Patient leaflet - Emylif 50 mg orodispersible film

1. What Emylif is and what it is used for

What Emylif is

The active substance in 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 form of motor neurone disease where attacks of the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle waste and paralysis.

The destruction of nerve cells in motor neurone disease may be caused by too much glutamate (a chemical messenger) in the brain and spinal cord. Emylif stops the release of glutamate and this may help in preventing the nerve cells being damaged.

Please consult your doctor for more information about ALS and the reason why this medicine has been prescribed for you.

2. What you need to know before you 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 increased blood
levels of some enzymes of the liver (transaminases),
if you are pregnant or breast-feeding.

Warnings and precautions

Talk to your doctor before taking Emylif:

if you have any liver problems: yellowing of your
skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick
if your kidneys are not working very well
if you have any fever: it may be due to a low
number of white blood cells which can cause an increased risk of infection
if you have excessive drooling or severe
swallowing difficulties.

If any of the above applies to you, or if you are not sure, tell your doctor who will decide what to do.

Children and adolescents

If you are less than 18 years of age, the use of Emylif is not recommended because there is no information available in this population.

Other medicines and Emylif

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

Pregnancy, breast-feeding and fertility

You MUST NOT take Emylif if you are or think you may be pregnant, or if you are breast-feeding. If you think you may be pregnant, or if you intend to breast-feed, ask your doctor for advice before taking Emylif.

Driving and using machines

You can drive or use any tools or machines, unless you feel dizzy or light-headed after taking this medicine.

Emylif contains:

2 mg fructose in each orodispersible film. May be harmful to the teeth.
sunset yellow FCF (E110). May cause allergic reactions.

3. How to take Emylif

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one orodispersible film, twice a day.

The orodispersible films should be taken by mouth, every 12 hours, at the same time of the day each day (e.g. in the morning and evening).

After taking this medicine, you can feel reduced oral sensitivity after 1 minute. Pay attention taking food until this feeling is over, which is usually in about 40 minutes.

Method of administration:

Instructions for oral use are reported below.

Step 1. Before Taking Emylif

Ensure hands are clean and dry before handling Emylif so the film does not stick to your fingers.
Check expiration date printed on foil sachet before use as shown in Figure 1. Do not use Emylif if expired.
Figure 1

Step 2. Open Sachet

Fold foil sachet along solid line at top as shown in Figure 2.
While keeping top of sachet folded over at solid line, tear down at the slit along the arrow on the side of the sachet to open.
Figure 2
Package leaflet: Information for the patient
EMYLIF 50 mg orodispersible film riluzole
Package leaflet: Information for the patient
EMYLIF 50 ^mg
orodispersible film
riluzole

Step 3. Remove Film

Remove Emylif film from foil sachet. Each sachet contains one dose of Emylif.
Do not fold Emylif film.
Figure 3

Step 4. Place Film on Tongue

Place Emylif film on top of the tongue as shown in Figure 4. The film will stick to the tongue and begin to dissolve.
Figure 4

Step 5. Close Mouth and Swallow Saliva Normally

Close mouth as shown in Figure 5 and swallow saliva normally as Emylif dissolves within 3 minutes.
Do not take Emylif with liquids
Do not chew, spit or talk while Emylif dissolves.
Figure 5

Step 6. After the administration of Emylif, wash your hands

If you take more Emylif than you should

If you take too many orodispersible film, contact your doctor or the nearest hospital emergency department immediately.

If you forget to take Emylif

If you forget to take your orodispersible film, leave out that dose completely and take the next orodispersible film at the usual time. Do not take a double dose to make up for a forgotten orodispersible film.

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.

IMPORTANT

Tell your doctor immediately

if you experience any fever (increase in
temperature) because Emylif may cause a decrease in the number of white blood cells. Your doctor may want to take a blood sample to check the number of white blood cells, which are important in fighting infections.
if you experience any of the following symptoms:
yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick, as this may be signs of liver disease (hepatitis). Your doctor may do regular blood tests while you are taking Emylif to make sure that this does not occur.
if you experience cough or difficulties in
breathing, as this may be a sign of lung disease (called interstitial lung disease).

Other side effects

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

tiredness
feeling sick
increased blood levels of some enzymes of the
liver (transaminases).
reduced oral sensitivity

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

dizziness
numbness or tingling of the mouth
vomiting
sleepiness
increase in heart beat
diarrhoea
headache
abdominal pain
pain

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

anaemia
allergic reactions
inflammation of the pancreas (pancreatitis).
Not known: frequency cannot be estimated from the available data
- rash

Reporting of side effects

If you get 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 via

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. How to store Emylif

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

Do not use this medicine after the expiry date which is stated on the sachet and carton after “EXP” The expiry date refers to the last day of that month.

Store below 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Emylif contains

The active substance is riluzole.
The other ingredients are:
polacrilex resin, pullulan (E1204), xylitol (E967), hypromellose (E464), glycerol (E422), glycerol mono-oleate, sucralose (E955), fructose, macrogol, flavor honey, xhanthan gum, flavor lemon, sunset yellow FCF (E110), white ink (water purified, titanium dioxide (E171), propylene glycol (E1520), hypromellose (E464), isopropyl alcohol, ethanol and methanol).
Trace levels of the antioxidant butylated hydroxytoluene (E321).

What Emylif looks like and content of the pack

Orodispersible film:

Orange, rectangular-shaped, orally dissolving thin film (32 mm x 22 mm) with “R50” printed in white on one side.

Emylif is available in a pack of 14, 28, 56, 112, 140 orodispersible film to be taken orally. Each carton box contains 14, 28, 56, 112, 140 sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Zambon S.p.A.

Via Lillo del Duca 10 20091 Bresso (MI) Italy Tel: +39 02665241

Fax: +39 02 66501492

Email: info.zambonspa@zambongroup.com

Manufacturer