qanastek/EMEA-V3 huggingface dataset:
Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure.
Angiotensin II hu sustanza magħmula fil- ġisem tiegħek li tikkawża djieq fil- vini/ arterji tad- demm jidjiequ, u b’ hekk tiżdied il- pressjoni tad- demm.
Pritor blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Pritor jimblokka l- effett ta ’ angiotensin II biex b’ hekk il- vini u l- arterji jitwessgħu, u l- pressjoni tad- demm tiegħek tonqos.
Pritor is used to treat essential hypertension (high blood pressure). ‘ Essential’ means that the high blood pressure is not caused by any other condition.
Pritor jintuża biex jikkura pressjoni għolja essenzjali (pressjoni tad- demm għolja). ‘ Essenzjali ’ tfisser li pressjoni tad- demm għolja mhijiex ikkawżata minn xi kundizzjoni oħra.
BEFORE YOU TAKE PRITOR
QABEL MA TUŻA PRITOR
• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Pritor tablets (see section Further information for a list of other ingredients). • during the last six months of pregnancy (see section Pregnancy and breast-feeding). • if you are breast-feeding. • if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.
Tiħux Pritor • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal telmisartan jew sustanzi oħra inklużi fil- pilloli Pritor (ara s- sezzjoni Aktar tagħrif għal- lista ta ’ ingredjenti oħrajn). • matul l- aħħar sitt xhur tat- tqala (ara s- sezzjoni Tqala u treddigħ) • jekk qed tredda ’. • jekk għandek problemi severi tal- fwied bħal kolestasi jew ostruzzjoni biljari (problemi fit - tnixxija tal- bila mill- fwied u mill- bużżieqa tal- marrara) jew kwalunkwe mard sever ieħor tal - fwied.
If any of the above applies to you, tell your doctor or pharmacist before taking Pritor.
Jekk xi wieħed minn dawn is- sintomi t’ hawn fuq japplika għalik, għid lit- tabib jew lill- ispiżjar tiegħek qabel ma tieħu Pritor.
Take special care with Pritor
Oqgħod attent ħafna bi Pritor
49 • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). • Liver disease. • Heart trouble. • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting. • Elevated potassium levels in your blood. • Diabetes.
52 • Mard tal- kliewi jew trapjant tal- kliewi. • Stenosi tal- arterji renali (tidjiq tal- vini/ arterji lejn kilwa waħda jew lejn iż- żewġ kliewi). • Mard tal- fwied. • Problemi tal- qalb. • Livelli għoljin ta ’ aldosterone (iż- żamma tal- ilma u l- melħ fil- ġisem flimkien ma ’ żbilanċ ta ’ minerali varji fid- demm). • Pressjoni tad- demm baxxa (ipotensjoni), x’ aktarx li sseħħ jekk tkun deidratat (telf eċċessiv ta ’ ilma mill- ġisem) jew jekk ikollok nuqqas ta ’ melħ minħabba terapija dijuretika (‘ pilloli tal - awrina ’), dieta b’ livelli baxxi ta ’ melħ, dijarea, jew rimettar. • Livelli għolja ta ’ potassium fid- demm tiegħek • Dijabete
Pritor is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section Pregnancy and breast-feeding).
Pritor mhuwiex rakkomandat matul l- ewwel stadji tat- tqala, u jista ’ jikkawża ħsara serja lit- tarbija tiegħek wara 3 xhur ta ’ tqala (ara s- sezzjoni Tqala u treddigħ).
In case of surgery or anaesthesia, you should tell your doctor that you are taking Pritor.
F’ każ li jkollok bżonn ta ’ operazzjoni jew loppju, għandek tgħid lit- tabib tiegħek li qed tieħu Pritor.
The use of Pritor in children and adolescents up to the age of 18 years is not recommended.
L- użu ta ’ Pritor fit- tfal u fl- adolexxenti sal- età ta ’ 18- il sena mhuwiex rakkomandat.
As with all other angiotensin II receptor antagonists, Pritor may be less effective in lowering the blood pressure in black patients.
Bħal fil- każ tal- antagonisti l- oħrajn kollha tar- riċettur ta ’ angiotensin II, Pritor jista ’ jkun inqas effettiv biex inaqqas il- pressjoni tad- demm f’ pazjenti suwed.
This applies especially to the medicines listed below taken at the same time with Pritor:
Dan japplika b’ mod speċjali għal mediċini elenkati hawn taħt li jittieħdu fl- istess ħin ma ’ Pritor:
• Lithium containing medicines to treat some types of depression. • Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e. g. aspirin or ibuprofen), heparin, immunosuppressives (e. g. cyclosporin or tacrolimus), and the antibiotic trimethoprim. • Diuretics ('water tablets'), especially if taken in high doses together with Pritor, may lead to excessive loss of body water and low blood pressure (hypotension).
• Mediċini li fihom il- lithium għall- kura ta ’ xi tipi ta ’ dipressjoni. • Mediċini li jistgħu jżidu il- livelli tal- potassium fid- demm bħal sostituti tal- melħ li fihom il - potassium, dijuretiċi li ma jneħħux potassium (ċerti ‘ pilloli tal- awrina ’), inibituri ACE, antagonisti tar- riċettur ta ’ angiotensin II, NSAIDs (mediċini mhux sterojdi kontra l - infjammazzjoni, eż. aspirina jew ibuprofen), eparina, immunosoppressivi (eż. cyclosporin jew tacrolimus), u l- antibijotiku trimethoprim. • Id- dijuretiċi (‘ pilloli tal- awrina ’), speċjalment jekk jittieħdu f’ dożi għoljin flimkien ma ’ Pritor, jistgħu jwasslu għal telf eċċessiv ta ’ ilma mill- ġisem u pressjoni tad- demm baxxa (ipotensjoni).
