Stygmistanon

Patient Information Leaflet: Information for the User

Stygmistanon, 60 mg, film-coated tablets
Pyridostigmini bromidum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Table of Contents

1. What Stygmistanon is and what it is 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 Stygmistanon is and what it is used for

The active substance in Stygmistanon, pyridostigmine bromide, belongs to a group of medicines called cholinesterase inhibitors. These active substances inhibit the breakdown of acetylcholine, a natural transmitter of nerve impulses to muscles. This enhances the action of acetylcholine and results in improved muscle strength in patients with excessive muscle weakness.
Stygmistanon is used in adults, adolescents, and children for the treatment of excessive muscle weakness (myasthenia gravis).

2. Important information before using Stygmistanon

When not to use Stygmistanon

• 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 gastrointestinal or urinary tract obstruction.

Warnings and precautions

Before starting treatment with Stygmistanon, discuss this with your doctor.

Special caution is required when taking Stygmistanon if the patient has any of the following conditions:

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

Respiratory disorders

If the patient has a respiratory disorder such as bronchial asthma, bronchospasm, or chronic obstructive pulmonary disease (COPD), taking this medicine may cause dangerous bronchoconstriction (narrowing of the airways that carry air from the trachea to the lungs) or reduced lung function. Therefore, Stygmistanon should be used with particular caution in such cases.

Heart disorders

In patients with heart conditions such as decompensated heart failure (symptoms at rest), conduction disorders in the heart (atrioventricular block), abnormal heart rhythm such as bradycardia (slow heartbeat), or recent myocardial infarction, the doctor must carefully weigh the risks and benefits of treatment with Stygmistanon.

Abnormal heart rhythms occur more frequently in elderly patients than in younger adults.

Nervous system

When very high doses of Stygmistanon are administered, it may be necessary to give atropine or other anticholinergic drugs to specifically counteract muscarinic effects without affecting nicotinic actions.

Overdosing on this medicine may lead to cholinergic crisis, characterized among others by marked or worsening muscle weakness (see section 3 "Use of a higher than recommended dose of Stygmistanon").

Stygmistanon and other medicines

Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take.

Immunosuppressive medicines (medicines that reduce immune system function)

When Stygmistanon is taken concomitantly with corticosteroids or other immunosuppressive medicines, dose adjustment may be necessary. Myasthenia symptoms may initially worsen after corticosteroid administration.

Methylcellulose

Methylcellulose prevents the absorption of this medicine; therefore, avoid taking medicines containing methylcellulose as an excipient at the same time as Stygmistanon.

Anticholinergic medicines

Atropine and scopolamine inhibit the muscarinic effects of pyridostigmine bromide. Reduced intestinal motility (movement of food through the digestive tract) caused by these medicines may impair the absorption of pyridostigmine bromide.

Medicines causing temporary skeletal muscle relaxation (muscle relaxants)

Pyridostigmine bromide inhibits the action of non-depolarizing muscle relaxants (e.g. pancuronium, vecuronium). The blocking effect of depolarizing muscle relaxants (e.g. suxamethonium) may be prolonged by pyridostigmine bromide.

Other medicines

Aminoglycoside antibiotics (e.g. neomycin, kanamycin), local anaesthetics, certain general anaesthetics, medicines used for cardiac arrhythmias, and other substances interfering with neuromuscular transmission may affect the action of pyridostigmine bromide.

Insect repellents

Avoid using Stygmistanon simultaneously with extensive topical application of N,N-diethyl-m-toluamide (DEET), an active ingredient commonly found in insect repellents.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

Pyridostigmine crosses the placental barrier. Therefore, this medicine should be used during pregnancy only if the physician considers it clearly necessary.

In particular, high doses should be avoided.

Intravenous administration of cholinesterase inhibitors, the group of substances to which Stygmistanon belongs, may cause premature uterine contractions during pregnancy. The risk of premature delivery is especially high towards the end of pregnancy.

It is not known whether this risk also applies to oral administration.

Breastfeeding

Small amounts of pyridostigmine pass into human milk. Based on very limited data, no effects on newborns/infants who are breastfed have been observed. However, if treatment with Stygmistanon is necessary, the infant should be monitored for possible adverse effects or breastfeeding should be discontinued.

Fertility

Animal studies have shown that pyridostigmine has no effect on fertility in males or females.

Driving and operating machinery

This medicine may affect vision and impair the ability to drive or operate machinery.

If the underlying disease is not adequately controlled or cholinergic effects occur due to relative overdose of Stygmistanon (see section 3 "Use of a higher than recommended dose of Stygmistanon"), this may affect the ability to drive or operate machinery.

Stygmistanon contains lactose and sucrose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Stygmistanon

This medicine should always be used as directed by the physician. In case of doubt, consult the
physician.
Dosage
The dose will be individually determined based on the severity of the disease and the response to
treatment. The following dosage recommendations are for guidance only.
Adults
The recommended dose is 1–3 coated tablets 2–4 times daily (corresponding to 120–720 mg of
pyridostigmine bromide per day).
Elderly patients
There are no specific dosage recommendations for elderly patients.
Patients with kidney disease
Pyridostigmine is primarily excreted unchanged by the kidneys. Therefore, patients with kidney
disease may require lower doses. The required dose should be individually adjusted based on the
drug's effect.
Patients with liver function disorders
There are no specific dosage recommendations for patients with liver function disorders.
Thymectomy
Following surgical removal of the thymus gland (thymectomy), a dose reduction may be necessary.
Children and adolescents
Children
In children, pharmaceutical forms with lower active substance content are recommended (e.g.
tablets containing 10 mg pyridostigmine bromide).
In children under 6 years of age, an initial daily dose of up to 30 mg pyridostigmine bromide is
recommended; in children aged 6–12 years, a daily dose of 1 coated tablet is recommended (corresponding to 60 mg pyridostigmine bromide/day).
The dose may be gradually increased by up to 30 mg pyridostigmine bromide per day.
Typically, the daily dose ranges from 30–360 mg pyridostigmine bromide (corresponding to up to 6
coated tablets per day).
Adolescents
No specific studies are available regarding dose determination in adolescents. The dose should be
determined based on disease severity, taking into account the recommended doses for children and
adults.
Method of administration
Stygmistanon is intended for oral use.
Tablets should be swallowed with liquid.
Duration of treatment
The physician will decide on the duration of treatment.
Taking more than the recommended dose of Stygmistanon
Inform the physician immediately.
Taking an excessive dose of this medicine may cause a cholinergic crisis, which may result in
pronounced or increased muscle weakness up to paralysis. If not controlled, there is a risk of life-threatening respiratory paralysis, which in particularly severe cases may lead to respiratory arrest and lack of oxygen in the brain.
Other accompanying symptoms may occur, such as very slow heartbeat up to cardiac arrest and
episodic rapid heartbeat, drop in blood pressure up to circulatory collapse, dizziness, nausea and
vomiting, involuntary urination, defecation (passing stool) with cramps, diarrhea, increased bronchial
secretion, bronchial muscle contraction with possible airway narrowing, fluid in the lungs (pulmonary
edema), increased tear secretion and increased salivation, increased nasal secretion, mild to severe
sweating, skin flushing, pupil constriction and visual disturbances, occasional muscle cramps,
involuntary muscle twitching, and general weakness.
Symptoms affecting the central nervous system may include restlessness, 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 missed dose.
Stopping Stygmistanon
Contact the physician before stopping treatment with Stygmistanon.
If you have any questions about using this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur during treatment with Stygmistanon:
Rare (may affect up to 1 in 1,000 people)

• Skin rash (usually resolves after discontinuation of the medicine. Medicines containing bromides should not be used)

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

• Hypersensitivity to the medicine (allergies)
• Fainting
• Constriction of the pupils
• Increased tear secretion
• Visual disturbances (e.g. blurred vision)
• Arrhythmia (e.g. rapid heartbeat), increased pulse, slowed heartbeat, cardiac conduction disorders (atrioventricular block), coronary artery spasm (Prinzmetal's angina)
• Flushing
• Low blood pressure (hypotension)
• Increased bronchial secretion associated with airway constriction; breathing difficulties may occur in patients with asthma
• Nausea, vomiting, diarrhoea
• Increased gastrointestinal motility, abdominal discomfort (e.g. pain, cramps)
• Excessive salivation
• Excessive sweating
• Intensified, itchy rash (urticaria)
• Increased muscle weakness
• Reduced muscle tone
• Involuntary muscle twitching
• Muscle tremor
• Muscle cramps
• Increased need to urinate

In patients with pre-existing brain damage, unusual mental states, and even psychosis, may occur during treatment with Stygmistanon; existing symptoms may worsen.
Adverse reactions are usually dose-dependent.
During treatment with Stygmistanon (particularly at oral doses exceeding 150–200 mg of pyridostigmine bromide/day), the following may occur in particular: sweating, increased salivation, increased tear secretion, increased bronchial secretion, nausea, vomiting, diarrhoea, abdominal cramps (due to increased gastrointestinal motility), increased frequency of urination, muscle tremor, muscle cramps, muscle weakness, and disturbances in eye accommodation for near or distant vision.

After higher doses (500–600 mg of pyridostigmine bromide/day orally), slowing of the heart rate and cardiovascular adverse reactions, as well as low blood pressure, may occur (see section 3 "Use of a higher than recommended dose of Stygmistanon").

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Stygmistanon

Keep the medicine out of the 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 stated month.
No special storage conditions required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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 anhydrous silica, povidone K-30, lactose monohydrate, talc, magnesium stearate, pregelatinized 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 tablets are available in blisters or in single-dose blister packs.
Pack sizes:
Packages 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 Authorisation 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

For further information, contact the Marketing Authorisation Holder:
STADA Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel. +48 22 737 79 20

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Pyridostigmin AL 60 mg überzogene Tabletten