Package Insert: Information for the User

Toshedra 7 mg/ml Syrup

Dried Extract of Hedera helix L. (Ivy)

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

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

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

Toshedra is an expectorant.

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

Toshedra is indicated for adults, adolescents, and children over 2 years old.

Do not take Toshedra:

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Toshedra.

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

Do not recommend concomitant use with other antitussives such as codeine or dextromethorphan without prior medical consultation.

Use with caution in patients with gastritis or gastric ulcers.

In case of worsening of symptoms or if no improvement occurs after 7 days of starting treatment, treatment should be discontinued and your 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 taken recently 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

No adequate and well-controlled studies have been conducted in pregnant women, so its administration is not recommended.

Breastfeeding:

No information is available on the passage of components of this medication to breast milk, so its administration is not recommended to women during the breastfeeding period.

Fertility:

No data are available on fertility.

Driving and operating machines:

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

Toshedra contains sorbitol.

This medication contains 385 mg of sorbitol in each ml.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) suffer from 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 (or your child) before taking this medication.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in 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 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).

Children 2 to 4 years old with persistent or recurrent cough require a medical diagnosis before starting treatment.

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

If you estimate that the action of Toshedra is too strong or too weak, inform 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 measuring cup included, which is graduated up to 10 ml.

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

If you take more Toshedra than you should

In the event that 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 Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

Do not exceed the recommended daily dose. The ingestion of significantly higher amounts (more than three times the daily dose) may cause nausea, vomiting, and diarrhea.

You should consult your doctor in this case.

If you forgot to take Toshedra

Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Rare (may affect between 1 and 10 of every 1,000 patients): allergic reactions such as urticaria, skin eruptions, difficulty breathing (dyspnea) have been reported.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

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

Reporting Adverse Effects

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

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 “CAD”. The expiration date is the last day of the month indicated.

Once the packaging is opened, it expires after 12 months. Please note the date of opening on the medication packaging.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Toshedra 7 mg/ml syrup:

The active ingredient is: dried extract of Hedera helix leaf. 2.5 ml of Toshedra contains 17.5 mg of dried extract of Hedera helix L. (ivy) (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 essence.

Appearance of the product and contents of the packaging:

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

Holder of the marketing authorization and responsible for manufacturing:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Last review date of this leaflet: November 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/