CRR: 342011 Ref: 22097 Date: 10 Mar 2016

Anuso/mmama

suppositories

hydrocortisone acetate, zinc oxide, bismuth oxide, bismuth subgallate,balsam peru, benzyl benzoate

■    This medicine is used for the relief of uncomplicated internal piles and anal itching.

■    This medicine is for use in adults over the age of 18 years.

■    Do not use this medicine:

■    If you are allergic to Anusol or any of the other ingredients of this medicine. See section 6 c

■    If you have fungal, viral or bacterial skin sores.

■    If you are pregnant or breastfeeding.

■    If you are under 18 years of age. See section 2 c

■    Speak to your doctor:

■    If you have rectal bleeding or blood in the stool

which has not been diagnosed as piles. See section 2 c

■    If your symptoms have worsened or not improved within 7 days of using this product. See section 2 c

■    Follow the instructions on how to use this product carefully. See section 3 c

Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.

1 What the medicine is for

Anusol Soothing Relief Suppositories help to relieve the swelling, itch and irritation of internal piles (haemorrhoids) and anal itching. It contains the following ingredients:

Hydrocortisone acetate is a mild steroid which helps reduce inflammation.

Zinc oxide and Bismuth salts are mildly astringent and antiseptic. They soothe and protect raw areas.

Balsam Peru is mildly antiseptic and has a protective action on sore areas and may help healing.

Benzyl benzoate has mild antiseptic properties. This product is for use by adults over the age of 18 years.

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 apply to you, 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 any of these bullet points apply to you, talk to a doctor or pharmacist.

A

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

3 How to use this medicine

Anusol Soothing Relief Suppositories should be inserted into the anus

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

■    Remove plastic cover from the suppository before use.

■    Wash your hands before and after using Anusol.

■    The suppository will melt after insertion.

a Children (under 18 years):

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

a Adults and the elderly:

Age    Dose

Adults and    Insert one suppository into the

the elderly    back passage (anus) far enough

so that it doesn't slip out, at night, in the morning and after each bowel movement.

■    Do NOT take orally

■    Do not use more than 3 suppositories a day

■    Do not use for more than 7 consecutive days

^k If anyone has used too much or swallowed this product.

If anyone has used too much or has accidentally swallowed Anusol Soothing Relief Suppositories, contact a doctor or your nearest Accident and Emergency department (Casualty), taking this leaflet and pack with you.

^k If you forget to use this medicine

If you forget a dose, use the next dose when needed. Do not use a double dose.

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 on application. 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 per suppositories are:

Hydrocortisone acetate 10 mg, Zinc oxide 296 mg, Bismuth subgallate 59mg, Balsam Peru 49 mg, Bismuth oxide 24 mg and Benzyl benzoate 33 mg.

Other ingredients are: Kaolin light, suppocire BS2 pastilles (hard fat).

What the medicine looks like

Anusol Soothing Relief Suppositories are white suppositories available in plastic strips with two strips (12 suppositories) in a box.

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

Manufacturer: Farmea, 10, rue Bouche Thomas, ZAC Sud d’Orgemont, 49000 ANGERS Cedex, France.

This leaflet was revised November 2015.

Anusol is a registered trade mark.

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 a 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.

A Healthy Living Plan 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^

^ Products Ltd.

22097/01 - 03/l6 15-0427

22097-PIL ANUSOL Soothing Relief Suppos x 12 UKv3.0.indd 2 10/03/16 16:06