qanastek/EMEA-V3 huggingface dataset:
Presumably through blockade of the renin-angiotensin-aldosterone 24 system, co-administration of ramipril to hydrochlorothiazide tends to reverse the potassium loss associated with these diuretics.
It- teħid flimkien ta ’ ramipril- hydrochlorothiazide F’ studji kliniċi, din l- għaqda irriżultat f’ tnaqqis akbar fil- pressjoni tad- demm milli meta ttieħdu l - prodotti waħidhom. Wisq probabbli minħabba l- inibizzjoni tas- sistema renin- anġjotensin- aldosterone, hemm tendenza li l- għoti flimkien ta ’ ramipril u hydrochlorothiazide jdawru bil- maqlub it- telf ta ’ pottasju li hu assoċjat ma ’ dawn id- dijuretiċi.
Combination of an ACE-inhibitor with a thiazide diuretic produces a synergistic effect and also lessens the risk of hypokalaemia provoked by the diuretic alone.
L- għaqda ta ’ inibitur ACE ma ’ dijuretiku thiazide għandha effett sinerġistiku u wkoll tnaqqas ir- riskju ta ’ ipokalimja li tista ’ tiġi kkawżata mill- użu tad - dijuretiku waħdu.
Pharmacokinetics and Metabolism
Farmakokinetika u Metaboliżmu
Absorption Following oral administration ramipril is rapidly absorbed from the gastrointestinal tract; peak plasma concentrations of ramipril are reached within one hour.
Assorbiment Wara t- teħid b’ mod orali, ramipril jiġi assorbit malajr mill- passaġġ gastrointestinali; l- ogħla konċentrazzjonijiet fil- plażma ta ’ ramipril jinlaħqu fi żmien siegħa.
Peak plasma concentrations of ramiprilat, the sole active metabolite of ramipril are reached 2-4 hours after ramipril intake.
L- ogħla konċentrazzjonijiet fil- plażma ta ’ ramiprilat, l -
Steady-state plasma concentrations of ramiprilat after once daily dosing with the usual doses of ramipril are reached by about the fourth day of treatment.
Wara dożaġġ ta ’ darba kuljum bid- dożi tas- soltu ta ’ ramipril, il- konċentrazzjonijiet fissi ta ’ ramiprilat fil - plażma jintlaħqu mar- raba ’ ġurnata ta ’ kura.
Metabolism Ramipril is almost completely metabolised to ramiprilat, and to the diketopiperazine ester, the diketopiperazine acid, and the glucuronides of ramipril and ramiprilat.
Metaboliżmu Ramipril jiġi kważi metabolizzat għal kollox f’ ramiprilat, u fl- ester diketopiperazine, fl- aċidu diketopiperazine u fil- glukuronidi ta ’ ramipril u ramiprilat.
After multiple once-daily doses of ramipril, the effective half-life of ramiprilat concentrations was 13- 17 hours for the 5-10 mg doses and longer for the lower 1.25-2.5 mg doses.
Wara dożi multipli ta ’ ramipril darba kuljum, il- half- life effettiv tal - konċentrazzjonijiet ta ’ ramiprilat kien ta ’ 13- 17- il siegħa għad- dożi ta ’ 5- 10 mg u itwal għad- dożi iżgħar ta ’ 1. 25- 2. 5 mg.
This difference is related to the saturable capacity of the enzyme to bind ramiprilat.
Din id- differenza hija minħabba l- kapaċità ta ’ saturazzjoni tal- enzima biex tintrabat ma ’ ramiprilat.
However, the effect of multiple doses is not known.
Ma nstabux traċċi ta ’ ramipril jew il- metaboliti tiegħu fil- ħalib tal- omm wara doża waħda li ttieħdet b’ mod orali. Madankollu, l- effett ta ’ dożi multipli mhux magħruf.
Renal excretion of ramiprilat is reduced in patients with impaired renal function, and renal ramiprilat clearance is proportionally related to creatinine clearance.
Pazjenti b’ indeboliment renali (ara sezzjoni 4. 2) It- tneħħija renali ta ’ ramiprilat hija mnaqqsa f’ pazjenti b’ indeboliment fil- funzjoni renali u t- tneħħija renali ta ’ ramiprilat hija relatata proporzjonalment mat- tneħħija tal- krejatinina.
In patients with impaired liver function, the metabolism of ramipril to ramiprilat was delayed due to diminished activity of hepatic esterases, and plasma ramipril levels in these patients were increased.
Pazjenti b’ indeboliment tal- fwied (ara sezzjoni 4. 2) F’ pazjenti b’ indeboliment fil- funzjoni tal- fwied, il- metaboliżmu ta ’ ramipril għal ramiprilat ġie mtawwal minħabba t- tnaqqis fl- attività tal- esterases epatiċi u l- livelli ta ’ ramipril fil- plażma ta ’ dawn il- pazjenti żdiedu.
Absorption Following oral administration about 70% of hydrochlorothiazide is absorbed from the gastrointestinal tract.
Assorbiment Wara t- teħid b’ mod orali, madwar 70% ta ’ hydrochlorothiazide jiġi assorbit mill- passaġġ gastrointestinali.
Peak plasma concentrations of hydrochlorothiazide are reached within 1.5 to 5 hours.
L- ogħla konċentrazzjonijiet ta ’ hydrochlorothiazide fil- plażma jintlaħqu fi żmien 1. 5 sa 5 sigħat.
Distribution The plasma protein binding of hydrochlorothiazide is 40%.
Distribuzzjoni L- irbit ta ’ hydrochlorothiazide mal- proteini fil- plażma hu ta ’ 40%.
25 Metabolism Hydrochlorothiazide undergoes negligible hepatic metabolism.
Metaboliżmu Il- metaboliżmu epatiku hu tista ’ tgħid insinifikanti.
Elimination Hydrochlorothiazide is eliminated almost completely (> 95%) in an unchanged form through the kidneys; 50 to 70% of a single oral dose is eliminated within 24 hours.
Eliminazzjoni Hydrochlorothiazide jiġi eliminat mill- kliewi kważi kompletament (> 95%) bla tibdil; 50 sa 70% ta ’ doża waħda li ttieħdet b’ mod orali tiġi eliminata fi żmien 24 siegħa.
The elimination half-life is 5 to 6 hours.
Il- half- life ta ’ eliminazzjoni hi ta ’ 5 sa 6 sigħat.
Patients with renal impairment (see section 4.2) Renal excretion of hydrochlorothiazide is reduced in patients with impaired renal function, and renal hydrochlorothiazide clearance is proportionally related to creatinine clearance.
