Ketoconazole CINFA 2% gel EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
ketoconazol cinfa 2% gel EFG
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- 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.
Leaflet Contents
- What ketoconazol cinfa is and what it is used for
- What you need to know before using ketoconazol cinfa
- How to use ketoconazol cinfa
- Possible side effects
- How to store ketoconazol cinfa
- Contents of the pack and other information
1. What ketoconazole cinfa is and what it is used for
Ketoconazole belongs to a group of medicines called antifungals (medicines used to treat infections caused by fungi and yeasts).
This medicine is indicated in adolescents and adults for the treatment and prevention of the following fungal and yeast skin infections:
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Pityriasis versicolor, a condition characterized by small, irregular, brownish or whitish patches distributed across the trunk.
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Seborrheic dermatitis, a condition affecting mainly the face and chest, causing redness and skin scaling.
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Pityriasis capitis (dandruff), characterized by scalp scaling.
2. What you need to know before using ketoconazole cinfa
Do not use ketoconazole cinfa
If you are allergic to ketoconazole or to any of the other ingredients of this medicine (listed in section 6).
After application, some allergic symptoms may include itching and irritation.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use ketoconazole cinfa.
For external use only. Contact with the eyes must be avoided. If accidental contact with the eyes occurs, rinse thoroughly with plenty of water and consult an ophthalmologist if necessary.
If you are using corticosteroid creams, ointments, or lotions, inform your doctor or pharmacist before starting treatment. You may begin treatment with this medicine, but you should not abruptly stop applying corticosteroids, as your skin may react, causing redness or itching. Continue your corticosteroid treatment as follows:
- apply the same amount during the first week,
- gradually reduce the frequency during the second to third week,
- completely discontinue corticosteroid use.
In case of an allergic reaction, wash the gel off the skin, stop treatment immediately, and consult your doctor without delay.
Children
The safety and efficacy of ketoconazole gel in children has not been established.
Other medicines and ketoconazole cinfa
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 may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
As a precautionary measure, it is preferable to avoid using this medicine during pregnancy and breastfeeding.
Driving and using machines
Given the characteristics of this medicine, no effects on driving or operating machinery are expected.
ketoconazole cinfa contains sodium lauryl sulfate
This medicine contains 480 mg of sodium lauryl sulfate per ml.
Sodium lauryl sulfate may cause local skin reactions (such as itching or burning sensation) or increase skin reactions caused by other medicines when applied to the same area.
ketoconazole cinfa contains ethanol
This medicine contains 26.3 mg of alcohol (ethanol) per ml.
It may cause a burning sensation on damaged skin.
3. How to use ketoconazole cinfa
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended frequency of application and duration of treatment for this medicine depends on the type of infection and whether it is intended for treatment or prevention, and is as follows:
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Pityriasis versicolor: Apply once daily for 5 days. For prevention, once a year and before summer, apply one course once daily for 3 consecutive days.
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Pityriasis capitis (dandruff) and seborrheic dermatitis: Apply twice a week for 2–4 consecutive weeks. To prevent recurrence after treatment, the gel may be applied once a week or once every two weeks. This helps prevent symptoms from reappearing.
If symptoms do not improve after 4 weeks of treatment, consult your doctor.
Continue using the gel for a few days after all symptoms have disappeared.
Elderly patients
There are no specific dosage recommendations for these patients.
Method of use
For topical use only.
The gel may be used to treat both the scalp and larger areas of the face and chest.
Wash the infected skin or scalp areas, allowing the medicine to remain in contact for 3 to 5 minutes before rinsing off. Make sure to wash both the skin and hair thoroughly. Usually, one handful of gel is sufficient for one wash.
If you use more ketoconazole cinfa than you should
If more ketoconazole is applied than your doctor has prescribed, you may experience a burning sensation, redness, or swelling, which will disappear once treatment is discontinued.
This medicine must not be ingested. If accidentally swallowed, contact your doctor.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use ketoconazole cinfa
Do not apply a double dose to make up for a missed dose.
If you interrupt treatment with ketoconazole cinfa
Do not interrupt treatment without consulting your doctor, as symptoms of your condition may reappear or worsen.
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 adverse effects (may affect up to 1 in 10 patients)
- Sensation of burning on the skin.
- Redness of the skin at the application site.
- Itching at the site of administration.
Uncommon adverse effects (may affect up to 1 in 100 patients)
- Inflammation of hair follicles.
- Allergic reactions (hypersensitivity).
- Increased tearing.
- Hair loss.
- Changes in hair texture.
- Localized eczema (contact dermatitis).
- Skin rash.
- Skin eruption.
- Skin exfoliation (desquamation).
- Oily, sticky skin.
- Other reactions at the site of administration: bleeding, discomfort, dryness, swelling, irritation, paresthesia (tingling, numbness).
Rare adverse effects (may affect up to 1 in 1,000 patients)
- Distorted taste perception.
- Eye irritation.
- Acne.
- Sensitive skin.
Adverse effects of unknown frequency (cannot be estimated from available data)
- Sudden swelling of the skin or mucous membranes, usually of the face, eyes, or lips.
- Changes in hair color.
- Urticaria.
Discontinue treatment in case of intolerance to the gel.
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 ketoconazole cinfa
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
After first opening, the contents should be used within 28 days.
After first opening, do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, 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 ketoconazole cinfa
- The active substance is ketoconazole. Each milliliter of gel contains 20 mg of ketoconazole.
- The other components are: sodium laureth sulfate, disodium laureth sulfosuccinate, monoethanolamide of ethoxylated rapeseed fatty acids, hydrolyzed collagen, polyethylene glycol 120 methyl glucose dioleate, hydrochloric acid (E-507), imidazolidinylurea, summer fragrance, erythrosine (E-127), sodium chloride and purified water.
Presentation of the product and contents of the container
ketoconazole cinfa is presented as a red, viscous liquid gel.
It is packaged in high-density polyethylene (HDPE) bottles, white, opaque, with a polypropylene (PP) cap.
Each package contains one 100 ml bottle.
Marketing Authorization Holder and Manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Date of the most recent review of this leaflet: May 2022
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66052/P_66052.html
QR code link: https://cima.aemps.es/cima/dochtml/p/66052/P_66052.html