TOSHEDRA 7 mg/ml SYRUP

2. What you need to know before taking Toshedra

Do not take Toshedra:

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

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

Children

In children between 2 and 4 years old with persistent or recurrent cough, a medical diagnosis is required before starting treatment.

Taking Toshedra with other medications

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

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, or 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.

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 385 mg of sorbitol per ml.

Sorbitol is a source of fructose. If your doctor has told you (or your child) that you suffer from an intolerance to certain sugars, or you 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 can cause gastrointestinal upset and a mild laxative effect.

3. How to take Toshedra

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

The recommended dose is:

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

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

• Children from 2 to 5 years old: 2.5 ml of syrup, 2 times a day, (equivalent to 35 mg daily of dry extract of ivy leaves).

In children from 2 to 4 years old with persistent or recurrent cough, a medical diagnosis is required before starting treatment.

Children under 2 years old: Toshedra should not be administered to children under 2 years old due to the risk of worsening respiratory symptoms.

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

Toshedra is taken orally. Shake the bottle well before use.

To ensure that you always take the recommended dose, you should use the dosing cup included, which is graduated up to 10 ml.

You should consult a doctor if it worsens or does 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 forgotten doses.

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 gets them.

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

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

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

If you notice symptoms of allergy (hypersensitivity), discontinue the use of 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 that does not appear in this 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 the sight and reach of children.

No special storage conditions are required.

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

Once the package is opened, it expires after 12 months. Remember to record the opening date on the medication package.

Medications should not be thrown down the drain or into the trash. Deposit the packages 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 packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Toshedra 7 mg/ml syrup:

The active ingredient is: dry extract of Hedera helix L. leaf. 2.5 ml of Toshedra contain 17.5 mg of dry extract of Hedera helix L. leaf (4-8:1), extraction solvent ethanol 30% (m/m). The other components are: non-crystallizable liquid sorbitol (E-420), xanthan gum, potassium sorbate, citric acid, purified water, simethicone, and cherry flavor.

Appearance of the product and package contents:

The medication is presented in 100 ml, 150 ml, or 200 ml amber PET bottles, with a child-resistant polypropylene closure. It includes a graduated polypropylene dosing cup in 2.5, 5, and 10 ml.

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 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/