qanastek/EMEA-V3 huggingface dataset:
60 • if you have severe kidney disease. • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
62 • jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal hydrochlorothiazide jew għal xi mediċini oħrajn derivati minn sulfonamide. • 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- bużżieqa tal- marrara) jew kwalunkwe mard sever ieħor tal- fwied. • jekk għandek mard sever tal- kliewi. • jekk it- tabib tiegħek jistabbilixxi li għandek livelli baxxi ta ’ potassium jew livelli għolja ta ’ calcium fid- demm li ma jitjibux bil- kura.
If any of the above applies to you, tell your doctor or pharmacist before taking Kinzalkomb.
Jekk xi wieħed minn dawn is- sintomi t’ hawn fuq japplika għalik, għid lit- tabib jew lill- ispiżjar tiegħek qabel ma tieħu Kinzalkomb.
Take special care with Kinzalkomb
Oqgħod attent ħafna bi Kinzalkomb
Please tell your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:
Jekk jogħġbok għid lit- tabib tiegħek jekk qed tbati jew jekk fil- passat batejt minn kwalunkwe mill - kundizzjonijiet jew mard li ġejjin:
- Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body
- Pressjoni tad- demm baxxa (ipotensjoni), x’ aktarx li sseħħ jekk inti tkun deidrat (telf eċċessiv ta ’
water) or have salt deficiency due to diuretic therapy (water tablets), low-salt diet, diarrhoea, vomiting, or haemodialysis.
ilma mill- ġisem) jew ikollok defiċjenza ta ’ melħ minħabba terapija dijuretika (pillola ta ’ l- awrina), dieta b’ livelli baxxi ta ’ melħ, dijarea, rimettar, jew emodijalisi
- Kidney disease or kidney transplant.
- Mard tal- kliewi jew trapjant tal- kliewi.
- Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
- Stenosi ta ’ l- arterji renali (tidjiq tal- vini/ arterji lejn kilwa waħda jew lejn iż- żewġ kliewi)
- Liver disease.
- Mard tal- fwied.
- Heart trouble.
- Problemi tal- qalb
- Diabetes.
- Dijabete.
- Gout.
- Gotta.
- Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood
- Livelli għoljin ta ’ aldosterone (iż- żamma tal- ilma u l- melħ fil- ġisem flimkien ma ’ żbilanċ ta ’
minerals).
diversi minerali fid- demm).
- Lupus erythematosus (also called “ lupus” or “ SLE”) a disease where the body’ s immune system
- Lupus erythematosus (imsejjaħ ukoll “ lupus ” jew “ SLE ”) marda fejn is- sistema immuni tal- ġisem
attacks the body.
tattakka lill- ġisem.
You must tell your doctor if you think that you are (or might become) pregnant.
Għandek tgħid lit- tabib tiegħek jekk taħseb li inti (jew jekk tista ’ toħroġ) tqila.
Kinzalkomb 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).
Kinzalkomb 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).
Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body.
Il- kura b’ hydrochlorothiazide tista ’ tikkawża żbilanċ ta ’ l- elettroliti f’ ġismek.
Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling sick), vomiting, tired muscles, and an abnormally fast heart rate (faster than 100 beats per minute).
Sintomi tipiċi ta ’ żbilanċ tal- fluwidu jew ta ’ l- elettroliti jinkludu ħalq xott, dgħjufija, letarġija, ngħas, nuqqas ta ’ kwiet f’ ġismek, uġigħ fil- muskoli jew bugħawwieġ, nawseja (tħossok ser tirremetti), rimettar, muskoli għajjenin, rata anormali ta ’ taħbit mgħaġġel tal- qalb (iktar minn 100 taħbita kull minuta).
If you experience any of these you should tell your doctor.
Jekk ikollok xi waħda minn dawn, għandek tgħid lit- tabib tiegħek.
You should also tell your doctor, if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal.
Għandek tgħid ukoll lit- tabib tiegħek jekk ikollok żieda fis- sensittività tal- ġilda għax- xemx b’ sintomi ta ’ ħruq mix- xemx (bħal ħmura, ħakk, nefħa, nfafet) li jseħħu iktar malajr min- normal.
In case of surgery or anaesthetics, you should tell your doctor that you are taking Kinzalkomb.
F’ każ ta ’ operazzjoni jew anestetiċi, għandek tgħid lit- tabib tiegħek li qed tieħu Kinzalkomb.
The use of Kinzalkomb in children and adolescents up to the age of 18 years is not recommended.
L- użu ta ’ Kinzalkomb fit- tfal u fl- adolexxenti sa l- età ta ’ 18- il sena mhuwiex rakkomandat.
As with all other angiotensin II receptor antagonists, telmisartan may be less effective in lowering the blood pressure in black patients.
Bħal fil- każ ta ’ l- antagonisti l- oħrajn kollha tar- riċettur ta ’ angiotensin II, telmisartan jista ’ jkun inqas effettiv fit- tnaqqis tal- pressjoni tad- demm f’ pazjenti suwed.
Your doctor may need to change the dose of these other medications or take other precautions.
It- tabib tiegħek jista ’ jkollu bżonn li jibdel id- doża ta ’ dawn il- mediċini l- oħrajn, jew jieħu prekawzjonijiet oħrajn.
In some cases you may have to stop taking one of the medicines.
F’ xi każijiet, jista ’ jkollok tieqaf tieħu
This applies especially to the medicines listed below taken at the same time with Kinzalkomb:
Dan japplika b’ mod speċjali għal mediċini elenkati hawn taħt li jittieħdu fl- istess ħin ma ’ Kinzalkomb:
- Lithium containing medicines to treat some types of depression.
- Mediċini li fihom il- lithium għall- kura ta ’ xi tipi ta ’ dipressjoni.
- Medicines associated with low blood potassium (hypokalaemia) such as other diuretics, ('water
- Mediċini marbuta ma ’ livell baxx ta ’ potassium fid- demm (ipokalemija) bħal dijuretiċi oħrajn,
61 amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.
('pilloli tal- awrina'), lassattivi (eż. castor oil), kortikosterojdi (eż. prednisone), ACTH (ormon), amphotericin (mediċina antifungali), carbenoxolone (jintuża għall- kura ta ’ ulċeri tal- ħalq), penicillin G sodium (antibijotiku), u salicylic acid u derivattivi tiegħu.
- Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium,
- Dijuretiċi li ma jipproduċux potassium, supplimenti tal- potassium, sostituti tal- melħ li jkun
ACE inhibitors that may increase blood potassium levels.
fihom il- potassium, inibituri ta ’ ACE li jistgħu jżidu l- livelli ta ’ potassium fid- demm
- Heart medicines (e. g. digoxin) or medicines to control the rhythm of your heart (e. g. quinidine,
- Mediċini tal- qalb (eż. digoxin) jew mediċini biex jikkontrollaw ir- rittmu tat- taħbit ta ’ qalbek
disopyramide).
(eż. quinidine, disopyramide)
- Medicines used for mental disorders (e. g. thioridazine, chlorpromazine, levomepromazine).
- Mediċini li jintużaw għal disturbi mentali (eż. thioridazine, chlorpromazine, levomepromazine)
- Other medicines used to treat high blood pressure, steroids, painkillers, medicines to treat
- Mediċini oħrajn li jintużaw biex jikkuraw pressjoni tad- demm għolja, sterodji, mediċini li
cancer, gout, or arthritis, and vitamin D supplements.
jtaffu l- uġigħ, mediċini għall- kura kanċer, gotta, jew artrite, u supplimenti ta ’ vitamina D.
Kinzalkomb may increase the blood pressure lowering effect of other medicines and you should consult with your doctor if you need to adjust the dose of your other medicine while taking Kinzalkomb.
Kinzalkomb jista ’ jżid l- effett li jbaxxi l- pressjoni tad- demm ta ’ mediċini oħrajn, u għandek tkellem lit- tabib tiegħek jekk ikollok bżonn taġġusta d- doża tal- mediċina l- oħra tiegħek meta tkun qed tieħu Kinzalkomb.
As with other blood pressure lowering medicines, the effect of Kinzalkomb may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e. g. aspirin or ibuprofen).
Bħal ma jiġri b’ mediċini oħrajn li jbaxxu l- pressjoni tad- demm, l- effetti ta ’ Kinzalkomb jistgħu jitnaqqsu meta tieħu NSAIDs (non steroidal anti- inflammatory drugs, eż. aspirina jew ibuprofen).
Taking Kinzalkomb with food and drink
Meta tieħu Kinzalkomb ma ’ l- ikel u x- xorb
You can take Kinzalkomb with or without food.
Tista ’ tieħu Kinzalkomb ma ’ l- ikel jew mingħajr l- ikel.
Usually, your doctor will advise you to take another medicine instead of Kinzalkomb, as Kinzalkomb 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 Kinzalkomb, għax Kinzalkomb mhuwiex rakkomandat matul l- ewwel stadji tat- tqala, u jista ’ jikkawża ħsara serja lit- tarbija tiegħek jekk jintuża wara 3 xhur ta ’ tqala.
Appropriate antihypertensive drug must usually replace Kinzalkomb before starting a pregnancy.
Mediċina adattata kontra l- pressjoni għolja trid normalment tissostitwixxi Kinzalkomb qabel il- bidu ta ’ tqala.
Kinzalkomb should not be used during the second and third trimester of pregnancy.
Kinzalkomb m’ għandux jintuża matul it- tieni u t- tielet trimestru tat- tqala.
Your doctor will normally advise you to stop taking Kinzalkomb as soon as you know you are pregnant.
It- tabib tiegħek, normalment ser jagħtik parir biex tieqaf tieħu Kinzalkomb hekk kif issir taf li inti tqila.
If you become pregnant during therapy with Kinzalkomb, please inform and see your doctor without delay.
Jekk inti toħroġ tqila matul kura b’ Kinzalkomb, jekk jogħġbok informa u ara lit- tabib tiegħek mingħajr dewmien.
You must not take Kinzalkomb if you are breast-feeding.
M’ għandekx tieħu Kinzalkomb jekk qed tredda ’.
No information is available on the effect of Kinzalkomb on the ability to drive or operate machinery.
M’ hemm l- ebda informazzjoni disponibbli dwar l- effett ta ’ Kinzalkomb fuq il- ħila li ssuq jew tħaddem makkinarju.
Some people feel dizzy or tired when they are treated for high blood pressure.
Xi nies iħossuhom storduti jew għajjenin meta jkunu kkurati għal pressjoni tad - demm għolja.
If you feel dizzy or tired, do not drive or operate machinery.
Jekk tħossok stordut jew għajjien, issuqx jew tħaddem makkinarju.
Important information about some of the ingredients of Kinzalkomb
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Kinzalkomb
Kinzalkomb contains milk sugar (lactose) and sorbitol.
Kinzalkomb fih zokkor tal- ħalib (lactose) u sorbitol.
If you are intolerant to some sugars, consult your doctor before taking Kinzalkomb.
Jekk għandek intolleranza għal xi tipi ta ’ zokkor, għandek tikkuntattja lit- tabib tiegħek qabel ma tieħu Kinzalkomb.
HOW TO TAKE KINZALKOMB
KIF GĦANDEK TIEĦU KINZALKOMB
Always take Kinzalkomb exactly as your doctor has told you.
64 Dejjem għandek tieħu Kinzalkomb skond il- parir eżatt tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat - tabib jew ma ’ l- ispiżjar jekk ikollok xi dubju.
The usual dose of Kinzalkomb is one tablet a day.
Id- doża normali ta ’ Kinzalkomb hi ta ’ pillola waħda darba kuljum.
Try to take a tablet at the same time each day.
Ipprova ħu pillola fl- istess ħin kuljum.
The tablets should be swallowed with some water or other non-alcoholic drink.
Il- pilloli għandhom jinbelgħu ma ’ ftit ilma jew ma ’ xi xarba oħra mhix alkoħolika.
It is important that you take Kinzalkomb every day until your doctor tells you otherwise.
Hu importanti li tieħu Kinzalkomb kuljum sakemm it - tabib tiegħek jagħtik parir ieħor.
62 If your liver is not working properly, the usual dose should not exceed 40 mg/ 12.5 mg once a day.
Jekk il- fwied tiegħek mhux qed jaħdem kif suppost, id- doża tas- soltu m’ għandhiex taqbeż 40 mg/ 12. 5 mg darba kuljum.
If you take more Kinzalkomb than you should If you accidentally take too many tablets contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Jekk tieħu Kinzalkomb aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda, ikkuntattja lit- tabib jew lill- ispiżjar tiegħek, jew lill- eqreb dipartiment ta ’ l- emerġenza immedjatament.
If you forget to take Kinzalkomb If you forget to take a dose, do not worry.
Jekk tinsa tieħu Kinzalkomb Jekk tinsa tieħu doża, tinkwetax.
Take it as soon as you remember then carry on as before.
Ħudha hekk kif tiftakar, imbagħad kompli ħudha bħas- soltu.
If you do not take your tablet on one day, take your normal dose on the next day.
Jekk ma tiħux il- pillola f’ jum wieħed, ħu d- doża normali tiegħek fil- jum ta ’ wara.
Do not take a double dose to make up for forgotten individual doses.
Tiħux doża doppja biex tpatti għad- dożi individwali li tkun insejt tieħu..
If you have further questions on the use of this product, ask your doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Kinzalkomb can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Kinzalkomb jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 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 persuna 1 minn kull 10 li jużawh komuni: jaffettwaw minn 1 sa 10 persuni minn kull 100 li jużawh mhux komuni: jaffettwaw minn 1 sa 10 persuni minn kull 1, 000 li jużawh rari: jaffettwaw minn 1 sa 10 persuni minn kull 10, 000 li jużawh rari ħafna: jaffettwaw inqas minn persuna 1 minn kull 10, 000 li jużawh mhux magħruf: ma tistax tittieħed stima mid- data disponibbli.
Dizziness
Sturdament.
Decreased blood potassium levels; anxiety; fainting (syncope); sensation of tingling, pins and needles (paraesthesia); feeling of spinning (vertigo); fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up; shortness of breath (dyspnoea); symptoms of an upset stomach such as diarrhoea; dry mouth, flatulence; back pain, muscle spasm, muscle pain; erectile dysfunction (inability to get or keep an erection); chest pain; and increased blood uric acid levels.
Tnaqqis fil- livelli tal- potassium fid- demm; ansjetà; ħass ħażin (sinkope); sensazzjoni ta ’ tnemnim, sensazzjoni bħal qisu xi ħadd qed iniggżek bil- labar (parestesija); tħoss kollox idur bik (vertigo); taħbit tal- qalb mgħaġġel (takikardija), disturbi fir- ritmu tat- taħbit tal- qalb, pressjoni tad- demm baxxa, il - pressjoni tad- demm taqa ’ f’ daqqa meta tkun bilwieqfa; qtugħ ta ’ nifs (dispneja); sintomi ta ’ stonku mqalleb bħal dijarea; ħalq xott, gass; uġigħ fid- dahar, spażmi fil- muskoli, uġigħ fil- muskoli; disfunzjoni erettili (ma tkunx kapaċi jkollok jew iżżomm erezzjoni); uġigħ fis- sider, żieda fil- livelli tal- uric acid fid- demm.
Rare side effects may include:
Effetti sekondarji rari jistgħu jinkludu:
Inflammation of the lung (bronchitis); feeling sad (depression); difficulty falling asleep (insomnia); impaired vision; difficulty breathing; abdominal pain, constipation, bloating (dyspepsia), feeling sick; abnormal liver function; rapid swelling of the skin and mucosa (angioedema), redness of the skin (erythema); allergic reactions such as itching or rash; increased sweating, hives (urticaria); joint pain (arthralgia) and pain in extremities, muscle cramps; flu-like-illness; pain; increased levels of uric acid, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.
Infjammazzjoni tal- pulmun (bronkite); tħossok imdejjaq (dipressjoni); diffikultà biex torqod (insomnja); indeboliment fil- vista; diffikultà biex tieħu n- nifs; uġigħ addominali, stitikezza, gass żejjed (dispepsja), tħossok imdardar; funzjoni anormali tal- fwied; nefħa malajr tal- ġilda u tal- mukuża (anġjoedima), ħmura tal- ġilda (eritema); reazzjonijiet allerġiċi bħal ħakk jew raxx; żieda fl- għaraq, ħorriqija (urtikarja); uġigħ fil- ġogi (artralġja) u uġigħ fl- estremitajiet, bugħawwieġ fil- muskoli; mard qisu influwenza; uġigħ; żieda fil- livelli tal- uric acid, livelli baxxi ta ’ sodium, żieda fil- livelli tal - krejatinina, enzimi epatiċi jew creatine phosphokinase fid- demm.
Side effects of unknown frequency may include:
Effetti sekondarji ta ’ frekwenza mhux magħrufa jistgħu jinkludu:
Sore throat, inflamed sinuses; inflammation of the stomach (gastritis)
Uġigħ fil- griżmejn, sinuses infjammati; infjammazzjoni tal- istonku (gastrite)
Telmisartan In patients taking telmisartan alone the following additional side effects have been reported:
65 Telmisartan F’ pazjenti li kienu qed jieħdu telmisartan waħdu, l- effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
Upper respiratory tract infection (e. g. sore throat, inflamed sinuses, common cold), urinary tract infections; increase in certain white blood cells (eosinophilia), deficiency in red blood cells (anaemia), low platelet count (thrombocytopenia); serious allergic reaction (e. g. hypersensitivity, anaphylactic reaction, drug rash); high potassium levels; slow heart rate (bradycardia); upset stomach; eczema (a
Infezzjoni fil- parti ta ’ fuq tal- apparat respiratorju (eż. uġigħ fil- griżmejn, sinuses infjammati, riħ komuni), infezzjoni fl- apparat urinarju; żieda f’ ċerti ċelluli bojod tad- demm (eosinofilja), tnaqqis fiċ - ċelluli ħomor tad- demm (anemija), għadd baxx tal- plejtlets (tromboċitopenija); reazzjoni allerġika serja (eż. sensittività eċċessiva, reazzjoni anafilattika, raxx minħabba l- mediċina); livelli għolja ta ’ potassium; rata ta ’ taħbit tal- qalb bil- mod (bradikardija); stonku mqalleb; ekżema (disturb fil- ġilda); infjammazzjoni tat- tendini; indeboliment fil- kliewi li jinkludi insuffiċjenza akuta tal- kliewi; dgħjufija; tnaqqis fl- emoglobina (proteina fid- demm), telmisartan ma jkunx effettiv.
Hydrochlorothiazide In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
Hydrochlorothiazide F’ pazjenti li kienu qed jieħdu hydrochlorothiazide waħdu, l- effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
Inflammation of the salivary gland; decreases in the number of cells in the blood, including low red and white blood cell count, low platelet count (thrombocytopenia); serious allergic reactions (e. g. hypersensitivity, anaphylactic reaction), inflammation of blood vessels (vasculitis necrotising), decreased or loss of appetite; restlessness, weakness, dizziness; blurred or yellowing of vision; inflamed pancreas, upset stomach; yellowing of the skin or eyes (jaundice); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, or blistering and peeling of the top layer of skin (toxic epidermal necrolysis); kidney inflammation or impaired kidney function; fever; impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, glucose in the urine (glycosuria), increased levels of glucose, uric acid, and fat in the blood.
Infjammazzjoni tal- glandola tal- bżieq; tnaqqis fin- numru ta ’ ċelluli fid- demm, li jinkludu għadd baxx taċ- ċelluli tad- demm ħomor u taċ- ċelluli tad- demm bojod, għadd baxx tal- plejtlets (tromboċitopenija); reazzjonijiet allerġiċi serji (eż. sensittività eċċessiva, reazzjoni anafilattika), infjammazzjoni tal- vini jew arterji (vaskulite nekrotizzanti), tnaqqis jew telf tal- aptit; nuqqas ta ’ kwiet f’ ġismek, dgħjufija, sturdament; vista mċajpra jew tara kollox isfar; frixa infjammata, stonku mqalleb; sfurija tal- ġilda jew ta ’ l- għajnejn (suffejra); disturbi tal- ġilda bħal vini jew arterji infjammati; żieda fis- sensittività għad - dawl tax- xemx, jew infafet u tqaxxir fis- saff ta ’ fuq tal- ġilda (nekrolisi epidermali tossika); infjammazzjoni tal- kliewi jew indeboliment fil- funzjoni tal- kliewi; deni; indeboliment fil- bilanċ tal - elettroliti, livelli għolja ta ’ kolesterol fid- demm, tnaqqis fil- volum tad- demm, glucose fl- awrina (glikosurja), żieda fil- livelli tal- glucose, uric acid, jew xaħam fid- demm.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE KINZALKOMB
KIF TAĦŻEN KINZALKOMB
Do not use Kinzalkomb after the expiry date which is stated on the carton after “ EXP”.
Tużax Kinzalkomb wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun wara “ JIS ”.
This medicine does not require any special storage conditions.
Dan il- prodott mediċinali m’ għandux bżonn ħażna speċjali.
You should store your medicine in the original package in order to protect the tablets from moisture.
Għandek taħżen il- mediċina tiegħek fil - pakkett oriġinali sabiex tipproteġi l- pilloli mill- umdità.
Occasionally, the outer layer of the blister pack separates from the inner layer between the blister pockets.
Xi kultant, is- saff ta ’ barra tal- pakkett tal- folji jinqala ’ mis- saff ta ’ ġewwa bejn il- pakketti tal- folji.
You do not need to take any action if this happens.
M’ hemm bżonn li tagħmel xejn jekk dan jiġri.
What Kinzalkomb contains
X’ fih Kinzalkomb
The active substances are telmisartan and hydrochlorothiazide.
66 Is- sustanzi attivi huma telmisartan u hydrochlorothiazide.
The other ingredients are lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, red iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)
Is- sustanzi l- oħra huma lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, red iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)
What Kinzalkomb looks like and contents of the pack
Id- dehra ta ’ Kinzalkomb u l- kontenuti tal- pakkett
Kinzalkomb 40 mg/ 12.5 mg tablets are red and white, oval-shaped two-layer tablets engraved with the code number'H4 '.
Il- pilloli Kinzalkomb 40 mg/ 12. 5 mg huma ħomor u bojod, b’ forma ovali, b’ żewġ saffi, imnaqqxa bin - numru tal- kodiċi 'H4'.
Kinzalkomb is available in blisters packs containing 14, 28, 56, or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.
Kinzalkomb hu disponibbli f’ pakketti tal- folji li fihom 14, 28, 56, 90 jew 98 pillola, jew pakketti tal - folji bid- doża ta ’ l- unità li fihom 28 x 1 pillola.
Not all pack sizes may be available in your country.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu disponibbli fil- pajjiż tiegħek.
64 Marketing Authorisation Holder Bayer HealthCare AG D-51368 Leverkusen Germany
Bayer HealthCare AG D- 51368 Leverkusen Il- Ġermanja
Manufacturer Bayer HealthCare AG D-51368 Leverkusen Germany
Bayer HealthCare AG D- 51368 Leverkusen Il- Ġermanja
65 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
België / Belgique / Belgien Bayer S. A. / N. V.
67 België / Belgique / Belgien Bayer S. A. / N. V.
66 PACKAGE LEAFLET:
68 FULJETT TA ’ TAGĦRIF:
Both substances help to control high blood pressure.
Iż - żewġ sustanzi jgħinu biex jikkontrollaw pressjoni tad- demm għolja.
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 li l - vini/ arterji tad- demm jidjiequ, u b’ hekk tiżdied il- pressjoni tad- demm.
your urine output to increase leading to a lowering of your blood pressure.
jikkawżaw żieda fl- ammont ta ’ l- awrina, u dan iwassal għal tnaqqis fil- pressjoni tad- demm tiegħek.
There are usually no symptoms of high blood pressure before damage occurs., Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Għaldaqstant hu importanti li tkejjel il- pressjoni tad- demm regolarment biex tivverifika li qiegħda fil- medda normali.
• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Kinzalkomb tablets (see "Further Information" for a list of other ingredients). • if you are allergic (hypersensitive) to hydrochlorothiazide or to any other sulfonamide-derived medicines. • 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 gall bladder) or any other severe liver disease.
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal telmisartan jew għal xi sustanzi oħra fil- pilloli Kinzalkomb (ara “ Tagħrif addizzjonali ” għal- lista ta ’ sustanzi oħra).
67 • if you have severe kidney disease. • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
69 • jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal hydrochlorothiazide jew għal xi mediċini oħrajn derivati minn sulfonamide. • 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- bużżieqa tal- marrara) jew kwalunkwe mard sever ieħor tal- fwied. • jekk għandek mard sever tal- kliewi. • jekk it- tabib tiegħek jistabbilixxi li għandek livelli baxxi ta ’ potassium jew livelli għolja ta ’ calcium fid- demm li ma jitjibux bil- kura.
- Heart trouble.
- Problemi tal- qalb.
- Diabetes.
- Dijabete
68 amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.
('pilloli tal- awrina'), lassattivi (eż. castor oil), kortikosterojdi (eż. prednisone), ACTH (ormon), amphotericin (mediċina antifungali), carbenoxolone (jintuża għall- kura ta ’ ulċeri tal- ħalq), penicillin G sodium (antibijotiku), u salicylic acid u derivattivi tiegħu.
ACE inhibitors that may increase blood potassium levels.
fihom il- potassium, inibituri ta ’ ACE li jistgħu jżidu l- livelli ta ’ potassium fid- demm.
disopyramide).
(eż. quinidine, disopyramide).
- Medicines used for mental disorders (e. g. thioridazine, chlorpromazine, levomepromazine).
- Mediċini li jintużaw għal disturbi mentali (eż. thioridazine, chlorpromazine,
You can take Kinzalkomb tablets with or without food.
Tista ’ tieħu Kinzalkomb ma ’ l- ikel jew mingħajr l- ikel.
Always take Kinzalkomb exactly as your doctor has told you.
71 Dejjem għandek tieħu Kinzalkomb skond il- parir eżatt tat- tabib.
Try to take the tablet at the same time each day.
Ipprova ħu l- pillola fl- istess ħin kuljum.
69 If your liver is not working properly, the usual dose should not exceed 40 mg/ 12.5 mg once a day.
Jekk il- fwied tiegħek mhux qed jaħdem kif suppost, id- doża tas- soltu m’ għandhiex taqbeż 40 mg/ 12. 5 mg darba kuljum.
If you take more Kinzalkomb than you should If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Jekk tieħu Kinzalkomb aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda, ikkuntattja lit- tabib jew lill- ispiżjar tiegħek, jew lill- eqreb dipartiment ta ’ l- emerġenza immedjatament.
Inflammation of the lung (bronchitis); feeling sad (depression); difficulty falling asleep (insomnia); impaired vision; difficulty breathing; abdominal pain, constipation, bloating (dyspepsia), feeling sick; abnormal liver function; rapid swelling of the skin and mucosa (angioedema), redness of the skin (erythema); allergic reactions such as itching or rash; increased sweating, hives (urticaria); joint pain (arthralgia) and pain in extremities, muscle cramps; flu-like-illness; pain; increased levels of uric acid, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.
Infjammazzjoni tal- pulmun (bronkite); tħossok imdejjaq (dipressjoni); diffikultà biex torqod (insomnja); indeboliment fil- vista; diffikultà biex tieħu n- nifs; uġigħ addominali, stitikezza, gass żejjed (dispepsja), tħossok imdardar; funzjoni anormali tal- fwied; nefħa malajr tal- ġilda u tal- mukuża (anġjoedima), ħmura tal- ġilda (eritema); reazzjonijiet allerġiċi bħal ħakk jew raxx; żieda fl- għaraq, (ħorriqija) urtikarja; uġigħ fil- ġogi (artralġja) u uġigħ fl- estremitajiet, bugħawwieġ fil- muskoli; mard qisu influwenza; uġigħ; żieda fil- livelli tal- uric acid, livelli baxxi ta ’ sodium, żieda fil- livelli tal - krejatinina, enzimi epatiċi jew creatine phosphokinase fid- demm.
Sore throat, inflamed sinuses; inflammation of the stomach (gastritis)
72 Uġigħ fil- griżmejn, sinuses infjammati; infjammazzjoni tal- istonku (gastrite)
Telmisartan In patients taking telmisartan alone the following additional side effects have been reported:
Telmisartan F’ pazjenti li kienu qed jieħdu telmisartan waħdu, l- effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
Inflammation of the salivary gland; decreases in the number of cells in the blood, including low red and white blood cell count, low platelet count (thrombocytopenia); serious allergic reactions; (e. g. hypersensitivity, anaphylactic reaction), inflammation of blood vessels (vasculitis necrotising), decreased or loss of appetite; restlessness, weakness, dizziness; blurred or yellowing of vision; inflamed pancreas, upset stomach; yellowing of the skin or eyes (jaundice); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, or blistering and peeling of the top layer of skin (toxic epidermal necrolysis); kidney inflammation or impaired kidney function; fever; impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, glucose in the urine (glycosuria), increased levels of glucose, uric acid, and fat in the blood.
Infjammazzjoni tal- glandola tal- bżieq; tnaqqis fin- numru ta ’ ċelluli fid- demm, li jinkludu għadd baxx taċ- ċelluli tad- demm ħomor u taċ- ċelluli tad- demm bojod, għadd baxx tal- plejtlets (tromboċitopenija); reazzjonijiet allerġiċi serji (eż. sensittività eċċessiva, reazzjoni anafilattika), infjammazzjoni tal- vini jew arterji (vaskulite nekrotizzanti), tnaqqis jew telf tal- aptit; nuqqas ta ’ kwiet f’ ġismek, dgħjufija, sturdament; vista mċajpra jew tara kollox isfar; frixa infjammata, stonku mqalleb; sfurija tal- ġilda jew ta ’ l- għajnejn (suffejra); disturbi tal- ġilda bħal vini jew arterji infjammati; żieda fis- sensittività għad - dawl tax- xemx, jew infafet u tqaxxir fis- saff ta ’ fuq tal- ġilda (nekrolisi epidermali tossika); infjammazzjoni tal- kliewi jew indeboliment fil- funzjoni tal- kliewi; deni; indeboliment fil- bilanċ tal - elettroliti, livelli għolja ta ’ kolesterol fid- demm, tnaqqis fil- volum tad- demm, glucose fl- awrina (glikosurja), żieda fil- livelli tal- glucose, uric acid, jew xaħam fid- demm.
The active substances are telmisartan and hydrochlorothiazide.
73 Is- sustanzi attivi huma telmisartan u hydrochlorothiazide.
Kinzalkomb 80 mg/ 12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the code number'H8 '.
Il- pilloli Kinzalkomb 80 mg/ 12. 5 mg huma ħomor u bojod, b’ forma ovali, b’ żewġ saffi, imnaqqxa bin - numru tal- kodiċi 'H8'.
Kinzalkomb is available in blisters packs containing 14, 28, 56, or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.
Kinzalkomb hu disponibbli f’ pakketti tal- folji li fihom 14, 28, 56, jew 98 pillola, jew pakketti tal- folji bid- doża ta ’ l- unità li fihom 28 x 1 pillola.
België / Belgique / Belgien Bayer S. A. / N. V.
74 België / Belgique / Belgien Bayer S. A. / N. V.
73 PACKAGE LEAFLET:
75 FULJETT TA ’ TAGĦRIF:
Do not take Kinzalkomb • if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Kinzalkomb tablets (see “ Further Information” for a list of other ingredients). • if you are allergic (hypersensitive) to hydrochlorothiazide or to any other sulfonamide-derived medicines. • 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 gall bladder), or any other severe liver disease. • if you have severe kidney disease.
Tiħux Kinzalkomb • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal telmisartan jew għal xi sustanzi oħra fil- pilloli Kinzalkomb (ara “ Tagħrif addizzjonali ” għal- lista ta ’ sustanzi oħra). • jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal hydrochlorothiazide jew għal xi mediċini oħrajn derivati minn sulfonamide.
74 • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
76 • 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- bużżieqa tal- marrara) jew kwalunkwe mard sever ieħor tal- fwied. • jekk għandek mard sever tal- kliewi. • jekk it- tabib tiegħek jistabbilixxi li għandek livelli baxxi ta ’ potassium jew livelli għolja ta ’ calcium fid- demm li ma jitjibux bil- kura.
water) or have salt deficiency due to diuretic therapy (water tablets), low-salt diet, diarrhoea, vomiting, or haemodialysis.
ilma mill- ġisem) jew ikollok defiċjenza ta ’ melħ minħabba terapija dijuretika (pillola ta ’ l- awrina), dieta b’ livelli baxxi ta ’ melħ, dijarea, rimettar, jew emodijalisi.
In some cases you may have to stop taking one of the medicines.
F’ xi każijiet, jista ’ jkollok tieqaf tieħu waħda mill- mediċini.
tablets'), laxatives (e. g. castor oil), corticosteroids (e. g. prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.
('pilloli tal- awrina'), lassattivi (eż. castor oil), kortikosterojdi (eż. prednisone), ACTH (ormon), amphotericin (mediċina antifungali), carbenoxolone (jintuża għall- kura ta ’ ulċeri tal- ħalq), penicillin G sodium (antibijotiku), u salicylic acid u derivattivi.
Always take Kinzalkomb exactly as your doctor has told you.
78 Dejjem għandek tieħu Kinzalkomb skond il- parir eżatt tat- tabib.
It is important that you take Kinzalkomb every day until your doctor tells you otherwise.
Hu importanti li tieħu Kinzalkomb kuljum sakemm it- tabib tiegħek jagħtik parir ieħor.
If your liver is not working properly, the usual dose should not exceed 40 mg/ 12.5 mg once a day.
Jekk il- fwied tiegħek mhux qed jaħdem kif suppost, id- doża tas- soltu m’ għandhiex taqbeż 40 mg/ 12. 5 mg darba kuljum.
76 If you take more Kinzalkomb than you should If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Jekk tieħu Kinzalkomb aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda, ikkuntattja lit- tabib jew lill- ispiżjar tiegħek, jew lill- eqreb dipartiment ta ’ l- emerġenza immedjatament.
Sore throat, inflamed sinuses; inflammation of the stomach (gastritis)
79 Uġigħ fil- griżmejn, sinuses infjammati; infjammazzjoni tal- istonku (gastrite)
Upper respiratory tract infection (e. g. sore throat, inflamed sinuses, common cold), urinary tract infections; increase in certain white blood cells (eosinophilia), deficiency in red blood cells (anaemia), low platelet count (thrombocytopenia); serious allergic reaction (e. g. hypersensitivity, anaphylactic reaction, drug rash); high potassium levels; slow heart rate (bradycardia); upset stomach; eczema (a skin disorder); inflammation of the tendons; kidney impairment including acute kidney failure; weakness; decreased haemoglobin (a blood protein), ineffectiveness of telmisartan.
