Dexacaps

Package Leaflet: Information for the Patient

DexaCaps, (167 mg + 50 mg + 20 mg)/capsule, hard capsule

Tiliae inflorescentiae extractum siccum + Melissae folii extractum siccum+ 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 patient leaflet or as directed by a doctor or pharmacist.

• The 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 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 consulted.

Table of Contents of the Leaflet

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

1. What is DexaCaps and what is it used for

DexaCaps contains dextromethorphan hydrobromide and auxiliary substances: dry extracts of lime flowers and lemon balm leaves. Dextromethorphan hydrobromide is a cough suppressant. Its action is based on inhibiting the cough center in the central nervous system, which reduces the frequency of dry cough attacks.

Indications:

In cases of exhausting, dry cough of various origins, not related to the accumulation of secretions in the respiratory tract.

2. Important information before taking DexaCaps

When not to take DexaCaps

• if the patient is allergic to the active substances 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 bronchial 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 within 14 days after their discontinuation;
• 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 DexaCaps, the patient should discuss it with a doctor or pharmacist.
Particular caution should be exercised when taking DexaCaps if the patient is taking buprenorphine (used to treat acute or chronic pain). Taking buprenorphine with DexaCaps may lead to serotonin syndrome, a life-threatening condition (see "DexaCaps and other medicines").
If the patient is taking such medicines as certain antidepressants or antipsychotics, DexaCaps 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, 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 a 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, the patient should consult a doctor or pharmacist. These may be symptoms of a serious illness.
Taking this medicine may lead to dependence. Therefore, treatment should be short-term.
The recommended doses should not be exceeded.
Cases of abuse of medicines containing dextromethorphan have been reported. Particular caution is recommended when taking 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 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.

DexaCaps and other medicines

The patient should inform the doctor or pharmacist about all medicines being taken currently or recently, as well as any medicines planned to be taken.
MAOIs
It is not recommended to take the medicine with MAOIs, as dextromethorphan hydrobromide enhances their effect, which manifests as drowsiness, nausea, high fever, and increased blood pressure.
After discontinuing MAOIs, a 14-day interval should be maintained.
Antibiotics
Linezolid: serotonin syndrome has been observed during concurrent use with dextromethorphan hydrobromide.
CYP2D6 inhibitors
Concomitant use of strong CYP2D6 enzyme inhibitors may increase the concentration of dextromethorphan in the body to a level much higher than normal. This increases the risk of toxic effects of dextromethorphan (excitement, disorientation, tremors, insomnia, diarrhea, and respiratory depression) and the development of serotonin syndrome. Strong 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 even 20-fold, which increases the risk of adverse effects 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 case of necessary concomitant use of CYP2D6 inhibitors and dextromethorphan, the patient should be monitored. It may also 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 DexaCaps and may cause the patient to experience symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movements, excitement, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, body temperature above 38°C. If the patient experiences such symptoms, they should consult a doctor.
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 and be toxic in relatively small doses.

DexaCaps with food, drink, and alcohol

The medicine should be taken after a meal, swallowing the capsule whole and drinking an appropriate amount of fluid.
During treatment, it is not recommended to consume alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
This 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.

3. How to take DexaCaps

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
Oral administration.
Adolescents over 12 years and adults: 1 capsule three times a day after a meal.
The daily dose of dextromethorphan hydrobromide should not exceed 120 mg.
The medicine should be taken by swallowing the capsule whole and drinking an appropriate amount of fluid.

Taking a higher dose of DexaCaps than recommended

Dextromethorphan hydrobromide is considered a low-toxicity compound; however, symptoms of its overdose are exacerbated when taken with alcohol and psychotropic drugs.
If the patient takes a higher dose of DexaCaps 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.

Missing a dose of DexaCaps

Missing a dose of the medicine does not significantly affect the course of the treatment. The treatment should be continued with the previously used dosage. A double dose should not be taken to make up for the missed dose.

Stopping the use of DexaCaps

The medicine is intended for use when symptoms occur.
In case of doubts related to the use of this medicine, the 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 of the skin and respiratory system;
• excitement, confusion;
• dizziness, convulsions;
• respiratory depression;
• vomiting, nausea, diarrhea;
• rash.

Reporting side effects

If any side effects occur, including those not listed in this 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store DexaCaps

Store in a tightly closed package, at a temperature not exceeding 25°C. Protect from moisture.
The medicine should be stored in a place invisible and inaccessible to children.
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Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What DexaCaps contains

• The active substances of the medicine are dextromethorphan hydrobromide, dry extract of lime flowers, and dry extract of lemon balm leaves. Each capsule contains: dextromethorphan hydrobromide - 20.0 mg, dry extract of lime flowers (DER 2.5-3:1) - 167.0 mg (excipient: maltodextrin up to 30%), [extraction solvent: ethanol 70% (V/V)] and dry extract of lemon balm leaves (DER 6-8:1) - 50.0 mg, [extraction solvent: purified water].
• Other ingredients are: maize starch, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate. Capsule shell: yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), gelatin.

What DexaCaps looks like and contents of the pack

PVC/PVDC/Aluminum blisters in a cardboard box.
10, 30, 60, or 90 capsules
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba

Date of the last update of the leaflet:

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