Tussidex

Package Leaflet: Information for the Patient

TUSSIDEX

30 mg, Soft Capsules

Dextromethorphan Hydrobromide

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Used Exactly as Described in this Patient Leaflet or as Advised by a Doctor, Pharmacist, or Nurse.

• Keep this Leaflet, so you can Read it Again if you Need to.
• If you Need Advice or Further Information, Consult a Pharmacist.
• If you Experience any Side Effects, including those not Listed in this Leaflet, Tell your Doctor, Pharmacist, or Nurse. See Section 4.
• If there is no Improvement or you Feel Worse after 7 Days, Consult a Doctor.

Table of Contents of the Leaflet:

• 1. What is Tussidex and what is it used for
• 2. Important Information Before Taking Tussidex
• 3. How to Take Tussidex
• 4. Possible Side Effects
• 5. How to Store Tussidex
• 6. Contents of the Pack and Other Information

1. What is Tussidex and what is it used for

Tussidex is a Medication with an Antitussive Effect. It Suppresses Cough by Inhibiting the Cough Center in the Brainstem.

Tussidex is Used for the Symptomatic Treatment of Acute, Dry Cough, not Associated with the Production of Excessive Mucus in the Airways.

If there is no Improvement or you Feel Worse after 7 Days, Consult a Doctor.

2. Important Information Before Taking Tussidex

When not to Take Tussidex:

• If you are Allergic to Dextromethorphan Hydrobromide or any other Ingredient of this Medication (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 you are Taking Monoamine Oxidase Inhibitors (MAOIs) or have Taken them in the Last 14 Days;
• In Breastfeeding Women.

Warnings and Precautions

Taking this Medication can Lead to Dependence. Therefore, Treatment should be Short-term.

Before Taking Tussidex, Discuss it with your Doctor, Pharmacist, or Nurse:

• If you are Taking certain Medications, such as some Antidepressants or Antipsychotics, Tussidex 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, Stiffness, Lack of Coordination, and (or) Gastrointestinal Symptoms (e.g., Nausea, Vomiting, Diarrhea).

If, despite Taking the Medication, the Cough Persists for more than 7 Days, or the Disease is Accompanied by Fever, Headache, Rash, Consult a Doctor.

Do not Take this Medication for Cough with Expectoration.

In Case of Liver Failure, Reduce the Dose of Dextromethorphan due to the Possibility of Impaired Metabolism of the Medication.

Due to the Risk of Overdose, Check if other Medications Taken at the same Time do not Contain Dextromethorphan.

Children and Adolescents

Do not Take Tussidex in Children Under 12 Years of Age.

In Adolescents Aged 12 to 16 Years, do not Take Tussidex without Clear Doctor's Recommendations.

Tussidex and other Medications

Tell your Doctor or Pharmacist about all Medications you are Currently Taking or have Recently Taken, as well as any Medications you Plan to Take.

Dextromethorphan Taken at the same Time as Monoamine Oxidase Inhibitors (MAOIs) and within 14 Days after Stopping these Medications may Cause Hypotension, Dizziness, Excitement, Nausea, Hallucinations, Coma, High Fever, and Increased Blood Pressure. Therefore, do not Take Dextromethorphan while being Treated with MAOIs or within 14 Days after Stopping these Medications (see "When not to Take Tussidex").

Before Taking Tussidex, Consult a Doctor if you are Taking the following Medications:

• Quinidine, Amiodarone (Medications used in Heart Rhythm Disorders); Concurrent Use of these Medications with Dextromethorphan may Enhance Side Effects;
• Fluoxetine (a Medication used in Depression); Concurrent Use of this Medication with Dextromethorphan may Enhance Side Effects;
• Medications that Act as Central Nervous System Depressants, such as Sedatives, Hypnotics, Anxiolytics; Concurrent Use of these Medications with Dextromethorphan may Enhance the Depressant Effect on the Central Nervous System.

Taking Tussidex with Alcohol

Do not Consume Alcohol or Take Medications Containing Alcohol while being Treated with Dextromethorphan.

Pregnancy and Breastfeeding

If you are Pregnant or Breastfeeding, Think you may be Pregnant, or Plan to have a Child, Consult a Doctor or Pharmacist before Taking this Medication.

It is not Recommended to Take this Medication during Pregnancy.

Dextromethorphan Passes into Breast Milk, so do not Take this Medication while Breastfeeding.

