Inovox na kashel smak miodovo-citrinovi

Package Leaflet: Information for the Patient

Inovox for Cough Honey-Lemon Flavor

10 mg, Hard Tablets

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 package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 to 5 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Inovox for Cough Honey-Lemon Flavor and what is it used for
• 2. Important information before taking Inovox for Cough Honey-Lemon Flavor
• 3. How to take Inovox for Cough Honey-Lemon Flavor
• 4. Possible side effects
• 5. How to store Inovox for Cough Honey-Lemon Flavor
• 6. Contents of the package and other information

1. What is Inovox for Cough Honey-Lemon Flavor and what is it used for

Inovox for Cough Honey-Lemon Flavor contains the active substance dextromethorphan hydrobromide, which acts as an antitussive: it inhibits the cough reflex by directly acting on the central nervous system.
Inovox for Cough Honey-Lemon Flavor is indicated for the symptomatic treatment of non-productive cough (irritating cough, dry cough, without expectoration of secretions) in adults and adolescents over 12 years of age.
If after 3 to 5 days there is no improvement or you feel worse, consult your doctor.

2. Important information before taking Inovox for Cough Honey-Lemon Flavor

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

When not to take Inovox for Cough Honey-Lemon Flavor:

• If you are allergic to dextromethorphan or any of the other ingredients of this medicine (listed in section 6).
• In children under 12 years of age.
• If you have severe lung disease.
• If you have asthma.
• If you have a cough with a large amount of secretions (productive cough).
• If you are taking or have taken in the last two weeks monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease or other diseases, as well as other selective serotonin reuptake inhibitors (SSRIs) used to treat depression such as fluoxetine, paroxetine, and sertraline; or also with bupropion, which is a medicine used to support smoking cessation or linezolid, which is an antibacterial medicine,

if you are taking or have taken in the last two weeks procarbazine, selegiline (see section: Inovox for Cough Honey-Lemon Flavor and other medicines).

• If you are taking or have taken in the last two weeks procarbazine, selegiline (see section: Inovox for Cough Honey-Lemon Flavor and other medicines).

Warnings and precautions

Before starting to take Inovox for Cough Honey-Lemon Flavor, discuss it with your doctor or pharmacist:

• if you are taking such medicines as certain antidepressants or antipsychotics, Inovox for Cough Honey-Lemon Flavor 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, as well as exaggerated reflexes, muscle stiffness, lack of coordination, and (or) symptoms related to the digestive system (e.g., nausea, vomiting, diarrhea).
• if you have persistent or chronic cough, such as smoker's cough. Especially in children, as chronic cough can be an early symptom of asthma.
• if you have liver disease.
• if you have atopic dermatitis (an inflammatory skin disease characterized by redness, itching, exudates, crusts, and scaling, which usually starts in infancy in people with a hereditary tendency to allergies).
• if you are taking sedatives, are weakened, or bedridden.

Cases of abuse of dextromethorphan-containing medicines have been reported in adolescents, so this possibility should be considered, as it can cause serious side effects (see section: "Taking a higher dose of Inovox for Cough Honey-Lemon Flavor than recommended").

Inovox for Cough Honey-Lemon Flavor and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
Do not take Inovox for Cough Honey-Lemon Flavor if you are taking or have taken in the last two weeks the following medicines, which may cause excitement, increase blood pressure, or body temperature above 40°C (hyperpyrexia):

• monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine, phenelzine, nialamide),
• selective serotonin reuptake inhibitors (SSRIs) (paroxetine, fluoxetine, sertraline),
• bupropion (used for smoking cessation),
• linezolid (an antibacterial medicine),
• procarbazine (an anticancer medicine),
• selegiline (a medicine used in Parkinson's disease).

Before taking Inovox for Cough Honey-Lemon Flavor, consult your doctor if you are taking any of the following medicines, as it may be necessary to adjust the dosage or discontinue treatment:

• amiodarone and quinidine (antiarrhythmic medicines)
• anti-inflammatory medicines (celecoxib, parecoxib, or valdecoxib)
• medicines acting on the central nervous system (some of them used to treat: mental illnesses, allergies, Parkinson's disease, etc.)
• expectorants and mucolytics (used to remove phlegm and mucus).

Inovox for Cough Honey-Lemon Flavor with food, drink, and alcohol

Drinking alcohol while taking dextromethorphan may cause side effects, so you should not consume alcoholic beverages during treatment.
Do not take dextromethorphan at the same time as grapefruit juice or bitter orange juice, as it may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
There are no well-documented studies on the safety of use.
The medicine may be used only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus. It is not recommended to use the medicine during pregnancy, especially in the first trimester.
Do not take this medicine while breastfeeding.

Driving and using machines

In rare cases, during treatment, dizziness or drowsiness may occur, so this should be taken into account when driving vehicles and operating machines.

Inovox for Cough Honey-Lemon Flavor contains sucrose and glucose

The medicine contains 1.6 g of sucrose and 0.85 g of glucose in one hard tablet. This should be taken into account in patients with diabetes. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Inovox for Cough Honey-Lemon Flavor 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, which means the medicine is considered "sodium-free".

3. How to take Inovox for Cough Honey-Lemon Flavor

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 you have any doubts, consult your doctor or pharmacist.

Recommended dose

Adults and adolescents over 12 years of age:

• When cough appears, dissolve one tablet in the mouth, maximum two, every 4 to 6 hours, as needed.
• Do not take more than 12 tablets (120 mg) in 24 hours, or exceed individual doses.
• Always use the smallest effective dose.

Children and adolescents
This medicine is contraindicated in children under 12 years of age.
Method of administration
Oral administration. Tablets should be dissolved in the mouth, not chewed or swallowed.
Do not drink grapefruit juice, bitter orange juice, or alcohol with the medicine (see section: "Inovox for Cough Honey-Lemon Flavor with food, drink, and alcohol").
Consult your doctor if your condition worsens or the cough persists for more than 3 to 5 days, or if it is accompanied by fever, skin rash, or persistent headache.

Taking a higher dose of Inovox for Cough Honey-Lemon Flavor than recommended

If you take a higher dose of Inovox for Cough Honey-Lemon Flavor than recommended, 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 disorders, and convulsions.
If you experience any of the above symptoms, seek medical attention immediately.
In the event of an overdose of Inovox for Cough Honey-Lemon Flavor, the following symptoms may be observed: disorientation, excitement, anxiety, nervousness, or irritability.
Accidental ingestion of high doses can cause children to become lethargic, hallucinate, become hysterical, nervous, nauseous, vomit, or have gait disturbances.
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 (coordination disorder), convulsions, respiratory depression, loss of consciousness, arrhythmias, and death.

Missing a dose of Inovox for Cough Honey-Lemon Flavor

Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• nausea and vomiting, gastrointestinal upset
• drowsiness, dizziness, excitement, convulsions, disorientation
• skin reactions, including rash

Very rare side effects (occurring in less than 1 in 10,000 patients):

• respiratory depression

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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 gather more information on the safety of the medicine.

5. How to store Inovox for Cough Honey-Lemon Flavor

Keep the medicine out of sight and reach of children.
There are no special storage temperature recommendations for the medicine.
Store in the original packaging to protect from light.
Do not use this medicine after the expiration date stated on the packaging after: EXP.
The expiration date means the last day of the given month.
Medicines should 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 package and other information

What Inovox for Cough Honey-Lemon Flavor contains

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

What Inovox for Cough Honey-Lemon Flavor looks like and what the package contains

Inovox for Cough Honey-Lemon Flavor is a yellow, round, hard tablet with a honey-lemon flavor.
Available package sizes: 12 and 24 hard tablets.
The packaging consists of a PVC/PE/PVDC/Aluminum blister pack in a cardboard box.

Marketing authorization holder

US Pharmacia Sp. z o.o.
ul. Ziębicka 40, 50-507 Wrocław
{logo of the marketing authorization holder}

Importer

FARMALIDER, S.A.
C/ Aragoneses, 2
28108, Alcobendas (Madrid),
Spain

To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:

USP Zdrowie Sp. z o.o.,
ul. Poleczki 35, 02-822 Warsaw,
phone: +48 (22) 543 60 00.

Date of the last update of the package leaflet: