Patient Leaflet Updated 13-Jun-2023 | Zambon UK Limited
Emylif 50 mg orodispersible film
Emylif 50 mg orodispersible film
riluzole
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.
Talk to your doctor before taking Emylif:
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.
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.
Instructions for oral use are reported below.
Step 1. Before Taking Emylif
Step 2. Open Sachet
Step 3. Remove Film
Step 4. Place Film on Tongue
Step 5. Close Mouth and Swallow Saliva Normally
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately
Very common side effects (may affect more than 1 in 10 people) of Emylif are:
Common side effects (may affect up to 1 in 10 people) of Emylif are:
Uncommon side effects (may affect up to 1 in 100 people) of Emylif are:
Not known: frequency cannot be estimated from the available data
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.
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.
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.
This leaflet was last revised in April 2023.
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