As with other blood pressure lowering medicines, the effect of Pritor may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e. g. aspirin or ibuprofen) or corticosteroids.
Bħala ma jiġri b’ mediċini oħrajn li jbaxxu l- pressjoni tad- demm, l- effetti ta ’ Pritor jistgħu jitnaqqsu meta tieħu NSAIDs (mediċini mhux sterojdi kontra l- infjammazzjoni, eż. aspirina jew ibuprofen) jew kortikosterojdi.
Pritor may increase the blood pressure lowering effect of other medicines used to treat high blood pressure.
Pritor jista ’ jżid l- effett ta ’ tnaqqis tal- pressjoni tad- demm ta ’ mediċini oħra li jintużaw għall- kura ta ’ pressjoni tad- demm għolja.
Taking Pritor with food and drink
Meta tieħu Pritor ma ’ l- ikel u max- xorb
You can take Pritor with or without food.
Tista ’ tieħu Pritor mal- ikel jew mingħajr l- ikel.
Usually, your doctor will advise you to take another medicine instead of Pritor, as Pritor is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Normalment, it- tabib tiegħek ser jagħtik parir biex tieħu mediċina oħra minflok Pritor, għax Pritor mhuwiex rakkomandat
Appropriate antihypertensive drug must usually replace Pritor before starting a pregnancy.
Mediċina adattata kontra l- pressjoni għolja trid normalment tissostitwixxi Pritor qabel il- bidu ta ’ tqala.
Pritor should not be used during the second and third trimester of pregnancy.
Pritor m’ għandux jintuża matul it- tieni u t- tielet trimestru tat- tqala.
50 Your doctor will normally advise you to stop taking Pritor as soon as you know you are pregnant.
It- tabib tiegħek, normalment ser jagħtik parir biex tieqaf tieħu Pritor hekk kif issir taf li inti tqila.
If you become pregnant during therapy with Pritor, please inform and see your doctor without delay.
Jekk inti toħroġ tqila matul kura bi Pritor, jekk jogħġbok informa u ara lit- tabib tiegħek mingħajr dewmien.
You must not take Pritor if you are breast-feeding.
M’ għandekx tieħu Pritor jekk qed tredda ’.
No information is available on the effect of Pritor on the ability to drive or operate machinery.
M’ hemm l- ebda informazzjoni disponibbli dwar l- effett ta ’ Pritor fuq il- ħila li ssuq jew tħaddem makkinarju.
Important information about some of the ingredients of Pritor
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Pritor
Pritor contains sorbitol.
Pritor fih is- sorbitol.
If you are intolerant to some sugars, consult your doctor before taking Pritor.
Jekk għandek intolleranza għal xi tipi ta ’ zokkor, għandek tikkuntattja lit- tabib tiegħek qabel ma tieħu Pritor.
HOW TO TAKE PRITOR
KIF GĦANDEK TUŻA PRITOR
Always take Pritor exactly as your doctor has told you.
Dejjem għandek tuża Pritor skond il- parir eżatt tat- tabib tiegħek.
The usual dose of Pritor is one tablet a day.
Id- doża normali ta ’ Pritor hi ta ’ pillola waħda darba kuljum.
It is important that you take Pritor every day until your doctor tells you otherwise.
Hu importanti li tieħu Pritor kuljum sakemm it- tabib tiegħek jgħidlek biex tieqaf.
If you have the impression that the effect of Pritor is too strong or too weak, talk to your doctor or pharmacist.
Jekk tħoss li l- effett ta ’ Pritor hu qawwi jew dgħajjef wisq, kellem lit- tabib jew lill- ispiżjar tiegħek.
The usual dose of Pritor for most patients is one 40 mg tablet once a day to control blood pressure over the 24-hour period.
Id- doża normali ta ’ Pritor għall- biċċa l- kbira tal- pazjenti hi ta ’ pillola waħda ta ’ 40 mg pillola darba kuljum biex tikkontrolla l- pressjoni tad- demm għal perjodu ta ’ 24 siegħa.
Pritor may also be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Pritor.
Pritor jista ’ jintuża flimkien ma ’ dijuretiċi (‘ pilloli tal- awrina ’) bħal hydrochlorothiazide, li ntwera li għandu effett addizzjonali ta ’ tnaqqis tal- pressjoni tad- demm bi Pritor.
If you take more Pritor than you should
Jekk tieħu Pritor aktar milli suppost
If you forget to take Pritor
Jekk tinsa tieħu Pritor
Like all medicines, Pritor can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Pritor jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
51 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Dawn l- effetti sekondarji jistgħu jseħħu b’ ċerti frekwenzi, li huma definiti kif ġej: komuni ħafna: jaffettwaw iktar minn utent 1 minn kull 10 komuni: jaffettwaw minn 1 sa 10 utenti minn kull 100 mhux komuni: jaffettwaw minn 1 sa 10 utenti minn kull 1, 000 rari: jaffettwaw minn 1 sa 10 utenti minn kull 10, 000 rari ħafna: jaffettwaw inqas minn utent 1 minn kull 10, 000 mhux magħrufa: l- frekwenza ma tistax tkun stmata mill- informazzjoni disponibbli.
Upper respiratory tract infection (e. g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), low platelet count (thrombocytopenia), feeling anxious, feeling sad (depression), impaired vision, fast heart beat (tachycardia), dizziness on standing up (orthostatic hypotension), upset stomach, vomiting, abnormal liver function, redness of skin, rapid swelling of the skin and mucosa (angioedema), hives (urticaria), joint pain (arthralgia), back pain, muscle cramps, pain in extremity, symptoms of weakness, flu-like-illness, increased levels of uric acid, creatinine, hepatic enzymes or creatine phosphokinase in the blood.
Effetti sekondarji rari jistgħu jinkludu: infezzjoni fl- apparat respiratorju ta ’ fuq (eż. uġigħ fil- griżmejn, sinuses infjammati, riħ komuni), nuqqas ta ’ ċelluli ħomor tad- demm (anemija), għadd baxx ta ’ plejtlits (tromboċitopenja), tħossok ansjuż/ a, tħossok imdejjaq/ imdejqa (dipressjoni), indeboliment fil- vista, rata mgħaġġla ta ’ taħbit tal - qalb (takikardija), tistordi meta tqum bilwieqfa (ipotensjoni ortostatika), stonku mqalleb, rimettar, funzjoni anormali tal- fwied, ħmura tal- ġilda, nefħa b’ mod mgħaġġel tal- ġilda u tal- mukuża (anġjodema), urtikarja, uġigħ fil- gogi (artralġja), uġigħ fid- dahar, bugħawwieġ fil- muskoli, uġigħ fl - estremitajiet, sintomi ta ’ dgħjufija, li jixbah l - influwenza, żieda fil- livelli tal- uric acid, krejatinina, enzimi epatiċi jew ta ’ creatine phosphokinase fid- demm.
Urinary tract infections, increase in certain white blood cells (eosinophilia), allergic reaction (e. g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), slow heart rate (bradycardia), drug rash, eczema (a skin disorder), inflammation of the tendons, ineffectiveness of Pritor and decreased haemoglobin (a blood protein).
Effetti sekondarji ta ’ frekwenza mhux magħrufa jistgħu jinkludu: infezzjonijiet fl- apparat urinarju, żieda f’ ċerti ċelluli tad- demm bojod (eosinofilja), reazzjoni allerġika (eż. raxx, ħakk, diffikultà biex tieħu n- nifs, tħarħir, nefħa tal- wiċċ jew pressjoni tad- demm baxxa), rata ta ’ taħbit tal- qalb bil- mod (bradikardija), raxx minħabba l- mediċina, ekżema (disturb tal- ġilda), infjammazzjoni tal- tendini, ineffettività ta ’ Pritor u tnaqqis fl- emoglobina (proteina tad- demm).
HOW TO STORE PRITOR
KIF TAĦŻEN PRITOR
Do not use Pritor after the expiry date which is stated on the carton after “ EXP”.
Tużax Pritor wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun wara “ JIS ”.
What Pritor contains
X’ fih Pritor
The active substance is telmisartan.
55 Is- sustanza attiva hi telmisartan.
What Pritor looks like and contents of the pack
Id- dehra ta ’ Pritor u l- kontenuti tal- pakkett
Pritor 20 mg tablets are white, round and engraved with the code number '50H 'on one side and the company logo on the other side.
Il- pilloli Pritor 20 mg huma bojod, b’ forma tonda u mnaqqxa bin- numru tal- kodiċi ‘ 50H ’ fuq naħa waħda u l- logo tal- kumpanija fuq in- naħa l- oħra.
52 Pritor is available in blister packs containing 14, 28, 30, 56, 90 or 98 tablets.
Pritor hu disponibbli f’ pakketti b’ folji ta ’ 14, 28, 30, 56, 90 jew 98 pillola.
Marketing Authorisation Holder Bayer HealthCare AG D-51368 Leverkusen Germany
Bayer HealthCare AG D- 51368 Leverkusen Il- Ġermanja
SmithKline Beecham Pharmaceuticals Manor Royal Crawley, West Sussex RH10 2QJ United Kingdom
SmithKline Beecham Pharmaceuticals Manor Royal Crawley, West Sussex RH10 2QJ Ir- Renju Unit
53 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
56 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
INFORMATION FOR THE USER Pritor 40 mg tablets Telmisartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Pritor 40 mg pilloli Telmisartan
Pritor belongs to a group of medicines known as angiotensin II receptor antagonists.
Pritor jagħmel parti minn klassi ta ’ mediċini magħrufa bħala antagonisti tar- riċetturi ta ’ angiotensin II.
55 • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). • Liver disease. • Heart trouble. • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting. • Elevated potassium levels in your blood. • Diabetes.
58 • Mard tal- kliewi jew trapjant tal- kliewi. • Stenosi tal- arterji renali (tidjiq tal- vini/ arterji lejn kilwa waħda jew lejn iż- żewġ kliewi). • Mard tal- fwied. • Problemi tal- qalb. • Livelli għoljin ta ’ aldosterone (iż- żamma tal- ilma u l- melħ fil- ġisem flimkien ma ’ żbilanċ ta ’ minerali varji fid- demm). • Pressjoni tad- demm baxxa (ipotensjoni), x’ aktarx li sseħħ jekk tkun deidratat (telf eċċessiv ta ’ ilma mill- ġisem) jew jekk ikollok nuqqas ta ’ melħ minħabba terapija dijuretika (‘ pilloli tal - awrina ’), dieta b’ livelli baxxi ta ’ melħ, dijarea, jew rimettar. • Livelli għolja ta ’ potassium fid- demm tiegħek • Dijabete
56 Your doctor will normally advise you to stop taking Pritor as soon as you know you are pregnant.
It- tabib tiegħek, normalment ser jagħtik parir biex tieqaf tieħu Pritor hekk kif issir taf li inti tqila.
If you become pregnant during therapy with Pritor, please inform and see your doctor without delay.
Jekk inti toħroġ tqila matul kura b’ Pritor, jekk jogħġbok informa u ara lit- tabib tiegħek mingħajr dewmien.
However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg.
Madankollu, xi kultant it - tabib tiegħek jista ’ jirrakkomanda doża aktar baxxa ta ’ 20 mg jew doża ogħla ta ’ 80 mg.
Alternatively, Pritor may be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Pritor.
