Pyridostigmine Bromide 60 Mg Tablets
PATIENT INFORMATION LEAFLET Mestinon® 60 mg Tablets
(Pyridostigmine bromide)
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.
Mestinon 60 mg Tablets will be referred to throughout this leaflet as Mestinon.
In this leaflet:
1. What Mestinon is and what it is used for
2. Before you take Mestinon
3. How to take Mestinon
4. Possible side effects
5. How to store Mestinon
6. Further information
1. WHAT MESTINON IS AND WHAT IT IS USED FOR
Mestinon is 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 belongs 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 is also used to treat some rare forms of constipation (paralytic ileus) and inability to pass urine after an operation.
2. BEFORE YOU TAKE MESTINON Do not take Mestinon if you:
• Are allergic (hypersensitive) to pyridostigmine, bromides or any of the other ingredients of Mestinon (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 is only for some types of constipation and inability to pass urine (see Section 1)
Take special care with Mestinon
Before treatment with Mestinon, 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.
There is no evidence to suggest that Mestinon has 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.
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. Mestinon can stop the effect of some medicines used to relax muscles during surgery (e.g. pancuronium, vencuronium).
Mestinon 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 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
Mestinon contains 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.
3. HOW TO TAKE MESTINON
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.
The dose will depend on your illness, your needs and on your age as follows:
For myasthenia gravis:
• The usual adult dose is % to 2 tablets (30 to 120 mg Mestinon) to be taken five to six times daily, or higher doses if needed, as recommended by your doctor.
• For children under 6 years, the usual dose is % 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) daily and for children % to 1 tablet (15 to 60 mg) daily, depending on the needs of the patient.
If you take more Mestinon 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.
If you forget to take Mestinon
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mestinon can cause side effects, although not everybody gets them.
Possible side effects with Mestinon:
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
• excessive sweating
• muscle weakness and twitching, shaking, muscle cramps
• sudden, compelling urge to urinate.
• rash
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 MESTINON
Keep Mestinon out of the sight and reach of children.
Do not store above 25°C.
Store in the original package.
Protect from light and moisture.
Keep container tightly closed.
Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of the month stated on the carton.
If your medicine become discoloured or deteriorates then seek medical advice from a doctor or pharmacist
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 contains
The active substance of Mestinon is pyridostigmine bromide.
Each tablet contains: 60 mg pyridostigmine bromide.
The other excipients are lactose, silicic acid, talc, magnesium stearate, potato starch and maize starch.
What Mestinon looks like and contents of the pack The tablets are white to off-white, round, biplane, bevel-edged tablets imprinted with ‘V M60' across one face and with two break marks forming a cross on the other side.
The tablets come in packs of 100 and 200.
A desiccant is enclosed in the bottles
Manufacturer: Labiana Pharmaceuticals S.L.U., Casanova, 27-31; -Corbera de Llobregat (Barcelona)
Procured from within the EU by
Product Licence holder: Ecosse Pharmaceuticals Ltd., 3 Young Place, East Kilbride, G75 0TD.
Re-packaged by Munro Wholesale Medical Supplies Ltd., 3 Young Place, East Kilbride, G75 0TD.
PL 19065/0447 [^^mI
This leaflet was revised: 24/10/2014
E0447L-1
Mestinon® is a registered trademark of Meda AB
PATIENT INFORMATION LEAFLET Pyridostigmine bromide® 60 mg Tablets
(Pyridostigmine bromide)
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.
Pyridostigmine bromide 60 mg Tablets will be referred to throughout this leaflet as Pyridostigmine bromide
In this leaflet:
1. What Pyridostigmine bromide is and what it is used for
2. Before you take Pyridostigmine bromide
3. How to take Pyridostigmine bromide
4. Possible side effects
5. How to store Pyridostigmine bromide
6. Further information
1. WHAT PYRIDOSTIGMINE BROMIDE IS AND WHAT IT IS USED FOR
Pyridostigmine bromide is 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.
Pyridostigmine bromide belongs 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.
Pyridostigmine bromide is also used to treat some rare forms of constipation (paralytic ileus) and inability to pass urine after an operation.
2. BEFORE YOU TAKE PYRIDOSTIGMINE BROMIDE Do not take Pyridostigmine bromide if you:
• Are allergic (hypersensitive) to pyridostigmine, bromides or any of the other ingredients of Pyridostigmine bromide (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 Pyridostigmine bromide is only for some types of constipation and inability to pass urine (see Section 1)
Take special care with Pyridostigmine bromide
Before treatment with Pyridostigmine bromide, 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.
There is no evidence to suggest that Pyridostigmine bromide has 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.
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 Pyridostigmine bromide. Pyridostigmine bromide can stop the effect of some medicines used to relax muscles during surgery (e.g. pancuronium, vencuronium). Pyridostigmine bromide 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 Pyridostigmine bromide passes into breast milk in small amounts.
Your doctor will then decide if you can take this medicine.
Driving and using machines
Pyridostigmine bromide 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 Pyridostigmine bromide
Pyridostigmine bromide contains 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.
3. HOW TO TAKE PYRIDOSTIGMINE BROMIDE
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 Pyridostigmine bromide.
The dose will depend on your illness, your needs and on your age as follows:
For myasthenia gravis:
• The usual adult dose is % to 2 tablets (30 to 120 mg Pyridostigmine bromide) to be taken five to six times daily, or higher doses if needed, as recommended by your doctor.
• For children under 6 years, the usual dose is % 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 Pyridostigmine bromide) daily and for children % to 1 tablet (15 to 60 mg) daily, depending on the needs of the patient.
If you take more Pyridostigmine bromide 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.
If you forget to take Pyridostigmine bromide
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pyridostigmine bromide can cause side effects, although not everybody gets them.
Possible side effects with Pyridostigmine bromide:
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
• excessive sweating
• muscle weakness and twitching, shaking, muscle cramps
• sudden, compelling urge to urinate.
• rash
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 PYRIDOSTIGMINE BROMIDE
Keep Pyridostigmine bromide out of the sight and reach of children.
Do not store above 25°C.
Store in the original package.
Protect from light and moisture.
Keep container tightly closed.
Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of the month stated on the carton.
If your medicine become discoloured or deteriorates then seek medical advice from a doctor or pharmacist
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 Pyridostigmine bromide contains
The active substance of Pyridostigmine bromide is pyridostigmine bromide.
Each tablet contains: 60 mg pyridostigmine bromide.
The other excipients are lactose, silicic acid, talc, magnesium stearate, potato starch and maize starch.
What Pyridostigmine bromide looks like and contents of the pack
The tablets are white to off-white, round, biplane, bevel-edged tablets imprinted with ‘V M60' across one face and with two break marks forming a cross on the other side.
The tablets come in packs of 100 and 200.
A desiccant is enclosed in the bottles.
Manufacturer: Labiana Pharmaceuticals S.L.U., Casanova, 27-31; -Corbera de Llobregat (Barcelona)
Procured from within the EU by
Product Licence holder: Ecosse Pharmaceuticals Ltd., 3 Young Place, East Kilbride, G75 0TD.
Re-packaged by Munro Wholesale Medical Supplies Ltd., 3 Young Place, East Kilbride, G75 0TD.
PL 19065/0447 [POM]
This leaflet was revised: 24/10/2014
E0447(pb)-1