TUSSIFORTIN

Patient Information Leaflet

Tussifortin, 2 mg/mL, oral solution
Dextromethorphani hydrobromidum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 to 5 days, or if your condition worsens, contact your doctor.

Table of Contents

1. What Tussifortin is and what it is 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 Tussifortin is and what it is used for

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

2. Important information before using Tussifortin

When not to use 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 asthmatic cough.
• If the patient has productive (e.g. wet, with expectoration of mucus) cough.
• If the patient has respiratory insufficiency.
• If the patient has severe hepatic impairment.
• If the patient is taking or has taken within the last two weeks: antidepressants - monoamine oxidase inhibitors (MAOIs); antidepressants - selective serotonin reuptake inhibitors (SSRIs); bupropion; linezolid; procarbazine; selegiline (see section Tussifortin with other medicines).

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

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

Dextromethorphan metabolism may be impaired in patients with liver disease. If the patient has liver disease, consult a doctor. The doctor should take this into account when determining dosage for such patients.
Dextromethorphan should not be taken if the patient is taking sedatives, is debilitated, or bedridden.
Chronic cough may be an early symptom of asthma; therefore, dextromethorphan is not indicated for relief of chronic cough, especially in children.
Dextromethorphan should not be used in cases of persistent or chronic cough, or cough related to smoking, as it may hinder expectoration and thus increase airway resistance.
Due to the risk of histamine release, dextromethorphan should be avoided in patients with atopic dermatitis.

Children and adolescents
Cases of dextromethorphan abuse, mainly among adolescents, have been reported. Therefore, the possibility of serious adverse effects should be considered. Tussifortin should not be used in children under 12 years of age.

Tussifortin with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Do not use Tussifortin if the patient is taking:

• antidepressant monoamine oxidase inhibitors (MAOIs) such as: pargyline and procarbazine, moclobemide, selegiline, tranylcypromine, isoniazid, and linezolid
• antidepressant selective serotonin reuptake inhibitors (SSRIs) such as: fluoxetine or paroxetine
• serotonergic drugs such as bupropion. Do not take Tussifortin within two weeks of using the above-mentioned medicines.

Consult a doctor before using Tussifortin if the patient is taking:

• strong inhibitors of the CYP2D6 enzyme such as: fluoxetine, paroxetine, quinidine, terbinafine, as they may increase dextromethorphan concentration in the body to levels many times higher than normal, increasing the risk of toxic effects of dextromethorphan (agitation, disorientation, tremor, insomnia, diarrhoea, respiratory depression) and development of serotonin syndrome.
• amiodarone, flecainide and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine and thioridazine.
• celecoxib, parecoxib or valdecoxib.
• psychotropic drugs, antihistamines or medicines used in the treatment of Parkinson's disease, as they may enhance central nervous system depression.
• expectorants and mucolytics.

Tussifortin with food, drink and alcohol
Do not take dextromethorphan together with grapefruit juice or bitter orange juice.
Drinking alcohol while taking dextromethorphan may increase the occurrence of adverse effects and cause mutual intensification of action; therefore, alcoholic beverages must not be consumed during treatment.
Taking this medicine together with other drinks or food does not affect the medicine's efficacy.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
There are no data or only limited data on the use of dextromethorphan in pregnant women.
Animal studies on harmful effects on reproduction are insufficient.
Tussifortin is not recommended for use during pregnancy or in women of childbearing age who are not using effective contraception.

Breastfeeding
It is unknown whether dextromethorphan and its metabolites pass into human milk. Risk to newborns and infants cannot be excluded.
The doctor will decide whether to discontinue breastfeeding or to discontinue Tussifortin therapy, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Fertility
No data available.

Driving and operating machinery
Rarely, dizziness or drowsiness may occur during treatment. This should be taken 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 improper excretion.

Tussifortin contains sorbitol (E 420)
Do not use in patients with 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 intolerance to certain sugars has previously been diagnosed in the patient (or their child) or if hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, has been diagnosed, the patient should contact a doctor before taking the medicine or giving it to a child.