Inkella, Pritor jista ’ jintuża flimkien ma ’ dijuretiċi (‘ pilloli tal- awrina ’), bħal hydrochlorothiazide, li ntwera li għandu effett addizzjonali ta ’ tnaqqis tal- pressjoni tad- demm bi Pritor.
57 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Dawn l- effetti sekondarji jistgħu jseħħu b’ ċerti frekwenzi, li huma definiti kif ġej: komuni ħafna: jaffettwaw iktar minn utent 1 minn kull 10 komuni: jaffettwaw minn 1 sa 10 utenti minn kull 100 mhux komuni: jaffettwaw minn 1 sa 10 utenti minn kull 1, 000 rari: jaffettwaw minn 1 sa 10 utenti minn kull 10, 000 rari ħafna: jaffettwaw inqas minn utent 1 minn kull 10, 000 mhux magħrufa: l- frekwenza ma tistax tkun stmata mill- informazzjoni disponibbli.
What Pritor contains
61 X’ fih Pritor
Pritor 40 mg tablets are white, oblong-shaped and engraved with the code '51H 'on one side.
Il- pilloli Pritor 40 mg huma bojod, b’ forma oblunga u mnaqqxa bin- numru tal- kodiċi '51H' fuq naħa waħda.
58 Pritor is available in blister packs containing 14, 28, 30, 56, 90, 98 or 280 tablets, or unit dose blister packs containing 28 x 1 tablets.
Pritor hu disponibbli f’ pakketti b’ folji ta ’ 14, 28, 30, 56, 90, 98 jew 280 pillola jew pakketti bil- folji bid- doża tal- unità li fihom 28 x 1 pilloli.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
62 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
INFORMATION FOR THE USER Pritor 80 mg tablets Telmisartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Pritor 80 mg pilloli Telmisartan
• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Pritor tablets (see section Further information for a list of other ingredients). • during the last six months of pregnancy (see section Pregnancy and breast-feeding). • if you are breast-feeding. • if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.
Tiħux Pritor • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal telmisartan jew sustanzi oħra inklużi fil- pilloli Pritor ara s- sezzjoni Aktar tagħrif għal- lista ta ’ ingredjenti oħrajn). • matul l- aħħar sitt xhur tat- tqala (ara s- sezzjoni Tqala u treddigħ) • jekk qed tredda ’. • jekk għandek problemi severi tal- fwied bħal kolestasi jew ostruzzjoni biljari (problemi fit - tnixxija tal- bila mill- fwied u mill- bużżieqa tal- marrara) jew kwalunkwe mard sever ieħor tal - fwied.
Please tell your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:
64 Jekk jogħġbok għid lit- tabib tiegħek jekk qed tbati jew jekk fil- passat batejt minn kwalunkwe mill - kundizzjonijiet jew mard li ġejjin:
61 • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys). • Liver disease. • Heart trouble. • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals). • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting. • Elevated potassium levels in your blood. • Diabetes.
• Mard tal- kliewi jew trapjant tal- kliewi. • Stenosi tal- arterji renali (tidjiq tal- vini/ arterji lejn kilwa waħda jew lejn iż- żewġ kliewi). • Mard tal- fwied. • Problemi tal- qalb. • Livelli għoljin ta ’ aldosterone (iż- żamma tal- ilma u l- melħ fil- ġisem flimkien ma ’ żbilanċ ta ’ minerali varji fid- demm). • Pressjoni tad- demm baxxa (ipotensjoni), x’ aktarx li sseħħ jekk tkun deidratat (telf eċċessiv ta ’ ilma mill- ġisem) jew jekk ikollok nuqqas ta ’ melħ minħabba terapija dijuretika (‘ pilloli tal - awrina ’), dieta b’ livelli baxxi ta ’ melħ, dijarea, jew rimettar. • Livelli għolja ta ’ potassium fid- demm tiegħek • Dijabete
As with all other angiotensin antagonists, Pritor may be less effective in lowering the blood pressure in black patients.
Bħal fil- każ tal- antagonisti l- oħrajn kollha ta ’ angiotensin, Pritor jista ’ jkun inqas effettiv biex inaqqas il- pressjoni tad- demm f’ pazjenti suwed.
You must tell your doctor if you think that you are (or might become) pregnant.
65 Għandek tgħid lit- tabib tiegħek jekk taħseb li inti (jew jekk tista ’ toħroġ) tqila.
Usually, your doctor will advise you to take another medicine instead of Pritor, as Pritor is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Normalment, it- tabib tiegħek ser jagħtik parir biex tieħu mediċina oħra minflok Pritor, għax Pritor mhuwiex rakkomandat matul l- ewwel stadji tat- tqala, u jista ’ jikkawża ħsara serja lit- tarbija tiegħek jekk jintuża wara 3 xhur ta ’ tqala.
62 Your doctor will normally advise you to stop taking Pritor as soon as you know you are pregnant.
It- tabib tiegħek, normalment ser jagħtik parir biex tieqaf tieħu Pritor hekk kif issir taf li inti tqila.
The usual dose of Pritor for most patients is one 40 mg tablet once a day to control blood pressure over the 24 hour period.
Id- doża normali ta ’ Pritor għall- biċċa l- kbira tal- pazjenti hi ta ’ pillola waħda ta ’ 40 mg pillola darba kuljum biex tikkontrolla l- pressjoni tad- demm għal perjodu ta ’ 24 siegħa.
Alternatively, Pritor may be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Pritor.
Inkella, Pritor jista ’ jintuża flimkien ma ’ dijuretiċi (‘ pilloli tal- awrina ’) bħal hydrochlorothiazide, li ntwera li għandu effett addizzjonali ta ’ tnaqqis tal- pressjoni tad- demm bi Pritor.
If your liver is not working properly, the usual dose should not exceed 40 mg once daily.
Jekk il- fwied tiegħek ma jkunx qed jaħdem kif suppost, id- doża tas- soltu m’ għandhiex taqbeż taqbeż 40 mg darba kuljum.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
66 Jekk ikollok aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, jekk jogħġbok staqsi lit- tabib jew lill - ispiżjar tiegħek.
63 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Dawn l- effetti sekondarji jistgħu jseħħu b’ ċerti frekwenzi, li huma definiti kif ġej: komuni ħafna: jaffettwaw iktar minn utent 1 minn kull 10 komuni: jaffettwaw minn 1 sa 10 utenti minn kull 100 mhux komuni: jaffettwaw minn 1 sa 10 utenti minn kull 1, 000 rari: jaffettwaw minn 1 sa 10 utenti minn kull 10, 000 rari ħafna: jaffettwaw inqas minn utent 1 minn kull 10, 000 mhux magħrufa: l- frekwenza ma tistax tkun stmata mill- informazzjoni disponibbli.
Pritor 80 mg tablets are white, oblong-shaped and engraved with the code '52H 'on one side.
Il- pilloli Pritor 80 mg huma bojod, b’ forma oblunga u mnaqqxa bin- numru tal- kodiċi '52H' fuq naħa waħda.
64 Pritor is available in blister packs containing 14, 28, 30, 56, 90, 98 or 280 tablets, or unit dose blister packs containing 28 x 1 tablets.
Pritor hu disponibbli f’ pakketti b’ folji ta ’ 14, 28, 30, 56, 90, 98 jew 280 pillola jew pakketti bil- folji bid- doża tal- unità li fihom 28 x 1 pilloli.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
68 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (ara parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is PritorPlus?
X' inhu PritorPlus?
PritorPlus is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
PritorPlus huwa mediċina li fiha żewġ sustanzi attivi, telmisartan u hydrochlorothiazide.
40 or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; yellow and white:
40 mg jew 80 mg telmisartan u 12. 5 mg hydrochlorothiazide; sofor u bojod:
What is PritorPlus used for?
Għal xiex jintuża PritorPlus?
PritorPlus is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
PritorPlus jintuża minn pazjenti li jkollhom ipertensjoni essenzjali (pressjoni tad- demm għolja), li ma tkunx ikkontrollata b' mod adegwat b' telmisartan biss.
The safety and effectiveness of PritorPlus have not been established in patients below 18 years of age.
'Essenzjali' tfisser li l- pressjoni tad- demm għolja mhijiex ikkawżata minn xi kundizzjoni oħra.
The medicine can only be obtained with a prescription.
Is- sigurtà u l- effikaċja ta 'PritorPlus ma ntwerewx f' pazjenti taħt l- età ta' 18- il sena.
How is PritorPlus used?
Kif jintuża PritorPlus?
PritorPlus is taken by mouth once a day with liquid, with or without food.
PritorPlus jittieħed oralment darba kuljum ma 'xarba likwida, ma' l- ikel jew mingħajru.
The dose of PritorPlus to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/ 12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/ 12.5 mg tablets.
Id- doża ta 'PritorPlus li għandha tintuża tiddependi mid- doża ta' telmisartan li l- pazjent kien qiegħed jieħu qabel: il- pazjenti li qegħdin jieħdu 40 mg telmisartan għandhom jieħdu pilloli ta 'l- 40/ 12. 5 mg filwaqt li l - pazjenti li kienu qegħdin jieħdu 80 mg telmisartan għandhom jieħdu pilloli tat- 80/ 12. 5 mg.
The 80/ 25 mg tablets are used in patients whose blood pressure is not controlled using the 80/ 12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to PritorPlus.
Il- pilloli tat- 80/ 25 mg jintużaw minn pazjenti li l- pressjoni tad- demm tagħhom mhijiex ikkontrollata permezz ta 'pilloli tat- 80/ 12. 5 mg jew li l- qagħda tagħhom ġiet stabbli permezz ta' żewġ sustanzi attivi meħuda separatament qabel ma qalbu għal PritorPlus.
How does PritorPlus work?
Kif jaħdem PritorPlus?
PritorPlus contains two active substances, telmisartan and hydrochlorothiazide.
PritorPlus fih żewġ sustanzi attivi, telmisartan u hydrochlorothiazide.
Telmisartan is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Telmisartan hu tip ta '' antagonist tar- riċetturi ta 'l- anġjotensina II' li tfisser li jimblokka l- azzjoni ta 'l - ormon fil- ġisem imsejjaħ l- anġjotensina II.
By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Billi jimblokka r- riċetturi li magħhom l- anġjotensina II teħel normalment, telmisartan iwaqqaf l- ormon milli jkollu effett, b' hekk iħalli l- arterji u l- vini jitwessgħu.
Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension.
Hydrochlorothiazide huwa dijuretika, li hija tip ieħor ta 'trattament ta' l- ipertensjoni.
It works by increasing urine output, reducing the amount of fluid in the blood and reducing blood pressure.
Taħdem billi tiżdied l- kwantità ta 'awrina u b' hekk tnaqqas il- kwantità ta' fluwidu fid- demm.
The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Il- kombinazzjoni taż - żewġ sustanzi attivi għandha effett ta 'żieda fit- tnaqqis tal- pressjoni tad- demm aktar minn waħda miż - żewġ mediċini waħedha.
By lowering blood pressure, the risk caused by high blood pressure, such as having a stroke, is reduced.
Bit- tnaqqis tal- pressjoni tad- demm, jitnaqqas ir- riskju kkawżata minn pressjoni għolja, bħall- puplesija.
How has PritorPlus been studied?
Kif ġie studjat PritorPlus?
