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Oily Pheno Jan 2014 Page 1

Read all of this leaflet carefully before you

are given this medicine.

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

•    If you have any further questions, ask your doctor or nurse.

•    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.

•    In this leaflet, Oily Phenol Injection BP 5% w/v Solution for Injection will be called Oily Phenol.

In this leaflet:

1.    What Oily Phenol is for

2.    Before you are given Oily Phenol

3.    How you will be given Oily Phenol

4.    Possible side effects

5.    How to store Oily Phenol

6.    Further information.

1.    What Oily Phenol is for

Oily Phenol belongs to a group of medicines called anti-haemorrhoidals.

Oily Phenol is for the treatment of piles (haemorrhoids). It relieves pain by numbing the nerves at the site of injection. It also hardens the tissue of the haemorrhoid causing a scar to be formed. Over time the haemorrhoids shrink and eventually disappear.

2.    Before you are given Oily Phenol Do not use Oily Phenol if:

•    You are allergic to phenol or the other ingredient almond oil

•    You are allergic to nuts

•    You are a child or a baby.

If any of the above applies to you talk to your doctor or pharmacist.

Pregnancy and breast-feeding

Do not use Oily Phenol if you are pregnant or breast-feeding unless your doctor tells you to.

Driving and using machines Oily Phenol may cause dizziness. If this happens to you, do not drive or use machinery.

Important information about one of the ingredients - Almond Oil

Oily Phenol contains almond oil. If you are allergic to nuts, do not use this medicine.

3. How you will be given Oily Phenol

Your doctor or nurse will inject this medicine.

Adults and the Elderly:

• The usual dose is 2-3 ml of the medicine injected into the skin at the base of the pile (haemorrhoid).

• If you need more injections your doctor will inject the medicine at a different position on the pile.

• The maximum total dose injected must not exceed 10 ml.

Children:

• Oily Phenol is not for use in children.

If you are given more Oily Phenol Injection than you should

As you are given the medicine by a doctor or nurse, it is unlikely you will be given too much. However, if you think you have had too much, contact your doctor or nurse immediately.

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

Like all medicines, Oily Phenol can cause side effects, although not everybody gets them.

Seek immediate medical help if you have any of the following:

• Itchy, red, or swollen skin and difficulty breathing. You may be having an allergic reaction.

•    Swollen, purple and blistered skin with pain, fever, diarrhoea and feeling or being sick. You may have a serious illness that destroys your skin, called Necrotising Fasciitis

•    Rapid heartbeat and breathing, with a fever, chills or confusion. You may have a serious infection of the blood called Retroperitoneal Sepsis.

6. Further information What Oily Phenol contains

The active substance is phenol at a concentration of 5%.

The other ingredient is almond oil.

What Oily Phenol looks like

Oily Phenol a clear pale yellow solution that comes in a glass container (ampoule). Each ampoule contains 5 ml of solution. There are ten ampoules in a carton.

Marketing Authorisation Holder

Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Busines Park, Clonee, Co. Meath, Ireland

Manufacturer

Recipharm Ltd, Vale of Bardsley, Ashton-

under-Lyne, OL7 9RR, UK

This leaflet was last updated {Approval Date}

If this leaflet is difficult to see or read or you would like it in a different format, please contact Phoenix Labs, Suite 12,

Bunkilla Plaza, Bracetown Business Park,

Clonee, Co. Meath, Ireland