Emylif 50 mg orodispersible film

Spain
Brand name Emylif 50 mg orodispersible film
Form tablets, orally disintegrating
Active substance / Dosage
RILUZOLE · 50 mg
Prescription type Hospital Use Only
ATC code
N07X N07XX N07XX02
Registration number 88570
Manufacturer Zambon S.P.A.
Emylif 50 mg orodispersible film tablets, orally disintegrating

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Emylif 50mg orodispersible film-coated tablet

riluzole

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents

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

1. What Emylif is and what it is used for

What Emylif is

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

What Emylif is 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 the muscles, leading to weakness, loss of muscle mass, 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 inhibits the release of glutamate, which may help prevent damage to nerve cells.

Consult your doctor for further information about ALS and the reason why this medicine has been prescribed for you.

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

Do not take Emylif

  • if you are allergic to riluzole or any of the other ingredients of this medicine (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 starting to take Emylif:

  • if you have any liver problems: yellowing of the skin or whites of the eyes (jaundice), widespread itching, dizziness, nausea;
  • if your kidneys are not working properly;
  • if you have a fever: this may be due to a decrease in white blood cell count, which could 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 you should do.

Children and adolescents

This medicine is not recommended for use in individuals under 18 years of age, as there is no available information in this population.

Other medicines and Emylif

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

Pregnancy, breastfeeding and fertility

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

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

Driving and use of machines

You may drive and operate all types of machinery and tools, unless you experience dizziness or lightheadedness after taking this medicine.

Emylif contains:

  • 2 mg of fructose in each orodispersible tablet. Fructose may harm teeth.
  • Sunset Yellow FCF (E110). May cause allergic-type reactions.

3. How to take Emylif

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one orodispersible film twice daily.

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

After taking this medicine, you may notice a reduced oral sensitivity within 1 minute. Exercise caution when eating until this sensation subsides, which usually occurs within about 40 minutes.

Method of administration:

The following are instructions for oral administration.

Step 1. Before taking Emylif

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

Do not take this medicine if it has expired.

Close-up of a black box in a package insert showing the notation MM/YYYY to indicate the month and year

Figure 1

Step 2. Open the pouch

  • Fold the aluminum pouch along the solid line at the top, as shown in Figure 2.
  • While holding the top of the pouch folded along the solid line, pull downward on the side slit in the direction of the arrow to open the pouch.

Medical diagram showing two phases for the

Figure 2

Step 3. Remove the film

  • Remove the Emylif film from the aluminum pouch. Each pouch contains one dose of Emylif.
  • Do not fold the Emylif film.

Two hands opening a white paper sachet folded along a dotted line at the top to remove its contents

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 adhere to the tongue and begin to dissolve.

A hand inserts a thin white strip under the tongue of a person with an open mouth for the

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 not take this medication with liquids.
  • Do not chew, spit, or talk while the medication is dissolving.

Stylized lateral profile of a human face showing the nose, lips, and chin in light gray on a white background

Figure 5

Step 6. After administering Emylif, wash your hands

If you take more Emylif than you should

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

If you forget to take Emylif

If you forget to take a buccodispersible film, skip the missed dose and take the next one at the usual time.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

IMPORTANT

Tell your doctor immediately

  • if you have fever (rise in body temperature), as this medicine may reduce the number of white blood cells. Your doctor may advise you to have a blood test to monitor your white blood cell count, since these cells are important for fighting infections;

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

  • if you develop cough or difficulty breathing, as these may be signs of lung disease (known as interstitial lung disease).

Other adverse effects

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

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

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

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

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

  • anemia
  • allergic reactions
  • inflammation of the pancreas (pancreatitis)

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

  • skin rash

Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Emylif

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

Do not use this medicine after the expiry date stated on the blister and the carton following “EXP”. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Emylif

  • The active substance is riluzole.
  • The other components are:

polacrilin resin, pullulan (E1204), xylitol (E967), hypromellose (E464), glycerol (E422), glycerol monooleate, sucralose (E955), fructose, macrogol, honey flavour, xanthan gum, lemon flavour, orange-yellow 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 container

Buccodispersible film:

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

Emylif is available in packages containing 14, 28, 56, 98, 112 and 140 buccodispersible oral films.

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

Only certain package sizes may be marketed.

Marketing Authorization Holder

Zambon S.p.A.

Via Lillo del Duca 10

20091 Bresso (MI), Italy

Tel.: +39 02665241

Fax: +39 02 66501492

Email: [email protected]

Manufacturer responsible for manufacturing

Zambon S.p.A.

Via della Chimica, 9

36100 Vicenza

Italy

Further information on this medicinal product is available upon request to 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

Tel: +34 93 544 64 00

This medicinal product 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 the most recent review of this leaflet: October 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/