Stigmistanon

Leaflet attached to the packaging: information for the user

Stygmistanon, 60 mg, coated tablets

Pyridostigmine bromide

Read the 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 those not listed in this leaflet, please tell your doctor. See section 4.

Table of contents of the leaflet

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

1. What is Stygmistanon and what is it used for

The active substance of Stygmistanon, pyridostigmine bromide, belongs to the group of cholinesterase inhibitors. These active substances inhibit the breakdown of acetylcholine, a natural neurotransmitter of nerve impulses to muscles. This increases the effect of acetylcholine and improves muscle strength in patients with excessive muscle weakness. Stygmistanon is used in adults, adolescents, and children to treat excessive muscle weakness (myasthenia gravis).

2. Important information before taking Stygmistanon

When not to take Stygmistanon

• if you are allergic to pyridostigmine, bromides, or any of the other ingredients of this medicine (listed in section 6);
• if you have a gastrointestinal or urinary tract obstruction.

Warnings and precautions

Before taking Stygmistanon, discuss it with your doctor. You should be particularly careful when taking Stygmistanon if you have any of the following:

• low blood pressure
• vagotonia (with symptoms such as low blood pressure, slow heart rate, constricted pupils)
• gastric ulcer disease
• gastrointestinal surgery
• epilepsy
• Parkinson's disease
• hyperthyroidism
• renal function disorders

Respiratory diseases If you have a respiratory disease, such as asthma, bronchial spasms, or chronic obstructive pulmonary disease (COPD), taking this medicine may cause dangerous bronchospasm or decreased lung function. For this reason, Stygmistanon should be used with particular caution in the case of these diseases. Heart diseases In the case of heart diseases, such as decompensated heart failure (symptoms at rest), conduction disorders in the heart (atrioventricular block), irregular heart rhythm, such as slow heart rate or recent myocardial infarction, the doctor must carefully weigh the risks and benefits associated with treatment with Stygmistanon. In elderly patients, irregular heart rhythm occurs more frequently than in young adults. Nervous system When taking very high doses of Stygmistanon, it may be necessary to administer atropine or other anticholinergic drugs to specifically counteract the muscarinic action without affecting the nicotinic action. Overdose of this medicine can lead to cholinergic crisis, which is characterized by, among other things, pronounced or increased muscle weakness (see section 3 "Taking a higher dose of Stygmistanon than recommended").

Stygmistanon and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as the medicines you plan to take. Immunosuppressive medicines In the case of taking Stygmistanon together with corticosteroids or immunosuppressive medicines, it may be necessary to reduce the dose. Myasthenia symptoms may initially worsen after corticosteroid administration. Methylcellulose Methylcellulose prevents the absorption of this medicine, so you should avoid taking medicines containing methylcellulose as an additive at the same time as Stygmistanon. Anticholinergic medicines Atropine and scopolamine inhibit the muscarinic action of pyridostigmine bromide. Reduced intestinal motility (movement of food through the digestive system) caused by these medicines may disrupt the absorption of pyridostigmine bromide by the body. Muscle relaxants Pyridostigmine bromide inhibits the action of non-depolarizing muscle relaxants (e.g., pancuronium, vecuronium). The blocking action of depolarizing muscle relaxants (e.g., suxamethonium) may be prolonged by pyridostigmine bromide. Other medicines Antibiotics (e.g., neomycin and kanamycin), local anesthetics, and some general anesthetics, as well as medicines used in arrhythmias and other substances that disrupt neuromuscular transmission, may affect the action of pyridostigmine bromide. Insect repellents You should avoid using the Stygmistanon medicinal product at the same time as applying N,N-diethyl-m-toluamide (DEET) externally over a large area - an active ingredient used in many insect repellents.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Pyridostigmine crosses the placental barrier. Therefore, the medicine should only be taken during pregnancy if the doctor considers it absolutely necessary. In particular, you should avoid high doses. Intravenous administration of cholinesterase inhibitors, a group of substances to which Stygmistanon belongs, may cause premature contractions during pregnancy. The risk of premature birth is particularly high at the end of pregnancy. It is not known whether the risk of premature birth also occurs when taken orally. Breastfeeding Small amounts of pyridostigmine pass into human milk. Based on a very limited number of cases, no effect on newborns/infants has been observed. If treatment with Stygmistanon is necessary, the infant should be monitored for possible effects or breastfeeding should be discontinued. Fertility Animal studies have shown that pyridostigmine has no effect on the fertility of males and females.

Driving and using machines

Taking this medicine may affect your vision and impair your ability to drive. If the underlying disease is not sufficiently controlled or cholinergic effects occur after relative overdose of Stygmistanon (see section 3 "Taking a higher dose of Stygmistanon than recommended"), it may affect your ability to drive or operate machines.

Stygmistanon contains lactose and sucrose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Stygmistanon

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor.

Dosage

The dose will be determined individually based on the severity of the disease and response to treatment. The following dosage recommendations are for guidance only. Adults The recommended dose is 1-3 coated tablets 2-4 times a day (corresponding to 120 to 720 mg of pyridostigmine bromide per day). Elderly patients There are no special dosage recommendations for elderly patients. Patients with kidney disease Pyridostigmine is mainly excreted unchanged by the kidneys. Therefore, patients with kidney disease may require lower doses. The required dose should be determined individually based on the effect of the medicine. Patients with liver function disorders There are no special dosage recommendations for patients with liver function disorders. Thymectomy After surgical removal of the thymus (thymectomy), it may be necessary to reduce the dose. Children and adolescents Children It is recommended to use pharmaceutical forms with a lower active substance content (e.g., tablets containing 10 mg of pyridostigmine bromide). In children under 6 years of age, the initial daily dose is 30 mg of pyridostigmine bromide, and in children between 6 and 12 years of age, the daily dose is 1 coated tablet (corresponding to 60 mg of pyridostigmine bromide per day). The dose can be gradually increased by a maximum of 30 mg of pyridostigmine bromide per day. Usually, the daily dose is 30-360 mg of pyridostigmine bromide (corresponding to a maximum of 6 coated tablets per day). Adolescents There are no special studies available for determining the dose in adolescents. The dose is determined based on the severity of the disease, taking into account the recommended doses for children and adults.

Method of administration

Stygmistanon is intended for oral use. The tablets should be swallowed with a liquid.

Duration of treatment

The doctor will decide on the duration of treatment.

Taking a higher dose of Stygmistanon than recommended

You should immediately inform your doctor. Taking too much of this medicine can cause a cholinergic crisis, which can result in pronounced or increased muscle weakness up to paralysis. If left uncontrolled, there is a risk of life-threatening respiratory paralysis, which in severe cases can lead to respiratory arrest and brain hypoxia. Other accompanying symptoms may include very slow heart rate up to cardiac arrest and periodic accelerated heart rate, decreased blood pressure up to circulatory collapse, dizziness, nausea, and vomiting, involuntary urination, defecation (passing stools) with spasms, diarrhea, increased bronchial secretion, bronchial spasm with possible bronchoconstriction, pulmonary edema, increased tear secretion, and increased salivation, increased nasal secretion, mild to severe sweating, flushing, pupillary constriction, and vision disturbances, occasional muscle spasms, involuntary muscle twitching, and general weakness. Symptoms from the central nervous system may include anxiety, disorientation, slurred speech, nervousness, irritability, and vivid hallucinations, as well as seizures and coma (see section 4 "Possible side effects").

Missing a dose of Stygmistanon

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

Stopping treatment with Stygmistanon

Consult your doctor before stopping treatment with Stygmistanon. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. During treatment with Stygmistanon, the following side effects may occur: Rare(may affect up to 1 in 1,000 people)

• skin rash (usually resolves after discontinuation of the medicine. Do not take medicines containing bromides)

Frequency not known(frequency cannot be estimated from the available data)

• hypersensitivity to the medicine (allergies)
• fainting
• pupillary constriction
• increased tear secretion
• vision disturbances (e.g., blurred vision)
• arrhythmia (e.g., rapid heart rate), accelerated pulse, slow heart rate, conduction disorders in the heart (atrioventricular block), coronary spasm (Prinzmetal's angina)
• flushing
• low blood pressure (hypotension)
• increased bronchial secretion with bronchoconstriction; in people with asthma, breathing problems may occur
• nausea, vomiting, diarrhea
• increased gastrointestinal motility, discomfort in the abdominal cavity (e.g., pain, spasms)
• excessive salivation
• excessive sweating
• intensified, itching rash (hives)
• increased muscle weakness
• decreased muscle tone
• involuntary muscle twitching
• muscle tremors
• muscle spasms
• increased need to urinate

In the case of existing brain damage during treatment with Stygmistanon, atypical mental states, and even psychosis, may occur; existing symptoms may worsen. Side effects are usually dose-dependent. During treatment with Stygmistanon (mainly at oral doses above 150-200 mg of pyridostigmine bromide per day), the following side effects may occur in particular: sweating, increased salivation, increased tear secretion, increased bronchial secretion, nausea, vomiting, diarrhea, abdominal spasms (due to increased gastrointestinal motility), increased urination, muscle tremors, muscle spasms, muscle weakness, and vision disturbances (e.g., difficulty adapting to near or far vision). After taking higher doses (500-600 mg of pyridostigmine bromide per day orally), there may be a slowing of heart rate and the occurrence of undesirable cardiovascular reactions, as well as low blood pressure (see section 3 "Taking a higher dose of Stygmistanon than recommended").

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 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 Stygmistanon

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. There are no special precautions for storage. 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 protect the environment.

6. Contents of the pack and other information

What Stygmistanon contains

The active substance is pyridostigmine bromide. Each tablet contains 60 mg of pyridostigmine bromide. The other ingredients are: Tablet core: colloidal silica, povidone K-30, lactose monohydrate, talc, magnesium stearate, maize starch Tablet coating: sucrose, talc, hypromellose, macrogol 3350, macrogol 4000, medium-chain triglycerides, glycerol monostearate, polyvinyl alcohol, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172)

What Stygmistanon looks like and contents of the pack

The tablets are reddish-brown, round, biconvex, smooth on both sides. Stygmistanon is available in blisters or unit-dose blisters. Pack sizes: Packs containing 50 and 100 coated tablets or 50 x 1 and 100 x 1 coated tablet in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Manufacturer/Importer

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Pharmadox Healthcare Limited

20a Zona Industrijali Ta' Kordin PLA 3000 Paola Malta

To obtain more detailed information, please contact the representative of the marketing authorization holder:

STADA Pharm Sp. z o.o. ul. Krakowiaków 44 02-255 Warsaw Tel. +48 22 737 79 20

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Pyridostigmin AL 60 mg überzogene Tabletten

Date of last revision of the leaflet: