CRR: 341982 Ref: F310615 Date: 13 Jan 2016

2 Before using this medicine

This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.

□ Do not use this medicine...

■    If you are allergic to Anusol or any of the other ingredients of this medicine (listed in section 6).

■    Do not use on broken or infected skin. Common skin infections include anal warts, genital herpes, thrush and jock itch.

■    If you are pregnant or breastfeeding.

■    If you are under 18 years of age.

If any of these applies, get advice from a doctor or pharmacist without using Anusol.

^k Talk to your doctor or pharmacist.

■    If you have rectal bleeding or blood in the stool or

if you are in doubt whether any bleeding you have experienced is caused by piles.

■    If symptoms worsen or do not improve after you have used the medicine for 7 days.

■    If you are taking or using any other medicines including:

corticosteroids (a type of anti-inflammatory medicine), e.g. betamethasone or hydrocortisone (used in eczema and dermatitis), dexamethasone, prednisolone.

If you are not sure about the medicine you are using then talk to your pharmacist or doctor for advice.

If any of these bullet points apply to you now or in the past, talk to a doctor or pharmacist.

A

■ If you are pregnant or breastfeeding do not use this medicine.

^k Some of the ingredients can cause problems

■    Castor oil may cause skin reactions.

■    Lanolin anhydrous may cause local skin reactions e.g. contact dermatitis which is a local irritation at the site of use.

3 How to use this medicine

Anusol Soothing Relief Ointment is for topical use only, which

means it is applied directly to the affected area.

■    Wash the anal area and dry gently with a soft towel before using the medicine.

■    There is a nozzle supplied with the product which can be used to apply the ointment into the back passage (anus).

■    For external piles - after washing and drying the affected area, the ointment should be applied using a gauze ressing.

■    For internal piles - after washing and drying the affected area, screw the nozzle provided onto the tube, remove the nozzle cap; insert the nozzle into the back passage and squeeze gently. Clean the nozzle after each use.

■    Wash your hands before and after using Anusol.

o Children (under 18 years):

This medicine is not for use in children under 18 years of age.

o Adults and the elderly:

Age	Dose
Adults and the elderly	Anusol Soothing Relief Ointment can be applied sparingly to the affected area at night, in the morning and after each bowel movement
■    Do not use more than 4 times a day. ■    Do not use for more than 7 consecutive days.

^k If anyone has swallowed this product

If anyone accidentally swallows Anusol Soothing Relief Ointment, contact a doctor or your nearest Accident and Emergency department (Casualty), taking this leaflet and pack with you.

^k If you forget to use the medicine

Anusol Soothing Relief Ointment should be used on an as required basis. However, if you are unable to use this product when needed, do not take a double dose next time you use it.

4    Possible side-effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience the following, stop using the medicine and talk to your doctor:

Rare: may affect up to 1 in 1,000 people

■    Hypersensitivity reactions (such as rash).

Other effects which may occur but it is unknown how often:

■    Burning, redness, irritation, itching, or pain may occur when applying the ointment. This does not usually last a long time, so if this lasts longer than a few days, tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5    Storing this medicine

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not use your medicine after the date shown as an expiry date on the packaging.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6    Further information

What's in this medicine?

The active substances are per 100 g:

Hydrocortisone acetate 0.25 g, Zinc oxide 10.75 g, Bismuth

subgallate 2.25 g, Balsam Peru 1.875 g, Bismuth oxide 0.875 g and Benzyl benzoate 1.25 g.

Other ingredients are: Magnesium stearate, cocoa butter, lanolin anhydrous, castor oil, kaolin light, calcium hydrogen phosphate and petroleum jelly white.

What the medicine looks like

Anusol Soothing Relief Ointment is a whitish ointment available in 15 g tubes.

Product Licence holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.

Manufacturer: Famar Orleans, 5 avenue de Concyr, 45071 Orleans, Cedex 2, France.

This leaflet was revised November 2015.

Anusol is a registered trade mark.

7 A Healthy Living Plan for Piles Sufferers

What are piles?

Piles (haemorrhoids) are swollen blood vessels which occur inside or outside the back passage (anus).

Symptoms

Some people have piles without experiencing any symptoms, but sufferers may notice the following:

■    Bleeding: Although streaks of bright red blood on the toilet paper are not uncommon in people with piles, it may be sign of a more serious condition and you should see your doctor to check this.

■    Swelling: The swollen blood vessels may be felt as a lump or blockage in the anus.

■    Pain, itching and irritation in the anal region.

At least 40% of people suffer from piles at some time in their lives. However, many people are too embarrassed to seek advice or treatment and, as a result, suffer unnecessary discomfort.

Fortunately, there is much you can do to ease the situation and relieve the symptoms.

What causes piles?

A number of factors can contribute to the development of piles:

■    The most common cause is straining during bowel movement, usually as a result of constipation.

■    During pregnancy, the growing baby exerts increased pressure on the anal vessels, which can lead to piles.

■    Heredity: You may be more likely to develop piles if your family has a history of suffering.

Healthy Tips for Piles Sufferers

You can reduce the risk of piles by following a healthy diet and lifestyle that helps to keep your bowels working regularly and prevents constipation. This can also help to speed recovery from piles.

■    Eat a high fibre diet including foods like brown rice, wholemeal bread, wholewheat pasta etc.

■    Eat plenty of fresh fruit, vegetables and salads.

■    Drink plenty of water.

■    Don't eat too much salty, fatty or sugary foods such as crisps, burgers and cakes.

■    Cut back on the amount of alcohol, tea and coffee you drink.

■    Exercise regularly.

A healthy diet and lifestyle will reduce the likelihood of constipation and encourage a regular bowel habit. Go to the toilet regularly and try to avoid straining. Leaning forward from the hips may help.

For external and internal piles, Ointment can be used. If internal haemorrhoids are the problem, Suppositories deliver a measured dose to the affected area.

For further information, please contact:

McNeil Products Ltd, Maidenhead, Berkshire,

SL6 3UG, UK.

McNeil^

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