Patient Information Leaflet

TUSSIDEX
30 mg, Soft Capsules
Dextromethorphani hydrobromidum
Please read this leaflet carefully before using the medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

Keep this leaflet for future reference.
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, pharmacist, or nurse. See section 4.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of Contents:

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

1. What Tussidex is and what it is used for

Tussidex is an antitussive medicine. It suppresses cough by acting on the cough center located in the medulla oblongata.
Tussidex is used temporarily for symptomatic treatment of acute, dry cough not associated with mucus accumulation in the respiratory tract.
If there is no improvement after 7 days, or if you feel worse, you should consult your doctor.

2. Important information before using Tussidex

When not to use Tussidex:

if the patient is allergic to dextromethorphan hydrobromide or any of the other ingredients of this medicine (listed in section 6);
in bronchial asthma;
in patients with chronic cough, pulmonary emphysema, or chronic bronchitis;
in severe hepatic impairment;
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;
in breastfeeding women.

Warnings and precautions
Use of this medicine may lead to dependence. Therefore, treatment should be short-term.
Before starting to use Tussidex, discuss this with your doctor, pharmacist, or nurse:

If the patient is taking medicines such as certain antidepressants or antipsychotics, Tussidex may interact with them, causing changes in mental state (e.g. excitement, hallucinations, stupor) and other symptoms such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflex responses, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).

If, despite using the medicine, cough persists for more than 7 days, or if the illness is accompanied by fever, headache, or rash, contact a doctor.
Do not use the medicine for productive cough (cough with mucus).
In case of hepatic impairment, the dose of dextromethorphan should be reduced due to possible impairment of drug metabolism.
Due to the risk of overdose, check whether other medicines currently taken contain dextromethorphan.

Children and adolescents
Do not use Tussidex in children under 12 years of age.
In adolescents aged 12 to 16 years, do not use Tussidex without clear instructions from a doctor.

Tussidex and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Dextromethorphan used simultaneously with monoamine oxidase inhibitors (medicines used, among others, in depression) or within 14 days after discontinuation of such medicines, may cause stupor, dizziness, excitement, nausea, hallucinations, coma, high fever, and increased blood pressure. Therefore, dextromethorphan should not be taken during treatment with monoamine oxidase inhibitors or within 14 days after stopping such treatment (see section "When not to use Tussidex").
Consult a doctor before using Tussidex if the patient is taking the following medicines:

quinidine, amiodarone (medicines used in cardiac arrhythmias); concomitant use of these medicines with dextromethorphan may increase adverse effects;
fluoxetine (a medicine used in depression); concomitant use of this medicine with dextromethorphan may increase adverse effects;
medicines with central nervous system depressant effects, e.g. sedatives, hypnotics, anxiolytics; concomitant use of these medicines with dextromethorphan may enhance central nervous system depression.

Use of Tussidex with alcohol
Do not consume alcohol or take medicines containing alcohol during treatment with dextromethorphan.

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.
Use of this medicine during pregnancy is not recommended.
Dextromethorphan passes into breast milk; therefore, the medicine should not be used in breastfeeding women.
In infants breastfed by mothers taking dextromethorphan, hypotension and respiratory depression may occur.

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

Tussidex contains sorbitol
The medicine contains 8.26 mg of sorbitol per capsule.

Tussidex contains carmine (E 124)
The medicine may cause allergic reactions.

Tussidex contains propylene glycol
The medicine contains 25 mg of propylene glycol per capsule.

3. How to use Tussidex

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.

Recommended dose:
Adults and adolescents aged 12 years and older: the usual dose is 1 capsule every 6–8 hours.
Do not take more than 4 capsules in 24 hours (120 mg of dextromethorphan bromide).
This medicine is for oral use.

Taking more Tussidex than recommended
Overdose and (or) dependence on dextromethorphan are rare and usually occur after prolonged use of high doses of this medicine.
If a patient takes more Tussidex than recommended, the following symptoms may occur:
nausea and vomiting, involuntary muscle contractions, restlessness, 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 large overdose may include: coma, severe breathing difficulties, and seizures.
If any of the above symptoms occur, seek immediate medical attention or go to a hospital. In case of overdose, symptomatic treatment is recommended.

Missed dose of Tussidex
Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed during the use of dextromethorphan:

Uncommon (less frequent than in 1 out of 1,000 patients but more frequent than in 1 out of 10,000 patients): stomach pain, constipation or diarrhoea, nausea, vomiting, disorientation, drowsiness, dizziness, headache;
Very rare (less frequent than in 1 out of 10,000 patients, including isolated cases):
Allergic reactions: rash, urticaria, angioedema (a serious allergic reaction causing swelling of the face, lips, tongue or throat, which may cause breathing difficulties), bronchospasm leading to breathing difficulties or wheezing.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw,
Tel.: +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 allows the collection of additional information on the safety of the medicine.

5. How to store Tussidex

Keep this medicine out of the sight and reach of children.
Store below 25 °C. Keep in the original packaging.
Do not use this medicine after the expiry date stated on the carton and blister pack. 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. These measures will help protect the environment.

6. Contents of the packaging and other information

What Tussidex contains

The active substance is dextromethorphan hydrobromide, 30 mg in one capsule.
The other components (excipients) are: macrogol 400, monoethyl ether of diethylene glycol, glycerol, propylene glycol, gelatin, sorbitol (dry residue from 70% sorbitol solution), carmine red (E 124), purified water.

What Tussidex looks like and contents of the pack
Tussidex is in the form of pink, oval soft capsules with a smooth, glossy surface.
One pack contains 10 or 15 soft capsules.
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
e-mail: [email protected]