Azebat Cream 30 Gm

1. What this product is and what it is used for
Azebat is a skin cream used to treat common acne (acne vulgaris).
Azebat Cream should only be used to treat acne. You should not use this
medicine for any other skin condition.
Azebat attacks the bacterium called Propionibacterium acnes, which
plays an essential part in causing acne. Azebat also reduces the growth of
the harder outermost skin cells that block the pores of the skin to cause
blackheads and whiteheads.
2. What you need to know before you use this product
Do not use Azebat Cream
If you are allergic to azelaic acid or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Azebat Cream
Azebat is for external use on the skin only. You should not allow Azebat to
come into contact with your eyes, mouth or other mucous membranes. If it
does, wash the eyes, mouth or other mucous membranes immediately with
large amounts of cool water.
Rarely, it has been reported that in some patients with asthma who were
treated with azelaic acid worsening of asthma symptoms had occurred.
Azebat is not recommended for use in children below the age of 12 due to a
lack of data on safety and efficacy.
Other medicines and Azebat
Tell your doctor or pharmacist if you are using, have recently used or might
use any other medicines.
Pregnancy and breast-feeding
There is limited experience with the use of the active substance azelaic acid
during pregnancy. 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.
Infants must not come into contact with treated skin or breast.
Driving and using machines
Azebat has no influence on the ability to drive and use machines.
This medicine contains 2 mg of benzoic acid in each g.
Benzoic acid may cause local irritation.
This medicine contains 125 mg propylene glycol in each g.
3. How to use this product.
Always use this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
Adults and Adolescents (12 – 18 years of age)
First, thoroughly wash with plain water the whole area to be treated. If
the skin is greasy use a mild skin cleanser. Dry the skin thoroughly before
applying Azebat.
Unless your doctor has told you otherwise, start treatment with Azebat
twice a day.
If your skin is very sensitive use Azebat once a day, in the evening
during the first week of treatment. Then change to twice a day.
The amount of Azebat you should use will depend on the size of the
area to be treated:
As a guide, if the whole of your face is affected, use 2.5 cm (approx. 0.5
g) of cream each time you apply Azebat.
If you have acne on your chest and back, as well as your face, adjust the
amount of cream accordingly.
Use the cream regularly. Rub it in gently.
Wash your hands thoroughly after using Azebat.
How long Azebat has to be used varies from person to person. It depends
upon how
bad your acne is when you start treatment. You should see a distinct
improvement after about 4 weeks. To get the best effect you will probably
have to use Azebat regularly for several months. However, you should not
use Azebat for more than 12 months at any time.
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.
Reasons to stop using Azebat
Stop using Azebat and see your doctor as soon as possible if you think you
are having an allergic reaction (e.g. rash) to Azebat.
Occasionally local skin irritation occurs with Azebat, usually at the start of
treatment. In most cases, the irritation is mild and usually gets better as
treatment continues. If skin irritation remains troublesome:
reduce the amount of Azebat you apply each time
or apply it only once a day
or stop treatment temporarily.
If skin irritation still remains troublesome tell your doctor.
The following side effects are based on reports from clinical studies and postmarketing surveillance with Azebat Cream starting with the most frequent
ones:
Very common (may affect more than 1 in 10 people): burning, itching or
abnormal redness of the skin (erythema) at the site of application.
Common (may affect up to 1 in 10 people): scaling, pain, dryness, skin
discolouration or irritation at the site of application.
Uncommon (may affect up to 1 in 100 people): greasy skin, acne or loss of
skin colour, tingling, dermatitis, discomfort or swelling at the site of
application.
Rare (may affect up to 1 in 1,000 people): cracking of the lips, vesicles (small
blisters), eczema, ulceration, warmth at the site of application, allergic
reaction, rash at the site of application.
Not Known (cannot be estimated from the available data) : skin swelling,
eye swelling, swelling face (which may occur with hypersensitivity), rash,
urticaria, worsening of asthama.
These additional side effects have been reported in patients using Azebat
Cream
(frequency unknown) since marketing approval.
5.Reporting of side effects
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5. How to store this product
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 after the word 'EXP'.
Do not store above 30°C.
To be used within 6 months from the first opening of the tube
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. Further information
a. What this product contains
What Azebat contains
Each gm contains
Active ingredient is azelaic acid. Each one gram of Azebat cream
contains 200 mg (20% w/w) of azelaic acid.
Inactive ingredients:
Glyceryl Stearate/ Cetearyl Alcohol /Cetyl Palmitate /Cocoglycerides
(CUTINA CBS), PEG – 5 Glyceryl stearate (Arlacel 983), Glycerine,
Propylene Glycol, Cetearyl Octanoate (PCL Liquid 100), Benzoic acid,
purified water.
b. What this product looks like and contents of the
pack
Azebat is White to yellowish-white smooth homogeneous cream. It is available in an aluminium tube of
30 g inside a carton box along with a patient information leaflet.