5%, 10% gel 
benzoyl peroxide

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
  • You need to talk to a doctor if your symptoms do not get better or if they get worse.

In this leaflet: 
1. What Basiron AC is and what it is used for 
2. What you need to know before you use Basiron AC 
3. How to use Basiron AC 
4. Possible side effects 
5. How to store Basiron AC 
6. Contents of the packaging and other information 

1. What Basiron AC is and what it is used for

Basiron AC is a drug used to treat acne. Benzoyl peroxide contained in Basiron AC has a bactericidal effect on the acne bacterium Propionibacterium acnes. Benzoyl peroxide also provides exfoliation of the skin and thus removes the excess horny substance that clogs the sebaceous sacs.

Benzoyl peroxide contained in Basiron AC may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

2. What you need to know before using Basiron AC

Do not use Basiron AC

  • if you are allergic to benzoyl peroxide or any of the other ingredients of these medicines (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before using Basiron AC.

  • Benzoyl peroxide can cause swelling and blistering of the skin and if any such symptoms occur, treatment should be discontinued.
  • The gel must not come into contact with the eyes, mouth, nostrils, or mucous membranes. If the gel comes in contact with eyes, rinse eyes with plenty of water.
  • People with sensitive skin should use Basiron AC with caution. This also applies to use on the neck, other sensitive areas, and thin or damaged skin. Always lubricate in a thin layer and if necessary less often.
  • During treatment, tanning and UV radiation (including tanning beds) should be avoided.
  • Gel one can bleach or discolor hair, fabric, and other materials.

Other medicines and Basiron AC

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Medicines or other products that cause flaking, irritation, or dehydration of the skin should not be used concomitantly with Basiron AC. Benzoyl peroxide contained in Basiron AC counteracts the effect of tretinoin (vitamin A acid). Basiron AC should therefore not be used at the same time as a medicine containing tretinoin (vitamin A acid). If both medicines are used, one should be used in the morning and the other in the evening.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Basiron AC should only be used during pregnancy when there is a clear need. Talk to your doctor before using Basiron AC if you are pregnant.

It is unknown whether Basiron AC passes into breast milk. Consult a physician before use during breast-feeding. Gel one should not be used in the breast area so that the baby is accidentally exposed to the drug.

Driving and using machines

No effects were observed.

Basiron AC contains propylene glycol

which can cause skin irritation.

3. How to use Basiron AC

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Use

Clean and dry the skin thoroughly before each treatment. Apply Basiron AC 5% thinly to the skin areas to be treated, once a day, unless your doctor prescribes otherwise. With continued treatment, the dose may be increased from one to two times daily, provided that you tolerate the medicine well. If you have sensitive skin, treatment is recommended once a day before bedtime.

If treatment with Basiron AC 5% does not help, treatment with Basiron AC 10% can be started. Apply Basiron AC 10% to the skin areas to be treated, once or twice daily. If you have sensitive skin, treatment is recommended once a day before bedtime.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you forget to use Basiron AC

Do not take double the amount at the next treatment to replace a forgotten treatment. Just follow your usual treatment schedule.

4. Possible side effects

Like all medicines, these medicines can cause side effects, although not everybody gets them.

Discontinue treatment with Basiron and consult a physician if you experience facial swelling and severe allergic reactions (reported; occurs in an unknown number of users).

Signs of severe allergic reactions may include:

  • raised and itchy rash
  • swelling of the face, eyes, lips, tongue or mouth, difficulty breathing
  • fainting.

Other side effects:

Very common (may affect more than 1 user in 10): dry skin, redness, scaling, burning sensation in the skin.

Common (may affect up to 1 in 10 people): itching, skin pain (pain and burning), skin irritation (irritating contact dermatitis )

Uncommon (may affect up to 1 in 100 people): contact dermatitis.

The symptoms are usually mild and disappear if the treatment is stopped temporarily or if the skin is treated less often.

In connection with long-term treatment, severe dehydration of the skin may occur.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Basiron AC

Do not store above 25 ° C. Store in a cold place.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is benzoyl peroxide. 
    1 gram of Basiron AC 5% contains 50 mg of benzoyl peroxide. 
    1 gram of Basiron AC 10% contains 100 mg of benzoyl peroxide.
  • The other ingredients are propylene glycol, glycerol, acrylate copolymer, Carbomer 940, sodium edetate, Poloxamer 182, docusate sodium, anhydrous colloidal silica, sodium hydroxide, and purified water.

What the medicine looks like and the contents of the pack

White to off-white gel.

Basiron AC is supplied in plastic tubes containing 40 g (non-prescription) or 60 g (prescription).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Tel: 018-444 0330

Fax: 018-444 0335

Email: nordic@galderma.com.

Manufacturer

Galderma Laboratories

ZI Montdésir

74540 Alby-sur-Chéran

France

Muhammad Nadeem

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