Package leaflet: Information for the user. Provera 2.5mg, 5mg and 10mg Tablets Medroxyprogesterone acetate

Transcription

1 Package leaflet: Infrmatin fr the user Prvera 2.5mg, 5mg and 10mg Tablets Medrxyprgesterne acetate Read all f this leaflet carefully befre yu start using this medicine because it cntains imprtant infrmatin fr yu. - Keep this leaflet. Yu may need t read it again. - If yu have any further questins, please ask yur dctr, pharmacist r nurse. - This medicine has been prescribed fr yu nly. D nt pass it n t thers. It may harm them, even if their signs f illness are the same as yurs. - If yu get any side effects, talk t yur dctr, pharmacist r nurse. This includes any pssible side effects nt listed in this leaflet. See sectin 4. What is in this leaflet 1. What Prvera Tablets are and what they are used fr 2. What yu need t knw befre yu take Prvera Tablets 3. Hw t take Prvera Tablets 4. Pssible side effects 5. Hw t stre Prvera Tablets 6. Cntents f the pack and ther infrmatin 1. What Prvera Tablets are and what they are used fr This medicine cntains medrxyprgesterne acetate, which is ne f a grup f medicines called prgestgens. Prgestgens are similar t the natural female hrmne, prgesterne. Prvera has several uses. Yu can take Prvera t treat r manage: Heavy perids Painful perids Irregular perids r perids that are mre frequent than nrmal Absence f perids Mild t mderate endmetrisis (where tissue frm yur wmb is fund utside yur wmb) Yu must talk t a dctr if yu d nt feel better r if yu feel wrse. 2. What yu need t knw befre yu take Prvera Tablets Prvera may nt be suitable fr all wmen. Please read the fllwing list carefully t see if any f these apply t yu. Cnsult yur dctr if yu are nt sure. D nt take Prvera if yu: are allergic t medrxyprgesterne acetate r ther similar hrmne medicines, r t any f the ther ingredients f this medicine (listed in sectin 6) are pregnant, r think yu might be pregnant. Yur dctr may give yu a pregnancy test befre starting treatment r if yu miss a perid during treatment. have nw r have had in the past breast cancer have nw r have had in the past bld clts frming in yur veins (venus thrmbsis) have nw r have had in the past bld clts frming in yur arteries (arterial thrmbsis) have liver prblems have prphyria where yur bdy lacks the ability t crrectly prduce certain enzymes and it manifests with either neurlgical cmplicatins r with skin prblems (r ccasinally bth) Warnings and precautins

2 Talk t yur dctr r pharmacist befre taking Prvera Tablets if yu have any f the fllwing cnditins t help him r her decide if Prvera is suitable fr yu: Epilepsy Migraine headaches Asthma Heart prblems Kidney prblems Diabetes Depressin r a histry f depressin High bld pressure Liver prblems Gallstnes Systemic lupus erythematsus (SLE) = an allergic cnditin which causes jint pain, skin rashes and fever Hearing prblems Prvera, especially in high dses, may cause weight gain and fluid retentin. Risk f Venus Thrmbemblism (VTE) All wmen have a small chance f having a bld clt in the veins f the leg, in the lung r ther part f the bdy. The chances f getting a clt are very slightly higher if yu are taking a hrmne medicine like Prvera. Yu are mre likely t get a clt whether r nt yu are taking Prvera if yu: are very verweight have had a bld clt in the veins r lungs befre have relatives wh have had bld clts are unable t mve fr lng perids f time (fr example after an peratin) have a serius injury r have majr surgery have a histry f repeated miscarriage Tell yur dctr if yu have just had an peratin r if yu are ging t have an peratin while taking Prvera. Sectin 4 f this leaflet Pssible side effects, als has mre infrmatin n the warning signs f bld clts. Other medicines and Prvera Tell yur dctr r pharmacist if yu are taking, have recently taken r might take any ther medicines, including medicines btained withut a prescriptin. The effect f Prvera may be altered when taken at the same time as any f the fllwing medicines: Aminglutethimide, smetimes used in Cushing s syndrme Medicines fr thinning the bld (e.g. warfarin) Medicines fr treating cnvulsins (e.g. phenbarbital, phenytin and carbamezapine) Ritnavir and nelfinavir, smetimes used t treat HIV and AIDS Medicines fr treating infectins (e.g. rifampicin, rifabutin, nevirapine, efavirenz) St Jhn s wrt, a herbal treatment fr depressin Pregnancy If yu are pregnant, think yu may be pregnant r are planning t have a baby, ask yur dctr r pharmacist fr advice befre taking this medicine. Prvera must nt be taken if yu are pregnant as hrmnal medicines can affect the develping baby. It is imprtant yu use anther methd f cntraceptin (e.g. a cndm) while taking Prvera, as it is nt a cntraceptive.

3 Breast-feeding If yu are breast-feeding, speak t yur dctr wh will advise whether yu shuld use an alternative methd f feeding yur baby. Driving and using machines N effect n the ability t drive r use machines has been seen with Prvera. Prvera Tablets cntain lactse, sucrse and sunset yellw (E110) Lactse and sucrse are types f sugar. If yu have been tld by yur dctr that yu have an intlerance t sme sugars, cntact yur dctr befre taking this medicinal prduct. Prvera 2.5 mg Tablets als cntain sunset yellw (E110) which may cause allergic reactins. 3. Hw t take Prvera Tablets Always take this medicine exactly as yur dctr r pharmacist has tld yu. Check with yur dctr r pharmacist if yu are nt sure. The number f tablets will depend n the cnditin yu are being treated fr. This infrmatin can als be fund n the label n the bx the tablets cme in. The fllwing infrmatin will help yu see what the usual dse is fr a particular prblem. Taking Prvera fr heavy r irregular bleeding and ther perid prblems Yu will usually take 2.5mg-10mg fr 5-10 days beginning 16 days t 21 days after yur last perid began. Treatment shuld be given fr 2 cnsecutive cycles. In sme cases, yur dctr may als prescribe estrgen t be taken at the same time as Prvera at dses f 5-10mg fr 10 days. A few days after yu stp taking the tablets yu may have bleeding like a perid (breakthrugh bleeding). Taking Prvera when yu have amenrrhea (when yu are nt having perids) Yu will usually take 2.5mg-10mg fr 5-10 days beginning n a day which has been calculated r assumed t represent Day 16 t Day 21 f yur menstrual cycle. Repeat the treatment fr 3 cnsecutive cycles. In sme cases, yur dctr may als prescribe estrgen t be taken at the same time as Prvera fr 10 days. A few days after yu stp taking the tablets, yu may have bleeding like a perid (breakthrugh bleeding). Taking Prvera fr endmetrisis (where tissue frm yur wmb is fund utside yur wmb) Yu will usually take 10mg 3 times a day (30mg) fr 3 mnths (90 days) starting n the first day f yur perid. If yu have any irregular sptting r bleeding during treatment this is nrmal and nthing t wrry abut. If yu d nt have a perid after yu finish a curse f Prvera, check with yur dctr in case yu are pregnant. If yu frget t take Prvera Take the tablet as sn as yu remember, and carry n taking the tablets at the nrmal times. D nt take a duble dse t make up fr a frgtten dse. If yu take mre Prvera than yu shuld If yu take t many tablets, cntact yur dctr straight away. Make sure that nbdy else takes yur tablets. If yu stp taking Prvera D nt stp taking yur medicine r alter the dse yu are currently taking withut seeing yur dctr first. It is imprtant t keep taking yur medicine.

