Tosystop 20 mg oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOSYSTOP 20 mg oral solution
Dextromethorphan hydrobromide
Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the administration instructions for this medicine as described in this leaflet or as indicated 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens, or if you also have high fever, skin rashes, or persistent headache, or if you do not improve after 7 days of treatment.
Contents of the leaflet
- What Tosysptop is and what it is used for
- What you need to know before taking Tosysptop
- How to take Tosysptop
- Possible side effects
- How to store Tosysptop
- Contents of the pack and other information
1. What Tosystop is and what it is used for
Dextromethorphan, the active substance in this medicine, is an antitussive that inhibits the cough reflex.
It is indicated for the symptomatic treatment of dry cough not accompanied by expectoration (irritant cough, nervous cough) 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 Tosystop
Do not take Tosystop:
- If you are allergic (hypersensitive) to dextromethorphan or to any of the other components of this medicine (listed in section 6).
- 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 being treated, or have been treated within the previous 2 weeks, with monoamine oxidase inhibitor (MAOI) medicines used to treat depression, Parkinson's disease, or other conditions, as well as other serotonin reuptake inhibitors used for depression such as fluoxetine and paroxetine; or also with bupropion, a medicine used to stop smoking, or linezolid, an antibacterial medicine (see section: Use of other medicines).
Warnings and Precautions
You should consult your doctor or pharmacist before taking Tosystop if you are a patient:
- With persistent or chronic cough, such as that caused by smoking. Particularly in children, chronic cough may be an early symptom of asthma.
- With liver disease.
- With 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 allergy).
- Who is sedated, weakened, or bedridden.
- If you are taking other medicines such as antidepressants or antipsychotics, Tosystop 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, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).
This medicine may cause dependence. Therefore, treatment should be short-term. Cases of abuse have been reported with medicines containing dextromethorphan in adolescents; therefore, this possibility should be taken into account, as serious adverse effects may occur (see section: If you take more Tosystop than you should).
Children and adolescents
This medicine may only be taken by adolescents aged 12 years and older.
Taking Tosystop 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 stopping, the following medicines, as it 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 using any of the following medicines, as it may be necessary to adjust the dose of one of them or interrupt treatment:
- Amiodarone and quinidine (used to treat heart arrhythmias)
- Anti-inflammatory medicines (celecoxib, parecoxib, or valdecoxib)
- Central nervous system depressants (some of which are used to treat: mental disorders, allergies, Parkinson's disease, etc.)
- Expectorants and mucolytics (used to eliminate phlegm and mucus).
Taking Tosystop with food, drinks, and alcohol
Do not consume alcoholic beverages during treatment, as this may cause adverse effects.
Do not take this medicine together with grapefruit juice or bitter orange juice, as they may increase the adverse effects of this medicine.
Other foods and drinks do not affect the effectiveness of the medicine.
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.
Pregnant or breastfeeding women should not take this medicine without consulting a doctor.
Driving and using machines
Rarely, drowsiness and mild dizziness may occur during treatment. If you experience these symptoms, you should not drive or operate dangerous machinery.
Tosystop contains maltitol (E-965), sodium benzoate (E-211), and amaranth (E-123)
This medicine contains maltitol (E-965). If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains 10 mg of sodium benzoate (E-211) per sachet.
This medicine may cause allergic-type reactions because it contains amaranth (E-123).
3. How to take Tosystop
Follow exactly the instructions for use 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 older:
- Take 1 sachet every 4–6 hours as needed. Do not exceed 6 sachets in 24 hours.
Always use the lowest effective dose.
Use in children
This medicine is only intended for adolescents aged 12 years and older.
How to take
Tosystop is taken orally.
Empty the contents of the sachet directly into the mouth, or dissolve it in a liquid, preferably water.
It can be taken with or without food.
Do not take with grapefruit juice or bitter orange juice, or with alcoholic beverages (see section: Taking Tosystop with food and drink).
If your symptoms worsen, if the cough persists for more than 7 days of treatment, or if it is accompanied by high fever, skin rash, or persistent headache, consult your doctor.
If you take more Tosystop than you should
If you take more Tosystop 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 disorders, psychosis with visual hallucinations, and hyperexcitability.
Other symptoms in cases of massive overdose may include: coma, severe breathing problems, and seizures.
Contact your doctor or go to hospital immediately if you experience any of the symptoms listed.
Taking very high doses of this medicine may cause children to become drowsy, experience hallucinations, nervousness, nausea, vomiting, or 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, Tosyspto may produce adverse effects, although not everyone will experience them.
During the period of use of dextromethorphan, the following adverse effects have been observed, whose frequency could not be established with accuracy:
- In some cases: somnolence, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting
- In rare cases: confusion and headache.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it involves possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tosystop
Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the container or sachet following EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Tosystop
- Each sachet of oral solution contains 10 mg of dextromethorphan hydrobromide as the active substance.
- The other components (excipients) are: Sodium benzoate (E-211), anhydrous citric acid, maltitol liquid (E-965), sodium saccharin, propylene glycol, strawberry flavor, blueberry flavor, amaranth (E-123), and purified water.
Appearance of the medicine and contents of the pack
This medicine is a pink solution with a strawberry flavor.
It is presented in polyester-aluminum-polyethylene sachets containing 5 mL of solution, packed in boxes of 12 or 24 sachets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Apotheke Laboratorios S.L.
Paseo de la Castellana No. 40, 8th floor
28046 Madrid
Spain
Manufacturers
FARMASIERRA MANUFACTURING S.L.
Ctra. Irún, km 26,200
San Sebastián de los Reyes
28709 Madrid
Spain
or
LABORATORIOS ALCALÁ FARMA, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares-Madrid
Spain
or
ZINEREO PHARMA, S.L.U.
A Relva, s/n.
36400 O Porriño – Pontevedra
Spain
or
EDEFARM, S.L.
Polígono Industrial Enchilagar del Rullo,
117, Villamarchante, 46191 Valencia
Date of the most recent revision of this leaflet: May 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/