NIZORAL 20 mg /G Cream

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.
3. Nizoral
4. 20 mg/g, Cream
   1. Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
5. What is Nizoral Cream and What is it Used for
   1. Indications for Use
6. Important Information Before Using Nizoral Cream
   1. When Not to Use Nizoral Cream
   2. Warnings and Precautions
   3. Nizoral Cream and Other Medications
   4. Pregnancy and Breastfeeding
   5. Driving and Operating Machines
   6. Nizoral Cream Contains Propylene Glycol, Cetyl Alcohol, and Stearyl Alcohol
7. How to Use Nizoral Cream
   1. Using More than the Recommended Dose of Nizoral Cream
   2. Missing a Dose of Nizoral Cream
8. Possible Side Effects
   1. Reporting Side Effects
9. How to Store Nizoral Cream
10. Package Contents and Other Information
    1. What Nizoral Cream Contains
    2. What Nizoral Cream Looks Like and What the Packaging Contains
    3. Marketing Authorization Holder in Romania, the Country of Export:
    4. Manufacturer:
    5. Parallel Importer:
    6. Repackaged by:
    7. Parallel Import Authorization Number: 394/22 Date of Approval of the Leaflet: 26.10.2022

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Nizoral

20 mg/g, Cream

Ketoconazole

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Used Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist.

• The Leaflet Should be Kept in Case it Needs to be Read Again.
• If Advice or Additional Information is Needed, a Pharmacist Should be Consulted.
• If the Patient Experiences any Side Effects, Including those not Listed in the Leaflet, the Doctor or Pharmacist Should be Informed. See Section 4.
• If there is no Improvement or the Patient Feels Worse, the Doctor Should be Contacted.

Table of Contents of the Leaflet

• 1. What is Nizoral Cream and What is it Used for
• 2. Important Information Before Using Nizoral Cream
• 3. How to Use Nizoral Cream
• 4. Possible Side Effects
• 5. How to Store Nizoral Cream
• 6. Package Contents and Other Information

1. What is Nizoral Cream and What is it Used for

Nizoral Cream Contains the Active Substance Ketoconazole with a Strong Antifungal Effect. Ketoconazole Acts on Dermatophytes of the Genus: Trichophyton, Epidermophyton,
Microsporumand Yeasts of the Genus Candidaand Malassezia( Pityrosporum).

Indications for Use

Local Treatment of Skin Fungus of the Trunk, Groin, Hands, and Feet Caused by the Following Dermatophytes: Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis,
Epidermophyton floccosum, as well as Skin Yeast Infections and Pityriasis Versicolor ( Pityriasis versicolor).
Nizoral Cream is also Recommended for the Treatment of Seborrheic Dermatitis Associated with the Presence of the Yeast Malassezia ovale( Pityrosporum ovale).

2. Important Information Before Using Nizoral Cream

When Not to Use Nizoral Cream

• If the Patient is Allergic to Ketoconazole or any of the Other Ingredients of this Medication (Listed in Section 6).

Warnings and Precautions

Before Starting to Use Nizoral Cream, the Doctor or Pharmacist Should be Consulted.
Contact of the Medication with the Eyes Should be Avoided.
In the Case of Previous Local Treatment of Seborrheic Dermatitis with Corticosteroids, Before Using Nizoral Cream, Corticosteroids Should be Gradually Discontinued Over a Period of 2 Weeks, as Sudden Discontinuation may Lead to an Increase in Disease Symptoms.

Nizoral Cream and Other Medications

No Data Available.
The Doctor or Pharmacist Should be Informed of all Medications Currently or Recently Used by the Patient, as well as any Planned Medications.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant, or Plans to Become Pregnant, they Should Consult a Doctor or Pharmacist Before Using this Medication.
During Pregnancy and Breastfeeding, Nizoral Cream Should only be Used if Advised by a Doctor, as there is no Data on the Safety of the Medication During Pregnancy and Breastfeeding.

Driving and Operating Machines

No Studies have been Conducted on the Effect of the Medication on the Ability to Drive Vehicles or Operate Machinery.

Nizoral Cream Contains Propylene Glycol, Cetyl Alcohol, and Stearyl Alcohol

The Medication Contains 193 mg of Propylene Glycol per 1 g of Cream. Propylene Glycol may Cause Skin Irritation.
Due to the Presence of Auxiliary Substances - Cetyl Alcohol and Stearyl Alcohol, the Medication may Cause Local Skin Reactions (e.g., Contact Dermatitis).

3. How to Use Nizoral Cream

This Medication Should Always be Used Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist. In Case of Doubt, the Doctor or Pharmacist Should be Consulted.
Nizoral Cream is Intended for Use on the Skin in Adults.
Yeast Infection of the Skin, Fungus of the Trunk, Groin, Fungus of the Hands and Feet, Pityriasis Versicolor:
The Medication Should be Applied to the Affected Areas of the Skin and the Surrounding Skin Once a Day.
Average Treatment Duration:

• Pityriasis Versicolor: 2 to 3 Weeks,
• Yeast Infection of the Skin: 2 to 3 Weeks,
• Groin Fungus: 2 to 4 Weeks,
• Trunk Fungus: 3 to 4 Weeks,
• Foot Fungus: 4 to 6 Weeks.

Seborrheic Dermatitis:
In Skin Infections Characterized by Brown-Red Spots or White and Yellow Scales (Seborrheic Dermatitis), Nizoral Cream Should be Used Once or Twice a Day. Symptoms of the Infection Usually Disappear After 2-4 Weeks.
Improvement is Usually Visible After 4 Weeks of Treatment. If there is no Improvement, the Doctor Should be Contacted.
The Medication Should be Used for a Few More Days After the Complete Disappearance of Infection Symptoms.
Even After Complete Recovery, to Prevent Relapse of the Disease, the Patient Should Use Nizoral Cream Once a Week or Once Every 2 Weeks.
During Treatment, to Prevent Re-infection, Basic Hygiene Rules Should be Followed.

Using More than the Recommended Dose of Nizoral Cream

Significant Overdose of the Medication may Cause Redness, Burning of the Skin, and Swelling.
If such Symptoms Occur, the Doctor Should be Contacted.
In Case of Accidental Ingestion of Nizoral Cream, the Doctor Should be Contacted to Provide Appropriate Treatment.

Missing a Dose of Nizoral Cream

If a Dose is Missed, it Should be Used as Soon as Possible. A Double Dose Should not be Used to Make up for the Missed Dose.

4. Possible Side Effects

Like all Medications, this Medication can Cause Side Effects, although not Everybody will Experience them.
The Following Side Effects may Occur:

• Often (in more than 1 in 100 and less than 1 in 10 Patients): Redness and Itching at the Application Site; Burning Sensation of the Skin,
• Uncommon (in more than 1 in 1000 and less than 1 in 100 Patients): at the Application Site, Bleeding, Discomfort, and Dryness, Inflammation, Irritation, Paresthesia (Unpleasant Sensation of Tingling, Numbness, or Temperature Change of the Skin, i.e., Feeling of Strong Heat or Cold), Reactions at the Application Site. Uncommonly, Hypersensitivity, Blistering, Contact Dermatitis, Rash, Scaling, and Stickiness of the Skin may Occur. After the Introduction of Nizoral Cream to the Market, Very Rarely (in less than 1 in 10,000 Patients) Urticaria has been Reported.

Reporting Side Effects

If any Side Effects Occur, including those not Listed in the Leaflet, the Doctor or Pharmacist Should be Informed. Side Effects can be Reported Directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Reporting Side Effects will Help to Gather more Information on the Safety of the Medication.

5. How to Store Nizoral Cream

The Medication Should be Stored in a Place Invisible and Inaccessible to Children.
Store at a Temperature Below 30°C, in the Original Packaging.
The Tube Should be Closed.
Do not Use this Medication After the Expiration Date Stated on the Packaging.
The Expiration Date Refers to the Last Day of the Specified Month.
Medications Should not be Disposed of in the Drain or Household Waste Containers. The Pharmacist Should be Asked how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Package Contents and Other Information

What Nizoral Cream Contains

• The Active Substance of the Medication is Ketoconazole. 1 g of Cream Contains 20 mg of Ketoconazole.
• Other Ingredients are: Propylene Glycol, Stearyl Alcohol, Cetyl Alcohol, Sorbitan Monostearate, Polysorbate 60, Isopropyl Myristate, Sodium Metabisulfite (E 221), Polysorbate 80, Purified Water.

What Nizoral Cream Looks Like and What the Packaging Contains

The Medication is a Cream.
The Packaging of the Medication is an Aluminum Tube Containing 15 g of Cream, in a Cardboard Box.
For more Detailed Information, the Marketing Authorization Holder or Parallel Importer Should be Contacted.

Marketing Authorization Holder in Romania, the Country of Export:

Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse, Belgium

Manufacturer:

Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse, Belgium

Parallel Importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization Number in Romania, the Country of Export:3804/2011/01

Parallel Import Authorization Number: 394/22 Date of Approval of the Leaflet: 26.10.2022

[Information about the Trademark]