INTERTOS 15 mg TABLETS

Introduction

Package Leaflet: Information for the User

INTERTOS 15 mg Tablets

Dextromethorphan hydrobromide

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

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

• Keep this package 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 it is a side effect not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days, or if the cough is accompanied by high fever, skin rash, or persistent headache.

Contents of the Package Leaflet

1. What INTERTOS is and what it is used for.
2. What you need to know before taking INTERTOS.
3. How to take INTERTOS.
4. Possible side effects.
5. Storage of INTERTOS.
6. Contents of the pack and further information.

1. What INTERTOS is and what it is used for

Dextromethorphan, the active substance of this medicine, is a cough suppressant that inhibits the cough reflex.

It is indicated for the symptomatic treatment of cough that is not accompanied by expectoration (irritative cough, nervous cough) in adults and adolescents from 12 years of age.

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 INTERTOS

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

Do not take INTERTOS:

• If you are allergic (hypersensitive) to dextromethorphan or to any of the other components of this medicine (listed in section 6).
• If you have a severe lung disease.
• If you have asthmatic cough.
• If you have cough accompanied by abundant secretions.
• If you are being treated or have been treated in the last 2 weeks with any monoamine oxidase inhibitor (MAOI) medication, used to treat depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitor medications used to treat 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 section: Use of INTERTOS with other medications).

Children under 12 years of age should not take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take INTERTOS.

If you are taking other medications such as antidepressants or antipsychotics, INTERTOS 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).

Especially, patients with:

• Persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough could be an early symptom of asthma.
• Liver or kidney disease.
• Atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, which begins in childhood in individuals with a hereditary allergic predisposition).
• Who are sedated, debilitated, or bedridden.
• With CYP2D6 polymorphism (genetic alteration that affects the activity of this liver enzyme).
• Concomitant use with alcohol should be avoided.

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 INTERTOS than you should).

This medicine can also be addictive, so its use at high doses or for a prolonged period can cause tolerance and mental and physical dependence. In patients with a tendency to abuse or dependence, it will only be administered under strict medical control and for short periods of time.

Children and adolescents

Children under 12 years of age should not take INTERTOS.

Use of INTERTOS with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

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

• monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranylcypromine, clorgyline, iproniazid, and isocarboxazid),
• serotonin reuptake inhibitor antidepressants (paroxetine, fluoxetine, sibutramine, or sertraline),
• bupropion (used to quit smoking),
• linezolid (used as an antibacterial),
• procarbazine (used to treat cancer),
• selegiline (used to treat Parkinson's disease).

Before starting to take this medicine, 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 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),
• CYP2D6 inhibitors such as haloperidol (used to treat mental illnesses).

Use of INTERTOS with food, beverages, and alcohol

Alcoholic beverages should not be consumed during treatment with this medicine, as it can cause adverse reactions.

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

The rest of the food and beverages can be taken with this medicine, as they do not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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 medicine.

Pregnant or breastfeeding women should not take this medicine without consulting a doctor.

Driving and using machines

During treatment with this medicine, you may experience drowsiness, dizziness, fatigue (tiredness), dystonia (involuntary muscle contractions), and visual hallucinations, so if you notice these symptoms, you should not drive vehicles or use hazardous machinery.

3. How to take INTERTOS

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents from 12 years of age: 1 tablet (15 mg of dextromethorphan hydrobromide) every 4 hours or 2 tablets (30 mg) every 6-8 hours, depending on the intensity of the cough. Do not take more than 8 tablets (120 mg) per day.

Always use the lowest effective dose.

Method of administration

Oral route.

Take the tablets with a little water. It can be taken with or without food. Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section: Use of INTERTOS with food, beverages, and alcohol).

If the cough worsens or persists for more than 7 days, or if it is accompanied by high fever, skin rash, or persistent headache, you should consult a doctor.

Use in children and adolescents

This medicine can only be taken by adolescents from 12 years of age.

If you take more INTERTOS than you should

If you take more INTERTOS than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, rapid involuntary eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and convulsions.

Contact your doctor or hospital immediately if you experience any of the mentioned symptoms.

If you take more INTERTOS than recommended, you may notice: confusion, excitability, restlessness, nervousness, and irritability. Depending on the degree of intoxication, the symptoms may vary.

Taking very high amounts of this medicine can cause children to become drowsy, nervous, nauseous, vomit, or have changes in their gait.

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

In case of intoxication, you should receive treatment according to the symptoms, which may include intravenous naloxone injection and stomach lavage.

In case of overdose or accidental ingestion, go to your doctor or call the Toxicological Information Service (phone: 91 562 04 20), indicating the medicine and the amount taken.

4. Possible side effects

Like all medicines, INTERTOS can cause side effects, although not everyone will experience them.

During the use of dextromethorphan, the following side effects have been observed, whose frequency has not been established with certainty.

• Nervous system disorders: drowsiness, dizziness, fatigue, involuntary muscle contractions, and more rarely mental confusion and headache.
• Gastrointestinal disorders: nausea, vomiting, gastrointestinal discomfort such as stomach pain, constipation.
• Ear and labyrinth disorders: vertigo
• Immune system disorders: hypersensitivity and anaphylactic reaction including symptoms such as: skin rash, urticaria, edema, pruritus, and cardio-respiratory difficulty.
• Psychiatric disorders: visual hallucinations and confusion. These effects are much more pronounced with overdose (see section: If you take more INTERTOS than you should).
• Skin and subcutaneous tissue disorders: skin rash, urticaria, pruritus, erythema, allergic dermatitis.

Other side effects in children

Taking very high amounts of this medicine can cause children to become drowsy, nervous, nauseous, vomit, or have changes in their gait.

Reporting of side effects:

If you experience any side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website (http://www.aemps.gob.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of INTERTOS

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

Do not use this medicine after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of INTERTOS

• Each tablet contains 15 mg of dextromethorphan hydrobromide as the active substance (equivalent to 10.993 mg of dextromethorphan)
• The other components (excipients) are: microcrystalline cellulose, cornstarch, magnesium stearate.

Appearance of the product and packaging contents

This medicine is presented in the form of round, white, biconvex tablets, scored on one side. The score line should not be used to divide the tablet.

It is presented in packs containing 20 tablets in aluminum-PVC and PVDC blisters.

Marketing authorization holder

INTERPHARMA, S.A.

C/ Santa Rosa 6

08921 Santa Coloma de Gramenet (Barcelona)

Spain

Manufacturer

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Date of the last revision of this package leaflet: June 2020

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