Consumer medicine information

ZINDACLIN®

1%w/w clindamycin (as clindamycin phopshate)


Consumer Medicine Information

What is in this leaflet?

Important information you should read before you use Zindaclin.

Please read this leaflet carefully before you use Zindaclin. It contains a summary of the information about your medicine. If you have any questions about Zindaclin, please ask your doctor or pharmacist.

Keep the leaflet with the medicine – you may need to read it again.

Remember

This medicine is only for you.

Only a doctor can prescribe it for you. Never give it to other people. It may harm them, even though their symptoms may seem to be the same as yours.

What is Zindaclin used for?

Zindaclin is used to treat acne (spots).

Zindaclin contains clindamycin phosphate which breaks down in the skin to clindamycin which is an antibiotic. Zindaclin reduces the number of bacteria. This will help to stop the pores becoming blocked and new spots forming. Zindaclin may also help to reduce the redness of the spots you already have.

As with other products it will take some time before you see your acne improving.

Acne is an extremely common skin condition. During adolescence grease glands in the skin produce extra grease in response to normal amounts of sex hormones in your body and this can cause blocked pores (i.e. blackheads). When this happens the pores are invaded by bacteria.

This produces chemicals which go into deeper parts of the skin to produce red spots filled with

pus. In some people acne starts or continues after adolescence.

Before you use Zindaclin

Is there any reason for not being given Zindaclin?

Make sure it is safe for you to use Zindaclin.

If you answer ‘YES’ to any of the following questions, or you are not sure, please tell your doctor or pharmacist.

  • Have you ever had a rash or other allergic reaction to Zindaclin, any of its ingredients (listed above) or lincomycin (another antibiotic)? An allergic reaction may include a rash, red skin, itching, swelling or breathing difficulties.
  • Have you ever had inflammatory bowel diseases such as colitis or Crohn’s disease?
  • Have you ever had severe diarrhoea after using an antibiotic?
  • Are you taking any other antibiotics?
  • Are you pregnant or could you be? No one is very sure whether it is safe to use Zindaclin during pregnancy. Therefore you should not use Zindaclin if you are pregnant, or think you might be pregnant, without discussing this with your doctor.
  • Are you breast-feeding? As clindamycin can pass into breast milk, even if you only use it on the skin, you should not breast-feed while using Zindaclin.

You should also tell your doctor or pharmacist about

all the medicines you are taking.

Zindaclin should not be used by children under the age of 12 years.

How should I use Zindaclin?

Read the label on the pack carefully and follow your doctor’s instructions.

Usually, you should use this medicine once a day. Wash as normal, rinse well and pat your skin dry.

Apply a small amount of gel in a thin layer to the whole of the area where you usually get spots. Don’t apply Zindaclin to areas where you do not usually get spots. Don’t just dab onto individual spots. Don’t apply a thick layer in any particular area as this will not get rid of spots any quicker.

Avoid covering Zindaclin with dressings (eg bandages and plasters) as this may increase the chance of Zindaclin causing irritation.

Take care to avoid your eyes, inside your nose and mouth, if you accidentally put gel on these areas, wash them straight away with plenty of water.

If you get any Zindaclin in your eye, wash it away with plenty of cool water.

Successful treatment of acne with most therapies can take several months treatment with Zindaclin. You may not see any effect of treatment for several weeks. After that you should note a gradual but definite improvement but maximum benefit may take several months.

Zindaclin should usually be used for a maximum of 12 weeks. You may need to use more than one tube of Zindaclin during each course of treatment.

Use Zindaclin for as long as your doctor tells you.

Do not use other topical acne treatments while you are using Zindaclin.

Zindaclin should not be used in combination with products containing erythromycin. Ask your pharmacist about other products you may be using for acne.

Try not to pick or squeeze spots as this make your acne worse and even lead to scarring.

What shall I do if I forget to use Zindaclin?

If you forget to use Zindaclin at any time, use it next time as if you had not missed an application. Do not use twice as much or use it twice as often to catch up with the application you have missed.

What will happen if I stop using Zindaclin?

The antibacterial effect will eventually wear off and the acne will not improve. Keep using Zindaclin for as long as your doctor has suggested.

What will happen if I use too much Zindaclin?

It is unlikely that you will apply too much Zindaclin if you follow the instructions given by your doctor. In the case of accidental application of a large quantity, contact your doctor or pharmacist. If you use too much, you may experience some of the side effects listed above.

If someone swallows Zindaclin

Telephone your doctor or the Poisons Information Centre if anyone swallows Zindaclin. In Australia call 13 11 26, in New Zealand call 0800 764 766.

Side effects

Does Zindaclin have any side effects?

All drugs have some side effects however those associated with Zindaclin are usually minor.

Your skin may become dry, painful, itchy, hot or red for a short time. You can relieve this by using an oil free moisturiser.

You may develop initial worsening of your acne or irritation around your eyes. A scaly skin rash has been reported rarely. Tell you doctor if any side effect worries you.

Clindamycin given by mouth of injection has caused inflammation of the bowel, leading to diarrhoea that can contain blood and mucus. This reaction is extremely rare when clindamycin is applied on the skin. If you do get diarrhoea, you must stop using Zindaclin straight away and tell your doctor immediately.

If you notice anything else that might be a side effect, tell your doctor or pharmacist.

After using Zindaclin

How should I store Zindaclin?

Do not use the gel after the ‘use before’ date.

It is important to replace the cap after you have used the gel.

Keep your gel in a safe place, where children cannot see or reach it. Your gel could harm them.

Disposal

If your doctor or pharmacist tells you to stop taking Zindaclin or it has passed the expiry date, ask your pharmacist what to do with any that is left over.

Product description

Pack size

Each pack contains 1 tube of Zindaclin which contains 15g or 30g of antibiotic gel.

Ingredients

The active ingredient of Zindaclin is clindamycin phosphate.

Each gram of gel contains 11.88 mg clindamycin phosphate equivalent to 10mg clindamycin (1% w/w).

Zindaclin also contains propylene glycol, purified water, ethanol, zinc acetate dihydrate, hydroxyethylcellulose and sodium hydroxide.

Supplier

www.ascentpharma.com.au

Ascent Pharma Pty Ltd
151-153 Clarendon Street
South Melbourne
VIC 3205
Australia.
For further information call 1800 554 414

Registration numbers
AUST R 101427

Date of Preparation
January 2011.

Published by MIMS December 2011