Skip to Content

PYRIDOSTIGMINE 60MG TABLETS

Active substance(s): PYRIDOSTIGMINE BROMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Space for
code

PYRIDOSTIGMINE 60MG TABLETS

pyridostigmine bromide
PATIENT INFORMATION LEAFLET

READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING THIS MEDICINE.
• 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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

Take special care with Pyridostigmine tablets
There is no evidence to suggest that pyridostigmine has
any special effects on elderly patients. However, tell your
doctor if you are elderly and have any heart condition.
Taking other medicine
Take special care with pyridostigmine tablets and consult
your doctor if you are taking any other medicines
including those not prescribed by your doctor. This is
extremely important, as using more than one medicine at
the same time can strengthen or weaken the effect of the
medicine.
The following medicines can prevent your tablets from working:
• Antimuscarinics e.g. atropine, hyoscine
• 
Medicines used to relax muscles during surgery e.g.
pancuronium, vencuronium

THE LEAFLET CONTAINS INFORMATION ON:
1. 
What Pyridostigmine tablets are and what they are
used for
2. Before you take Pyridostigmine tablets
3. How to take Pyridostigmine tablets
4. Possible side effects
5. How to store Pyridostigmine tablets
6. Further Information
1. WHAT PYRIDOSTIGMINE TABLETS ARE AND
WHAT THEY ARE USED FOR?

The following medicines can increase the effect of your
tablets:
• Steroids
• Other muscle relaxants e.g. suxamethonium
• Immunosuppressant drugs

Pyridostigmine belongs to a group of medicines known
as anticholinesterase inhibitors. It helps messages pass from
the brain to the muscles so that the muscle works properly.

Please tell your doctor or pharmacist if you are taking or
have recently taken any other Medicines including
medicines obtained without a prescription.

Pyridostigmine is used to treat:
• myasthenia gravis, a condition that prevent messages
reaching the muscles from the brain. The
muscles quickly become tired and weak and, in
severe cases may become paralysed. This medicine
helps the messages to get through more easily.
• some rare forms of constipation (paralytic ileus)
• the inability to pass urine after an operation.

Taking Pyridostigmine tablets with food or drink
Pyridostigmine tablets should be taken 30 to 60 minutes before
a meal.
Pregnancy and breast-feeding
The safety of pyridostigmine for use during pregnancy
has not been established. Hence, it should be taken only
if your doctor advises to do so.

2. BEFORE YOU TAKE PYRIDOSTIGMINE TABLETS

Pyridostigmine passes into breast milk in small amounts.
Your doctor will decide if it is appropriate for you to
continue taking pyridostigmine while breast-feeding.

Do not take Pyridostigmine tablets if you:
• 
are allergic (hypersensitive) to pyridostigmine
bromide or any of the other ingredients.
• are constipated or cannot urinate, unless your doctor
has told you to use this medicine.

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

Take special care with Pyridostigmine tablets and
consult your doctor if you:
• suffer from asthma
• have recently had coronary thrombosis (heart attack)
• have a slow heart beat
• have low blood pressure
• have a stomach ulcer
• have epilepsy
• have Parkinson’s disease
• have kidney problems
• suffer from a condition called vagotonia (a condition where
over activity of the vagus nerve causes
symptoms such as slow heart rate, low blood pressure,
constipation, sweating and painful muscle spasms)
• have had an operation to remove your thymus gland.

Driving and using machines
The effects of pyridostigmine on the ability to drive and
operate machinery have not been established. Hence do
not drive or use machinery when you are on
pyridostigmine tablets unless you are sure your
judgement and co-ordination are not affected.
Important
information
about
some
of
the
ingredients of Pyridostigmine tablets
Pyridostigmine tablets contain lactose. If you have been
told by your doctor that you have intolerance to
some sugars, contact your doctor before taking this medicinal
product.

Pyridostigmine Bromide 60 mg tablets PIL - UK
item no:
print proof no:
origination date:
approved for print/date

AAAI8154
2
21.03.16

originated by:

DR

revision date:

06.04.16

revised by:

DR

supplier: IL/Intas Pharmaceuticals, Ltd

dimensions: 160x270mm
pharmacode:
min pt size: 9pt

colours/plates:
1. Black
2.
3.
4.
5.
6.

Technical Approval
date sent: 21.03.16
technically app. date: 22.03.16

Non Printing Colours
1. Profile
2.
3.

3. HOW TO TAKE PYRIDOSTIGMINE TABLETS

The following side effects have been reported:
• feeling or being sick
• diarrhoea or stomach cramps
• you may produce more saliva than usual.

Follow your doctor’s directions about when and how to
take your tablets and look at the label on the carton.
Your pharmacist will also help if you are not sure.

If you are concerned about any of these effects talk
to your doctor or pharmacist.

You should try to take your medicine so that it can work when
your muscles are needed most, for example, when you get up
and at meal times. The tablets take 30 to 60 minutes to start
working after you have taken them so you should try to take
your first dose of the day when you get up and other doses
about 30 to 60 minutes before a meal.

Reporting of side effects:
If you get any side effects, talk to your doctor or
pharmacist.This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme (Website:
www.mhra.gov.uk/yellowcard). By reporting side effects you
can help provide more information on the safety of this
medicine.

Swallow the tablets with water or another non-alcoholic drink.
If you have difficulty swallowing, you can break the tablets into
pieces.
The dose will depend on your illness and on your age as
follows:

5. HOW TO STORE PYRIDOSTIGMINE TABLETS
• Keep out of the sight and reach of children.
• Do not use Pyridostigmine tablets after the expiry date.
The expiry date refers to the last day of the month. Expiry
date can be found on the bottle label and carton.
• Store your tablets in the original container. Do not store
above 25°C.
• Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

For myasthenia gravis:
The normal adult dose is ½ to 2 tablets (30 to 120 mg
pyridostigmine) to be taken five to six times daily or higher
doses if needed as recommended by your doctor.
If you have myasthenia gravis, the effect of each dose should
last about four hours during the day and about six hours at
night.
For paralytic ileus and post-operative inability to
pass urine:
The normal adult dose is 1 to 4 tablets (60 to 240 mg
pyridostigmine) daily and for children ¼ to 1 tablet (15 to
60 mg) daily, depending on the needs of the patient.

6. FURTHER INFORMATION
What Pyridostigmine tablets contain
The name of your medicine is Pyridostigmine 60mg tablets.
The active substance in your tablet is pyridostigmine bromide.
Each tablet contains 60mg of pyridostigmine bromide. Other
ingredients are silicon dioxide, lactose monohydrate, maize
starch, purified talc and magnesium stearate.

For children
For children under 6 years the usual dose is ½ tablet (30 mg).
For children aged 6 to 12 years, the usual starting dose is 1
tablet (60 mg). The doctor will then gradually increase the dose
until maximum improvement is seen. In children the total dose
per day is usually 30 to 360 mg.

What Pyridostigmine tablets look like and contents of
the pack
Pyridostigmine 60mg tablets are white to off white, flat faced,
round, bevelled edges, uncoated tablet with cross scoring on
one side and debossed ‘NM’ on the other side.
Pyridostigmine 60mg tablets are supplied in Type III amber
glass bottle with PP child-resistant closure or white opaque
HDPE bottle, containing HDPE desiccant (silica gel) canister,
with a PP child-resistant closure. Each bottle contains 200
tablets.

If you take more Pyridostigmine tablets than you should
It is important to stick to the dose on the label of the medicine.
If you or someone else swallows several of these tablets all
together, contact your doctor or nearest hospital emergency
department immediately. Always take any tablets left over with
you and also the box, as this will allow easier identification of
the tablets.
If you forget to take Pyridostigmine tablets
If you forget to take a dose, take it as soon as you remember. If
it is almost time for your next dose do not take a double dose to
make up for a forgotten dose, just carry on as before.

Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Lime Pharma Ltd, Whiddon Valley, Barnstaple, North Devon,
EX32 8NS, United Kingdom.

If you stop taking Pyridostigmine tablets
It is important that you keep taking these tablets until your
doctor tells you to stop.
Do not change the prescribed dose yourself. If you think the
effect of your medicine is too weak or too strong, talk to your
doctor. Always tell your doctor if you want to stop taking the
medicine.
If you have any further questions on the use of this product ask
your doctor or pharmacist.

Manufacturer:
Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon,
EX32 8NS, United Kingdom.
This leaflet was prepared in 02/2016

4. POSSIBLE SIDE EFFECTS
Like all medicines, Pyridostigmine tablets can have side effects
although not everybody gets them.
AAAI8154

Pyridostigmine Bromide 60 mg tablets PIL - UK
item no:
print proof no:
origination date:
approved for print/date

AAAI8154
2
21.03.16

originated by:

DR

revision date:

06.04.16

revised by:

DR

supplier: IL/Intas Pharmaceuticals, Ltd

dimensions: 160x270mm
pharmacode:
min pt size: 9pt

colours/plates:
1. Black
2.
3.
4.
5.
6.

Technical Approval
date sent: 21.03.16
technically app. date: 22.03.16

Non Printing Colours
1. Profile
2.
3.

Space for
code

PYRIDOSTIGMINE 60MG TABLETS

pyridostigmine bromide
PATIENT INFORMATION LEAFLET

READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING THIS MEDICINE.
• 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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

Take special care with Pyridostigmine tablets
There is no evidence to suggest that pyridostigmine has
any special effects on elderly patients. However, tell your
doctor if you are elderly and have any heart condition.
Taking other medicine
Take special care with pyridostigmine tablets and consult
your doctor if you are taking any other medicines
including those not prescribed by your doctor. This is
extremely important, as using more than one medicine at
the same time can strengthen or weaken the effect of the
medicine.
The following medicines can prevent your tablets from working:
• Antimuscarinics e.g. atropine, hyoscine
• 
Medicines used to relax muscles during surgery e.g.
pancuronium, vencuronium

THE LEAFLET CONTAINS INFORMATION ON:
1. 
What Pyridostigmine tablets are and what they are
used for
2. Before you take Pyridostigmine tablets
3. How to take Pyridostigmine tablets
4. Possible side effects
5. How to store Pyridostigmine tablets
6. Further Information
1. WHAT PYRIDOSTIGMINE TABLETS ARE AND
WHAT THEY ARE USED FOR?

The following medicines can increase the effect of your
tablets:
• Steroids
• Other muscle relaxants e.g. suxamethonium
• Immunosuppressant drugs

Pyridostigmine belongs to a group of medicines known
as anticholinesterase inhibitors. It helps messages pass from
the brain to the muscles so that the muscle works properly.

Please tell your doctor or pharmacist if you are taking or
have recently taken any other Medicines including
medicines obtained without a prescription.

Pyridostigmine is used to treat:
• myasthenia gravis, a condition that prevent messages
reaching the muscles from the brain. The
muscles quickly become tired and weak and, in
severe cases may become paralysed. This medicine
helps the messages to get through more easily.
• some rare forms of constipation (paralytic ileus)
• the inability to pass urine after an operation.

Taking Pyridostigmine tablets with food or drink
Pyridostigmine tablets should be taken 30 to 60 minutes before
a meal.
Pregnancy and breast-feeding
The safety of pyridostigmine for use during pregnancy
has not been established. Hence, it should be taken only
if your doctor advises to do so.

2. BEFORE YOU TAKE PYRIDOSTIGMINE TABLETS

Pyridostigmine passes into breast milk in small amounts.
Your doctor will decide if it is appropriate for you to
continue taking pyridostigmine while breast-feeding.

Do not take Pyridostigmine tablets if you:
• 
are allergic (hypersensitive) to pyridostigmine
bromide or any of the other ingredients.
• are constipated or cannot urinate, unless your doctor
has told you to use this medicine.

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

Take special care with Pyridostigmine tablets and
consult your doctor if you:
• suffer from asthma
• have recently had coronary thrombosis (heart attack)
• have a slow heart beat
• have low blood pressure
• have a stomach ulcer
• have epilepsy
• have Parkinson’s disease
• have kidney problems
• suffer from a condition called vagotonia (a condition where
over activity of the vagus nerve causes
symptoms such as slow heart rate, low blood pressure,
constipation, sweating and painful muscle spasms)
• have had an operation to remove your thymus gland.

Driving and using machines
The effects of pyridostigmine on the ability to drive and
operate machinery have not been established. Hence do
not drive or use machinery when you are on
pyridostigmine tablets unless you are sure your
judgement and co-ordination are not affected.
Important
information
about
some
of
the
ingredients of Pyridostigmine tablets
Pyridostigmine tablets contain lactose. If you have been
told by your doctor that you have intolerance to
some sugars, contact your doctor before taking this medicinal
product.

Pyridostigmine Bromide 60 mg tablets PIL - UK
item no:
print proof no:
origination date:
approved for print/date

AAAI8153
2
21.03.16

originated by:

DR

revision date:

06.04.16

revised by:

DR

supplier: IL/Intas Pharmaceuticals, Ltd

dimensions: 160x270mm
pharmacode:
min pt size: 9pt

colours/plates:
1. Black
2.
3.
4.
5.
6.

Technical Approval
date sent: 21.03.16
technically app. date: 22.03.16

Non Printing Colours
1. Profile
2.
3.

3. HOW TO TAKE PYRIDOSTIGMINE TABLETS

The following side effects have been reported:
• feeling or being sick
• diarrhoea or stomach cramps
• you may produce more saliva than usual.

Follow your doctor’s directions about when and how to
take your tablets and look at the label on the carton.
Your pharmacist will also help if you are not sure.

If you are concerned about any of these effects talk
to your doctor or pharmacist.

You should try to take your medicine so that it can work when
your muscles are needed most, for example, when you get up
and at meal times. The tablets take 30 to 60 minutes to start
working after you have taken them so you should try to take
your first dose of the day when you get up and other doses
about 30 to 60 minutes before a meal.

Reporting of side effects:
If you get any side effects, talk to your doctor or
pharmacist.This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme (Website:
www.mhra.gov.uk/yellowcard). By reporting side effects you
can help provide more information on the safety of this
medicine.

Swallow the tablets with water or another non-alcoholic drink.
If you have difficulty swallowing, you can break the tablets into
pieces.
The dose will depend on your illness and on your age as
follows:

5. HOW TO STORE PYRIDOSTIGMINE TABLETS
• Keep out of the sight and reach of children.
• Do not use Pyridostigmine tablets after the expiry date.
The expiry date refers to the last day of the month. Expiry
date can be found on the bottle label and carton.
• Store your tablets in the original container. Do not store
above 25°C.
• Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

For myasthenia gravis:
The normal adult dose is ½ to 2 tablets (30 to 120 mg
pyridostigmine) to be taken five to six times daily or higher
doses if needed as recommended by your doctor.
If you have myasthenia gravis, the effect of each dose should
last about four hours during the day and about six hours at
night.
For paralytic ileus and post-operative inability to
pass urine:
The normal adult dose is 1 to 4 tablets (60 to 240 mg
pyridostigmine) daily and for children ¼ to 1 tablet (15 to
60 mg) daily, depending on the needs of the patient.

6. FURTHER INFORMATION
What Pyridostigmine tablets contain
The name of your medicine is Pyridostigmine 60mg tablets.
The active substance in your tablet is pyridostigmine bromide.
Each tablet contains 60mg of pyridostigmine bromide. Other
ingredients are silicon dioxide, lactose monohydrate, maize
starch, purified talc and magnesium stearate.

For children
For children under 6 years the usual dose is ½ tablet (30 mg).
For children aged 6 to 12 years, the usual starting dose is 1
tablet (60 mg). The doctor will then gradually increase the dose
until maximum improvement is seen. In children the total dose
per day is usually 30 to 360 mg.

What Pyridostigmine tablets look like and contents of
the pack
Pyridostigmine 60mg tablets are white to off white, flat faced,
round, bevelled edges, uncoated tablet with cross scoring on
one side and debossed ‘NM’ on the other side.
Pyridostigmine 60mg tablets are supplied in Type III amber
glass bottle with PP child-resistant closure or white opaque
HDPE bottle, containing HDPE desiccant (silica gel) canister,
with a PP child-resistant closure. Each bottle contains 200
tablets.

If you take more Pyridostigmine tablets than you should
It is important to stick to the dose on the label of the medicine.
If you or someone else swallows several of these tablets all
together, contact your doctor or nearest hospital emergency
department immediately. Always take any tablets left over with
you and also the box, as this will allow easier identification of
the tablets.
If you forget to take Pyridostigmine tablets
If you forget to take a dose, take it as soon as you remember. If
it is almost time for your next dose do not take a double dose to
make up for a forgotten dose, just carry on as before.

Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Lime Pharma Ltd, Whiddon Valley, Barnstaple, North Devon,
EX32 8NS, United Kingdom.

If you stop taking Pyridostigmine tablets
It is important that you keep taking these tablets until your
doctor tells you to stop.
Do not change the prescribed dose yourself. If you think the
effect of your medicine is too weak or too strong, talk to your
doctor. Always tell your doctor if you want to stop taking the
medicine.
If you have any further questions on the use of this product ask
your doctor or pharmacist.

Manufacturer:
Auden Mckenzie (Pharma Division) Ltd, Mckenzie House,
Bury Street, Ruislip, Middlesex, HA4 7TL, United Kingdom.
This leaflet was prepared in 02/2016

4. POSSIBLE SIDE EFFECTS
Like all medicines, Pyridostigmine tablets can have side effects
although not everybody gets them.
AAAI8153

Pyridostigmine Bromide 60 mg tablets PIL - UK
item no:
print proof no:
origination date:
approved for print/date

AAAI8153
2
21.03.16

originated by:

DR

revision date:

06.04.16

revised by:

DR

supplier: IL/Intas Pharmaceuticals, Ltd

dimensions: 160x270mm
pharmacode:
min pt size: 9pt

colours/plates:
1. Black
2.
3.
4.
5.
6.

Technical Approval
date sent: 21.03.16
technically app. date: 22.03.16

Non Printing Colours
1. Profile
2.
3.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide