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.
Nizoral Antidandruff Shampoo
⚠ 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 Ketoconazole may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
How to take it
this product
This product is suitable for most people, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.
Check the table below to see how much product to use.
Do not use this product… ■ 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 Nizoral Anti-Dandruff Treatment 2% w/w Shampoo.
If you are pregnant or breast-feeding ■ You can use Nizoral Anti-Dandruff Treatment 2% w/w Shampoo if you are pregnant, think you might be pregnant or are breast-feeding.
Special warnings about this product ■ This medicine contains 380mg/g sodium lauryl ether sulphate in each application, which is equivalent to 24% w/w. Sodium lauryl ether sulphate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area. ■ As with most shampoos, if any gets into your eyes bathe them gently with water. ■ If you have been regularly using a lotion or cream, which contains a steroid (such as betamethasone or hydrocortisone) to control your dandruff, gradually use it less over 2 – 3 weeks as you start to use Nizoral Anti-Dandruff Treatment 2% w/w Shampoo. This will stop your condition flaring up while Nizoral Anti-Dandruff Treatment 2% w/w Shampoo starts to work. If you have any questions about stopping your steroid lotion or cream, speak to your doctor or pharmacist.
■ Use this medicine only on your skin. ■ Do not use more often than directed in the table. If you need to use a shampoo to wash your hair more often, use your usual shampoo. If your hair is very thick, you can wash with your usual shampoo and then use Nizoral Anti-Dandruff Treatment 2% w/w Shampoo.
Adults and adolescents over 12 years. Age
How to apply
Adults and adolescents over 12 years
■ Wet hair thoroughly ■ Apply a small amount of Nizoral
Anti-Dandruff Treatment 2% w/w Shampoo to your scalp and massage into a lather. ■ Leave the lather on your scalp for 3- 5 minutes. ■ Rinse thoroughly.
Dandruff: ■ Use every 3 or 4 days for 2 – 4 weeks ■ If your scalp has not cleared within 4 weeks, speak to your doctor or pharmacist. ■ To keep your scalp clear and to prevent dandruff returning, use Nizoral Anti-Dandruff Treatment 2% w/w Shampoo once every 1 – 2 weeks. If you stop using Nizoral Anti-Dandruff Treatment 2% w/w Shampoo altogether, your symptoms may become a problem again. ■ Not for children aged under 12. Tinea Versicolor: ■ Once daily for a maximum of 5 days. ■ Once daily for a maximum of 3 days before exposure to sunshine. ■ Not for children aged under 12.
This product is for use in adults and adolescents over 12 years. 9309041 2301 GB
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If anyone accidentally swallows this product If anyone accidentally swallows Nizoral AntiDandruff Treatment 2% w/w Shampoo, contact a doctor or your nearest Accident & Emergency department (Casualty) taking this leaflet and pack with you.
If you forget an application If you forget to use Nizoral Anti-Dandruff Treatment 2% w/w Shampoo use as per the directions next time you wash your hair.
4 Possible side-effects Nizoral Anti-Dandruff Treatment 2% w/w Shampoo 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 talk to your doctor: ■ Severe allergic reactions including swelling of the face, lips, tongue or throat. Uncommon side-effects (less than 1 in 100 people) which may occur include: ■ Application site reactions including itching, irritation, blistering, red, dry or tender skin or a skin burning sensation ■ Inflamed hair follicles, hair loss or changes in hair texture ■ Increased tear production ■ Skin rash and dry skin
6 Further information
Rare side-effects (less than 1 in 1000 people) which may occur include: ■ A change in the way some things taste ■ Eye irritation ■ Acne ■ Skin inflammation (dermatitis) ■ Flaking skin ■ Application site reactions including blistering and over-sensitivity (allergic) reactions ■ General allergic reaction (over-sensitivity)
What's in this product? The active ingredient in 1g of Nizoral Anti-Dandruff Treatment 2% w/w Shampoo is 20mg ketoconazole.
Other side effects which occur but it is unknown how often: ■ Hair discolouration and hives, which is known as nettle rash or urticaria
Other ingredients are: sodium lauryl ether sulphate, disodium monolauryl ether sulphosuccinate, coconut fatty acid diethanolamide, laurdimonium hydrolysed animal collagen, macrogol 120 methyl glucose dioleate, sodium chloride, concentrated hydrochloric acid, imidurea, sodium hydroxide, erythrosine sodium (E127), purified water.
What the product looks like Nizoral Anti-Dandruff Treatment 2% w/w Shampoo is a pink liquid shampoo. It is available in bottles of 60ml.
Reporting of side effects If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible sideeffects not listed in this leaflet. You can also report
Possible side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Product licence holder and Manufacturer: Thornton & Ross Ltd., Linthwaite, Huddersfield, HD7 5QH, UK. This leaflet was revised January 2024
By reporting side-effects you can help provide more information on the safety of this medicine.
