TUSSI 5 mg /5 Ml Syrup

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Tussi Drill, 5 mg/5 ml, Syrup
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
3. What is Tussi Drill and What is it Used for
   1. Indications for Use:
4. Important Information Before Taking Tussi Drill
   1. When Not to Take Tussi Drill:
   2. Warnings and Precautions
   3. Children
   4. Tussi Drill and Other Medications
   5. Tussi Drill and Alcohol
   6. Pregnancy, Breastfeeding, and Fertility
   7. Driving and Operating Machinery
   8. Tussi Drill Contains Ethanol
   9. Tussi Drill Contains Maltitol
   10. Tussi Drill Contains Methyl Parahydroxybenzoate Sodium (E 219) and Propyl Parahydroxybenzoate Sodium
   11. Tussi Drill Contains Sodium
   12. Tussi Drill Contains Glucose
   13. Tussi Drill Contains Propylene Glycol (E 1520)
   14. Tussi Drill Contains Sulfur Dioxide (E 220)
5. How to Take Tussi Drill
   1. Children and Adolescents
   2. Taking a Higher than Recommended Dose of Tussi Drill
   3. Missing a Dose of Tussi Drill
6. Possible Undesirable Effects
   1. Reporting Undesirable Effects
7. How to Store Tussi Drill
8. Contents of the Pack and Other Information
   1. What Tussi Drill Contains
   2. What Tussi Drill Looks Like and What the Pack Contains
   3. Marketing Authorization Holder
   4. Manufacturer
   5. Date of the Last Update of the Leaflet:

Package Leaflet: Information for the Patient

Tussi Drill, 5 mg/5 ml, Syrup

Dextromethorphan Hydrobromide

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

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

• Keep this Leaflet to be Able to Read it Again if Necessary.
• If Advice or Additional Information is Needed, Consult a Pharmacist.
• If the Patient Experiences any Undesirable Effects, Including any Undesirable Effects not Listed in this Leaflet, they Should Inform their Doctor or Pharmacist. See Section 4.
• If there is no Improvement After 5 Days or the Patient Feels Worse, they Should Consult a Doctor.

Table of Contents of the Leaflet

• 1. What is Tussi Drill and What is it Used for
• 2. Important Information Before Taking Tussi Drill
• 3. How to Take Tussi Drill
• 4. Possible Undesirable Effects
• 5. How to Store Tussi Drill
• 6. Contents of the Pack and Other Information

1. What is Tussi Drill and What is it Used for

Tussi Drill Syrup Belongs to a Group of Medications Used to Suppress and Relieve Dry Cough, Known as Antitussive Medications.
This Medication is an Oral Syrup for Short-Term Treatment of Acute, Dry Cough.
The Medication is Intended for Children Over 6 Years of Age.

Indications for Use:

For Acute, Dry Cough.
If there is no Improvement After 5 Days or the Patient Feels Worse, they Should Consult a Doctor.

2. Important Information Before Taking Tussi Drill

When Not to Take Tussi Drill:

If the Patient is Allergic to Dextromethorphan or any of the Other Ingredients of this Medication (Listed in Section 6).
If the Patient has Breathing Difficulties (Respiratory Failure or Risk of Respiratory Failure).
If the Patient has Severe Obstructive Pulmonary Disease (Narrowing of the Airways in the Lungs) or Asthma.
If the Patient is Taking Antidepressant Medications from the Group of Monoamine Oxidase Inhibitors (MAOIs) or has Taken such Medications in the Last 14 Days.
If the Patient is Taking a Medication Containing Cinacalcet (a Medication that Lowers Parathyroid Hormone Levels in the Blood).
If the Patient is Breastfeeding.
In Children Under 6 Years of Age.

Warnings and Precautions

Taking this Medication can Lead to Dependence. Therefore, Treatment Should be Short-Term.
Consult a Doctor or Pharmacist Before Giving this Medication to a Child.
There are Two Types of Cough: Dry Cough and Wet Cough (with Secretion). Tussi Drill Should not be Used to Treat Wet Cough. It Should be Remembered that Wet Cough is an Important Defense Mechanism of the Airways and Lungs, Serving to Remove Bronchial Secretion, and Therefore Should not be Suppressed.
Cough is a Symptomatic Condition and if there is no Improvement Within 5 Days or the Cough Recurs Despite Taking the Medication, a Doctor Should be Consulted to Determine the Cause of the Cough and to Initiate Appropriate Treatment.
Tussi Drill Should not be Used if there is Chronic or Persistent Cough or if there is Cough with Excessive Secretion.
Before Starting Tussi Drill, the Patient Should Talk to a Doctor or Pharmacist:
If the Patient has Liver Disease (Liver Function Disorders, Liver Failure), as there is Insufficient Data on the Use of the Medication in Patients with Liver Function Disorders,
If the Patient is Taking Certain Antidepressant or Antipsychotic Medications, as Tussi Drill may Interact with them, Causing Changes in Mental Status (e.g., Excitement, Hallucinations, Coma) and Other Symptoms, such as Body Temperature Above 38°C, Increased Heart Rate, Unstable Blood Pressure, as well as Exaggerated Reflex Reactions, Muscle Stiffness, Lack of Coordination, and (or) Gastrointestinal Symptoms (e.g., Nausea, Vomiting, Diarrhea).
During Treatment, the Doctor Should be Informed if:
The Cough Becomes a Wet Cough with Secretion that Blocks the Airways, or if the Patient has a Fever.
If there is no Improvement After 5 Days of Treatment.
If the Patient Feels Worse.
During Treatment, the Patient Should Avoid Consuming Alcoholic Beverages and Medications Containing Alcohol (see: "Tussi Drill and Other Medications").

Children

Tussi Drill Should not be Given to Children Under 6 Years of Age.

Tussi Drill and Other Medications

The Patient Should Tell their Doctor or Pharmacist About all Medications they are Currently Taking or have Recently Taken, as well as any Medications they Plan to Take.
Concomitant Use of Other Antitussive Medications is not Recommended to Avoid Exceeding the Maximum Recommended Dose of the Medication.
While Taking Tussi Drill, the Patient Should not Take:

• Antidepressant Medications, Including Monoamine Oxidase Inhibitors (MAOIs), e.g., Moclobemide;
• Medications Containing Cinacalcet (Medications that Lower Parathyroid Hormone Levels in the Blood);
• Expectorant Medications;

The Patient Should Also Avoid Concomitant Use of Tussi Drill with Alcohol and Medications Containing Alcohol, as the Sedative Effect of the Antitussive Medication is Enhanced by Alcohol.
Before Taking Tussi Drill with the Following Medications, the Patient Should Consult a Doctor, as Caution is Required when Taking them Concomitantly:

• Medications that Act on the Central Nervous System: Opioids (Pain Relievers, Antitussive Medications, Products Used in Opioid Substitution Therapy), Antipsychotic Medications (Neuroleptics), Barbiturates; Benzodiazepines, Anxiolytic Medications Other than Benzodiazepines, Sleep Aids; Medications Used to Treat Sleep Disorders Associated with Depression; Medications Used to Treat High Blood Pressure (Hypertension);
• Anticholinergic Medications (Including Imipramine Derivatives, Antispasmodic Medications, Anticholinergic Medications Used to Treat Parkinson's Disease);
• Medications Used to Treat Depression (Fluoxetine, Paroxetine, Sertraline, Fluvoxamine, Bupropion);
• Medications Used to Treat Arrhythmias (Amiodarone, Propafenone, Quinidine, Flecainide, Dyzopyramide);
• Pain Relievers (Methadone);
• Antifungal Medications (Terbinafine);
• Medications Used to Treat Mental Disorders (Haloperidol, Perphenazine, Thioridazine);
• Antihistamine Medications (Used in Case of Allergic Reactions);
• Medications Used to Treat Attention Deficit Hyperactivity Disorder (ADHD) in Children;
• Baclofen (Used to Relax Muscles in Conditions such as Multiple Sclerosis, Cerebral Palsy, or Other Conditions Affecting the Brain and Nervous System);
• Thalidomide (Used to Treat Multiple Myeloma).

Cautious Use of Tussi Drill is also Recommended with Other Opioid Derivatives not Listed Above.
In Case of Doubt, Whether the Patient is Taking any of the Above Medications, they Should Consult a Doctor.

Tussi Drill and Alcohol

This Section Does not Apply to Tussi Drill, as it is Intended for Children Over 6 Years of Age. However, the Following Information is Relevant to the Active Substance of the Medication, Dextromethorphan Hydrobromide.
Tussi Drill may Cause Drowsiness and Dizziness. This Effect may be Enhanced by Concomitant Consumption of Alcohol, as the Sedative Effect of the Antitussive Medication is Enhanced by Alcohol. The Patient Should Avoid Alcoholic Beverages and Medications Containing Alcohol.