In Infants Breastfed by Mothers Taking Dextromethorphan, there may be a Decrease in Blood Pressure and Respiratory Arrest.

Driving and Operating Machinery

Be Cautious, as this Medication may Impair your Ability to Drive or Operate Machinery (there is a Risk of Drowsiness and Dizziness).

Tussidex Contains Sorbitol

The Medication Contains 8.26 mg of Sorbitol in each Capsule.

Tussidex Contains Carmoisine (E 124)

The Medication may Cause Allergic Reactions.

Tussidex Contains Propylene Glycol

The Medication Contains 25 mg of Propylene Glycol in each Capsule.

3. How to Take Tussidex

Always Take this Medication Exactly as Described in this Patient Leaflet or as Advised by a Doctor, Pharmacist, or Nurse.

The Recommended Dose is:

Adults and Adolescents over 12 Years: Usually Take 1 Capsule every 6-8 Hours.

Do not Exceed the Maximum Daily Dose of 4 Capsules (120 mg of Dextromethorphan Hydrobromide).

Take the Medication Orally.

Overdose of Tussidex

Overdose and (or) Dependence on Dextromethorphan are Rare, usually Occurring after Prolonged Use of High Doses of this Medication.

If you have Taken more than the Recommended Dose of Tussidex, you may Experience the following Symptoms:

Nausea and Vomiting, Involuntary Muscle Contractions, Excitement, Confusion, Drowsiness, Impaired Consciousness, Involuntary Rapid Eye Movements, Cardiovascular Disorders (Rapid Heart Rate), Coordination Disorders, Psychosis with Visual Hallucinations, and Increased Irritability.

Other Symptoms of a Large Overdose may Include: Coma, Severe Respiratory Disturbances, and Seizures.

Other Overdose Symptoms Include: Disorientation, Dizziness, Anxiety, Irritability.

If you Experience any of these Symptoms, Seek Medical Attention Immediately.

Missed Dose of Tussidex

Do not Take a Double Dose to Make up for a Missed Dose.

If you have any Further Questions about Taking this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Tussidex can Cause Side Effects, although not Everybody gets them.

The following Side Effects have been Observed during Treatment with Dextromethorphan:

• Rare (less than 1 in 1000 Patients, but more than 1 in 10,000 Patients) - Stomach Pain, Constipation or Diarrhea, Nausea, Vomiting, Disorientation, Drowsiness, Dizziness, Headache;
• Very Rare (less than 1 in 10,000 Patients, including Single Cases)
• Allergic Reactions: Rash, Urticaria, Angioedema (a Severe Allergic Reaction that can Cause Swelling of the Face, Lips, Tongue, or Throat, which can Make Breathing Difficult, Bronchospasm that can Cause Difficulty Breathing or Wheezing).

Reporting Side Effects

If you Experience any Side Effects, including those not Listed in this Leaflet, Tell your Doctor, Pharmacist, or Nurse.

Side Effects can be Reported Directly to the Department of Post-Marketing Surveillance 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,

Website: https://smz.ezdrowie.gov.pl

Side Effects can also be Reported to the Marketing Authorization Holder.

Reporting Side Effects will Help to Gather more Information on the Safety of this Medication.

5. How to Store Tussidex

Keep the Medication out of Sight and Reach of Children.

Store in a Temperature below 25°C. Store in the Original Packaging.

Do not Take this Medication after the Expiration Date Stated on the Box and Blister. The Expiration Date refers to the Last Day of the Specified Month.

Do not Dispose of Medications through Sewage or Household Waste. Ask your Pharmacist how to Dispose of Medications that are no longer Needed. This will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Tussidex Contains

• The Active Substance of the Medication is Dextromethorphan Hydrobromide, 30 mg in one Capsule.
• Other Ingredients (Excipients) are: Macrogol 400, Ethyl Ether of Diethylene Glycol, Glycerol, Propylene Glycol, Gelatin, Sorbitol (Dry Residue from 70% Sorbitol Solution), Carmoisine (E 124), Purified Water.

What Tussidex Looks like and what the Pack Contains

The Medication is in the Form of Oval, Pink, Smooth, and Shiny Capsules.

One Pack of the Medication Contains 10 or 15 Soft Capsules.

Marketing Authorization Holder and Manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.

51-131 Wrocław, ul. Żmigrodzka 242 E

Medication Information

Phone: +48 22 742 00 22

Email: informacjaoleku@hasco-lek.pl

Date of the Last Update of the Leaflet: