Read all of this leaflet carefully before you start taking this medicine.

Transcription

1 Due t regulatry changes, the cntent f the fllwing Patient Infrmatin Leaflet may vary frm the ne fund in yur medicine pack. Please cmpare the 'Leaflet prepared/revised date' twards the end f the leaflet t establish if there have been any changes. If yu have any dubts r queries abut yur medicatin, please cntact yur dctr r pharmacist. Package leaflet infrmatin fr the user Primlut N 5 mg tablets (nrethisterne) Read all f this leaflet carefully befre yu start taking this medicine. Keep this leaflet. Yu may need t read it again. If yu have mre questins, ask yur dctr r pharmacist. This medicine has been prescribed fr yu. D nt pass it n t thers. It may harm them, even if their symptms are the same as yurs. If any f the side effects gets serius, r if yu ntice any side effects nt listed in this leaflet, please tell yur dctr r pharmacist. In this leaflet 1. What Primlut N is and what it is used fr 2. Befre yu take Primlut N 3. Hw yu take Primlut N 4. Pssible side effects 5. Hw t stre Primlut N 6. Further infrmatin 1. What Primlut N is and what it is used fr Primlut N cntains nrethisterne, which belngs t a grup f medicines called prgestgens, which are female hrmnes. v009_0 Page 1 f 7

2 Primlut N can be used in several different circumstances: t treat irregular, painful r heavy perids t treat endmetrisis (where tissue frm the lining f the wmb is present in places where it is nt nrmally fund) t treat premenstrual syndrme (als knwn as premenstrual tensin, PMS r PMT) t delay perids 2. Befre yu take Primlut N D nt take Primlut N if yu are: allergic t nrethisterne r any f the ther ingredients. The ingredients are listed in sectin 6 pregnant r if yu think yu might be pregnant breastfeeding. r if yu have: (r are recvering frm) a liver disease and the bld tests shw that yur liver is nt yet wrking nrmally (r have ever had) liver tumurs. angina r recently have had a heart attack r strke diabetes which is affecting yur bld vessels. any type f cancer which might be made wrse by expsure t female sex hrmnes (including breast cancer). prblems with genital bleeding fr which the cause is nt yet knwn. a cnditin called endmetrial hyperplasia which has nt been treated. Bld clts D nt take Primlut N if yu have bld clts in the legs, lungs, eyes r elsewhere, r have any medical cnditin which makes yu mre at risk f develping clts. T reduce the risk f bld clts, treatment with Primlut N must be stpped: six weeks befre any planned majr peratin befre any surgery t the legs befre medical treatment fr varicse veins if yu are ging t be immbilised fr a lng time (e.g. if yu need bed-rest after an accident r peratin, r if yu have a plaster cast n a brken leg) In additin, d nt take Primlut N if yu have had any f the fllwing cnditins when yu were pregnant: yellwing f the skin (idipathic jaundice f pregnancy) itching f the whle bdy (pruritus f pregnancy) v009_0 Page 2 f 7

3 Tell yur dctr if any f these apply t yu and d nt take Primlut N. The dctr will take special care: If yu have diabetes. Primlut N can prduce changes in bld sugar levels. If yu are diabetic, yur dctr will check yur bld sugar befre starting treatment and regularly during treatment. If yu suffer frm epilepsy, migraine, asthma, heart prblems r kidney prblems. If yu have previusly had a cnditin called chlasma where the skin n yur face may develp brwnish bltches. Yu may be advised t avid expsure t the sun and t ultravilet light while yu are taking Primlut N. If yu have previusly suffered frm depressin. If yu have an intlerance t sme types f sugar (galactse intlerance, Lapp lactase deficiency r glucse-galactse malabsrptin). Tell yur dctr befre yu take Primlut N if any f these applies t yu. Other medicines and Primlut N Tell yur dctr abut any ther medicines that yu are taking, r tk recently. This includes any prducts yu bught withut a prescriptin. Sme medicines may affect the way Primlut N wrks. Tell yur dctr if yu are taking: Phenytin, xcarbazepine, primidne r carbamazepine. These drugs are ften used t treat epilepsy. Sedative drugs called barbiturates. The antibitic drugs rifampicin r rifabutin. An antifungal drug called grisefulvin. St Jhn s wrt t treat depressin. Sme ther medicines may be affected by Primlut N. Tell yur dctr if yu are taking a drug called ciclsprin which is ften used after an rgan transplant. Taking Primlut N can affect the results f sme bld and urine tests. Tell yur dctr that yu are taking Primlut N if yu are asked t prvide a bld r urine sample. Other things yu shuld knw: Once yu have finished taking a curse f Primlut N, yu will usually have a menstrual bleed (perid) 2-3 days after taking yur last tablet. If yu d nt have a perid, yu must make sure that yu are nt pregnant befre taking any mre tablets. The risk f bld clts ccurring in the veins and arteries is slightly greater in wmen wh take the cmbined ral cntraceptive pill than in wmen wh dn t. Peple d nt always fully recver frm such bld clts, which can cause strkes, heart attacks and bleeding int the brain (subarachnid haemrrhage). In very rare cases these bld clts can be fatal. Althugh Primlut N is nt an ral cntraceptive, the risk f develping bld clts still exists. This risk may be higher if yu: v009_0 Page 3 f 7

4 have had bld clts befre, r if a clse family member has had bld clts. are very verweight. suffer frm a cnditin called systemic lupus erythematus. On rare ccasins, the use f hrmnes has been assciated with sme types f liver cancer. These may lead t bleeding in the abdmen. Tell yur dctr if yu feel pain in the upper abdmen that des nt g away. Pregnancy D nt take Primlut N if yu are pregnant. If yu think yu might be pregnant r are planning a family, tell yur dctr befre taking Primlut N. D nt take Primlut N if yu are breastfeeding. Driving and using machines Primlut N is unlikely t affect yur ability t drive r use machines. 3. Hw yu take Primlut N Take the tablets as instructed by yur dctr. The number f tablets that yu need t take and the number f days per mnth when yu need t take them will depend n why the dctr has prescribed Primlut N. A cmmn dsage wuld be 2-3 tablets each day. Fr sme cnditins Primlut N has t be taken every day, but this is nt always the case. Ask yur dctr r pharmacist, if yu are nt sure abut the number f tablets that yu need t take, when they shuld be taken r hw lng yu shuld take them fr. Swallw the tablets whle with a drink f water. If yu take t many tablets Taking t many tablets is unlikely t cause serius prblems. If yu take t many, cntact yur dctr wh will tell yu what d. If yu frget t take the tablets If yu frget a dse, wait until it is time t take the next prescribed dse. D nt take the missed dse. If yu are wrried, cntact yur dctr r pharmacist. 4. Pssible side effects Like all medicines, Primlut N can have side effects but nt everybdy gets them. Reasns fr stpping Primlut N immediately: Stp taking Primlut N and speak t yur dctr immediately if yu experience any f the fllwing: v009_0 Page 4 f 7

5 migraine fr the first time unusually bad headaches, ccurring mre ften than befre sudden changes t yur eyesight, hearing r speech sudden changes t yur senses f smell, taste r tuch symptms f bld clt frmatin r symptms f inflammatin f the veins cmbined with the frmatin f bld clts (thrmbphlebitis): unusual pains in yur leg(s) unusual swelling f yur arms r legs sharp pains in yur chest r sudden shrtness f breath crushing pains r feelings f heaviness r tightness in yur chest cughing fr n apparent reasn ne side f yur bdy suddenly becming very weak r numb Primlut N must als be stpped immediately if: yu becme pregnant yu develp jaundice r ther liver prblems yu develp itching (pruritus) yur dctr finds that yur bld pressure is t high General side effects: Side effects that have been reprted with Primlut N are listed belw accrding t the frequency with which they ccur. Very cmmn side effects (These may affect mre than 1 in 10 peple) Vaginal bleeding, including sptting. Perids that are much shrter than nrmal and where bld flw is reduced. Cmmn side effects (These may affect less than 1 in 10 peple) Headache Feeling sick (nausea) Absence f a perid Swelling Uncmmn side effects (These may affect less than 1 in 100 peple) Migraine Rare side effects (These may affect less than 1 in 1,000 peple) Allergic reactins including skin rash r hives v009_0 Page 5 f 7

6 Very rare side effects (These may affect less than 1 in 10,000 peple) Visual disturbances Difficulty in breathing Other side effects (Frequency unknwn) Wrsening f depressin Dizziness Abdminal pain Jaundice Chlestasis Tell yur dctr if any side effect gets serius, r if yu experience any effects nt listed in this leaflet. Yu shuld als tell yur dctr if yu ntice any changes in yur health r general sense f well-being while yu are taking Primlut N. 5. Hw t stre Primlut N Keep this medicine ut f the reach and sight f children. Stre in the riginal cartn. D nt use after the expiry date which is marked n bth the uter cntainer and n each blister strip f tablets. D nt dispse f medicines in waste water r husehld rubbish. Any unused Primlut N tablets shuld be returned t a pharmacist (chemist) wh will dispse f them prperly. This helps the envirnment. 6. Further infrmatin What Primlut N cntains Each tablet cntains 5 mg f the active ingredient, nrethisterne. The ther ingredients are lactse, maize starch and magnesium stearate (E572). What s in the pack Each pack cntains 30 tablets (3 fil blister packs cntaining 10 tablets each). Each white tablet has AN embssed in a regular hexagn n ne side. Marketing authrisatin hlder: Bayer plc Bayer Schering Pharma Bayer Huse Strawberry Hill Newbury Berkshire RG14 1JA v009_0 Page 6 f 7

7 United Kingdm Manufacturers: Bayer Pharma AG, Berlin, Germany r Bayer Weimar GmBH und C. KG, Weimar, Germany This leaflet last revised: December 2012 Prduct licence number: PL 00010/0553 v009_0 Page 7 f 7