Tussifortin contains propylene glycol
The medicine contains 4.8 mg of propylene glycol in each 1 mL of oral solution, equivalent 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 use Tussifortin

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
Adults and adolescents over 12 years of age:
10 mg (5 mL of syrup) to 20 mg (10 mL of syrup) every 4 hours. Maximum daily dose is 120 mg.
Do not take more than 6 doses per day.
Alternatively, 15 mL of syrup (30 mg) may be administered every 6 to 8 hours.
Maximum daily dose is 60 mL of syrup (120 mg per day).
Method of administration
For oral use.
The dose should be measured using the measuring device provided with the package.
It is recommended to take the dose with a glass of water. It is advisable to drink plenty of fluids throughout the day.
Do not take this medicine with grapefruit juice, bitter orange juice, or alcohol.
Concomitant administration of this medicine with other liquids or food does not affect its efficacy.
If the patient's condition worsens or cough persists for more than 3–5 days, or if accompanied by high fever, skin rash, or persistent headache, consult a doctor.
Use of a higher than recommended dose of Tussifortin
If a patient takes more than the recommended dose of Tussifortin, the following symptoms may occur:
nausea and vomiting, involuntary muscle spasms, excitation, confusion, drowsiness, disturbances of consciousness, involuntary rapid eye movements, cardiac disorders (rapid heartbeat), coordination disturbances, psychosis with visual hallucinations, and increased excitability.
Other symptoms of severe overdose may include: coma, severe respiratory depression, and seizures.
If any of the above symptoms occur, seek immediate medical attention or go to hospital.
Symptoms of overdose include disorientation, excitation, restlessness, nervousness, or irritability.
If a higher than recommended dose of Tussifortin has been taken or if any of the following symptoms occur, seek immediate medical attention or go to hospital.
Accidental ingestion of high doses may cause drowsiness or lethargy, hallucinations, hysteria, facial swelling, excitation, nausea, vomiting, or gait disturbances in children.
These effects subside after inducing vomiting and gastric lavage.
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 opioid effects of dextromethorphan in children.
In case of seizures, benzodiazepines should be administered intravenously or rectally, depending on age.
The decision on treatment method is made solely by a doctor. In case of overdose, the patient should immediately contact a doctor or go to hospital.
There have been sporadic reports of dextromethorphan abuse, particularly among adolescents, associated with serious adverse effects such as: anxiety, panic, memory loss, tachycardia (rapid heartbeat), lethargy, hypertension or hypotension, pupil dilation, restlessness, dizziness, gastrointestinal disturbances, hallucinations, speech disorders, nystagmus, fever, rapid breathing, brain damage, ataxia (a disorder characterized by difficulty in smooth and precise execution of movements), seizures, respiratory depression, loss of consciousness, cardiac arrhythmias, and death.
Missed dose of Tussifortin
Do not take a double dose to make up for a missed dose.
Discontinuation of Tussifortin
If you have any further questions 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 everybody gets them.

The following adverse reactions have been reported during the use of dextromethorphan:

Very rare adverse reactions (occurring in fewer than 1 in 10,000 patients):

• headache, disorientation

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• drowsiness, dizziness, vertigo
• nausea, vomiting, constipation, gastrointestinal discomfort

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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:
Al. Jerozolimskie 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 helps provide more information on the safety of this medicine.

5. How to store the medicine Tussifortin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Period of validity after first opening: 12 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Tussifortin contains

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

What Tussifortin looks like and contents of the pack
Tussifortin is a yellow oral solution with a strawberry taste.
Tussifortin is a yellow, clear oral solution in an orange PET bottle with an aluminium cap with a PE seal, placed in a cardboard box. Each bottle is supplied with a PP dosing syringe with the following graduations: 2.5 mL, 5 mL, 7.5 mL, 10 mL and 15 mL.
Pack sizes: 125 mL and 200 mL bottles containing oral solution.

Marketing Authorisation Holder
MEDICOFARMA S.A.
Sokołowska Street 9, Unit 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