Benzoyl Peroxide Gel 2.5%w/w Taj Pharma

Benzoyl Peroxide 2.5% w/w Gel Taj Pharma

1. Name of the medicinal product

Benzoyl Peroxide 2.5% w/w Gels

2. Qualitative and quantitative composition

Hydrous benzoyl peroxide equivalent to Benzoyl Peroxide 2.5% w/w

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Topical Gel

4. Clinical particulars

4.1 Therapeutic indications

Topical therapy for the treatment of acne vulgaris

4.2 Posology and method of administration

For external use only.

Adults and children:

Before each application, the skin should be cleaned and dried. Apply in a thin layer once or twice daily or as directed to the affected areas. Persons with sensitive skin should be directed to apply the gel once daily before going to bed. The extent of any drying or peeling may be adjusted by modifying the dosage schedule.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

For external use only.

Benzoyl Peroxide may cause swelling and blistering of the skin, if any of these symptoms occur, medication has to be discontinued.

A mild burning sensation will probably be felt on first application and some reddening and peeling of the skin will occur within a few days. During the first weeks of treatment a sudden increase in peeling will occur in most patients. This is not harmful and will normally subside within a day or two if treatment is temporarily discontinued. If severe irritation occurs, patients should be directed to use the medication less frequently, to temporarily discontinue use or to discontinue use altogether.

Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation.

Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy may occur, which sometimes may be severe, especially with the use of peeling, desquamating, or abrasive agents.

Benzoyl peroxide gel should not come into contact with the eyes, mouth, angles of the nose or mucous membranes. If the preparation enters the eye, wash thoroughly with water. Caution should be exercised when applying the drug to the neck and other sensitive areas.

As Benzoyl Peroxide may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sunlight or UV radiation should be avoided or minimised. When strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing.

Contact with any coloured material including hair and dyed fabrics may result in bleaching or discoloration.

Due to the risk of sensitisation, benzoyl peroxide gel should not be applied on damaged skin.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed; however, drugs with desquamative, irritant and drying effects should not be used concurrently with benzoyl peroxide gel.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is no safety concern relating to the effects of cutaneously applied benzoyl peroxide on reproductive function, fertility, teratogenicity, embryotoxicity, or peri- and post- natal development from animal data. In widespread clinical use for the cutaneous treatment of acne vulgaris, at concentrations up to 10% w/w for several decades, benzoyl peroxide has never been associated with such effects. Benzoyl Peroxide should only be used by a pregnant woman if clearly needed.

Breast-feeding

It is unknown whether benzoyl peroxide/metabolites are excreted in human milk. A risk to the new-borns/infants cannot be excluded. Caution should be exercised when benzoyl peroxide is administered to a nursing woman and the preparation should not be applied on the chest to avoid accidental transfer to the infant.

4.7 Effects on ability to drive and use machines

Benzoyl Peroxide Gel has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

The adverse reactions resulting from clinical trials are all skin disorders. They are reversible when treatment is reduced in frequency or discontinued.

The following categories are used to indicate the frequency of occurrence of adverse effects:

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥ 1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000)

Unknown (Frequency not assessable based on the available data).

They are presented in the table below:

Swelling face and allergic reactions, including application site hypersensitivity and anaphylaxis (not know frequency) have been reported during post-marketing surveillance.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Benzoyl peroxide gel is a preparation indicated for topical treatment only. If the medication is applied excessively, no more rapid or better results will be obtained and severe irritation might develop. In this event, treatment must be discontinued and appropriate symptomatic therapy should be instituted.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anti-acne preparations for topical use,

Benzoyl peroxide is an established and effective keratolytic agent with antibacterial properties. It has been shown to be effective in reducing the local population of Propionibacterium acnes leading to a reduction in the production of irritant fatty acids in the sebaceous glands.

5.2 Pharmacokinetic properties

Not applicable. Benzoyl Peroxide is a topical preparation.

5.3 Preclinical safety data

In animal studies by the cutaneous route, benzoyl peroxide is associated with a minimal to moderate skin irritation potential including erythema and oedema. Phototoxic and photoallergic reactions have been reported for benzoyl peroxide therapy.

6. Pharmaceutical particulars

6.1 List of excipients

Docusate sodium, Disodium edetate, Poloxamer 182, Carbomer 940, Propylene glycol, Acrylates copolymer or glycerol microsponge

Glycerol, Colloidal Anhydrous Silica, Purified water, Sodium hydroxide to adjust the pH.

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years

6.4 Special precautions for storage

Do not store above 25°C.

Do not freeze.

6.5 Nature and contents of container

White low density polyethylene tubes. Pack sizes 15g, 30g and 60g.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Manufactured in India by:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com

Benzoyl Peroxide 2.5% w/w Gel Taj Pharma

Package leaflet: Information for the user

Benzoyl Peroxide 2.5% w/w Gel

Benzoyl Peroxide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

1. What Benzoyl Peroxide is and what it is used for
   2. What you need to know before you use Benzoyl Peroxide
   3. How to use Benzoyl Peroxide
   4. Possible side effects
   5. How to store Benzoyl Peroxide
   6. Contents of the pack and other information
2. What Benzoyl Peroxide is and what it is used for

• Benzoyl Peroxide contains the active ingredient benzoyl peroxide which attacks the bacteria (germs) known as Propionibacterium acnes, one of the main causes of acne.
• Your doctor or pharmacist has recommended this medicine to treat your acne. Acne appears as blackheads and whiteheads which people often refer to as pimples or spots.
• Acne of the face, chest or back may be treated with this medicine.

