Tussifortin

Package Leaflet: Information for the Patient

Tussifortin, 2 mg/mL, Oral Solution

Dextromethorphan Hydrobromide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• 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 this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 to 5 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Tussifortin and what is it used for

Tussifortin is an oral, yellow solution with a strawberry flavor. Tussifortin contains the active substance dextromethorphan hydrobromide. Tussifortin is intended for the symptomatic treatment of non-productive cough (e.g., dry, irritating, without expectoration) in adults and adolescents over 12 years of age.
If there is no improvement after 3 to 5 days or if the patient feels worse, they should consult their doctor.

2. Important information before taking Tussifortin

When not to take Tussifortin:

• If the patient is allergic to dextromethorphan or any of the other ingredients of this medicine (listed in section 6).
• In children under 12 years of age.
• If the patient has asthma cough.
• If the patient has a productive cough (e.g., wet, with expectoration).
• If the patient has respiratory failure.
• If the patient has severe liver failure.
• If the patient is taking or has taken in the last two weeks: antidepressant monoamine oxidase inhibitors (MAOIs); selective serotonin reuptake inhibitors (SSRIs); bupropion; linezolid; procarbazine; selegiline (see section Tussifortin and other medicines).

Warnings and precautions

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

• If the patient is taking certain antidepressants or antipsychotics, Tussifortin 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).

Dextromethorphan metabolism may be impaired in patients with liver disease. If the patient has liver disease, they should consult their doctor. The doctor should take this into account when determining the dosage for such patients.
If the patient is taking sedatives, is weak, or bedridden, they should not take dextromethorphan.
Chronic cough may be an early symptom of asthma, so dextromethorphan is not indicated for relieving chronic cough, especially in children.
Dextromethorphan should not be used for persistent or chronic cough, cough associated with smoking, as it may hinder expectoration, thereby increasing respiratory resistance.
Due to the risk of histamine release, dextromethorphan should be avoided in patients with atopic dermatitis.

Children and adolescents

There have been reports of dextromethorphan abuse, mainly in adolescents. Therefore, the possibility of serious side effects should be considered. The medicine should not be used in children under 12 years of age.

Tussifortin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
The patient should not take Tussifortin if they are taking:

• monoamine oxidase inhibitors (MAOIs) such as pargyline and procarbazine, moclobemide, selegiline, tranylcypromine, isoniazid, and linezolid
• selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine or paroxetine
• serotoninergic medicines, such as bupropion. The patient should not take Tussifortin within two weeks of taking these medicines.

Before taking Tussifortin, the patient should consult their doctor if they are taking:

• strong CYP2D6 inhibitors such as fluoxetine, paroxetine, quinidine, terbinafine, as they may increase the concentration of dextromethorphan in the body to a level much higher than normal, increasing the risk of toxic effects of dextromethorphan (excitement, disorientation, tremors, insomnia, diarrhea, and respiratory depression) and the development of serotonin syndrome.
• amiodarone, flecainide, and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine, and thioridazine.
• celecoxib, parecoxib, or valdecoxib
• psychotropic medicines, antihistamines, or medicines used to treat Parkinson's disease, as they may increase the sedative effect on the central nervous system
• cough and mucolytic medicines.

Tussifortin with food, drink, and alcohol

The patient should not take dextromethorphan with grapefruit juice or bitter orange juice.
Drinking alcohol while taking dextromethorphan may increase the occurrence of side effects and cause mutual enhancement of action, so the patient should not consume alcoholic beverages during treatment.
Taking this medicine with other liquids or food does not affect the efficacy of the medicine.

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
There are no data or only limited data on the use of dextromethorphan in pregnant women.
Animal studies on the harmful effects on reproduction are insufficient.
Tussifortin is not recommended for use during pregnancy and in women of childbearing age not using effective contraception.
Breastfeeding
It is not known whether dextromethorphan and its metabolites pass into breast milk. The risk to newborns and infants cannot be excluded.
The doctor will decide whether to stop breastfeeding or stop taking Tussifortin, considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Fertility
There are no available data.

Driving and using machines

In rare cases, dizziness or drowsiness may occur during treatment, so the patient should take this into account when driving or operating machinery.

Tussifortin contains aspartame (E 951)

Tussifortin contains aspartame. The medicine contains 2 mg of aspartame in each 1 mL of oral solution.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its impaired excretion.

Tussifortin contains sorbitol (E 420)

The patient should not take Tussifortin if they have a rare hereditary fructose intolerance.
Tussifortin contains sorbitol (E 420). The medicine contains 0.575 mg of sorbitol in each 1 mL of oral solution. Sorbitol is a source of fructose. If the patient has previously been diagnosed with an intolerance to some sugars or has a hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their child.

Tussifortin contains propylene glycol

The medicine contains 4.8 mg of propylene glycol in each 1 mL of oral solution, which corresponds to 24 mg in 5 mL.

Tussifortin contains sodium benzoate (E 211)

The medicine contains 3 mg of sodium benzoate in each 1 mL of oral solution.

3. How to take Tussifortin

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

Recommended dose

Adults and adolescents over 12 years of age:
10 mg (5 mL syrup) to 20 mg (10 mL syrup) every 4 hours. The maximum dose is 120 mg per day.
The patient should not take more than 6 doses per day.
The patient can also take 15 mL syrup (30 mg) every 6-8 hours.
The maximum daily dose is 60 mL syrup (120 mg per day).

