Package Leaflet: Information for the user

Hemocane Cream

lidocaine hydrochloride, zinc oxide, bismuth oxide, cinnamic acid, benzoic acid

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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

•    Ask your pharmacist if you need more information or advice.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

•    You must talk to a doctor if you do not feel better or if you feel worse.

In this leaflet:

1.    What Hemocane Cream is and what it is used for

2.    What you need to know before you use Hemocane Cream

3.    How to use Hemocane Cream

4.    Possible side effects

5.    How to store Hemocane Cream

6.    Contents of the pack and other information

1. What Hemocane Cream is and what it is used for

The name of your medicine is Hemocane Cream. It contains the active ingredients lidocaine hydrochloride, zinc oxide, bismuth oxide, cinnamic acid and benzoic acid.

Lidocaine hydrochloride acts as a local anaesthetic.

Zinc oxide and bismuth oxide are astringents, which help to reduce swelling and to soothe and protect sore areas.

Benzoic acid and cinnamic acid have mild antiseptic properties.

Hemocane Cream is used to treat the symptoms of haemorrhoids and other ano-rectal conditions, such as pain, itching and swelling. Haemorrhoids, also known as piles, are swollen blood vessels inside or outside the back passage (anus), which can cause discomfort particularly after a bowel movement.

2. What you need to know before you use Hemocane Cream

Do not use Hemocane Cream if you are allergic (hypersensitive) to lidocaine hydrochloride, zinc oxide, bismuth oxide, cinnamic acid, benzoic acid, or any of the other ingredients of Hemocane Cream (see section 6).

Warnings and precautions

Avoid excessive and/or long-term use, as lidocaine may cause sensitisation of the anal skin.

Other medicines and Hemocane Cream

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

Please consult your doctor or pharmacist if you are pregnant, planning to become pregnant or are breast-feeding before using Hemocane Cream.

Important information about some of the ingredients of Hemocane Cream

This medicinal product contains:

•    Benzoic acid, which can mildly irritate the skin, eyes and mucous membranes

•    Propylene glycol, which may cause skin irritation

•    Glycerol, which may have a mild laxative effect

•    Cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis)

3. How to use Hemocane Cream

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

•    Gently clean the area around the back passage and dry with a soft towel.

•    Wash your hands.

•    Each tube of cream is sealed. Check the tube seal is not broken before first use. If it is, do not use the cream. Use the spiked end of the cap to pierce the seal.

•    For haemorrhoids outside the back passage: gently apply a small amount of cream directly onto the affected area.

•    For haemorrhoids inside the back passage: use the nozzle applicator in the pack to apply the cream into the back passage. Screw the applicator onto the tube and remove the protective cover. Squeeze the tube to fill and lubricate the applicator. Carefully insert the applicator into the back passage and gently squeeze the tube while slowly withdrawing the applicator. After use, detach and thoroughly clean the applicator before replacing the protective cover.

•    Replace the cap firmly on the tube.

•    Wash your hands.

Adults: Apply morning and at night and after bowel movements until the condition is controlled.

This medicine should not be used in children.

If you accidentally swallow or use more Hemocane Cream than you should: consult your doctor or pharmacist immediately.

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

4. Possible side effects

Like all medicines, Hemocane Cream can cause side effects, although not everybody gets them.

If you experience any of the following, stop using Hemocane Cream and get immediate medical help: swelling of the face, lips, tongue or throat; a red itchy skin rash; wheezing or difficulty breathing; feeling faint and dizzy; a strange metallic taste in the mouth; collapse. You may be having an allergic reaction.

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 Hemocane Cream

•    Keep this medicine out of the sight and reach of children.

•    Do not store above 25°C.

•    Do not use Hemocane Cream after the expiry date shown on the pack. The expiry date refers to the last day of that month.

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 to protect the environment.

6. Contents of the pack and other information

What Hemocane Cream contains

There are five active substances in Hemocane Cream:

•    Lidocaine hydrochloride (0.65% w/w)

•    Zinc oxide (10% w/w)

•    Bismuth oxide (2% w/w)

•    Cinnamic acid (0.45% w/w)

•    Benzoic acid (0.4% w/w)

The other ingredients are polypropylene glycol, glycerol, cetostearyl alcohol, Polawax EM3354, Arlacel 83, polysorbate 80.

What Hemocane cream looks like and contents of the pack

Hemocane Cream is a smooth, whitish cream. It is available in 25g and 45g aluminium tubes with a plastic applicator. Not all pack sizes may be marketed.

Marketing Authorisation holder:

Boston Healthcare Ltd., 6 Navigation Court, Calder Park,

Wakefield WF2 7BJ, United Kingdom.

Manufacturer:

Kleva S.A., 189 Parnithos Avenue, 136 75 Acharnai, Greece.

This leaflet was last revised in July 2014 Hemocane is a registered trademark

BOSTON

a Healthcare Limited