TEGLUTIK 5 mg /Ml Zawiesina Doustna
Ocena recepty online
Lekarz przeanalizuje Twój przypadek i zdecyduje, czy wystawienie recepty jest medycznie uzasadnione.
Porozmawiaj z lekarzem o tym leku
Omów swoje objawy i opcje leczenia podczas szybkiej konsultacji online.
Jak stosować TELUTIK
Treść ulotki
TEGLUTIK 5mg/ml oral suspension
Riluzole
Read this leaflet carefully before you start 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 or pharmacist. See section 4.
Contents of this leaflet:
- 1. What TEGLUTIK is and what it is used for
- 2. What you need to know before you take TEGLUTIK
- 3. How to take TEGLUTIK
- 4. Possible side effects
- 5. How to store TEGLUTIK
- 6. Contents of the pack and other information
1. What is TEGLUTIK and what is it used for
What is TEGLUTIK
The active substance contained in TEGLUTIK is riluzole, which acts on the nervous system.
What is TEGLUTIK used for
TEGLUTIK is used in patients with amyotrophic lateral sclerosis (ALS).
ALS is a form of motor neuron disease in which the attack on nerve cells responsible for
sending instructions to the muscles leads to weakness, muscle function decline and paralysis.
The destruction of nerve cells in motor neuron disease can be caused by too much
glutamate (a chemical messenger) in the brain and spinal cord. TEGLUTIK interrupts the
release of glutamate and this may help to prevent damage to nerve cells.
Ask your doctor for advice for more information about ALS and why this medicine
has been prescribed for you.
2. What you need to know before taking TEGLUTIK
Do not take TEGLUTIK
- if you are allergic(hypersensitive) to riluzole or to any of the other ingredients of this medicine (listed in section 6),
- if you suffer from liver diseasesor have increased levels of certain liver enzymes in your blood (transaminases),
- if you are pregnantor are breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking TEGLUTIK:
- if you have liver problems:yellowing of the skin or the white of the eye (jaundice), itching all over the body, if you feel unwell, if you are feeling sick;
- if your kidneysare not working very well;
- if you should develop a fever:this could be due to a decrease in white blood cells, such a decrease could cause an increased risk of infections;
If any of the above cases should occur, or if you are not sure, consult your doctor who will decide what to do.
Children and adolescents
If you are under 18 years of age, the use of TEGLUTIK is not recommended in children because there is no
information available in this population.
Other medicines and TEGLUTIK
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those available without a prescription.
Pregnancy, breastfeeding and fertility
DO NOT take TEGLUTIK if you are pregnant or think you might be, or if you are breastfeeding.
If you think you may be pregnant or if you intend to breastfeed, ask your doctor for advice before
taking TEGLUTIK.
Driving and using machines
You can drive or use any tool or machinery unless, after taking this medicine,
you experience dizziness or lightheadedness.
TEGLUTIK contains liquid sorbitol (E420)
This medicine contains 4000 mg of sorbitol (E420) in 10 ml of oral suspension.
Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to some sugars, or
if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients
cannot transform fructose, talk to your doctor before taking this medicine.
This medicine contains less than 1 mmol (23mg) of sodium per 10 ml of oral suspension, i.e.
essentially ‘sodium-free’.
3. How to take TEGLUTIK
The suspension can be administered orally or alternatively is also suitable for administration via an enteral nutrition tube.
Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
The recommended dose is 100 mg per day (50 mg every 12 hours).
10 ml of oral suspension, containing 50 mg of riluzole, must be taken by mouth every 12 hours,
every day at the same time (for example in the morning and in the evening). The suspension is administered
using a graduated dosing syringe.
The oral suspension must be shaken manually and gently for at least 30 seconds,
rotating the bottle 180°, and its homogeneity must then be verified visually.
Method of administration
Instructions for oral administration:
Open the bottle: press the cap and turn counterclockwise (figure 1).
Take the syringe, remove the cap and insert it into the adapter opening (figure 2). Turn the
bottle upside down (figure 3).
Fill the syringe with a small amount of suspension by pulling the plunger down (figure
3), then press the plunger upwards to remove any possible bubbles (figure 3). Pull the
plunger down to the graduation line corresponding to the amount in milliliters (ml) prescribed
by your doctor (figure 3).
Turn the bottle upright (figure 4A). Remove the syringe from the adapter (figure 4B).
o Administer the entire contents of the syringe orally. Dilution with water is not necessary.
o Close the bottle with a plastic cap.
o Wash the syringe with water only and replace its cap once dry (figure 5).
Instructions for administration via enteral feeding tube
Ensure that the enteral feeding tube is not obstructed before
administration.
- 1. Flush the enteral tube with 30 ml of water.
- 2. Administer the required dose of Teglutik oral suspension with a graduated dosing syringe.
- 3. Flush the enteral tube with 30 ml of water.
If you take more TEGLUTIK than you should
If you take too much suspension, contact your doctor or the emergency room
of the nearest hospital immediately.
