Mycoseb®, shampoo, 20 mg/g 100ml

The distribution of this drug over the Internet is strictly prohibited and regulated by the laws of the Republic of Serbia, while its presentation on the Internet is allowed, solely for the purpose of informing the general and professional public about its purpose and better familiarization with the basic characteristics of the drug itself.

YOU CAN VIEW THE REGULATION ON THE METHOD OF ADVERTISING MEDICINE, REGARDING MEDICINE ("Sl. Gl. RS", no. 79/2010) HERE.

Mycoseb®
, shampoo, 20 mg/g
Packaging: plastic bottle, 1 x 100 mL
Manufacturer: HEMOFARM AD VRŠAC
Address: Beogradski put bb, Vršac
Applicant: HEMOFARM AD VRŠAC
Address: Beogradski put bb, Vršac, Republic of Serbia
Decision number: 515-01-02705-14-001 dated June 18, 2015. for the drug Mycoseb®
; shampoo; 20mg/g; plastic bottle, 1x100mL
2 out of 6
Mycoseb®
, shampoo, 20 mg/g
INN: ketoconazole
Read this manual carefully, because it contains information that is important to you.
This medicine can be obtained without a prescription. However, it is necessary to use Mycoseb with care,
to get the best results with it.
Save the instructions. You may need to read it again.
If you have any further questions, ask your pharmacist.
If your symptoms worsen or you do not feel better after 4 weeks, you must contact your doctor.
If any side effect becomes serious or you notice any side effect not listed in
this instruction, please inform your doctor or pharmacist about it.
In this guide you will read:
1. What is the drug Mycoseb and what is it for?
2. What you need to know before taking Mycoseb
3. How to use the drug Mycoseb
4. Possible side effects
5. How to store the medicine Mycoseb
6. Additional information
Decision number: 515-01-02705-14-001 dated June 18, 2015. for the drug Mycoseb®
; shampoo; 20mg/g; plastic bottle, 1x100mL
3 out of 6
1. WHAT IS MYCOSEB AND WHAT IS IT FOR?
The drug Mycoseb shampoo contains the active substance ketoconazole. Ketoconazole belongs to a group of medicines called
antifungals used to treat fungal infections.
The drug Mycoseb shampoo is used for the prevention and treatment of dandruff and seborrheic dermatitis of the hairy part of the head.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYCOSEB
You must not use Mycoseb if:
- you are allergic (hypersensitive) to ketoconazole or to any of the auxiliary substances in the medicine Mycoseb
shampoo (see section 6).
When using the drug Mycoseb, take special care:
Care must be taken not to let the shampoo come into contact with the eyes. If this happens, the eyes should be washed with water.
Before using the medicine, inform your doctor or pharmacist:
- if you use a lotion or cream that contains a corticosteroid, such as betamethasone or hydrocortisone.
In this case, during the application of Mycoseb shampoo, it is necessary to gradually reduce the doses
corticosteroids for 2-3 weeks. In this way, you will prevent your illness from getting worse
Mycoseb shampoo does not start to work.
If the desired therapeutic effect on the scalp is not achieved within 4 weeks, you should consult a doctor or
pharmacist.
Administration of other drugs
Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including
those that can be obtained without a doctor's prescription.
There are no known interactions with other drugs when applying ketoconazole topically.
Application of the drug Mycoseb during pregnancy and breastfeeding
Before you start taking any medicine, consult your doctor or pharmacist.
You can use Mycoseb shampoo if you are pregnant or breastfeeding. However, before applying either
which medicine during pregnancy or breastfeeding, consult your doctor for advice.
The effect of Mycoseb on driving and using machines
The drug Mycoseb does not affect the ability to drive motor vehicles and operate machines.
Decision number: 515-01-02705-14-001 dated June 18, 2015. for the drug Mycoseb®
; shampoo; 20mg/g; plastic bottle, 1x100mL
4 out of 6
Important information about some of the ingredients of Mycoseb
Mycoseb shampoo contains sodium methylparahydroxybenzoate as an auxiliary substance, which can cause
allergic reactions, even delayed.
3. HOW TO USE THE MEDICINE MYCOSEB
Always use Mycoseb shampoo exactly as your doctor has explained it to you. Mycoseb shampoo is
intended only for local application on the skin or hair. If you are not completely sure, check with your doctor or
a pharmacist.
For local application.
Adults and adolescents over 12 years of age
The shampoo is applied to the affected region and after 3 to 5 minutes it is washed off with water.
Therapy
Wash your hair with Mycoseb shampoo every 3 to 4 days for 2 to 4 weeks.
Prevention
In order to prevent the recurrence of dandruff and seborrheic dermatitis, the hair is washed with Mycoseb shampoo
once a week or every other week.
Mycoseb shampoo must not be applied more often than prescribed.
If you have swallowed a small amount of Mycoseb shampoo
In case you accidentally swallow the shampoo, contact your doctor immediately.
If you forget to apply Mycoseb shampoo
If you skipped applying Mycoseb shampoo, carry out the treatment as soon as possible. Do not use
a double dose of the medicine to make up for the missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
The drug Mycoseb shampoo, like other drugs, can cause side effects, although they may not be manifested
with everyone.
Inform your doctor or pharmacist if you notice or suspect any of the following side effects
actions:
Occasional side effects (may occur in up to 1 in 100 patients taking the medicine):
hair root infections, increased tear production, unusual hair loss or thinning hair, dry skin,
measles, burning sensation of the skin, redness of the skin at the application site, irritation at the application site, itching and reactions
at the place of shampoo application.
Decision number: 515-01-02705-14-001 dated June 18, 2015. for the drug Mycoseb®
; shampoo; 20mg/g; plastic bottle, 1x100mL
5 out of 6
Rare side effects (may occur in up to 1 in 1000 patients taking the medicine):
hypersensitivity, taste disturbance, eye irritation, acne, skin inflammation, skin peeling, hypersensitivity and changes
on the skin filled with purulent content.
Adverse effects of unknown frequency (the frequency cannot be estimated from the available
data): swelling of blood vessels, hives, changes in hair color
Reporting adverse reactions
If you experience any unwanted reaction, you need to inform your doctor or pharmacist or
nurse. This includes any possible side effects that are not listed in this guide.
By reporting side effects, you can help evaluate the safety of this medicine. Doubt on
You can report adverse reactions to the Agency for Medicines and Medical Devices of Serbia (ALIMS):
Agency for Medicines and Medical Devices of Serbia
National Center for Pharmacovigilance
Vojvode Stepe 458, 11221 Belgrade
Republic of Serbia
website: www.alims.gov.rs
e-mail: nezeljene.reakcije@alims.gov.rs
5. HOW TO STORE MYCOSEB
Keep out of the reach and sight of children!
Expiration date:
2 (two) years.
Shelf life after first opening: until the end of the shelf life of the finished medicine, if the medicine is stored in
temperature up to 30°C in the original packaging.
Storage:
Store the medicine at a temperature of up to 30°C in the original packaging, in order to protect from light.
Medicines should not be thrown into the sewer or household waste. Ask your pharmacist how to remove medicines that
You don't need them anymore. These measures help to preserve the environment.
Unused medicine is destroyed in accordance with current regulations.
6. ADDITIONAL INFORMATION
What Mycoseb contains
Active substance:
The active substance is ketoconazole. One gram of shampoo contains 20 mg of ketoconazole.
Decision number: 515-01-02705-14-001 dated June 18, 2015. for the drug Mycoseb®
; shampoo; 20mg/g; plastic bottle, 1x100mL
6 out of 6
Other ingredients are:
Texapon NSO (sodium laureth sulfate 27%); Texapon SB 3 KC (disodium laureth sulfosuccinate 40%);
Comperlan COD (Cocamide DEA 80,5%); Tagat L2 (PEG-20 glyceryl laurate); Lamequat L/NP (Lauryldimonium Hydroxypropyl Hydrolyzed Collagen 35%); Blue Edition, Dragaco 0256194; Nipagin M sodium
(Sodium-methylparahydroxybenzoate); Hydrochloric acid, concentrated; Sodium sulphite, anhydrous;
Sodium citrate, pentasesquihydrate; Erythrosine E127 CI 45430; Water, purified.
What Mycoseb looks like and contents of the pack
Viscous solution, pinkish-orange in color, with a slight perfume smell.
Plastic (HDPE) bottle of 100 ml with a dropper made of low density polyethylene (LDPE), closed with a plastic
shutter. A collapsible cardboard box contains 1 vial and 1 Medication Guide.

Licensee and Manufacturer
License holder:
HEMOFARM AD VRŠAC, Beogradski put bb, Vršac
Manufacturer:
HEMOFARM AD VRŠAC, Beogradski put bb, Vršac, Republic of Serbia
This instruction was last approved:
March, 2015
Mode of administration of the drug:
The drug is issued without a doctor's prescription.
License number and date:
515-01-02705-14-001 from 18.06.2015.