4 If yu have any further questins n the use f this medicine, ask yur dctr r pharmacist. 4. Pssible side effects Like all medicines, this medicine can cause side effects, althugh nt everyne gets them. Reasns fr stpping Prvera treatment immediately Rarely, Prvera may cause a severe allergic reactin which can be life-threatening in sme cases. Yu can get sme r all f the fllwing symptms: wheezing, difficulty breathing, feeling faint, swelling f the face r tngue, hands and feet, intense itchy skin rash. If yu think yu are reacting badly t the medicine, get emergency medical help immediately. If yu get any f the fllwing symptms, yu shuld stp taking the tablets and see yur dctr immediately. These culd all be warning signs f thrmbsis (a bld clt) which will need urgent treatment. Sudden, severe, sharp pain in yur chest Cughing up bld Yu suddenly becme shrt f breath Yur heart beats mre rapidly These are symptms f a bld clt in the lungs Yu have an unusually severe r lng headache Yur sight is affected in any way Yu find it difficult t speak Yu cllapse r faint Any part f yur bdy feels weak r numb These can be symptms f a bld clt in the brain ( a strke ) Yu have severe pain, tenderness r swelling in yur calf, ankle r ft Yu have purple discluratin f the skin f the leg r the skin becmes red and warm t tuch These are symptms f a deep-vein thrmbsis (DVT). Other side effects Yu can als get the fllwing side effects with medicines like Prvera: Effects n the reprductive system and breasts: breast pain and tenderness, a milky discharge frm the breast when nt pregnant r breastfeeding (galactrrhea). Effects n the nervus system: headache, depressin, dizziness, fatigue, difficulty sleeping, feeling sleepy, nervusness. Effects n the stmach and intestines: feeling sick. Effects n yur heart and circulatin: bld clts, including clts in the lung, and swelling in the veins due t bld clts, strke, heart attacks. Effects n yur skin, nse, thrat r hair: generalised itching, rash, hives, acne, excessive hair grwth n the face r bdy, hair lss. Miscellaneus: fluid retentin and swelling f hands and ankles, weight changes, decreased tlerance t sugars like glucse. Reprting f side effects If yu get any side effects, talk t yur dctr, pharmacist r nurse. This includes any pssible side effects nt listed in this leaflet. Yu can als reprt side effects directly via the Yellw

5 Card Scheme at: By reprting side effects, yu can help prvide mre infrmatin n the safety f this medicine. 5. Hw t stre Prvera Tablets Keep this medicine ut f the sight and reach f children. Prvera tablets shuld nt be used after the expiry date which is stated n the cartn, blister strip r bttle label after EXP. The expiry date refers t the last day f that mnth. D nt stre yur tablets abve 25 C, and keep yur blister strips securely in the uter cartn. D nt thrw away any medicines via wastewater r husehld waste. Ask yur pharmacist hw t thrw away medicines yu n lnger use. These measures will help prtect the envirnment. 6. Cntents f the pack and ther infrmatin What Prvera lks like and cntents f the pack Prvera 2.5mg tablets are range and are available in blisters cntaining 10, 30, 50, r 100 tablets r in bttles cntaining 100 tablets. Prvera 5mg tablets are blue and are available in packs f 10, 20 r 100 tablets r in bttles cntaining 100 tablets. Prvera 10mg tablets are white and are available in packs f 10, 20, 30, 50, 90 r 100 tablets r in bttles cntaining 50 tablets. Nt all pack sizes may be marketed. What Prvera Tablets cntains The active ingredient is medrxyprgesterne acetate, the tablets als cntain the fllwing inactive ingredients: 2.5 mg: Lactse mnhydrate, sucrse, maize starch, liquid paraffin, talc, calcium stearate, sunset yellw (E110), purified water. 5 mg: Lactse mnhydrate, starch, sucrse, liquid paraffin, calcium stearate, talc, the clur FD & C Blue N. 2 Aluminium Lake, purified water. 10 mg: Lactse mnhydrate, sucrse, maize starch, liquid paraffin, talc, calcium stearate, purified water. Marketing Authrisatin Hlder and Manufacturer Marketing Authrisatin Hlder: Pfizer Limited, Ramsgate Rad, Sandwich, Kent, CT13 9NJ, United Kingdm. Manufacturer: Pfizer Italia S.r.l., Lcalità Marin del Trnt, Ascli Picen (AP), Italy. Cmpany Cntact Address: Fr further infrmatin n yur medicine, please cntact Medical Infrmatin, Pfizer Limited, Waltn Oaks, Drking Rad, Tadwrth, Surrey, KT20 7NS, UK. Telephne: This leaflet was last revised in 12/2014 Ref: PV LD 8_3