TEXT FOR NON-MARKETED PACKS

PIL FOR ANACAL RECTAL OINTMENT 30g

PACKAGE LEAFLET: INFORMATION FOR THE USER ANACAL® RECTAL OINTMENT (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 Rectal Ointment is and what it is used for

2.    Before you use Anacal Rectal Ointment

3.    How to use Anacal Rectal Ointment

4.    Possible side-effects

5.    How to store Anacal Rectal Ointment

6.    Further information

1.    WHAT ANACAL RECTAL OINTMENT IS AND WHAT IT IS USED FOR

Anacal Rectal Ointment is an anti-inflammatory, analgesic (pain relieving) and anti-pruritic (antiitching) preparation which provides 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 RECTAL OINTMENT

Anacal Rectal Ointment is for external use only. Do NOT swallow.

Do not use Anacal Rectal Ointment:

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

Anacal Rectal Ointment 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.

Important information about some ingredients in Anacal Rectal Ointment

Anacal Rectal Ointment contains the preservative methyl parahydroxybenzoate (E218).

This ingredient may cause allergic reactions (possibly delayed).

3.    HOW TO USE ANACAL RECTAL OINTMENT

Always take Anacal Rectal Ointment 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 Rectal Ointment.

Before use, pierce the tube seal with the spiked top of the cap. If possible, empty your bowels before using Anacal Rectal Ointment.

Wash the anal area thoroughly and then dry carefully with a soft towel before using the ointment. Apply the ointment gently to the affected area up to four times daily as required, unless otherwise directed (e.g. at night, in the morning or after emptying the bowels).

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

Please read the back of this leaflet.

*Trademark

If internal application is required, screw the nozzle firmly onto the tube, and spread a little ointment onto the nozzle to ease insertion. Insert the nozzle gently into the anus (back passage), squeeze the tube gently and slowly withdraw the nozzle at the same time (as shown). Always wash the nozzle and your hands after each application.

If you accidentally swallow some of this ointment, 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 Rectal Ointment 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 ointment.

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 RECTAL OINTMENT Keep out of reach and sight of children

Do not use Anacal Rectal Ointment 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 Rectal Ointment are 0.2% w/w heparinoid and 5.0% oxypolyethoxydodecane.

The other ingredients are methyl parahydroxybenzoate (E218), liquid paraffin, polyethylene highpolymer 1500 and sorbitan monostearate.

What Anacal Rectal Ointment looks like and the contents of the pack

Anacal Rectal Ointment is white ointment available in aluminium lacquered tubes of 30 grams.

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PL 06831/0172 Anacal Rectal Ointment 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.

*Trademark

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