Patient Information Leaflet

DexaPico (1625 mg + 6.5 mg)/5ml, syrup
Aqueous extract of Tiliae flos + Dextromethorphani hydrobromidum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be taken 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

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

1. What DexaPico is and what it is used for

DexaPico is a syrup containing dextromethorphan hydrobromide and aqueous extract of lime flower (Tiliae flos).
DexaPico is an antitussive medicine. Its effect, lasting 6–8 hours, works by suppressing the cough centre in the central nervous system, thereby reducing the frequency of dry coughing episodes.
The lime flower extract soothes irritation of the upper respiratory tract caused by coughing.
Indications:
For the relief of exhausting, dry cough of various origins, not associated with mucus accumulation in the airways.

2. Important information before using DexaPico

When not to use DexaPico

if the patient is allergic to linden flower or to dextromethorphan hydrobromide, or to any of the other ingredients of this medicine (listed in section 6);
in case of cough with a large amount of mucus;
in patients with bronchial asthma;
in patients with severe liver disease;
in patients with respiratory insufficiency or at risk of its occurrence;
if the patient is currently taking monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuation of such treatment;
in patients taking selective serotonin reuptake inhibitors (SSRIs);
in patients taking mucolytic agents (medicines that thin mucus in the respiratory tract).

Warnings and precautions
Before starting treatment with DexaPico, consult your doctor or pharmacist.
Use of this product may lead to dependence. Therefore, treatment should be short-term.
Particular caution is required when using DexaPico in patients taking buprenorphine (used in the treatment of acute or chronic pain). Concurrent use of buprenorphine and DexaPico may lead to serotonin syndrome, a potentially life-threatening condition (see section "DexaPico with other medicines").
If the patient is taking medicines such as 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, exaggerated reflex responses, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
In case of chronic or persistent cough, consult a doctor before using this medicine. If symptoms persist for more than 7 days, or if the patient experiences recurrent cough accompanied by fever, rash, or persistent headache, medical advice should be sought from a doctor or pharmacist. These may be signs of a serious illness.
Do not exceed the recommended doses.
Cases of abuse of medicines containing dextromethorphan have been reported. Particular caution is advised when using this medicine in adolescents and young adults, as well as in 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 extensive hepatic metabolism of dextromethorphan hydrobromide, caution is required in patients with impaired liver function.
Caution is also required in patients who are poor metabolizers via CYP2D6 or who are concurrently taking CYP2D6 inhibitors, due to the possibility of enhanced and/or prolonged effects of dextromethorphan.

Children
The use of this medicine is not recommended in children under 2 years of age due to lack of data on its use in infants and young children.
In children aged 2 to 12 years, the medicine should be given only on a doctor's advice.

DexaPico with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

MAO inhibitors
This medicine should not be used in patients taking MAO inhibitors or within 14 days after discontinuation of MAO inhibitor therapy, as serotonin syndrome (high fever, hypertension, cardiac arrhythmias) may occur. Severe adverse reactions, and occasionally fatal cases, have been reported after administration of dextromethorphan hydrobromide in patients receiving MAO inhibitors.

Antibacterial agents
Linezolid: serotonin syndrome has been observed during concomitant use with dextromethorphan hydrobromide.

CYP2D6 inhibitors
Concomitant use of strong inhibitors of the CYP2D6 enzyme may increase dextromethorphan concentrations in the body to levels many times higher than normal. This increases the risk of toxic effects of dextromethorphan (agitation, disorientation, tremor, insomnia, diarrhoea, respiratory depression) and development of serotonin syndrome. Strong CYP2D6 inhibitors include fluoxetine, paroxetine, quinidine, and terbinafine. When used concomitantly with quinidine, plasma concentrations of dextromethorphan may increase up to 20-fold, significantly increasing the risk of central nervous system adverse effects associated with this medicine. A similar effect on dextromethorphan metabolism is also caused by amiodarone, flecainide and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine, and thioridazine. If concomitant use of CYP2D6 inhibitors and dextromethorphan is necessary, the patient must be monitored. Dose reduction of dextromethorphan may also be required.

Buprenorphine
Dextromethorphan should not be used together with buprenorphine without prior consultation with a doctor. This medicine may interact with DexaPico and may cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. If such symptoms occur, consult a doctor immediately.

Due to the presence of dextromethorphan hydrobromide, concomitant use of this medicine with alcohol or other central nervous system depressants may enhance their depressive effects on the central nervous system and may be toxic even at relatively low doses.

DexaPico, food, drink and alcohol
Alcohol consumption is not recommended during treatment.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use in pregnant or breastfeeding women.
There are no data available on effects on fertility.

Driving and operating machinery
Due to the possibility of drowsiness, caution should be exercised when driving or operating machinery.

DexaPico contains sucrose, sodium benzoate and sodium
This 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 certain sugars, medical advice should be sought before taking this medicine.
This medicine contains 6.25 mg of sodium benzoate in 5 ml of syrup.
This medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of syrup, meaning the medicine is considered "sodium-free".

3. How to use DexaPico

This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
For oral use.
In children aged 2 to 12 years, this medicine should only be used on the explicit recommendation of a physician.
Recommended dose:

children aged 2 to 6 years: 2.5 ml of syrup three times daily
children aged 6 to 12 years: 5 ml of syrup three times daily
adolescents over 12 years and adults: 15 ml of syrup three times daily
Do not exceed the recommended dosage.

Children and adolescents
In cases of overdose in children, serious adverse effects may occur, including neurological disorders.
Caregivers should not administer doses higher than recommended.
Taking more DexaPico than recommended
If a patient takes more DexaPico than recommended, the following symptoms may occur:
nausea and vomiting, involuntary muscle contractions, excitation, confusion, drowsiness, disturbances
of consciousness, involuntary rapid eye movements, cardiac disorders (rapid heartbeat), coordination
impairment, psychosis with visual hallucinations, and increased excitability.
Other symptoms of a significant overdose may include: coma, severe respiratory depression, and seizures.
If any of the above symptoms occur, seek immediate medical advice or go to a hospital.
Missing a dose of DexaPico
Missing a dose of the medicine has no significant impact on the ongoing treatment. Continue therapy
as previously prescribed.
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody experiences them.
Rare (less frequent than in 1 out of 1,000 people):

somnolence.

Frequency unknown (frequency cannot be estimated from available data):

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

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 DEXApico

Store in tightly closed packaging at a temperature not exceeding 25°C.
Opalescence of the syrup and a foam layer that may appear on its surface are related to the presence of a naturally derived ingredient and do not indicate a defect in the medicinal product.
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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What DexaPico contains

The active substances in this medicine are aqueous extract of lime flower and dextromethorphan hydrobromide. 100 g of syrup contains aqueous extract of lime flower (DER 1:5) – 25.0 g and dextromethorphan hydrobromide – 0.1 g.
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 pack
An amber glass bottle with a polyethylene cap with a tamper-evident ring and a polypropylene measuring cup,
in a cardboard box.
1 bottle with a capacity of 115 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
„Herbapol-Lublin” S.A.
ul. Diamentowa 25, 20-471 Lublin