Cinfahelix syrup
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Cinfahelix syrup
Dry extract of Hedera helix L. (ivy)
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 7 days.
Leaflet contents
- What Cinfahelix is and what it is used for
- What you need to know before taking Cinfahelix
- How to take Cinfahelix
- Possible adverse effects
- How to store Cinfahelix
- Contents of the pack and other 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 starting to take Cinfahelix
Do not take Cinfahelix
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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).
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Do not administer to children under 2 years of age, as there is a risk that respiratory symptoms may worsen.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Cinfahelix.
You should consult a doctor or pharmacist if you experience 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.
If symptoms worsen or if there is no improvement after 7 days of starting treatment, treatment should be discontinued and you should consult your doctor.
Children
In children aged 2 to 4 years with persistent or recurrent cough, a medical diagnosis is required before starting treatment.
Other medicines and Cinfahelix
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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; therefore, administration is not recommended.
Breastfeeding
There is no information on whether the components of this medicine pass into breast milk; therefore, administration is not recommended to women during breastfeeding.
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 informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, consult your doctor before taking this medicine.
3. How to take Cinfahelix
Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult 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 ivy leaf extract).
Children between 6 and 12 years of age: 4 ml of syrup, twice daily (equivalent to 66 mg daily of dry ivy leaf extract).
Children from 2 to 5 years of age: 2 ml of syrup, twice daily (equivalent to 33 mg daily of dry ivy leaf extract).
In children aged 2 to 4 years with persistent or recurrent cough, a medical diagnosis is required before starting treatment.
Children under 2 years of age: Cinfahelix must not be given to children under 2 years of age due to the risk of worsening respiratory symptoms.
If you think that the effect 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 you always take the recommended dose, use the dosing cup supplied, which is graduated at 1 ml, 2 ml, 2.5 ml, 4 ml, and other measurements up to 20 ml.
You should consult a doctor if your condition worsens or does not improve after one 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 at telephone number 91 562 04 20, indicating the medication 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 such cases, 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 further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Frequent (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, or breathing difficulty (dyspnea) have been reported.
If you notice any of the aforementioned adverse effects, stop taking the medicine and consult your doctor.
If you experience symptoms of allergy (hypersensitivity), discontinue taking Cinfahelix.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Remember to record the date of opening on the medicine container.
This medicine does not require any special storage conditions.
Discard 3 months after opening.
After first opening the container, do not store at temperatures above 25°C.
Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cinfahelix
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The active substance is: dried leaf 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).
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The other components are: non-crystallizable liquid sorbitol (E-420), xanthan gum, potassium sorbate, anhydrous citric acid, purified water.
Appearance of the medicinal product and contents of the container
Cinfahelix syrup is an opalescent brown liquid with a sweet taste. It is presented in brown glass bottles of 100 ml or 200 ml, with a high-density polyethylene screw cap.
The dosing device is a dosing cup with graduations at 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 most recent revision of this leaflet: January 2021
Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/