10 mg tablets, 60 mg coated tablets
pyridostigmine bromide

What Mestinon is and what it is used for

Mestinon inhibits the breakdown of the neurotransmitter acetylcholine, which transmits nerve impulses to the muscles. The nerve impulses can then more strongly affect the muscles and make them work better.

Mestinon is used in Myasthenia gravis (severe muscle weakness), lack of motility in the intestine ( tarmatoni ).

What you need to know before using Mestinon

Do not use Mestinon

  • if you are allergic to pyridostigmine bromide or any of the other ingredients of this medicine (listed in section 6).
  • if you have a blocked intestinal passage or urinary tract obstruction.

Warnings and cautions

Talk to your doctor or pharmacist before using Mestinon

  • if you have breathing problems ( asthma or chronic obstructive pulmonary disease (COPD))
  • if you have some heart problems, irregular or slow heart rate , low blood pressure or if you have recently had a blockage of the heart’s small blood vessels
  • if you have a disorder of the underlying nervous system (vagotomy)
  • if you have stomach ulcers
  • if you have epilepsy or parkinsonism (a condition with symptoms similar to Parkinson’s disease )
  • if you have venom goiter
  • if you have impaired kidney function
  • if you have had surgery to remove the thymus (also called thymus )

Other medicines and Mestinon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The treatment effect may be affected if Mestinon is taken at the same time as certain other medicines.

It is especially important to tell your doctor if you are taking the following medicines:

  • drugs that suppress the immune system ( immunosuppressive drugs)
  • drugs containing methylcellulose
  • drugs that have antispasmodic effect on smooth muscle (atropine and hyoscin)
  • muscle relaxants
  • certain medicines for infection (aminoglycoside antibiotics)
  • anesthetics ( local anesthesia and certain general anesthetics)
  • medicines for arrhythmias in the heart

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Data from the treatment of pregnant women are limited. Animal studies have shown effects on the fetus. Mestinon should be used during pregnancy only when needed.

Breast-feeding

Mestinon passes into breast milk. The mother’s need for treatment with Mestinon and the benefits of breastfeeding must be weighed against the potential risks to the baby. Ask your doctor or pharmacist for advice before taking this medicine.

Fertility

Studies have not shown any adverse effects on the ability to conceive.

Driving and using machines

During treatment with Mestinon, side effects such as a drop in blood pressure and visual disturbances may occur. This should be taken into account when sharpened attention is required, for example when driving a car.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Mestinon 10 mg tablets contain lactose and Mestinon 60 mg coated tablets contain sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Mestinon

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor, who adjusts it individually for you.

Never change the prescribed dose yourself without consulting your doctor.

The recommended dose for adults:

Myasthenia gravis: 60-180 mg 3-6 times a day.

Tarmatoni: 60 mg at appropriate intervals, eg every 4 hours.

The effect lasts 3-6 hours depending on the size of the dose.

Mestinon should be taken with plenty of water.

If you take more Mestinon than you should

Patients who have taken too much Mestinon have the following symptoms: respiratory failure, abdominal cramps, muscle contractions in the trachea and intestinal wall, diarrhea, sweating, nausea, vomiting, increased mucus or saliva production, pupillary constriction. Muscle cramps, muscle weakness, paralysis, muscle twitching, and general weakness. Drops in blood pressure, slow heart rate, and cardiac arrest can also occur, as well as effects on the central nervous system such as agitation, confusion, speech disorders, nervousness, irritation, visual hallucinations, seizures, and coma.

Contact your doctor or hospital immediately if you experience any of the listed symptoms.

If you forget to take Mestinon

Do not take a double dose to make up for a forgotten tablet of Mestinon.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Common (may affect up to 1 in 10 people): Pupil reduction, increased tear flow, accommodation problems (difficulty reading fine print and difficulty focusing), eye inflammation, disturbed heart rhythm, increased mucus production in the airways in connection with pre-existing lung disease, difficulty breathing, breathing difficulties nose, nausea, vomiting, diarrhea, increased bowel movements, stomach symptoms (eg unpleasant pain, abdominal cramps), increased salivation and sweat production, muscle weakness, small muscle twitches, cramps, difficulty urinating, loss of appetite

Uncommon (may affect up to 1 in 100 people): Dizziness, restlessness, difficulty falling asleep.

Rare (may affect up to 1 in 1,000 people): Rash, hair loss with long-term treatment.

Very rare (may affect up to 1 in 10,000 people): Heart rhythm disorder, hives

Has been reported (occurs in an unknown number of users): Prinzmetal’s angina (a variant of angina with spasm in the coronary arteries of the heart), flushing, drop in blood pressure, fainting, drug hypersensitivity

How to store Mestinon

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

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

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.

Other information

Content declaration

– The active substance is pyridostigmine bromide

– The other ingredients are:

Tablets 10 mg: lactose monohydrate 30 mg, corn starch, anhydrous colloidal silica, pregelatinized potato starch, talc, magnesium stearate.

Coated tablets 60 mg: sucrose 162 mg, rice starch, talc, acacia, solid paraffin, liquid paraffin, anhydrous colloidal silica, maize starch, povidone, pregelatinized potato starch, magnesium stearate, red and yellow iron oxide (E172).

What the medicine looks like and contents of the pack

Mestinon 10 mg tablets are white, biconvex

Mestinon 60 mg coated tablets are beige, biconvex

Glass jar.

Pack sizes:

Mestinon 10 mg: 250 tablets

Mestinon 60 mg: 150 tablets

Marketing Authorisation Holder:

Meda AB

Box 906

170 09 Solna

Phone: 08-630 19 00

Manufacturer:

ICN Polfa Rzeszów SA

ul. Przemyslowa 2

35-959 Rzeszów

Poland

Labiana Pharmaceuticals, SLU

Casanova 27-31

08757 Corbera de Llobregat, Barcelona

Spain

Muhammad Nadeem

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