Mestinon

Package Leaflet: Information for the User

Mestinon, 60 mg, Tablets

Pyridostigmine Bromide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 only. 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 effects, including any not listed in this leaflet, please tell your doctor. See section 4.

Table of Contents of the Leaflet

• 1. What is Mestinon and what is it used for
• 2. Important information before taking Mestinon
• 3. How to take Mestinon
• 4. Possible side effects
• 5. How to store Mestinon
• 6. Contents of the pack and other information

1. What is Mestinon and what is it used for

Mestinon is a medicine that inhibits the action of cholinesterase, an enzyme that breaks down acetylcholine, which is responsible for transmitting information from the brain to the muscles. It causes an increase in the amount of acetylcholine and better stimulation of the muscles. Mestinon is used to treat myasthenia (myasthenia gravis), paralytic ileus, and postoperative urinary retention.

2. Important information before taking Mestinon

When not to take Mestinon

Warnings and precautions

Before starting treatment with Mestinon, discuss it with your doctor. You should be particularly careful:

• obstructive airway disease, such as asthma or chronic obstructive pulmonary disease (COPD),
• heart rhythm disorders, such as bradycardia (heart rate below 60 beats per minute) and atrioventricular block,
• hypotension,
• vagotonia (a disorder of neurovegetative regulation characterized by symptoms dependent on vagus nerve stimulation, such as significant slowing of heart rate, lowering of blood pressure),
• peptic ulcer disease of the stomach and/or duodenum,
• epilepsy,
• Parkinson's disease,
• hyperthyroidism,
• renal function disorders,
• if you are taking atropine to avoid side effects of the medicine, as it may mask symptoms of pyridostigmine overdose,

So far, it has not been found that the medicine has a special effect on the elderly. However, these patients are more prone to heart rhythm disorders than young adults. When using high doses of Mestinon in patients with myasthenia, the doctor will consider the need to use atropine or another anticholinergic medicine (these are medicines that counteract the action of Mestinon) to eliminate certain side effects. However, it should be remembered that these medicines, by slowing down bowel movements, may affect the absorption of pyridostigmine. In patients with suspected cholinergic crisis (sudden deterioration of the patient's condition, which manifests as difficult breathing, muscle tremors, slowing of heart rate below 60 beats per minute, narrowing of the pupils) caused by Mestinon overdose, the doctor should consider myasthenic crisis resulting from the exacerbation of myasthenia (sudden deterioration of the patient's condition, which manifests as difficult breathing, increased heart rate above 60 beats per minute, dilation of the pupils). Both conditions are characterized by increased muscle weakness, but they require completely different treatment (myasthenic crisis may require intensification of Mestinon treatment, while cholinergic crisis requires immediate withdrawal of Mestinon and symptomatic treatment, including assisted breathing).

Mestinon and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Inform your doctor if you are taking:

• corticosteroids or immunosuppressive medicines (medicines that suppress the immune system, used, among other things, to prevent transplant rejection), as it may be necessary to reduce the dose of Mestinon; however, the addition of corticosteroids may initially exacerbate myasthenia symptoms;
• methylcellulose and medicines containing methylcellulose as an excipient, as it may lead to inhibition of Mestinon absorption;
• antimuscarinic medicines, such as atropine or hyoscine (medicines that counteract the action of Mestinon, causing pupil dilation, muscle relaxation, and increased heart rate), as it may lead to elimination of the action or disruption of Mestinon absorption;
• non-depolarizing muscle relaxants (e.g., pancuronium and vecuronium), as it may lead to elimination of their action;
• depolarizing muscle relaxants (e.g., suxamethonium), as it may lead to prolongation of their action;
• aminoglycoside antibiotics;
• local anesthetics;
• general anesthetics;
• antiarrhythmic medicines;
• other medicines that disrupt neuromuscular conduction.

You should also inform your doctor if you have had a thymectomy, as it may be necessary to reduce the dose of Mestinon.

Taking Mestinon with food and drink

Mestinon should not be taken with meals, as it delays the onset of its action.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Pupil constriction and accommodation disorders caused by pyridostigmine or related to inadequate treatment of myasthenia may impair vision and reaction, as well as the ability to drive vehicles and operate machines.

Mestinon contains sucrose

The medicine contains sucrose. If you have been diagnosed with intolerance to certain sugars, you should contact your doctor before taking the medicine.

3. How to take Mestinon

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. MyastheniaAdults and children over 12 years: Orally, 30 mg to 180 mg (1/2 to 3 tablets) several times a day, during periods when maximum physical strength is needed (e.g., before getting up, before meals). The medicine usually works for 3 to 4 hours after administration (if taken before bedtime, it works for about 6 hours). The total daily dose is usually 120 mg (2 tablets) to 1200 mg (20 tablets), although higher doses may be necessary. Children under 12 years: The initial dose is 30 mg (1/2 tablet) per day for children under 6 years or 60 mg (1 tablet) per day for children 6-12 years. It should be gradually increased by 15 mg to 30 mg per day until maximum improvement is achieved. The total daily dose is usually 30 mg to 360 mg (1/2 to 6 tablets) per day. Paralytic ileus and postoperative urinary retentionAdults and children over 12 years: Orally, usually 60 mg to 240 mg (1 to 4 tablets) per day. Children under 12 years: Orally, usually 15 mg to 60 mg (1/4 to 1 tablet) per day. The frequency of administration may vary depending on the patient's needs. Dosage in the elderly There are no special recommendations. Renal function disorders Pyridostigmine, the active substance of Mestinon, is excreted mainly in the urine in its unchanged form, so in patients with renal function disorders, it may be necessary to use lower doses, and treatment should be based on adjusting the dose to achieve the desired effect. Hepatic function disorders There are no special recommendations. Method of administration Mestinon should be taken with water (half a glass or a full glass of water).

Overdose of Mestinon

Mestinon can cause a cholinergic crisis. Symptoms of overdose include: abdominal cramps, increased intestinal peristalsis, diarrhea, nausea, and vomiting, increased secretion of bronchial mucus and saliva, bronchospasm, excessive sweating, pupil constriction, muscle cramps, fasciculations (short-term, minor contractions of muscle fiber groups), general weakness, up to muscle paralysis, which can cause respiratory failure and, in extremely severe cases, brain hypoxia, hypotension, up to cardiovascular collapse, and bradycardia (heart rate below 60 beats per minute), up to cardiac arrest. The effect on the central nervous system may manifest as excitement, confusion, slurred speech, nervousness, irritability, visual hallucinations, convulsions, and coma. In case of overdose, Mestinon should be discontinued immediately and a doctor consulted, who will provide appropriate treatment.

Missed dose of Mestinon

If a dose of Mestinon is missed, it should be taken as soon as possible. However, if the time for the next dose is near, the missed dose should be skipped. Do not take a double dose to make up for the missed dose.

Stopping treatment with Mestinon

Stopping treatment with Mestinon may cause exacerbation of the symptoms of the disease for which it is being used (e.g., myasthenia).

4. Possible side effects

Like all medicines, Mestinon can cause side effects, although not everybody gets them. As with all cholinergic medicines, Mestinon may have an undesirable effect on the autonomic nervous system (the part of the nervous system that innervates internal organs). Muscarinic-like side effects may occur, such as nausea, vomiting, diarrhea, abdominal cramps, increased intestinal peristalsis, increased secretion of bronchial mucus and saliva, bradycardia (heart rate below 60 beats per minute), and pupil constriction. The basic nicotinic effect is to cause muscle cramps, fasciculations (short-term, minor contractions of muscle fiber groups), and muscle weakness. The frequency of the following side effects is unknown (cannot be estimated from the available data). Immune system disorders: hypersensitivity to the medicine Nervous system disorders: fainting Eye disorders: pupil constriction, increased lacrimation, accommodation disorders (e.g., blurred vision) Cardiac disorders: heart rhythm disorders (including bradycardia - slow heart rate, tachycardia - fast heart rate, atrioventricular block), Prinzmetal's angina (one of the forms of coronary artery disease) Vascular disorders: sudden flushing, especially of the face, hypotension Respiratory, thoracic, and mediastinal disorders: increased bronchial mucus secretion with accompanying bronchospasm Gastrointestinal disorders: nausea, vomiting, diarrhea, excessive intestinal motility, excessive salivation, abdominal symptoms (discomfort, pain, cramps, etc.) Skin and subcutaneous tissue disorders: rarely (occurs in ≥1/10,000 to <1>

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mestinon

Do not store above 25°C. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the month. The shelf life after opening the bottle is 3 months.

6. Contents of the pack and other information

What Mestinon contains

• The active substance of the medicine is pyridostigmine in the form of bromide. One tablet contains 60 mg of pyridostigmine bromide.
• The other ingredients of the medicine are: colloidal anhydrous silica, corn starch, povidone K-30, potato starch, talc, magnesium stearate, crystalline sucrose (1 tablet contains 161.569 mg of sucrose - see also "Mestinon contains sucrose" in section 2 "Important information before taking Mestinon"), rice starch, arabic gum, solid paraffin, liquid paraffin, talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Mestinon looks like and contents of the pack

Orange glass bottle closed with a PE-HD cap in a cardboard box. 20, 100, or 150 tablets in a bottle.

Marketing authorization holder

Viatris Healthcare Sp. z o.o. ul. Postępu 21B 02-676 Warsaw

Manufacturer

ICN Polfa Rzeszów S.A. ul. Przemysłowa 2 35-959 Rzeszów Poland Labiana Pharmaceuticals, S.L. Corbera de Llobregat, C/Casanova 27-31 Barcelona Spain

For more information, please contact the marketing authorization holder:

Viatris Healthcare Sp. z o.o. tel.: 22 546 64 00 Date of last revision of the leaflet:02/2024