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Vagisil Medicated Creme

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VAG-UK-0018-A 11-6-15 UK VAGISIL Leaflet


VagisiL_

Vagisil Medicated Creme® 2.0% Lidocaine


PACKAGE LEAFLET:
INFORMATION FOR THE USER

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 Vagisil 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 after one week.

•    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 Vagisil is and what it is used for

2.    Before you use Vagisil

3.    How to use Vagisil

4.    Possible side effects

5.    How to store Vagisil

6.    Further information

1. What Vagisil is and what it is used for

Vagisil is an emulsion cream. The active ingredient is Lidocaine.

Vagisil is formulated to provide prompt effective relief from the discomfort of minor itching, and irritation of the skin just outside of the vagina and around the anus (back passage). Lidocaine works below the skin surface to anaesthetise skin, to stop itching and irritation and remove the urge to scratch.


2.    Before You Use Vagisil

Do not use Vagisil:

•    if you are allergic (hypersensitive) to Lidocaine or any of the other ingredients of Vagisil. See Section 6 for a full list of ingredients.

•    if you are under 12 years of age.

•    on your eyes.

Take special care with Vagisil:

Medicines are not always suitable for everyone. Before you use Vagisil you should consult your doctor if you have general itching all over your body.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

•    Do not use Vagisil if you are pregnant or breast-feeding without first consulting a doctor.

•    Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

There are no effects on ability to drive and use machines.

Important information about some of the ingredients of Vagisil

Vagisil contains sulfonated castor oil which may cause skin reactions.

3.    How to use Vagisil

Always use Vagisil exactly as detailed in the instructions. You should check with your doctor or pharmacist if you are not sure how to use the product.

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Vagisil is for external use on the skin just outside of the vagina and around the anus (back passage) by adults and children aged 12 years and above.

Apply the cream to the affected area. You can repeat the treatment as needed 3 to 4 times daily for up to one week. If symptoms persist for more than one week, consult your doctor. On rare occasions a persistent itch may be a sign of another condition that only your doctor can diagnose and treat.

If you forget to use Vagisil, do not use a double application to make up for a forgotten treatment. When you remember, apply the cream and continue with the treatment.

If you use more Vagisil than you should: Overdose is unlikely but talk to your doctor or pharmacist straight away, even if you do not feel any symptoms. An overdose may include using more than the recommended amount, applying the cream to large areas or using the cream for longer than recommended.

If you accidentally swallow Vagisil it is unlikely to be harmful but contact your doctor or pharmacist if you are worried.

The symptoms of overdose may include: blurred vision, dizziness or drowsiness, difficulty breathing, trembling, chest pain or an irregular heartbeat. Accidental ingestion may additionally cause: numbness of the throat, nausea, sickness or stomach upset.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Vagisil can cause side effects, although not everybody gets them. The use of Vagisil may result in a skin reaction called sensitivity. This could become apparent by reddening of the skin, minor swelling, blistering, or through an intensification of the itch and/or irritation.

In the unlikely event that you experience these symptoms, stop using Vagisil and consult your doctor for advice.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard.

Alternatively you can fill in a paper form available from your local pharmacy.

5. How To Store Vagisil

Keep out of the reach and sight of children. This medicinal product does not require any special storage conditions.

Do not use after the expiry date which is stated on the packaging and on the seal of the tube. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

6. Further information

What Vagisil contains

The active substance is Lidocaine 2.0%.

The other ingredients are: Stearic acid, Self-emulsifying glyceryl monostearate, Glycerol, Triethanolamine, Zinc oxide, Sul-fonated castor oil, Isopropyl alcohol, Chloro-thymol, Fragrance, Docusate sodium, Diethylene glycol monoethyl ether, Purified water.

What Vagisil looks like and contents of the pack

Vagisil is an emulsion cream supplied in a decorated metal tube and an outer carton. Available in 30g and 20g pack sizes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Combe International Limited Leatherhead, KT22 9RX, UK

Manufacturer

Laleham Health and Beauty Limited Alton, GU34 2PR, UK This leaflet was last amended in 10/2015

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