Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Daktarin Aktiv Cream
⚠ This medicine appears to have been discontinued
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 Miconazole nitrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
How to take it
this medicine Check the table below to see how often to use. ■ Each tube of cream is sealed – use the cap to pierce the seal. ■ For cutaneous 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.
How to apply the cream Wash the infected area and dry it well. 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 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. ■
Adults and children of all ages Age
Dose
Adults and children of all ages
Apply the cream to the infected skin twice a day (e.g. at night and in the morning).
Continue treatment for 7 days after all the symptoms have cleared to prevent them from coming back. ■ If symptoms persist talk to your doctor. ■
Some of the ingredients can cause problems ■
Benzoic acid (E210) may cause local irritation. It may
turn over
LARGEST TEXT SIZE
14.00 pt
AVE. TEXT SIZE
8 pt
SMALLEST TEXT SIZE
FONTS USED
Arial-BoldMT Avenir-Heavy AvenirLTPro-Roman AvenirLTStd-Heavy AvenirLTStd-Oblique AvenirLTStd-Roman FuturaLTPro-BoldOblique HelveticaNeueLTStd-Cn ZapfDingbatsStd
Interstate-LightCondensed
145 x 260mm
4.00 pt
27-10-2021 Beerse
JJSC_00119_V1
Leaflet
WHITE
Beerse/Insert/006/V1 INSTRUCTION
LITHO OFFSET LITHO OFFSET
PANTONE Reflex Blue C Black
REPRESENTATION:
Colours represented with a diagonal line have been modified to aid PDF approval.
110
Date 24-09-2025
en (English)
404238177_r2 Product / Eurocode / Mat. ID Code 8747308
727204 Old Component / Item Code
PC-0006331 PC Spec
Languages
786890 New Component / Item Code
Job / Version No.
CHILD
Project Name / Design Miconazole PRAC – Daktarin Aktiv cream 15g,30g/UK/Leaflet/CRD14823,14824/786890
110
110
If anyone has swallowed this product
If anyone accidentally swallows Daktarin Aktiv Cream, contact a doctor or your nearest Accident and Emergency department (Casualty), taking this leaflet and pack with you.
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.
Possible side effects
Daktarin Aktiv Cream can have side-effects, like all medicines, although these don't affect everyone and are usually mild.
If you experience any of the following, stop using the medicine and seek immediate medical help: A severe allergic reaction which may include: ■ Swelling of the face, lips, mouth, tongue or throat ■ Difficulty in swallowing or breathing ■ Itchy rash (hives) ■ skin burning sensation, application site reactions, application site irritation, application site burning, application site warmth, application site itchiness, skin inflammation, skin discolouration. ■
Other side-effects which may occur but it is unknown how often: Rash, skin irritation, itchiness or redness If you experience any side-effects not included in this leaflet or are not sure about anything, talk to your doctor or pharmacist. ■
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 Do not store above 25oC. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after 'Expiry'. 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.
6 Further information What's in this medicine? The active ingredient in 1 g of Daktarin Aktiv Cream is: Miconazole nitrate 20 mg. Other ingredients are: PEG-6, PEG-32 and glycol stearate, oleoyl macroglycerides, liquid paraffin, benzoic acid (E210), butylated hydroxyanisole (E320), purified water.
What the medicine looks like Daktarin Aktiv Cream is a white cream available in tubes of 15 g and 30 g. 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 September 2025. Daktarin is a registered trade mark.
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. 15-0388 GB – 786890
Frequently asked questions about Daktarin Aktiv Cream
How do I take Daktarin Aktiv Cream?
Daktarin Aktiv Cream comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Daktarin Aktiv Cream?
The active substance in Daktarin Aktiv Cream is miconazole nitrate.
Are there equivalent medicines to Daktarin Aktiv Cream?
Medicines with the same active substance, strength and form include: Daktarin 2% Cream, Daktarin 2% w/w cream. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Daktarin Aktiv Cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Daktarin Aktiv Cream without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: miconazole nitrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For the treatment of athlete's foot.
4.2. Posology and method of administration
For all ages.
Apply some cream to the lesions two times daily. Rub the cream into the skin with your finger until it has fully penetrated. If the powder is used with the cream, a once daily application of both formulations is recommended. The duration of therapy varies from 2 to 6 weeks depending on the localisation and the severity of the lesion. Treatment should be continued at least one week after disappearance of all signs and symptoms.
Method of administration: Cutaneous application.
4.3. Contraindications
Hypersensitivity to the active substance, other imidazole derivatives or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Daktarin Aktiv Cream must not come into contact with the mucosa of the eyes.
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin Aktiv Cream and with other miconazole topical formulations (see Adverse Reactions). If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.
This medicine contains 2 mg of Benzoic acid (E210) per gram. Benzoic acid may cause local irritation. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
This medicine also contains 0.052 mg/g of Butylated hydroxyanisole (E320) which may cause local skin reactions (e.g., contact dermatitis), or irritation to the eyes and mucous membranes.
Miconazole administered systemically is known to inhibit CYP3A4/2C9, which can lead to prolonged effects of warfarin or other vitamin K antagonists. While systemic absorption is limited with topical formulations, the concomitant use of Daktarin Aktiv Cream and warfarin or other vitamin K antagonists should be done with caution and the anticoagulant effect should be carefully monitored and titrated. Patients should be advised of the symptoms of bleeding events and to immediately stop treatment with miconazole and seek medical advice should they occur (see section 4.5).
4.5. Interaction with other medicinal products and other forms of interaction
Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on warfarin or other vitamin K antagonists, caution should be exercised and anticoagulant effect should be monitored.
4.6. Fertility, pregnancy and lactation
Pregnancy
In animals, miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses. Only small amounts of miconazole nitrate are absorbed following topical administration. However, as with other imidazoles, miconazole nitrate should be used with caution during pregnancy.
Breast-feeding
Topically applied miconazole is minimally absorbed into the systemic circulation, and it is not known whether miconazole is excreted in human breast milk. Caution should be exercised when using topically applied miconazole products during lactation.
4.7. Effects on ability to drive and use machines
Daktarin Aktiv Cream has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Adverse drug reactions reported among 834 patients who received miconazole nitrate 2% cream (n=426) and/or placebo cream base (n=408) in 21 double- blind clinical trials are presented in Table 1 below. Moreover, adverse drug reactions from spontaneous reports during the worldwide post-marketing experience with Daktarin that meet threshold criteria are included in Table 1. The adverse drug reactions are ranked by frequency, using the following convention:
Very common ≥1/10
Common ≥1/100 and <1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000 and <1/1,000
Very rare <1/10,000, including isolated reports
Adverse reactions obtained from clinical studies and post-marketing surveillance are presented by frequency category based on incidence in clinical trials or epidemiology studies, when known.
Table 1: Adverse reactions in clinical trials and post-marketing experience
System Organ Class
Adverse Reactions
Frequency Category
Uncommon
(≥1/1,000 to <1/100)
Not known
Immune System Disorders
Anaphylactic reaction
Hypersensitivity
Skin and Subcutaneous Tissue Disorders
Skin burning sensation
Skin inflammation
Skin hypopigmentation
Angioedema
Urticaria
Contact dermatitis
Rash
Erythema
Pruritus
General Disorders and Administration Site Conditions
Application site irritation
Application site burning
Application site pruritus
Application site reaction
NOS
Application site warmth
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.
4.9. Overdose
Symptoms
Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.
Treatment
Daktarin Aktiv Cream is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, use appropriate supportive care.
💬 Ask about this leaflet
Ask anything about Daktarin Aktiv 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.