Leaflet: information for the user

Tosidrin 10 mg/ml oral drops in solution

Dihydrocodeine bitartrate

Read this leaflet carefully before you start taking the medicine, 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 medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Tosidrin is and what it is used for

2. What you need to know before you start taking Tosidrin

3. How to take Tosidrin

4. Possible side effects

5. Storage of Tosidrin

6. Contents of the pack and additional information

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

Tosidrin is indicated for the symptomatic treatment of unproductive cough (without mucosities).

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 old.
• If you have respiratory problems (asthma bronchial, pulmonary emphysema, or respiratory depression).
• If you have seizures.
• If you are in a coma.
• If 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.

This medication is not recommended for use:

• In cases of consciousness disorders and high intracranial pressure.
• During 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 diarrhea caused by poisoning until the toxic material has been eliminated from the gastrointestinal tract.
• If you have opioid dependence.

This medication should be administered with caution:

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

• Older patients.
• If you have liver, heart, or kidney problems.
• If you have hypothyroidism.
• If you have benign prostatic hypertrophy (enlarged prostate), chronic ulcerative colitis (inflammatory disease of the colon or large intestine and rectum), biliary tract diseases, multiple sclerosis, and diseases that cause decreased respiratory capacity.

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

This medication should not be taken for a prolonged period 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

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

The use of 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 recommended to leave a 15-day interval after the end of treatment with MAO inhibitors and the use of this medication.

Other medications that interact with this medication are medications for allergy treatment, 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 depressive effect on the central nervous system.

Pregnancy and breastfeeding

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

Pregnancy

Do not take this medication in the third trimester of pregnancy, as it may cause damage to the fetus.

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

Breastfeeding

This medication passes into breast milk. For this reason, do not take it during breastfeeding. If the treatment with this medication is necessary, it is recommended to interrupt breastfeeding.

Driving and operating machinery

This medication may cause drowsiness and may interfere with the ability to drive or operate hazardous machinery. Therefore, it is recommended to avoid driving vehicles and/or operating hazardous machinery during treatment. This effect is intensified by the action of alcohol or other medications that may impair reaction time.

Use in athletes

This medication contains a component that may produce a positive result in opioid control analysis.

Important information about some components of Tosidrin

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will inform you of 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 old : 20 to 30 drops, with a maximum of 4 doses per day.

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

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

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

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

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

• Children under 2 years old : This medication is contraindicated.

Tosidrin is a solution for oral administration. 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 appear are initial excitement, anxiety, insomnia, and subsequently, in certain cases, drowsiness, lack of reflexes, headache, blood pressure alteration, arrhythmia, dry mouth, hypersensitivity reactions, tachycardia, convulsions, gastrointestinal disturbances, nausea, vomiting, and respiratory depression.

In case of overdose or accidental ingestion, you should immediately go to the doctor to seek symptomatic treatment or consult the Toxicological 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 compensate for the missed doses.

If you interrupt treatment with Tosidrin

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

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

Like all medications, this medication may have adverse effects, although not everyone may experience them.

During the period of use of Tosidrin, the following adverse effects have been observed, whose frequency has not been established with precision.

Gastrointestinal:

Nausea, vomiting, constipation.

Central Nervous System:

Dizziness, drowsiness, convulsions.

Skin and subcutaneous tissue:

Itching.

Immune system:

Cutaneous eruptions 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 adverse effects are, fundamentally, two: high doses and prolonged treatment.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for human use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No special storage conditions are required.

Keep out of sight and reach of children.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

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 drosera, Raspberry essence, Glycerol (E422), Ethanol, Sodium saccharin, and Purified water.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Laboratorio de Aplicaciones Farmacodinámicas, S.A. – FARDI logo

Grassot, 16 - 08025 Barcelona (Spain)

Date of the last review of this leaflet: November 2015

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