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RESOLVE PLUS 1.0

Hydrocortisone, miconazole nitrate


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Resolve Plus 1.0. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

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

Keep this leaflet with your medicine. You may need to read it again.

What Resolve Plus is used for

Resolve Plus 1.0 is used on the skin to treat inflamed skin conditions such as:

  • tinea;
  • thrush;
  • seborrhoeic dermatitis;
  • thrush infected napkin rash;
  • inflamed fungal infections where bacterial infection may be present.
  • fungal infected eczema/dermatitis

Resolve Plus is a broad-spectrum anti-fungal and anti-inflammatory cream. Miconazole nitrate acts against fungal organisms to help treat infections, while hydrocortisone reduces the irritation and redness of inflamed skin.

For conditions without inflammation use an anti-fungal agent without hydrocortisone, such as Resolve Tinea.

Before you use RESOLVE PLUS

When you must not use it

Do not use Resolve Plus if:

  1. you are allergic to hydrocortisone, miconazole nitrate, phenethyl alcohol or any ingredient listed under Other ingredients below;
  2. you have herpes or other viral diseases of the skin (such as chicken pox);
  3. you have perioral dermatitis or ulcerative skin conditions;
  4. you have any other infection;
  5. the packaging is torn or the tamper evident seal is broken;
  6. the expiry date printed on the pack has passed.

Do not use Resolve Plus on children under 2 years unless your doctor or pharmacist tells you to.

Before you start to use it

Tell your doctor or pharmacist if:

  1. you have any allergies to any other medicine or any other substances such as foods, preservatives or dyes.
  2. you have cuts or abrasions at or near the place of treatment.

The chance of unwanted effects may be increased.

  1. you are pregnant or intend to become pregnant

Your doctor will discuss the risks and benefits of using Resolve Plus when pregnant.

  1. you are breast-feeding or intend to breast-feed

Your doctor will discuss the risks and benefits of using Resolve Plus when breast-feeding.

Taking other medicines

At the recommended dosages of Resolve Plus, interactions with other medicines are unlikely.

How to use Resolve Plus

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions in this leaflet, ask your doctor or pharmacist for help.

How much to use

Resolve Plus is for external use only.

How to use it

Gently rub into the infected skin and surrounding area 2 times daily. Once the inflammation has subsided continue treatment with an anti-fungal agent without hydrocortisone, such as Resolve Cream until symptoms disappear. Continue treatment for 14 days after symptoms disappear. Regular application is essential for successful treatment.

If you use it less often than you should, it may not work as well and your skin problem may not improve. Using it more often than you should may not improve your skin problem any faster and may cause or increase side effects.

How long to use it

You should check with your doctor if you need to use Resolve Plus for more than 7 days.

If you use Resolve Plus for a long time without medical supervision, the chance of side effects increases.

If you forget to use it

If you forget to use Resolve Plus, use it as soon as you remember, and then go back to using it as you would normally. Do not try to make up for the amount you missed by using more than you would normally use.

If you swallow it

Immediately telephone your doctor or Poisons Information Centre if you think that you or anyone else may have swallowed RESOLVE PLUS. Poisons Information Centre: 13 11 26 (Australia), 03 474 7000 (New Zealand)

While you are using Resolve Plus

Things you must do

Tell all doctors and pharmacists who are treating you that you are using Resolve Plus.

If you feel that Resolve Plus is not helping your condition, tell your doctor or pharmacist.

Tell your doctor or pharmacist if, for any reason, you have not used Resolve Plus exactly as prescribed. Otherwise, your doctor or pharmacist may think that it was not effective and change your treatment unnecessarily.

If you become pregnant while using Resolve Plus, tell your doctor or pharmacist.

Things you must not do

Do not use in or near the eyes.

Do not use for acne.

Do not give Resolve Plus to anyone else, even if they have the same symptoms as yours.

Do not use Resolve Plus to treat other complaints unless your doctor or pharmacist tells you to.

