Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ketoconazole may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
this medicine
This medicine is suitable for most adults but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.
Check the tables below to see how often to use. ■ Each tube of cream is sealed – unscrew the cap and use the cap to pierce the seal. ■ For topical use only, which means it is applied directly to the affected area of skin. ■ Do not use more often than the stated dose shown in the table.
Do not use this medicine… If you have ever had a bad reaction to any of the ingredients. If this applies to you, get advice from a doctor or pharmacist without using Daktarin Intensiv Cream. ■
Talk to your doctor or pharmacist… If you recently used a cream, ointment or lotion on your skin infection that contains a corticosteroid (a group of medicines that work by reducing inflammation caused by a variety of skin conditions): You should continue to apply a mild corticosteroid (such as hydrocortisone) cream, ointment or lotion in the morning whilst applying Daktarin Intensiv cream in the evening. The mild corticosteroid treatment can then be gradually stopped over a period of 2 to 3 weeks. ■ If you are a diabetic you should visit your healthcare professional for regular check ups as diabetes can increase the risk of foot problems. If you are not sure about any of the medicines you are taking, show the bottle or pack to your pharmacist. ■
If you are pregnant or breast-feeding You can use Daktarin Intensiv cream if you are pregnant or breast-feeding. Do not apply directly to the breast whilst breast-feeding. ■ However, always ask your doctor or pharmacist for advice before using any medicine if you are pregnant or breast-feeding. ■
Special warnings about this medicine ■
Do not let the cream get into your eyes.
Some of the ingredients can cause problems ■ ■
Propylene glycol may cause skin irritation. Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
How to apply the cream Wash the infected area and dry it well (especially between the toes). As many skin conditions are contagious, you should keep a towel and flannel for your own use and not share it so that you do not infect anyone else. ■ Apply the cream thinly onto the infected area and surrounding skin. ■ Wash your hands carefully after applying the cream to avoid spreading the infection to other parts of the body or to other people. Similarly, clothing which comes into contact with the infected areas, such as socks, should be washed and changed frequently. For skin infections of the trunk, groin, feet and hands, apply Daktarin Intensiv Cream to the affected and immediate surrounding area once or twice a day. Your doctor will tell you how often to use it and for how long. Depending on the type of infection, treatment may last 2 to 6 weeks. The recommended dose is: ■
For Athletes Foot (infections between the toes) Age Adults
Dose Rub the cream gently between the toes and surrounding area once or twice a day (morning and night) for 4 to 6 weeks. Treatment may be necessary for up to 6 weeks. ■ Continue to apply the cream to the affected areas for a few days after signs of infection have cleared to prevent them coming back. ■ If symptoms have not improved within 4 weeks talk to your doctor. turn over ▶
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Age Adults
Dose Rub the cream into the affected and surrounding area once or twice daily. ■ Continue treatment for a few days after signs of infection have cleared. Treatment may be necessary for up to 4 weeks. You may feel relief from symptoms quickly but it is important that you continue to use the cream as described to prevent them from coming back. ■ If symptoms have not improved within 4 weeks talk to your doctor.
If anyone has swallowed this product If anyone accidentally swallows Daktarin Intensiv Cream, contact a doctor or your nearest Accident and Emergency department (Casualty), taking this leaflet and pack with you.
Uncommon: (less than 1 in 100 but more than 1 in 1000 people are affected) ■ Localised eczema (dermatitis), skin rash, sticky skin, irritation, prickling sensation, inflammation, discomfort, dryness, bleeding or other reactions at the application site. Other effects: ■ Urticaria also known as hives, where the skin looks blotchy with white raised wheals (bumps surrounded by redness). Reporting of side-effects If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side-effects not listed in this leaflet. You can also report side-effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side-effects you can help provide more information on the safety of this medicine.
5 Storing this medicine
Daktarin Intensiv Cream can have side-effects, like all medicines, although these don't affect everyone and are usually mild.
Do not store above 25oC. Keep this medicine out of the sight and reach of children. Do not use your medicine after the date shown as the expiry date on the packaging. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
If you experience any of the following, stop using the medicine and seek immediate medical help:
6 Further information What's in this medicine?
Uncommon (less than 1 in 100 but more than 1 in 1000 people are affected) ■ Severe allergic reactions including peeling or blistering of the skin.
The active ingredient in 1 g of Daktarin Intensiv Cream is prescription strength: Ketoconazole 20 mg. Other ingredients are: Propylene glycol, stearyl alcohol, cetyl alcohol, sorbitan stearate, polysorbate 60, polysorbate 80, isopropyl myristate, sodium sulphite (E221) and purified water.
If you forget to use the medicine If you forget to use a dose, use the next dose when needed. Do not use a double dose.
If you experience any of the following, stop using the medicine and talk to your doctor: Common (less than 1 in 10 but more than 1 in 100 people are affected) ■ Itchiness or redness at the application site. ■ A skin burning sensation may also occur.
