Patient Information Leaflet

TUSSIDEX mite
15 mg, soft capsules
Dextromethorphani hydrobromidum
Please read carefully this leaflet before using the medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

Contents of this leaflet:

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

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

Tussidex mite is an antitussive medicine. It suppresses cough by inhibiting the cough center located in the medulla oblongata.
Indications
Tussidex mite is indicated for short-term symptomatic treatment of acute, dry cough not associated with mucus accumulation in the respiratory tract.

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 bronchial asthma,
in patients with chronic cough, pulmonary emphysema, or chronic bronchitis,
in severe heart failure,
in respiratory insufficiency or if there is a risk of its occurrence,
in children under 12 years of age,
if the patient is taking monoamine oxidase inhibitors (MAOIs) or has taken such medicines within the last 14 days (see also section "Tussidex mite and other medicines"),
in breastfeeding women.

Warnings and precautions

Before starting treatment with Tussidex mite, consult your doctor or pharmacist.

if, despite treatment, cough persists for more than 7 days, or if the illness is accompanied by fever, headache, or rash, contact your doctor,
depending on the degree of heart failure determined by the doctor, follow the instructions in the section "When not to use Tussidex mite", or reduce the dose due to slowed metabolism and increased risk of accumulation,
the medicine should not be used in cases of productive cough (with expectoration),
alcohol and medications containing alcohol should not be consumed during treatment with dextromethorphan,
the medicine contains dextromethorphan – due to the risk of overdose, check whether other concurrently used medicines also contain dextromethorphan.

Tussidex mite and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking or plan to take.

Dextromethorphan taken simultaneously with monoamine oxidase inhibitors (medicines used, among others, in depression), or within 14 days after discontinuation of such medicines, may cause seizures, dizziness, excitation, nausea, hallucinations, somnolence, high fever, and increased blood pressure. Therefore, dextromethorphan should not be taken during treatment with MAO inhibitors or within 14 days after stopping such treatment (see section "When not to use Tussidex mite").

Before using Tussidex mite, consult your doctor if the patient is taking any of the following medicines:

quinidine, amiodarone (medicines used in cardiac arrhythmias); concomitant use with dextromethorphan may increase the risk of adverse effects,
fluoxetine (a medicine used in depression); concomitant use with dextromethorphan may increase adverse effects,
medicines with central nervous system depressant effects, e.g. sedatives, sleeping pills, antihistamines; concomitant use with dextromethorphan may enhance the depressant effect on the central nervous system.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

The use of this medicine is not recommended during pregnancy.

Dextromethorphan passes into breast milk; therefore, the medicine should not be used in breastfeeding women. In infants breastfed by mothers taking dextromethorphan, low blood pressure and respiratory depression may occur.

Driving and operating machinery

Exercise caution, as the medicine may impair the ability to drive or operate machinery (due to the risk of drowsiness and dizziness).

Tussidex mite contains sorbitol

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Tussidex mite contains carmine (cochineal red)

The medicine may cause allergic reactions.

3. How to take Tussidex mite

This medicine should always be taken exactly as described in the patient leaflet or according to the instructions of a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is taken orally.
Adults and children aged 12 years and older: 15 to 30 mg (1 to 2 capsules) every 6 to 8 hours.
Do not exceed 120 mg of dextromethorphan hydrobromide per day (8 capsules per day).

Taking more than the recommended dose of Tussidex mite
If you take more than the recommended dose of this medicine, seek immediate advice from a doctor or pharmacist.
Symptoms of overdose include: confusion, drowsiness, dizziness, nausea, vomiting, nervous stimulation, restlessness, irritability. Respiratory dysfunction may also occur.
After a significant overdose, symptoms of poisoning with psychotic features (nervous stimulation, visual and auditory hallucinations) as well as stupor and convulsions may appear.
Overdose and/or dependence on dextromethorphan occur rarely, usually after long-term use of high doses.
In case of overdose, symptomatic treatment is recommended.

Missed dose of Tussidex mite
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not in everyone.

The following adverse effects may occur during use of dextromethorphan:

Rare (occurring in 1 to 10 patients out of 10,000):

allergic reactions: rash, urticaria, angioedema (a serious allergic reaction causing swelling of the face, lips, tongue or throat, which may make breathing difficult), bronchospasm causing difficulty in breathing or wheezing,
dizziness, drowsiness, headache,
stomach pain, constipation or diarrhoea, nausea, vomiting.

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 also be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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: [email protected].
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tussidex mite

Keep the medicine out of the sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require. This will help protect the environment.

6. Contents of the package and other information

What Tussidex mite contains

The active substance is dextromethorphan hydrobromide. Each soft capsule contains 15 mg of dextromethorphan hydrobromide.
The other ingredients (excipients) are: macrogol 400, monoethyl ether of diethylene glycol, glycerol, propylene glycol, purified water; capsule shell composition: gelatin, glycerol, sorbitol (dry residue from 70% sorbitol solution), carmine red (E 124), purified water.

What Tussidex mite looks like and contents of the pack
Tussidex mite is a transparent, oval, pink soft capsule with a smooth surface.
One pack contains 10, 15, 20 or 30 soft capsules in a cardboard box together with
the patient leaflet.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel. +48 (22) 742 00 22
email: [email protected]