Benzaknen 10% gel, 50 g

Instructions for use for Benzaknen 10% gel, 50 g

Important notes (compulsory information):

Benzaknen ® 10% gel. Active ingredient: benzoyl peroxide. Areas of application: All forms of acne severe expression as well as acne diseases in which the use of low concentrated benzoyl peroxide preparation does not lead to the therapy success. Is used in adolescents (from 12 years) and adults. Warnings: Contains propylene glycol.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


LEAFLET: INFORMATION FOR THE USER

Benzaken® 10 %
gel
Active substance: benzoyl peroxide

Read the entire leaflet carefully because it contains important information for you.
This medicine is available without prescription. In order to achieve the best possible treatment success, Benzaknen 10% however, be applied correctly.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If your symptoms get worse or no improvement occurs, you must definitely visit a doctor.
• If one of the listed side effects you significantly affect it or notice side effects that are not specified in this information information, please inform your doctor or pharmacist.

This leaflet contains:

1. What is Benzaken * 10% and what is it used for?
2. What do you need before using Benzaken8 10% NOTE?
3. How is Benzaken® 10% to apply?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep Benzaken® 10?
6. ADDITIONAL INFORMATION

1. What is Benzaken "10% and what is it used for?

Benzaknen ® 10% is an acne to use on the skin. Benzaknen ® 10% is used in all forms of acne severe expression as well as acne diseases in which the use of a low concentrated benzoyl peroxide preparation does not lead to the therapy success. Benzaknen ® 10% is used in adolescents (from 12 years) and adults.

2. What do you need before using Benzaken® 10% NOTE?

Benzaknen ® 10% must not be used

• if you hypersensitive (allergic) against benzoyl peroxide or any of the other ingredients of Benzaknen ® 10% are. Take special care with the application of Benzaknen ® 10% is required
• if you tend to hay fever, allergic asthma or neurodermitis (atopia) and your skin is dry and produced little sebum (sebostase). In this case please ask your doctor before using Benzaknen ® 10%.
• Do not apply any additional skin irritants, otherwise it can lead to increased skin irritation.
• Avoid intensive UV light irradiation (sun, solariums) Since it can come to increased skin irritation.
• Benzaknen ® 10% must not be brought into contact with mucous membranes, abrupt skin, eyes or oral, nose and eye angle.
• if Benzaknen ® 10% accidentally came into contact with the eyes. Contact with the eyes leads to redness and burning. The eye should then be rinsed for about 15 minutes with plenty of fluid water.
• –when Benzaknen ® 10% accidentally taken. Benzoyl peroxide, the active ingredient of Benzaknen ® 10%, can cause complaints in the field of esophagus and stomach in accidental ingestion. Locate a doctor.
• The in Benzaknen ® 10% contained active substance benzoyl peroxide can be used for bleaching (decolorization) or color change of hair (including eyebrows) and colored textiles (e.g. T-shirts, bed linen, pajamas, washcloths, towels) lead and damage them. These effects can be used with direct contact of the product with textiles or Hair, but also with indirect contact, e.g. over the hands or the treated skin, occur. Even after pulling the product into the skin or after washing the product from the skin, the bleaching effect may remain. To prevent possible damage is recommended during the duration of the treatment, the hands after the application of Benzaknen ® 10% thorough with soap and possibly Cleaning nail brush and avoid contacting the product or skin treated with hairs, e.g. by using hair ties or hair clips. During the duration of treatment, the use of white textiles is recommended.

Children:
The safety and efficacy of Benzaknen ® 10% were not studied in children before puberty (under 12 years), as acne vulgaris rarely occurs in this age group. When using Benzaknen ® 10% with other medicines:

Please inform your doctor or pharmacist if you take / use other medicines or recently taken / applied, even if it is non-prescription medicines.

However, the preparation should not be applied simultaneously with skin irritant ointments, creams, etc. (see above).

Pregnancy and breast feeding period:
There are no animal experimental studies with regard to reproductive toxicity. Data for use in pregnancy in humans are not available. Benzaknen ® 10% should be used in pregnancy and lactation after careful estimation of the benefit risk ratio. In the last month of pregnancy, the preparation should not be used. Findings about the transition to breast milk after external use in lactation are not available.

Ask your doctor or pharmacist for advice before taking / application of all medicines.

Driveion and use of machines:
There are no special precautions required. Important information about specific ingredients of Benzaknen ® 10% propylene glycol can cause skin irritation.

