Uniroid-HC Ointment

Hydrocortisone, Cinchocaine hydrochloride

Read all of this leaflet carefully before you start using this medicine.    204289    LC210    1/L/m/5

•    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 this medicine is and what it is used for

2.    Before you use Uniroid-HC Ointment

3.    How to use Uniroid-HC Ointment

4.    Possible side effects

5.    How to store Uniroid-HC Ointment

6.    Further information

1. What this medicine is and what it is used for

Uniroid-HC Ointment contains hydrocortisone and cinchocaine hydrochloride.

•    Hydrocortisone soothes and relieves irritations and inflammation of the skin.

•    Cinchocaine hydrochloride, a local anaesthetic, provides pain relief.

It is used to treat:

•    external haemorrhoids (piles), providing short-term relief of pain, irritation and associated itching around the back passage (anus)

•    internal haemorrhoids using the nozzle applicator provided.

2. Before you use Uniroid-HC Ointment

Do NOT use Uniroid-HC Ointment if you:

•    are allergic to hydrocortisone, or to any other steroids

•    are allergic to cinchocaine, or to any other local anaesthetics

•    are allergic to any of the other ingredients (see Section 6)

•    have tuberculosis

•    have any kind of skin infection (e.g. thrush of the back passage, viruses affecting the skin).

Do not use ointment in children under 12 years of age unless directed by the doctor.

If any of the above apply to you, speak to your doctor or pharmacist.

Take special care with Uniroid-HC Ointment

Before using the ointment, tell your doctor if you:

•    have had a bad reaction to this or similar products before

•    are pregnant or planning a pregnancy

•    are breast-feeding.

Do NOT cover the skin with bandages, plasters or any other dressing. However, it is safe to cover the skin with your clothes.

Taking 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, and herbal preparations.

Some medicines may be affected by Uniroid-HC or they may affect how well Uniroid-HC will work.

Pregnancy and breast-feeding

Do not use the ointment if pregnant or breast-feeding

unless advised by your doctor.

Ask your doctor or pharmacist for advice before taking any medicine if you might be pregnant or breast-feeding. Driving and using machines

Uniroid-HC is unlikely to affect your ability to operate machinery or to drive.

Important information about some of the ingredients of Uniroid-HC Ointment

•    cetostearyl alcohol

This may cause local skin reactions, such as contact dermatitis.

3. How to use Uniroid-HC Ointment

Always use Uniroid-HC Ointment exactly as your doctor has told you, and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure.

•    To open the tube remove and turn the cap upside down and use it to pierce the seal at the top of the nozzle.

•    Gently wash the area around the back passage with water and pat dry with cotton wool.

Using without the applicator

1.    Wash your hands, then squeeze a small quantity of the ointment onto a finger and spread it onto the affected area without rubbing. Do NOT use toilet paper to apply the ointment.

2.    Wash your hands thoroughly.

Using with the applicator (inside the back passage)

1.    Your ointment contains a plastic nozzle applicator to help you apply the ointment inside the back passage. Clean the nozzle applicator thoroughly in warm, soapy water before and after each use.

2.    Screw the nozzle applicator onto the end of the

ointment tube and insert the nozzle applicator fully into the back passage.

3.    Squeeze the tube gently from the lower end while slowly pulling it out of the back passage.

4.    Unscrew the nozzle applicator and wash both it and your hands.

Do NOT apply a dressing after using this ointment as this can increase the risk of an allergic reaction (see Section 4).

Doses

Adults, elderly and children over 12 years: apply the ointment twice a day (morning and evening) and after each time you empty your bowels unless your doctor has told you otherwise.

Do not use the ointment for more than 7 days. If the problem is no better, tell your doctor.

Children under 12 years: this medicine is NOT suitable for children under 12 years.

If you use more than you should

If you apply too much ointment, wipe off the excess with

cotton wool.

If you accidentally insert too much ointment or if you or anyone else swallows any of the ointment:

1.    Tell your doctor, pharmacist or nearest hospital casualty department immediately.

2.    Take the ointment tube with you so that people can see what you have used or taken.

3.    Do this even if you feel well.

If you forget to use

If you forget to use the ointment, use it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual.

Do not use a double dose to make up for a missed dose.

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

4. Possible side effects

Like all medicines, Uniroid-HC Ointment can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor if you get the following side effect:

• an allergic reaction such as itching, pain or rash around the back passage.

Large doses and regular use may suppress the adrenal glands. This may cause complex changes in your body. If you use Uniroid-HC Ointment regularly, discuss this with 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. How to store Uniroid-HC Ointment

•    Keep out of the reach and sight of children.

•    Do not use after the expiry date stated on the tube and on the carton. The expiry date refers to the last day of that month.

•    Do not store above 25°C. Store in the original package.

•    Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.

6. Further information

What Uniroid-HC Ointment contains

•    The active ingredients are hydrocortisone (5 mg in 1 g of ointment) and cinchocaine hydrochloride (5 mg in 1 g of ointment).

•    The other ingredients are cetostearyl alcohol and white soft paraffin. (See end of Section 2 for further information on cetostearyl alcohol).

What Uniroid-HC Ointment looks like and contents of the pack

Uniroid-HC Ointment is a translucent or off-white odourless ointment. It is available in aluminium tubes of 15 g and 30 g. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chemidex Pharma Ltd, Chemidex House, Egham Business

Village, Crabtree Road, Egham, Surrey TW20 8RB.

Manufacturer

Purna Pharmaceuticals NV, Rijksweg 17, 2870 Puurs, Belgium. This leaflet was last revised in April 2015

'Uniroid' and 'Chemidex' are registered trademarks.

CHEMIDEX PHARMA

1/L/m/5    LC210    204289