Mestinon

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Mestinon

60 mg, chewable tablets

Pyridostigmine bromide

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

When not to use Mestinon

• if the patient is allergic to pyridostigmine, bromides, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has mechanical obstruction of the gastrointestinal or urinary tract.

Warnings and precautions

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

• if the patient has:
• obstructive respiratory 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 a predominance of symptoms dependent on vagus nerve stimulation, such as significant slowing of heart rate, lowering of blood pressure),
• gastric or duodenal ulcer disease,
• epilepsy,
• Parkinson's disease,
• hyperthyroidism,
• renal function disorders,
• if the patient has recently had coronary artery occlusion,
• when the patient is taking atropine to avoid side effects of the medicine, as it may mask the symptoms of pyridostigmine overdose,
• if the doctor has previously diagnosed the patient with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.

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 effects 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 worsening of the patient's condition, which manifests as difficulty breathing, muscle twitching, heart rate below 60 beats per minute, pupil constriction) caused by an overdose of Mestinon, the doctor should consider a myasthenic crisis resulting from the exacerbation of myasthenia (sudden worsening of the patient's condition, which manifests as difficulty breathing, increased heart rate above 60 beats per minute, pupil dilation). 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).

• immediately discontinue Mestinon and provide symptomatic treatment, including assisted breathing.

Mestinon and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You should 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, although the use of additional new corticosteroids may initially exacerbate myasthenia symptoms;
• methylcellulose and medicines containing methylcellulose as an excipient, as this may lead to inhibition of Mestinon absorption;
• antimuscarinic medicines, such as atropine or hyoscine (medicines that counteract the effects of Mestinon, causing pupil dilation, muscle relaxation, and increased heart rate), as this may lead to elimination of the effect or disruption of Mestinon absorption;
• non-depolarizing muscle relaxants (e.g., pancuronium and vecuronium), as this may lead to elimination of their effect;
• depolarizing muscle relaxants (e.g., suxamethonium), as this may lead to prolonged 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.

Using Mestinon with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using 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, consequently, reaction ability and 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 this medicine.

3. How to use Mestinon

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor.
Myasthenia
Adults and children over 12 years old:
Orally, 30 mg to 180 mg (½ 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 going to bed, 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 old:
The initial dose is 30 mg (½ tablet) per day for children under 6 years old or 60 mg (1 tablet) per day for children between 6 and 12 years old. 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 (½ to 6 tablets) per day.
Paralytic ileus and postoperative urinary retention
Adults and children over 12 years old:
Orally, usually 60 mg to 240 mg (1 to 4 tablets) per day.
Children under 12 years old:
Orally, usually 15 mg to 60 mg (¼ to 1 tablet) per day.
The frequency of administration may vary depending on the patient's needs.
Dosing in the elderly
There are no special recommendations.
Renal impairment
Pyridostigmine, the active substance of Mestinon, is mainly excreted in the urine in its unchanged form, so in patients with renal impairment, it may be necessary to use lower doses, and treatment should be based on adjusting the dose to achieve the desired effect.
Hepatic impairment
There are no special recommendations.
Method of administration
Mestinon should be taken with water (half a glass or a full glass of water).

Using a higher dose of Mestinon than recommended

Mestinon may cause a cholinergic crisis. Symptoms of overdose include: abdominal cramps, increased intestinal peristalsis, diarrhea, excessive sweating, 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.

Missing a dose of Mestinon

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

Stopping Mestinon treatment

Stopping Mestinon treatment may cause worsening 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 unwanted effect on the autonomic nervous system (the part of the nervous system that innervates the 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 determined from 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: rare (occurs in ≥1/10,000 to <1>rash (usually resolves soon after withdrawal of the medicine. Medicines containing bromides should not be used again); unknown frequency: excessive sweating, urticaria.
Musculoskeletal and connective tissue disorders: increased muscle weakness, fasciculations (short-term, minor contractions of muscle fiber groups), tremors, and muscle cramps or decreased muscle tone.
Renal and urinary disorders: sudden urge to urinate.
Since these symptoms may indicate a cholinergic crisis, you should immediately inform your doctor to determine the correct diagnosis.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mestinon

Store in a temperature below 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 packaging. The expiry date refers to the last day of the month.
The shelf life after opening the bottle is 90 days.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Mestinon contains

• The active substance of Mestinon is pyridostigmine in the form of pyridostigmine bromide (Pyridostigmini bromidum). 1 chewable 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,
• coating: sucrose, rice starch, gum arabic, solid paraffin, liquid paraffin, talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Mestinon looks like and contents of the pack

A brown glass bottle closed with an HDPE cap, in a cardboard box.
The packaging contains 20 or 100 chewable tablets in a bottle.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Portugal, the country of export:

BGP Products, Unipessoal Lda.
Av. D. João II, Edifício Atlantis, nº 44C - 7.3 e 7.4
1990-095 Lisbon, Portugal

Manufacturer:

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów, Poland
Labiana Pharmaceuticals S.L.
C/ Casanova, 27-31 - Corbera de Llobregat
08757 Barcelona, Spain

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Portugal, the country of export:4328282
8987701

Parallel import authorization number: 54/23 Date of approval of the leaflet: 23.03.2023