50 mg / g + 10 mg / g gel 
benzoyl peroxide (anhydrous) + clindamycin

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

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • 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.

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

1. What Duac is and what it is used for

Duac gel contains two drugs: benzoyl peroxide and clindamycin. Duac gel belongs to a group of medicines called “anti-infective drugs for acne”. Duac gel is used to treat mild to moderate acne on the skin.

Benzoyl peroxide is an antibiotic that reduces the number of comedones (blackheads and pimples). It also kills bacteria involved in acne.

• Clindamycin is an antibiotic that prevents the bacteria that cause acne from returning.

Used together in Duac gel, they work by:

• Fight bacteria that can cause acne

Treat existing blackheads, pimples, and blisters

• Reduce the number of red inflamed pimples

Duac gel is intended for adults and adolescents aged twelve years or older

2. What you need to know before using Duac

Do not use Duac

  • if you are allergic to benzoyl peroxide, clindamycin, lincomycin, or any of the other ingredients of this medicine (listed in section 6). Do not use Duac gel if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Duac gel.

Warnings and cautions

Talk to your doctor or pharmacist before using Duac gel.

• Duac gel should only be used on the skin. Avoid areas such as eyes, lips, mouth,h, and inside of the nose.

• Do not use Duac gel on irritated skin areas e.g. if you have cuts, abrasions, sunburn, or damaged skin.

• If you accidentally get Duac gel in your eyes, mouth, or nose, rinse with plenty of water.

• Do not use too much Duac gel on sensitive skin areas.

• Many patients experience redness and scaling during the first weeks of treatment. If your skin becomes irritated, you can use an oil-free moisturizer, use Duac gel less often, or stop using the medicine for a short period of time to allow the skin to recover and then resume treatment.

• Discontinue treatment and talk to your doctor if skin irritation is severe (severe redness, dryness, itching, stinging, or burning sensation) or does not improve.

• Try to avoid Duac gel coming into contact with colored fabrics, including clothing, towels, bedding, furniture, or carpets. Duac gel can whiten these materials.

Duac gel can bleach hair.

Duac gel can make your skin more sensitive to the sun’s harmful effects. Avoid tanning beds/lamps and minimize the time you spend in the sun. You should use sunscreen and wear opaque clothing when using Duac gel.

Talk to your doctor before using this medicine if:

• you have ever had inflammation of the colon (eg ulcerative colitis or Crohn’s disease) or intestinal inflammation associated with antibiotic treatment

• If you experience stomach cramps or diarrhea that is severe or does not get better, stop using Duac gel and contact your doctor immediately. Antibiotics can cause a condition that results in severe diarrhea and stomach cramps. Although this is unlikely to happen with antibiotics applied to the skin.

• If you have recently used medicines containing clindamycin or erythromycin, there is an increased risk that Duac gel will not work as well as it should.

• Tell your doctor or pharmacist if you have recently used any other medicines containing clindamycin or erythromycin.

Children and young people

Children

Do not give this medicine to children under twelve years of age. Because it is not known if it works or if it is safe for them.

Other drugs and Duac

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

Talk to your doctor or pharmacist if you are taking any of the following:

• other acne treatment, including antibiotics used on the skin

• medical or abrasive soaps and detergents

• soaps and cosmetics that have a strong drying effect

• products with a high concentration of alcohol or astringents.

These products, when used with Duac gel, can eventually irritate your skin.

Duac gel may make other acne medicines less effective when used at the same time. These include:

• Acne treatment applied to the skin containing tretinoinisotretinoin, or tazarotene

• Talk to your doctor or pharmacist if you are also using any of these drugs. You may need to use the products at different times of the day (for example, one in the morning and the other in the evening). Concomitant use of other acne medications may increase the risk of skin irritation.

• Discontinue treatment and talk to your doctor if skin irritation becomes severe (severe redness, dryness, itching, stinging, or burning sensation).

Duac gel should not be used with medicines containing erythromycin.

• Application of Duac gel together with dapsone and sulfacetamide may cause temporary discoloration of the skin or facial hair (yellow/orange color). The color change is not permanent.

• One of the active substances in Duac gel may affect the functioning of certain anesthetics (so-called “neuromuscular blocking agents”).

• Talk to your doctor or pharmacist if you have surgery.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Duac gel.

Pregnancy, breastfeeding, and fertility

There is only limited information on the safety of Duac gel in pregnant women.

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.

Your doctor will consider the benefits to you and the risk to your baby of using Duac gel during your pregnancy.

It is not known if the ingredients in Duac gel pass over to the breast milk. One of the substances in Duac gel is clindamycin. When clindamycin is taken or injected, it can pass into breast milk. If you are breast-feeding, talk to your doctor before using Duac gel.

Do not use Duac gel on your breasts if you are breast-feeding.

3. How to use Duac

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

• Use Duac gel once a day, in the evening.

• It may take 2 to 5 weeks before you see the effect of Duac gel.

• Do not treat for more than 12 weeks at a time. Your doctor will tell you how long the treatment should last.

