€

MercuryPharma

Package leaflet: Information for the user

Glycopyrronium Bromide 3g Powder for Solution for Iontophoresis

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

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

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

-    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

What is in this leaflet

1.    What Glycopyrronium Bromide Powder is and what it is used for

2.    What you need to know before you use Glycopyrronium Bromide Powder

3.    How to use Glycopyrronium Bromide Powder

4.    Possible side effects

5.    How to store Glycopyrronium Bromide Powder

6.    Contents of the pack and other information

1. WHAT GLYCOPYRRONIUM BROMIDE POWDER IS AND WHAT IT IS USED FOR

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

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

2. WHAT YOU NEED TO KNOW BEFORE YOU USE GLYCOPYRRONIUM BROMIDE POWDER

Do not use Glycopyrronium Bromide Powder:

•    if you are allergic to glycopyrrolate.

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

•    if you are pregnant.

•    if you have fungal or other skin infections.

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Glycopyrronium Bromide powder:

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

•    if you have an overactive thyroid gland.

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

•    if you have a lung problem called chronic bronchitis.

Other medicines and Glycopyrronium Bromide Powder

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Pregnancy, breast-feeding and fertility

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Do not use during pregnancy or breast feeding.

Driving and using machines

Glycopyrronium Bromide 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 GLYCOPYRRONIUM BROMIDE POWDER

Glycopyrronium Bromide Powder will be administered to you by a qualified healthcare professional.

(    'N

REGULATORY AUTHORITY APPROVAL CONFIRMATION

Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, HPRA, etc ) and that Mercury Pharma have license approval to distribute this component for sale in the relevant market.

Accept Artwork / Reject Artwork

(Please strike off whichever NOT applicable)

Signature .......................................................................

Name .............................................................................

Date ...............................................................................

V_/

PAGE 1 OF 2

Method of administration:

Your doctor will give you Glycopyrronium Bromide Powder using a technique known as iontophoresis, which enables the drug to be passed through the skin by means of an electric current. Glycopyrronium Bromide 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 Glycopyrronium Bromide 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.

If you use more Glycopyrronium Bromide 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 medicine ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines this medicine can cause side effects, although not everybody gets them.

Consult a doctor straight away if you notice any of the following symptoms - you may need urgent medical treatment:

Swelling mainly of the face, lips or throat which makes it difficult to swallow or breathe, itching and rashes. This could be a sign of a severe allergic reaction or angioedema (frequency not known, cannot be estimated from the available data).

All medicines can cause allergic reactions although serious allergic reactions are rare.

The following side effects have also been reported under the following frequency:

Not known (frequency cannot be estimated from the available data)

•    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. 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. m h ra.gov. u k/yel lowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE GLYCOPYRRONIUM BROMIDE POWDER

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

Do not use this medicine after the expiry date which is stated on the label. 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 protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Glycopyrronium Bromide Powder contains

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

There are no other ingredients.

What Glycopyrronium Bromide Powder looks like and contents of the pack

Glycopyrronium Bromide Powder is a white crystalline powder.

Each screw top amber bottle contains 3 grams Glycopyrronium Bromide Powder.

Marketing Authorisation Holder

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

Manufacturer

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

This leaflet was last revised in August 2016.    102051 /LF/035/02

F1311

(    'N

REGULATORY AUTHORITY APPROVAL CONFIRMATION

Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, HPRA, etc ) and that Mercury Pharma have license approval to distribute this component for sale in the relevant market.

Accept Artwork / Reject Artwork

(Please strike off whichever NOT applicable)

Signature .......................................................................

Name .............................................................................

Date ...............................................................................

V_/

PAGE 2 OF 2