PYRIDOSTIGMINE 60MG TABLETS

Space for
code 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.
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?
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 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.
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.
2. BEFORE YOU TAKE PYRIDOSTIGMINE TABLETS
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.
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.
Please tell your doctor or pharmacist if you are taking or
have recently taken any other Medicines including
medicines obtained without a prescription.
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.
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.
Ask your doctor or pharmacist for advice before taking
any medicine.
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 colours/plates:

1. Black

item no: AAAI8154 dimensions: 160x270mm 2.

3.
print proof no: 2 pharmacode:
4.
origination date: 21.03.16 min pt size: 9pt 5.
originated by: DR 6.
approved for print/date Non Printing Colours
revision date: 06.04.16 Technical Approval
1. Profile
revised by: DR date sent: 21.03.16
2.
supplier: IL/Intas Pharmaceuticals, Ltd technically app. date: 22.03.16 3.
3. HOW TO TAKE PYRIDOSTIGMINE TABLETS The following side effects have been reported:
Follow your doctor’s directions about when and how to • feeling or being sick
take your tablets and look at the label on the carton. • diarrhoea or stomach cramps
Your pharmacist will also help if you are not sure. • you may produce more saliva than usual.

You should try to take your medicine so that it can work when If you are concerned about any of these effects talk
your muscles are needed most, for example, when you get up to your doctor or pharmacist.
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 Reporting of side effects:
your first dose of the day when you get up and other doses If you get any side effects, talk to your doctor or
about 30 to 60 minutes before a meal. pharmacist.This includes any possible side effects
not listed in this leaflet. You can also report side
Swallow the tablets with water or another non-alcoholic drink. effects directly via the Yellow Card Scheme (Website:
If you have difficulty swallowing, you can break the tablets into www.mhra.gov.uk/yellowcard). By reporting side effects you
pieces. can help provide more information on the safety of this
medicine.
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.
For myasthenia gravis: • Do not use Pyridostigmine tablets after the expiry date.
The normal adult dose is ½ to 2 tablets (30 to 120 mg The expiry date refers to the last day of the month. Expiry
pyridostigmine) to be taken five to six times daily or higher date can be found on the bottle label and carton.
doses if needed as recommended by your doctor. • Store your tablets in the original container. Do not store
above 25°C.
If you have myasthenia gravis, the effect of each dose should • Medicines should not be disposed of via wastewater or
last about four hours during the day and about six hours at household waste. Ask your pharmacist how to dispose of
night. medicines no longer required. These measures will help to
protect the environment.
For paralytic ileus and post-operative inability to
pass urine: 6. FURTHER INFORMATION
The normal adult dose is 1 to 4 tablets (60 to 240 mg
What Pyridostigmine tablets contain
pyridostigmine) daily and for children ¼ to 1 tablet (15 to
The name of your medicine is Pyridostigmine 60mg tablets.
60 mg) daily, depending on the needs of the patient.
The active substance in your tablet is pyridostigmine bromide.
For children
Each tablet contains 60mg of pyridostigmine bromide. Other
For children under 6 years the usual dose is ½ tablet (30 mg).
ingredients are silicon dioxide, lactose monohydrate, maize
For children aged 6 to 12 years, the usual starting dose is 1
starch, purified talc and magnesium stearate.
tablet (60 mg). The doctor will then gradually increase the dose
until maximum improvement is seen. In children the total dose
What Pyridostigmine tablets look like and contents of
per day is usually 30 to 360 mg.
the pack
Pyridostigmine 60mg tablets are white to off white, flat faced,
If you take more Pyridostigmine tablets than you should
round, bevelled edges, uncoated tablet with cross scoring on
It is important to stick to the dose on the label of the medicine.
one side and debossed ‘NM’ on the other side.
If you or someone else swallows several of these tablets all
Pyridostigmine 60mg tablets are supplied in Type III amber
together, contact your doctor or nearest hospital emergency
glass bottle with PP child-resistant closure or white opaque
department immediately. Always take any tablets left over with
HDPE bottle, containing HDPE desiccant (silica gel) canister,
you and also the box, as this will allow easier identification of
with a PP child-resistant closure. Each bottle contains 200
the tablets.
tablets.
If you forget to take Pyridostigmine tablets
Marketing Authorisation Holder and Manufacturer
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
Marketing authorisation holder:
make up for a forgotten dose, just carry on as before.
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
Manufacturer:
doctor tells you to stop.
Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon,
Do not change the prescribed dose yourself. If you think the
EX32 8NS, United Kingdom.
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
This leaflet was prepared in 02/2016
medicine.
If you have any further questions on the use of this product ask
your doctor or pharmacist.

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 colours/plates:

1. Black

item no: AAAI8154 dimensions: 160x270mm 2.

3.
print proof no: 2 pharmacode:
4.
origination date: 21.03.16 min pt size: 9pt 5.
originated by: DR 6.
approved for print/date Non Printing Colours
revision date: 06.04.16 Technical Approval
1. Profile
revised by: DR date sent: 21.03.16
2.
supplier: IL/Intas Pharmaceuticals, Ltd technically app. date: 22.03.16 3.