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GLYCOPYRRONIUM BROMIDE 1MG TABLETS

Active substance(s): GLYCOPYRRONIUM BROMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Assicco 1mg Tablets
Assicco 2mg Tablets
Glycopyrronium Bromide
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.
What is in this leaflet
1. What Assicco Tablets are and what they are
used for
2. What you need to know before you take
Assicco Tablets
3. How to take Assicco Tablets
4. Possible side effects
5. How to store Assicco Tablets
6. Contents of the pack and other information
1. What Assicco 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
Assicco Tablets
Do not take Assicco 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
Assicco Tablets if:
- you are over 60 years of age,
- you are a child or this medicine has been
prescribed for a 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

Item Code

M0094LAMUKNAB1-S-001

Proof By

LHE

Proof No.

3

Date

13/12/2017

MPS No.

912592

artwork.leicester@cirrus-artwork.com
Warning! We cannot accept responsibility for any errors in this
proof after approval. Whilst we take extreme care at all times to
ensure accuracy to our client’s brief,
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Customer

Morningside Healthcare

Description

Glycopyrronium Bromide Leaflet

Item Code

M0094LAMUKNAB1-S-001

Barcode

EAN 13 N/A

PharmaCode

N/A

Proof By

LHE

Proof No.

3

Date

13/12/2017

Artwork No.

912592

Production Desc.

Keyline Ref

MLEAF037

Dimensions

170mm×310mm

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 Assicco 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 sideeffects 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.

Colours Used
Black
Keyline (Non-Printing)

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.
Assicco 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 your doctor for
advice.
Assicco 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 Assicco 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:
Assicco Tablets 1 mg
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.
Assicco Tablets 2 mg
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 Assicco 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 Assicco 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 Assicco 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),

Item Code

M0094LAMUKNAB1-S-001

Proof By

LHE

Proof No.

3

Date

13/12/2017

MPS No.

912592

artwork.leicester@cirrus-artwork.com
Warning! We cannot accept responsibility for any errors in this
proof after approval. Whilst we take extreme care at all times to
ensure accuracy to our client’s brief,
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

MLEAF037

Dimensions

170mm×310mm

5. How to store Assicco 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 Assicco 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 Assicco Tablets look like and contents
of the pack
Assicco 1 mg Tablets are white to off white
capsule shaped, flat, beveled edge, scored
tablets engraved with “I 21” on the scored side
and plain on other side.
Assicco 2 mg Tablets are white to off white
capsule shaped, flat, beveled edge, scored
tablets engraved with “I 22” 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 0PA
UK
Manufacturer
Morningside Pharmaceuticals Ltd
5 Pavilion Way
Loughborough
Leicestershire
LE11 5GW
UK
This leaflet was last revised in December 2017.
M0094LAMUKNAB1-S-001

Customer

Morningside Healthcare

Description

Glycopyrronium Bromide Leaflet

Item Code

M0094LAMUKNAB1-S-001

Barcode

EAN 13 N/A

PharmaCode

N/A

Proof By

LHE

Proof No.

3

Date

13/12/2017

Artwork No.

912592

Production Desc.

Keyline Ref

- irregular heart beat, slow heart beats 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,
- 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
or search for MHRA Yellow Card in the Google
Play or Apple App Store.
By reporting side effects you can help provide
more information on the safety of this medicine.

Colours Used
Black
Keyline (Non-Printing)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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