Mitelase

Package Leaflet: Information for the Patient

Mytelase, 10 mg, Tablets

Ambenonium Chloride

Read the Leaflet Carefully Before Taking the Medication, 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, pharmacist, or nurse.
• 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 any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Mytelase and what is it used for

Mytelase is available in tablet form and contains the active substance ambenonium chloride.
Ambenonium chloride is a parasympathomimetic with strong inhibitory action on the enzyme acetylcholinesterase, which leads to an increase in acetylcholine concentration in nerve endings.
The consequence of the drug's action is an increase in neuromuscular conduction and muscle contraction.
Ambenonium increases the contractility of skeletal muscles.
Mytelase is used:

• For symptomatic treatment of myasthenia.

2. Important information before taking Mytelase

When not to take Mytelase:

• during breastfeeding.

Warnings and precautions

Before starting treatment with Mytelase, discuss it with your doctor or pharmacist:

• Taking the medicine in patients with asthma, Parkinson's disease, mechanical obstruction of the gastrointestinal or urinary tract requires special precautions.
• Taking the medicine in patients with bradycardia (slow heart rate) or conduction disorders in the heart requires special precautions.
• During treatment with ambenonium chloride, do not take atropine or its derivatives, as they may mask the symptoms of overdose.
• Mytelase should not be given to patients taking such medications as mecamylamine and pempidine (autonomic ganglion blockers).

Mytelase and other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.
Due to the longer duration of action of ambenonium compared to other medicines used in myasthenia, Mytelase should not be taken at the same time as other cholinomimetic medicines (mimicking the action of acetylcholine, stimulating the parasympathetic nervous system) such as edrophonium and neostigmine, unless the patient is under direct medical supervision.
Atropine and its derivatives, autonomic ganglion blockers, see section: Warnings and precautions.

Mytelase with food and drink

Mytelase should be taken during meals.

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.

Driving and using machines

There are no data on the negative effect of ambenonium chloride on the ability to drive and use machines.

Mytelase contains lactose

Mytelase contains lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Mytelase

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
The tablet can be divided into equal doses.
The dose should be determined individually for each patient, depending on the severity of the disease and individual differences in sensitivity to cholinergic medicines.
Treatment should be started with a dose of 5 mg; for patients with moderately severe disease, the effective dose is from 5 to 25 mg, 3 or 4 times a day.
The initial dose may be gradually increased to achieve the desired therapeutic effect.
If you feel that the effect of Mytelase is too weak or too strong, consult your doctor.

Taking a higher dose of Mytelase than recommended

As a result of an overdose of ambenonium chloride, the following symptoms may occur: sweating, gastrointestinal disorders (diarrhea, vomiting), excessive salivation, pallor of the skin, frequent urination, blurred vision, pupil constriction, increased blood pressure, anxiety, tremors, and paralysis of voluntary muscles.
In case of overdose, the patient should be hospitalized and the use of the medicine should be temporarily discontinued; gastric lavage should be performed, and atropine sulfate should be administered intravenously in a dose of 0,25 mg (if necessary, the dose can be repeated), and pralidoxime methanesulfonate in a dose of 10 mg/kg body weight per day.
If necessary, assisted ventilation should be used with a respirator.
In case of overdose, consult your doctor immediately.
If you have taken more than the recommended dose of the medicine, consult your doctor or pharmacist immediately.

Missing a dose of Mytelase

If you miss a dose, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.
If you are unsure, consult your doctor.

Stopping treatment with Mytelase

If you have any further questions about taking this medicine, consult 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 ambenonium chloride, the following side effects may occur: intestinal cramps, nausea, vomiting, diarrhea, excessive salivation, increased secretion of mucus in the respiratory tract, lacrimation, pupil constriction, muscle cramps, and tremors of skeletal muscles.
Very rarely, general malaise with anxiety and dizziness may occur.
Heart disorders: bradycardia, conduction disorders in the heart.
In some people, other side effects may occur during treatment with Mytelase.
If you experience any of the mentioned or other side effects, inform your doctor.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. 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 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, E-mail: ndl@urpl.gov.pl. Reporting side effects will help to gather more information on the safety of the medicine.

• By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mytelase

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Mytelase contains

• The active substance is ambenonium chloride.
• The other ingredients (excipients) are: corn starch, calcium hydrogen phosphate, lactose, magnesium stearate.

What Mytelase looks like and contents of the pack

Orange glass bottle in a cardboard box.
The pack contains 50 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sanofi-Aventis France, 82, Avenue Raspail, Gentilly, 94250, France

Manufacturer

SOFARIMEX - Industria Quimica e Farmaceutica, Lda, Av. das Industrias, Alto de Colaride, Agualva, 2735-213 Cacem, Portugal
Date of last revision of the leaflet:October 2015