Prospecto: Information for the User

Iniston TOS 1.5 mg/ml Syrup

Dextromethorphan hydrobromide

Read this prospect carefully before starting to take this medicine, because it contains important information for you

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

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

Content of the prospect:

1. What Iniston TOS is and what it is used for
2. What you need to know before starting to take Iniston TOS
3. How to take Iniston TOS
4. Possible adverse effects
5. Storage of Iniston TOS
6. Contents of the container and additional information

Dextromethorphan, the active ingredient of this medication, is an antitussive that inhibits the cough reflex.

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

Consult a doctor if it worsens or does not improve after 7 days of treatment.

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 serious lung disease.

- If you have asthma.

- If you have a cough accompanied by abundant secretions.

- If you are being treated or have been treated in the past 2 weeks with any monoamine oxidase inhibitor (MAOI) used for the treatment of depression, Parkinson's disease, or other diseases, as well as other medications that inhibit serotonin reuptake used for the treatment of depression such as fluoxetine and paroxetine; or also with bupropion, which is a medication used to quit smoking, or with linezolid, which is an antibacterial medication. (See Interaction of Iniston Tos with other medications).

Warnings and precautions:

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

- Patients with persistent or chronic cough, such as that caused by tobacco. Especially in children, chronic cough could be an early symptom of asthma.

- Patients with liver disease.

- Patients with atopic dermatitis (inflammatory skin disease characterized by erythema, pruritus, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition).

- Patients who are sedated, weakened, or bedridden.

This medication may cause dependence. Therefore, treatment should be of short duration.

Cases of abuse with medications containing dextromethorphan in adolescents have been reported, so this possibility should be taken into account, as it may lead to severe adverse effects (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 used recently, or may need to use any other medication.

Do not take this medication, or in the 2 weeks following it, with the following medications, as it may cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

- Monoamine oxidase inhibitors (MAOI) used for the treatment of depression, Parkinson's disease, or other diseases (moclobemide, tranylcypromine).

- Serotonin reuptake inhibitors used for the treatment of depression (paroxetine, fluoxetine).

- Bupropion (used to quit smoking).

- Linezolid (used as an antibacterial medication).

- Procarbazine (used to treat cancer).

- Selegiline (used for the treatment of Parkinson's disease).

- Metoprolol (used for the treatment of severe cardiovascular diseases, especially hypertension and acute myocardial infarction).

- Isoconazole (used to treat invasive aspergillosis and mucormycosis).

Before starting to take this medication, 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 discontinue treatment:

- Amiodarone and quinidine (used to treat heart arrhythmias).

- Anti-inflammatory medications (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 high body temperature, increased heart rate, high blood pressure, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, and diarrhea).

Interaction of Iniston Tos with food, drinks, and alcohol:

Do not consume alcoholic beverages during treatment, as it may cause adverse effects.

Do not take it with orange or bitter lemon juice, as it may increase the adverse effects of this medication.

Pregnancy and Lactation

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

Driving and operating machinery

In rare cases, during treatment, drowsiness and dizziness may occur, so if you notice these symptoms, you should not drive cars or operate hazardous machinery.

Iniston Tos contains ethanol

This medication contains approximately 0.491 g of alcohol (ethanol) per dose of 10 ml, which is equivalent to 49.1 mg/ml. The amount of alcohol contained 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 contained in this medication will have a perceptible effect on adults or adolescents. It may have some effects on small children, such as drowsiness. The amount of alcohol contained 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 indicated that you have an intolerance to certain sugars, consult with him before taking this medication. Patients with diabetes mellitus should be aware that this medication contains 4.8 g of glucose per dose.

Iniston Tos contains sucrose

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

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

Iniston Tos contains sorbitol

This medication contains sorbitol (E-420). If your doctor has indicated that you have an intolerance to certain sugars, consult with him 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 invert sugar

The aromas of this medication contain traces of invert 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 dose of 10 ml, so it is essentially "sodium-free". This medication contains 5.48 mg of propylene glycol (E-1520) per dose of 10 ml, which is equivalent to 0.548 mg/ml.

Iniston Tos contains sorbitol

This medication containssorbitol. 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 per dose of 10 ml, which is equivalent to 0.548 mg/ml.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The recommended dose is:

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

You can also 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 Iniston TOS interaction with food, drinks, and alcohol section).

You should consult your doctor if you worsen, if symptoms are accompanied by high fever, skin eruptions, or persistent headache, or if you 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, conversion disorder (also known as 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 drowsiness, nervousness, nausea, vomiting, or gait disturbances in children.

Cases of abuse with dextromethorphan-containing medications have been reported, which can lead to severe adverse effects such as: tachycardia (rapid heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, hallucinations, mumbling speech, nystagmus (uncontrolled and involuntary eye movement), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

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

If you forgot to take Iniston TOS:

If you forgot to take Iniston TOS, do not take a double dose to compensate for the missed dose. If symptoms continue, take the medication in the same way as indicated in the 3. How to take Iniston TOS section.

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

Like all medications, Iniston TOS can produce adverse effects, although not all people may experience them.

During the period of dextromethorphan use, the following adverse effects have been observed, although their frequency has not been established with precision:

• In some cases: drowsiness or insomnia, dizziness,psychomotor restlessness,dizziness, constipation or diarrhea, gastrointestinal discomfort, nausea, and vomiting.
• In rare instances: mental confusion and headache. It may also cause angioedema, itching,eruption,urticaria, and pruritus, and insomnia.

Reporting Adverse Effects:

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

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

Do not store at a temperature above 86°F (30°C).

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofInistonTOS

-The active principle is Dextromethorphan Hidrobromide. Each ml of syrup contains 1.5 mg of dextromethorphan hidrobromide.

-The other components (excipients) are: Glucose, Sucrose, Sorbitol (E-420), Ethanol, Glycerol (E-422), Sodium Saccharin, Citric Acid Monohydrate, Sodium Benzoate (E-211), T12 Caramel (which contains inverted sugar), Peach Flavor (which contains Propylene Glycol (E-1520) and ethanol), L-Menthol, Carboxymethyl Cellulose, and Purified Water.

Appearance of the product and contents of the packaging:

Iniston TOS is a clear, pale brown syrup.

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

Trade name of the marketing authorization and responsible manufacturer:

Trade name of the marketing authorization:

Responsible manufacturer:

DELPHARM ORLEANS

5 Avenue de Concyr

45100.Orleans (France)

Date of the last review of this leaflet: July2020

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