Glycopyrronium Bromide 1mg Tablets
Package leaflet: Information for the patient
Glycopyrronium Bromide 1mg Tablets Glycopyrronium Bromide 2mg Tablets
Glycopyrronium Bromide
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information foryou.
• 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.
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. Howto 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 belongs to a group of medicines called anticholinergic or antimuscarinic drugs.
It is used together with other medicines, to make the stomach contents less acid 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:
• if you are allergic to Glycopyrronium Bromide or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from:
. glaucoma (increased pressure in the eye),
. an enlarged prostate gland (prostatic hypertrophy),
. obstruction of the stomach (pyloric stenosis) or bowel causing vomiting, abdominal pain and swelling (paralytic ileus),
. myasthenia gravis (leading to muscle weakness and fatigue).
Warnings and precautions
Talk to your doctor or pharmacist before taking Glycopyrronium Bromide Tablets if:
• you are over 60 years of age,
• you are a child or this medicine has been prescribed fora child,
• you have just had a heart attack or are suffering from heart disease, irregular heart beats or high blood pressure,
• you have a condition characterised by rapid heart beat (including an overactive thyroid gland, heart failure or heart surgery),
• you are receiving inhalation anaesthesia (to put you to sleep before an operation) as it may cause a change in your normal heart rhythm,
• you have gastric reflux (a condition in which the liquid stomach contents backs up into the gullet),
• you have diarrhoea,
• you have ulcerative colitis (a chronic inflammation of the large intestine (colon) which can cause abdominal pain, diarrhoea, and bleeding from the back passage),
• you have a high temperature (fever) as the medicine will inhibit sweating,
• you have kidney disease as your dose may need to be decreased.
Children
This medicine is not recommended for use in children.
Other medicines and Glycopyrronium Bromide Tablets
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Taking some medicines together can be harmful. Remember the doctor at the hospital may not have been informed if you have recently begun a course of treatment for another illness.
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:
• drugs for depression such as tricyclic antidepressants (for example amitriptyline or imipramine) or monoamine oxidase inhibitor (MAOIs) antidepressants (for example phenelzine, tranylcypromine),
• clozapine (used to treat schizophrenia),
• phenothiazines used to treat mental problems or nausea, vomiting or vertigo (for example chlorpromazine, fluphenazine, prochlorperazine, trifluoperazine),
• antihistamines used to treat allergies (for example 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 (these are drugs that affect chemicals in the body which are involved in transmission of nerve impulses to a muscle) (for example carbachol, neostigmine, physostigmine),
• ritodrine (used to prevent complicated premature labour),
• corticosteroids used to treat various conditions including: asthma and inflammatory disease (for example 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 owing to the dry mouth which Glycopyrronium Bromide causes.
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 taking this medicine.
Glycopyrronium Bromide tablets should be used during pregnancy only if considered essential by the doctor.
You should not breast-feed if you are taking this medicine.
Driving and using machines
Glycopyrronium Bromide may cause your eyesight to become blurred and this could interfere with your ability to drive or operate machinery safely. Do not drive or operate machinery until these effects have fully cleared. If you are in any doubt, ask yourdoctorfor advice.
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
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for adults is:
Glycopyrronium Bromide Tablets 1 ma One tablet three times daily (in the morning, early afternoon, and at bedtime). Some patients may require two tablets at bedtime to control symptoms overnight. When your symptoms are controlled, a dose of one tablet twice a day may be sufficient.
Glycopyrronium Bromide Tablets 2 ma
One tablet two or three times a day at equally
spaced intervals.
The score line is not intended for breaking the tablet.
Children
This medicine is not recommended for use in children.
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. Always take any leftover tablets with you, as well as the container and label, so that the medical staff knows what you have taken.
If you forget to take Glycopyrronium Bromide Tablets
If you miss a dose, take your dose as soon as you can, then carry on as before. Do not take a double dose to make up for the forgotten one.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects are not known (frequency cannot be estimated from the available data): Swelling mainly of the face, lips or throat which makes it difficult to swallow or breathe (possible angioedema), as well as itching and rashes. This could be a sign of a severe allergic reaction. Stop taking Glycopyrronium Bromide Tablets and see a doctor straight away, if you notice any of the following serious side effects-you may need urgent medical treatment.
If you notice any of the following symptoms, and if these are persistent or troublesome, tell your doctor:
• dry mouth,
• difficulty in passing stools (constipation),
• irregular heart beat, slow heart beats followed by rapid heart beats,
• 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,
• eye disorder (glaucoma),
• flushing and/or dryness of the skin,
• giddiness,
• confusion, especially in the elderly.
If any of the side effects get serious, or you notice any unwanted effects that are not mentioned here, tell your doctor or pharmacist.
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 this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater. 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 contains
The active substance is glycopyrronium bromide.
The other ingredients are lactose monohydrate, dibasic calcium phosphate, 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 capsule shaped, flat, beveled edge, scored tablets engraved with “121” on the scored side and plain on other side.
Glycopyrronium Bromide 2 mg Tablets are white to off white capsule shaped, flat, beveled edge, scored tablets engraved with “122” on the scored side and plain on other side.
Tablets are supplied in pack sizes of 10, 14, 28, 30, 56, 60, 90 and 112 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road, Leicester, LE3 OPA, UK
Manufacturer
Morningside Pharmaceuticals Ltd 5 Pavilion Way, Loughborough, Leicestershire LE11 5GW.UK
This leaflet was last revised in August 2016.