Leaflet: information for the user

INTERTOS 15 mg tablets

Dextromethorphan hydrobromide

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

Follow exactly the administration instructions contained 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days, or if your cough is accompanied by high fever, skin eruptions, or persistent headache.

1. What is INTERTOS and what it is used for.

2. What you need to know before starting to take INTERTOS.

3. How to take INTERTOS.

4. Possible side effects.

5. Storage of INTERTOS.

6. Contents of the pack and additional information.

The dextromethorphan, active principle of this medication, is an antitussive that inhibits the cough reflex.

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

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

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

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 serious lung disease.
• If you have asthma cough.
• If you have a 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) used for the treatment of depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitors 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 section: Use of INTERTOS with other medicines).

Children under 12 years old cannot take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take INTERTOS.

If you are taking other medicines such as antidepressants or antipsychotics, INTERTOS may interact with these medicines 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 exaggeration of reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Especially, patients with persistent or chronic cough, such as that due to smoking, should consult their doctor before using this medicine. Especially in children, chronic cough could be an early sign of asthma.

• With liver or kidney disease.
• With atopic dermatitis (inflammatory skin disease characterized by erythema, pruritus, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition).
• Who is sedated, weakened, or bedridden.
• With CYP2D6 polymorphism (genetic alteration affecting the activity of this liver enzyme).
• Concomitant use with alcohol should be avoided.

Cases of abuse with dextromethorphan-containing medications have been reported in adolescents, so this possibility should be taken into account, as it may cause severe adverse effects (see section: If you take more INTERTOS than you should).

This medicine may also be addictive, so its use at high doses or for a prolonged period may cause 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 old cannot take INTERTOS.

Use of INTERTOS and other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

• monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine, clorgiline, iproniazid, and isocarboxazid),
• serotonin reuptake inhibitors (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 medicines, as it may be necessary to modify the dose of one of them or interrupt treatment:

• amiodarone and quinidine (used to treat heart arrhythmias),
• anti-inflammatory agents (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 mucus and phlegm),
• CYP2D6 inhibitors such as haloperidol (used to treat mental illnesses).

Use of INTERTOS with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment with this medicine, as it may cause adverse reactions.

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

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and operating machinery

During treatment with this medicine, you may experience mild drowsiness and dizziness, fatigue, muscle dystonia, and visual hallucinations, so if you notice these symptoms, you should not drive cars or operate hazardous machinery.

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

The recommended dose is:

Adults and adolescents 12 years and older: 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.

Administration form

Oral route.

Swallow the tablets with a little water. You can take them with or without food. Do not take with grapefruit or orange juice or with alcoholic beverages (see section Taking INTERTOS with food, drinks, and alcohol).

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

Use in children and adolescents

This medication can only be taken by adolescents 12 years and older

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, altered consciousness, involuntary and rapid eye movements, cardiac disturbances (accelerated heart rate), coordination disturbances, psychosis with visual hallucinations, and hyperexcitability.

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

Immediately contact your doctor or hospital 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, symptoms may vary.

Taking very high doses of this medication may cause in children a state of drowsiness, nervousness, nausea, vomiting, or gait disturbances.

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

In case of intoxication, appropriate treatments for symptoms will be applied, which may include intravenous naloxa injection and stomach lavage.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicological Information Service (phone: 91 562 04 20), indicating the medication and the amount ingested.

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

During the period of use of dextromethorphan, the following adverse effects have been observed, whose frequency has not been established with precision.

- Nervous system disorders: drowsiness, dizziness, fatigue, involuntary muscle contractions, and less frequently, mental confusion and headache.

- Gastrointestinal disorders: nausea, vomiting, gastrointestinal discomfort such as stomach pain, constipation.

- Ear and labyrinth disorders: vertigo

- Immunological system disorders: hypersensitivity and anaphylactic reaction, including symptoms such as: skin rash, urticaria, edema, pruritus, and respiratory-cardiovascular 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 adverse effects in children

The intake of very high doses of this medication can produce in children a state of drowsiness, nervousness, nausea, vomiting, or alterations in gait.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines 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 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.

Medications 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 of INTERTOS

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

Appearance of the product and content of the packaging

This medication is presented in the form of round, white, bicameral, and scored tablets. The score should not be used to break the tablet.

It is presented in packaging containing aluminum PVC and PVDC blisters with 20 tablets.

Holder of the marketing authorization

INTERPHARMA, S.A.

C/ Santa Rosa 6

08921 Santa Coloma de Gramenet (Barcelona)

Spain

Responsible for manufacturing

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Last review date of this leaflet: June 2020

The 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)