Tosidrin 10 mg/ml oral solution drops
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Tosidrin 10 mg/ml oral drops solution
Dihydrocodeine bitartrate
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms, as it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Tosidrin is and what it is used for
- What you need to know before taking Tosidrin
- How to take Tosidrin
- Possible side effects
- How to store Tosidrin
- Contents of the pack and other information
1. What Tosidrin is and what it is used for
Dihydrocodeine bitartrate, the active substance in Tosidrin, is a compound that suppresses or relieves cough (antitussive activity).
Tosidrin is indicated for the symptomatic treatment of dry (non-productive) cough.
2. What you need to know before starting to take Tosidrin
Do not take Tosidrin:
- If you are allergic to dihydrocodeine or to any of the other components of this medicine (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.
- 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 medicine.
Its use is not recommended:
- In cases of disorders of consciousness and in conditions 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 diarrhea caused by poisoning, until the toxic substance has been eliminated from the gastrointestinal tract.
- If you have opioid dependence.
Use with caution:
Before taking this medicine, you should especially consult your doctor:
- Elderly patients.
- If you have liver, heart, or kidney problems.
- If you have hypothyroidism.
- If you have benign prostatic hyperplasia (enlarged prostate), chronic ulcerative colitis (inflammatory disease of the colon or large intestine and rectum), biliary tract disorders, multiple sclerosis, or diseases associated with reduced respiratory capacity.
Do not take this medicine if you know you metabolize codeine or dihydrocodeine very rapidly, as this may increase the risk of adverse effects.
Prolonged use of this medicine is not recommended, as it may lead to physical and psychological dependence (addiction).
Children
Consult your doctor if a child has chronic cough, as this may be a symptom of asthma.
Taking Tosidrin with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines:
Taking this medicine together 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, a 15-day interval should be left between stopping treatment with MAO inhibitors and starting this medicine.
Other medicines that interact with this medicine include antihistamines used to treat allergies, both first-generation (chlorpheniramine) and second-generation (cetirizine and ebastine); calcium channel blockers (such as nifedipine and verapamil); as well as methysergide, naloxone, and hydroxyzine.
Taking Tosidrin with food, drinks, and alcohol
Do not consume alcoholic beverages during treatment, as this may enhance 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 medicine.
Pregnancy
This medicine must not be taken during the third trimester of pregnancy, as it may harm the fetus.
Do not take this medicine during the first and second trimesters of pregnancy unless your doctor considers it strictly necessary.
Breastfeeding
This medicine passes into breast milk. Therefore, you should not take it during breastfeeding. If treatment with this medicine is essential, interruption of breastfeeding is recommended.
Driving and use of machines
This medicine may cause drowsiness and may impair your ability to drive or operate dangerous machinery. Therefore, you should avoid driving vehicles and/or operating dangerous machinery during treatment. This effect is intensified by alcohol or by medicines that may also impair reaction capacity.
Use in athletes
This medicine contains a component that may result in a positive analytical test for opioids.
Important information about some of the components of Tosidrin
This medicine contains 5% v/v ethanol (alcohol), a small amount corresponding to 40.2 mg/ml.
3. How to take Tosidrin
Follow exactly the dosage instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Your doctor will advise you on how long to take Tosidrin.
The recommended dose of this medicine, unless otherwise directed by your doctor, is as follows:
- Adults and adolescents over 12 years of age: 20 to 30 drops, up to a maximum of 4 doses per day.
Do not exceed the maximum daily dose of 30 mg of dihydrocodeine, equivalent to 100 drops of this medicine per day.
- Children from 6 to 12 years of age: 1–2 drops per year of age, up to a maximum of 4 doses per day.
Do not exceed the maximum daily dose of 15 mg of dihydrocodeine, equivalent to 50 drops of this medicine per day.
- Children from 2 to 5 years of age: 1 drop per year of age, up to a maximum of 4 doses per day.
Do not exceed the maximum daily dose of 7.5 mg of dihydrocodeine, equivalent to 25 drops of this medicine per day.
- Children under 2 years of age: This medicine must not be used; it is contraindicated.
Tosidrin is an oral solution. It may be taken directly or diluted in water.
If you take more Tosidrin than you should
If you take more Tosidrin than recommended, possible symptoms include initial excitement, anxiety, insomnia, and subsequently, in some cases, drowsiness, loss of reflexes, headache, changes in blood pressure, arrhythmia, dry mouth, hypersensitivity reactions, tachycardia, seizures, gastrointestinal disturbances, nausea, vomiting, and respiratory depression.
In case of overdose or accidental ingestion, seek immediate medical attention for symptomatic treatment, or contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and 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 missed doses.
If you stop taking Tosidrin
Treatment should be discontinued gradually after prolonged use, as physical dependence and tolerance may develop with repeated administration of this drug.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may have adverse effects, although not everyone experiences them.
During the period of use of Tosidrin, the following adverse effects have been observed, whose frequency could not be established accurately.
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 occurrence of these adverse effects are mainly two: high doses and prolonged treatment.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tosidrin
No special storage conditions are required.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container, following EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the container and other information
Composition of Tosidrin
- The active substance 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 flavor, Glycerol (E422), Ethanol, Sodium saccharin and Purified water.
Appearance of the product and contents of the container
Tosidrin is a brown-colored solution with a raspberry odor, supplied in amber glass bottles with a dropper cap and tamper-evident closure, 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 most recent revision of this leaflet: November 2015
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/