Leaflet: information for the user

Cinfahelix syrup

Dried extract ofHedera helixL.(ivy)

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 7 days.

Cinfahelix is a plant-based medication used as an expectorant for productive cough in adults, adolescents, and children over 2 years old.

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 medication (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.

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.

Caution is recommended in patients with gastritis or gastric ulcer.

In case of worsening of symptoms or if no improvement occurs after 7 days of starting treatment, treatment should be interrupted 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.

Other medications and Cinfahelix

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 effects on the ability to drive and operate machinery.

Cinfahelix contains sorbitol.

This medication contains 708 mg of sorbitolper ml. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have an 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's doctor) before taking this medication.

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: 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 old:4 ml of syrup, 2 times a day (equivalent to 66 mg daily of dry extract of ivy leaves).

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

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

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

If you estimate that the action of Cinfahelix is too strong or too weak, inform your doctor or pharmacist.

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

You should consult a doctor if you 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 Toxicological Information Service, phone 91 562 04 20, 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.Consult your doctor in this case.

If you forgot to take Cinfahelix

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

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 may experience them.

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

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

If you notice any of the adverse effects mentioned above, discontinue taking the medication and consult your doctor.

If you notice allergy symptoms (hypersensitivity), discontinue taking Cinfahelix.

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 on the safety of this medication.

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

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.

Remember to record the opening date on the medication packaging.

This medication does not require special storage conditions.

Dispose of after 3 months after opening.

After the first opening of the packaging, do not store at a temperature above 25°C.

Medications should not be thrown down the drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Cinfahelix

• The active principle is: dried extract of Hedera helix L . 1 ml of Cinfahelix syrup (equivalent to 1.18 g) contains 8.25 mg of dried extract of Hedera helix L ., leaf (ivy leaves) (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.

Appearance of the product and contents of the packaging

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

The dosing device is a dosing cup with a graduation of 1 ml, 2 ml, 2.5 ml, 4 ml, and other measurements up to 20 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

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 review of this leaflet: January 2021

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/