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PYRIDOSTIGMINE BROMIDE 60MG TABLETS

Active substance(s): PYRIDOSTIGMINE BROMIDE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

MESTINON® 60mg TABLETS
PYRIDOSTIGMINE BROMIDE 60mg TABLETS
(Pyridostigmine bromide)
Patient Information Leaflet

In this leaflet:
1. What Mestinon Tablets are and what they are used for
2. Before you take Mestinon Tablets
3. How to take Mestinon Tablets
4. Possible side effects
5. How to store Mestinon Tablets
6. Further information
1. What Mestinon Tablets are and what they are used for
Mestinon Tablets are used for the treatment of myasthenia gravis. In patients who suffer from myasthenia
gravis the muscles quickly become tired and weak and, in severe cases, the muscles may become paralysed.
Myasthenia gravis is caused by excessive activity in the body of a protein called cholinesterase.
Mestinon Tablets belong to a group of medicines known as cholinesterase inhibitors.
Cholinesterase inhibitors stop the excessive activity of cholinesterase and in this way help muscles to work
properly.
Mestinon Tablets are also used to treat some rare forms of constipation (paralytic ileus) and inability to pass
urine after an operation.

WARNING!

There is no evidence to suggest that Mestinon Tablets have any special effects on elderly patients.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.

UK PIL DATED JUNE 2014
REPORTING OF SIDE EFFECTS

CODE:

06464/2994A

TVT CHECKED

This is extremely important, as using more than one medicine at the same time can strengthen or weaken
the effect of the medicines. In particular, tell your doctor if you are taking any of the following medicines:
• Medicines known as steroids or other immunosuppressant medicines.
• Medicines known as antimuscarinics (e.g. atropine, hyoscine).
• Medicines containing methylcellulose
• Antibiotics
• Medicines to treat an irregular heart beat
• Other medicines that interfere with transmission between nerves and muscles
If you are going to have surgery
Tell your doctor that you are taking Mestinon Tablets. Mestinon Tablets can stop the effect of some medicines
used to relax muscles during surgery (e.g. pancuronium, vencuronium).
Mestinon Tablets can also prolong the effect of other muscle relaxants (e.g. suxamethonium).
Pregnancy and breast-feeding
Tell your doctor before you start treatment if you:
• Are pregnant, if you think you are pregnant, or if you intend to become pregnant.
• Are breast-feeding, as Mestinon passes into breast milk in small amounts.
Your doctor will then decide if you can take this medicine.
Driving and using machines
Mestinon Tablets may reduce the sharpness of your eyesight and therefore your ability to drive or use
machines. Do not drive or operate machines if this medicine affects your ability to see clearly.
Important information about some of the ingredients of Mestinon Tablets
Mestinon Tablets contain lactose. Therefore, if you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.

Colour
Swatch

Black

WARNING!

DATE:
DATE:

Take special care with Mestinon Tablets
Before treatment with Mestinon Tablets, tell your doctor if you:
• Suffer from asthma or have other chest problems such as wheeziness, difficulty in breathing or
chronic cough.
• Have recently had coronary obstruction (heart attack), have a slow heart beat or any other heart
condition.
• Have low blood pressure.
• Have a stomach ulcer.
• Have epilepsy.
• Have Parkinson’s disease.
• Have kidney problems.
• Suffer from a condition called vagotonia (this is a condition where overactivity of the vagus nerve
causes symptoms such as slow heart rate, low blood pressure, constipation, sweating and painful
muscle spasms).
• Have an overactive thyroid gland
• Have had an operation to remove your thymus gland.

11/08/14
DATE OF PROOF:

ARTWORKER:

DT

CUSTOMER
APPROVED:
CUSTOMER: Waymade
PRODUCT: Mestinon 60mg tabs

PRE-PRESS NO.:

05-0440

Q.A.
APPROVED:

2. Before you take Mestinon Tablets
Do not take Mestinon Tablets if you:
• Are allergic (hypersensitive) to pyridostigmine, bromides or any of the other ingredients of Mestinon
Tablets (these are listed in section 6, ˝Further Information˝).
• Are constipated or cannot urinate, unless your doctor has told you to use this medicine. This is
because Mestinon Tablets are only for some types of constipation and inability to pass urine (see
Section 1).

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

This product is known as the above names but will be referred to as Mestinon Tablets throughout this leaflet.
Please read all of this leaflet carefully before you start taking 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 you experience any side effect and this becomes serious, tell your doctor or pharmacist.

PROOF HISTORY:
v.2 - waymade - 11/08/14

Leaflet Flat Size = 148 x 317

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

3. How to take Mestinon Tablets
Swallow the tablets with water or another non-alcoholic drink. If you have difficulty swallowing, you can break
the tablets into pieces.
You should check with your doctor or pharmacist if you are not sure how to take Mestinon Tablets.

For children under 6 years, the usual dose is ½ a 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.

The tablets take 30 to 60 minutes to start working after you have taken them.
The effect of each dose should last about four hours during the day and about six hours at night.
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 about 30 to 60 minutes before a meal.
For paralytic ileus (constipation) and post-operative inability to pass urine:
• The usual adult dose is 1 to 4 tablets (60 to 240 mg Mestinon Tablets) daily and for children ¼ to 1
tablet (15 to 60 mg) daily, depending on the needs of the patient.
If you take more Mestinon Tablets than you should
If you take too many tablets or someone else accidentally takes your medicine, contact your doctor,
pharmacist or nearest hospital straight away.

WARNING!

If you forget to take Mestinon Tablets
If you forget to take one of your daily doses, take it as soon as you remember, and take the next dose at the
normal time. Do not take a double dose to make up for a forgotten dose. If you miss more than a single dose,
you should contact your doctor for advice.

Possible side effects with Mestinon Tablets
Side effects of unknown frequency:
• visual disturbance, producing more tears than usual
• an irregular heart beat, heart block, low blood pressure, fainting
• producing more phlegm than usual combined with constriction of the airways
• feeling sick, vomiting, diarrhoea, stomach cramps, producing more saliva than usual
• rash
• excessive sweating
• muscle weakness and twitching, shaking, muscle cramps
• sudden, compelling urge to urinate.

DATE:

CUSTOMER
APPROVED:

4. Possible side effects
Like all medicines, Mestinon Tablets can cause side effects, although not everybody gets them.









TVT CHECKED




5. How to store Mestinon Tablets
Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package.
Keep the bottle tightly closed.
Protect from light.
Protect from moisture.
Do not use Mestinon Tablets after the expiry date which is stated on the bottle label and outer carton
after the text ˝EXP˝. The expiry date refers to the last day of that month.
If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the
advice of your doctor or pharmacist who will tell you what to do.
Medicines must 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.

6. Further information
What Mestinon Tablets contain
Each tablet contains 60 mg pyridostigmine bromide.

UK PIL DATED JUNE 2014
REPORTING OF SIDE EFFECTS

06464/2994A

Other ingredients: lactose, silicic acid, maize starch, talc, magnesium stearate and potato starch.

CODE:

DATE:
11/08/14

DT
ARTWORKER:

DATE OF PROOF:

Q.A.
APPROVED:
CUSTOMER: Waymade
PRODUCT: Mestinon 60mg tabs

PRE-PRESS NO.:

05-0440

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.

What Mestinon Tablets look like and contents of the pack
''V ''
White to off-white, round, biplanar, bevel-edged tablets imprinted with
on one side and with two break
M60
marks forming a cross on the other.
Mestinon Tablets are available in pack sizes of 100 tablets.
The pack also contains a desiccant.
POM

PL No: 06464/2994

This product is manufactured by Labiana Pharmaceuticals S.L.U., Casanova, 27-31; 08757-Corbera de
Llobregat, Barcelona, Spain and is procured from within the EU and repackaged by the Product Licence
holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 11.08.2014
Mestinon® is a registered trademark of Valeant Pharmaceuticals

Colour
Swatch

Black

WARNING!



WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

The dose will depend on your illness, your needs and on your age as follows:
For myasthenia gravis:
• The usual adult dose is ½ to 2 tablets (30 to 120 mg Mestinon Tablets) to be taken five to six times
daily, or higher doses if needed, as recommended by your doctor.

PROOF HISTORY:
v.2 - waymade - 11/08/14

Leaflet Flat Size = 148 x 317

27mm

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.

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