2. What you need to know before you use Benzoyl Peroxide

Do not use Benzoyl Peroxide if you are:

• Allergic (hypersensitive) to benzoyl peroxide or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include a rash or itching.

Warnings and precautions

Talk to your doctor or pharmacist before using Benzoyl Peroxide.

• Avoid contact with the eyes, mouth, angles of the nose and other mucous surfaces such as the lining of your nose. If accidental contact should occur, rinse thoroughly with warm water.
• Benzoyl Peroxide should not be applied to damaged skin.
• Benzoyl Peroxide may cause swelling and blistering of the skin, if any of these symptoms occur, use of the product should be discontinued.
• This product may bleach hair and coloured fabrics including clothing, towels and bed linen. Be careful to avoid contact of the gel with these materials. Please make sure that you wash your hands thoroughly after you have used it.
• Caution should be exercised when applying Benzoyl Peroxide to the neck and other sensitive areas.
• Avoid repeated exposure to sunlight or other sources of UV light (e.g. sun bed)

Other medicines and Benzoyl Peroxide

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

• You should not use medicines with peeling, irritant and drying effects at the same time as Benzoyl Peroxide.
• Do not use Benzoyl Peroxide with any other acne products that are used on the skin, unless your doctor or pharmacist has told you that you can, as this may cause your skin to become red and very sore.

Pregnancy and breast-feeding

• If you are pregnant or think you may be pregnant or are breast-feeding, do not use this product unless your doctor has told you that you can.
• Avoid using this product if you are breast-feeding unless your doctor has told you otherwise. If your doctor has recommended the use of this product while you are breast-feeding, you must not apply the gel onto your chest, this is to avoid exposure of your child to this product.

Ask your doctor or pharmacist for advice before taking any medicine.

Benzoyl Peroxide contains propylene glycol.

Propylene glycol may cause skin irritation.

3. How to use Benzoyl Peroxide

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Benzoyl Peroxide is for EXTERNAL USE ONLY.
• Unless your doctor or pharmacist has told you otherwise,
  • Wash the affected area with a mild skin cleanser and water, and gently pat your skin dry.
  • Apply the gel in a thin layer once or twice a day to all the affected areas.
  • If you have sensitive skin apply the gel once daily before going to bed
  • Any drying or peeling which may occur to your skin may be reduced if you alter the number of times you apply, i.e. to once a day or once every two days, until your skin adjusts to the product.
• You should try to avoid exposure to strong sunlight while using Benzoyl Peroxide. If exposure is unavoidable, use a suitable sunscreen lotion and apply Benzoyl Peroxide in the evening. Remember to wash the affected area before use.
• How long you will have to use Benzoyl Peroxide will depend on how quickly your condition improves. After you have used it for one month, you should see your doctor or pharmacist again. He or she can then check the improvement of your condition.

If you use more Benzoyl Peroxide than you should or accidentally swallow the gel

• If you should accidentally use too much gel, you may find that your skin becomes irritated. Wash off as much as you can, and when the irritation has gone down, start using it again as directed.
• In the rare event that you accidentally swallow any of this product, seek medical advice.

If you forget to use Benzoyl Peroxide

• Don’t worry if you forget to use your gel at the right time. When you remember, start using the product again, in the same way as before.

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

4. Possible side effects

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

If your skin becomes severely irritated, or severe redness, itching or peeling of the skin occurs, or you experience face swelling, discontinue use immediately and consult your doctor or pharmacist.

Tell your doctor immediately if you develop a severe allergic reaction:

Signs of severe allergic reactions may include:

• Raised and itchy rash (hives)
• Swelling of the face, eyes, lips, tongue or mouth (angioedema), having difficulty in breathing
• Fainting

Benzoyl Peroxide may cause the following side effects:

Very common: may affect more than 1 in 10 people

• Dry skin
• Skin redness
• Peeling of the skin
• Burning sensation of the skin

Common: may affect up to 1 in 10 people

• Itching of the skin (pruritus)
• Pain of the skin (pain, stinging)
• Skin irritation (irritant contact dermatitis)

Uncommon: may affect up to 1 in 100 people

• Allergic contact dermatitis

These symptoms are usually reversible if the treatment is reduced in frequency or discontinued.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Benzoyl Peroxide

• 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 tube and carton. The expiry date refers to the last day of that month.
• Do not store above 25°C. Do not freeze.
• Store the closed tube away from direct heat.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Benzoyl Peroxide contains

The active substance is hydrous benzoyl peroxide equivalent to benzoyl peroxide 2.5% w/w in an aqueous, non-alcoholic gel base.

The other ingredients are docusate sodium, disodium edetate, poloxamer 182, carbomer 940, propylene glycol, acrylates copolymer, glycerol, colloidal anhydrous silica, purified water and sodium hydroxide to adjust the pH.

What Benzoyl Peroxide looks like and contents of the pack

Benzoyl Peroxide is a white to off-white gel. It is available in tubes of 15g, 30g and 60g from your pharmacist or on prescription from your doctor.

Not all pack sizes may be marketed.

7. Manufactured in India by:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com