3. How is Benzaken® to apply 10?

Use Benzaknen ® 10% always exactly after the instruction in this leaflet. Please ask your doctor or pharmacist if you are not sure. Benzaknen ® 10% is only used for adults and adolescents at the age of 12 Years and about it.

Unless otherwise prescribed by the doctor, the usual dose is:
Benzaknen ® 10% is applied for therapy of therapy for 1 - 2 times a day on the diseased skin parts. In the further course of therapy, the application can be increased to 3 times a day. If you have sensitive skin, a 1-day daily application is recommended before bedtime.

Clean the skin before using Benzaknen ® 10% - best with a medical skin cleaning agent. After drying, wear the gel thinly. The preparation is intended exclusively for use on the skin.

The average application time is 4-12 weeks.

Please talk to your doctor or pharmacist if you have the impression that the effect of Benzaknen ® 10% too strong or too weak if you have a larger quantity Benzaknen "10% have applied as they should

The application to large quantities Benzaknen ® 10% can result in excessive drying and reinforced peeling of the skin. In these cases, use the application of Benzaknen ® 10% and search for a doctor if necessary.

If you use the application of Benzaknen ® 10% have forgotten:
Continue treatment according to the specified dosing instructions.

If you use the application of Benzaknen ® Cancel 10:
No special measures are required.

If you have further questions about the application of the medicine, ask your doctor or pharmacist.

4. Which side effects are possible?

How all medicines can Benzaknen 10% side effects that need not occur with everyone. The assessment of side effects is based on the following frequency information:

Very common: More than 1 treated from 10
Frequently: 1 to 10 Treated by 100
Occasionally: 1 to 10 treated by 1000
Rarely: 1 to 10, treated from 10000
Very rare: less than 1 treated from 10 000
Unknown: Frequency on the basis of the available data is not estimable

All side effects observed in clinical trials concern the skin, s. The following table:

Organ Class System (MEDDRA)	Frequency	Side effect
Diseases of the skin and subcutaneous tissue	Very often	Redness (erythema), burning, dryness and peeling of the skin
	Frequently	Itching skin irritation stinging the skin
	Occasionally	Contactallergic sensitizations

Occasionally benzoyl peroxide or other ingredients of Benzaknen ® 10%, such. As propylene glycol, lead to hypersensitivity reactions (contact allergic sensitization). In these cases, the preparation should be discontinued and the doctor is visited.

The start of the therapy can be associated with sensitive patients with easy skin extraction, burning and itching. These concomitants usually sound after a few days. A peeling of the skin is with the therapy with Benzaknen ® 10% Desirable and promotes healing. With prolonged therapy, it can lead to a stronger dehydration of the skin in particularly predisposed patients.

Should the treatment phenomena such. B. clamping or drying out the skin, redness and burning too strong, last longer than a week and occur allergic reactions, the doctor must be searched and the preparation optionally deposited. After decaying the acute phenomena, treatment can be continued in most cases with less frequent application. In case of doubt, please visit your attending physician.

Please inform your doctor or pharmacist if one of the listed side effects will significantly affect it or notice side effects that are not specified in this document formation.

5. How is Benzaken® to keep 10?

Store drug out of reach of children.

You must not use the medicinal product after the expiry date specified on the outer carton and container according to "until". The expiry date refers to the last day of the month. Storage conditions: Do not store more than 25 ° C.

Note on durability after a break
The duration of the durability of Benzaknen ® 10% after a break is 3 Months.

6. Further information

What Benzaknen ® 10% includes:
The active ingredient is: benzoyl peroxide. 1 g gel contains 100 mg benzoyl peroxide.

The other ingredients are:
Carbomer 940, sodium date (pH. EUR.), Docusate sodium, high-dispenser silica, propylene glycol, poloxamer 182, Glycerol, acrylate copolymer, sodium hydroxide, purified water.

Like Benzaknen ® 10% looks and content of the pack:
Benzaknen ® 10% is a white gel.

Benzaknen ® 10% is available in the following packing sizes:
Tube with 25 g gel
Tube with 50 g gel
Double pack with 2 tubes to 50 g gel

Pharmaceutic entrepreneur
Galderma Laboratorium GmbH
Georg-Glock-Str. 8th
D-40474 Dusseldorf
E-Mail: [email protected]

Manufacturer:
Laboratoires Galderma Zone Industrial
Montdesir F-74540 Alby-sur-Cheran

This information information was last revised in July 2011.

Source: Information of the leaflet
Status: 08/2014