TOSIVY SYRUP

Introduction

PACKAGE LEAFLET

Package Leaflet: Information for the User

Tosivy Syrup

Dry extract of Hedera helixL. (ivy)

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of the medicine 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 it worsens or does not improve after 7 days.

Contents of the package leaflet

1. What is Tosivy and what is it used for
2. What you need to know before taking Tosivy
3. How to take Tosivy
4. Possible side effects

5 Conservation of Tosivy

1. Contents of the packaging and additional information

1. What is Tosivy and what is it used for

Tosivy is a traditional herbal medicinal product developed from the dry extract of Hedera helix(ivy) leaves used as an expectorant for productive cough.

It is indicated for adults, adolescents, and children over 2 years of age for use in specific indications based on traditional use.

2. What you need to know before taking Tosivy

Do not take Tosivy

If you are allergic to ivy (Hedera helixL.), to plants of the Araliaceaefamily, or to any of the other components of this medicine (listed in section 6).

Do not administer to children under 2 years of age, as there is a risk that expectorants may worsen respiratory symptoms.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tosivy.

If dyspnea, fever, and bloody or purulent expectorations occur, consult a doctor immediately.

Patients with gastritis or gastric ulcer should use this medicine with caution.

Tosivy contains a plant extract, which may cause the syrup to be slightly cloudy.

Children

In the case of persistent or recurrent cough in children, consult a doctor before starting treatment.

Warning about excipients:

Tosivy contains sorbitol(E 420): 320 milligrams per milliliter of syrup.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Use in patients with impaired renal and/or hepatic function

If you have renal or hepatic insufficiency, consult your doctor or pharmacist before taking the medicine. There are no data for dosage recommendations in these patients.

Taking Tosivy with other medicines

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

No interaction of Tosivy with other medicines is known.

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

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 medicine.

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 medicine into breast milk, so its administration is not recommended in breastfeeding women.

Driving and using machines

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

3. How to take Tosivy

Follow the administration instructions of the medicine 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: 3-4 ml of syrup, 2 or 3 times a day (which corresponds to 44.4 mg or 88.8 mg of ivy extract)

Children from 6 to 11 years of age: 2.5 ml of syrup, 2 or 3 times a day (which corresponds to 37 mg or 55.5 mg of extract)

Children from 2 to 5 years: 1.5 ml, 3 times a day (which corresponds to 33.3 mg of extract)

For administration to children between 2 and 4 years of age with persistent or recurrent cough, medical diagnosis is required before starting treatment.

The use of Tosivy in children under 2 years of age is contraindicated (see section 4.3).

Treatment duration

If symptoms persist during the use of the medicine for more than one week, consult a doctor or pharmacist.

Tosivy is taken/administered orally. Shake the bottle well before use. To ensure that you always take the recommended dose, you must use the dosing syringe, graduated every 0.5 ml up to 5 ml, included in the packaging.

If you take more Tosivy than you should

Do not exceed the recommended daily dose.

In case of taking more Tosivy 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 medicine and the amount ingested.

Taking higher amounts than recommended may cause nausea, vomiting, diarrhea, and nervousness.

If you forget to take Tosivy

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Tosivy

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Gastrointestinal reactions (nausea, vomiting, diarrhea) have been described. The frequency is unknown.

Allergic reactions (urticaria, skin rash, dyspnea, anaphylactic reaction) have been described. The frequency is unknown.

If you notice any of the above-mentioned side effects, particularly symptoms of allergy, stop taking the medicine and consult your doctor.

If any other type of adverse reactions not mentioned above occurs, consult your doctor or pharmacist.

Reporting of side effects

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

5. Conservation of Tosivy

Keep this medicine out of the sight and reach of children.

Store below 30 °C.

Do not use this medicine after the expiration date stated on the carton and label after the abbreviation CAD. The expiration date is the last day of the month indicated.

Once the packaging is opened, the validity will be 3 months. Remember to record the opening date on the medicine packaging.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines 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 medicines you no longer need. This way, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Tosivy

1 ml of syrup contains 7.4 mg of dry extract of Hedera helixL. (ivy) leaves, (4.0 – 8.0:1) extraction solvent ethanol 30% m/m.

• The active principle is: dry extract of Hedera helixL. (ivy) leaves.
• The other components (excipients) are: potassium sorbate, non-crystallizable liquid sorbitol 70% (320 mg per ml), propylene glycol, xanthan gum, citric acid monohydrate, purified water.

Appearance of the product and contents of the packaging

The medicine is presented in type III amber glass bottles with 100 ml of syrup. Child-resistant closure made of high-density polyethylene (HDPE).

Dosing syringe made of low-density polyethylene (LDPE) of 5 ml, graduated every 0.5 ml, with a plunger made of polyethylene (PE).

Marketing authorization holder

Laboratorios Lorien

Av. Josep Tarradellas, 8, Ático 1ª

08029 Barcelona

Spain

Manufacturer

Instituto Universitario de Ciencia y Tecnología, S.A.

c/ Álvarez de Castro, 63

08100 Mollet del Vallès

Spain

Date of the last revision of this package leaflet:October 2019

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