BICASAN 2 mg/ml SYRUP

Introduction

Leaflet: Information for the user

Bicasan 2 mg/ml Syrup

Dextromethorphan, hydrobromide

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
• You should consult your doctor if your symptoms worsen, or if you also have a high fever, skin rash, or persistent headache, or if you do not improve after 7 days of treatment.

Contents of the leaflet

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

1. What is Bicasan and what is it used for

The active ingredient of this medicine, dextromethorphan, 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 children from 2 years of age and adults.

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 Bicasan

Do not take Bicasan:

• If you are allergic (hypersensitive) to dextromethorphan or any of the other components of this medicine
• Children under 2 years of age cannot take this medicine
• 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 a monoamine oxidase inhibitor (MAOI) used to treat depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitors used to treat depression, such as fluoxetine and paroxetine; or also with bupropion, which is a medicine used to quit smoking, or with linezolid, which is an antibacterial medicine. (See section on use of other medicines).

Warnings and precautions

Patients should consult a doctor before starting to take this medicine:

• with persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough could be an early symptom of asthma.
• with liver disease
• with 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.

There have been cases of abuse with medicines containing dextromethorphan by adolescents, so this possibility should be taken into account, as serious side effects can occur (see section: If you take more Bicasan than you should).

Taking Bicasan with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

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

• MAOIs (moclobemide, tranilcipromine)
• Serotonin reuptake inhibitors (paroxetine, fluoxetine)
• 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 (to treat heart arrhythmias)
• Anti-inflammatory drugs (celecoxib, parecoxib, or valdecoxib)
• CNS depressants (some of which are used to treat mental illnesses, allergies, Parkinson's disease, etc.)

• Expectorants and mucolytics (used to eliminate phlegm and mucus).

Taking Bicasan with food, drinks, and alcohol

Alcoholic beverages should not be consumed during treatment, as they may cause side effects.

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

Pregnancy and breastfeeding

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 their doctor.

Driving and using machines

Rarely, during treatment, drowsiness and mild dizziness may occur, so if you experience these symptoms, you should not drive vehicles or operate hazardous machinery.

Bicasan contains glucose, fructose, and red Ponceau colorant

This medicine contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. Patients with diabetes mellitus should note that this medicine contains 5g of glucose per 5ml.

This medicine contains fructose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine may cause allergic reactions because it contains red Ponceau 4R colorant (E-124).

It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Bicasan

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 12 years:take 5 to 10 ml depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

It can also be taken 15 ml every 6 or 8 hours if necessary.

The maximum amount that can be taken in 24 hours is 60 ml divided into several doses.

Use in children

Children between 6-11 years:take 2.5 to 5 ml depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

It can also be taken 7.5 ml every 6 or 8 hours if necessary. The maximum amount that can be taken in 24 hours is 30 ml divided into several doses.

Children between 2-5 years:take 1.25 to 2.5 ml depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

It can also be taken 3.75 ml every 6 or 8 hours if necessary.

The maximum amount that can be taken in 24 hours is 15 ml divided into several doses.

Children under 2 years:This medicine is contraindicated in children under 2 years of age.

How to take

Bicasan is administered orally. To take the correct amount of this medicine, use the measuring spoon (1.25 - 2.5 - 5 ml) included in the package. After each dose, wash the measuring spoon.

It can be taken with or without food.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section on taking Bicasan with food or drinks).

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

If you think the effect of Bicasan is too strong or too weak, tell your doctor or pharmacist.

If you take more Bicasan than you should

If you take more Bicasan than recommended, you may notice: confusion, excitability, restlessness, nervousness, and irritability.

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

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

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service (telephone 91.562.04.20), indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, Bicasan can have side effects.

During the use of dextromethorphan, the following side effects have been observed, whose frequency cannot be established with precision:

• In some cases: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting
• In rarer cases: mental confusion and headache.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storage of Bicasan

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

Do not freeze.

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

Do not use Bicasan if you notice that the liquid is not transparent.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Bicasan

• Each ml of syrup contains: 2 milligrams of dextromethorphan as the active ingredient.
• The other components (excipients) are methyl p-hydroxybenzoate sodium (E-219), propylene glycol, liquid glucose, fructose, citric acid monohydrate, honey flavor, purified water, quinoline yellow colorant (E-104), red Ponceau 4R colorant (E-124).

Appearance of the product and package contents

It is a syrup with a light orange color, transparent, and with a honey odor.

It is presented in a topaz-colored plastic bottle containing 250 ml of syrup. For correct dosing, a measuring spoon with the following measures is included: 5 ml, 2.5 ml, and 1.25 ml.

Marketing authorization holder:

PHARMINICIO S.L.

C/ Aribau, 168

08036 Barcelona, Spain

Manufacturer:

GENERFARMA, S.L.U

Ronda Isaac Peral, 6

Parc Tecnológic

46980 Paterna

Valencia.

This leaflet was approved in February 2013

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