TOSHEDRA 35 MG ORAL SOLUTION IN SACHETS

Introduction

Package Leaflet: Information for the User

Toshedra 35 mg Syrup in Sachets

Dry extract of Hedera helix L. (ivy)

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

1. What is Toshedra and what is it used for
2. What you need to know before taking Toshedra
3. How to take Toshedra
4. Possible side effects
5. Storage of Toshedra
6. Package Contents and Additional Information

1. What is Toshedra and what is it used for

Toshedra is an expectorant.

Toshedra is a plant-based medication used as an expectorant for productive cough accompanying benign bronchial conditions. It facilitates the elimination of mucus.

Toshedra is indicated for adults, adolescents, and children over 6 years of age.

2. What you need to know before taking Toshedra

Do not take Toshedra:

• If you are allergic to ivy (Hedera helix L.), plants of the Araliaceae family, or any of the other components of this medication (listed in section 6).

• Do not administer to children under 2 years of age, as there is a risk of worsening respiratory symptoms.

Warnings and Precautions:

Consult your doctor or pharmacist before starting to take Toshedra.

You should consult your doctor or pharmacist in cases of dyspnea (difficulty breathing), fever, or purulent sputum.

Concomitant use with other antitussives such as codeine or dextromethorphan is not recommended without prior medical consultation.

Cautions are recommended in patients with gastritis or gastric ulcers.

This medication should not be administered to children between 2 and 5 years of age, as it cannot be dosed adequately; there are other formulations more suitable for this age group.

In case of worsening symptoms or if no improvement occurs after 7 days of starting treatment, treatment should be discontinued and a doctor should be consulted.

Taking Toshedra with other medications:

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Pregnancy, Breastfeeding, and Fertility:

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:

There are no adequate and well-controlled studies in pregnant women, so its administration is not recommended.

Breastfeeding:

There is no information on the passage of the components of this medication into breast milk, so its administration is not recommended in breastfeeding women.

Fertility:

No data are available on fertility.

Consult your doctor or pharmacist before using any medication.

Driving and Using Machines

No studies have been conducted on the effects on the ability to drive and use machines.

Toshedra contains sorbitol.

This medication 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 told you that you (or your child) have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

3. How to take Toshedra

Follow the administration instructions of this medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults and adolescents over 12 years of age: 5 ml of syrup (1 sachet), 3 times a day, (equivalent to 105 mg daily of dry extract of ivy leaves).

• Children between 6 and 12 years of age:5 ml of syrup (1 sachet), 2 times a day, (equivalent to 70 mg daily of dry extract of ivy leaves).

If you think the action of Toshedra is too strong or too weak, tell your doctor or pharmacist.

Toshedra is taken orally.

For more details on the use of the sachets, follow the diagrams below:

Press the sachet gently before using it, as shown.

Hold the sachet firmly and tear it along the dotted lines.

Swallow the medication, squeezing the sachet until it is empty.

You should consult a doctor if your symptoms worsen or do not improve after a week of treatment.

If you take more Toshedra than you should

In case you have taken more Toshedra than you should or in case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 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 other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Frequent (may affect 1 to 10 in every 100 patients): gastrointestinal system reactions such as nausea, vomiting, or diarrhea have been reported.

Uncommon (may affect 1 to 10 in every 1,000 patients): allergic reactions such as hives, skin rashes, difficulty breathing (dyspnea) have been reported.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

If you notice symptoms of an allergy (hypersensitivity), discontinue taking Toshedra.

Reporting side effects

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

5. Storage of Toshedra

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging, after "EXP". 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 SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Toshedra 35 mg syrup in sachets:

The active ingredient is: dry extract of Hedera helix L. leaf. 5 ml of Toshedra contains 35 mg of dry extract of Hedera helix L. leaf (4-8:1), extraction solvent: ethanol 30% (m/m). The other components are: purified water, potassium sorbate, citric acid, non-crystallizable sorbitol liquid (E-420), xanthan gum, and cherry flavor.

Appearance of the product and package contents:

Toshedra 35 mg syrup is presented in easy-to-open single-dose sachets of 5 ml each, formed by a complex aluminum laminate (PET/Alu/PE/PET/PE).

Package with 20 sachets.

Marketing Authorization Holder and Manufacturer:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Date of the last revision of this package leaflet: November 2023

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