Nizoral is a registered trademark
5 Storing this product Keep out of the sight and reach of children. Do not store above 25°C. Do not use this product after the expiry date shown on the packaging. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
9309041 2301 GB 1362003
Produkt/Product: NIZORAL ANTIDAN 2% SHA 6X60ML TR GB:PIL
STADA Mat.-Nr./Mat.-No.: 9309041 DZ: 2301
STADA Art.-Nr./Art.-No.: 178630
Hersteller/Manufacturer: Hemofarm A.D.
Hersteller Art.-Nr./ Manufacturer Art.-No.: 1362003
Format/Size: 180 x 270 mm
Schriftgröße/Font-size: 9 pt – 14.5 pt
PZN/EAN: –
Pharma-Code: 2860
Pantone Rubine Red C
Black
Flattermarke/Collating mark: –
2. Farbe/Colour:
Datum/Date: 09.02.2024
1. Farbe/Colour:
3. Farbe/Colour: –
4. Farbe/Colour: –
5. Farbe/Colour: –
6. Farbe/Colour: –
7. Farbe/Colour: –
8. Farbe/Colour: –
Version: 11. Loop
Agentur/Agency: STADA Agency
Grafik erstellt von/Graphic made by: D.O.
Aktueller Umlauf/Current loop: D.O.
Genehmigt/Approved
Frequently asked questions about Nizoral Antidandruff Shampoo
What is the active substance in Nizoral Antidandruff Shampoo?
The active substance in Nizoral Antidandruff Shampoo is ketoconazole.
Are there equivalent medicines to Nizoral Antidandruff Shampoo?
Medicines with the same active substance, strength and form include: Boots Anti-Dandruff Ketoconazole 2% w/w Shampoo, Boots Anti-Dandruff Ketoconazole 2% w/w Shampoo, Nizoral 2% Shampoo. In total there are 5 equivalent products. 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 Nizoral Antidandruff Shampoo, 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 Nizoral Antidandruff Shampoo 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: ketoconazole
- 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
In the prevention and treatment of the scalp condition dandruff.
4.2. Posology and method of administration
For topical administration.
Ketoconazole shampoo 2% is for use in adolescents and adults:
Wash affected areas and leave for 3-5 minutes before rinsing. Usually, a palmful of shampoo suffices for one wash.
Treatment:
Dandruff and seborrhoeic dermatitis:
Wash hair twice weekly for 2-4 weeks.
Tinea versicolor:
Once daily for a maximum of 5 days.
Prophylaxis:
Dandruff and seborrhoeic dermatitis:
Use once every 1-2 weeks.
Tinea versicolor:
Once daily for a maximum of 3 days before exposure to sunshine.
4.3. Contraindications
Known hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water.
In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral anti-dandruff treatment 2%w/w Shampoo, to prevent any potential rebound effect.
If the scalp has not cleared within 4 weeks, a doctor or pharmacist should be consulted.
Excipient warnings:
This medicine contains 24% w/w sodium lauryl ether sulfate in each application. Sodium lauryl ether sulfate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.
4.5. Interaction with other medicinal products and other forms of interaction
None Known
4.6. Fertility, pregnancy and lactation
There are no adequate and well-controlled studies in pregnant or lactating women. 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. No effects on the breastfed newborn/infant are anticipated. See Pharmacokinetic properties, section 5.2.
Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral anti-dandruff treatment 2%w/w Shampoo to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Nizoral anti-dandruff treatment 2%w/w Shampoo on the whole body. There are no known risks associated with the use of Nizoral anti-dandruff treatment 2%w/w Shampoo in pregnancy or lactation.
4.7. Effects on ability to drive and use machines
None likely
4.8. Undesirable effects
The safety of ketoconazole 2% shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Ketoconazole 2% shampoo was administered topically to the scalp and/or skin. Based on pooled safety data from these clinical trials, there were no ADRs reported with an incidence ≥1%.
The following table displays ADRs that have been reported with the use of Ketoconazole 2% Shampoo 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 form the available clinical trial data).
System Organ Class
Adverse Drug Reactions
Frequency Category
Uncommon
(≥1/1,000 to <1/100)
Rare
(≥1/10,000 and <1/1,000)
Not Known
Immune System disorders
Hypersensitvity
Nervous System Disorders
Dysgeusia
Infections and Infestations
Folliculitis
Eye Disorders
Increased lacrimation
Eye irritation
Skin and Subcutaneous Tissue Disorders
Alopecia
Dry skin
Hair texture abnormal
Rash
Skin burning sensation
Acne
Dermatitis contact
Skin disorder
Skin exfoliation
Angioedema
Urticaria
Hair colour changes
General Disorders and Administration Site Conditions
Application site erythema
Application site irritation
Application site pruritus
Application site reaction
Application site hypersensitivity
Application site pustules
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
In the event of accidental ingestion, supportive and symptomatic measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.
💬 Ask about this leaflet
Ask anything about Nizoral Antidandruff Shampoo. 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.