Toshedra 35 mg syrup in sachets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Toshedra 35 mg Syrup in sachets
Dry extract of Hedera helix L. (ivy)
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for administration of the medicine contained in this leaflet or those 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 you worsen or do not improve after 7 days.
Contents of the leaflet
- What Toshedra is and what it is used for
- What you need to know before taking Toshedra
- How to take Toshedra
- Possible side effects
- How to store Toshedra
- Contents of the pack and other information
1. What Toshedra is and what it is used for
Toshedra is an expectorant.
Toshedra is a herbal medicine used as an expectorant for productive cough associated with benign bronchial conditions. It facilitates the elimination of mucus.
Toshedra is indicated for use in adults, adolescents, and children over 6 years of age.
2. What you need to know before taking Toshedra
Do not take Toshedra:
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If you are allergic to ivy (Hedera helix L.), to plants of the Araliaceae family, or to any of the other components of this medicine (listed in section 6).
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Do not administer to children under 2 years of age, as there is a risk that respiratory symptoms may worsen.
Warnings and precautions:
Consult your doctor or pharmacist before starting to take Toshedra.
You should consult your doctor or pharmacist if you have dyspnea (difficulty breathing), fever, or purulent sputum.
Concomitant use with other antitussives such as codeine or dextromethorphan is not recommended without prior medical advice.
Caution is advised in patients with gastritis or gastric ulcer.
This medicine should not be administered to children aged 2 to 5 years, as it cannot be adequately dosed; there are other formulations more suitable for this age group.
If symptoms worsen or do not improve after 7 days of starting treatment, treatment should be discontinued and medical advice sought.
Taking Toshedra with other medicines:
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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.
Pregnancy:
There are no adequate and well-controlled studies in pregnant women; therefore, administration is not recommended.
Breastfeeding:
There is no information on whether the components of this medicine pass into breast milk; therefore, administration is not recommended to women during breastfeeding.
Fertility:
No data are available regarding fertility.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines:
No studies have been conducted on the effects on the ability to drive or operate machinery.
Toshedra contains sorbitol.
This medicine contains 1.925 mg of sorbitol in each 5 ml sachet (385 mg per ml).
Sorbitol is a source of fructose. If your doctor has advised you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot break down fructose, consult your doctor before taking this medicine.
Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
3. How to take Toshedra
Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
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Adults and adolescents over 12 years of age: 5 ml of syrup (1 sachet), 3 times daily (equivalent to 105 mg daily of dry ivy leaf extract).
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Children between 6 and 12 years of age: 5 ml of syrup (1 sachet), 2 times daily (equivalent to 70 mg daily of dry ivy leaf extract).
If you feel that the effect of Toshedra is too strong or too weak, inform your doctor or pharmacist.
Toshedra is taken orally.
For further details on the use of the sachets, follow the diagrams below:
Gently squeeze the sachet before use, as shown.
Hold the sachet firmly and tear along the dotted lines.
Swallow the medicine, squeezing the sachet until it is empty.
You should consult a doctor if your condition worsens or does not improve after one week of treatment.
If you take more Toshedra than you should
If you have taken more Toshedra than you should, or in case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 915 620 420, indicating the medication and the amount ingested.
Do not exceed the recommended daily dose. Ingestion of significantly higher amounts (more than three times the daily dose) may cause nausea, vomiting, and diarrhea.
In this case, you should consult your doctor.
If you forget to take Toshedra:
Do not take a double dose to make up for the forgotten dose.
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 can cause adverse effects, although not everyone will experience them.
Common (may affect between 1 and 10 out of every 100 patients): gastrointestinal system reactions such as nausea, vomiting, or diarrhea have been reported.
Uncommon (may affect between 1 and 10 out of every 1,000 patients): allergic reactions such as urticaria, skin rashes, or difficulty breathing (dyspnea) have been reported.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
If you notice symptoms of allergy (hypersensitivity), stop taking Toshedra.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Toshedra
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging, following “EXP”. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the container and additional information
Composition of Toshedra 35 mg syrup in sachets:
The active substance is: dried leaf extract of Hedera helix. 5 ml of Toshedra contain 35 mg of dried leaf extract of Hedera helix L. (ivy) (4-8:1), extraction solvent: ethanol 30% (m/m). The other components are: purified water, potassium sorbate, citric acid, non-crystallizable liquid sorbitol (E-420), xanthan gum, and cherry flavor.
Appearance of the product and contents of the pack:
Toshedra 35 mg syrup is presented in single-dose sachets with easy opening, each containing 5 ml, made from a complex aluminum laminate (PET/Alu/PE/PET/PE).
Pack containing 20 sachets.
Marketing Authorization Holder and Manufacturer:
Kern Pharma, S.L.
Venus, 72 – Pol. Ind. Colón II
08228 Terrassa – Barcelona
Spain
Date of the most recent review of this leaflet: November 2023
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/