Inovox for cough honey-lemon flavor

Patient Information Leaflet

Inovox na kaszel smak miodowo-cytrynowy
10 mg, hard pastilles
Dextromethorphani hydrobromidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken 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 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 the patient feels worse, consult a doctor.

Table of Contents

1. What Inovox na kaszel smak miodowo-cytrynowy is and what it is used for
2. Important information before taking Inovox na kaszel smak miodowo-cytrynowy
3. How to take Inovox na kaszel smak miodowo-cytrynowy
4. Possible side effects
5. How to store Inovox na kaszel smak miodowo-cytrynowy
6. Contents of the pack and other information

1. What Inovox na kaszel smak miodowo-cytrynowy is and what it is used for

Inovox na kaszel smak miodowo-cytrynowy contains the active substance dextromethorphan hydrobromide, which acts as a cough suppressant: it suppresses the cough reflex through direct action on the central nervous system.
Inovox na kaszel smak miodowo-cytrynowy is indicated for the symptomatic treatment of non-productive cough (irritating, dry cough without sputum production) 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, consult a doctor.

2. Important information before using Inovox na kaszel smak miodowo-cytrynowy

Use of this medicine may lead to dependence. Therefore, treatment should be short-term.

When not to use Inovox na kaszel smak miodowo-cytrynowy:

• 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 severe lung disease.
• If the patient has asthma.
• If the patient has a cough with a large amount of mucus (productive cough).
• If the patient is taking or has taken within the last two weeks monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease or other conditions, as well as other selective serotonin reuptake inhibitors (SSRIs) used in the treatment of depression such as fluoxetine, paroxetine and sertraline; or also with bupropion, which is a medicine used to help stop smoking, or linezolid, which is an antibacterial medicine.
• If the patient is taking or has taken within the last two weeks procarbazine, selegiline (see section: Inovox na kaszel smak miodowo-cytrynowy and other medicines).

Warnings and precautions

Before taking Inovox na kaszel smak miodowo-cytrynowy, discuss with your doctor or pharmacist:

• If the patient is taking medicines such as certain antidepressants or antipsychotics, Inovox na kaszel smak miodowo-cytrynowy may interact with them, causing changes in mental status (e.g. agitation, hallucinations, coma) and other symptoms such as body temperature above 38°C, increased heart rate, unstable blood pressure, as well as exaggerated reflex responses, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
• If the patient has persistent or chronic cough, such as smoker's cough. Especially in children, as chronic cough may be an early sign of asthma.
• If the patient has liver disease.
• If the patient has atopic dermatitis (an inflammatory skin disease characterized by redness, itching, oozing, scabs and peeling, which usually begins in infancy and occurs in individuals with a hereditary tendency to allergy).
• If the patient is taking sedatives, is debilitated or bedridden.

Cases of abuse of medicines containing dextromethorphan have been reported in adolescents; therefore, this possibility should be considered, as it may cause serious adverse effects (see section: "Use of a higher than recommended dose of Inovox na kaszel smak miodowo-cytrynowy").

Inovox na kaszel smak miodowo-cytrynowy and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Do not use Inovox na kaszel smak miodowo-cytrynowy if the patient is taking or has taken any of the following medicines within the last two weeks, as they may cause agitation, increase blood pressure or raise body temperature above 40°C (hyperpyrexia):

• Antidepressant monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine, phenelzine, nialamide),
• Selective serotonin reuptake inhibitors (SSRIs) (paroxetine, fluoxetine, sertraline),
• Bupropion (used to help stop smoking),
• Linezolid (an antibacterial medicine),
• Procarbazine (an anticancer medicine),
• Selegiline (a medicine used in Parkinson's disease).

Consult a doctor before taking Inovox na kaszel smak miodowo-cytrynowy if the patient is taking any of the following medicines, as dose adjustment or discontinuation of treatment may be necessary:

• Amiodarone and quinidine (antiarrhythmic medicines),
• Anti-inflammatory medicines (celecoxib, parecoxib or valdecoxib),
• Medicines acting on the central nervous system (some of which are used to treat: psychiatric disorders, allergies, Parkinson's disease, etc.),
• Expectorants and mucolytics (used to remove phlegm and mucus).

Inovox na kaszel smak miodowo-cytrynowy with food, drink and alcohol

Drinking alcohol while taking dextromethorphan may cause adverse effects; therefore, alcoholic beverages should not be consumed during treatment.

Do not take dextromethorphan together with grapefruit juice or bitter orange juice, as this may increase the occurrence of adverse effects.

Pregnancy, breastfeeding and fertility

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

There is a lack of well-documented studies on the safety of use.