What the medicine looks like Daktarin Intensiv Cream is a white cream available in a 5 g, 15 g or 30 g tube. Not all pack sizes may be marketed. Product Licence holder: McNeil Products Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.
Manufacturer: Janssen Pharmaceutica NV, Turnhoutseweg 30, B2340, Beerse, Belgium. This leaflet was revised February 2020. Daktarin is a registered trade mark.
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For Dhobie Itch (Jock Itch)
7 Facts about Athlete's Foot: How do you catch Athlete's Foot?
It's extremely infectious so anyone can pick it up, especially people sharing communal changing rooms and showers. Once the fungal spores have been transferred onto the feet, they thrive in the warm, moist areas between the toes. The skin soon becomes inflamed and itchy with flaking or cracking occurring. The infected flakes of skin are then shed onto the floor or into the socks and shoes by walking or friction. Someone else will be easily infected if they step on these flakes, or if they share towels or footwear with someone who has already got athlete's foot. What is more, even if you've already got rid of your Athlete's Foot, it's very easy to re-infect yourself. The spores can live on or in your shoes or socks and if you don't change them regularly, or treat them with antifungal powders or spray powders, the Athlete's Foot soon returns.
How to prevent re-infection
If you want to avoid the vicious circle of re-infection, here are a few helpful hints. ■ Spray inside your shoes and socks with fungicidal powder before putting them on. ■ Don't wear the same pair of shoes every day. This helps reduce the build-up of sweat which provides the moisture on which the fungus thrives. ■ Avoid synthetic footwear. Choose cotton socks and leather shoes which allow your feet to breathe. ■ Avoid sharing towels or footwear. ■ Avoid walking barefoot in changing rooms. ■ Dry thoroughly between your toes and keep toenails short as this reduces the number of places fungi can grow. GB – AW_169917 18-0228 © 2020
Daktarin Intensiv Cream comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Daktarin Intensiv Cream is ketoconazole.
Medicines with the same active substance, strength and form include: Daktarin Gold 2% Cream, Nizoral 2% Cream. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Daktarin Intensiv Cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the treatment of the following mycotic infections of the skin: tinea pedis and tinea cruris.
Ketoconazole cream is for use in adults.
For the treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie itch).
Tinea cruris and tinea pedis: It is recommended that Daktarin Intensiv Cream be applied once or twice daily to cover the affected and immediate surrounding area.
The usual duration of treatment is tinea cruris 2-4 weeks, tinea pedis 4-6 weeks.
Treatment should be continued, until a few days after disappearance of all symptoms. The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks of treatment.
Method of administration: Topical administration
Paediatric patients
The safety and efficacy of Daktarin Intensiv Cream in children (17 years and younger) has not been established.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Daktarin Intensiv cream is not for ophthalmic use.
To prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids it is recommended to continue applying a mild topical corticosteroid in the morning and to apply Daktarin Intensiv cream in the evening, and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.
This medicine contains cetyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). Also contains propylene glycol which may cause skin irritation.
None known.
There are no adequate and well-controlled studies in pregnant or lactating women. To date, no other relevant epidemiological data are available. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity at doses that are not relevant to the topical administration of ketoconazole.
Plasma concentrations of ketoconazole are not detectable after topical application of Daktarin Intensiv cream to the skin of non-pregnant humans (See Pharmacokinetic properties, section 5.2). There are no known risks associated with the use of Daktarin Intensiv cream in pregnancy or lactation.
This medicine has no influence on the ability to drive and use machines.
The safety of ketoconazole cream was evaluated in 1079 subjects who participated in 30 clinical trials. Ketoconazole cream was applied topically to the skin.
Based on pooled safety data from these clinical trials, the most commonly reported (≥1% incidence) ADRs were (with % incidence): application site pruritus (2%), skin burning sensation (1.9%), and application site erythema (1%). Including the above-mentioned adverse drug reactions (ADRs), the following table displays ADRs that have been reported with the use of ketoconazole cream from either clinical trial or postmarketing experiences. The displayed frequency categories use the following convention:
Very Common
(≥1/10)
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1,000 to <1/100)
Rare
(≥1/10,000 to <1/1,000)
Very rare
(<1/10,000)
Not Known
(cannot be estimated from the available clinical trial data).
System Organ Class
Adverse Drug Reactions
Frequency Category
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1,000 to <1/100)
Not Known
Immune System Disorders
Hypersensitivity
Skin and Subcutaneous Tissue Disorders
Skin burning sensation
Bullous eruption
Dermatitis contact
Rash
Skin exfoliation
Sticky skin
Urticaria
General Disorders and Administration Site Conditions
Application site erythema
Application site pruritus
Application site bleeding
Application site discomfort
Application site dryness
Application site inflammation
Application site irritation
Application site paraesthesia
Application site reaction
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Topical application
Excessive topical application may lead to erythema, oedema and a burning sensation, which will disappear upon discontinuation of the treatment.
In the event of accidental ingestion, supportive and symptomatic measures should be carried out.
Ask anything about Daktarin Intensiv Cream. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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