Toshedra 35 mg jarabe en sobres

Package Insert: Information for the User

Toshedra 35 mg Sugar Coated Tablets in Blister Packs

Dried Extract of Hedera helix L. (Ivy)

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

Follow exactly the administration instructions of the medicine 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 your condition worsens or does 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 6 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.

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

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

Taking Toshedra with other medications:

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

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, believe 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 this medication's components to breast milk, so its administration is not recommended to women during the breastfeeding period.

Fertility:

No data are available on fertility.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

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

The recommended dose is:

If you estimate that the action of Toshedra is too strong or weak, inform 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 the sachet along the indicated lines.

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

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.

In this case, you should consult your doctor.

If you forgot to take Toshedra:

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

If you have any other questions 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 out of 100 patients): gastrointestinal reactions such as nausea, vomiting, or diarrhea have been reported.

Infrequent (may affect between 1 and 10 out of 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 adverse effects not listed in this prospectus.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects 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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and the

medications you no longer need at the SIGRE drop-off pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications you no longer need. By doing so, you will help protect the environment..

Composition of Toshedra 35 mg syrup in sachets:

The active ingredient is: dried extract of Hedera helix leaf. 5 ml of Toshedra contain 35 mg of dried 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 essence.

Appearance of the product and content of the packaging:

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

Package with 20 sachets.

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 medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/