Pazjenti b’ indeboliment renali (ara sezzjoni 4. 2) It- tneħħija renali ta ’ hydrochlorothiazide hija mnaqqsa f’ pazjenti b’ indeboliment fil- funzjoni renali u t- tneħħija renali ta ’ hydrochlorothiazide hija relatata proporzjonalment mat- tneħħija tal- krejatinina.
This results in elevated plasma concentrations of hydrochlorothiazide, which decrease more slowly than in subjects with normal renal function.
Dan jirriżulta f’ konċentrazzjonijiet ogħla fil- plażma li jonqsu aktar bilmod meta mqabbla ma ’ pazjenti b’ funzjoni renali normali.
Patients with liver impairment (see section 4.2) In patients with hepatic cirrhosis the pharmacokinetics of hydrochlorothiazide has not changed significantly.
24 F’ pazjenti b’ ċirrożi epatika, il- farmakokinetika ta ’ hydrochlorothiazide ma tinbidilx b’ mod sinifikanti.
The pharmacokinetics of hydrochlorothiazide has not been studied in patients with cardiac failure.
Il- farmakokinetika ta ’ hydrochlorothiazide ma ġietx studjata f’ pazjenti b’ insuffiċjenza kardijaka.
Ramipril and Hydrochlorothiazide The concurrent administration of ramipril and hydrochlorothiazide does not affect their bioavailability.
Ramipril u Hydrochlorothiazide L- għoti fl- istess ħin ta ’ ramipril u hydrochlorothiazide ma jaffettwax il- bijodisponibilità tagħhom.
The combination product can be considered as bioequivalent to products containing the individual components.
Dan il- prodott ta ’ għaqda bejn iż- żewġ mediċini jista ’ jitqies bħala bijoekwivalenti għal prodotti li fihom il - komponenti individwali.
Repeated doses administration studies performed in rats and monkeys revealed only disturbances in electrolytes balance.
Fil- firien u l- ġrieden, l- għoti flimkien ta ’ ramipril u hydrochlorothiazide ma kellu ebda attività tossika akuta sa 10, 000 mg/ kg. Studji ta ’ għoti ta ’ dożi ripetuti fil- firien u x- xadini wrew biss distubi fil- bilanċ elettrolitiku.
No studies on mutagenicity and carcinogenicity have been performed with the combination as studies with individual components showed no risk.
Ma sarux studji ta ’ mutaġeniċità u ta ’ karċinoġeniċità b’ dan il- prodott ta ’ mediċini magħqudin peress li studji bil- komponenti individwali ma wrew ebda riskju.
Reproduction studies in rats and rabbits revealed that the combination is somewhat more toxic than either of the single components but none of the studies revealed a teratogenic effect of the combination.
Studji fuq is- sistema riproduttiva fil- firien u l- fniek urew li dan il- prodott ta ’ mediċini magħqudin kien daqsxejn iżjed tossiku minn kemm wieħed u l- ieħor tal- komponenti individwali iżda ebda studju ma wera li dan il- prodott ta ’ mediċini magħqudin għandu effett teratoġeniku.
26 [To be completed nationally]
[Biex timtela mill- pajjiż partikolari]
[See Annex I - To be completed nationally] {Name and address} {tel} {fax} {e-mail}
[Ara Anness I - Biex timtela mill- pajjiż partikolari]
27 LABELLING
27 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
KARTUNA TA ’ BARRA
TRITAZIDE and associated names (see Annex I) 2.5 mg/12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/25 mg tablets
TRITAZIDE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 2. 5 mg / 12. 5 mg TRITAZIDE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 5 mg / 12. 5 mg TRITAZIDE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 5 mg / 25 mg
ramipril/hydrochlorothiazide
ramipril/ hydrochlorthiazide
[See Annex I - To be completed nationally
[Ara Anness I – Biex timtela mill- pajjiż partikolari]
30 MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS
29 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
ramipril/hydrochlorothiazide
Ramipril/ hydrochlorthiazide
[See Annex I - to be completed nationally]
[Ara Anness I – Biex timtela mill- pajjiż partikolari]
31 PACKAGE LEAFLET
31 FULJETT TA ’ TAGĦRIF:
TRITAZIDE and associated names (see Annex I) 2.5 mg/12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/25 mg tablets [See Annex I - To be completed nationally]
TRITAZIDE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 2. 5 mg / 12. 5 mg TRITAZIDE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 5 mg / 12. 5 mg TRITAZIDE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 5 mg / 25 mg [Ara Anness I – Biex timtela mill- pajjiż partikolari]
Ramipril/Hydrochlorothiazide
Ramipril/ hydrochlorthiazide
What TRITAZIDE is and what it used for 2.
X’ inhu TRITAZIDE u għalxiex jintuża 2.
Before you take TRITAZIDE 3.
Qabel ma tieħu TRITAZIDE 3.
How to take TRITAZIDE 4.
Kif għandek tieħu TRITAZIDE 4.
How to store TRITAZIDE 6.
Kif taħżen TRITAZIDE 6.
WHAT TRITAZIDE IS AND WHAT IT IS USED FOR
X’ INHU TRITAZIDE U GĦALXIEX JINTUŻA
TRITAZIDE is a combination of two medicines called ramipril and hydrochlorothiazide.
TRITAZIDE hu l- għaqda ta ’ żewġ mediċini flimkien imsejħa ramipril u hydrochlorthiazide.
Ramipril belongs to a group of medicines called “ACE inhibitors” (Angiotensin Converting Enzyme Inhibitors).
Ramipril jagħmel parti minn grupp ta 'mediċini li jissejħu inibituri ta' ACE (Inibituri ta 'l- Enzima li Tikkonverti Angiotensin).
It works by: • Decreasing your body’s production of substances that raise your blood pressure • Making your blood vessels relax and widen • Making it easier for your heart to pump blood around your body.
Jaħdem billi: • Inaqqas il- produzzjoni mill- ġisem ta 'sustanzi li jistgħu jgħollulek il- pressjoni • Jirrilassa u jwessa' l- kanali tad- demm • Jiffaċilita l- ippumpjar tad- demm mill- qalb madwar ġismek kollu.
Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics” or water tablets.
Hydrochlorthiazide jagħmel parti minn grupp ta ’ mediċini msejħa “ dijuretiċi thiazide ” jew pilloli tal - ilma.
It works by increasing the amount of water (urine) you produce.
Jaħdem billi jżid l- ammont ta ’ ilma (awrina) li tipproduċi.
This lowers your blood pressure.
Dan ibaxxi l- pressjoni tad- demm tiegħek.
TRITAZIDE is used to treat high blood pressure.
TRITAZIDE jintuża għall- kura ta ’ pressjoni għolja tad- demm.
The two active substances work together to lower your blood pressure.
