Tussal Antitussicum

Package Leaflet: Information for the User

Tussal Antitussicum, 15 mg, coated tablets

Dextromethorphan hydrobromide

Before taking the medicine, carefully read the package leaflet, as it contains important information for the patient.

• This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. Keep this leaflet, you may need to read it again.
• If you need advice or additional information, 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 4 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

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

1. What is Tussal Antitussicum and what is it used for

Tussal Antitussicum contains dextromethorphan, an antitussive substance.
Dextromethorphan acts by inhibiting the cough center in the central nervous system.

Indications for use of Tussal Antitussicum are:

• -symptomatic treatment of dry cough of various origins (not related to the accumulation of secretions in the airways).

If after 4 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Tussal Antitussicum

When not to take Tussal Antitussicum:

• if the patient is allergic to dextromethorphan hydrobromide or any of the other ingredients of this medicine (listed in section 6),
• if the patient has asthma or inflammatory conditions of the lower airways,
• if the patient has respiratory failure or is at risk of its occurrence,
• if the patient has severe liver failure,
• if the patient is currently taking monoamine oxidase inhibitors or has taken them within the last 14 days (see also section "Tussal Antitussicum and other medicines"),
• if the patient has a cough with expectoration,
• if the patient is breastfeeding,
• if the child is under 6 years of age.

Warnings and precautions

Taking this medicine may lead to dependence. Therefore, treatment should be short-term.
Before starting treatment with Tussal Antitussicum, the patient should discuss it with their doctor or pharmacist:

• if, despite taking Tussal Antitussicum, the cough persists for more than 4 days and the disease is accompanied by fever, headache, or rash, the patient should immediately consult their doctor,
• in patients with liver function disorders (see also section "When not to take Tussal Antitussicum"). Before taking the medicine, the patient should consult their doctor.

Tussal Antitussicum contains dextromethorphan. Due to the risk of overdose, the patient should check if other medicines taken concurrently do not contain dextromethorphan. Particular caution is recommended when using this product in adolescents and young adults, as well as in patients with a history of drug or psychoactive substance abuse.
During treatment with Tussal Antitussicum, the patient should not drink alcohol.

Tussal Antitussicum and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
The patient should not take Tussal Antitussicum while being treated with monoamine oxidase inhibitors (medicines used, among others, in depression) and for 14 days after the end of treatment with such medicines (see section "When not to take Tussal Antitussicum"), as dextromethorphan taken together with monoamine oxidase inhibitors and within 14 days after the end of treatment with such medicines may cause collapse, coma, nausea, high fever, and increased blood pressure.
Before taking Tussal Antitussicum, the patient should consult their doctor or pharmacist if they are taking the following medicines:

• quinidine, amiodarone, flecainide, propafenone (medicines used in arrhythmias), fluoxetine (a medicine used in depression); these medicines may inhibit the metabolism of dextromethorphan in the liver, which may lead to an increase in its concentration in the blood serum and intensification of side effects.
• medicines with a central nervous system depressant effect, such as sedatives, hypnotics, anxiolytics, antidepressants (paroxetine, sertraline, bupropion), antipsychotics (haloperidol, perphenazine, thioridazine); concurrent use of these medicines with dextromethorphan may enhance the central nervous system depressant effect, which may manifest as excitement, disorientation, tremors, insomnia, diarrhea, and respiratory depression.
• other medicines that inhibit the 2D6 enzyme of the cytochrome P450 enzyme system in the liver and thus inhibit the metabolism of dextromethorphan, such as methadone, terbinafine, cinacalcet.
• certain antidepressant or antipsychotic medicines, Tussal Antitussicum may interact with them, causing changes in mental state (such as 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 (such as nausea, vomiting, diarrhea).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Before taking any medicine, the patient should consult their doctor or pharmacist.
The medicine may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding
Before taking any medicine, the patient should consult their doctor or pharmacist.
It is not known whether dextromethorphan passes into breast milk, therefore, the medicine should not be used in breastfeeding women.

Driving and using machines

Tussal Antitussicum may impair the ability to drive and use machines.

Tussal Antitussicum contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Tussal Antitussicum

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is taken orally.
Forchildren and adolescents from 6 to 16 years of age, Tussal Antitussicum tablets should only be given on
the advice of a doctor.
Children from 6 to 12 years of age
1 tablet every 6-8 hours. The maximum daily dose is 60 mg of dextromethorphan (4 tablets).
Adults and children over 12 years of age
2 tablets every 6-8 hours. The maximum daily dose is 120 mg of dextromethorphan (8 tablets).
Do not exceed the recommended dose.
Children and adolescents
In case of overdose in children, severe side effects may occur, including neurological disorders. Caregivers should not give a higher dose than recommended.

Using Tussal Antitussicum in elderly patients

Dose adjustment is not necessary.

Taking a higher dose of Tussal Antitussicum than recommended

If the patient takes a higher dose of Tussal Antitussicum than recommended, the following symptoms may occur: nausea and vomiting, central nervous system stimulation (excitement, nervousness, anxiety, irritability), dizziness, blurred speech, ataxia, blurred vision, involuntary muscle contractions, confusion, drowsiness, impaired consciousness, involuntary rapid eye movements (nystagmus), 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 their doctor or go to the hospital.
In case of overdose, symptomatic and supportive treatment is recommended.

Missing a dose of Tussal Antitussicum

Do not take a double dose to make up for a missed dose.

Stopping treatment with Tussal Antitussicum

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tussal Antitussicum can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with the medicine:
Gastrointestinal disorders: nausea, vomiting, stomach pain, constipation.
Nervous system disorders:dizziness, drowsiness.
Immune system disorders:allergic reactions: rash, urticaria, angioedema (a severe allergic reaction that causes swelling of the face, lips, tongue, or throat, which may make breathing difficult), bronchospasm (causing difficulty breathing or wheezing).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
phone: +48 22 49 21 301, fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tussal Antitussicum

Store in a temperature below 25°C.
Store in the original package.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tussal Antitussicum contains

• The active substance is dextromethorphan hydrobromide. One tablet contains 15 mg of dextromethorphan hydrobromide.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, magnesium stearate. The coating contains: hypromellose, titanium dioxide, macrogol 400.

What Tussal Antitussicum looks like and contents of the pack

Tussal Antitussicum tablets are round, coated, biconvex, white, with a smooth surface, and have a notch on one side.
The tablet can be divided into two halves.
Packaging:
A carton box containing 10 tablets in a blister pack.
The batch number and expiry date are stated on the outer packaging and blister pack.
The inscription on the blister pack: the first part (embossed with 6 digits) indicates the batch number, and the second part (6 consecutive digits) indicates the expiry date.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:

Poland

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland
phone: 061 66 51 500

Date of revision of the leaflet: