This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use EMYLIF 50 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Emylif 50mg buccal film

riluzole

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Keep this package leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

What is Emylif and what is it used for
What you need to know before taking Emylif
How to take Emylif
Possible side effects
Storage of Emylif
Contents of the pack and further information

1. What is Emylif and what is it used for

What is Emylif

The active substance of Emylif is riluzole, which acts on the nervous system.

What is Emylif used for

Emylif is used in adult patients with amyotrophic lateral sclerosis (ALS).

ALS is a type of motor neuron disease that affects the nerve cells responsible for sending signals to muscles, leading to weakness, muscle loss, and paralysis.

The destruction of nerve cells in motor neuron diseases may be due to an excess of glutamate (a chemical messenger) in the brain and spinal cord. Emylif stops the release of glutamate, which may help prevent damage to nerve cells.

Consult your doctor for more information about ALS and why this medication has been prescribed for you.

2. What you need to know before taking Emylif

Do not take Emylif

if you are allergic to riluzole or any of the other ingredients of this medication (listed in section 6),
if you have any liver disease or elevated blood levels of certain liver enzymes (transaminases),
if you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor before taking Emylif:

if you have any liver problems: yellowing of the skin or whites of the eyes (jaundice), generalized itching, dizziness, nausea;
if your kidneys do not function properly;
if you have a fever: it may be due to a decrease in the number of white blood cells, which can increase the risk of infection;
if you experience excessive drooling or severe swallowing difficulties.

If you are in any of the above situations or are unsure, consult your doctor for advice on what to do.

Children and adolescents

The use of this medication is not recommended in children under 18 years of age, as there is no information available for this population.

Other medications and Emylif

Tell your doctor if you are taking, have recently taken, or may take any other medications.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, DO NOT take this medication.

If you are planning to become pregnant or breastfeed, consult your doctor before taking this medication.

Driving and using machines

You can drive and use all types of machines and tools, unless you experience dizziness or drowsiness after taking this medication.

Emylif contains:

2 mg of fructose in each buccal film. Fructose can damage teeth.
Orange Yellow S (E110). May cause allergic reactions.

3. How to take Emylif

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one buccal film twice a day.

The buccal film should be taken orally, every 12 hours, at the same time each day (e.g., morning and night).

After taking this medication, you may experience a decrease in oral sensitivity after 1 minute. Until this sensation disappears, which usually takes about 40 minutes, be cautious when consuming food.

Method of administration:

The following are the oral administration instructions.

Step 1. Before taking Emylif

Make sure your hands are clean and dry before handling this medication to prevent the film from sticking to your fingers.
Before use, check the expiration date printed on the aluminum sachet, as shown in Figure 1.

Do nottake this medication if it has expired.

Rectangular black auto-injector device with transparent window and two red circles highlighting its size

Figure 1

Step 2. Open the sachet

Fold the aluminum sachet along the continuous line at the top, as shown in Figure 2.
While keeping the top of the sachet folded along the continuous line, pull down the lateral opening in the direction of the arrow to open the sachet.

Broken glass ampoule showing liquid extraction with a red arrow indicating the direction

Figure 2

Step 3. Remove the film

Remove the Emylif film from the aluminum sachet. Each sachet contains one dose of Emylif.
Do notfold the Emylif film.

Hand holding an applicator device with a short needle protruding from one end for subcutaneous injection

Figure 3

Step 4. Place the film on your tongue

Place the Emylif film on your tongue, as shown in Figure 4. The film will stick to your tongue and start to dissolve.

Hand placing a sublingual tablet under the tongue with the mouth slightly open

Figure 4

Step 5. Close your mouth and swallow saliva normally Close your mouth as shown in Figure 5 and swallow saliva normally while the medication dissolves over 3 minutes. Do nottake this medication with liquids. Do notchew, spit, or talk while the medication is dissolving.
	Figure 5

Step 6. After administering Emylif, wash your hands

If you take more Emylif than you should

If you take too many buccal films, contact your doctor or go to the emergency department of the nearest hospital immediately.

If you forget to take Emylif

If you forget to take a buccal film, skip it and take the next one at the usual time.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

IMPORTANT

Tell your doctor immediately

if you have a fever (increased body temperature), as this medication may reduce the number of white blood cells. Your doctor may advise you to have a blood test to check your white blood cell count, as they are important for fighting infections;

if you experience any of the following symptoms: yellowing of the skin or whites of the eyes (jaundice), generalized itching, dizziness, or nausea, as they may be signs of liver disease (hepatitis). Your doctor may recommend that you have regular blood tests while taking Emylif to ensure this does not occur;

if you have a cough or difficulty breathing, as they may be signs of lung disease (interstitial lung disease).

Other side effects

Very common side effects(may affect more than 1 in 10 people) of this medication are:

fatigue
dizziness
increased blood levels of certain liver enzymes (transaminases)
decreased oral sensitivity

Common side effects(may affect up to 1 in 10 people) of this medication are:

dizziness
numbness or tingling in the mouth
vomiting
drowsiness
increased heart rate
diarrhea
headache
abdominal pain
pain

Uncommon side effects(may affect up to 1 in 100 people) of this medication are:

anemia
allergic reactions
pancreatitis (inflammation of the pancreas)

Side effect of unknown frequency(cannot be estimated from available data) of this medication is:

skin rash

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Emylif

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

Do not use this medication after the expiration date stated on the sachet and carton after "EXP". The expiration date is the last day of the month indicated.

Store below 30°C.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Emylif

The active substance is riluzole.
The other ingredients are:

polacrilin, pullulan (E1204), xylitol (E967), hypromellose (E464), glycerol (E422), glycerol monooleate, sucralose (E955), fructose, macrogol, honey flavor, xanthan gum, lemon flavor, orange yellow S (E110), white ink (purified water, titanium dioxide [E171], propylene glycol [E1520], hypromellose [E464], isopropyl alcohol, ethanol, and methanol).

Insufficient levels of the antioxidant butylated hydroxytoluene (E321).

Appearance of the product and pack contents

Buccal film:

Thin, rectangular, orange-colored buccal film (32 mm x 22 mm) with "R50" printed in white on one side.

Emylif is available in packs of 14, 28, 56, 98, 112, and 140 buccal films for oral administration.

Each carton contains 14, 28, 56, 98, 112, and 140 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder

Zambon S.p.A.

Via Lillo del Duca 10

20091 Bresso (MI), Italy

Phone: +39 02665241

Fax: +39 02 66501492

Email: info.zambonspa@zambongroup.com

Manufacturer

Zambon S.p.A.

Via della Chimica, 9

36100 Vicenza

Italy

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

Zambon, S.A.U.

Maresme 5

Polígono Can Bernades - Subirà

08130 Santa Perpetua de Mogoda (Barcelona) Spain

Phone: +34 93 544 64 00

This medication is authorized in the EEA member states under the following names:

Emylif: Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, Netherlands.

Date of last revision of this package leaflet: October 2022

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

EMYLIF 50 mg ORALLY DISINTEGRATING TABLETS