Pregnancy, Breastfeeding, and Fertility

This Section Does not Apply to Tussi Drill, as it is Intended for Children Over 6 Years of Age. However, the Following Information is Relevant to the Active Substance of the Medication, Dextromethorphan Hydrobromide.
If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant, or is Planning to have a Child, they Should Consult a Doctor or Pharmacist Before Taking this Medication.
Pregnancy
Tussi Drill Should not be Used During Pregnancy and in Women of Childbearing Age not Using Effective Contraception.
High Doses of Dextromethorphan Given in the Late Stage of Pregnancy may Lead to Respiratory Depression in the Newborn. Even Short-Term Use of Dextromethorphan, Regardless of Dose, by Women in the Third Trimester of Pregnancy may Cause Withdrawal Syndrome in Newborns.
Due to the Alcohol Content, Tussi Drill Should not be Used During Pregnancy.
Breastfeeding
Dextromethorphan Taken in Doses Higher than Recommended may Cause Respiratory Depression and Decreased Muscle Tone in Infants.
Dextromethorphan is Contraindicated During Breastfeeding.

Driving and Operating Machinery

Since the Medication is Intended Only for Children, these Recommendations are Informative.
When Taking this Medication, the Following Undesirable Effects may Occur: Drowsiness and Dizziness, which may be Hazardous when Driving or Operating Machinery.
Alcohol may Enhance the Sedative Effect of Dextromethorphan (the Active Substance of Tussi Drill).

Tussi Drill Contains Ethanol

The Medication Contains 18 mg of Alcohol (Ethanol) in 5 ml of Syrup. The Amount of Alcohol in 5 ml of the Medication is Equivalent to Less than 1 ml of Beer or 1 ml of Wine.
The Small Amount of Alcohol in this Medication will not Have Noticeable Effects.

Tussi Drill Contains Maltitol

5 ml of Syrup Contains 5 g of Liquid Maltitol. If the Patient has Previously been Diagnosed with Intolerance to some Sugars, they Should Consult a Doctor Before Taking the Medication. The Medication may have a Mild Laxative Effect. The Energy Value of 2.3 kcal/g Maltitol.

Tussi Drill Contains Methyl Parahydroxybenzoate Sodium (E 219) and Propyl Parahydroxybenzoate Sodium

The Medication may Cause Allergic Reactions (Possible Late-Stage Reactions).

Tussi Drill Contains Sodium

The Medication Contains Less than 1 mmol (23 mg) of Sodium per Dose (5 ml of Syrup), i.e., the Medication is Considered "Sodium-Free".

Tussi Drill Contains Glucose

If the Patient has Previously been Diagnosed with Intolerance to some Sugars, they Should Consult a Doctor Before Taking the Medication.

Tussi Drill Contains Propylene Glycol (E 1520)

The Medication Contains 23.5 mg of Propylene Glycol in 5 ml of Syrup, which Corresponds to a Maximum Daily Dose of 4.7 mg/kg Body Weight/Day.

Tussi Drill Contains Sulfur Dioxide (E 220)

The Medication may Rarely Cause Severe Hypersensitivity Reactions and Bronchospasm.

3. How to Take Tussi Drill

This Medication Should Always be Taken Exactly as Described in this Patient Leaflet or as Advised by a Doctor or Pharmacist.
In Case of Doubt, the Patient Should Consult a Doctor or Pharmacist.
The Medication is Intended for Children Over 6 Years of Age.
The Maximum Single Dose of Dextromethorphan Hydrobromide in Children is 0.25 mg/kg Body Weight.
This Dose can be Given no More than 4 Times a Day, at Intervals of not Less than 6 Hours, e.g., for a Child Weighing 20 kg: 1 Measuring Spoon 4 Times a Day.
The Smallest Effective Dose Should be Used.
A Single Dose Greater than 0.25 mg/kg Body Weight Should not be Taken.
The Daily Dose Should not Exceed 1 mg/kg Body Weight.
Symptomatic Treatment Should be Short-Term (up to 5 Days). If there is no Improvement After 5 Days or the Patient Feels Worse, a Doctor Should be Consulted.
Tussi Drill Should be Used Only for the Short-Term Treatment of Acute, Dry Cough.
The Maximum Dose Should not be Exceeded.
1 Measuring Spoon Contains 5 ml of Syrup (5 mg of Dextromethorphan Hydrobromide).
The Medication Should be Taken Orally, Using a Measuring Spoon. After Each Use, the Measuring Spoon Should be Rinsed with Water.