Iż- żewġ sustanzi attivi jaħdmu flimkien biex ibaxxu l- pressjoni tad- demm.
They are used together when treatment with just one did not work.
Jintużaw flimkien meta l- kura b’ wieħed minnhom biss ma taħdimx.
BEFORE YOU TAKE TRITAZIDE
QABEL MA TIEĦU TRITAZIDE
Do not take TRITAZIDE: • If you are allergic (hypersensitive) to ramipril, hydrochlorothiazide or any of the other ingredients of TRITAZIDE (see section 6) • If you are allergic (hypersensitive) to medicines similar to TRITAZIDE (other ACE inhibitors or sulphonamide derived medicines).
Tieħux TRITAZIDE: • Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal ramipril hydrochlorthiazide jew għal xi ingredjenti oħra ta ’ TRITAZIDE (ara sezzjoni 6) • Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal mediċini simili għal TRITAZIDE (inibituri ACE oħra jew mediċini ġejjin mis- sulfonamidi).
Signs of an allergic reaction may include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
Is- sinjali ta 'reazzjoni allerġika jistgħu jinkludu raxx, problemi biex tibla' jew tieħu nifs, nefħa f' xufftejk, f' wiċċek, f' griżmejk jew f' ilsienek
33 • If you have ever had a serious allergic reaction called “angioedema”.
32 • Jekk qatt xi darba kellek reazzjoni allerġika serja msejħa "anġjoedima".
The signs include itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing • If you are having dialysis or any other type of blood filtration.
Is- sinjali jinkludu ħakk, urtikarja, marki ħomor fl- idejn, saqajn u griżmejn, nefħa tal- griżmejn u l- ilsien, nefħa madwar l - għajnejn u x- xufftejn, diffikultà biex tieħu nifs u tibla '• Jekk qiegħed/ qegħda tagħmel dijalisi jew xi tip ieħor ta' filtrazzjoni tad- demm.
Depending on the machine that is used, TRITAZIDE may not be suitable for you • If you have severe liver problems • If you have abnormal amounts of salt substances (calcium, potassium, sodium) in your blood • If you have kidney problems where the blood supply to your kidney is reduced(renal artery stenosis) • During the last 6 months of pregnancy (see section below on “Pregnancy and breast-feeding”) • If you are breast-feeding (see section below on “Pregnancy and breast-feeding”).
Skont il- magna li qed tintuża, TRITAZIDE jista 'ma jkunx adattat għalik • Jekk għandek problemi serji fil- fwied • Jekk għandek ammonti mhux normali ta ’ sustanzi ta ’ melħ (kalċju, potassju, sodju) fid- demm tiegħek • Jekk għandek problemi tal- kliewi fejn il- provvista tad- demm għall- kliewi hija mnaqqsa (stenosi ta' l- arterja renali) • Waqt l- aħħar 6 xhur ta ’ tqala (ara s- sezzjoni hawn taħt "Tqala u treddigħ") • Jekk qeda tredda ’ (ara s- sezzjoni hawn taħt "Tqala u treddigħ")
Do not take TRITAZIDE if any of the above apply to you.
Jekk għandek xi dubju, kellem lit- tabib tiegħek qabel ma tieħu TRITAZIDE.
If you are not sure, talk to your doctor before taking TRITAZIDE.
Oqgħod attent ħafna b’ TRITAZIDE
This may be given for an operation or any dental work.
Ikkonsulta mat- tabib jew spiżjar tiegħek qabel ma tieħu l- mediċina tiegħek: • Jekk għandek problemi tal- qalb, fwied jew kliewi • Jekk tlift ammont kbir ta 'melħ tal- ġisem jew fluwidi (għax kont ma tiflaħx (tirrimetti), kellek id- dijarea, għereqt aktar mis- soltu, qiegħed/ qegħda fuq dieta bi ftit melħ, qiegħed/ qegħda tieħu dijuretiċi (pilloli ta' l- ilma) għal żmien twil jew kellek dijalisi) • Jekk ser tieħu kura biex tnaqqas allerġija għal tingiż tan- naħal jew żunżan (tneħħija ta 'sensittività) • Jekk ser tirċievi anestesija minħabba operazzjoni jew proċedura dentali.
You may need to stop your TRITAZIDE treatment one day beforehand; ask your doctor for advice • If you have high amounts of potassium in your blood (shown in blood test results) • If you have a collagen vascular d isease such as scleroderma or systemic lupus erythematosus • You must tell your doctor if you think that you are (or might become) pregnant.
Ġurnata qabel jista ’ jkollok bżonn twaqqaf il- kura b’ TRITAZIDE; staqsi t- tabib għal parir. • Jekk għandek ammonti kbar ta 'potassju fid- demm (muri fir- riżultati tat- testijiet tad- demm) • Jekk għandek mard vaskulari ta' collagen bħal skleroderma jew lupus eritematosu sistemiku. • Għandek tgħid lit- tabib jekk taħseb li inti (jew li tista ’ ssir) tqila.
TRITAZIDE is not recommended in the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section below on “Pregnancy and breast-feeding”).
TRITAZIDE mhux rakkomandat fl- ewwel tliet xhur ta ’ tqala u jista ’ jikkawża ħsara serji lit- tarbija tiegħek wara tliet xhur ta ’ tqala (ara s- sezzjoni hawn taħt "Tqala u treddigħ").
Children TRITAZIDE is not recommended for children and young people under the age of 18 years.
Tfal TRITAZIDE mhux rakkomandat fit- tfal u fl- adolexxenti taħt it- 18- il sena.
This is because the drug has never been used in these age groups.
Dan għax il- mediċina qatt ma ntużat f’ dawn il- gruppi ta ’ etajiet.
If any of the above apply to you (or you are not sure), talk to your doctor before taking TRITAZIDE.
Jekk xi waħda minn dawn ta 'hawn fuq tapplika għalik (jew għandek xi dubju), kellem lit- tabib tiegħek qabel ma tieħu TRITAZIDE.
Taking TRITAZIDE with other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (including herbal medicines).
Meta tieħu TRITAZIDE ma 'mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed/ qegħda tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta (inklużi medicini mill- ħxejjex).
This is because TRITAZIDE can affect the way some other medicines work.
Dan għaliex TRITAZIDE jista 'jaffettwa l- mod kif jaħdmu mediċini oħra.
Also some medicines can affect the way TRITAZIDE works.
Barra minn hekk, xi mediċini jistgħu jaffettwaw il - mod kif jaħdem TRITAZIDE.
They can make TRITAZIDE work less well: • Medicines used to relieve pain and inflammation (e.g.
B' dawn TRITAZIDE jista 'jaħdem inqas: • Mediċini li jintużaw biex itaffu l- uġigħ u l- infjammazzjoni (eż.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin) • Medicines used for the treatment of low blood pressure, shock, cardiac failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline.
