New Zealand Consumer Medicine Information. Tramadol hydrochloride immediate release capsules (50 mg) and solution for injection (50 mg/ml, 100 mg/2ml)

Transcription

1 New Zealand Cnsumer Medicine Infrmatin TRAMAL Tramadl hydrchlride immediate release capsules (50 mg) and slutin fr injectin (50 mg/ml, 100 mg/2ml) What is in this leaflet Please read this leaflet carefully befre yu start using TRAMAL. This leaflet answers sme cmmn questins abut TRAMAL. It des nt cntain all the available infrmatin. It des nt take the place f talking t yur dctr r pharmacist. All medicines have risks and benefits. Yur dctr has weighed the risks f yu taking TRAMAL against the benefits this medicine is expected t have fr yu. If yu have any cncerns abut taking this medicine, ask yur dctr r pharmacist. Keep this leaflet with the medicine. Yu may need t read it again. What TRAMAL is used fr TRAMAL is used t relieve mderate t severe pain and belngs t a grup f medicines called analgesics (pain relievers). Yur dctr may have prescribed TRAMAL fr anther reasn. Ask yur dctr if yu have any questins abut why TRAMAL has been prescribed fr yu. This medicine is available nly with a dctr s prescriptin. TRAMAL is nt nrmally addictive althugh sme cases have been reprted. Befre yu use TRAMAL When yu must nt use it D nt use TRAMAL if: yu have a knwn allergy t TRAMAL r ther pids r any f the ingredients listed at the end f this leaflet. Sme f the symptms f an allergic reactin may include skin rash, itching, difficulty breathing and swelling f the face (including lips, tngue, thrat etc) yu are taking medicine fr depressin cntaining a "mnamine xidase inhibitr" (such as Nardil, Parnate ), r have taken ne within the past tw weeks. yu are suffering frm uncntrlled epilepsy/cnvulsins r epilepsy nt cntrlled by treatment

2 yu drink large amunts f alchl regularly, are dependent/addicted t ther drugs r are underging treatment fr drug r alchl withdrawal D nt use TRAMAL after the expiry date printed n the pack. If yu take this medicine after the expiry date has passed, it may nt wrk as well. D nt use TRAMAL if the packaging is trn r shws signs f tampering. D nt give TRAMAL Capsules t children under 12 years. There is n experience with the use f TRAMAL Capsules in children. If yu are nt sure whether yu shuld start using TRAMAL, talk t yur dctr. Befre yu start t use it Yu must tell yur dctr if: yu have a knwn allergy t TRAMAL r any f the ingredients listed at the end f this leaflet. yu are knwn t be sensitive t piids. yu drink alchl every day. yu have r ever had any ther health prblems, including: any lung r breathing prblems any diseases f the kidney, liver r pancreas severe stmach prblems a serius head injury any fits r cnvulsins/ epilepsy. yu have r have had any prblems with drug r alchl dependence. yu are pregnant r intend t becme pregnant. TRAMAL is nt recmmended fr use during pregnancy. Talk t yur dctr abut the risks and benefits f using TRAMAL during pregnancy. yu are breast-feeding r plan t breast-feed. TRAMAL is nt recmmended fr use during breast-feeding. Talk t yur dctr abut the risks and benefits f using TRAMAL when breast- feeding. If yu have nt tld yur dctr abut any f the abve, tell them befre yu use TRAMAL. Taking ther medicines Tell yur dctr if yu are taking any ther medicines, including medicines that yu buy withut a prescriptin frm yur pharmacy, supermarket r health fd shp. Yu shuld als tell any health prfessinal wh is prescribing a new medicatin fr yu that yu are taking TRAMAL. Sme medicines may interfere with TRAMAL. These include:

3 carbamazepine (eg. Tegretl ) cumarin derivatives (eg. warfarin: Sme Brand names are Cumadin, r Marevan ) medicine fr irregular r rapid heart beat medicines fr depressin, sleeplessness r mental cnditins such as selective sertnin reuptake inhibitrs (SSRI s eg. citalpram brand names Cipramil r Celapram ), sertnin-nradrenaline reuptake inhibitrs (SNRI s eg. dulxetine - brand name Cymbalta ), tricyclic anti-depressants, quinidine, phenthiazines r anti-psychtics sme antibitics. These medicines may be affected by TRAMAL, r may affect hw well it wrks. Yu may need different amunts f yur medicine, r yu may need t take different medicines. Other interactins nt listed abve may als ccur. Yur dctr r pharmacist has mre infrmatin n medicines t be careful with r avid while taking TRAMAL. Hw TRAMAL is used TRAMAL is available as capsules (t swallw) and injectins (t be given int a vein r muscle). Yur dctr will decide: hw yu will receive TRAMAL, what dse and fr hw lng. TRAMAL INJECTIONS TRAMAL Injectin may be given t adults, adlescents r children ver the age f 2 years. TRAMAL Injectin shuld nly be given t children ver the age f 2 years under supervisin f yur dctr. If yu r yur child has been prescribed TRAMAL injectins, yur dctr r nurse will administer them fr yu. Take them with yu when yu visit yur dctr. TRAMAL injectins can be injected int a vein r a muscle. TRAMAL CAPSULES Hw much t take D nt give TRAMAL Capsules t children under 12 years. There is n experience with the use f TRAMAL Capsules in children. Fr mderate pain, ne TRAMAL capsule may be enugh fr the first dse, fllwed by ne r tw capsules tw r three times a day as required. Fr mderate t severe pain, tw TRAMAL capsules are usually required fr the first dse, fllwed by ne r tw capsules every fur t six hurs as required. Patients ver 75 years f age may require a lwer daily dse. D nt take mre than eight TRAMAL capsules per day. Fllw carefully all directins given t yu by yur dctr and pharmacist. These directins may differ frm the infrmatin in this leaflet. If yu d nt understand the instructins n the pack, ask yur dctr r pharmacist fr help.

4 Hw t take it TRAMAL capsules shuld be swallwed whle, with water. When t take it Yu can take TRAMAL befre, with, r after fd. Hw lng t take it Depending n the medical cnditin fr which yu require TRAMAL, yur dctr may tell yu t take it fr nly a day r tw r lnger, up t a few mnths r mre. If yu frget t take it If yu frget t take a dse, yu can take it as sn as yu remember. The next dse shuld be taken after fur r six hurs, r as prescribed by yur dctr. D nt take a duble dse t make up fr the dse that yu missed. While yu are using TRAMAL Things yu must d If yu becme pregnant while yu are taking TRAMAL, tell yur dctr immediately. If yu are abut t be started n any new medicine, tell yur dctr and pharmacist that yu are taking TRAMAL. If yur pain is nt severe and yu feel that yu d nt need as much TRAMAL as yur dctr rdered, cnsult yur dctr. Tell yur dctr if yur pain gets wrse. D nt take extra dses withut checking with yur dctr. If yu have t have any tests tell yur dctr yu are taking TRAMAL. TRAMAL may affect the results f sme tests. Things yu must nt d D nt give TRAMAL t anyne else, even if they have the same cnditin as yu. D nt use TRAMAL t treat any ther cmplaints unless yur dctr tells yu t. Things t be careful f Be careful driving r perating machinery until yu knw hw TRAMAL affects yu. TRAMAL may make yu drwsy r dizzy. In case f verdse If yu take t much (verdse) Immediately telephne yur dctr r the Natinal Pisns Centre POISON ( ) r g t accident and emergency at yur nearest hspital, if yu think that yu r anyne else may have taken t much TRAMAL. D this even if there are n signs f discmfrt r pisning.

5 Yu may need urgent medical attentin. If yu take t many capsules, this may result in breathing difficulty and fits r cnvulsins. Side effects Check with yur dctr as sn as pssible if yu have any prblems while taking TRAMAL, even if yu d nt think the prblems are cnnected with the medicine r are nt listed in this leaflet. Like ther medicines, TRAMAL can cause side effects. If they ccur, mst are likely t be minr and temprary. Hwever, sme may be serius and need medical attentin. Ask yur dctr r pharmacist t answer any questins yu may have. Tell yur dctr if yu ntice any f the fllwing and they wrry yu. Cmmn side effects: dizziness sedatin, fatigue headache cnstipatin nausea r vmiting sweating dry muth Less cmmn side effects: indigestin changes in appetite skin reactins sudden nset f lw bld pressure, cllapse muscle weakness tremr seizures respiratry depressin imprvement in md cnfusin sleep disturbance blurred visin difficulty in passing urine Sertnin Syndrme: signs f this vary and are nt specific. They may include sweating, agitatin, muscle twitching, tremr, spntaneus muscle cntractin and high bdy temperature. Sertnin Syndrme may result frm interactin f tramadl with ther medicines which increase sertnin effects, fr example, the SSRI antidepressants. Tell yur dctr immediately if yu experience any f the fllwing side-effects, as urgent medical treatment may be required: skin rash (red spts r patches), itching, hives, skin lumps swelling r puffiness f the eyelids, face r lips chest tightness, wheezing r pain in the chest heart palpitatins, faintness r cllapse hallucinatins cnvulsins.

6 Other side effects nt listed abve may als ccur in sme patients. Tell yur dctr if yu ntice anything else that is making yu feel unwell. D nt be alarmed by this list f pssible side effects. Yu may nt experience any f them. Can TRAMAL be addictive? When used as prescribed by yur dctr, addictin t TRAMAL is unlikely. If yu are taking TRAMAL fr a prlnged perid f time, yur bdy may becme used t the medicine and mild withdrawal symptms may ccur if yu suddenly stp taking the medicine. It is imprtant therefre t take TRAMAL nly as directed by yur dctr, and d nt suddenly stp taking it. Yur dsage may need t be gradually reduced. After using TRAMAL Strage Keep yur TRAMAL in the pack until it is time t take them. If yu take TRAMAL ut f the pack it may nt keep well. Keep it in a cl dry place where the temperature stays belw 30 C. D nt stre it in the bathrm r near a sink. D nt leave it in the car r n windw sills. Heat and dampness can destry sme medicines. Keep it where children cannt reach it. A lcked cupbard at least 1½ metres abve the grund is a gd place t stre medicines. Dispsal If yur dctr tells yu t stp taking TRAMAL r it passes its expiry date, ask yur pharmacist what t d with any TRAMAL that is left ver. TRAMAL descriptin What it lks like TRAMAL is available as capsules r injectins. Capsules: Each capsule is yellw in clur. They are available in packs f 10, 20, 30 r 50 capsules. Injectins: Clear liquid cntained in 1mL r 2mL glass ampules. Available in packs f 5 ampules. Ingredients Active ingredient: TRAMAL capsules: cntain 50 mg tramadl hydrchlride per capsule. TRAMAL injectins: cntain tramadl hydrchlride either: 50 mg in 1 ml ampules r 100 mg in 2 ml ampules

7 Inactive ingredients: TRAMAL capsules: cellulse-micrcrystalline magnesium stearate sdium starch glycllate silica-cllidal anhydrus irn xide yellw (CI 77492) titanium dixide gelatine sdium lauryl sulfate TRAMAL injectins: sdium acetate water fr injectins. TRAMAL capsules and injectins d nt cntain lactse, sucrse, tartrazine r any ther az dyes. Spnsr Details TRAMAL is supplied in New Zealand by: Seqirus (NZ) Ltd P O Bx Greenlane, Auckland 1546 NEW ZEALAND Telephne: TRAMAL is made in Germany by Grunenthal GmbH. Date f Preparatin Date f Preparatin f this Infrmatin: March 2001 Date f Update f this Infrmatin: March 2017 TRAMAL is a registered trademark f Grunenthal GmbH used by Seqirus as authrised user.