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Robinul 10g Powder For Solution For Iontophoresis

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MercuryPharma

PATIENT INFORMATION LEAFLET Robinul 10g Powder for Solution for Iontophoresis

Glycopyrronium Bromide

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.

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

The product is known by the name above but will be referred to as Robinul Powder throughout the rest of this leaflet.

In this leaflet:

1.    What Robinul Powder is and what it is used for

2.    Before you use Robinul Powder

3.    How to use Robinul Powder

4.    Possible side effects

5.    How to store Robinul Powder

6.    Further information

1. WHAT IS ROBINUL POWDER AND WHAT IT IS USED FO

Robinul Powder contains Glycopyrronium Bromide which belongs to a group of medicines called anticholinergic drugs. Its purpose is to block certain nerve impulses.

Robinul Powder is used for the treatment of excessive sweating from the palms of your hands and soles of your feet.

2. BEFORE YOU ARE GIVEN ROBINUL POWDER

DO NOT use Robinul Powder if:

•    you know that you are allergic to glycopyrrolate.

•    you suffer from glaucoma (increased pressure in the eye).

•    you are pregnant.

Make sure your doctor knows if you suffer from any of these.

Before you are given Robinul Powder, you should tell your doctor if:

•    you are suffering from heart problems, irregular heartbeats or abnormal blood pressure.

•    you have an overactive thyroid gland.

•    you have a blockage in your urinary passages such as bladder or kidneys.

•    you suffer from fungal skin disease or other skin infections.

•    you have a lung problem called chronic bronchitis.

Tell your doctor if any of these apply to you.

Taking other medicines

Please talk to your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Pregnancy and breast-feeding

Do not use during pregnancy or breast feeding.

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

Driving and using machines

Robinul Powder may cause drowsiness. Do not drive or use machines until you are sure this medicine does not affect your ability to drive.

3. HOW TO USE ROBINUL POWDEI

Your doctor will give you Robinul Powder using a technique known as iontophoresis, which enables the drug to be passed through the skin by means of an electric current. Robinul Powder is made into a solution and then poured into a non-metal container with a large piece of sheet metal (known as an anode) used to conduct electricity. The palm of your hand or sole of your foot will be placed in the solution and separated from the metal sheet by plastic foam or a layer of lint or a sponge sheet.

At the same time, another limb is placed in a similar container holding luke warm tap water instead of a solution of Robinul Powder. As before, your limb will be shielded from the metal sheet (this time called the cathode) used to conduct electricity by plastic foam or a lint or sponge sheet. The electric current will vary according to your age. Treatment will last about 12 minutes but will depend on your skin tolerance, body weight and size. Only one site will be treated at a time and only two sites will be treated in any one day. Your treatment will not be repeated within seven days but may be repeated later, perhaps varying the treatment, according to your condition.

What to do if you have more Robinul Powder than you should:

This is unlikely because the dose will be administered by a healthcare professional. If you suspect you have been given too much, you should tell the doctor immediately.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines Robinul Powder can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

The following side effects have also been reported but their frequency is not known:

•    Dry mouth and eating difficulties, such as problems with swallowing

•    Blurring of vision

•    A rapid heart beat

•    Mild discomfort in your tummy

•    Difficulty in passing urine

•    A mild tingling feeling in the areas which have been recently treated

You should avoid over exertion particularly in hot weather, until any unwanted effects have disappeared.

If any of these become serious, or you notice any side effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE ROBINUL POWDER

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

Do not use after the expiry date printed on the label. The expiry date refers to the last day of that month.

The active substance is glycopyrrolate (glycopyrronium bromide) 100%w/w.

There are no other ingredients.

What Robinul Powder looks like and contents of pack

Robinul Powder is a white crystalline powder.

Each screw top amber bottle contains 3 grams, 5 grams or 10 grams Robinul Powder. Not all pack sizes may be marketed.

Marketing Authorisation Holder

MercuryPharm Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland. Manufacture

Dales Pharmaceuticals Limited, Snaygill Industrial Estate, Keighley Road, North Yorkshire, Skipton, BD23 2RW, United Kingdom.

This leaflet was last revised in September, 2012 MercuryPharm Ltd is licensed to use the registered trademark