Patient Information Leaflet

Emylif 50mg buccal film

riluzole

Read this leaflet carefully before you start 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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Emylif is and what it is used for

2.What you need to know before you start taking Emylif

3.How to take Emylif

4.Possible side effects

5.Storage of Emylif

6.Contents of the pack and additional information

What is Emylif

The active ingredient of Emylif is riluzol, 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 motor neuron cells responsible for sending signals to muscles and produces weakness, muscle wasting, and paralysis.

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

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

Do not take Emylif

-if you areallergicto riluzol or any of the other components of this medication (listed in section6),

-if you have anyliver diseaseor elevated blood concentrations of certain liver enzymes (transaminases),

-if you arepregnant or breastfeeding.

Warnings and precautions

Consult your doctor before starting to take Emylif:

-if you have anyliver problems: yellowing of the skin or the white part of the eyes (jaundice), generalized itching, feeling of dizziness, nausea;

-if yourkidneysdo not function correctly;

-if you havefever: it may be due to a decrease in the number of white blood cells, which may increase the risk of infection;

-if you experienceexcessive droolingorsevere swallowing difficulties.

If you find yourself in any of the above circumstances or are unsure, consult your doctor to determine what you should do.

Children and adolescents

The use of this medication is not recommended in individuals under 18years because there is no information available for this population.

Other medications and Emylif

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding or believe you may be pregnant, DO NOT TAKE THIS MEDICATION.

If you believe you may be pregnant or intend to breastfeed, consult your doctor before taking this medication.

Driving and operating machines

You may drive and use all types of machines and tools, unless you notice a feeling of dizziness or drowsiness after taking this medication.

Emylif contains:

-2mg of fructose in each buccal dispersible film. Fructose may damage teeth.

-Yellow-orange S (E110). It may cause allergic reactions.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, 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., in the morning and at night).

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

Administration Form:

Below are the oral administration instructions.

If you take more Emylif than you should

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

If you forget to take Emylif

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

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

IMPORTANT

Inform your doctor immediately

-if you havefever(elevated body temperature), as this medicine may reduce the number of white blood cells. Your doctor may instruct you to have a blood test to control the number of white blood cells, as they are important for fighting infections;

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

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

Other side effects

Frequent side effects(may affect more than 1 in 10 people) of this medicine are:

- fatigue

- sensation of dizziness

- increase in blood concentrations of certain liver enzymes (transaminases)

- decreased sensitivity of the mouth

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

- dizziness

- numbness or tingling in the mouth

- vomiting

- drowsiness

- increased heart rate

- diarrhea

- headache

- abdominal pain

- pain

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

- anemia

- allergic reactions

- inflammation of the pancreas (pancreatitis)

Side effect of unknown frequency(cannot be estimated with available data) of this medicine is:

- skin rash

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute toproviding more information on the safety of this medicine.

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

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

Store below 30°C.

Medicines should not be disposed of through drains or in the trash.Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Emylif

- The active ingredient is riluzol.

- The other components are:

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

Insignificant levels of the antioxidant butyl hydroxytoluene (E321).

Appearance of the product and contents of the packaging

Oral dispersible film:

A thin, rectangular, orange-colored oral dispersible film (32 mm x 22 mm) with "R50" printed in white on one side.

Emylif is presented in packaging of 14, 28, 56, 98, 112, and 140 oral dispersible films for oral administration.

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

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Zambon S.p.A.

Via Lillo del Duca 10

20091 Bresso (MI), Italy

Phone: +39 02665241

Fax: +39 02 66501492

Email: [email protected]

Responsible for Manufacturing

Zambon S.p.A.

Via della Chimica, 9

36100 Vicenza

Italy

For more information about this medicine, please contact 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 medicine is authorized in the EEA member states with the following names:

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

Last review date of this leaflet: October 2022

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/