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Anacal Suppositories

Document: leaflet MAH BRAND_PL 06831-0173 change

TEXT FOR NON-MARKETED PACKS

PIL FOR ANACAL SUPPOSITORIES 10’s

PACKAGE LEAFLET: INFORMATION FOR THE USER ANACAL SUPPOSITORIES (heparinoid and oxypolyethoxydodecane)

Read all of this leaflet carefully before you start taking this medicine.

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

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

1.    What Anacal Suppositories are and what they are used for

2.    Before you use Anacal Suppositories

3.    How to use Anacal Suppositories

4.    Possible side-effects

5.    How to store Anacal Suppositories

6.    Further information

1.    WHAT ANACAL SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR

Anacal Suppositories are anti-inflammatory, analgesic (pain relieving) and anti-pruritic (anti-itching) preparations which provide relief of symptoms associated with internal and external haemorrhoids (piles), inflammation and irritation of the anus, and other related ano-rectal conditions.

2.    BEFORE YOU USE ANACAL SUPPOSITORIES

Anacal Suppositories are for external use only. Do NOT swallow.

Do not use Anacal Suppositories:

• if you are allergic (hypersensitive) to heparinoid, oxypolyethoxydodecane or any of the other ingredients of Anacal Suppositories (see section 6 - Further information for details).

Anacal Suppositories should NOT be used on children under the age of 12 years old.

Using 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

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

3.    HOW TO USE ANACAL SUPPOSITORIES


Always use Anacal Suppositories exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. Read the label carefully to remind yourself of how your doctor wants you to use Anacal Suppositories.

To remove the suppository from its wrapper, tear the foil from the pre-cut position (as shown).

If possible, empty your bowels before using Anacal Suppositories.



Wash the anal area thoroughly and then dry carefully with a soft towel before inserting the suppository. Gently insert one suppository once or twice daily, unless otherwise directed (e.g. at night, in the morning or after emptying the bowels) as deeply into the anus (back passage) as possible (as shown).

Please read the back of this leaflet.

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You may find it easier to stand with one leg raised (e.g. resting on the side of the bath) during applications (as shown).

Always wash your hands after inserting a suppository. Try to avoid emptying your bowels for at least an hour after insertion.

If you accidentally swallow one of these suppositories, it is unlikely to be serious. However, you should contact your doctor or a hospital casualty department.

4.    POSSIBLE SIDE-EFFECTS

Like all medicines, Anacal Suppositories can cause side-effects, although not everybody gets them.

Haemorrhoids and other ano-rectal conditions may sometimes be of a serious nature. In cases of rectal bleeding, or if the condition worsens, consult your doctor.

Chronic constipation or poor dietary habits may worsen haemorrhoids. It is important to maintain good hygiene in the ano-rectal areas whilst using the suppositories.

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

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.    HOW TO STORE ANACAL SUPPOSITORIES Keep out of reach and sight of children

Do not use Anacal Suppositories after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month. Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. FURTHER INFORMATION

The active substances in Anacal Suppositories are 4mg heparinoid and 50mg of oxypolyethoxydodecane. The other ingredients are hard fat and medium chain triglycerides.

What Anacal Suppositories looks like and the contents of the pack

Anacal Suppositories are smooth surfaced, torpedo shaped suppositories available in aluminiumpolypropylene blister packs of ten 2 gram suppositories.

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PL 06831/0173 Anacal Suppositories

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.

Manufacturers:

Mobilat Produktions GmbH, Luitpoldstrasse 1, 85276 Pfaffenhofen, Germany.

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany.

This leaflet was last approved in August 2014.

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