Iniston Tos 1.5 mg/ml syrup

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Iniston TOS 1.5 mg/ml syrup

Dextromethorphan, hydrobromide

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

Follow exactly the instructions for use provided in this leaflet or those given 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
• You should consult a doctor if your condition worsens, if symptoms are accompanied by high fever, skin rash, or persistent headache, or if you do not improve after 7 days.

Contents of the leaflet:

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

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

Dextromethorphan, the active substance of this medicine, is an antitussive that suppresses the cough reflex.

It is indicated for the symptomatic treatment of dry cough (irritant cough, nervous cough) in adults and adolescents over 12 years of age.

You should consult a doctor if 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 to any of the other ingredients of this medicine listed in section 6.
• If you have a serious lung disease.
• If you have asthmatic cough.
• If you have a cough accompanied by abundant secretions.
• If you are currently being treated or have been treated within the previous 2 weeks with a monoamine oxidase inhibitor (MAOI) used for the treatment of depression, Parkinson's disease, or other conditions, as well as other serotonin reuptake inhibitors used for depression such as fluoxetine and paroxetine; or also with bupropion, a medicine used to stop smoking, or with linezolid, an antibacterial medicine. (See section: Interaction of Iniston TOS with other medicines.)

Warnings and precautions:

Talk to your doctor or pharmacist before taking Iniston TOS if you:

• Have persistent or chronic cough, such as that caused by smoking. In children especially, chronic cough may be an early sign of asthma.
• Have liver disease.
• Have atopic dermatitis (an inflammatory skin condition characterized by erythema, itching, exudation, crusting, and scaling, which begins in childhood in individuals with hereditary predisposition to allergy).
• Are sedated, weakened, or bedridden.

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

Cases of abuse have been reported with medicines containing dextromethorphan in adolescents; therefore, this possibility should be considered, as serious adverse effects may occur (see section: If you take more Iniston TOS than you should).

Children:

Do not give this medicine to children under 12 years of age.

Taking Iniston TOS with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take this medicine, or within 2 weeks after stopping it, together with the following medicines, as this may cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• Antidepressant monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine).
• Serotonin reuptake inhibitor antidepressants (paroxetine, fluoxetine).
• Bupropion (used to stop 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 this medicine, consult your doctor if you are taking any of the following medicines, as it may be necessary to adjust the dose or interrupt treatment:

• Amiodarone and quinidine (to treat heart arrhythmias).
• Anti-inflammatory medicines (celecoxib, parecoxib, or valdecoxib).
• Central nervous system depressants (some of which are used to treat: mental disorders, allergies, Parkinson's disease, etc.).
• Expectorants and mucolytics (used to eliminate phlegm and mucus).

Talk to your doctor or pharmacist before taking Iniston TOS.

If you are taking other medicines such as antidepressants or antipsychotics, Iniston TOS may interact with them, 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, 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 this may cause adverse effects.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

Driving and using machines

Rarely, drowsiness and mild dizziness may occur during treatment. If you experience these symptoms, do not drive or operate dangerous machinery.

Iniston TOS contains ethanol

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

Iniston TOS contains glucose

This medicine contains glucose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. Patients with diabetes mellitus should be aware that this medicine contains 4.8 g of glucose per dose.

Iniston TOS contains sucrose

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

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

Iniston TOS contains sorbitol

This medicine contains sorbitol (E-420). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may cause a mild laxative effect as 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 flavors in this medicine contain traces of invert sugar. Patients with hereditary fructose intolerance (HFI) or glucose-galactose malabsorption should not take this medicine.

Iniston TOS contains sodium

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

Iniston TOS contains sorbitol

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

Iniston TOS contains propylene glycol (E-1520)

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

3. How to take Iniston TOS

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

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

Alternatively, 20 ml may be taken every 6 or 8 hours as needed.

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

How to take

Iniston TOS is taken orally. Use the measuring cup provided for administering the medicine.

It can be taken with or without food.

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

Consult your doctor if your condition worsens, if symptoms are accompanied by high fever, skin rash, or persistent headache, or if there is no improvement after 7 days of treatment.

If you take more Iniston TOS than you should:

If you take more Iniston TOS than recommended, you may experience: confusion, excitability, restlessness, nervousness, conversion disorder (also known as functional neurological symptom disorder, a condition in which psychological stress manifests in physical ways), clumsiness, coma, tremor, constricted pupils, urinary retention, and irritability.

Taking very high doses of this medicine may cause children to become drowsy, nervous, nauseous, vomit, or experience difficulty walking.

Cases of abuse have occurred with medications containing dextromethorphan, potentially leading to serious adverse effects such as: tachycardia (rapid heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), midriasis (dilation of the eye pupil), agitation, dizziness, gastrointestinal discomfort, hallucinations, slurred speech, nystagmus (involuntary, uncontrolled eye movements), fever, tachypnea (rapid, shallow breathing), brain damage, ataxia (lack of coordination), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

Keep this medicine out of sight and reach of children. In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service (telephone: 915620420), stating the name of the medicine 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 symptoms persist, take the medicine again as indicated in section 3. How to take Iniston TOS.

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

4. Possible adverse effects

Like all medicines, Iniston TOS may produce adverse effects, although not everyone will experience them.

During the period of use of dextromethorphan, the following adverse effects have been observed, although their frequency cannot be accurately determined:

• In some cases: drowsiness or insomnia, dizziness, psychomotor agitation, vertigo, constipation or diarrhoea, gastrointestinal discomfort, nausea and vomiting.
• More rarely: confusion and headache. Angioedema, itching, rash, urticaria, pruritus, and insomnia may also occur.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Iniston Tos

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

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 month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Iniston COUGH

• The active substance 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, Monohydrate Citric Acid, Sodium Benzoate (E-211), Caramel T12 (containing invert sugar), Peach flavouring (containing propylene glycol (E-1520) and ethanol), L-Menthol, Carbomer, and Purified Water.

Nature of the product and pack contents:

Iniston COUGH is a clear, pale brown syrup.

It is presented in amber-coloured bottles containing 120 ml and 200 ml.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Manufacturer:

DELPHARM ORLEANS

5 Avenue de Concyr

Orleans (France)

Date of the most recent review of this leaflet: July 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/