PritorPlus has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
PritorPlus ġiet studjat f' ħames studji ewlenin li involvew total ta '2, 985 pazjent li jbatu minn ipertensjoni minn ħafifa għal moderata.
In four of these studies (2,272 patients), PritorPlus was compared with placebo (a dummy treatment) and with telmisartan taken alone.
F' erbgħa fost dawn l- istudji (jiġifieri 2, 272 pazjent), PritorPlus tqabbel mal- plaċebo (trattament finta) u ma 'telmisartan meħud waħdu.
In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Fl- istudji kollha, il- kejl ewlieni ta 'l- effikaċja kien it- tnaqqis tal- pressjoni tad- demm dijastolika (pressjoni tad - demm mkejla bejn żewġ taħbitiet tal- qalb).
What benefit has PritorPlus shown during the studies?
X' inhuma l- benefiċċji ta 'PritorPlus li ntwerew f' dawn l- istudji?
PritorPlus was more effective than placebo and than telmisartan alone in reducing diastolic blood pressure.
PritorPlus kellu aktar effett mill- plaċebo u minn telmisartan waħdu fit- tnaqqis tal- pressjoni tad- demm dijastolika.
In patients who were not controlled on the 80/ 12.5 mg tablet, switching to the 80/ 25 mg tablet was more effective in reducing diastolic blood pressure than remaining on the lower dose.
Fil- pazjenti li ma kinux ikkontrollati bil- pilloli tat- 80/ 12. 5 mg, il- fatt li qalbu għall- pilloli tat- 80/ 25 mg kellu aktar effett fit- tnaqqis tal- pressjoni tad- demm dijastolika milli jekk baqgġu fuq doża inferjuri.
What is the risk associated with PritorPlus?
X' inhuma r- riskji assoċjati ma 'PritorPlus?
The most common side effects with PritorPlus (seen in between 1 and 10 patients in 100) are bronchitis (inflammation of the lungs), pharyngitis (sore throat), sinusitis (inflammation of the sinuses, air-filled passageways in the bones around the nose and eyes), upper respiratory tract infections (colds), urinary tract infections (infections of the structures that carry urine), hypercholesterolaemia (high blood cholesterol levels), hypokalaemia (low blood potassium levels), anxiety, dizziness, vertigo (a spinning sensation), abdominal (tummy) pain, diarrhoea, dyspepsia (heartburn), gastritis (inflammation of the stomach lining), eczema (itchy, scaly skin), arthralgia (joint pain), osteoarthritis (swelling and pain in the joints), muscle spasms, pain in the extremities (arms and legs), myalgia (muscle pain), erectile dysfunction (inability to get or keep an erection), flu-like illness and pain.
L- aktar effetti sekondarji komuni b' PritorPlus (li dehru f' bejn pazjent wieħed u 10 fost 100) huma bronkite (infjammazzjoni tal- pulmuni), farinġite (griżmejn misluħa), sinużite (infjammazzjoni tas - sinus, passaġġi mimlijin bl- arja fl- għadam ta 'madwar l- imnieħer u l- għajnejn), infezzjonijiet fil - passaġġ respiratorju (tan- nifs) ta' fuq (irjiħat), infezzjonijiet fl- apparat urinarju (infezzjonijiet ta 'l - istrutturi li jġorru l- awrina), iperkolesterolemija (livelli għoljin ta' kolesterol fid- demm), ipokaljemija (livelli baxxi ta 'potassju fid- demm), ansjetà, sturdament, mejt (vertiġini, sens ta' tidwir) uġigħ addominali (ta 'żaqq), dijarrea, dispepsija (qrusa ta' l- istonku), gastrite (infjammazzjoni tal- mukuża ta 'l- istonku), ekzema (ġilda li ġġiegħel il- ħakk u bil- qxur), artralġija (uġigħ fil- ġogi), osteoartrite (nefħa u wġigħ fil- ġogi), spażmi muskolari, uġigħ fid- dirgħajn u fir- riġlejn, mijalġija (uġigħ fil- muskoli) disfunzjoni erettili (inkapaċità li tintħaħaq u tinżamm erezjoni), mard u wġigħ influwenzali.
For the full list of all side effects reported with PritorPlus, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrappurtata b' PritorPlus, ara l- Fuljett ta' Tagħrif.
PritorPlus should not be used in people who may be hypersensitive (allergic) to telmisartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients (including sorbitol).
PritorPlus ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal telmisartan, hydrochlorothiazide, sulfonamide jew kwalunkwe fost l- ingredjenti l- oħra (inkluż sorbitol).
PritorPlus should also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
PritorPlus ma għandux jintuża wkoll minn persuni li jbatu minn problemi gravi fil- fwied, kliewi jew problemi biljari, persuni li jkollhom livelli wisq baxxi ta 'potassju fid- demm, jew livelli wisq għoljin ta' kalċju fid- demm.
Care must be taken when using PritorPlus with other medicines that have an effect on blood potassium levels.
PritorPlus għandu jintuża b' kawtela meta użat ma 'mediċini oħra li jkollhom effett fuq il- livelli ta' potassju fid- demm.
Why has PritorPlus been approved?
Għaliex ġie approvat PritorPlus?
The Committee for Medicinal Products for Human Use (CHMP) decided that PritorPlus’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Mill- Bniedem (CHMP) iddeċieda li PritorPlus għandu iktar benefiċċji milli riskji fit- trattament ta 'l- ipertensjoni essenzjali f' pazjenti li l- pressjoni tad- demm tagħhom mhijiex adegwatament ikkontrollata b' telmisartan waħdu.
The Committee recommended that PritorPlus be given marketing authorisation.
Il- Kumitat irrakkomanda li PritorPlus jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about PritorPlus:
Tagħrif ieħor dwar PritorPlus:
The European Commission granted a marketing authorisation valid throughout the European Union for PritorPlus on 22 April 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal PritorPlus fit- 22 ta 'April 2002.
