Intertos 15 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

INTERTOS 15 mg tablets

Dextromethorphan hydrobromide

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

Follow exactly the instructions for administration of this medicine contained in this leaflet or as advised 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 effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days, or if cough is accompanied by high fever, skin rash, or persistent headache.

Leaflet contents

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 adverse effects.
5. How to store INTERTOS.
6. Contents of the pack and other information.

1. What INTERTOS is and what it is used for

Dextromethorphan, the active substance in this medicine, is an antitussive that inhibits the cough reflex.

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

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

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

This medicine may 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 a cough with abundant secretions.
• If you are currently taking or have taken within the previous 2 weeks any monoamine oxidase inhibitor (MAOI) medicine used to treat depression, Parkinson's disease, or other conditions, as well as other serotonin reuptake inhibitor medicines used to treat depression, such as fluoxetine and paroxetine; or also bupropion, a medicine used to stop smoking, or linezolid, an antibacterial medicine. (See section: Use of INTERTOS with other medicines).

Children under 12 years of age must not 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 exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Patients should especially consult a doctor before using this medicine if they:

• Have persistent or chronic cough, such as that due to smoking. Particularly in children, chronic cough may be an early symptom of asthma.
• Have liver or kidney disease.
• Have atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, which begins in childhood in individuals with hereditary predisposition to allergy).
• Are sedated, weakened, or bedridden.
• Have CYP2D6 polymorphism (a genetic alteration affecting the activity of this liver enzyme).
• The concomitant use with alcohol should be avoided.

Cases of abuse of medicines containing dextromethorphan have been reported in adolescents; therefore, this possibility should be considered, as it may lead to serious 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 prolonged periods may lead to tolerance and mental and physical dependence. In patients with a tendency to abuse or dependence, it should only be administered under strict medical supervision and for short periods.

Children and adolescents

Children under 12 years of age must not take INTERTOS.

Use of INTERTOS and other medicines

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

Do not take this medicine during treatment with the following medicines, or within 2 weeks after such treatment, as it may 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 stop smoking),
• linezolid (used as an antibacterial),
• procarbazine (used to treat cancer),
• selegiline (used to treat Parkinson's disease).

Before starting to take 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 (used to treat heart arrhythmias),
• anti-inflammatory medicines (celecoxib, parecoxib, or valdecoxib),
• central nervous system depressants (some used to treat: mental disorders, allergies, Parkinson's disease, etc.),
• expectorants and mucolytics (used to eliminate phlegm and mucus),
• CYP2D6 inhibitors such as haloperidol (used to treat mental disorders).

Use of INTERTOS with food, drinks, and alcohol

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

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

All other foods and drinks may be consumed with this medicine, as they do not affect its efficacy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 use of machines

During treatment with this medicine, drowsiness and mild dizziness, fatigue (tiredness), dystonia (involuntary muscle contractions), and visual hallucinations may occur. Therefore, if you experience these symptoms, you should not drive or operate dangerous machinery.

3. How to take INTERTOS

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dosage:

Adults and adolescents aged 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.

Method of administration

Oral use.

Swallow the tablets with a little water. They may be taken 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 rash, or persistent headache, you should consult your doctor.

Use in children and adolescents

This medicine is only suitable for adolescents aged 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, disturbances of consciousness, involuntary and rapid eye movements, cardiac disorders (increased heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

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

Contact your doctor or go to hospital immediately if you experience any of the symptoms listed above.

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

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

Cases of abuse have been reported with medicines containing dextromethorphan, which may lead to serious adverse effects such as: anxiety, panic, memory loss, tachycardia (increased heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (dilation of the pupil of the eye), agitation, dizziness, gastrointestinal discomfort, slurred speech, nystagmus (involuntary and uncontrollable 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 the symptoms will be administered, which may include intravenous naloxone injection and gastric lavage.

In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service (telephone: 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible adverse effects

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

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

• Nervous system disorders: somnolence, 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 in cases of 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

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 INTERTOS

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other 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, corn starch, magnesium stearate.

Appearance of the medicine and contents of the pack

This medicine is presented as round, white, biconvex tablets, scored on one side. The score line is not intended for dividing the tablet.

It is available 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 most recent revision of this leaflet: June 2020

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