Leaflet: information for the user

Bicasan 2 mg/ml Syrup

Dextromethorphan hydrobromide

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, 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.
• You should consult your doctor if you get worse, or if you also have high fever, skin eruptions or persistent headache, or if you do not improve after 7 days of treatment.

1. What Bicasan is and what it is 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. Contents of the pack and additional information

Dextromethorphan, the active ingredient of this medication, is an antitussive 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 old and adults.

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

Do not take Bicasan:

• If you are allergic (hypersensitive) to dextromethorphan or any of the other components of this medication
• Children under 2 years old cannot take this medication
• 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 past 2 weeks with any monoamine oxidase inhibitor (MAOI) medication used to treat depression, Parkinson's disease, or other conditions, as well as other medications that inhibit serotonin reuptake 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 the section on the use of other medications)

Warnings and precautions

You should consult a doctor before starting to take this medication if you have:

• Persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough could be an early symptom of asthma.
• Liver disease
• Atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition)
• You are sedated, weakened, or bedridden.

Cases of abuse with medications containing dextromethorphan have been reported in adolescents. Therefore, this possibility should be taken into account, as it can lead to severe adverse effects (see the section: If you take more Bicasan than you should).

Taking Bicasan with other medications

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

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

• MAOI antidepressants (moclobemide, tranylcypromine)
• SSRI antidepressants (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 medication, 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 (used 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 mucus and phlegm).

Taking Bicasan with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment, as it can cause adverse effects

Do not take this medication with orange or bitter lemon juice, as it can increase the adverse effects of this medication.

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 medication.

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

Driving and operating machinery

In rare cases, during treatment, drowsiness and mild dizziness may occur, so if you notice these symptoms, you should not drive cars or operate hazardous machinery.

Bicasan contains glucose, fructose, and red Ponceau dye

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

This medication contains fructose.

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

This medication may cause allergic reactions because it contains red Ponceau 4R (E-124) dye. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubts, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents 12 years and older:take5 to10 mldepending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

You can also take 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:take2.5 to5 ml depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

You can also take 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:take1.25 to2.5 mldepending on the intensity of the cough every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

You can also take 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 medication is contraindicated in children under 2 years

How to take

Bicasan isadministered orally. To take the correct amount of this medication, use the dosing spoon (1.25 - 2.5 - 5 ml) included in the package. After each dose, wash the dosing spoon.

It can be taken with or without food

Do not take with orange or bitter lemon juice or with alcoholic beverages (See section 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 eruptions, or persistent headache, consult your doctor.

If you estimate that the action of Bicasan is too strong or too weak, inform your doctor or pharmacist.

If you take more Bicasan than you should

If you take more Bicasanthan recommended, you may notice: Confusion, excitement, restlessness, nervousness, and irritability.

Taking very high doses can cause in children a state of drowsiness, nervousness, nausea, vomiting, or alterations in gait.

Severe adverse effects have been reported with medications containing dextromethorphan, including: anxiety, panic, memory loss, tachycardia (rapid heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, mumbling speech, nystagmus (uncontrolled eye movement), fever, tachypnea (rapid breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

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, Bicasan may have adverse effects.

During the period of dextromethorphan use, the following adverse effects have been observed, but their frequency has not been established with precision:

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

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in the prospectus.

Keepthis medicationout of sight and reach of children.

Do not freeze.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not useBicasan if you observe that the liquid is not transparent.

Medicines should not be thrown down the drains or intothe trash. Disposeof the packaging and medications that you no longer need at the SIGRE collection pointofthe pharmacy. Incase of doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Bicasan

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

Appearance of the product and contents of the packaging

It is a clear orange syrup, transparent, and with a honey-like odor.

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

Marketing Authorization Holder's title:

PHARMINICIO S.L.

C/ Aribau, 168

08036 Barcelona, Spain

Responsible for manufacturing:

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 medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/