Mediċini Anti- infjammatorji Mhux Sterojdi (NSAIDs) bħal ibuprofen jew indometacin u aspirina) • Mediċini li jintużaw għall- kura tal- pressjoni baxxa, xokk, insuffiċjenza kardijaka, ażma jew allerġiji bħal ephedrine, noradrenaline jew adrenaline.
They can increase the chance of getting side effects if you take them with TRITAZIDE: • Medicines used to relieve pain and inflammation (e.g.
Jistgħu jżiedu l- probabbilità li jseħħu effetti sekondarji jekk teħodhom ma 'TRITAZIDE:
34 • Medicines which can lower the amount of potassium in your blood.
Mediċini Anti- infjammatorji Mhux Sterojdi (NSAIDs) bħal ibuprofen jew indometacin u aspirina) • Mediċini li jistgħu jbaxxu l- ammont ta 'potassju fid- demm tiegħek.
These include medicines for constipation, diuretics (water tablets), amphotericin B (used for fungal infections) and ACTH (used to test if your adrenal glands are working properly) • Medicines for cancer (chemotherapy) • Medicines for heart problems, including problems with your heartbeat • Medicines to stop the rejection of organs after a transplant such as ciclosporin • Diuretics (water tablets) such as furosemide • Medicines which can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts, and heparin (for thinning blood) • Steroid medicines for inflammation such as prednisolone • Calcium supplements • Allopurinol (used to lower the uric acid in your blood) • Procainamide (for heart rhythm problems) • Colestyramine (for reducing fat amounts in your blood) • Carbamazepine (for epilepsy).
Dawn jinkludu mediċini għall- istitikezza, dijuretiċi (pilloli tal- ilma), amphotericin B (użat għall- infezzjonijiet mill - fungu) u ACTH (użat biex jiċċekkja jekk il- glandoli adrenali m’ humiex jaħdmu tajjeb) • Mediċini għall- kanser (kimoterapija) • Mediċini għall- problemi tal- qalb, li jinkludu problem bit- tħabit tal- qalb • Mediċini li jwaqqfu r- riġettar ta 'organi ttrapjantati bħal ciclosporin • Dijuretiċi (pilloli ta' l- ilma) bħal furosemide • Mediċini li jistgħu jżidu l- ammont ta 'potassju fid- demm tiegħek bħal spironolactone, triamterene, amiloride, melħ ta' potassium u eparina (għat- traqqiq tad- demm) • Mediċini sterojdi għall- infjammazzjoni bħal prednisolone • Supplimenti tal- kalċju • Allopurinol (jintuża biex ibaxxi l- aċidu uriku fid- demm tiegħek) • Procainamide (għal problemi fir- ritmu tal- qalb). • Colestyramine (biex inaqqas l- ammont ta ’ xaħam fid- demm tiegħek) • Cabamazepine (għall- epilessija)
They may be affected by TRITAZIDE: • Medicines for diabetes such as oral glucose lowering medicines and insulin.
Dawn jistgħu jiġu affettwati minn TRITAZIDE: • Mediċini għad- dijabete bħall- insulina u mediċini orali li jbaxxu glucose.
TRITAZIDE may lower your blood sugar amounts.
TRITAZIDE jista 'jbaxxilek iz- zokkor fid- demm.
Check your blood sugar amounts closely while taking TRITAZIDE • Lithium (for mental health problems).
Iċċekkja b' attenzjoni z- zokkor fid- demm waqt li tkun qiegħed/ qegħda tieħu TRITAZIDE • Lithium (għal problemi ta 'saħħa mentali).
TRITAZIDE may increase the amount of lithium in your blood.
TRITAZIDE jista 'jżid l- ammont ta' lithium fid - demm tiegħek.
Your lithium amount will need to be closely checked by your doctor • Medicines to relax your muscles • Quinine (for malaria) • Medicines that contain iodine, these may be used when you are having a scan or X-ray in hospital • Penicillin (for infections) • Medicines to thin the blood that you take by mouth (oral anticoagulants) such as warfarin.
L- ammont ta 'lithium irid jiġi ċċekkjat b' attenzjoni mit- tabib tiegħek. • Mediċini li jirilassaw il- muskoli tiegħek • Quinine (għal malarja) • Mediċini li fihom l- jodju, dawn jistgħu jintużaw meta tkun qed/ a tagħmel xi skenn jew X- ray fl - isptar • Penicillin (għall- infezjonijiet) • Mediċini li tieħu mill- ħalq biex traqqaq id- demm (antikoagulanti orali) bħal warfarin.
Tests Check with your doctor or pharmacist before taking your medicine: • If you are having a test for parathyroid function.
Testijiet Qabel ma tieħu l- mediċina tiegħek iċċekkja mat- tabib jew mal- ispiżjar tiegħek: • Jekk se tagħmel test għal funzjoni tal- paratirojde.
TRITAZIDE might affect the results of the test • If you are sports person having an anti-doping test.
TRITAZIDE jista ’ jaffettwa ir- riżultati tat - test. • Jekk inti sportiv u se jkollok test kontra d- doping.
TRITAZIDE might give you a positive result.
TRITAZIDE jista ’ juri riżultat pożittiv.
Taking TRITAZIDE with food and alcohol • Drinking alcohol with TRITAZIDE may make you feel dizzy or light-headed.
Meta tieħu TRITAZIDE mal- ikel u max- xorb • Ix- xorb alkoħoliku ma TRITAZIDE jista 'jagħmlek sturdut.
If you are concerned about how much you can drink while you are taking TRITAZIDE, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects. • TRITAZIDE may be taken with or without food.
Jekk trid tkun taf kemm tista 'tixrob waqt li tkun qiegħed/ qegħda tieħu TRITAZIDE, kellem lit- tabib tiegħek billi mediċini li jintużaw biex ibaxxu l- pressjoni tad- demm u l- alkoħol jistgħu jkollhom effetti miżjuda. • TRITAZIDE jista' jittieħed ma 'l- ikel jew fuq stonku vojt.
Pregnancy and breast-feeding You must tell your doctor if you think that you are (or might become) pregnant You should not take TRITAZIDE in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby.
M’ għandekx tieħu TRITAZIDE fl- ewwel 12- il ġimgħa ta ’ tqala u m’ għandekx tieħdu wara t- tlettax- il ġimgħa għax l- użu tiegħu waqt it- tqala jista ’ jkun ta ’ periklu għat- tarbija.
If you become pregnant while on TRIT AZIDE, tell your doctor immediately.
Jekk issir tqila waqt li qeda tieħu TRITAZIDE għid lit- tabib tiegħek minnufih.
