Patient Information Leaflet

DEXAPINI, (426 mg + 65 mg + 6.5 mg)/5 ml, syrup
Pini extractum fluidum + Foeniculi tinctura + Dextromethorphani hydrobromidum
Please read this leaflet carefully before using the 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, as you may need to read it again.
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 or if you feel worse after 7 days, consult your doctor.

Table of Contents

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

1. What Dexapini is and what it is used for

Dexapini is a syrup containing dextromethorphan hydrobromide and supportive active ingredients: pine fluid extract and fennel tincture.
Dextromethorphan hydrobromide is an antitussive agent. Its effect, lasting 6–8 hours, acts by suppressing the cough center in the central nervous system, thereby reducing the frequency of dry cough attacks.
Indications:

Dry cough associated with inflammatory conditions of the upper respiratory tract, such as common cold, influenza, or pharyngitis.

2. Important information before using Dexapini

When not to use Dexapini

if the patient is allergic to the active substances or to plants of the Apiaceae family (formerly Umbelliferae) (such as anise, cumin, celery, coriander, and dill), or to anethole, or to any of the other ingredients of this medicine (listed in section 6);
in cases of productive cough with large amounts 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 drugs (which thin mucus in the respiratory tract).

1313 var IB seq 0015 Pg. 1
Warnings and precautions
Before starting treatment with Dexapini, consult your doctor or pharmacist.
Use of this medicine may lead to dependence. Therefore, treatment should be short-term.
Special caution is required when using Dexapini in patients taking buprenorphine (used to treat acute or chronic pain). Concurrent use of buprenorphine and Dexapini may lead to serotonin syndrome, a potentially life-threatening condition (see section "Dexapini with other medicines").
If the patient is taking medicines such as certain antidepressants or antipsychotics, Dexapini may interact with them, causing changes in mental status (e.g. agitation, hallucinations, coma) and other symptoms such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea).
In cases 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. Extreme 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 specific studies have been conducted on the use of dextromethorphan bromide in patients with renal or hepatic impairment.
Due to the extensive hepatic metabolism of dextromethorphan bromide, caution should be exercised in patients with impaired liver function.
Caution is advised in patients who are poor metabolizers via CYP2D6 or who are concurrently taking CYP2D6 inhibitors, due to the possibility of increased and/or prolonged effects of dextromethorphan.
Children
Due to the presence of dextromethorphan bromide, the medicine may release histamine; therefore, it should be used with caution in children with atopic diseases.
Use of this medicine is not recommended in children under 4 years of age.
In children aged 4 to 6 years, the medicine should only be administered after consultation with a doctor, and the maximum daily dose of 30 mg of dextromethorphan bromide must not be exceeded.
Dexapini with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
MAO inhibitors
This medicine should not be used in patients taking MAO inhibitors or within 14 days after stopping MAOI treatment, as serotonin syndrome (high fever, hypertension, cardiac arrhythmias) may occur. Severe adverse reactions, and occasionally fatal outcomes, have been reported after administration of dextromethorphan bromide in patients receiving MAO inhibitors.
1313 var IB seq 0015 Pg. 2
Antibacterial agents
Linezolid: serotonin syndrome has been observed during concomitant use with dextromethorphan bromide.
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, diarrhea, and respiratory depression) and the 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, 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 closely 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 Dexapini and may cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movement, agitation, hallucinations, coma, excessive sweating, tremor, hyperreflexia, increased muscle tone, and body temperature above 38°C. If such symptoms occur, consult a doctor immediately.
Due to the presence of dextromethorphan bromide, concomitant use of this medicine with alcohol or other centrally acting nervous system depressants may enhance their depressant effects on the central nervous system and may be toxic even at relatively low doses.
Dexapini with 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 women or women who are breastfeeding.
There is 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. The ethanol (alcohol) content of the medicine should also be considered: a single 15 ml dose contains up to 1100 mg of ethanol, equivalent to 27 ml of beer or 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, consult a doctor before using this medicine.
The medicine contains up to 7% (m/v) ethanol (alcohol), i.e. up to 367 mg per dose (5 ml), equivalent to 9 ml of beer or 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), equivalent to 27 ml of beer or 11.3 ml of wine per dose (15 ml).
Harmful for individuals with alcohol dependence.
1313 var IB seq 0015 Pg. 3
This should be taken into account when administering to pregnant or breastfeeding women, children, and individuals in high-risk groups, such as patients with liver disease or epilepsy.

3. How to use Dexapini

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Oral use.
Recommended dose:

children 6 to 11 years: 5 ml of syrup three times daily;
adolescents aged 12 years and adults: 15 ml of syrup three times daily.

Children and adolescents
In the case of overdose in children, severe adverse reactions may occur, including neurological disorders. Caregivers should not administer a dose higher than recommended.
Taking more Dexapini than recommended
If a patient takes more Dexapini 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 (fast heartbeat), coordination disturbances, 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 Dexapini
Missing a dose of the medicine does not have a significant impact on the course of treatment. Continue treatment as previously dosed. Do not take a double dose to make up for a missed dose.
Stopping Dexapini treatment
This medicine is intended for use when symptoms occur.
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in all individuals.
Rare (less than 1 in 1,000 people):

drowsiness.

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

allergic reactions affecting the skin and respiratory system;
agitation, confusion;
dizziness, convulsions;
respiratory depression;
vomiting, nausea, diarrhoea;
rash.

1313 var IB seq 0015 Pg. 4
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Dexapini

Keep the medicine in its tightly closed packaging, at a temperature not exceeding 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dexapini contains

The active substances are dextromethorphan hydrobromide, pine extract, and fennel tincture. 5 ml of syrup contains: dextromethorphan hydrobromide – 6.5 mg; liquid extract of Pinus sylvestris L., turiones (pine shoots, dry) (DER 1:1.6), [extraction solvent: ethanol 90% (V/V)] – 426 mg; tincture of Foeniculum vulgare Miller subsp. vulgare var. vulgare, fructus (fruit of bitter fennel) (DER 1:5), [extraction solvent: ethanol 70% (V/V)] – 65 mg.
Other components of the medicine are: sucrose, concentrated phosphoric acid, calcium lactate pentahydrate, purified water. The medicine contains up to 7% (m/v) ethanol (alcohol).

What Dexapini looks like and contents of the pack
An amber glass bottle with a polyethylene cap and a measuring cup in a cardboard box.
1 bottle with a capacity of 115 ml
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
„Herbapol-Lublin” S.A.
Diamentowa Street 25, 20-471 Lublin
1313 var IB seq 0015 Pg. 5
1313 var IB seq 0015 Pg. 6