Bicasan 2 mg/ml syrup

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bicasan 2 mg/ml Syrup

Dextromethorphan, hydrobromide

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

Follow exactly the instructions for taking this medicine as described in this leaflet or as directed 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.
• You should consult your doctor if your condition worsens, or if you develop high fever, skin rashes, or persistent headache, or if you do not improve after 7 days of treatment.

Contents of the leaflet

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. How to store Bicasan
6. Contents of the pack and other information

1. What Bicasan is and what it is used for

Dextromethorphan, the active ingredient in this medicine, is an antitussive that suppresses the cough reflex.

It is indicated for the symptomatic treatment of dry cough (non-productive cough, irritant cough, nervous cough) in children from 2 years of age and adults.

You should consult a doctor if 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 to any of the other components of this medicine
• Children under 2 years of age must not take this medicine
• If you have a severe lung disease
• If you have asthmatic cough
• If you have a cough accompanied by abundant secretions
• If you are currently being treated, or have been treated within the previous 2 weeks, with a 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 with bupropion, a medicine used to stop smoking, or with linezolid, an antibacterial medicine. (See section on use of other medicines).

Warnings and precautions

Patients should consult a doctor before starting 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 disease
• Have atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, which begins in childhood in individuals with a hereditary predisposition to allergic reactions)
• Are sedated, debilitated, or bedridden.

Cases of abuse of medicines containing dextromethorphan have been reported among adolescents; therefore, this possibility should be taken into account, as serious adverse effects may occur (see section: If you take more Bicasan than you should).

Taking Bicasan with other medicines

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

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

• Antidepressant monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine)
• Antidepressant serotonin reuptake inhibitors (paroxetine, fluoxetine)
• Bupropion (used to stop smoking)
• Linezolid (used as an antibacterial)
• Procarbazine (used to treat cancer)
• Selegiline (used to treat Parkinson's disease)

Before starting this medicine, consult your doctor if you are taking any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:

• Amiodarone and quinidine (to treat heart arrhythmias)

• Anti-inflammatory medicines (celecoxib, parecoxib, or valdecoxib)

• Central nervous system depressants (some of which are used to treat: mental illnesses, allergy, Parkinson's disease, etc.)

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

Taking Bicasan with food, drinks, and alcohol

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

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

Pregnancy and breastfeeding

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.

Women who are pregnant or breastfeeding should not take this medicine without consulting a doctor.

Driving and operating machinery

Rarely, during treatment, drowsiness and mild dizziness may occur; therefore, if you experience these symptoms, you should not drive cars or operate dangerous machinery.

Bicasan contains glucose, fructose, and the red dye Ponceau

This medicine contains glucose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine. Patients with diabetes mellitus should be aware that this medicine contains 5 g of glucose per 5 ml.

This medicine contains fructose.

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

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

It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Bicasan

Follow exactly the dosing instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents aged 12 years and over: Take 5 to 10 ml, depending on the severity of the cough, every 4 hours if needed. Do not exceed 6 doses in 24 hours.

Alternatively, 15 ml may be taken every 6 or 8 hours if needed.

The maximum daily dose is 60 ml, divided into several doses.

Use in children

Children aged 6–11 years: Take 2.5 to 5 ml, depending on the severity of the cough, every 4 hours if needed. Do not exceed 6 doses in 24 hours.

Alternatively, 7.5 ml may be taken every 6 or 8 hours if needed.

The maximum daily dose is 30 ml, divided into several doses.

Children aged 2–5 years: Take 1.25 to 2.5 ml, depending on the severity of the cough, every 4 hours if needed. Do not exceed 6 doses in 24 hours.

Alternatively, 3.75 ml may be taken every 6 or 8 hours if needed.

The maximum daily dose is 15 ml, divided into several doses.

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

How to take

Bicasan is administered orally. To ensure accurate dosing, use the dosing spoon (1.25 - 2.5 - 5 ml) provided in the package. After each dose, wash the dosing spoon.

It may be taken with or without food.

Do not take with grapefruit juice or bitter orange juice, or with alcoholic beverages (see section "Taking Bicasan with food and drink").

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

If you feel that the effect 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 Bicasan than recommended, you may experience: confusion, excitability, restlessness, nervousness, and irritability.

Taking very high doses may cause drowsiness, nervousness, nausea, vomiting, or unsteady gait in children.

Cases of abuse have been reported with medications containing dextromethorphan, potentially leading to serious adverse effects such as anxiety, panic, memory loss, tachycardia (rapid heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, dizziness, gastrointestinal discomfort, slurred speech, nystagmus (involuntary, uncontrolled eye movements), fever, tachypnea (rapid, shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

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

4. Possible adverse effects

Like all medicines, Bicasan may have adverse effects.

During the period of use of dextromethorphan, the following adverse effects have been observed, whose frequency cannot be established with accuracy:

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

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Do not use Bicasan if the liquid is not clear.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This helps protect the environment.

6. Contents of the package and other information

Composition of Bicasan

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

Appearance of the product and contents of the package

It is a clear orange-coloured, transparent syrup with a honey odour.

It is supplied in a 250 ml plastic amber-coloured bottle. For accurate dosing, a dosing spoon is included with the following measurements: 5 ml, 2.5 ml and 1.25 ml.

Marketing Authorisation Holder:

PHARMINICIO S.L.

C/ Aribau, 168

08036 Barcelona, Spain

Manufacturer:

GENERFARMA, S.L.U

Ronda Isaac Peral, 6

Parc Tecnológic

46980 Paterna

Valencia, Spain.

This patient information leaflet was approved in February 2013.

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