How to apply Duac gel

  1. Carefully remove all cosmetics.
  2. Wash the affected skin area thoroughly. Then rinse with warm water and pat it dry gently.
  3. Using your fingertips, apply a thin layer of gel to the entire affected area of ​​the skin.
  4. Apply gel one on all areas that have acne, not just on every single pimple. If the gel does not penetrate the skin quickly, you have taken too much. To treat only the face, use the amount of gel from the tube that extends from the fingertip to the first joint (first crease on the finger). This is a “fingertip”.For face and back, use a total of two and a half “fingertips”.
  5. If you become very dry in the skin or scales, you can use an oil-free moisturizer, use Duac gel less frequently or stop the treatment for a short period, to allow the skin to adapt to the treatment. This medicine may not work properly if it is not applied every day.
  6. Wash hands after using Duac gel.
  7. Once the gel has dried, water-soluble cosmetics can be used.

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

If you use more Duac than you should 

• Do not apply too much. Applying too much Duac gel or applying Duac gel more frequently than recommended will not remove your pimples faster, and can cause skin irritation. If this happens, use Duac gel less often or stop the treatment for a few days. Then try treating with Duac gel again.

If you happen to swallow Duac gel

• If you accidentally swallow Duac gel, contact your doctor. You may experience symptoms similar to those you may get when you take antibiotics (stomach upset).

If you forget to use Duac

Do not take a double dose to make up for a forgotten dose.

• Apply the next dose at the usual time.

If you stop using Duac

Do not stop treatment without consulting your doctor. Do not use Duac gel for more than 12 consecutive weeks without talking to your doctor. Use Duac gel for as long as your doctor recommends it. Do not stop treatment without your doctor’s advice. It is important to continue using Duac gel as prescribed by your doctor. If you stop treatment too soon, your acne may return.

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

4. Possible side effects

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

The following side effects may occur with this medicine:

Stop using Duac gel and contact a doctor immediately if any of the following serious side effects occur – you may need urgent medical treatment:

• signs of an allergic reaction (swelling of the face, eyes, lips, or tongue, hives or difficulty breathing, collapse).

• severe or prolonged diarrhea or abdominal cramps

• burning sensation, scaling or itching

Other side effects that may occur:

If you experience any of these side effects, try using Duac gel less often for a while or stop the treatment for a few days. Then try treating with gel again.

Very common side effects are

(occurs in at least 1 in 10 users)

At the application site:

• Skin redness, flaking, dryness

These side effects are usually mild.

Common side effects are

(occurs in less than 1 in 10 users)

• Headache

At the application site:

• Burning sensation, pain, sensitivity to sunlight

Uncommon side effects are

(occurs in less than 1 in 100 users)

• Tingling ( paresthesia ), worsening of acne, red, itchy skin, rash ( dermatitis, red rash).

Other side effects are

The following adverse reactions have occurred in a very small number of patients but the exact frequency is unknown:

• Allergic reactions

Intestinal inflammation, diarrhea, including bloody diarrhea, abdominal pain

At the application site:

• Skin reaction, discoloration of the skin

• Elevated itchy rash (hives)

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

5. How to store Duac

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

Pharmacy staff: Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.

Patient: After receiving Duac gel from the pharmacy staff, store at a maximum of 25 ºC and discard the tube after 2 months.

Do not use this medicine after the expiry date which is stated on the tube and package 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 (s) is benzoyl peroxide (hydrate) corresponding to 5% w / w (50 mg / g), benzoyl peroxide (anhydrate), clindamycin phosphate, corresponding to 1% w / w (10 mg / g) clindamycin.
  • The other ingredients are carbomer, dimethicone, disodium monolauryl sulfosuccinate, disodium edetate, glycerol, colloidal hydrated silica, poloxamer 182, purified water, and sodium hydroxide.

What the medicine looks like and the contents of the pack

White to pale yellow homogeneous gel.

Pack sizes: 5, 6, 15, 25, 30, 50, 55, 60 and 70 g.

Each carton contains a tube of Duac gel.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Boots Laboratories Legacy (Ireland) Ltd.,

Unit 2, Building 2500, Avenue 2000,

Cork Airport Business Park,

Cork,

Ireland

Manufacturer:

Boot Laboratories (Ireland) Ltd, Finisklin Business Park, Sligo, Ireland

or

Glaxo Operations UK Ltd, (trading as Glaxo Wellcome Operations)

Harmire Road, Barnard Castle, Co. Durham, DL12 8DT, United Kingdom

or

GlaxoSmithKline Pharmaceuticals SA

ul. Grunwaldzka 189, 60-322 Poznan, Poland

For any information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

GlaxoSmithKline AB

Box 516

169 29 Solna

Tel. 08-638 9300

info.produkt@gsk.com

This medicinal product is authorized under the European Economic Area under the names:

Austria, Denmark, Greece: Clindoxyl Gel

Cyprus: Indoxyl Gel

Czech Republic, Estonia, Hungary, Iceland, Italy, Lithuania, Portugal, Slovakia, Spain, Duac gel

Finland: Clindoxyl Gelli

Germany: Duac gel Acne Gel

Netherlands: Duac gel Acne Gel

Lithuania, Poland: Duac gel

Ireland, Malta, UK: Duac gel Once Daily Gel

Muhammad Nadeem

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