BENZACNE 100 mg /G Gel

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Benzacne, 50 mg/g, Gel
3. Benzacne, 100 mg/g, Gel
   1. Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
4. What is Benzacne and What is it Used For
5. Important Information Before Using Benzacne
   1. When Not to Use Benzacne
   2. Warnings and Precautions
   3. Benzacne and Other Medications
   4. Children and Adolescents
   5. Pregnancy and Breastfeeding
   6. Driving and Operating Machines
6. How to Use Benzacne
   1. Using a Higher Dose of Benzacne than Recommended
   2. Missing a Dose of Benzacne
7. Possible Side Effects
   1. Reporting Side Effects
8. How to Store Benzacne
9. Contents of the Pack and Other Information
   1. What Benzacne Contains
   2. What Benzacne Looks Like and What the Pack Contains
   3. Marketing Authorization Holder:
   4. Manufacturer:

Package Leaflet: Information for the Patient

Benzacne, 50 mg/g, Gel

Benzacne, 100 mg/g, Gel

Benzoyl Peroxide

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.

• Keep this Leaflet, You May Need to Read it Again.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If You Experience any Side Effects, Including those not Listed in this Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If After 4 to 6 Weeks There is no Improvement or You Feel Worse, Consult a Doctor.

Table of Contents of the Leaflet

• 1. What is Benzacne and What is it Used For
• 2. Important Information Before Using Benzacne
• 3. How to Use Benzacne
• 4. Possible Side Effects
• 5. How to Store Benzacne
• 6. Contents of the Pack and Other Information

1. What is Benzacne and What is it Used For

Benzacne is a Medication in the Form of a Gel with Anti-Acne Action, Intended for Local Application to the Skin.
The Medication Contains the Active Substance Benzoyl Peroxide. Benzoyl Peroxide, After Application to the Skin, Easily Penetrates the Stratum Corneum and Inhibits the Growth of Anaerobic Bacteria Propionibacterium Acnes, which are one of the Causes of Common Acne.
It also Acts as a Keratolytic Agent on the Skin, Reducing the Number of Comedones.
Benzacne is Indicated for the Treatment of Various Forms of Common Acne (Acne Vulgaris).

2. Important Information Before Using Benzacne

When Not to Use Benzacne

• If the Patient is Allergic to the Active Substance or any of the other Ingredients of this Medication (Listed in Section 6).
• If the Patient has Eczema, Chronic Skin Inflammation, Skin Burns, also Caused by Excessive Sun Exposure.

Warnings and Precautions

Before Starting to Use Benzacne, Discuss it with a Doctor or Pharmacist.

• Protect the Eyes, Mouth, and Mucous Membranes from Contact with the Medication. Do not Apply the Medication to Irritated Skin and Open Wounds, as well as to the Breast Area During Breastfeeding. If these Areas Come into Contact with the Medication, Rinse them Abundantly with Water.
• In Case of Concurrent Use of Benzacne with other Anti-Acne Medications for Local Application to the Skin, it is Recommended to Use them at Different Times of the Day, e.g., in the Morning or Evening, to Reduce the Risk of Skin Irritation.
• Use with Caution on Sensitive Skin, e.g., on the Neck or other Sensitive Areas.
• Avoid Exposure to UV Radiation (Quartz Lamps, Solarium) and Sun.
• The Medication may Cause Discoloration of Hair and Fabrics.

Benzacne and Other Medications

Tell Your Doctor or Pharmacist about all Medications You are Currently Taking or have Recently Taken, as well as any Medications You Plan to Take.
Concurrent Use of Benzacne with:

• other Anti-Acne Medications for Local Application to the Skin Containing: Tretinoin, Isotretinoin, Resorcinol, Salicylic Acid, Sulfur, Ethyl Alcohol on the Same Skin Surface may Enhance Skin Irritation and Dryness;
• Locally Applied Antibiotics (e.g., Clindamycin, Erythromycin) or Medications Containing Retinoids (e.g., Adapalene, Tretinoin) Leads to a Weakening of their Action.

In Case of Need for Concurrent Use of any other Medications, Consult a Doctor to Determine Possible Changes in the Use of Benzacne.

