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Hydrogen Peroxide Solution 6% (20 Vol) B.P.

Document: leaflet MAH GENERIC_PL 28444-0135 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

HYDROGEN PEROXIDE 6% (20 vol) BP

(Hydrogen Peroxide BP 6% w/v)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Hydrogen Peroxide carefully to get the best results from it.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    You must contact a doctor if your symptoms worsen or do not improve.

-    If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Hydrogen Peroxide Solution is and what it is used for

2.    Before you use Hydrogen Peroxide Solution

3.    How to use Hydrogen    Peroxide    Solution

4.    Possible side effects

5.    How to store Hydrogen    Peroxide Solution

6.    Further information

1.    WHAT HYDROGEN PEROXIDE SOLUTION IS AND WHAT IT IS USED FOR

The name of your medicine is Hydrogen Peroxide 6% (20 vol) BP. It contains the active ingredient called Hydrogen Peroxide BP 6% w/v. It works as a disinfectant, antimicrobial agent and also as an oxidiser.

It is used as a gargle or mouthwash and for the treatment of cuts, wounds and superficial damage to the skin (abrasions).

2.    BEFORE YOU USE HYDROGEN PEROXIDE SOLUTION

Do not use Hydrogen Peroxide solution if you are allergic (hypersensitive) to Hydrogen Peroxide or any of the other ingredients. See section 6.

Do not use undiluted solution as irritating burns of the skin, mouth or eyes may result. For serious ‘burns’, please contact your nearest Hospital A&E Department or doctor.

Take special care with Hydrogen Peroxide solution

•    Avoid contact with eyes.

•    Product is not suitable for rectal administration.

•    It is dangerous to instill Hydrogen Peroxide into closed body cavities from which the released oxygen has no free exit.

Urine/Glucose tests strips- Hydrogen peroxide could interfere with the Clinitest (test for sugar) and Labstix test (urine test) giving false positive results.

Taking other medicines

Please consult your pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription. Hydrogen Peroxide may react with other medicines and products.

Pregnancy and Breast-feeding

Hydrogen Peroxide can be used during pregnancy and lactation.

3. HOW TO USE HYDROGEN PEROXIDE SOLUTION

Follow the directions on this package leaflet or pack carefully, and ask your pharmacist to explain any part you do not understand.

As a gargle or mouthwash (DO NOT SWALLOW):

For adults, including the elderly & children over 8:

Use three 5ml spoonfuls (15ml) in half a glass of water.

For treatment of cuts, wounds & abrasions

(DO NOT USE UNDILUTED AS IRRITATING BURNS OF THE SKIN, MOUTH OR EYES MAY RESULT)

For adults, including the elderly & children:

Dilute with an equal quantity of water. Apply to the dressing and leave to soak before positioning on the wound. Affix with a bandage or sticking plaster.

If you use more Hydrogen Peroxide solution than you should, please consult your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Hydrogen Peroxide may cause side-effects, although not everybody gets them.

Very serious side effects -if any of the following happens, stop using Hydrogen Peroxide solution and tell your doctor immediately or go to the nearest hospital emergency department:

•    Swallowing of diluted solution may cause feeling of sickness (nausea) or vomiting.

•    Accidental ingestion of concentrated solutions of hydrogen peroxide may lead to blockage of veins and arteries (venous or arterial embolism)

Rare (occurring in less than 1 in 1,000 patients)

•    Isolated reports of gullet (oesophageal) and stomach (Gastric) irritation

Other side effects

•    If you continuously use Hydrogen peroxide as a mouthwash, it may lead to increase in size of the tiny projections that cover the surface of the tongue (reversible hypertrophy of the papillae of the tongue). In such a case, stop using Hydrogen peroxide solution.

If any of the side-effects gets serious or if you notice any side-effect not listed here, please tell your doctor or pharmacist.

5.    HOW TO STORE HYDROGEN PEROXIDE SOLUTION

Keep out of the reach and sight of children.

Store in a cool dry place. Protect from direct sunlight. Keep the container tightly closed. Do not use Hydrogen Peroxide solution after the expiry date which is stated on the label. The expiry date refers to the last date of that month.

Hydrogen Peroxide should not be disposed of via wastewater or household waste. Ask your

pharmacist how to dispose of this product no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Hydrogen Peroxide contains:

The active substance is Hydrogen Peroxide. The other ingredient is stabiliser (0.025% w/v).

What Hydrogen Peroxide looks like and contents of the pack:

Hydrogen Peroxide is a solution and comes in opaque containers with lids in pack sizes of 100ml, 175ml, 200ml & 2000ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Activase Pharmaceuticals Limited, 11 Boumpoulinas, 3rd Floor, P.C. 1060, Nicosia, Cyprus. Manufacturer

GlobeGen Laboratories Ltd., 1406 Coventry Road, South Yardley, Birmingham, B25 8AE, UK.

Date of last revision September 2013

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