You should not take TRITAZIDE if you are breast-feeding.
M’ għandekx tieħu TRITAZIDE jekk qeda tredda ’.
Driving and using machines
34 Qabel ma tieħu xi mediċina saqsi lit- tabib jew lill- ispiżjar għal parir.
35 You may feel dizzy, while taking TRITAZIDE.
Sewqan u tħaddim ta ’ magni Tista 'tħossok sturdut waqt li tkun qed tieħu TRITAZIDE.
This is more likely to happen when you start taking TRITAZIDE or start taking a higher dose.
Dan huwa aktar probabbli meta tibda tieħu TRITAZIDE jew tibda tieħu doża akbar.
HOW TO TAKE TRITAZIDE
KIF GĦANDEK TIEĦU TRITAZIDE
Always take TRITAZIDE exactly as your doctor has told you.
Dejjem għandek tieħu TRITAZIDE skont il- parir eżatt tat- tabib.
Taking this medicine • Take this medicine by mouth at the same time of day each day, usually in the morning. • Swallow the tablets with liquid. • Do not crush or chew the tablets.
Meta tieħu din il- mediċina Ħu din il- mediċina mill- ħalq fl- istess ħin kuljum. • Ibla 'l- pilloli b’ xi likwidu. • Tfarrakx u tomogħdx il- pilloli. •
Treatment of high blood pressure Your doctor will adjust the amount you take until your blood pressure is controlled.
Kura tal- pressjoni għolja It- tabib se jbiddel l- ammont li tieħu sakemm il- pressjoni tad- demm tkun taħt kontroll.
If you take more TRITAZIDE than you should Tell a doctor or go to the nearest hospital casualty department straight away.
Jekk tieħu TRITAZIDE aktar milli suppost Għid lil tabib jew mur fl- eqreb emerġenza mill- ewwel.
If you forget to take TRITAZIDE • If you miss a dose, take your normal dose when it is next due. • Do not take a double dose to make up for a forgotten tablet.
Jekk tinsa tieħu TRITAZIDE • Jekk tinsa tieħu doża, ħu d- doża tas- soltu meta jkun jerġa 'jmissek. • Tiħux doża doppja biex tagħmel tajjeb għall- pillola/ kapsula li nsejt tieħu.
Like all medicines, TRITAZIDE can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, TRITAZIDE jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Stop taking TRITAZIDE and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment: • Swelling of the face, lips or throat which make it difficult to swallow or breathe, as well as itching and rashes.
Jekk tinnota xi wieħed mill- effetti sekondarji serji li ġejjin, waqqaf TRITAZIDE u ara tabib mill- ewwel – jista 'jkollok bżonn kura medika urġenti: • Nefħa tal- wiċċ, xufftejn jew griżmejn li tikkawżalek diffikultà biex tibla' jew tieħu nifs, kif ukoll ħakk u raxxijiet.
This could be a sign of a severe allergic reaction to TRITAZIDE • Severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin disease, reddening, blistering or detachment of skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiform).
Dan jista 'jkun sinjal ta' reazzjoni allerġika serja għal TRITAZIDE • Reazzjonijiet tal- ġilda serji fosthom raxx, ulċeri f' ħalqek, iggravar ta 'mard tal- ġilda diġà eżistenti, ħmura, bżieżaq jew stakkar tal- ġilda (bħal sindromu ta' Stevens- Johnsons, nekroliżi tossika tal- ġilda jew eritema multiforma).
Tell your doctor immediately if you experience: • Faster heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness in your chest or more serious problems including heart attack and stroke • Shortness of breath, cough fever lasting 2 to 3 days and feeling less hungry.
Għid lit- tabib tiegħek minnufih jekk tesperjenza: • Rata mgħaġġla tal- qalb, taħbit tal- qalb irregolari jew qawwi (palpitazzjonijiet), uġigħ fis- sider, rassa f' sidrek jew problemi aktar serji fosthom attakk tal- qalb jew puplesija • Qtugħ ta 'nifs, sogħla, deni li jdum għal jumejn jew tlett ijiem ma jkollokx ġuħ.
These could be signs of lung problems including inflammation • Bruising more easily, bleeding for longer than normal, any sign of bleeding (e.g. bleeding from the gums), purple spots, blotching on the skin or getting infections more easily than usual, sore throat and
Dawn jistgħu jkunu sinjali ta 'problemi tal- pulmun inkluż l- infjammazzjoni • Titbenġel malajr, tinfasad għat- tul aktar mis- soltu, xi sinjal ta' fsada (eż. fsada mill- ħanek), tbajja 'vjola li joħorġu fil- ġilda jew tieħu infezzjonijiet aktar faċilment mis- soltu, griżmejk
36 fever, feeling tired, faint, dizzy or having pale skin.
35 juġgħuk u deni, tħossok għajjien, debboli, sturdut jew ikollok ġilda pallida.
These can be signs of blood or bone marrow problems. • Severe stomach pain which may reach through to your back.
Dawn jistgħu jkunu sinjali ta 'problemi fid- demm jew mudullun • Uġigħ qawwi fl- istonku li jista' jinfirex għal daharek.
This could be a sign of pancreatitis (inflammation of the pancreas) • Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice).
Dan jista 'jkun sinjal ta' pankreatite (infjammazzjoni tal- pankreas). • Deni, tkexkix, għeja, telf ta 'aptit, uġigħ fl- istonku, tqalligħ, sfura fil- ġilda jew għajnejk (suffejra).
Common (affects less than 1 in 10 people) • Headache, feeling week or tired • Feeling dizzy.
Komuni (jaffettwa anqas minn 1 minn kull 10 persuni) • Uġigħ ta 'ras, tħossok debboli jew għajjien • Tħossok sturdut.
This is more likely to happen when you start taking TRITAZIDE or start taking a higher dose • Dry tickly cough or bronchitis • Blood test showing a higher amount of sugar than usual in your blood.
Dan huwa aktar probabbli meta tibda tieħu TRITAZIDE jew tibda tieħu doża akbar • Sogħla vojta b’ tagħrixa fil- griżmejn jew bronkite • Testijiet tad- demm li juru ammonti ogħla mis- soltu ta ’ zokkor fid- demm.
If you have diabetes, this may make your diabetes worse • Blood test showing a higher amount of uric acid or more fat than usual in your blood • Painful, red, and swollen joints
Jekk għandek id - dijabete, din tista ’ tagħmilha agħar. • Testijiet tad- demm li juru ammonti ogħla mis- soltu ta ’ aċidu uriku jew xaħam. • Uġigħ fil- ġogi li jkunu ħomor u minfuħin
Uncommon (affects less than 1 in 100 people) • Skin rash with or without raised area • Flushing, fainting, hypotension (abnormally low blood pressure), especially when you stand or sit up quickly • Balance problems (vertigo) • Itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia) • Loss or change in the way things taste • Sleep problems • Feeling depressed, anxious, more nervous or shaky than usual • Blocked nose, inflammation of your sinuses (sinusitis), shortness of breath • Inflammation of the gums (gingivitis), swollen mouth • Red, itchy, swollen or watery eyes • Ringing in your ears • Blurred vision • Hair loss • Chest pain • Pain in your muscles • Constipation, stomach or gut pain • Indigestion or feeling sick • Passing more water (urine) than usual over the day • Sweating more than usual or feeling thirsty • Loss or decrease of appetite (anorexia), feeling less hungry • Increased or irregular heartbeat • Swollen arms and legs.
Mhux komuni (jaffettwa anqas minn 1 minn kull 100 persuna) • Raxx fil- ġilda bil- ponot jew mingħajrhom • Fawra, ħass ħażin, ipotensjoni (pressjoni baxxa tad- demm li mhix normali) speċjalment meta tkun bil- wieqfa jew meta tqum malajr ħafna • Problemi tal- bilanċ (vertiġini) • Ħakk u sensazzjonijiet fil- ġilda mhux tas- soltu bħal titrix, tnemnim, tingiż, ħruq jew tkexkix fil - ġilda (parasteżija) • Telf jew bidla fit- togħma ta 'xi affarijiet • Problemi ta' rqad • Tħossok imdejjaq, ansjuż, aktar nervuż mis- soltu u bla sabar • Imnieħrek miżdud, infjammazzjoni tas- sinuses tiegħek (sinusite), taqta ’ nifsek malajr • Infjammazzjoni tal- ħanek (ġinġivite), ħalq minfuħ • Għajnejn ħomor, jikluk, minfuħin jew idemmgħu • Żarżir f’ widnejk • Vista mċajpra • Jaqagħlek xagħrek • Uġigħ fis- sider • Uġigħ fil- muskoli • Stitikezza, uġigħ fl- istonku u fl- imsaren • Indiġestjoni jew tħossok se tirremetti • Tagħmel l- ilma (awrina) aktar mis- soltu f' ġurnata • Tegħreq aktar mis- soltu jew tħossok bil- għatx • Telf jew nuqqas ta 'aptit (anoressija), ma jkollokx ġuħ daqs is- soltu • Taħbit tal- qalb mgħaġġel jew irregolari • Dirgħajn u saqajn minfuħin.
This may be a sign of your body holding onto more water than usual • Fever • Sexual inability in men • Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets or in the amount of haemoglobin • Blood tests showing changes in the way your liver, pancreas or kidneys are working • Blood tests showing less potassium than usual in your blood.
Jista 'jkun sinjal li ġismek qiegħed iżomm aktar ilma mis- soltu • Deni • Nuqqas ta ’ kapaċità sesswali fl- irġiel • Testijiet tad- demm li juru tnaqqis fin- numru ta' ċelluli tad- demm ħomor, celluli tad- demm bojod jew plejtlits jew fl- ammont ta 'emoglobina. • Testijiet tad- demm li juru tibdil fil- mod ta' kif jaħdmu il- fwied, il- pankreas jew il- kliewi tiegħek. • Testijiet tad- demm li juru anqas potassju mis- soltu fid- demm tiegħek
37 Very rare (affects less than 1 in 10,000 people) • Being sick, getting diarrhoea or heartburn • Red swollen tongue or dry mouth • Blood tests showing more potassium than usual in your blood.
36 Rari ħafna (jaffettwa anqas minn 1 minn kull 10, 000 persuna) • Tħossok imdardar, ikollok dijarea jew ħruq ta ’ stonku • Ilsien aħmar u minfuħ jew ħalq xott • Testijiet tad- demm li juru aktar potassju mis- soltu fid- demm tiegħek
Please tell your doctor if any of the following gets serious or lasts longer than a few days. • Difficulty concentrating, feeling restless or confused • Fingers and toes changing colour when cold and then tingling or painful when you warm up.
Jekk jogħġbok għid lit- tabib tiegħek jekk xi wieħed minn dawn li ġejjin jiggravaw jew idumu aktar minn ftit jiem. • Diffikultà biex tikkonċentra, tħossok aġitat/ a jew konfuż/ a • Swaba 'ta' l- idejn u tas- saqajn jibdlu l- kulur meta tħoss il- bard u jnemnmu jew juġgħu meta tħossok sħun.
This could be R aynaud's phenomenon • Breast enlargement in men • Blood clots • Disturbed hearing • Your eyes watering less than usual • Objects looking yellow • Dehydration • Swelling, pain and redness in your cheek (inflammation of a salivary gland) • A swelling in your gut called “intestinal angioedema” presenting with symptoms like abdominal pain, vomiting and diarrhoea • Being more sensitive to the sun than usual • Severe flaking or peeling of the skin, itchy, lumpy rash or other skin reactions such as red rash on your face or forehead • Skin rash or bruising • Blotches on your skin and cold extremities • Nail problems (e.g. loosening or separation of a nail from its bed) • Musculoskeletal rigidity or not being able to move your jaw (tetany) • Weakness or cramps in your muscles • Reduced sexual desire in men or women • Blood in your water (urine).
Dan jista ’ jkun il- fenomenu ta 'Raynaud • Jikber is- sider fl- irġiel • Ċapep ta ’ demm • Problemi fis- smigħ • L- għajnejn idemmgħu anqas mis- soltu • L- affarijiet jidhru sofor • Deidratazzjoni • Ħaddejn ħomor, juġgħu u minfuħin (infjammazjoni ta ’ glandola salivarja) • Nefħa fl- imsaren imsejħa "anġjoedima intestinali" li tippreżenta b' sintomi bħal uġigħ addominali, rimettar u dijarea • Tkun sensittiv għax- xemx aktar mis- soltu. • Tfarfir jew tqaxxir tal- ġilda gravi, raxx bil- ħakk u bil- boċoċ jew reazzjonijiet tal- ġilda oħra bħal raxx aħmar fuq il- wiċċ jew fuq il- moħħ • Raxx fil- ġilda jew tbenġil • Tbabar fil- ġilda u estremitajiet kesħin • Problemi tad- dwiefer (eż. difer li jinħall jew jinqala' mill- qiegħ) • Riġidità muskolu- skeltrali jew ma tkunx tista ’ ċċaqlaq ix- xedaq (tetani) • Għeja jew bugħawwiġijiet fil- muskoli tiegħek • Nuqqas ta 'ħajra sesswali fl- irġiel jew fin- nisa • Demm fl- ilma (awrina) tiegħek.
This could be a sign of a kidney problem (interstitial nephritis) • More sugar than usual in your water (urine) • An increased number of certain white blood cells (eosinophilia) found during a blood test • Blood tests showing too few blood cells in your blood (pancytopenia) • Blood tests showing a change in the amount of salts such as sodium, calcium, magnesium and chloride in your blood • Slowed or impaired reactions • Change in the way things smell • Difficulty breathing or worsening of asthma
Dan jista ’ jkun sinjal ta ’ problema fil- kliewi (nefrite interstizjali) • Aktar zokkor mis- soltu fl- ilma (awrina) tiegħek • Numru ogħla ta 'tip ta' ċelluli tad- demm bojod (eosinofilja) jinstab f' test tad- demm • Testijiet tad- demm juru ftit wisq ċelluli tad- demm fid- demm tiegħek (panċitopinja) • Testijiet tad- demm juru tibdil fl- ammont ta ’ mluħa bħal sodju, kalċju, magnesju u klorju fid - demm tiegħek. • Tirreaġixxi aktar bil- mod jew b' mod batut • Bidla f' kif jinxtammu l- affarijiet • Diffikultà biex tieħu n- nifs jew l- ażma tmur għall- agħar
HOW TO STORE TRITAZIDE
KIF TAĦŻEN TRITAZIDE
[To be completed nationally]
X’ fih TRITAZIDE [Biex timtela mill- pajjiż partikolari]
38 What TRITAZIDE looks like and contents of the pack
Id- Dehra ta ’ TRITAZIDE u l- kontenuti tal- pakkett
Tablets [To be completed nationally]
37 Pilloli, [Biex timtela mill- pajjiż partikolari]
{Name and address} {tel} {fax} {email}
{Isem u indirizz} {telefon} {fax} {e- mail}
39 Hungary:
L- Ungerija:
Italy:
38 L- Italja:
{MM/YYYY} [To be completed nationally]
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS} [Biex timtela mill- pajjiż partikolari]
This leaflet does not contain all the information about your medicine.
Dan il- fuljett ma fihx it- tagħrif kollu dwar il- mediċina tiegħek.
If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Jekk għandek xi mistoqsijiet jew għandek xi dubju, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Ref.
Londra, 18 ta ’ Marzu 2009 Dok. ta ’ Ref.
EMEA/ CHMP/ 204584/ 2009
EMEA/ 202996/ 2009
Questions and answers on the referral for Tritazide tablets containing ramipril and hydrochlorothiazide 2.5/ 12.5 mg, 5/ 12.5 mg, 5/ 25 mg
Mistoqsijiet u tweġibiet dwar ir- referenza għall- pilloli Tritazide li fihom ramipril u hydrochlorothiazide 2. 5/ 12. 5 mg, 5/ 12. 5 mg, 5/ 25 mg
The European Medicines Agency (EMEA) has completed a review of Tritazide.
L- Aġenzija Ewropea dwar il- Mediċini (EMEA) temmet reviżjoni ta ’ Tritazide.
The Agency’ s Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Tritazide in the European Union and the European Economic Area (EEA).
Il- Kumitat tal- Aġenzija għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li hemm ħtieġa li l - informazzjoni tal- preskrizzjoni għal Tritazide tkun armonizzata fl- Unjoni Ewropea (UE) u fiż- Żona Ekonomika Ewropea (ŻEE).
What is Tritazide?
X’ inhu Tritazide?
Tritazide contains two active substances, ramipril and hydrochlorothiazide.
Tritazide fih żewġ sustanzi attivi, ramipril u hydrochlorothiazide.
Ramipril is an angiotensin converting enzyme (ACE) inhibitor.
Ramipril huwa inibitur tal- enzima li tikkonverti l- anġjotensina (ACE).
This allows the heart to pump blood more easily, and the blood flow increases due to more blood being pumped into and through larger passageways.
Dan jgħin lill- qalb tippompja d- demm b’ mod aktar faċli, u l- fluss tad- demm jiżdied minħabba li aktar demm ikun qiegħed jiġi ppumpjat ġo u minn passaġġi usa ’.
Hydrochlorothiazide (HCTZ) is a diuretic.
Hydrochlorothiazide (HCTZ) huwa dijuretiku.
It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.
Jaħdem billi jżid il- produzzjoni tal- awrina, inaqqas l- ammont ta ’ fluwidu fid- demm u jbaxxi l- pressjoni tad- demm.
Tritazide is used in the treatment of hypertension and it is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or hydrochlorothiazide alone.
Tritazide jintuża fil- kura tal- ipertensjoni u huwa indikat f’ pazjenti li l- pressjoni tad- demm tagħhom mhijiex ikkontrollata b’ mod adegwat b’ ramipril waħdu jew b’ hydrochlorothiazide waħdu.
Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden.
Tritazide ilu awtorizzat fl- UE sa mill- 1993, l- ewwel fil- Ġermanja u mbagħad fil- pajjiżi li ġejjin: fl - Awstrija, fil- Belġju, fil- Bulgarija, f’ Ċipru, fir- Repubblika Ċeka, fid- Danimarka, fl- Estonja, fil - Finlandja, fi Franza, fil- Ġermanja, fil- Greċja, fl- Ungerija, fl- Irlanda, fl- Italja, fil- Lussemburgu, fl - Olanda, fil- Polonja, fil- Portugall, fir- Rumanija, fis- Slovakja, fis- Slovenja, u fl- Iżvezja.
Tritazide can also be available in the EU and the EEA under other trade names:
Tritazide jista ’ jkun disponibbli wkoll fl- UE u fiż- ŻEE taħt ismijiet kummerċjali oħra:
Tritace Plus, Triatec Plus, Triatec Comp, Tritace Comp, Tritace Comb, Triatec Composto, Triatec Composto Forte, Cardace Comp, Cardace Plus, Cotriatec, Delix Plus, Ramilich Comp, Tritace HCT, Triatec HCT, Ramipril e Idrocloritiazide, Ramicor D, and Triatec Comp Mite, Hypren Plus, Hypren Plus Forte, Vesdil Plus, Ramipril HCT Zentiva, Unipril Diur, Idroquark..
Tritace Plus, Triatec Plus, Triatec Comp, Tritace Comp, Tritace Comb, Triatec Composto, Triatec Composto Forte, Cardace Comp, Cardace Plus, Cotriatec, Delix Plus, Ramilich Comp, Tritace HCT, Triatec HCT, Ramipril e Idrocloritiazide, Ramicor D, u Triatec Comp Mite, Hypren Plus, Hypren Plus Forte, Vesdil Plus, Ramipril HCT Zentiva, Unipril Diur, Idroquark.
The company that markets Tritazide is Sanofi-aventis.
Il- kumpanija li tikkummerċjalizza Tritazide hija Sanofi- aventis.
Why was Tritazide reviewed?
Għaliex ġie rivedut Tritazide?
Tritazide is authorised in the European Union (EU) via national procedures.
Tritazide huwa awtorizzat fl- Unjoni Ewropea (UE) permezz ta ’ proċeduri nazzjonali.
This has led to divergences across member states on the way the medicine can be used, as seen in the differences observed in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed.
Dan wassal għal diverġenzi fost l- Istati Membri dwar il- mod kif tista ’ tintuża l- mediċina, kif jidher fid- differenzi osservati fis- Sommarji tal- Karatteristiċi tal- Prodott (SPCs), fit- tikketta u fil- fuljett ta ’ tagħrif fil- pajjiżi
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. fejn jiġi kummerċjalizzat il- prodott.
On 18 January 2008, the European Commission referred the matter to the Committee for Medicinal Products for Human Use (CHMP) in order to harmonise the marketing authorisations for Tritazide in the EU and the EEA.
Fit- 18 ta ’ Jannar 2008, il- Kummissjoni Ewropea rreferiet il- kwistjoni lill- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) sabiex jarmonizza l- awtorizzazzjonijiet għat- tqegħid fis - suq għal Tritazide fl- UE u fiż- ŻEE.
The CHMP noted inconsistencies in the wording of the indication across countries, with terms including ‘ essential hypertension’, ‘ arterial hypertension’ and ‘ arterial essential hypertension’ being used.
Is- CHMP innota inkonsistenzi fil- kliem tal- indikazzjoni madwar il- pajjiżi, bl- użu ta ’ termini li jinkludu ‘ ipertensjoni essenzjali ’, ‘ ipertensjoni arterjali ’ u ‘ ipertensjoni essenzjali arterjali ’.
The CHMP highlighted that fact that the indication should be hypertension, and as add-on therapy when each monotherapy has failed.
Is- CHMP enfasizza l- fatt li l- indikazzjoni għandha tkun ipertensjoni, u bħala kura addizzjonali meta kull monoterapija tkun falliet.
The combination ramipril 2.5 mg/ HCTZ 12.5 mg led to greater reduction in blood pressure than the treatment with individual components and the combination of 5 mg/ 25 mg produced a better therapeutic effect than doubling the ramipril dose to 10 mg.
Il- kombinazzjoni ta ’ ramipril 2. 5 mg / HCTZ 12. 5 mg wasslet għal tnaqqis akbar fil- pressjoni tad - demm milli l- kura b’ komponenti individwali u l- kombinazzjoni ta ’ 5 mg/ 25 mg ipproduċiet effett terapewtiku aħjar mill- irduppjar tad- doża ta ’ ramipril għal 10 mg.
Considering that no major concern can be established concerning the safety, efficacy and clinical adverse event of the ramipril/ HCTZ combination in non responders to HCTZ and ramipril alone, the CHMP adopted the following two harmonised wordings for indications: • Treatment of hypertension • This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or hydrochlorothiazide alone.
Meta wieħed jikkunsidra li ma jista ’ jiġi stabbilit l- ebda tħassib kbir rigward is- sigurtà, l- effikaċja u l - avveniment kliniku avvers tal- kombinazzjoni ta ’ ramipril/ HCTZ f’ dawk li ma jirreaġixxux għal HCTZ u ramipril waħedhom, is- CHMP adotta ż- żewġ frażijiet armonizzati li ġejjin għal indikazzjonijiet: • Kura ta ’ ipertensjoni • Din il- kombinazzjoni ta ’ doża fissa hija indikata f’ pazjenti li l- pressjoni tad- demm tagħhom mhijiex ikkontrollata b’ mod adegwat b’ ramipril waħdu jew b’ hydrochlorothiazide waħdu.
The CHMP discussed the areas where there was a divergence identified in the dose recommendations.
Is- CHMP iddiskuta l- oqsma fejn ġiet identifikata diverġenza fir- rakkomandazzjonijiet tad- dożi.
In most cases the initial recommended dose was the same, but there were differences with respect to subsequent titration (both in terms of frequency of increase and maximum daily dose).
Fil - parti l- kbira tal- każijiet id- doża inizjali rrakkomandata kienet l- istess, iżda kien hemm differenzi fir - rigward tat- titrazzjoni sussegwenti (kemm f’ dak li jirrigwarda l- frekwenza taż- żieda kif ukoll id- doża massima ta ’ kuljum).
The CHMP also noted that there were limited trial data regarding titration steps with the combination.
Is- CHMP innota wkoll li kien hemm dejta limitata dwar il- provi rigward il- passi tat- titrazzjoni bil- kombinazzjoni.
The CHMP adopted the harmonised wording:
Is- CHMP adotta l- kliem armonizzat:
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Id- doża għandha tkun individwalizzata skont il- profil tal- pazjent (ara sezzjoni 4. 4) u l- kontroll tal - pressjoni tad- demm.
The administration of the fixed combination of ramipril and hydrochlorothiazide is usually recommended after dosage titration with one of the individual components.
L- amministrazzjoni tal- kombinazzjoni fissa ta ’ ramipril u hydrochlorothiazide hija normalment irrakkomandata wara titrazzjoni b’ wieħed mill- komponenti individwali.
Tritazide and associated names should be started at the lowest available dosage.
Tritazide u l- ismijiet assoċjati għandhom jinbdew fl- iżgħar doża disponibbli.
If necessary, the dose can be progressively increased to achieve target blood pressure; the maximum permitted doses are 10 mg of ramipril and 25 mg of hydrochlorothiazide daily.
Jekk ikun meħtieġ, id - doża tista ’ tiżdied bil- mod il- mod biex wieħed jilħaq il- pressjoni tad- demm mixtieqa; id- dożi massimi permessi huma ta ’ 10 mg ta ’ ramipril u 25 mg ta ’ hydrochlorothiazide kuljum.
The majority of the contraindications are related to use of ramipril as a component of Tritazide.
Il- parti l- kbira tal- kontraindikazzjonijiet huma marbutin mal- użu ta ’ ramipril bħala komponent ta ’ Tritazide.
They are extended with the contraindications of HCTZ.
Dawn huma estiżi bil- kontraindikazzjonijiet ta ’ HCTZ.
The CHMP noted that some of the contraindications in local SPCs (such as acute hypertension or primary aldosteronism) were in fact non-indications.
Is- CHMP innota li xi wħud mill - kontraindikazzjonijiet f’ SPCs lokali (bħal pressjoni għolja akuta jew aldosteroniżmu primarju) ma kinux fil- fatt indikazzjonijiet.