Method of administration

Oral administration.
The dose of the medicine should be measured with the measuring cup provided with the packaging.
The patient should drink a glass of water after taking the dose. The patient is advised to drink plenty of fluids throughout the day.
The patient should not drink grapefruit juice, bitter orange juice, or alcohol with the medicine.
Taking this medicine with other liquids or food does not affect the efficacy of the medicine.
If the patient's condition worsens or the cough persists for more than 3-5 days, or if it is accompanied by a high fever, skin rash, or persistent headache, they should consult their doctor.

Overdose of Tussifortin

If the patient takes more than the recommended dose of Tussifortin, the following symptoms may occur:
nausea and vomiting, involuntary muscle contractions, excitement, confusion, drowsiness, impaired consciousness, involuntary rapid eye movements, cardiac disorders (rapid heartbeat), coordination disorders, psychosis with visual hallucinations, and increased excitability.
Other symptoms of a large overdose may include: coma, severe respiratory impairment, and seizures.
If any of these symptoms occur, the patient should immediately consult their doctor or go to the hospital.
Symptoms of overdose include disorientation, excitement, anxiety, nervousness, or irritability.
If the patient takes more than the recommended dose of Tussifortin and experiences any of the following symptoms, they should immediately consult their doctor or go to the hospital.
Accidental ingestion of high doses may cause children to feel drowsy or lethargic, have hallucinations, become hysterical, experience facial swelling, excitement, nausea, vomiting, or gait disturbances.
These effects disappear after inducing vomiting and rinsing the stomach.
In case of respiratory depression, naloxone should be administered and respiratory support provided. Naloxone (at a dose of 0.01 mg/kg) has been successfully used to reverse the central or peripheral effects of opioid dextromethorphan in children.
In case of seizures, benzodiazepines should be administered intravenously or rectally, depending on the age.
The decision on the treatment method is made only by the doctor. In case of an overdose, the patient should first consult their doctor or go to the hospital.
There have been reports of sporadic cases of dextromethorphan abuse, especially among adolescents, with serious side effects, such as anxiety, panic, memory loss, tachycardia (tachyarrhythmia), lethargy, hypertension or hypotension, dilated pupils, anxiety, dizziness, gastrointestinal disorders, hallucinations, speech disorders, oculogyric crisis, fever, rapid breathing, brain damage, ataxia (a disorder characterized by difficulties in performing smooth and precise movements), seizures, respiratory depression, loss of consciousness, cardiac rhythm disorders, and death.

Missed dose of Tussifortin

The patient should not take a double dose to make up for a missed dose.

Stopping Tussifortin treatment

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tussifortin can cause side effects, although not everybody gets them.
The following side effects have been reported during treatment with dextromethorphan:
Very rare side effects (occurring in less than 1 in 10,000 patients):

• headache, disorientation

Side effects of unknown frequency (frequency cannot be estimated from the available data):

• drowsiness, dizziness, feeling of spinning
• nausea, vomiting, constipation, feeling of discomfort in the gastrointestinal tract.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side 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:
Jerozolimskie Avenue 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 the medicine.

5. How to store Tussifortin

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the specified month.
There are no special precautions for storing the medicine.
The shelf life of the medicine after first opening: 12 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tussifortin contains

• The active substance of the medicine is dextromethorphan hydrobromide. One mL of oral solution contains 2 mg of dextromethorphan hydrobromide.
• The other ingredients are: aspartame (E 951), sodium benzoate (E 211), liquid, non-crystallizing sorbitol (E 420), sodium saccharin (E 954), povidone K-30, citric acid, strawberry flavor (propylene glycol 96%, 2,3-pentanedione, 2-octyl hexyl, 2-methylvaleric acid, 2-methylbutyric acid, 3-hexen-1-ol, 4-(p-hydroxyphenyl)-2-butanone, 4-hydroxy-2,5-dimethyl-3(2H)-furanone, acetic acid, acetoin, cis-3-hexen-1-yl acetate, ethyl butyrate, ethyl hexanoate, ethyl isovalerate, ethyl 2-methylbutyrate, gamma-decalactone, hexyl alcohol, isoamyl acetate, maltol, methyl cinnamate, methyl salicylate, purified water).

What Tussifortin looks like and contents of the pack

Tussifortin is an oral, yellow solution with a strawberry flavor.
Tussifortin is a clear oral solution, yellow in color, in an orange PET bottle with an aluminum cap with a PE seal, placed in a cardboard box. Each bottle comes with a measuring cup made of PP with the following graduations: 2.5 mL, 5 mL, 7.5 mL, 10 mL, and 15 mL.
Pack sizes: bottles with a capacity of 125 mL and 200 mL with oral solution.

Marketing authorization holder

MEDICOFARMA S.A.
Sokołowska Street 9, local U19
01-142 Warsaw
Phone number: +48 22 654 77 70

Manufacturer

Laboratorios Alcalá Farma S.L.
Avenida de Madrid, 82, Alcalá de Henares,
28802 Madrid
Spain

Date of last revision of the leaflet: