Duac 50 mg/g + 10 mg/g gel Benzoyl Peroxide (anhydrous) + Clindamycin
1. What IS Duac And How To Use Duac Gel
Duac gel contains two drugs: benzoyl peroxide and clindamycin. This gel belongs to a group of medicines called “anti-infective drugs for acne”. Duac gel uses 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 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 Gel
- 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 the 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 the 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 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 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 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 treatments, 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 Duac gel uses, can eventually irritate your skin.
The gel may make other acne medicines less effective when used at the same time. These include:
• Acne treatment applied to the skin containing tretinoin, isotretinoin, 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 Duac acne 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 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 pregnant women’s Duac gel uses.
If you are pregnant or breastfeeding, 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 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 breastfeeding, talk to your doctor before using Duac gel.
Do not use gel on your breasts if you are breastfeeding.
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 the gel.
- Do not treat for more than 12 weeks at a time. Your doctor will tell you how long the Duac acne treatment should last.
How to apply gel
- Carefully remove all cosmetics.
- Wash the affected skin area thoroughly. Then rinse with warm water and pat it dry gently.
- Using your fingertips, apply a thin layer of gel to the entire affected area of the skin.
- 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 the face and back, use a total of two and a half “fingertips”.
- 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.
- Wash hands after using gel.
- 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 gel or applying 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 it with gel again.
If you happen to swallow Duac gel
• If you accidentally swallow 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 Acne Treatment
Do not stop treatment without consulting your doctor. Do not use gel for more than 12 consecutive weeks without talking to your doctor. Use the gel for as long as your doctor recommends it. Do not stop treatment without your doctor’s advice. It is important to continue using the gel as prescribed by your doctor. If you stop treatment too soon, your acne may return.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible Duac Gel 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 gel less often for a while or stop the treatment for a few days. Then try treating it with gel again.
Very common Duac gel 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 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