PACKAGE LEAFLET: INFORMATION FOR THE USER TERAZOSIN ACCORD 1 mg TABLETS TERAZOSIN ACCORD 2 mg TABLETS TERAZOSIN ACCORD 5 mg TABLETS TERAZOSIN

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER TERAZOSIN ACCORD 1 mg TABLETS TERAZOSIN ACCORD 2 mg TABLETS TERAZOSIN ACCORD 5 mg TABLETS TERAZOSIN 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 any further 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. 1. What Terazsin Tablets is and what it is used fr Terazsin belngs t the class f drugs knwn as alpha-1- selective adrenreceptr blcking agents. Terazsin Tablets are used t: treat mild t mderate high bld pressure (hypertensin) treat a cnditin called benign prstatic hyperplasia (BPH). This cnditin is caused by vergrwth f the prstate gland and is cmmn in lder men. When the prstate gland grws t big, it can partially blck the flw f urine ut f the bladder. This leads t symptms such as: a weak r intermittent flw f urine a need t pass water mre frequently r at night a sudden need t pass water. 2. Befre yu take Terazsin Tablets D nt take Terazsin Tablets: If yu are allergic (hypersensitive) t the active ingredient, terazsin, t ther quinazlines (e.g. prazsin, dxazsin alfuzsin, indramin r tamsulsin) r t any f the excipients. If yu have ever experienced a brief lss f cnsciusness when passing water, r just after passing water. This symptm happens mre cmmnly if yu get up during the night t pass water. Take special care with Terazsin Tablets: Please tell yur dctr if yu are suffering r have ever suffered frm any f the fllwing cnditins r illnesses. Fainting, unsteadiness r vertig (a sensatin f spinning arund) caused by lw bld pressure n standing up. It is mre cmmn: when yu first start treatment when yu restart treatment after a few days break if yur bdy des nt have enugh fluids if yu are n a lw-salt diet in elderly peple (ver 65 years f age) Yu may be mre likely t experience fainting n standing if: yur dse f Terazsin is increased rapidly yu are als taking a diuretic (water tablet) r ther medicine t help reduce yur bld pressure. Yu may ntice that yu have a rapid heartbeat just befre fainting. The risk f fainting is greatest between 30 and 90 minutes after having taken yur dse f Terazsin. Hyptensin (lw bld pressure). Yur dctr will mnitr yur bld pressure. Heart prblems such as water in the lungs r heart failure Impaired liver functin Advanced kidney failure that requires intensive treatment r dialysis Absence f urine prductin r decrease f the flw f urine Upper urinary tract bstructin (when it is difficult fr the urine t flw frm the kidneys t the bladder) Persistent infectin f the urinary tract (an infectin that culd nt been cured by treatment) Bladder stnes If yu are underging eye surgery because f cataract (cludiness f the lens) please infrm yur eye specialist befre the peratin that yu are using r have previusly used Terazsin. This is because Terazsin may cause cmplicatins during the surgery, which can be managed if yur specialist is prepared in advance. Using ther medicines: If yu are taking mre than ne medicine, there is always a risk that the medicines interfere with each ther. Therefre, please tell yur dctr r pharmacist if yu are taking r have recently taken any ther medicines, including medicines btained withut a prescriptin.

2 It is especially imprtant fr yur dctr t knw if yu are already taking any f the fllwing: Other medicines used in the treatment f high bld pressure (ther antihypertensive agents r ther alphareceptr blckers) Clnidine (administered intravenusly) Nitrates used t treat heart pain (angina) Nn-steridal anti-inflammatry drugs (NSAIDs), such as ibuprfen r diclfenac, used as an antirheumatic r pain reliever Oestrgens (female hrmnes, e.g. used in cntraceptives) Medicines including any f the fllwing substances: dpamine, ephedrine, adrenaline, metaraminl, methxamine, phenylephrine Sympathmimetics (e.g. medicines t increase bld pressure r heart frequency r widen the windpipes such as epinephrine used in the treatment f severe allergic reactins and beta-2-agnists used in the treatment f asthma) Medicines used fr the treatment f erectile dysfunctin (PDE-5 inhibitrs e.g. sildenafil, tadalafil, vardenafil) Taking Terazsin Tablets with fd and drink: Taking fd and drink has n influence n yur treatment with Terazsin Tablets. Please be aware that alchl may increase the risk f dizziness, light-headedness r drwsiness. Pregnancy and breast-feeding: Terazsin Tablets are nt recmmended during pregnancy and breast-feeding. Ask yur pharmacist r dctr fr advice befre taking any medicine Driving and using machines: Terazsin tablets have a majr influence n the ability t drive and use machines. Dizziness, light-headedness r drwsiness may ccur with the initial dse r in assciatin with missed dses and subsequent restart f terazsin therapy. Patients shuld be cautined abut these pssible adverse events and the circumstances in which they may ccur and advised t avid driving r hazardus tasks fr apprximately the first 12 hurs after the initial dse r when the dse is increased. Imprtant infrmatin abut sme f the ingredients f Terazsin Tablets: This medicine cntains milk sugar (lactse). If yu knw that yu have intlerance t sme sugars, cntact yur dctr befre taking this medicine. 3. Hw t take Terazsin Tablets Always take Terazsin Tablets exactly as yur dctr has instructed yu. Yu shuld check with yur dctr r pharmacist if yu are nt sure. The tablets shuld be taken nce daily at bedtime, since there is always a risk f dizziness r weariness. Avid sudden changes in psitin r activities, which culd cause dizziness r weariness. This is especially imprtant if yu are elderly (ver 65 years f age) and/r when the treatment is started. Treatment f high bld pressure (hypertensin) Yur dctr will adjust yur dse depending n hw yu respnd t treatment. The usual dse schedule is shwn belw: Treatment f hypertensin First week f treatment Secnd week f treatment Usual maintenance dse (if bld pressure is well cntrlled) If bld pressure is nt cntrlled at a dse f, the dse may be dubled at weekly intervals. D nt take mre than the maximum dse indicated belw. Maximum dse Recmmended Dse f Terazsin Tablets 1 mg daily 20 mg daily Yur dctr will increase yur dse f Terazsin until yur bld pressure is well cntrlled. Once yur bld pressure is well cntrlled, yur dse will nt be changed. The usual maintenance dse is 2 mg per day, thugh smetimes it is necessary t use a higher dse. D nt take mre than the maximum dse f 20 mg. Treatment f high bld pressure with Terazsin is usually lng-term. Yu shuld nt stp therapy unless yu are tld t d s by yur dctr. If it becmes necessary t interrupt yur treatment with Terazsin fr a shrt time, yu shuld re-start treatment at the starting dse. If yur dctr prescribes anther bld pressure medicine in additin t Terazsin, he/she will reduce the dse f Terazsin. Treatment f benign prstatic hyperplasia (BPH)

3 Yur dctr will adjust yur dse depending n hw yu respnd t treatment. The usual dse schedule is shwn belw: Treatment f BPH First week f treatment Secnd and third week f treatment Furth week f treatment: respnse t treatment is reviewed and dse increased if necessary Usual recmmended dse Maximum daily dse Recmmended Dse f Terazsin Tablets 1 mg daily up t 5 mg daily 5 mg nce daily 10 mg daily Yu may suffer shrt-lived undesirable effects (see Sectin 4 Pssible side effects) each time yur dse is increased. If any f these undesirable effects persists, yur dctr may reduce yur dse. After 4 weeks n the maintenance dse, yur dctr will assess hw well yu are respnding t the treatment. Children and adlescents Terazsin is nt recmmended fr children and adlescents under 18 years. Elderly Patients N dse adjustment is necessary in the elderly (ver 65 years f age). Yu shuld take yur tablets at the same time each day e.g. bedtime. Swallw yur tablets with half a glass f water. D nt break r crush them. If yu take mre Terazsin Tablets than yu shuld: If yu have taken mre Terazsin Tablets than yu were tld t, r if smene else has taken any Terazsin Tablets, cntact accident and emergency department f yur nearest hspital immediately fr advice. Take any left ver tablets r empty bx with yu fr easier identificatin. Taking t may tablets may cause yur bld pressure t fall t lw and ther serius effects. Likely symptms f verdse The likely symptms f verdse are: dizziness cnfusin fainting shrtness f breath fall in bld pressure palpitatins (being able t feel yur heart beating in yur chest) rapid heartbeat nausea (feeling sick) lw levels f glucse (sugar) in the bld lw levels f ptassium in the bld muscle spasm (cramps) If yu frget t take Terazsin Tablets: If yu frget t take a dse f Terazsin Tablets, yu can take it as sn as yu remember unless it is time fr the next dse, in which case yu shuld cntinue with yur medicatin as prescribed. D nt take a duble dse t make up fr a frgtten dse. D nt take mre than ne tablet a day. If yu stp taking Terazsin Tablets: D nt stp taking Terazsin Tablets unless yur dctr tells yu t. If yu have any further questins n the use f this prduct, ask yur dctr r pharmacist. 4. Pssible side effects Like all medicines Terazsin Tablets can cause side effects, althugh nt everybdy gets them. The fllwing side effects are imprtant and will require immediate actin if yu experience them. Yu shuld stp taking Terazsin Tablets and see yur dctr immediately if the fllwing symptms ccur: Rare side effects affecting fewer than 1 in 1,000 patients Prlnged and painful penile erectin Very rare side effects affecting fewer than 1 in 10,000 patients a sudden allergic reactin with shrtness f breath, rash, wheezing and drp f bld pressure

