MESTINON 60 mg TABLETS

Introduction

Package Leaflet: Information for the User

Mestinon 60 mg Tablets

Piridostigmine, bromide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Mestinon and what is it used for
2. What you need to know before you take Mestinon
3. How to take Mestinon
4. Possible side effects
5. Storage of Mestinon
6. Contents of the pack and further information

1. What is Mestinon and what is it used for

Mestinon belongs to a group of medicines known as cholinesterase inhibitors. It helps to transfer stimuli from the brain to the muscles. In this way, the muscle can work correctly.

Mestinon is used for the treatment of:

Adults and children:

• Myasthenia gravis (an immune system disease that causes muscle weakness).

Adults:

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

2. What you need to know before you take Mestinon

Do not take Mestinon

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you are constipated or cannot urinate, unless your doctor tells you to.

Warnings and precautions

Talk to your doctor before taking Mestinon:

• If you have 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 disease in which the activity of the vagus nerve produces symptoms such as a slow heartbeat, 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 (increased function of the thyroid gland).
• If you have kidney problems.
• If you have had an operation to remove your thymus gland. In this case, your doctor may need to reduce the dose of Mestinon.

Using Mestinon with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is especially important that you inform your doctor if you are taking one of the following medicines, as the combined use of both medicines may cause one of them not to work:

• Immunosuppressive medicines (used for immune system suppression)
• Corticosteroid medicines
• Medicines containing methylcellulose as a component.
• Antimuscarinics (medicines used for airway disorders, such as atropine and hyoscine).
• Muscle relaxants, such as pancuronium or vecuronium. Piridostigmine may prolong the effect of depolarizing muscle relaxants (e.g., suxamethonium).
• Aminoglycoside antibiotics
• Local anesthetics and some general anesthetics
• Antiarrhythmics (medicines used for heart rhythm disorders).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

The safety of piridostigmine in pregnant women has not been established. If you are pregnant, your doctor will prescribe this medicine if he considers that the benefits of treatment are greater than the possible risks for you and your baby.

Breastfeeding:

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

Fertility:

The safety of piridostigmine in human fertility has not been established. Investigations in rats have not suggested any negative effect on reproduction.

Driving and using machines

Mestinon may impair visual acuity and, therefore, reaction capacity, as well as the ability to drive and use machines.

This medicine contains lactose,if your doctor has told you that you have an intolerance to some sugars, consult with him before taking this medicine.

3. How to take Mestinon

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

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

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 intake, administered 2-4 times a day. The total daily dose is normally 2 to 20 tablets (120-1200 mg). However, your doctor may consider an even higher dose if you have myasthenia gravis. The effect of each dose may last 3 to 4 hours during the day and 6 hours at night, since 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, assessing your response at intervals of 15-30 mg per day. The total daily dose is normally half to 6 tablets (30-360 mg).

Paralytic ileus

Adults

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

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

Patients with kidney disease

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

If you take more Mestinon than you should

It is important 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 Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount ingested.

In cases of poisoning, abdominal cramps, increased intestinal movement, diarrhea, nausea, and vomiting, increased bronchial secretion and saliva, bronchial spasm, increased sweating, and pupil contraction (miosis) may occur.

Muscle cramps, fasciculations (mild muscle contractions), and general weakness up to paralysis; heart rhythm disorders that can lead to cardiac arrest, and decreased blood pressure that can lead to cardiovascular collapse, lack of oxygen when breathing, and in the brain may also occur.

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

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

If you forget to take Mestinon

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

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

If you stop taking Mestinon

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side 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 side effects (may affect up to 1 in 1000 patients):

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

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

• Hypersensitivity to the medicine.
• Fainting.
• Slow or fast heartbeat, loss of consciousness, or low blood pressure, Prinzmetal's angina.
• Pupil contraction, increased tearing, vision disorders, such as blurred vision.
• Increased bronchial secretion along with contraction of the muscle surrounding the bronchi.
• Diarrhea, nausea, vomiting, increased intestinal movement, increased saliva, abdominal pain or discomfort, cramps.
• Increased muscle weakness, fasciculation (mild muscle contraction), tremors, and muscle cramps or decreased muscle tone (flaccidity).
• Urinary incontinence.
• Increased sweating, itching.
• Redness.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mestinon

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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 further information

Composition of Mestinon

• The active substance is piridostigmine bromide.
• The other ingredients are lactose monohydrate, silicon dioxide, corn starch, talc, magnesium stearate, and potato starch.

Appearance of the product and pack contents

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

Marketing authorisation holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Manufacturer

Labiana Pharmaceuticals, S.A.

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

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of last revision of this leaflet: March 2018

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/