Things to be careful of

Do not use Resolve Plus under dressings or on large areas of skin unless your doctor or pharmacist tells you to. If you use large amounts for a long time, the chance of absorption through the skin and the chance of side effects increases.

Side effects

Check with your doctor or pharmacist as soon as possible if you have any problems while using Resolve Plus, even if you do not think the problems are connected with the medicine or are not listed in this leaflet. Like other medicines, Resolve Plus can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

After the application of Resolve Plus a slight stinging sensation may occasionally be noticed. This transient symptom is most likely to disappear after several applications.

Other side effects include:

  • itching
  • redness
  • allergy
  • thinning of the skin

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

This is not a complete list of all possible side effects.

After using Resolve Plus

Storage

Keep Resolve Plus in a cool dry place where the temperature stays below 25 °C. Do not store Resolve Plus in the car or on window sills. Heat can destroy some medicines.

Keep Resolve Plus where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using Resolve Plus or it has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product description

What it looks like

Resolve Plus is a white glossy cream in tubes of 15 g and 30 g.

Active ingredients

Hydrocortisone 1% w/w, miconazole nitrate 2% w/w.

Other ingredients

Resolve Plus also contains phenethyl alcohol as preservative and the inactives: water, 1,3-butylene glycol, cetostearyl alcohol, citric acid - anhydrous, dimethicone 350, disodium edetate, self emulsifying glyceryl monostearate, light liquid paraffin, PEG-40 stearate, povidone, sodium phosphate - dibasic anhydrous and xanthan gum.

Manufacturer

EGO PHARMACEUTICALS PTY. LTD.
21-31 Malcolm Road,
Braeside,3195.

AUST R 75601

Date of preparation: September 2003

'Ego' and 'Resolve' are Trade Marks of Ego Pharmaceuticals Pty. Ltd.
www.egopharm.com

Distributors

BAHRAIN
Maskati Pharmacy
PO Box 1110
Manama, Bahrain

CYPRUS
Cazacor Trading Limited
26A Larnaca Avenue
2101 Aglandjia, Nicosia
Cyprus

HONG KONG, GUANGDONG & MACAU
Lision Hong
Flat G, 7/F Valiant Industrial Centre
2-12 Au Pui Wan Street
Fo Tan, Shatin, NT
Hong Kong

INDONESIA
PT Mahakam Beta Farma
Jl Pulokambing II No 20
Kawasan Industri-Pulogadung
Jakarta, Timur 13930
Indonesia

JORDAN
Munir Sukhtian Group Ltd
PO Box 1027
Amman 11118, Jordan

KUWAIT
Maseela Pharmaceuticals Co Ltd
PO Box 26596
Safat 13126, Kuwait

MALAYSIA & BRUNEI
Somedico Sdn Bhd
68 Jalan SS 21/39, Damansara Utama
47400 Petaling Jaya, Selangor
Malaysia

MALTA
Pharmasud Ltd
Bella Vista Court
Bella Vista Street
San Gwann SGN03
Malta

NEW ZEALAND
Douglas Pharmaceuticals Ltd
PO Box 45027, Auckland 8
New Zealand

PAPUA NEW GUINEA, FIJI & SOUTH WEST PACIFIC
Exsel Pacific
PO Box 133, Red Hill
Queensland 4059
Australia

SAUDI ARABIA
Salehiya Establishment
PO Box 991
Riyadh 11421
Saudi Arabia

SINGAPORE
Grafton Pharmasia Pte Ltd
66 Tannery Lane
Singapore 347805

SRI LANKA
Hemas Pharmaceuticals
Hemas Building
36 Bristol Street
Colombo 11, Sri Lanka

TAIWAN
Yung Hung Hong
8F, 58 Ming Chuan E. Rd
Sec 3, Taipei
Taiwan ROC

UNITED ARAB EMIRATES
Al Muhairy General Trading Co
PO Box 26288
Abu Dhabi
United Arab Emirates

Published by MIMS February 2004

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