Prospecto: information for the user

Mestinon 60 mg tablets

Piridostigmina, bromide

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.

If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What Mestinon is and for what it is used

2.What you need to know before starting to take Mestinon

3.How to take Mestinon

4.Possible adverse effects

5.Storage of Mestinon

6.Contents of the package and additional information

Mestinon belongs to a group of medications known as cholinesterase inhibitors.It helpsstimuli to be transferred from the brain to the muscles.In this way, the muscle can work in a correct manner.

Mestinon is used for the treatment of:

Adults and children:

• Myasthenia gravis (a disease of the immune system that produces muscle weakness).

Adults:

• Paralytic ileus (intestinal obstruction caused by paralysis of the intestinal wall).

Do not take Mestinon

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• if you are constipated or unable to urinate, unless your doctor advises you to do so.

Warnings and precautions

Consult your doctor before starting to take Mestinon:

• if you suffer from asthma or chronic obstructive pulmonary disease (COPD).
• if you have any cardiovascular disease such as bradycardia, atrioventricular block, or coronary occlusion.
• if you have low blood pressure.
• if you have vagotonia (a condition in which the activity of the vagus nerve produces symptoms such as a slow heart rate, low blood pressure, constipation, sweating, and painful muscle spasms).
• if you have a stomach ulcer.
• if you have epilepsy or Parkinson's disease.
• if you have hyperthyroidism (an increase in the function of the thyroid gland).
• if you have kidney problems.
• if you have had a thymus gland removal operation. In this case, your doctor may need to reduce the dose of Mestinon.

Use of Mestinon with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is especially important to inform your doctor if you are taking one of the following medications, as the combined use of both medications may make one of them ineffective:

• immunosuppressive medications (used to suppress the immune system)
• corticosteroids
• medications containing methylcellulose as a component
• antimuscarinic medications (used to treat respiratory disorders, such as atropine and hyoscyamine)
• muscle relaxants, such as pancuronium or vecuronium. Pyridostigmine may prolong the effect of depolarizing muscle relaxants (e.g., suxamethonium).
• aminoglycoside antibiotics
• local anesthetics and some general anesthetics
• antiarrhythmic medications (used to treat heart rhythm disorders)

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

The safety of pyridostigmine in pregnant women has not been established. If you are pregnant, your doctor will prescribe this medication if they consider that the benefits of treatment outweigh the possible risks to you and your child.

Breastfeeding:

Studies indicate that only small amounts pass into breast milk. While taking this medication during breastfeeding, your doctor will monitor any possible effects on the baby.

Fertility:

The safety of pyridostigmine in human fertility has not been established. Research in rats has not suggested any negative effects on reproduction.

Driving and operating machinery

Mestinon may impair vision and reaction time, as well as the ability to drive and operate machinery.

This medication contains lactose,if your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

This medication should be taken in such a way that it works when it is needed most, for example when getting up and at mealtime. The tablets take about 30 minutes to start taking effect after they have been taken, so you should try to take the first dose of the day when you get up and other doses 30 minutes before mealtime.

Swallow the tablets with a glass of water. If you have difficulty swallowing, you can break the tablets into smaller pieces.

The tablet can be divided into equal doses.

The recommended dose will depend on the disease you have:

Myasthenia Gravis

Adults

The usual dose is half to 3 tablets (30-180 mg) per dose, administered 2-4 times a day. The total daily dose is usually 2 to 20 tablets (120-1200 mg). However, your doctor may evaluate a higher dose if you have myasthenia gravis. The effect of each dose can last from 3 to 4 hours during the day, and 6 hours at night, as physical activity is reduced.

Use in children and adolescents

Children under 6 years: The initial dose is half a tablet (30 mg) of Mestinon.

Children from 6 to 12 years: The initial dose is 1 tablet (60 mg) of Mestinon.

Your doctor will gradually increase the dose, evaluating your response in intervals of 15-30 mg per day. The total daily dose is usually half to 6 tablets (30-360 mg).

Paralytic Ileus

Adults

The usual dose is 1 to 4 tablets (60-240 mg) per day.

The frequency of these doses may vary depending on the patient's needs.

Patients with kidney disease

If you have any kidney disease, your doctor will prescribe the appropriate dose.

If you take more Mestinon than you should

It is essential to take only the dose that your doctor has indicated.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Telephone 91 562 04 20, indicating the medication and the amount ingested.

In cases of intoxication, abdominal cramps, increased intestinal movement, diarrhea, nausea, and vomiting, increased bronchial and salivary secretions, bronchial spasm, increased sweating, and pupil constriction (miosis) may appear.

Additionally, muscle cramps, fasciculations (light muscle contractions), and general weakness up to paralysis may occur; cardiac rhythm disturbances that may lead to cardiac arrest, and a drop in blood pressure that may lead to cardiovascular collapse, lack of oxygen when breathing, and in the brain.

Agitation, confusion, difficulty speaking, nervousness, irritability, hallucinations, convulsions, and coma may also appear.

In these cases, it is essential to stop treatment with Mestinon and go to the nearest hospital immediately.

If you forgot to take Mestinon

Do not take a double dose to compensate for the missed doses.

If you have forgotten to take a dose, take it as soon as you remember. If it is close to the time of the next dose, do not take it and continue as usual. If you have forgotten several doses, consult your doctor.

If you interrupt treatment with Mestinon

It is essential to continue taking the treatment until your doctor tells you to stop.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following adverse effects have been observed with the use of Mestinon. With any of these symptoms, you should inform your doctor immediately, as they may be an indication of a crisis.

Rare adverse effects (may affect up to 1 in 1000 patients):

• Skin rash (usually disappears shortly after stopping the medication).

Adverse effects of unknown frequency (cannot be estimated from available data):

• Medication hypersensitivity.
• Syncope.
• Slow or rapid heart rate, loss of consciousness, or decreased blood pressure, Prinzmetal's angina.
• Pupil constriction, increased tearing, vision disturbances, such as blurred vision.
• Increased bronchial secretion along with contraction of the bronchial muscle.
• Diarrhea, nausea, vomiting, increased intestinal motility, increased saliva, abdominal pain or discomfort, cramps.
• Increased muscle weakness, fasciculation (mild muscle contraction), tremors, muscle cramps, or decreased muscle tone (flaccidity).
• Urinary incontinence.
• Increased sweating, itching.
• Redness.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash.Depositthe packaging and medications you no longer need at the SIGRE collection pointat your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Mestinon

• The active ingredient is bromide of piridostigmine.
• The other components are lactose monohydrate, silicon dioxide, cornstarch, talc, magnesium stearate, and potato starch.

Appearance of the product and content of the container

Brown glass bottle with a white cap, containing 100 tablets.

Holder of the marketing authorization

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Responsible for manufacturing

Labiana Pharmaceuticals, S.A.

C/ Casanova, 27-31; 08757 - Corbera de Llobregat (Barcelona) Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Last review date of this leaflet: March 2018

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/