Tussidex mite

Leaflet included in the packaging: patient information

TUSSIDEX mite

15 mg, soft capsules

Dextromethorphan hydrobromide
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or according to the
recommendations of a doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if necessary.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Tussidex mite and what is it used for
• 2. Important information before using Tussidex mite
• 3. How to use Tussidex mite
• 4. Possible side effects
• 5. How to store Tussidex mite
• 6. Contents of the packaging and other information

1. What is Tussidex mite and what is it used for

Tussidex mite is a cough suppressant medicine. It works by blocking the cough center in the brain.

Indications for use

Tussidex mite is used for the symptomatic treatment of acute, dry cough, not associated with the accumulation of secretions in the airways.

2. Important information before using Tussidex mite

When not to use Tussidex mite:

• if the patient is allergic to dextromethorphan or any of the other ingredients of the medicine (listed in section 6),
• in asthma,
• in patients with chronic cough, pulmonary emphysema, chronic bronchitis,
• in severe liver failure,
• in respiratory failure or if there is a risk of its occurrence,
• in children under 12 years of age,
• if the patient is using monoamine oxidase inhibitors (MAOIs) or has taken them within the last 14 days (see also the section "Tussidex mite and other medicines"),
• in breastfeeding women.

Warnings and precautions

Before starting to use Tussidex mite, you should discuss it with your doctor or pharmacist.

• if, despite using the medicine, the cough persists for more than 7 days, or the disease is accompanied by fever, headache, rash, you should contact your doctor,
• depending on the degree of liver failure determined by the doctor, you should follow the section "When not to use Tussidex mite", or reduce the dose of the medicine due to its slowed metabolism and increased risk of accumulation,
• the medicine should not be used in case of cough with expectoration,
• during treatment with dextromethorphan, you should not consume alcohol or take medicines containing alcohol,
• the medicine contains dextromethorphan - due to the risk of overdose, you should check if other medicines taken at the same time do not contain dextromethorphan.

Tussidex mite and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, as well as about medicines you plan to take.
Dextromethorphan used at the same time as monoamine oxidase inhibitors (medicines used, among others, in depression) and within 14 days after stopping the use of such medicines may cause the occurrence of agitation, dizziness, excitement, nausea, hallucinations, drowsiness, and increased blood pressure. Therefore, you should not take dextromethorphan during treatment with monoamine oxidase inhibitors or within 14 days after stopping treatment with such medicines (see the section "When not to use Tussidex mite").
Before using Tussidex mite, you should consult your doctor if you are taking the following medicines:

• quinidine, amiodarone (medicines used in heart rhythm disorders); concurrent use of these medicines with dextromethorphan may enhance side effects,
• fluoxetine (a medicine used in depression); concurrent use of this medicine with dextromethorphan may enhance side effects,
• medicines acting on the central nervous system, such as sedatives, sleeping pills, antihistamines; concurrent use of these medicines with dextromethorphan may enhance the sedative effect on the central nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
The use of the medicine is not recommended during pregnancy.
Dextromethorphan passes into breast milk, so you should not use the medicine if you are breastfeeding. In infants breastfed by mothers using dextromethorphan, there may be a decrease in blood pressure and respiratory depression.

Driving and using machines

You should be cautious, as the medicine may impair your ability to drive and use machines (there is a risk of drowsiness and dizziness).

Tussidex mite contains sorbitol

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Tussidex mite contains carmoisine

The medicine may cause allergic reactions.

3. How to use Tussidex mite

This medicine should always be used exactly as described in the patient leaflet or according to the recommendations of a doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
The medicine is used orally.
Adults and children over 12 years: 15 to 30 mg (1 to 2 capsules) every 6 to 8 hours.
You should not use more than 120 mg of dextromethorphan hydrobromide per day (8 capsules per day).

Using a higher dose of Tussidex mite than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately consult your doctor or pharmacist.
Symptoms of overdose include: disorientation, drowsiness, dizziness, nausea, vomiting, nervous excitement, anxiety, irritability. There may also be respiratory function disorders.
After significant overdose, symptoms of psychotic intoxication (nervous excitement, visual and auditory hallucinations) and drowsiness and convulsions may occur.
Overdose and (or) dependence on dextromethorphan are rare and occur after long-term use of high doses.
In case of overdose, symptomatic treatment is recommended.

Missing a dose of Tussidex mite

You should not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with dextromethorphan, the following side effects may occur:
Rarely(occurring in 1 to 10 patients out of 10,000):

• allergic reactions: rash, urticaria, angioedema (severe allergic reaction causing swelling of the face, lips, tongue, or throat, which may cause difficulty breathing, bronchospasm causing breathing difficulties or wheezing),
• disorientation, drowsiness, dizziness, headache,
• stomach pain, constipation or diarrhea, nausea, vomiting.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw,
tel. +48 22 49 21 301, fax: + 48 22 49 21 309,
e-mail: ndl@urpl.gov.pl.
Thanks to the reporting of side effects, it is possible to gather more information on the safety of the use of the medicine.

5. How to store Tussidex mite

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C, in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tussidex mite contains

• The active substance of the medicine is dextromethorphan hydrobromide. One soft capsule contains 15 mg of dextromethorphan hydrobromide.
• The other ingredients (excipients) are: macrogol 400, ethyl ether of diethylene glycol, glycerol, propylene glycol, purified water; the ingredients of the capsule shell are: gelatin, glycerol, sorbitol (dry residue from 70% sorbitol solution), carmoisine (E 124), purified water.

What Tussidex mite looks like and what the packaging contains

Tussidex mite is a transparent, oval, pink capsule with a smooth surface.
One packaging of the medicine contains 10, 15, 20, or 30 soft capsules in a cardboard box with a patient leaflet.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information about the medicine
tel.
+48 (22) 742 00 22
email: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet: