Tuesday, October 11, 2016

Mestinon 60 mg Tablets






Mestinon 60 mg Tablets



Pyridostigmine (as bromide)




Please read this leaflet carefully before you start to take your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.




What Is Mestinon?


Mestinon contains the active ingredient pyridostigmine, which belongs to a group of medicines known as cholinesterase inhibitors. It helps messages to pass from the brain to the muscles so that the muscles will work properly.


Each white tablet contains 60 mg of pyridostigmine as pyridostigmine bromide and the other ingredients colloidal hydrated silica, maize starch, lactose monohydrate, talc and magnesium stearate.


The tablets are scored on one side so that they can be broken into halves or quarters and the words 'v' and 'M60' are imprinted on the other side.


The tablets come in packs of 200.



The Marketing Authorisation Holder is



Valeant Pharmaceuticals Ltd.

Cedarwood

Chineham Business Park

Basingstoke

Hampshire

RG24 8WD

UK




The medicine is manufactured by



Labiana Pharmaceuticals S.L.

Casanova 27-31

08757 - Corbera de Llobregat (Barcelona)

Spain





What Is Mestinon Used For?


Mestinon is used for the treatment of myasthenia gravis, a condition that prevents 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.


This medicine is also used to treat some rare forms of constipation (paralytic ileus) and inability to pass urine after an operation.




When Must Mestinon Not Be Used?


If you are allergic to any of the substances it contains or to any medicines containing bromide.


If you are constipated or cannot urinate, unless your doctor has told you to use this medicine.



When Should You Be Extra Careful While Taking Mestinon?


Make sure your doctor knows 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.

  • Are taking 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 medicines.

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


  • There is no evidence to suggest that Mestinon has any special effects on elderly patients. However, tell your doctor if you are elderly and have any heart condition.

  • As the product contains 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.



May Mestinon Be Used During Pregnancy Or While Breastfeeding?


You must tell your doctor if you are pregnant, if you think you are pregnant, or if you intend to become pregnant. Your doctor will then decide if you can take this medicine.


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





How Should Mestinon Be Taken?


  • Always take the tablets exactly as your doctor tells you to. The dose will depend on your illness and on your age as follows:


  • For myasthenia gravis: The normal adult dose is half 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 half 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.
    For paralytic ileus and post-operative inability to pass urine: The normal adult dose is 1 to 4 tablets (60 to 240 mg Mestinon) daily and for children quarter to 1 tablet (15 to 60 mg) daily, depending on the needs of the patient.

  • 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.

  • If you have myasthenia gravis, the effect of each dose should last about four hours during the day and about six hours at night.

  • Swallow the tablets with water or another non-alcoholic drink. If you have difficulty swallowing, you can break the tablets into pieces.

  • 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 two doses together. If you miss more than a single dose, you should contact your doctor for advice.

  • 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 take too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.



What Are The Possible Unwanted Effects Of Mestinon?


It is possible that unwanted effects will occur during treatment, even when this medicine is used as directed. Feeling or being sick, diarrhoea or stomach cramps may occur and you may produce more saliva than usual.


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




How Should Mestinon Be Stored?


  • Desiccant enclosed.
    Store in the original package. Keep the bottle tightly closed.
    Do not store above 25ÂșC.

  • Keep this medicine out of reach and sight of children.

  • This medicine must not be used after the date (EXP) printed on the bottle and carton. Return any left over medicine to your pharmacist. Only keep it if your doctor tells you to.

  • REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.



Further Information


You can get more information on this medicine from your doctor or pharmacist.



The medicine is distributed in Ireland by



Allphar Services Ltd

Belgard Road

Tallaght

Dublin 24





DATE OF PREPARATION/LAST REVIEW


December 2007



33010E0UE-C00






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