4 The fllwing side-effects have als been reprted: Cmmn side effects (less than 1 per 10, but at least 1 per 100 patients): Nervusness Blurred r altered visin Breathlessness (Dyspnea) Back pain Palpitatins Nausea Erectile failure Dizziness Itching Sleepiness Cnstipatin Skin rash Tingling sensatin in skin Diarrhea Nasal cngestin Sensatin f spinning Vmiting Sinusitis arund (Vertig) Fast heart beat Light-headedness Nse bleed (Epistaxis) Chest pain Headache Fluid retentin and swelling Feeling f weakness Pain in the extremities Fainting n standing Uncmmn side effects (less than 1 per 100, but at least 1 per 1000 patients): Depressin Decreased sex drive Weight gain Hives Lss f cnsciusness Rare side effects (less than 1 per 1,000, but at least 1 per 10,000 patients): Urinary tract infectin and urinary incntinence (primarily reprted in pst-menpausal wmen) Very rare side effects (less than 1 f 10,000 patients): Easy bruising r bleeding Irregular heart beat (Atrial fibrillatin) In additin, the fllwing side effects have been reprted in clinical trials r during marketing experience (the side effects may nt necessarily have been caused by terazsin): fever; pain in back, shulder r abdmen; redness f skin; dry muth; indigestin; flatulence; gut; pain in jints r muscles; anxiety; brnchitis; cld and flu symptms; sre thrat; cugh; sweating; cnjunctivitis; ringing in ears and frequent urinatin. 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. 5. Hw t stre Terazsin Tablets Keep ut f the reach and sight f children. Stre in the riginal package in rder t prtect frm light. D nt take the tablets past the expiry date, which is clearly marked n the cartn and blister pack after EXP. The expiry date refers t the last day f that mnth. Medicines shuld nt be dispsed f via wastewater r husehld waste. Ask yur pharmacist hw t dispse f medicines n lnger required. These measures will help t prtect the envirnment. 6. Further infrmatin What Terazsin Tablets cntains: The active substance is terazsin (as terazsin mnhydrchlride dihydrate). Each tablets cntains 1 mg f terazsin. Each tablets cntains 2 mg f terazsin. Each tablets cntains 5 mg f terazsin. The ther ingredients are lactse mnhydrate, maize starch, talc and magnesium stearate (E470B). Terazsin 2 mg tablets als cntain the clurant Quinline yellw (E104) Terazsin 5 mg tablets als cntain the clurant Irn xide red (E172) What Terazsin Tablets lks like and cntent f the pack: Terazsin Tablets 1 mg (White, rund flat, tablets with beveled edges and scre line n ne side f the tablet) The scre line is nly t facilitate breaking fr ease f swallwing and nt t divide int equal dses. Terazsin Tablets 2 mg (Yellw clured, rund flat, tablets with beveled edges and scre line n ne side f the tablet) This tablet can be divided in t equal halves Terazsin Tablets 5 mg (Light pink clured, rund flat, tablets with beveled edges and scre line n ne side f the tablet) The scre line is nly t facilitate breaking fr ease f swallwing and nt t divide int equal dses. Terazsin Tablets are available in PVC/PVdC - aluminium blister packs cntaining: 1mg tablets: 14 2mg tablets: 14, 28 5mg tablets: 28 Nt all pack sizes may be marketed.

5 Marketing authrisatin hlder and Manufacturer: Accrd Healthcare Limited, Sage huse, 319, Pinner Rad, Nrth Harrw, Middlesex HA1 4HF, UK. This medicinal prduct is authrised in the Member States f the EEA under the fllwing names: Cuntry Prpsed Name Bulgaria : Terazsin Accrd 1 / 2 / 5 mg Tablets Czech Republic : Terazsin Accrd 1 / 2 / 5 mg Tablets Denmark : Terazsin Accrd 1 / 2 / 5 mg Tablets Estnia : Terazsin Accrd Germany : Terazsin Accrd 1 / 2 / 5 mg Tabletten Greece : Δισκία Terazsin Accrd 1 / 2 / 5 mg Hungary : Terazsin Accrd 1 / 2 / 5 mg Tablets Ireland : Terazsin 1 / 2 / 5 mg Tablets Latvia : Terazsin Accrd 1 / 2 / 5 mg Tablets Lithuania : Terazsin Accrd 1 / 2 / 5 mg tabletės Malta : Terazsin Accrd 1 / 2 / 5 mg Tablets Pland : Terazsin Accrd 1 / 2 / 5 mg Tabletki Prtugal : Terazsina Accrd Rmania : Terazsin Accrd 1 / 2 / 5 mg Cmprimate Spain : Terazsin Accrd 1 / 2 / 5 mg Cmprimids EFG Sweden : Terazsin Accrd 1 / 2 / 5 mg Tablets The Netherland : Terazsine Accrd 1 / 2 / 5 mg Tabletten UK : Terazsin 1 / 2 / 5 mg Tablets The leaflet was last apprved in T be cmpleted natinally.