CINFAHELIX SYRUP

Introduction

Package Leaflet: Information for the User

Cinfahelix Syrup

Dry extract of Hedera helixL.(ivy)

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

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this 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 leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

1. What Cinfahelix is and what it is used for
2. What you need to know before taking Cinfahelix
3. How to take Cinfahelix
4. Possible side effects
5. Storage of Cinfahelix
6. Package Contents and Additional Information

1. What Cinfahelix is and what it is used for

Cinfahelix is a herbal medicine used as an expectorant for productive cough in adults, adolescents, and children over 2 years of age.

2. What you need to know before taking Cinfahelix

Do not take Cinfahelix

• If you are allergic to ivy (Hedera helix L.), to plants of the Araliaceae family, 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 of worsening respiratory symptoms.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Cinfahelix.

You should consult 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.

Cautious use is recommended in patients with gastritis or gastric ulcers.

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

Children

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

Other Medicines and Cinfahelix

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you might 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 effects on the ability to drive and use machines.

Cinfahelix contains Sorbitol.

This medicine contains 708 mg of sorbitol per ml. Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have 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 medicine.

3. How to take Cinfahelix

Follow the administration instructions for the medicine contained in this 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: 4 ml of syrup, 2 or 3 times a day (equivalent to 66-99 mg daily of dry extract of ivy leaves).

Children between 6 and 12 years of age: 4 ml of syrup, 2 times a day (equivalent to 66 mg daily of dry extract of ivy leaves).

Children from 2 to 5 years of age: 2 ml of syrup, 2 times a day (equivalent to 33 mg daily of dry extract of ivy leaves).

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

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

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

Cinfahelix is taken orally. Shake the bottle well before use. To ensure you always take the recommended dose, you should use the measuring cup included, which is graduated in 1 ml, 2 ml, 2.5 ml, 4 ml, and other measures up to 20 ml.

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

If you take more Cinfahelix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine 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 Cinfahelix

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

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 everybody gets them.

Common(may affect up to 1 in 10 patients): gastrointestinal system reactions such as nausea, vomiting, or diarrhea have been reported.

Uncommon(may affect up to 1 in 100 patients): allergic reactions such as urticaria, skin rashes, difficulty breathing (dyspnea) have been reported.

If you notice any of the above side effects, stop taking the medicine and consult your doctor.

If you notice symptoms of an allergy (hypersensitivity), stop taking Cinfahelix.

Reporting Side Effects

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

5. Storage of Cinfahelix

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

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

Remember to record the opening date on the medicine packaging.

This medicine does not require special storage conditions.

Discard 3 months after opening.

After the first opening of the package, do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Cinfahelix Composition

• The active ingredient is: dry extract of Hedera helix L. leaf. 1 ml of Cinfahelix syrup (equivalent to 1.18 g) contains 8.25 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, anhydrous citric acid, purified water.

Product Appearance and Package Contents

Cinfahelix syrup is a brown, opalescent liquid with a sweet taste. It is presented in 100 ml or 200 ml brown glass bottles with a high-density polyethylene screw cap.

The measuring device is a measuring cup with graduations of 1 ml, 2 ml, 2.5 ml, 4 ml, and other measures up to 20 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

Phytopharm Kleka S.A.

Kleka 1

63-40 Nowe Miasto nad Warta

Poland

Date of the Last Revision of this Leaflet:January 2021

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/