Инструкция по применению RILUTSOLO TSENTIVA
Содержание инструкции
Riluzolo Zentiva 50mg film-coated tablets
riluzolo
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 Riluzolo Zentiva is and what it is used for
- 2. What you need to know before you take Riluzolo Zentiva
- 3. How to take Riluzolo Zentiva
- 4. Possible side effects
- 5. How to store Riluzolo Zentiva
- 6. Contents of the pack and other information
1. What is Riluzolo Zentiva and what is it used for
What is Riluzolo Zentiva
The active substance contained in Riluzolo Zentiva is riluzole, which acts on the nervous system.
What is Riluzolo Zentiva used for
Riluzolo Zentiva 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 atrophy 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. Riluzolo Zentiva interrupts
the release of glutamate and this can help prevent damage to nerve cells.
Ask your doctor for more information about ALS and why this
medicine has been prescribed for you.
2. What you need to know before taking Riluzolo Zentiva
Do not take Riluzolo Zentiva
- if you are allergicto 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 breastfeeding.
Warnings and precautions
Talk to your doctor before taking Riluzolo Zentiva
- 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 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. Use of Riluzolo Zentiva is not recommended because there is no
information available in this population.
Other medicines and Riluzolo Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Pregnancy, breastfeeding and fertility
DO NOT take Riluzolo Zentiva 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 Riluzolo Zentiva.
Driving and operating machinery
You can drive or use any tool or machinery unless, after taking this medicine,
you feel dizzy or lightheaded.
3. How to take Riluzolo Zentiva
Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one tablet twice a day.
The tablets must be taken by mouth, every 12 hours, at the same time of day each
day (e.g. in the morning and in the evening).
If you take more Riluzolo Zentiva than you should
If you take too many tablets, contact your doctor immediately or the emergency department
of the nearest hospital.
If you forget to take Riluzolo Zentiva
If you have forgotten to take your tablet, skip the missed dose and take the next tablet at its
usual time.
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
IMPORTANT
Contact your doctor immediately
- if you should develop fever(increased temperature) as Riluzolo Zentiva 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 experience 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 are feeling sick, as this may indicate a liver disease(hepatitis). Your doctor may perform regular blood tests while you are taking Riluzolo Zentiva to ensure that this does not occur.
- if you should develop 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) of Riluzolo
Zentiva are:
- fatigue
- discomfort
- increases in blood levels of certain liver enzymes (transaminases)
Common side effects(may affect up to 1 in 10 people but less than 1 in 100)
of Riluzolo Zentiva are:
dizziness numbness or tingling of the mouth vomiting
drowsiness increased heartbeat diarrhea
headache abdominal pain pain
Uncommon side effects(may affect up to 1 in 1,000 people but less than 1
in 100) of Riluzolo Zentiva are:
- anemia
- allergic reactions
- inflammation of the pancreas (pancreatitis).
Not known:frequency cannot be estimated based on the 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 listed in Annex V. By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Riluzolo Zentiva
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 pack and on the blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
6. Contents of the pack and other information
What Riluzolo Zentiva contains
- The active substance is riluzole
- The other ingredients are: Core: anhydrous dibasic calcium phosphate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, sodium croscarmellose. Coating: hypromellose, macrogol 6000, titanium dioxide (E 171).
Description of the appearance of Riluzolo Zentiva and contents of the pack
The tablets are film-coated, capsule-shaped and white. Each tablet contains 50 mg of
riluzole, with “RPR 202” inscribed on one side.
Riluzolo Zentiva is available in packs of 28, 56, 98, 112 or 168 tablets for oral
use.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic
Manufacturers
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France
For any further information on this medicine, please contact the local representative of the Marketing
Authorisation Holder:
België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 280 86 420
[email protected]
Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]
България
Zentiva, k.s.
Тел: +35924417136
[email protected]
Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]
Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]
Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]
Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]
Malta
Zentiva, k.s.
Tel: +356 277 82 052
[email protected]
Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]
Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]
Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]
Norge
Zentiva Denmark ApS
Tlf: +47 219 66 203
[email protected]
Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]
Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]
España
Zentiva, k.s.
Tel: +34 931 815 250
[email protected]
Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]
France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]
Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]
Hrvatska
Zentiva d. o. o.
Tel: +385 1 6641 830
[email protected]
Ireland
Zentiva, k.s.
Tel: +353 766 803 944
[email protected]
România
ZENTIVA S.A.
Tel: +4 021.304.7597
[email protected]
Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]
Ísland
Zentiva Denmark ApS
Sími: +354 539 0650
[email protected]
Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]
Italia
Zentiva Italia S.r.l.
+39-02-38598801
[email protected]
Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]
Κύπρος
Zentiva, k.s.
Τηλ: +357 240 30 144
[email protected]
Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]
Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]
United Kingdom (Northern Ireland)
Zentiva, k.s.
Tel: +44 (0) 800 090 2408
[email protected]
Annex IV
Scientific conclusions and justifications for the variation of the terms of the marketing
authorisations
Scientific conclusions
Taking into account the evaluation by the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Reports (PSUR) for riluzole, the scientific conclusions of the
Committee for Human Medicinal Products (CHMP) are as follows:
In light of the available data from spontaneous reports relating to skin rash, which include in
some cases a close temporal relationship, a dechallenge and/or a positive rechallenge, the PRAC has
concluded that a causal relationship between riluzole and skin rash is at least a reasonable
possibility and that the product information of products containing riluzole must be
modified accordingly.
The CHMP agrees with the PRAC’s scientific conclusions.
Justifications for the variation of the terms of the marketing authorisations
Based on the scientific conclusions on riluzole, the CHMP considers that the benefit/risk ratio
of the medicinal products containing riluzole remains unchanged, subject to the proposed changes to the
product information.
The CHMP recommends the variation of the terms of the marketing authorisations.
- Страна регистрации
- Форма выпускаFilm-coated tablet, 50 MG
- Код АТХN07XX02
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги RILUTSOLO TSENTIVAФорма выпуска: Orodispersible film, 50 MGДействующее вещество: РилузолПроизводитель: ZAMBON S.P.A.Отпускается по рецептуФорма выпуска: Film-coated tablet, 50 MGДействующее вещество: РилузолПроизводитель: SANOFI WINTHROP INDUSTRIEОтпускается по рецептуФорма выпуска: Film-coated tablet, 50 MGДействующее вещество: РилузолПроизводитель: AUROBINDO PHARMA (ITALIA) S.R.L.Отпускается по рецепту
Аналоги RILUTSOLO TSENTIVA в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог RILUTSOLO TSENTIVA в Испания
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Действующее вещество RILUTSOLO TSENTIVA — Рилузол. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
RILUTSOLO TSENTIVA производится компанией ZENTIVA K.S.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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