The marketing authorisation holder is Bayer Healthcare AG.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq hu Bayer Healthcare AG.
The marketing authorisation was renewed on 22 April 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 22 ta 'April 2007.
The full EPAR for PritorPlus is available here.
L- EPAR sħiħ dwar PritorPlus jista 'jiġi kkonsultat hawn.
This summary was last updated in 08-2008.
Dan is- sommarju kien aġġornat l- aħħar fi:
40 mg/ 12.5 mg 40 mg/ 12.5 mg 40 mg/ 12.5 mg 40 mg/ 12.5 mg 40 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 12.5 mg 40 mg/ 12.5 mg 80 mg/ 12.5 mg 40 mg/ 12.5 mg 80 mg/ 12.5 mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg
40 mg/ 12. 5 mg 40 mg/ 12. 5 mg 40 mg/ 12. 5 mg 40 mg/ 12. 5 mg 40 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 12. 5 mg 40 mg/ 12. 5 mg 80 mg/ 12. 5 mg 40 mg/ 12. 5 mg 80 mg/ 12. 5 mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg 80 mg/ 25mg
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (polyamide/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC)
folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (polyamide/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC) folja (PA/ alu/ PVC)
14 tablets 28 tablets 28 x 1 tablets 56 tablets 98 tablets 14 tablets 28 tablets 28 x 1 tablets 56 tablets 98 tablets 90 tablets 90 tablets 30 tablets 30 tablets 14 tablets 28 tablets 28 x 1 tablets 30 tablets 56 tablets 90 tablets 98 tablets
14- il pillola 28 pillola 28 x 1 pillola 56 pillola 98 pillola 14- il pillola 28 pillola 28 x 1 pillola 56 pillola 98 pillola 90 pillola 90 pillola 30 pillola 30 pillola 14- il pillola 28 pillola 28 x 1 pillola 30 pillola 56 pillola 90 pillola 98 pillola
PritorPlus 40 mg/ 12.5 mg tablets
PritorPlus 40 mg/ 12. 5 mg pilloli
PritorPlus fixed dose combination (40 mg telmisartan/ 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.
It- taħlita fissa tad- doża ta ’ PritorPlus (40 mg telmisartan/ 12. 5 mg ta ’ hydrochlorothiazide) hi indikata għal pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew b’ telmisartan waħdu.
Adults PritorPlus should be taken once daily with liquid, with or without food in patients whose blood pressure is not adequately controlled by telmisartan alone.
Adulti PritorPlus għandu jittieħed darba kuljum mal- likwidu, ma ’ l- ikel jew mingħajr ikel f’ pazjenti li l - pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew b’ telmisartan waħdu.
• PritorPlus 40 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Pritor 40 mg • PritorPlus 80 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by Pritor 80 mg
• PritorPlus 40 mg/ 12. 5 mg jista ’ jingħata lil pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew bi Pritor 40 mg • PritorPlus 80 mg/ 12. 5 mg jista ’ jingħata lil pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata sew bi Pritor 80 mg
In patients with mild to moderate hepatic impairment the posology should not exceed PritorPlus 40 mg/ 12.5 mg once daily.
F’ pazjenti b’ indeboliment epatiku minn ħafif sa moderat, il- pożoloġija m’ għandhiex taqbeż PritorPlus 40 mg/ 12. 5 mg darba kuljum.
PritorPlus is not indicated in patients with severe hepatic impairment.
PritorPlus mhuwiex indikat f’ pazjenti b’ indeboliment epatiku sever.
PritorPlus is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
PritorPlus mhuwiex rakkomandat għall- użu fit- tfal taħt it- 18- il sena, minħabba nuqqas ta ’ dejta dwar is- sigurtà u l- effikaċja.
PritorPlus should not be given to patients with cholestasis, biliary obstructive disorders or severe hepatic insufficiency (see section 4.3) since telmisartan is mostly eliminated with the bile.
PritorPlus m’ għandux jingħata lil pazjenti b’ kolestasi, b’ disturbi ostruttivi tal - marrara jew li għandhom insuffiċjenza epatika severa (ara sezzjoni 4. 3), għax telmisartan hu eliminat fil- biċċa l- kbira tiegħu mal- bili.
In addition, PritorPlus should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Flimkien ma ’ dan, PritorPlus għandu jintuża bl- attenzjoni f’ pazjenti b’ indeboliment tal- funzjoni epatika jew mard progressiv tal- fwied, għax tibdil żgħir fil- fluwidu u fil- bilanċ ta ’ l- elettroliti jista ’ jikkawża koma epatika.
There is no clinical experience with PritorPlus in patients with hepatic impairment.
M’ hemm l- ebda esperjenza klinika bi PritorPlus f’ pazjenti b’ indeboliment epatiku.
PritorPlus should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.3).
PritorPlus m’ għandux jintuża f’ pazjenti b’ indeboliment renali sever (rata ta ’ tneħħija tal- krejatinina ta ’ < 30 ml/ min) (ara sezzjoni 4. 3).
There is no experience regarding the administration of PritorPlus in patients with recent kidney transplantation.
M’ hemmx esperjenza dwar l- għoti ta ’ PritorPlus f’ pazjenti bi trapjant riċenti tal- kliewi.
Experience with PritorPlus is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
L- esperjenza bi PritorPlus hi modesta f’ dawk il- pazjenti b’ indeboliment renali minn ħafif sa moderat, u għalhekk, monitoraġġ pejodiku tal- livelli tal- potassium, tal- krejatinina u ta ’ l- uric acid serum hu rakkomandat.
Such conditions should be corrected before the administration of PritorPlus.
Dawn il- kundizzjonijiet għandhom ikunu kkoreġuti qabel l- għoti ta ’ PritorPlus.
Therefore, the use of PritorPlus is not recommended.
Għalhekk, l- użu ta ’ PritorPlus mhuwiex rakkomandat.
An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in PritorPlus, minimal or no effects were reported.
Żieda fil- livelli tal- kolesterol u tat- trigliċeridi kienet assoċjata ma ’ terapija dijuretika b’ thiazide; madankollu, bid- doża ta ’ 12. 5 mg li hemm fi PritorPlus, effetti minimi kienu rrappurtati, jew l- ebda effett.
Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of PritorPlus, hyperkalaemia might occur.
Għal kuntrarju, minħabba l- antaġoniżmu tar- riċetturi ta ’ angiotensin II (AT1) mill- komponent ta ’ telmisartan ta ’ PritorPlus, tista ’ sseħħ l- iperkalemija.
Although clinically significant hyperkalaemia has not been documented with PritorPlus, risk factors for the development of hyperkalaemia include renal insufficiency and/ or heart failure, and diabetes mellitus.
Għalkemm iperkalemija klinikament sinifikanti ma kinitx dokumentata bi PritorPlus, fatturi ta ’ riskju għall- iżvilupp ta ’ iperkalemija jinkludu insuffiċenzja renali u/ jew insuffiċjenza tal- qalb, u dijabete mellitus.
Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with PritorPlus (see section 4.5).
Dijuretiċi potassium- sparing, supplimenti tal- potassium jew sostituti tal- potassium li fihom il- melħ, għandhom jingħataw bl - attenzjoni flimkien ma ’ PritorPlus (ara sezzjoni 4. 5).
There is no evidence that PritorPlus would reduce or prevent diuretic-induced hyponatraemia.
M’ hemm l- ebda evidenza li PritorPlus jista ’ inaqqas jew jimpedixxi iponatremija kkawżata mid - dijuretiċi.
Rare cases have also been reported with angiotensin II receptor antagonists (including PritorPlus).
Każijiet rari kienu irrappurtati wkoll b’ antagonisti ta ’ riċetturi ta ’ angiotensin II (li jinkludu PritorPlus).
Co-administration of lithium and PritorPlus is not recommended (see section 4.4).
L- għoti flimkien ta ’ lithium u PritorPlus mhuwiex rakkomandat (ara sezzjoni 4. 4).
Medicinal products associated with potassium loss and hypokalaemia (e. g. other kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid and derivatives):
Prodotti mediċinali marbuta ma ’ telf tal- potassium u ipokalemija (eż. dijuretiċi kaliuretiċi oħrajn, lassattivi, kortikosterojdi, ACTH, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid u derivattivi tiegħu tiegħu):
Periodic monitoring of serum potassium and ECG is recommended when PritorPlus is administered with these medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes.
Monitoraġġ perjodiku tal- livell tal- potassium fis- serum u ECG huma rakkomandati meta PritorPlus jingħata ma ’ dawn il - prodotti mediċinali affettwati minn disturbi fil- livell tal- potassium fis- serum (eż. digitalis glycosides, u anti- arritimiċi) u mal- prodotti mediċinali li ġejjin li jinduċu torsades de pointes (li jinkludu xi anti - arritimici), bl- ipokalemija, li hi fattur li jippredisponi t- torsades de pointes.
There are no adequate data from the use of PritorPlus in pregnant women.
M’ hemmx tagħrif biżżejjed mill- użu ta ’ PritorPlus f’ nisa tqal.
PritorPlus is contraindicated during lactation since it is not known whether telmisartan is excreted in human milk.
PritorPlus hu kontra- indikat matul it- treddigħ għax mhux magħruf jekk telmisartan jitneħħiex fil- ħalib tal- bniedem.
Fixed Dose Combination The overall incidence of adverse events reported with PritorPlus was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Taħlita Fissa tad- Doża L- inċidenza totali ta ’ avvenimenti avversi rrappurtati bi PritorPlus kienet komparabbli ma ’ dawk irrappurtati b’ telmisartan waħdu fi provi kkontrollati u randomised li saru fuq 1471 pazjent li kienu randomised biex jirċievu telmisartan flimkien ma ’ hydrochlorothiazide (835) jew telmisartan biss
Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with PritorPlus.
Reazzjonijiet avversi li huma magħrufa li jseħħu meta kull komponent jingħata waħdu, iżda li ma kinux osservati fil- provi kliniċi, jistgħu jseħħu matul il- kura bi PritorPlus.
Hyperuricaemia, hyponatraemia
Ipokalemija, Iperurikemija, ipernatremija
8 Undesirable effects previously reported with one of the individual components may be potential undesirable effects with PritorPlus, even if not observed in clinical trials with this product.
Informazzjoni addizzjonali dwar komponenti individwali L- effetti mhux mixtieqa li kienu rrappurtati qabel b’ wieħed mill- komponenti individwali jistgħu jsaħħu l- effetti mhux mixtieqa bi PritorPlus, anki jekk dawn ma kinux osservati fil- provi kliniċi li saru fuq dan il- prodott.
leukopenia, neutropenia, agranulocytosis, thrombocytopenia
Anemija aplastika, anemija emolitika, insuffiċjenza fil - funzjoni tal- mudullun, lewkopenija, newtropenija, agranuloċitosi, tromboċitopenija
Hypokalaemia may result in
L- iktar sinjali u sintomi komuni ta ’ doża eċċessiva huma nawseja u ngħas.
10 muscle spasms and/ or accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.
L- ipokalemija tista ’ tirriżulta fi spażmi tal- muskoli u/ jew iżżid l- arritmija marbuta ma ’ l- użu fl- istess ħin ta ’ digitalis glycosides jew ċerti prodotti mediċinali anti- arritmijaċi.