Consumer medicine information

Stieprox Liquid Shampoo

Ciclopirox olamine

BRAND INFORMATION

Brand name

Stieprox Liquid Shampoo

Active ingredient

Ciclopirox olamine

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Stieprox Liquid Shampoo.

What is in this leaflet

Please read this leaflet carefully before you start using STIEPROX Liquid.

This leaflet answers some common questions about STIEPROX Liquid. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using STIEPROX Liquid against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What STIEPROX is used for

STIEPROX Liquid contains ciclopirox olamine 1.5% w/w as the active ingredient. It is used to treat dandruff and seborrhoeic dermatitis affecting the scalp.

It also helps to reduce the formation of scales and flakes and remove those that have already formed.

This medicine belongs to a group of medicines called broad-spectrum antifungal agents.

This medicine works by inhibiting the growth of the yeast known as Pityrosporum ovale or Pityrosporum orbiculare, which is associated with conditions such as dandruff and seborrhoeic dermatitis.

Dandruff is a skin condition that is characterised by excessive scaling of the scalp. It presents itself as dry whitish scales generally without red or inflamed skin. Dandruff is more obvious when the scales become trapped in your hair and drop onto your clothing.

Seborrhoeic dermatitis is considered a severe form of dandruff. People who have seborrhoeic dermatitis generally have red, itchy and scaling areas on the scalp and possibly on other areas of the body, such as the face, eyebrows, beard area, upper chest and back and in the underarm area.

Ask your doctor if you have any questions about why this medicine has been recommended for you.

Your doctor or pharmacist may have recommended it for another reason.

Before you use STIEPROX

When you must not use it

Do not use STIEPROX Liquid if you have an allergy to:

  • any medicine containing ciclopirox or ciclopirox olamine
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Do not use this medicine on a child under the age of 12 years.

Safety and effectiveness in children younger than 12 years have not been established.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should use this medicine, talk to your doctor or pharmacist.

Before you start to use it

Tell your doctor or pharmacist if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor or pharmacist if you are pregnant or plan to become pregnant or are breast-feeding.

STIEPROX Liquid is not recommended for pregnant or breast-feeding women. Your doctor will discuss the risks and benefits of using STIEPROX Liquid if you are pregnant or breast-feeding.

If you do breast-feed your baby while you are using STIEPROX Liquid (on your doctor’s advice), ensure that you wash off all traces of STIEPROX Liquid from your breasts after bathing/showering before you begin breast-feeding.

You should not allow STIEPROX Liquid to come into contact with your eyes; STIEPROX Liquid is for external use only. If STIEPROX Liquid comes into contact with your eyes, wash thoroughly with water.

If you have not told your doctor or pharmacist about any of the above, tell him/her before you start using STIEPROX Liquid.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and STIEPROX Liquid may interfere with each other.

How to use STIEPROX

STIEPROX Liquid is for use by adults and children 12 years and over.

STIEPROX Liquid is for topical application to the scalp.

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the carton or bottle, ask your doctor or pharmacist for help.

How to use it

The hair should be wetted and sufficient STIEPROX Liquid applied to produce an abundant lather.

The scalp and adjacent areas should be vigorously massaged with the fingertips.

Rinse thoroughly and repeat the procedure.

Over the two applications, the shampoo should be left in the hair for a total time of 3 to 5 minutes.

STIEPROX Liquid contains a hair conditioner, but you can use a separate conditioner after STIEPROX Liquid if you wish.

How long to use it

STIEPROX Liquid should be used two to three times weekly for 4 weeks.

STIEPROX Liquid will provide temporary relief during the period of use and dandruff and/or seborrhoeic dermatitis may recur if treatment is discontinued.

You can use a mild shampoo on the days you are not using STIEPROX Liquid.

If your doctor or pharmacist has recommended other ways of using STIEPROX Liquid you should follow their advice.

If you forget to use it

If you forget to use STIEPROX Liquid, just apply the next day instead.

If you are not sure what to do, ask your doctor or pharmacist.

If you use too much (overdose)

In case of accidental ingestion, contact the Poisons Information Centre (Phone 13 11 26 for Australia); or the National Poisons Centre (telephone 0800 POISON or 0800 764 766 for New Zealand) for advice.

Avoid contact with the eyes. If STIEPROX Liquid comes into contact with your eyes, wash thoroughly with water.

While you are using STIEPROX

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using STIEPROX Liquid.

If you become pregnant while using STIEPROX Liquid, tell your doctor or pharmacist immediately.

Things you must not do

Do not use STIEPROX Liquid to treat any other complaints unless your doctor or pharmacist tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

STIEPROX Liquid may cause your hair to change colour if you have grey, white or chemically damaged hair (for example, due to hair dye).

Check with your doctor or pharmacist before using this shampoo if you think this may apply to you. Your doctor or pharmacist will decide whether STIEPROX Liquid is suitable for you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using STIEPROX Liquid.

This medicine helps most people with dandruff and seborrhoeic dermatitis, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • Skin irritation at the application site including itching, burning sensation and rash.
  • Redness at the application site.

The above list includes the more common side effects of your medicine.

Tell your doctor as soon as possible if you notice any of the following:

  • allergic reaction at or around the site of application
  • flaking of the skin
  • eczema (itchy skin rash)
  • unusual hair loss or thinning
  • hair colour or texture changes

Some of these effects can also be symptoms of the condition you are treating. However, if you experience any of these effects for the first time after starting to use STIEPROX Liquid, or you experience worsening of these effects, stop using STIEPROX Liquid and tell your doctor or pharmacist.

The above list includes serious side effects that may require medical attention. Serious side effects are rare

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After using STIEPROX Liquid

Storage

Store STIEPROX Liquid below 30°C.

As with all medicines you should keep STIEPROX Liquid out of the reach of children.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

An expiry date is printed on the bottle. Do not use the STIEPROX Liquid after this date.

If STIEPROX Liquid has passed its expiry date, dispose of it safely by returning it to your local pharmacist.

Disposal

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

Product description

What it looks like

STIEPROX Liquid comes in a bottle containing 60 ml or 150 ml of a clear, straw to light orange coloured liquid, with a characteristic odour.

Ingredients

STIEPROX Liquid contains Ciclopirox Olamine 1.5% w/w as the active ingredient.STIEPROX Liquid also contains the following inactive ingredients:

  • sodium laureth sulfate 70%,
  • cocamidopropyl betaine,
  • sodium phosphate – dibasic dodecahydrate,
  • citric acid monohydrate,
  • cocamide DEA,
  • hexylene glycol,
  • oleyl alcohol,
  • polysorbate 80,
  • polyquaternium-10,
  • Timotei Fragrance AF17050,
  • sodium hydroxide and
  • purified water.

Supplier

STIEPROX Liquid is manufactured in Singapore for
GlaxoSmithKline Australia Pty Ltd
Level 4
436 Johnston Street
Abbotsford
Victoria 3067
Australia

STIEPROX Liquid is supplied in New Zealand by:
GlaxoSmithKline NZ Ltd
Private Bag 106600
Downtown
Auckland 1143
New Zealand

Stieprox® is a registered trade mark of Stiefel Laboratories, Inc.

AUST R 95879

This document was prepared in November 2013.

Version 8.0

BRAND INFORMATION

Brand name

Stieprox Liquid Shampoo

Active ingredient

Ciclopirox olamine

Schedule

S2