Glycopyrronium Bromide 2mg Tablets
160 mm Folding Size: 80 x 20 mm
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PACKAGE LEAFLET: INFORMATION FOR THE USER
GLYCOPYRRONIUM BROMIDE 1 MG & 2 MG TABLETS
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Read all of this leaflet carefully before you start taking 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Glycopyrronium Bromide Tablets are and what they are used for
2. What you need to know before you take Glycopyrronium Bromide Tablets
3. How to take Glycopyrronium Bromide Tablets
4. Possible side effects
5. How to store Glycopyrronium Bromide Tablets
6. Contents of the pack and other information
1. WHAT GLYCOPYRRONIUM BROMIDE TABLETS ARE
AND WHAT THEY ARE USED FOR_
Glycopyrronium bromide (the active substance in Glycopyrronium Bromide Tablets) belongs to a group of medicines called anticholinergics or antimuscaranics.
It is used together with other medicines to make the stomach contents less acidic and to help treat peptic (stomach) ulcers in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
GLYCOPYRRONIUM BROMIDE TABLETS_
DO NOT take Glycopyrronium Bromide Tablets and talk to your doctor if:
• you are allergic to glycopyrronium bromide or any of the ingredients of this medicine (listed in section 6 at the end of the leaflet)
• you suffer from:
o glaucoma (increased pressure in the eye) o an enlarged prostate gland (prostatic hypertrophy) o obstruction of the stomach (pyloric stenosis) or bowel causing vomiting, abdominal pain and swelling (paralytic ileus)
o myasthenia gravis (leading to muscle weakness and fatigue).
Tell your doctor if you are not sure about any of the above. Warnings and precautions
Talk to your doctor or pharmacist before taking Glycopyrronium Bromide Tablets if you:
• are over 60 years of age
• are a child or this medicine has been prescribed for a child
• have recently had a heart attack or are suffering from heart disease, irregular heartbeat or high blood pressure
• have a condition characterised by rapid heartbeat (including an overactive thyroid gland, heart failure or conditions due to heart surgery)
• are about to receive inhalation anaesthesia (to put you to sleep before an operation), as it may cause a change in your normal heart rhythm
• have gastric reflux (a condition in which the liquid contents of the stomach back up into the gullet)
• have diarrhoea
• have ulcerative colitis (a chronic inflammation of the large intestine (colon) which can cause abdominal pain, diarrhoea, and bleeding from the back passage)
• have a high temperature (fever), as this medicine will prevent sweating
• have kidney disease; your dose may need to be decreased. Children
This medicine is NOT recommended for use in children (see section 3).
Other medicines and Glycopyrronium Bromide Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If they are taken with Glycopyrronium Bromide Tablets, their effect or the effect of Glycopyrronium Bromide Tablets may be changed.
Use of Glycopyrronium Bromide along with one or more similar medicines can increase side effects such as dry mouth, retention of urine and constipation. The elderly may become confused.
Please tell the doctor if you are taking, or have recently taken:
• medicines for depression such as tricyclic antidepressants (eg. amitriptyline or imipramine) or monoamine oxidase inhibitor (MAOIs), antidepressants (eg. phenelzine, tranylcypromine)
• clozapine, used to treat schizophrenia
• phenothiazines used to treat mental problems or nausea, vomiting or vertigo (eg. chlorpromazine, fluphenazine, prochlorperazine, trifluoperazine)
• antihistamines, used to treat allergies (eg. promethazine)
• nefopam, used to treat acute and chronic pain
• pethidine, used to treat moderate to severe pain
• domperidone or metoclopramide, used to treat nausea and vomiting
• ketoconazole, used to treat fungal infections
• amantadine, levodopa, used to treat Parkinson's disease
• memantine, used to treat Alzheimer's disease
• parasympathomimetics, medicines that affect chemicals in the body which are involved in transmission of nerve impulses to a muscle (eg. carbachol, neostigmine, physostigmine)
• ritodrine, used to prevent complicated premature labour
• corticosteroids, used to treat various conditions including asthma and inflammatory disease (eg. prednisolone)
• slow-dissolving digoxin tablets, disopyramide, used to treat heart problems
• glyceryl trinitrate tablets, used to treat angina, may not dissolve under the tongue as well as usual due to the dry mouth which Glycopyrronium Bromide causes.
