Avance bobina - Medicines

1 1 SANOFI AMBARES - FRANCE libell : NOT EPILIM CHR CP QC RL GBSens d enroulementPortrait4a Nord/North4A - 4 BXPaysage1a Est/East 1A - 2B-Item Code:789982 Article : Leaflet/NoticeCode laetus : 5630 Country : GBColor Nbr : 2 Ref Fiche TechniqueBased on: 778350 Format : 170X210-QCFont : Ocean Sans Pro SanAMBRS-M002187 NOT_S-Proof n : 5C. requirement: CRGB-V1-05/2012 Font size : 9ptAMBRS-M002188 NOT_DCAMBRS-M002189 NOT_DP-Creation Date: 31/08/2020 Used Color printable :Pantone Black et Reflex blue +d grad et tram No printable color :PlanBy : NOT_TCAMBRS-M002191 NOT_TPModif Date: 12/10/2020By : I. SOURBEAMBRS-M002192 NOT_QPXPACKAGE LEAFLET: INFORMATION FOR THE USERE pilim Chrono 200, 300 and500 Controlled Release Tabletssodium valproateIs this leaflet hard to see or read?Phone 0800 035 2525 for helpThis medicine is subject to additional will allow quick identification of new safetyinformation.

2 You can help by reporting any side effectsyou may get. See the end of section 4 for how to reportside all of this leaflet carefully before you starttaking this medicine because it contains importantinformation for you. 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. Do notpass it on to others. It may harm them even if theirsymptoms are the same as yours. If you get any side effects, talk to your doctor orpharmacist. This includes any possible side effectsnot listed in this leaflet. See section 4. What is in this leaflet1. What Epilim Chrono is and what it is used for2. What you need to know before you take EpilimChrono3. How to take Epilim Chrono4. Possible side effects5. How to store Epilim Chrono6. Contents of the pack and other informationWhat Epilim Chrono isThe name of your medicine is Epilim Chrono 200, 300or 500 Controlled Release Tablets (called EpilimChrono in this leaflet).

3 Controlled release means thatthe active ingredient sodium valproate is slowlyreleased from the tablets over a period of Epilim Chrono containsEpilim Chrono contains sodium valproate. It belongs toa group of Medicines called anti-convulsants or anti-epileptic agents. It works by helping to calm the Epilim Chrono is used forEpilim Chrono is used to treat epilepsy (fits) in adultsand not take Epilim Chrono and tell yourdoctor if:XYou are allergic (hypersensitive) to sodium valproateor any of the other ingredients of Epilim Chrono(listed in section 6).Signs of an allergic reaction include: a rash,swallowing or breathing problems, swelling of yourlips, face, throat or have liver problems or you or your family havea history of liver have a rare illness called have a known metabolic disorder, a ureacycle have a genetic problem caused by amitochondrial disorder ( Alpers-Huttenlocher syndrome).XYou are pregnant, unless nothing else works for you(see Pregnancy, breast-feeding and fertility Important advice for women below).

4 1. What Epilim Chrono is and what it is used for2. What you need to know before you take EpilimChronoTurnOver Epilim Chrono, sodium valproate, can seriouslyharm an unborn baby when taken duringpregnancy. If you are a female able to have ababy you should use an effective method of birthcontrol (contraception) without interruption duringyour entire treatment with Epilim Chrono. Yourdoctor will discuss this with you but you must alsofollow the advice in section 2 of this an urgent appointment with your doctorif you want to become pregnant or if you thinkyou are not stop taking Epilim Chrono unless yourdoctor tells you to as your condition may you are a parent or caregiver of a female childtreated with Epilim Chrono, you must also readsection 2 of this leaflet carefully and contact yourchild s doctor once they experience their AMBARES - FRANCE libell : NOT EPILIM CHR CP QC RL GBSens d enroulementPortrait4a Nord/North4A - 4 BXPaysage1a Est/East 1A - 2B-Item Code:789982 Article : Leaflet/NoticeCode laetus : 5630 Country : GBColor Nbr : 2 Ref Fiche TechniqueBased on: 778350 Format : 170X210-QCFont : Ocean Sans Pro SanAMBRS-M002187 NOT_S-Proof n : 5C.

5 Requirement: CRGB-V1-05/2012 Font size : 9ptAMBRS-M002188 NOT_DCAMBRS-M002189 NOT_DP-Creation Date: 31/08/2020 Used Color printable :Pantone Black et Reflex blue +d grad et tram No printable color :PlanBy : NOT_TCAMBRS-M002191 NOT_TPModif Date: 12/10/2020By : I. SOURBEAMBRS-M002192 NOT_QPXIf you are a woman able to have a baby you must nottake Epilim Chrono unless you use an effective methodof birth control (contraception) at all times during yourtreatment with Epilim Chrono. Do not stop takingEpilim Chrono or your contraception until you havediscussed this with your doctor. Your doctor will adviseyou further (see below under Pregnancy, breast-feeding and fertility Important advice for women ).Do not take this medicine if any of the above apply toyou. If you are not sure, talk to your doctor orpharmacist before taking Epilim and precautions A small number of people being treated with anti-epileptics such as sodium valproate have hadthoughts of harming or killing themselves.