The medicine may be used only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus. Use of the medicine during pregnancy, especially during the first trimester, is not recommended.

This medicine should not be used during breastfeeding.

Driving and operating machinery

In rare cases, dizziness or drowsiness may occur during treatment. Therefore, this should be taken into account when driving or operating machinery.

Inovox na kaszel smak miodowo-cytrynowy contains sucrose and glucose

The medicine contains 1.6 g of sucrose and 0.85 g of glucose per hard tablet. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

Inovox na kaszel smak miodowo-cytrynowy contains propylene glycol

The medicine contains 0.18 mg of propylene glycol in each hard tablet.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Inovox na kaszel smak miodowo-cytrynowy

This medicine should always be used 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:

• At the onset of cough, dissolve one tablet in the mouth, up to a maximum of two tablets, every 4 to 6 hours as needed.
• Do not exceed 12 tablets (120 mg) per day, or exceed individual doses.
• Always use the lowest effective dose.

Children and adolescents
This medicine is contraindicated in children under 12 years of age.

Method of administration
For oral use. The tablets should be dissolved in the mouth; do not chew or swallow them whole.
Do not take this medicine with grapefruit juice, bitter orange juice, or alcohol (see section: "Inovox na kaszel smak miodowo-cytrynowy with food, drink and alcohol").

Consult a doctor if the patient's condition worsens or if cough persists for more than 3 to 5 days, or if it is accompanied by fever, skin rash, or persistent headache.

Overdose of Inovox na kaszel smak miodowo-cytrynowy
If a patient takes more than the recommended dose of Inovox na kaszel smak miodowo-cytrynowy, 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 a hospital.

Following ingestion of higher than recommended doses of Inovox na kaszel smak miodowo-cytrynowy, symptoms such as disorientation, excitation, anxiety, nervousness, or irritability may be observed.

Accidental swallowing of high doses may cause stupor, hallucinations, hysteria, nervousness, nausea, vomiting, or gait disturbances in children.

There have been reports of sporadic abuse of dextromethorphan, particularly among adolescents, leading to serious adverse effects such as: anxiety, panic, memory loss, tachycardia (rapid heartbeat), lethargy, hypertension or hypotension, dilated pupils, restlessness, dizziness, gastrointestinal disturbances, hallucinations, speech disorders, nystagmus, fever, rapid breathing, brain damage, ataxia (impaired motor coordination), seizures, respiratory depression, loss of consciousness, cardiac arrhythmias, and death.

Missed dose of Inovox na kaszel smak miodowo-cytrynowy
Do not take a double dose to make up for a missed dose.

If you have any further doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been reported during the use of dextromethorphan:

Uncommon adverse reactions (occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients):

• vomiting, gastrointestinal disturbances
• drowsiness, dizziness, excitation, convulsions, disorientation
• skin reactions including rash

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

• respiratory depression

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 to provide more information on the safety of the medicine.

5. How to store Inovox na kaszel smak miodowo-cytrynowy

Keep this medicine out of sight and reach of children.
There are no special storage temperature requirements for this medicine.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the container following: EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Inovox na kaszel smak miodowo-cytrynowy contains

• The active substance is dextromethorphan hydrobromide. Each hard pastille contains 10 mg of dextromethorphan hydrobromide.
• The other ingredients are: polyacrylic acid resin (cross-linked), liquid glucose, sucrose, sodium saccharin (E 954), citric acid monohydrate, sodium hydroxide (for pH adjustment), flavour lemon 051416T (natural flavouring substances, flavouring substances, flavouring preparations, alpha-tocopherol (E 307)), flavour honey 051672A (glyceryl triacetate (E 1518), flavouring substances, propylene glycol (E 1520), natural flavouring substances, flavouring preparations, triethyl citrate (E 1505)), light liquid paraffin, liquid wax.

What Inovox na kaszel smak miodowo-cytrynowy looks like and contents of the pack
Inovox na kaszel smak miodowo-cytrynowy is yellow, round hard pastilles with a honey-lemon flavour.
Pack sizes available: 12 and 24 hard pastilles.
The pack consists of a PVC/PE/PVDC/Aluminium blister in a cardboard box.
Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
ul. Ziębicka 40, 50-507 Wrocław
{logo of the marketing authorisation holder}
Importer
FARMALIDER, S.A.
C/ Aragoneses, 2
28108, Alcobendas (Madrid),
Spain
For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:
USP Zdrowie Sp. z o.o.,
ul. Poleczki 35, 02-822 Warsaw,
tel. +48 (22) 543 60 00.