If you forget to take TEGLUTIK
If you forget to take your dose, skip the missed dose and take the next dose at the usual
time.
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, TEGLUTIK can cause side effects, although not everybody gets them.
manifest.
Important
Contact your doctor immediately
- if you should develop a fever(increase in temperature) because TEGLUTIK can cause a decrease in the number of white blood cells. Your doctor may ask you to have a blood test to check the number of white blood cells, which are important in fighting infections.
- if you should have any of the following symptoms: yellowing of the skin or the white of the eye (jaundice), itching all over the body, if you feel unwell, if you feel sick, because this may indicate a liver disease(hepatitis). Your doctor can perform regular blood tests while you are taking TEGLUTIK to make sure this does not happen.
- if you should have a cough or difficulty 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)
- fatigue
- malaise
- increases in blood levels of certain liver enzymes (transaminases)
Common side effects(may affect more than 1 in 100 people but less than 1 in 10)
- dizziness
- numbness or tingling of the mouth
- vomiting
- drowsiness
- increased heart rate
- diarrhoea
- headache
- abdominal pain
Uncommon side effects(may affect more than 1 in 1,000 people but less than 1 in
100)
- anaemia
- allergic reactions
- inflammation of the pancreas (pancreatitis)
Because riluzole oral suspension is absorbed more quickly than riluzole tablets,
it cannot be excluded that taking it may cause fatigue, dizziness, diarrhoea and increased
transaminases more frequently than riluzole tablets.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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 TEGLUTIK
Keep out of sight and reach of children.
Do not use TEGLUTIK after the expiry date which is stated on the pack and bottle, after
Expiry.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Once opened, use the contents of the bottle within 15 days.
Do not dispose of any medicine in wastewater 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 TEGLUTIK contains
- The active ingredient is riluzole. 1 ml of oral suspension contains 5 mg of riluzole.
- The other ingredients are: liquid sorbitol (E420), aluminium magnesium silicate, xanthan gum, sodium saccharin, simeticone emulsion 30%, sodium lauryl sulfate, macrogol cetostearyl ether, purified water.
Description of the appearance of TEGLUTIK and contents of the pack
This medicine, after gentle manual shaking, appears as an opaque,
homogeneous and slightly brown oral suspension.
TEGLUTIK is available in 250 ml and 300 ml bottles with a graduated plastic dosing syringe.
The product is available in the following pack sizes:
- one or two bottles containing 250 ml of Riluzolo 5 mg/ml oral suspension
- one bottle containing 300 ml of Riluzolo 5 mg/ml oral suspension
The syringe is graduated in millilitres up to 10 ml.
Marketing Authorisation Holder
Italfarmaco S.p.A
Viale Fulvio Testi, 330 - Milan
Tel: +39.02.64431
Fax: +39.02.644346
e-mail: [email protected]
Manufacturer and final control
Italfarmaco S.A.
28108 Alcobendas (Madrid) (E), San Rafael, 3 – Polig. Industrial de Alcobendas
Tel: +34.916572336
Fax: +34. 916572361
This leaflet was last approved
Nie jesteś pewien, czy ten lek jest odpowiedni dla ciebie?
Omów swoje objawy i leczenie z lekarzem online.
Zacząłeś przyjmować lek i masz pytania?
Omów swoje objawy i leczenie z lekarzem online.
- Kraj rejestracji
- Postać farmaceutycznaOral suspension, 5 MG/ML
- Kod ATCN07XX02
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki TELUTIKPostać farmaceutyczna: Orodispersible film, 50 MGSubstancja czynna: riluzoleProducent: ZAMBON S.P.A.Wymaga receptyPostać 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 recepty
Odpowiedniki TELUTIK w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik TELUTIK w Hiszpania
Odpowiednik TELUTIK w Polska
Odpowiednik TELUTIK w Ukraina
Lekarze online w sprawie TELUTIK
Omów stosowanie TELUTIK, bezpieczeństwo i ocenę zasadności recepty zgodnie z obowiązującymi przepisami.
Uzyskaj receptę na TELUTIK online
Wypełnij 2-minutowy formularz
Opisz swoje objawy, historię choroby i lek, o który prosisz.
Wybierz lekarza lub pozwól nam przydzielić
Wybierz specjalistę lub dopasujemy Cię do najbliższego dostępnego lekarza.
Lekarz analizuje Twój przypadek
Zazwyczaj w ciągu 30 minut. Może zadawać dodatkowe pytania przez czat.
Odbierz w dowolnej aptece
Recepta elektroniczna wysłana na Twój e-mail — ważna w całej Polsce.
Często zadawane pytania
TELUTIK nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w TELUTIK jest riluzole. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
TELUTIK jest produkowany przez ITALFARMACO 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 TELUTIK 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 TELUTIK 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. EMYLIF, RILUTEK, RILUTSOLO AUROBINDO. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