Children and Adolescents

In Case of Overdose in Children, Severe Undesirable Effects may Occur, Including Neurological Disorders. Caregivers Should not Give a Dose Greater than Recommended.

Taking a Higher than Recommended Dose of Tussi Drill

If the Patient Takes a Higher Dose of Tussi Drill than Recommended, the Following Symptoms may Occur:
Nausea and Vomiting, Involuntary Muscle Contractions, Excitement, Confusion, Drowsiness, Impaired Consciousness, Involuntary Rapid Eye Movements, Cardiovascular Disorders (Rapid Heartbeat), Coordination Disorders, Psychosis with Visual Hallucinations, and Increased Excitability.
Other Symptoms of a Large Overdose may Include: Coma, Severe Respiratory Depression, and Seizures.
In Case of any of the Above Symptoms, the Patient Should Immediately Consult a Doctor or Go to the Hospital.

Missing a Dose of Tussi Drill

A Double Dose Should not be Taken to Make up for a Missed Dose.
If a Dose is Missed, the Next Dose Should be Taken as Soon as Possible, if the Patient is Still Coughing. However, the Patient Should not Take More than the Recommended Daily Dose of the Medication.

4. Possible Undesirable Effects

Like all Medications, Tussi Drill can Cause Undesirable Effects, although not Everybody will Experience them.
The Following Undesirable Effects may Occur (the Frequency of these Effects is Unknown (Cannot be Estimated from the Available Data)):
Nausea, Vomiting, Constipation.
Drowsiness, Dizziness.
Allergic Reactions, such as: Itching, Rash, Urticaria, Redness, Swelling of the Face, Tongue, and Throat, Difficulty Breathing, which may Appear Suddenly. In Case of an Allergic Reaction, the Medication Should be Discontinued and a Doctor Consulted Immediately.
There have been Reports of Dextromethorphan Abuse to Improve Mood and Cause Hallucinations, Particularly in Young People, Adolescents, and Patients who Abuse Medications or Psychotropic Substances (see also Section "Warnings and Precautions").

Reporting Undesirable Effects

If any Undesirable Effects Occur, Including any Undesirable Effects not Listed in the Leaflet, the Patient Should Inform their Doctor or Pharmacist. Undesirable Effects can be Reported Directly to the Department of 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, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Help to Gather More Information on the Safety of the Medication

5. How to Store Tussi Drill

The Medication Should be Stored in a Place that is Inaccessible to Children.
The Medication Should not be Used After the Expiration Date Stated on the Carton and Bottle: EXP. The Expiration Date Refers to the Last Day of the Specified Month.
There are no Special Precautions for Storing the Medication.
Shelf Life After First Opening the Bottle: 5 Days.
The Medication Should not be Used After the Expiration Date.
Medications Should not be Disposed of in the Drain or Household Waste Containers. The Patient Should Ask a 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 Tussi Drill Contains

• The Active Substance of the Medication is Dextromethorphan Hydrobromide. 5 ml (1 Measuring Spoon) of Syrup Contains 5 mg of Dextromethorphan Hydrobromide.
• The Other Ingredients are: Liquid Maltitol, Methyl Parahydroxybenzoate Sodium (E 219), Propyl Parahydroxybenzoate Sodium, Caramel Flavor 28A103 (including Glucose Syrup, Ethanol, Flavoring Substances, Caffeine, Propylene Glycol (E 1520), and Sulfur Dioxide (E 220) - see Section 2), Lactic Acid, Purified Water.

What Tussi Drill Looks Like and What the Pack Contains

Tussi Drill is a Thick, Transparent, Almost Colorless Syrup.
Packaging: 150 ml of Syrup, in a Glass Bottle, in a Cardboard Box with a 5 ml Measuring Spoon.

Marketing Authorization Holder

PIERRE FABRE MEDICAMENT
Les Cauquillous
81500 Lavaur
France

Manufacturer

PIERRE FABRE MEDICAMENT PRODUCTION
Site PROGIPHARM
Rue du Lycée
45500 Gien
France
To Obtain More Detailed Information, the Patient Should Contact the Representative of the Marketing Authorization Holder:
Pierre Fabre Medicament Polska sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw
tel. 22 559 63 00

Date of the Last Update of the Leaflet: