INISTON TOS 1.5 mg/ml SYRUP

Introduction

Leaflet: Information for the user

Iniston TOS 1.5 mg/ml syrup

Dextromethorphan, hydrobromide

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
• You should consult a doctor if your symptoms worsen, if they are accompanied by high fever, skin rash, or persistent headache, or if they do not improve after 7 days.

Contents of the leaflet:

1. What is Iniston TOS and what is it used for
2. What you need to know before taking Iniston TOS
3. How to take Iniston TOS
4. Possible side effects
5. Storage of Iniston TOS
6. Package contents and additional information

1. What is Iniston TOS and what is it used for

The active ingredient of this medication, dextromethorphan, is a cough suppressant that inhibits the cough reflex.

It is indicated for the symptomatic treatment of non-productive cough (irritative cough, nervous cough) in adults and adolescents over 12 years old.

You should consult a doctor if your symptoms worsen or do not improve after 7 days of treatment.

2. What you need to know before taking Iniston TOS

Do not take Iniston TOS:

• If you are allergic to dextromethorphan or any of the other components of this medication listed in section 6.
• If you have a severe lung disease.
• If you have asthma.
• If you have a cough with abundant secretions.
• If you are being treated or have been treated in the previous 2 weeks with a monoamine oxidase inhibitor (MAOI) used to treat depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitors used to treat depression, such as fluoxetine and paroxetine; or with bupropion, which is a medication used to quit smoking, or with linezolid, which is an antibacterial medication. (See section Interactions of Iniston TOS with other medications).

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Iniston TOS in the following cases:

• Patient with persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough could be an early symptom of asthma.
• Patient with liver disease.
• Patient with atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, which begins in childhood in individuals with a hereditary allergic predisposition).
• Patient who are sedated, debilitated, or bedridden.

This medication may cause dependence. Therefore, treatment should be short-term.

There have been cases of abuse with medications containing dextromethorphan in adolescents, so this possibility should be taken into account, as serious side effects can occur (see section If you take more Iniston TOS than you should).

Children:

Do not administer this medication to children under 12 years old.

Taking Iniston TOS with other medications:

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Do not take this medication, nor in the 2 weeks following it, with the following medications, as it can cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• Antidepressant monoamine oxidase inhibitors (MAOIs) (moclobemide, tranilcipromine).
• Antidepressant serotonin reuptake inhibitors (paroxetine, fluoxetine).
• Bupropion (used to quit smoking).
• Linezolid (used as an antibacterial).
• Procarbazine (used to treat cancer).
• Selegiline (used to treat Parkinson's disease).
• Metoprolol (used to treat severe cardiovascular diseases, especially hypertension and acute myocardial infarction).
• Isavuconazole (used to treat invasive aspergillosis and invasive mucormycosis).

Before starting to take this medication, you should consult your doctor if you are using any of the following medications, as it may be necessary to modify the dose of one of them or interrupt treatment:

• Amiodarone and quinidine (to treat heart arrhythmias).
• Anti-inflammatory drugs (celecoxib, parecoxib, or valdecoxib).

• Central nervous system depressants (some of which are used to treat mental illnesses, allergies, Parkinson's disease, etc.).

• Expectorants and mucolytics (used to eliminate phlegm and mucus).

Consult your doctor or pharmacist before taking Iniston TOS.

If you are taking other medications such as antidepressants or antipsychotics, Iniston TOS may interact with these medications, and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, high blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Interaction of Iniston TOS with food, beverages, and alcohol:

Alcoholic beverages should not be consumed during treatment, as they can cause side effects.

Do not take with grapefruit or bitter orange juice, as they can increase the side effects of this medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication. The use of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and using machines

Rarely, during treatment, drowsiness and dizziness may occur, so if you notice these symptoms, you should not drive vehicles or operate hazardous machinery.

Iniston TOS contains ethanol

This medication contains approximately 0.491 g of alcohol (ethanol) per 10 ml dose, which is equivalent to 49.1 mg/ml. The amount of alcohol in each dose (10 ml) of this medication is equivalent to 12 ml of beer or 5 ml of wine. It is unlikely that the amount of alcohol in this medication will have any noticeable effect on adults or adolescents. However, it may have some effects on small children, such as drowsiness. The amount of alcohol in this medication may alter the effect of other medications. Consult your doctor or pharmacist if you are taking other medications. If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medication. If you have an alcohol addiction, consult your doctor or pharmacist before taking this medication.

Iniston TOS contains glucose

This medication contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. Patients with diabetes mellitus should note that this medication contains 4.8 g of glucose per dose.

Iniston TOS contains sucrose

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 3.26 g of sucrose per 10 ml dose.

Iniston TOS contains sorbitol

This medication contains sorbitol (E-420). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause a mild laxative effect because it contains 0.7 g of sorbitol per dose. Caloric value: 2.6 kcal/g of sorbitol.

Iniston TOS contains traces of inverted sugar

The flavors of this medication contain traces of inverted sugar. Patients with hereditary fructose intolerance (HFI) or problems with glucose or galactose absorption should not take this medication.

Iniston TOS contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per 10 ml dose, which is essentially "sodium-free". This medication contains 5.48 mg of propylene glycol (E-1520) in each 10 ml dose, which is equivalent to 0.548 mg/ml.

Iniston TOS contains sorbitol

This medication contains sorbitol. Patients with hereditary fructose intolerance should not take this medication.

Iniston TOS contains propylene glycol (E-1520)

This medication contains 5.48 mg of propylene glycol in each 10 ml dose, which is equivalent to 0.548 mg/ml.

3. How to take Iniston TOS

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubts, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 12 years old: take 10 ml every 6 or 4 hours, if necessary.

It is also possible to take 20 ml every 6 or 8 hours as needed.

The maximum amount that can be taken in 24 hours is 4 doses of 20 ml.

How to take

Iniston TOS is taken orally. To administer the medication, use the measuring cup.

It can be taken with or without food.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section Interaction of Iniston TOS with food, beverages, and alcohol).

You should consult a doctor if your symptoms worsen, if they are accompanied by high fever, skin rash, or persistent headache, or if they do not improve after 7 days of treatment.

If you take more Iniston TOS than you should:

If you take more Iniston TOS than recommended, you may notice: confusion, excitability, restlessness, nervousness, disorder of conversation (also called functional neurological symptom disorder, a condition in which you demonstrate psychological stress in physical ways), clumsiness, coma, tremors, constricted pupils, urinary retention, and irritability.

Taking very high doses of this medication can cause children to become drowsy, nervous, nauseous, vomit, or have altered gait.

There have been cases of abuse with medications containing dextromethorphan, which can cause serious side effects such as tachycardia (rapid heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, hallucinations, slurred speech, nystagmus (involuntary eye movement), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

Keep this medication out of the sight and reach of children. In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service (telephone: 915620420), indicating the medication and the amount ingested.

If you forget to take Iniston TOS:

If you forget to take Iniston TOS, do not take a double dose to make up for the missed dose. If your symptoms continue, take the medication again as indicated in section 3. How to take Iniston TOS.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Iniston TOS can cause side effects, although not everyone will experience them.

During the use of dextromethorphan, the following side effects have been observed, whose frequency could not be established with precision:

• In some cases: drowsiness or insomnia, dizziness, psychomotor restlessness, vertigo, constipation or diarrhea, gastrointestinal discomfort, nausea, and vomiting.
• In rarer cases: mental confusion and headache. It can also cause angioedema, itching, rash, urticaria, and pruritus, and insomnia.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Iniston TOS

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Iniston TOS

• The active ingredient is Dextromethorphan Hydrobromide. Each ml of syrup contains 1.5 mg of dextromethorphan hydrobromide.
• The other components (excipients) are: Glucose, Sucrose, Sorbitol (E-420), Ethanol, Glycerol (E-422), Sodium Saccharin, Citric Acid Monohydrate, Sodium Benzoate (E-211), Caramel T12 (which contains inverted sugar), Peach Flavor (which contains propylene glycol (E-1520) and ethanol), L-Menthol, Carbomer, and Purified Water.

Appearance of the product and package contents:

Iniston TOS is a clear, pale brown syrup.

It is presented in a topaz-colored bottle containing 120 and 200 ml.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Manufacturer:

DELPHARM ORLEANS

5 Avenue de Concyr

1. Orleans (France)

Date of the last revision of this leaflet: July 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/