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Mycoseb shampoo 20 mg/g (ketoconazole), 100 ml – treatment and prevention of dandruff and seborrhoeic dermatitis of the scalp
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- Stock: Zabrana online prodaje
- Brand: HEMOFARM-EN
- Model: BR-5556
Mycoseb shampoo is a medicine containing the active substance ketoconazole (20 mg per 1 g of shampoo). Ketoconazole is an imidazole/triazole antifungal for topical use (ATC D01AC08) and acts on Malassezia yeasts, which play an important role in dandruff and seborrhoeic dermatitis.
According to the official leaflet, Mycoseb is used for the prevention and treatment of dandruff and seborrhoeic dermatitis of the scalp (scaling of the scalp with greasy flakes) in adults and adolescents over 12 years. It is made by Hemofarm AD Vršac and is available without a prescription in Serbia. Unlike cosmetic anti-dandruff shampoos, Mycoseb is an authorised medicine and is used according to a defined schedule.
Important warning
- Supply status in Serbia: available without a prescription (OTC).
- It is intended only for the scalp and hair, in adults and adolescents over 12 years; do not use it more often than recommended.
- If you have been using a corticosteroid lotion or cream, do not stop it suddenly – reduce it gradually over 2–3 weeks while using Mycoseb.
- If there is no improvement within 4 weeks, see a doctor or pharmacist.
- This page is for information only and is not an offer to buy the medicine online.
What is Mycoseb shampoo used for and how should it be applied?
Key facts about the medicine
| Name of the medicine | Mycoseb®, shampoo, 20 mg/g |
|---|---|
| Active substance | ketoconazole |
| Strength | 20 mg ketoconazole per 1 g of shampoo |
| Pharmaceutical form | shampoo for topical use on the scalp |
| Therapeutic group | topical antifungals; imidazole and triazole derivatives (ATC D01AC08) |
| Pack | plastic bottle with 100 ml of shampoo |
| Marketing authorisation holder | Hemofarm AD Vršac |
| Supply status (Serbia) | available without a prescription |
What is Mycoseb shampoo used for?
According to the official patient leaflet, Mycoseb shampoo is used for:
- treatment of dandruff;
- treatment of seborrhoeic dermatitis of the scalp (greasy flakes, often with redness and itching);
- prevention of recurrence of dandruff and seborrhoeic dermatitis.
The official leaflet for this shampoo does not list use on the body skin (e.g. pityriasis versicolor) – for body skin lesions ask a doctor or pharmacist.
How is it used and dosed?
| Phase | Frequency | Duration |
|---|---|---|
| Treatment | wash the hair with Mycoseb every 3–4 days | 2–4 weeks |
| Prevention (maintenance) | once a week or every other week | as needed, on the advice of a doctor or pharmacist |
How to use:
- Wet the hair completely.
- Apply a small amount of shampoo to the affected area of the scalp and massage until it lathers.
- Leave the lather on for 3–5 minutes – if it is rinsed off immediately, the effect is weaker.
- Rinse thoroughly with water.
Do not use the shampoo more often than stated. If the desired effect is not achieved within 4 weeks, ask a doctor or pharmacist.
Special patient groups
- Children under 12 years: the leaflet provides for use in adults and adolescents over 12 years.
- Elderly people, kidney or liver disease: no special adjustment is stated; no interactions with other medicines are known for topical ketoconazole.
Contraindications – when the medicine must not be used
Do not use Mycoseb shampoo if you are allergic (hypersensitive) to ketoconazole or any of the other ingredients.
Precautions and warnings
- Avoid contact with the eyes; if this happens, rinse the eyes gently with water.
- If you use a corticosteroid lotion or cream (e.g. betamethasone, hydrocortisone) for dandruff or seborrhoeic dermatitis, the corticosteroid should be reduced gradually over 2–3 weeks while using Mycoseb so that the condition does not worsen.
- The medicine contains sodium methyl parahydroxybenzoate, which may cause allergic reactions, possibly delayed.
- If you stop using it completely, the symptoms may return – this is why there is a maintenance phase.
Interactions with other medicines, alcohol and food
No interactions with other medicines are known for topical ketoconazole. Still, tell your doctor or pharmacist about all medicines you use, especially corticosteroid creams and lotions for the scalp.
Pregnancy and breastfeeding
Mycoseb shampoo may be used during pregnancy and breastfeeding, but you should ask your doctor before using any medicine during this time.
Driving and using machines
Mycoseb shampoo has no effect on the ability to drive and use machines.
Possible side effects
- Uncommon (up to 1 in 100): hair follicle infection, increased tearing, unusual hair loss or change in hair texture, dry skin, rash, burning sensation, redness, irritation and itching at the application site.
- Rare (up to 1 in 1,000): hypersensitivity, taste disturbance, eye irritation, acne, skin inflammation and lesions, skin peeling, pustules at the application site.
- Frequency not known: hives, change in hair colour; severe allergic reactions with swelling of the face, lips, tongue and throat.
Report suspected side effects to your doctor, pharmacist or ALIMS.
Overdose, missed dose and stopping treatment
- If you accidentally swallow the shampoo, contact a doctor or the nearest healthcare facility immediately and take the leaflet with you.
- Missed application: apply the next dose as usual; do not use a double dose.
- Stopping: if you stop completely, dandruff and seborrhoeic dermatitis may return.
When to seek medical help immediately?
- swelling of the face, lips, tongue or throat, difficulty breathing or swallowing
- widespread hives or rash after washing the hair
- severe eye irritation that does not settle after rinsing with water
- accidental swallowing of the shampoo, especially by a child
Pharmacist's advice
As a pharmacist, I often hear that patients are not satisfied with Mycoseb, and the reason is almost always incorrect use. The 3–5 minute rule is key: apply the shampoo, massage it into the scalp and leave the lather on before rinsing.
During treatment use it every 3–4 days for 2 to 4 weeks and do not stop as soon as the dandruff disappears – then switch to maintenance once a week or every other week. Between Mycoseb washes you can use a mild, non-irritating shampoo; if your hair becomes dry or stiff, tell your pharmacist.
Availability and price
Mycoseb shampoo is available without a prescription, but under Serbian regulations medicines are not sold online. This page is for information only.
Please contact a pharmacy to check availability.
Related information
- Best anti-dandruff shampoo – a guide
- Dermatological shampoos for seborrhoeic dermatitis
- Dandruff or dry scalp – how to tell the difference
For additional care and support with dandruff and seborrhoea, see also the Preparations against dandruff and seborrhoeic category – products in this category do not replace the medicine you have been prescribed.
Composition, packaging and manufacturer
- Active substance: ketoconazole, 20 mg per 1 g of shampoo.
- Other ingredients: sodium laureth sulfate, disodium laureth sulfosuccinate, cocamide DEA, PEG-20 glyceryl laurate, lauryldimonium hydroxypropyl hydrolysed collagen, fragrance, sodium methyl parahydroxybenzoate, concentrated hydrochloric acid, anhydrous sodium sulfite, sodium citrate, erythrosine colour (E127), purified water.
- Appearance: viscous pink-orange solution with a mild fragrance.
- Pack: plastic (HDPE) bottle with 100 ml of shampoo in a carton.
- Marketing authorisation holder and manufacturer: Hemofarm AD Vršac, Beogradski put bb, Vršac.
- Authorisation number: 515-01-05111-19-001 of 12.08.2020.
Storage
- Store below 30 °C in the original package to protect from light.
- After first opening it can be used until the expiry date if stored under these conditions.
- Keep out of the sight and reach of children; return unused medicine to a pharmacy.
Frequently asked questions
How often should hair be washed with Mycoseb?
During treatment every 3–4 days for 2–4 weeks, and to prevent recurrence once a week or every other week. More frequent use than recommended is not advised.
How long should Mycoseb stay on the hair?
Leave the lather on for 3 to 5 minutes, then rinse the hair thoroughly with water.
Can children use Mycoseb?
According to the leaflet, the shampoo is intended for adults and adolescents over 12 years.
Can Mycoseb be used during pregnancy?
The leaflet states that it may be used during pregnancy and breastfeeding, but you should ask your doctor before use.
What if there is no improvement after 4 weeks?
Then see a doctor or pharmacist – it may not be dandruff or seborrhoeic dermatitis, or a different treatment may be needed.
Sources
- ALIMS – Patient leaflet Mycoseb®, shampoo, 20 mg/g (August 2020)
- ALIMS – Summary of product characteristics Mycoseb®, shampoo, 20 mg/g
Sources checked on: 23 October 2026.
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