with DexaPico may lead to serotonin syndrome, a life-threatening disease (see "DexaPico and other medicines").
If the patient is taking certain antidepressants or antipsychotics, DexaPico 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, the patient should consult their doctor before taking the medicine. If the symptoms persist for more than 7 days, the patient has a recurring cough or cough with accompanying fever, rash, or persistent headaches, they should consult their doctor or pharmacist. These may be symptoms of a serious disease.
The recommended dose should not be exceeded.
There have been reports of abuse of medicines containing dextromethorphan. Particular caution is advised when administering this medicine to adolescents and young adults, as well as to patients with a history of abuse of medicinal products or psychoactive substances.
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

The use of the medicine is not recommended in children under 2 years of age, due to the lack of data on the use of the medicine in infants and young children.
In children from 2 to 12 years of age, the medicine should only be administered on the advice of a doctor.

DexaPico 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.
MAOIs
The medicine should not be taken by patients taking MAOIs and for 14 days after discontinuing MAOI treatment, as serotonin syndrome (high fever, hypertension, cardiac arrhythmias) may occur. Serious adverse reactions, sometimes fatal, have been reported after the administration of dextromethorphan hydrobromide to patients receiving MAOIs.
Antibiotics
Linezolid: serotonin syndrome has been observed during concomitant use with dextromethorphan hydrobromide.
CYP2D6 inhibitors
Concomitant use of potent CYP2D6 enzyme 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. Potent CYP2D6 enzyme 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. When concomitantly using 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 DexaPico and cause symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, body temperature above 38°C. If the patient experiences such symptoms, they should contact their doctor.
Due to the presence of dextromethorphan hydrobromide, concomitant use of the medicine with alcohol or other medicines with a central nervous system depressant effect may enhance their depressant effect on the central nervous system and be toxic in relatively small doses.

DexaPico with food, drinks, and alcohol

It is not recommended to consume alcohol during treatment.

Pregnancy and breastfeeding

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.
The medicine should not be taken by pregnant or breastfeeding women.
There is 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.

DexaPico contains sucrose, sodium benzoate, and sodium

The medicine contains 3900 mg 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 some sugars, they should consult their doctor before taking the medicine.
The medicine contains 6.25 mg of sodium benzoate in 5 ml of syrup.
The medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of syrup, which means the medicine is considered "sodium-free".

3. How to take DexaPico

This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist.
In case of doubt, the patient should consult their doctor or pharmacist.
Oral administration.
In children from 2 to 12 years of age, the medicine should only be administered on the advice of a doctor.
Recommended dose

• children from 2 to 6 years of age: 2.5 ml of syrup 3 times a day
• children from 6 to 12 years of age: 5 ml of syrup 3 times a day
• adolescents over 12 years of age and adults: 15 ml of syrup 3 times a day Do not exceed the recommended dose.

Children and adolescents

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

Taking a higher dose of DexaPico than recommended

If the patient takes a higher dose of DexaPico 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, the patient should immediately consult their doctor or go to the hospital.

Missing a dose of DexaPico

Missing a dose of the medicine has no significant impact on the course of treatment. The patient should continue therapy with the previously used dosage.
The patient should not take a double dose to make up for the missed dose.

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):

• agitation, confusion;
• dizziness, convulsions;
• respiratory depression;
• vomiting, nausea, diarrhea;
• rash.

Reporting side effects

If any side effects occur, including those not listed in this package 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store DexaPico

Store in a tightly closed container, at a temperature not exceeding 25°C.
The opalescence of the syrup and the foam layer that may appear on its surface are related to the presence of a natural ingredient and do not constitute a defect of the medicine.
The medicine should be stored 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 specified 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 package and other information

What DexaPico contains

• The active substances of the medicine are linden flower aqueous extract and dextromethorphan hydrobromide. 100 g of syrup contains linden flower aqueous extract (DER 1:5) - 25.0 g and dextromethorphan hydrobromide - 0.1 g.
• The other ingredients are: sucrose, concentrated aronia juice 65%, citric acid monohydrate, sodium benzoate, potassium sorbate, purified water.

What DexaPico looks like and contents of the package

Brown glass bottle with a polyethylene cap and a polypropylene measuring cup with a capacity of 30 ml in a cardboard box.
1 bottle with a capacity of 115 ml.

Marketing authorization holder and manufacturer

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
Date of last update of the package leaflet: August 2024