EMYLIF 50 mg Film Orodispersyjny
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Treść ulotki
Emylif 50 mg orodispersible film
riluzole
Read this leaflet carefully before taking this medicine as it contains important information for you.
- Keep this leaflet. 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 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
1. What is Emylif and what is it used for
What is Emylif
The active ingredient in Emylif is riluzole, 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 motor neuron disease, in which the attack on nerve cells responsible for sending
instructions to the muscles leads to weakness, muscle atrophy and paralysis.
The destruction of nerve cells in motor neuron disease may be caused by an excessive amount of glutamate (a chemical messenger) in the brain and spinal cord. Emylif interrupts the
release of glutamate and this may help to prevent damage to nerve cells.
Please consult your doctor for more information about ALS and why
this medicine has been prescribed for you.
2. What you need to know before taking Emylif
Do not take Emylif
- if you are allergicto riluzole or to any of the other ingredients of this medicine (listed in section 6),
- if you have any liver diseaseor an increase in the levels of certain liver enzymes (transaminases) in the blood,
- if you are pregnant or breastfeeding.
Warnings and precautions
Talk to your doctor before taking Emylif:
- if you have any liver problems: yellowing of the skin or the white of your eyes (jaundice), widespread itching, feeling unwell, malaise
- if your kidneysare not working very well
- if you have fever: this could be due to a low number of white blood cells which can cause an increased risk of infection
- if you have excessive salivationor severe difficulty swallowing.
If any of the above occur, or if you are not sure, talk to your doctor who will decide what to do.
Children and adolescents
If you are under 18 years of age, the use of Emylif is not recommended as 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, breastfeeding and fertility
You MUST NOT take Emylif if you are pregnant or think you might be, or if you are breastfeeding.
If you think you might be pregnant, or if you are planning to breastfeed, ask your doctor for advice before taking Emylif.
Driving and using machines
You can drive vehicles or use tools or machines, unless you feel dizzy or drowsy
after taking this medicine.
Emylif contains:
- 2 mg of fructose in each orally disintegrating tablet. This may be harmful to your teeth.
- Yellow sunset FCF (E110). This may cause allergic reactions.
3. How to take Emylif
Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is one orally disintegrating film, twice a day.
The orally disintegrating films must be taken by mouth, every 12 hours, at the same time each day (e.g. at
morning and evening).
After taking this medicine, you may experience reduced oral sensitivity after 1 minute. You should
be careful to avoid eating food until this sensation has disappeared, which usually happens
in about 40 minutes.
Method of administration:
Instructions for oral use are reported below.
Step 1. Before taking Emylif
- Make sure your hands are clean and dry before handling Emylif so that the film does not stick to your fingers.
- Before use, check the expiry date printed on the aluminum blister, as shown in Figure 1. Do notuse Emylif if expired.
Figure 1
Step 2. Open the blister
- Fold the aluminum blister along the continuous line at the top, as shown in Figure 2.
- To open, hold the top of the blister folded along the continuous line and pull down starting from the notch point following the arrow on the side of the blister.
Figure 2
Step 3. Remove the film
- Remove Emylif film from the aluminum blister. Each blister contains one dose of Emylif.
- Do notfold Emylif film.
Figure 3
Step 4. Place the film on the tongue
- Place Emylif film above the tongue, as shown in Figure 4. The film will stick to the tongue and begin to dissolve.
Figure 4
Step 5 Close your mouth and swallow saliva
normally
- Close your mouth as shown in Figure 5 and swallow saliva normally while Emylif dissolves within 3 minutes.
- Do nottake Emylif with liquids.
- Do notchew, spit or speak while Emylif is dissolving. Figure 5
Step 6 Wash your hands after administering Emylif.
If you take more Emylif than you should
If you take too many orally disintegrating films, contact your doctor or the emergency room
of the nearest hospital immediately.
If you forget to take Emylif
If you forget to take the orally disintegrating film, skip the missed dose and take the next orally disintegrating film
at the usual time.
Do not take a double dose to make up for the missed orally disintegrating 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 develop fever(increased temperature), because Emylif can cause a decrease in the number of white blood cells. Your doctor may decide to take a blood sample to check the number of white blood cells, which are important in fighting infections.
- if you develop any of the following symptoms: yellowing of the skin or the white of the eyes (jaundice), itching all over the body, if you feel unwell, if you are feeling sick, as this may indicate liver disease(hepatitis). While you are taking Emylif, your doctor may perform blood tests regularly to make sure this does not happen.
- if you develop a cough or difficulty breathing, as this could be a sign of a lung disease (called interstitial lung disease).
Other side effects
Very common side effects(may affect more than 1 in 10 people) of Emylif are:
- fatigue
- nausea
- increased levels of certain liver enzymes (transaminases) in the blood
- reduced oral sensitivity
Common side effects(may affect up to 1 in 10 people) of Emylif are:
- dizziness
- tingling or numbness of the mouth
- vomiting
- drowsiness
- increased heart rate
- diarrhea
- headache
- abdominal pain
- pain Uncommon side effects(may affect up to 1 in 100 people) of Emylif are:
- anemia
- allergic reactions
- inflammation of the pancreas (pancreatitis)
Not known:the frequency cannot be estimated based on available data:
- skin rash
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . 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 the box after
“Exp.”. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Emylif contains
- The active ingredient is riluzole.
- The other ingredients are: polacrilex resin, pullulan (E1204), xylitol (E967), hypromellose (E464), glycerol (E422), glycerol mono-oleate, sucralose (E955), fructose, macrogol, honey flavour, xanthan gum, lemon flavour, sunset yellow FCF (E110), white ink (purified water, titanium dioxide [E171], propylene glycol [E1520], hypromellose [E464], isopropyl alcohol, ethanol and methanol). Traces of the antioxidant butylated hydroxytoluene (E321).
Description of the appearance of Emylif and contents of the pack
Orodispersible film:
Thin (32 mm x 22 mm) orally dispersible film of orange colour and rectangular shape with the
writing “R50” printed in white on one side.
Emylif is available in packs of 14, 28, 56, 112, 140 orodispersible films to be taken orally.
Each cardboard 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
E-mail: [email protected]
Manufacturer
Zambon S.p.A.
Via della Chimica, 9
36100 Vicenza
Italy
This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Emylif: Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Luxembourg,
Norway, Portugal, Spain, Sweden, Netherlands.
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- Kraj rejestracji
- Postać farmaceutycznaOrodispersible film, 50 MG
- Kod ATCN07XX02
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki EMYLIFPostać farmaceutyczna: Film-coated tablet, 50 MGSubstancja czynna: riluzoleProducent: SANOFI WINTHROP INDUSTRIEWymaga receptyPostać farmaceutyczna: Film-coated tablet, 50 MGSubstancja czynna: riluzoleProducent: AUROBINDO PHARMA (ITALIA) S.R.L.Wymaga receptyPostać farmaceutyczna: Film-coated tablet, 50 MGSubstancja czynna: riluzoleProducent: SANDOZ S.P.A.Wymaga recepty
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EMYLIF wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w EMYLIF jest riluzole. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
EMYLIF jest produkowany przez ZAMBON S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie EMYLIF jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić EMYLIF w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (riluzole) to m.in. RILUTEK, RILUTSOLO AUROBINDO, RILUTSOLO SANDOTS. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