Children and Adolescents

Do not Use in Children Under 12 Years of Age.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You may be Pregnant or are Planning to have a Child, Consult a Doctor or Pharmacist Before Using this Medication.
Do not Apply the Medication to the Breast Area During Breastfeeding.

Driving and Operating Machines

Benzacne Does not Affect the Ability to Drive and Operate Machines.

3. How to Use Benzacne

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, Consult a Doctor or Pharmacist.
Recommended Dose
Adults and Children Over 12 Years of Age
Apply Once or Twice a Day.
Usually, Within the First 2 to 3 Weeks of Treatment, the Medication with a Benzoyl Peroxide Content of 50 mg/g is Used, and if Necessary, the Treatment is Continued with the Medication with a Benzoyl Peroxide Content of 100 mg/g.
Method of Administration
The Medication is Intended for Local Application to the Skin.
After Washing and Drying the Skin, Apply a Small Amount of the Medication, Sufficient to Cover the Affected Areas, and Gently Rub it in.
After Applying the Medication, Wash Your Hands.
If You Feel that the Action of the Medication is too Strong or too Weak, Consult a Doctor.

Using a Higher Dose of Benzacne than Recommended

A Symptom of Overuse of Benzacne is Redness or Swelling of the Skin. If they Occur, Stop Using the Medication Immediately and Consult a Doctor.
Cold Compresses can be Applied to the Irritated Areas.

Missing a Dose of Benzacne

Do not Use a Double Dose to Make up for a Missed Dose.

4. Possible Side Effects

Like all Medications, Benzacne can Cause Side Effects, although not Everybody gets them.
During Treatment with Benzacne, the Following may Occur:

• Dryness or Excessive Peeling of the Skin;
• Redness of the Skin;
• A Feeling of Heat or Mild Stinging at the Site of Application. These Symptoms may Appear in the First Week of Treatment and do not Indicate a Need to Discontinue the Medication. If they Occur, Reduce the Frequency of Application of Benzacne.

If the Following Symptoms Occur, Stop Using the Medication and Consult a Doctor:

• Allergic Contact Dermatitis or Painful Skin Irritation;
• Burning of the Skin;
• Skin Rash.

Reporting Side Effects

If You Experience any Side Effects, including those not Listed in this Leaflet, Tell Your Doctor or Pharmacist, or Nurse. 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 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side Effects can also be Reported to the Marketing Authorization Holder.
By Reporting Side Effects, You can Help Provide more Information on the Safety of this Medication.

5. How to Store Benzacne

Store the Medication at a Temperature Below 25°C. Do not Freeze.
Store the Medication in a Place Out of Sight and Reach of Children.
Do not Use this Medication After the Expiration Date Stated on the Tube and Carton after the EXP. The Expiration Date Refers to the Last Day of the Specified Month.
Medications should not be Disposed of in Sewers or Household Waste Containers. Ask Your Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Benzacne Contains

• The Active Substance of the Medication is Benzoyl Peroxide. 1 g of Gel Contains 50 mg or 100 mg of Benzoyl Peroxide.
• Other Ingredients are: Carbomer, Sodium Hydroxide, Purified Water.

What Benzacne Looks Like and What the Pack Contains

Benzacne is a White, Odorless Gel.
50 mg/g: The Medication is Available in a Tube Containing 30 g of Gel, Placed in a Cardboard Box.
100 mg/g: The Medication is Available in a Tube Containing 20 g of Gel, Placed in a Cardboard Box.

Marketing Authorization Holder:

Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
To Obtain more Detailed Information about this Medication, Contact the Local Representative of the Marketing Authorization Holder:
Orifarm Healthcare Sp. z o.o.
ul. Przyokopowa 31
01-208 Warsaw
Poland
[email protected]

Manufacturer:

50 mg/g:
Orifarm Manufacturing Poland Sp. z o.o.
ul. Księstwa Łowickiego 12
99-420 Łyszkowice
Poland
100 mg/g:
Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares,
Rua Outeiro da Armada, No 5,
Condeixa-a-Nova 3150-194
Portugal
Date of Last Update of the Leaflet:08/2024