6 If at anytime you have these thoughts, immediately contactyour doctor. As with other anti-epileptic drugs, convulsions maybecome worse or happen more frequently whilsttaking this medicine. If this happens contact yourdoctor to your doctor or pharmacist before taking EpilimChrono if: You have diabetes. This medicine may affect theresults of urine tests. You have a carnitine palmitoyltransferase type IIdeficiency. You have kidney problems. Your doctor may giveyou a lower dose. You have a brain disease or a metabolic conditionaffecting your brain. You have a urea cycle disorder where too muchammonia builds up in the body. You have an illness called systemic lupuserythematosus (SLE) a disease of the immunesystem which affects skin, bones, joints and internalorgans. You know that there is a genetic problem caused bya mitochondrial disorder in your you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking gainTaking Epilim Chrono may make you put on to your doctor about how this will affect testsYour doctor may wish to do blood tests before youstart taking Epilim Chrono and during your Medicines and Epilim ChronoPlease tell your doctor or pharmacist if you are takingor have recently taken any other Medicines .

7 Thisincludes Medicines you buy without a prescription,including herbal Medicines . This is because EpilimChrono can affect the way some other Medicines some Medicines can affect the way Epilim following Medicines can increase the chance ofyou getting side effects, when taken with EpilimChrono: Some Medicines used for pain and inflammation(salicylates) such as aspirin. Some other Medicines used to treat fits (epilepsy) see page 2, section 3, Patients taking othermedicines for fits . This includes Medicines such asphenobarbital, primidone, phenytoin,carbamazepine, rufinamide, topiramate,acetazolamide, lamotrigine and Chrono may increase the effect of thefollowing Medicines : Medicines used for thinning the blood (such aswarfarin). Zidovudine used to treat HIV infection. Temozolomide used to treat cancer. Medicines for depression. Monoamine oxidase inhibitors (MAOI) such asmoclobemide, selegiline, linezolid.

8 Medicines used to calm emotional and mentalhealth problems (including schizophrenia, bipolardisorder and depression) such as quetiapine,diazepam and olanzapine. Nimodipine. Propofol used for following Medicines can affect the way EpilimChrono works: Oestrogen-containing products (including some birthcontrol pills). Some Medicines used for the prevention andtreatment of malaria such as mefloquine andchloroquine. Cimetidine used for stomach ulcers. Protease inhibitors such as lopinavir and ritonavir used for HIV infection and AIDS. Carbapenem agents (antibiotics used to treatbacterial infections) such as imipenem, meropenem,rifampicin and erythromycin. The combination ofEpilim Chrono and carbapenems should be avoidedbecause it may decrease the effect of your medicine. Cholestyramine used to lower blood fat (cholesterol) Epilim Chrono with food and drinkAlcohol intake is not recommended during AMBARES - FRANCE libell : NOT EPILIM CHR CP QC RL GBSens d enroulementPortrait4a Nord/North4A - 4 BXPaysage1a Est/East 1A - 2B-Item Code:789982 Article : Leaflet/NoticeCode laetus : 5630 Country : GBColor Nbr : 2 Ref Fiche TechniqueBased on: 778350 Format : 170X210-QCFont : Ocean Sans Pro SanAMBRS-M002187 NOT_S-Proof n : 5C.

9 Requirement: CRGB-V1-05/2012 Font size : 9ptAMBRS-M002188 NOT_DCAMBRS-M002189 NOT_DP-Creation Date: 31/08/2020 Used Color printable :Pantone Black et Reflex blue +d grad et tram No printable color :PlanBy : NOT_TCAMBRS-M002191 NOT_TPModif Date: 12/10/2020By : I. SOURBEAMBRS-M002192 NOT_QPXP regnancy, breast-feedingand fertilityImportant advice for women You must not use Epilim Chrono if you are pregnant,unless nothing else works for you. If you are a woman able to have a baby, you mustnot take Epilim Chrono unless you use an effectivemethod of birth control (contraception) during your entire treatment with Epilim Chrono. Do not stop taking Epilim Chrono or your birthcontrol (contraception), until you have discussed thiswith your doctor. Your doctor will advise you risks of valproate when taken during pregnancy Talk to your doctor immediately if you are planningto have a baby or are pregnant.

10 Valproate carries a risk if taken during higher the dose, the higher the risks but alldoses carry a risk. It can cause serious birth defects and can affect theway in which the child develops as it grows. Birthdefects which have been reported include spinabifida(where the bones of the spine are not properlydeveloped); facial and skull malformations; heart,kidney, urinary tract and sexual organ malformations;limb defects. Hearing problems or deafness havebeen reported in children exposed to valproateduring pregnancy. If you take valproate during pregnancy you have ahigher risk than other women of having a child withbirth defects that require medical valproate has been used for many years weknow that in women who take valproate around 10babies in every 100 will have birth defects. Thiscompares to 2-3 babies in every 100 born to womenwho don t have epilepsy. It is estimated that up to 30-40% of preschoolchildren whose mothers took valproate duringpregnancy may have problems with early childhooddevelopment.