Emylif 50 mg orodispersible film

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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 take Emylif
3. How to take Emylif
4. Possible side effects
5. How to store Emylif
6. Contents of the pack and other information

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

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.

• 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.

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.

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.

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

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.

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

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

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.

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.

Step 3. Remove Film

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

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.

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.

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

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

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.

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).

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

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 the 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.

• 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).

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.