PACKAGE INSERT

Package Insert: Information for the User

Tosivy Syrup

Dried extract ofHedera helixL. (ivy)

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

Follow exactly the administration instructions for the medication 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.
• Ifyou need advice or more information, consult your pharmacist..
• If you experience 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.

1. What is Tosivy and for what it is used

2. What you need to know before starting to take Tosivy

3. How to take Tosivy

4. Possible adverse effects

5. Storage of Tosivy

6. Contents of the package and additional information

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

It is indicated for use in adults, adolescents, and children, aged 2 years and older, for specific indications based on its traditional use.

Do not take Tosivy

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

Do not administer to children under 2 years old as there is a risk of worsening respiratory symptoms with expectorants.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tosivy

If you experience shortness of breath, fever, and bloody or purulent cough, consult a doctor immediately.

Patients with gastritis or gastric ulcers should use this medication with caution.

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

Children

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

Warning about excipients:

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

If your doctor has indicated that you have intolerance to certain sugars, consult with them before taking this medication.

Use in patients with renal and/or hepatic dysfunction

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

Taking Tosivy with other medications

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

No interactions of Tosivy with other medications are known.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 administration is not recommended.

Breastfeeding:

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

Driving and operating machinery

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

Follow exactly the medication administration instructions 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:

Adults and adolescents over 12 years old: 3- 4 ml of syrup, 2 or 3 times a day (corresponding to 44.4 mg or 88.8 mg of extract of ivy)

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

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

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

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

Treatment duration

If symptoms persist during the use of the medication 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 graduated dosing syringe, included in the packaging, which measures 0.5 ml to 5 ml.

If you take more Tosivy than you should

Do not exceed the recommended daily dose.

In the event that more Tosivy has been taken than should have been or in case of overdose or accidental ingestion, consult a doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

Taking quantities above the recommended amounts may cause nausea, vomiting, diarrhea, and nervousness.

If you forgot to take Tosivy

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

If you interrupt the treatment with Tosivy

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 may experience them.

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

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

If you notice any of the mentioned adverse effects, particularly allergy symptoms, discontinue medication use and consult your doctor.

If any other type of adverse reactions not mentioned previously occur, you must consult your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 on the safety of this medication.

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

Store below 30 °C.

Do not use this medication after the expiration date that appears on the box 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 medication packaging.

Medications should not be thrown down the drains or in the trash.Deposit the packaging and themedications that you no longer need at the SIGRE collection pointof the pharmacy. In case of doubt, please ask your pharmacist how to dispose of the packaging and the medications that you no longer need. By doing so, you will help protect the environment.

Composition of Tosivy

1 ml of syrup contains7.4 mg of dried extract ofHedera helixL. (ivy) leaves,(4.0 – 8.0:1) extraction solvent ethanol 30 % m/m.

• The active principle is: dried extract ofHedera 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 amber-colored type III glass bottles with 100 ml of syrup. Child-resistant HDPE (high-density polyethylene) cap.

5 ml LDPE (low-density polyethylene) dosing syringe, graduated every 0.5 ml, with PE (polyethylene) plunger.

Holder of the marketing authorization

Laboratorios Lorien

Avenida Josep Tarradellas, 8, 1st Floor

08029 Barcelona

Spain

Responsible for manufacturing

Instituto Universitario de Ciencia y Tecnología, S.A.

c/ Álvarez de Castro, 63

08100 Mollet del Vallès

Spain

Last review date of this leaflet:October 2019

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