If you are in doubt about any of these medicines, ask your doctor or pharmacist.
Pregnancy and breast-feeding
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 taking this medicine.
Glycopyrronium Bromide Tablets may be used in pregnancy only if considered essential by the doctor.
You should NOT breast-feed if you are taking this medicine.
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Driving and using machines
Glycopyrronium Bromide Tablets may cause your eyesight to become blurred, which could interfere with your ability to drive or operate machinery safely. If you are affected in this way, DO NOT drive or operate machinery until such symptoms go away.
Glycopyrronium Bromide Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE GLYCOPYRRONIUM BROMIDE
TABLETS_
Follow your doctor's instructions exactly. You should check with your doctor or pharmacist if you are not sure.
The recommended dose for adults is:
Glycopyrronium Bromide 1 mg Tablets:
One tablet three times daily (in the morning, early afternoon, and at bedtime). Some patients may require two tablets at bedtime to control the symptoms overnight.
When your symptoms are controlled, a dose of one tablet twice a day may be sufficient.
Glycopyrronium Bromide 2 mg Tablets:
One tablet two or three times a day at equally spaced intervals.
The score line is not intended for breaking the tablet.
Children MUST NOT take Glycopyrronium Bromide Tablets.
If you take more Glycopyrronium Bromide Tablets than you should
Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital right away. Always take any leftover medicine with you, as well as the container and label, so that the medical staff know what you have taken.
If you forget to take Glycopyrronium Bromide Tablets
Do not worry. If you remember later on that day, take that day's dose as usual. If you miss a whole day's dose, take the normal dose on the next day. DO NOT take a double dose to make up for a forgotten dose. If you are not sure, ask your doctor or pharmacist.
If you stop taking Glycopyrronium Bromide Tablets
Your doctor will tell you how long to take the treatment for. DO NOT stop earlier than you are told, even if you feel better.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS_
Like all medicines, Glycopyrronium Bromide Tablets can cause side effects, although not everybody gets them.
If you experience any of the side effects detailed below, and f these are persistent or troublesome, consult your doctor:
• dry mouth
• difficulty in passing stools (constipation)
• irregular heartbeat, slow heartbeats followed by rapid heartbeats
• reduced secretions in the lungs
• reduced sweating
• difficulty in passing urine
• enlarged pupils accompanied by visual disturbances
• increased sensitivity towards light (photophobia)
• confusion
• nausea (feeling sick), vomiting (being sick)
• eye disorder (glaucoma)
• flushing and/or dryness of the skin
• giddiness
• confusion, especially in the elderly.
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 GLYCOPYRRONIUM BROMIDE
TABLETS_
Keep this medicine out of the sight and reach of children.
Do not use Glycopyrronium Bromide Tablets after the expiry date, which is stated on the pack. The expiry date refers to the last day of that month.
After opening the container, Glycopyrronium Bromide Tablets can be used for 3 months.
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 Tablets contain
The active substance is glycopyrronium bromide.
Each 1 mg tablet contains 1 mg of glycopyrronium bromide.
Each 2 mg tablet contains 2 mg of glycopyrronium bromide.
The other ingredients are: calcium hydrogen phosphate dihydrate, lactose anhydrous, povidone, sodium starch glycolate and magnesium stearate.
What Glycopyrronium Bromide Tablets look like and contents of the pack
Glycopyrronium Bromide 1 mg Tablets are white to off-white round scored uncoated tablets, engraved with GP and ”1” on either side of the score line and plain on the other.
Glycopyrronium Bromide 2 mg Tablets are white to off-white round scored uncoated tablets, engraved with GP & ”2” on ether side of the score line and plain on the other.
Tablets are supplied in pack sizes of 10, 14, 28, 30, 56, 60, 90 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Kinedexe UK Limited, Unit 15 Moorcroft, Harlington Road, Uxbridge, UB8 3HD, Unted Kingdom.
This leaflet was last revised in 01/2016.
Kinedex