TOSIDRIN 10 mg/ml ORAL DROPS IN SOLUTION

Introduction

Leaflet: Information for the user

Tosidrin 10 mg/ml oral drops in solution

Dihydrocodeine bitartrate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What is Tosidrin and what is it used for

The dihydrocodeine bitartrate, the active ingredient of Tosidrin, is a substance that calms or relieves cough (antitussive activity).

Tosidrin is indicated for the symptomatic treatment of non-productive cough (without mucus).

2. What you need to know before taking Tosidrin

Do not take Tosidrin:

• If you are allergic to dihydrocodeine or any of the other components of this medication (listed in section 6).
• Children under 2 years of age
• If you have respiratory problems (bronchial asthma, pulmonary emphysema, or respiratory depression).
• If you have seizures
• If you are in a coma.
• You are in the third trimester of pregnancy.
• If you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

It is not recommended for use:

• in cases of disorders of consciousness and in states of high intracranial pressure.
• if you are in the first four months of pregnancy.
• if you have chronic constipation.
• if you have diarrhea associated with pseudomembranous colitis (inflammation of the colon) caused by antibiotics or in diarrhea caused by poisoning until the toxic material has been eliminated from the gastrointestinal tract.
• if you have opioid dependence

It should be administered with caution:

Before taking this medication, you should consult your doctor, especially:

• Elderly patients.
• If you have liver, heart, or kidney problems.
• If you have hypothyroidism.
• If you have prostatic hyperplasia (enlarged prostate), chronic ulcerative colitis (inflammatory disease of the colon or rectum), gallbladder conditions, multiple sclerosis, and diseases that cause decreased respiratory capacity.

Do not take this medication if you know you metabolize codeine or dihydrocodeine very quickly, as there may be a risk of greater side effects.

Prolonged use of this medication is not recommended, as it may cause physical and psychological dependence (addiction).

Children

Consult your doctor if the child has chronic cough, as it may be a symptom of asthma.

Taking Tosidrin with other medications

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

Taking this medication with opioid agonists (narcotics) and other central nervous system depressants (including ethanol) and tricyclic antidepressants and MAO inhibitors may cause additive depression of the central nervous system. As a precaution, it is advisable to leave a 15-day interval after finishing treatment with MAOI and taking this medication.

Other medications that interact with this medication are medications to treat allergies, both first-generation antihistamines (chlorpheniramine) and second-generation antihistamines (cetirizine and ebastine); and calcium antagonists (such as nifedipine and verapamil), and also methysergide, naloxone, and hydroxyzine.

Taking Tosidrin with food, drinks, and alcohol

During treatment, do not consume alcoholic beverages, as they may potentiate the depressant effect on the central nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

In the third trimester of pregnancy, it should not be taken, as it may cause harm to the fetus.

Do not take this medication during the first and second trimester of pregnancy, unless your doctor considers it strictly necessary.

Breastfeeding

This medication passes into breast milk. For this reason, it should not be taken during breastfeeding. If treatment with this medication is essential, breastfeeding should be interrupted.

Driving and using machines

This medication may cause drowsiness and may interfere with the ability to drive or operate hazardous machinery. Therefore, driving vehicles and/or operating hazardous machinery should be avoided during treatment. This effect is intensified by the action of alcohol or medications that may also impair reaction capacity.

Use in athletes

This medication contains a component that may produce a positive result in the analytical control of opioids.

Important information about some of the components of Tosidrin

This medication contains 5% v/v ethanol (alcohol), which corresponds to 40.2 mg/ml.

3. How to take Tosidrin

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with Tosidrin.

The recommended dose of this medication, unless your doctor indicates otherwise, is as follows:

• Adults and adolescents over 12 years: 20 to 30 drops, with a maximum of 4 doses per day.

Do not exceed the maximum dose of 30 mg of dihydrocodeine per day, which corresponds to 100 drops per day of this medication.

• Children from 6 to 12 years: 1-2 drops per year of age, with a maximum of 4 doses per day.

Do not exceed the maximum dose of 15 mg of dihydrocodeine per day, which corresponds to 50 drops per day of this medication.

• Children from 2 to 5 years: 1 drop per year of age, with a maximum of 4 doses per day.

Do not exceed the maximum dose of 7.5 mg of dihydrocodeine per day, which corresponds to 25 drops of this medication.

• Children under 2 years: This medication is contraindicated and should not be taken.

Tosidrin is an oral solution. It can be taken directly or diluted in water.

If you take more Tosidrin than you should

In case you take more Tosidrin than you should, the symptoms that may occur are initial excitement, anxiety, insomnia, and later, in certain cases, drowsiness, lack of reflexes, headache, alteration of blood pressure, arrhythmia, dry mouth, hypersensitivity reactions, tachycardia, convulsions, gastrointestinal disorders, nausea, vomiting, and respiratory depression.

In case of overdose or accidental ingestion, you should immediately consult your doctor for symptomatic treatment or contact the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

In the treatment of overdose, an opioid antagonist should be administered.

If you forget to take Tosidrin

If you forget to take a dose, take it as soon as possible. Do not take a double dose to make up for forgotten doses.

If you stop taking Tosidrin

Administration should be gradually suspended after prolonged use, as physical dependence and tolerance may occur with repeated administration of this medication.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication may have side effects, although not everyone experiences them.

During the use of Tosidrin, the following side effects have been observed, whose frequency could not be established with precision.

Gastrointestinal:

Nausea, vomiting, constipation.

Central Nervous System:

Dizziness, drowsiness, convulsions.

Skin and subcutaneous tissue:

Itching.

Immune system:

Skin rashes in allergic patients.

Respiratory, thoracic, and mediastinal:

Bronchospasm, respiratory depression at high doses

Psychiatric:

Confusion, euphoria, restlessness.

The conditions that favor the appearance of these side effects are, fundamentally, two: high doses and prolonged treatment.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for human use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tosidrin

No special storage conditions are required.

Keep out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Tosidrin

• The active ingredient of Tosidrin is dihydrocodeine bitartrate. Each ml (equivalent to 33 drops) contains 10 mg of dihydrocodeine bitartrate.
• The other components (excipients) are: Fluid extract of thyme, Fluid extract of sundew, Raspberry essence, Glycerol (E422), Ethanol, Sodium saccharin, and Purified water.

Appearance of the product and package contents

Tosidrin is a brown-colored solution with a raspberry odor, presented in amber glass bottles with a pilfer-proof dropper cap, containing 15 ml and 30 ml.

Marketing authorization holder and manufacturer

LABORATORIO DE APLICACIONES FARMACODINAMICAS, S.A. – FARDI logo

Grassot, 16 - 08025 Barcelona (Spain)

Date of the last revision of this leaflet: November 2015

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