Dextromethorphan Codramol 10 mg lozenges honey-lemon flavor

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Dextromethorphan CODRAMOL 10 mg sucking tablets, honey-lemon flavour

Dextromethorphan hydrobromide

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

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• 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, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet.
• You should consult a doctor if your condition worsens, if symptoms are accompanied by high fever, skin rash, or persistent headache, or if you do not improve after 7 days of treatment.

Leaflet contents:

1. What Dextromethorphan CODRAMOL is and what it is used for
2. What you need to know before taking Dextromethorphan CODRAMOL
3. How to take Dextromethorphan CODRAMOL
4. Possible side effects
5. How to store Dextromethorphan CODRAMOL
6. Contents of the pack and other information

1. What Dextromethorphan Codramol 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 not accompanied by expectoration (irritative cough, nervous cough). For use 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 taking Codramol

Do not take Dextromethorphan CODRAMOL

• If you are allergic (hypersensitive) to dextromethorphan or to any of the other ingredients of this medicine
• Children under 12 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 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 inhibitors 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 with other medicines)

Warnings and precautions

Patients should consult a doctor before taking this medicine if they:

• Have a persistent or chronic cough, such as that caused by smoking. In children especially, chronic cough may be an early sign of asthma.
• Have liver disease
• Have atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, beginning in infancy in individuals with a hereditary predisposition to allergy)
• Are sedated, weakened, or bedridden.

If you are taking other medicines such as antidepressants or antipsychotics, Dextromethorphan Codramol 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, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhoea).

This medicine may lead to dependence. Therefore, treatment should be short-term. Cases of abuse have been reported with medicines containing dextromethorphan, particularly among adolescents; therefore, this possibility should be considered, as serious adverse effects may occur (see section: If you take more Dextromethorphan CODRAMOL than you should).

Taking Dextromethorphan CODRAMOL with other medicines

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

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

• Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranylcypromine)
• Serotonin reuptake inhibitor antidepressants (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 (used to treat heart arrhythmias)
• Anti-inflammatory medicines (celecoxib, parecoxib, or valdecoxib)
• Central nervous system depressants (some used to treat: mental disorders, allergy, Parkinson’s disease, etc.)
• Expectorants and mucolytics (used to clear mucus and phlegm)

Taking Dextromethorphan CODRAMOL with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment, as this 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, 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

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

Dextromethorphan CODRAMOL contains sucrose and glucose

This medicine contains sucrose and glucose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 1.6 g of sucrose per lozenge.

Patient Information Leaflet – Required Excipient Warnings

This medicinal product contains:

• Sucrose: Patients with hereditary fructose intolerance (HFI), glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take this medicine.
• Glucose: May be harmful for patients with glucose metabolism disorders.
• Sorbitol (if applicable – confirm presence in formulation): May have a laxative effect in high doses.
• Aspartame (if applicable – confirm presence in formulation): A source of phenylalanine, which may be harmful for patients with phenylketonuria (PKU).
• Lactose (if applicable – confirm presence in formulation): Not suitable for patients with lactose intolerance.

Note: The full list of excipients is provided in Section 6.1 of the Summary of Product Characteristics. The above warnings apply to excipients requiring declaration according to regulatory requirements.

3. How to take Dextromethorphan Codramol

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

Adults and adolescents aged 12 years and older: Allow 1 tablet to dissolve slowly in the mouth when cough occurs, up to a maximum of 2 tablets every 4–6 hours as needed.

Do not exceed a total dose of 12 tablets (120 mg) in 24 hours, divided into several doses.

Always use the lowest effective dose.

Use in children

This medicine is contraindicated in children under 12 years of age.

How to take it:

This medicine is taken orally. Slowly suck the tablet in the mouth until it dissolves completely. Do not chew or swallow it.

Do not take with grapefruit juice or Seville orange juice, or with alcoholic beverages (see section "Taking Dextromethorphan CODRAMOL 10 mg with food or drinks").

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 take more Dextromethorphan CODRAMOL than you should

If you take more Dextromethorphan Codramol than recommended, 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 problems, psychosis with visual hallucinations, and hyperexcitability.

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

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

Taking very high doses of this medicine may cause children to become drowsy, restless, nauseous, vomit, or experience disturbances in walking.

Cases of abuse have been reported with medicines containing dextromethorphan, which may lead to serious adverse effects such as: anxiety, panic, memory loss, tachycardia (rapid heartbeat), 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 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 overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service (telephone: 91.5620420), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Dextrometorphan CODRAMOL may produce adverse effects, although not everyone experiences them.

During the period of use of dextromethorphan, the following adverse effects have been observed, although their frequency could not be established with certainty:

• In some cases: drowsiness, 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 Dextromethorphan Codramol

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

No special storage conditions are required. Store in the original packaging.

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

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

6. Contents of the pack and other information

Composition of Dextrometorfano CODRAMOL

• The active substance is dextromethorphan. Each lozenge contains 10 mg of dextromethorphan hydrobromide.

• The other components (excipients) are cross-linked polyacrylic acid resin, liquid glucose, sucrose, sodium saccharin, citric acid monohydrate, sodium hydroxide, lemon flavor, and honey flavor.

Appearance of the product and contents of the pack

This medicine is available as yellow, round honey-lemon flavored lozenges. It is available in packs containing 12 and 24 lozenges.

Marketing Authorization Holder

Farmalider, S.A.

C/La Granja, 1

28108 Alcobendas, Madrid

Spain

Manufacturer

Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas, Madrid

Spain

Date of the most recent revision of this leaflet: April 2020

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