Infezzjoni fil- parti ta ’ fuq tal- apparat respiratorju (eż. uġigħ fil- griżmejn, sinuses infjammati, riħ komuni), infezzjoni fl- apparat urinarju; żieda f’ ċerti ċelluli bojod tad- demm (eosinofilja), tnaqqis fiċ - ċelluli ħomor tad- demm (anemija), għadd baxx tal- plejtlets (tromboċitopenija); reazzjoni allerġika serja (eż. sensittività eċċessiva, reazzjoni anafilattika, raxx minħabba l- mediċina); livelli għolja ta ’ potassium; rata ta ’ taħbit tal- qalb bil- mod (bradikardija); stonku mqalleb; ekżema (disturb fil- ġilda); infjammazzjoni tat- tendini; indeboliment fil- kliewi li jinkludi insuffiċjenza akuta tal- kliewi; dgħjufija; tnaqqis fl- emoglobina (proteina fid- demm), telmisartan ma jkunx effettiv.
77 Hydrochlorothiazide In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
Hydrochlorothiazide F’ pazjenti li kienu qed jieħdu hydrochlorothiazide waħdu, l- effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
Inflammation of the salivary gland; decreases in the number of cells in the blood, including low red and white blood cell count, low platelet count (thrombocytopenia); serious allergic reactions (e. g. hypersensitivity, anaphylactic reaction), inflammation of blood vessels (vasculitis necrotising); decreased or loss of appetite; restlessness, weakness, dizziness; blurred or yellowing of vision; inflamed pancreas, upset stomach; yellowing of the skin or eyes (jaundice); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, or blistering and peeling of the top layer of skin (toxic epidermal necrolysis); kidney inflammation or impaired kidney function; fever; impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, glucose in the urine (glycosuria), increased levels of glucose, uric acid, and fat in the blood.
Infjammazzjoni tal- glandola tal- bżieq; tnaqqis fin- numru ta ’ ċelluli fid- demm, li jinkludu għadd baxx taċ- ċelluli tad- demm ħomor u taċ- ċelluli tad- demm bojod, għadd baxx tal- plejtlets (tromboċitopenija); reazzjonijiet allerġiċi serji (eż. sensittività eċċessiva, reazzjoni anafilattika), infjammazzjoni tal- vini jew arterji (vaskulite nekrotizzanti), tnaqqis jew telf tal- aptit; nuqqas ta ’ kwiet f’ ġismek, dgħjufija, sturdament; vista mċajpra jew tara kollox isfar; frixa infjammata, stonku mqalleb; sfurija tal- ġilda jew ta ’ l- għajnejn (suffejra); disturbi tal- ġilda bħal vini jew arterji infjammati; żieda fis- sensittività għad - dawl tax- xemx, jew infafet u tqaxxir fis- saff ta ’ fuq tal- ġilda (nekrolisi epidermali tossika); infjammazzjoni tal- kliewi jew indeboliment fil- funzjoni tal- kliewi; deni; indeboliment fil- bilanċ tal - elettroliti, livelli għolja ta ’ kolesterol fid- demm, tnaqqis fil- volum tad- demm, glucose fl- awrina (glikosurja), żieda fil- livelli tal- glucose, uric acid, jew xaħam fid- demm.
You do not need to take any action need be taken if this happens.
M’ hemm bżonn li tagħmel xejn jekk dan jiġri.
The active substances are telmisartan and hydrochlorothiazide.
80 Is- sustanzi attivi huma telmisartan u hydrochlorothiazide.
The other ingredients are lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, yellow iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)
Is- sustanzi l- oħra huma lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, yellow iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)
Kinzalkomb 80 mg/ 25 mg tablets are yellow and white, oval-shaped, two-layer tablets engraved with the code'H9 '.
Il- pilloli Kinzalkomb 80 mg/ 25 mg huma sofor u bojod, b’ forma ovali, b’ żewġ saffi, imnaqqxa bil - kodiċi 'H9'.
Kinzalkomb is available in blister packs containing 14, 28, 56, or 98 tablets, or unit dose blister packs containing 28 x 1 tablets
Kinzalkomb hu disponibbli f’ pakketti tal- folji li fihom 14, 28, 56, jew 98 pillola, jew pakketti tal- folji bid- doża ta ’ l- unità li fihom 28 x 1 pillola.
78 Marketing Authorisation Holder Bayer HealthCare AG D-51368 Leverkusen Germany
Bayer HealthCare AG D- 51368 Leverkusen Il- Ġermanja
79 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
België / Belgique / Belgien Bayer S. A. / N. V.
81 België / Belgique / Belgien Bayer S. A. / N. V.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d - Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Kinzalmono?
X’ inhu Kinzalmono?
Kinzalmono is a medicine that contains the active substance telmisartan.
Kinzalmono huwa mediċina li fiha s- sustanza attiva telmisartan.
It is available as white tablets (round:
Jiġi bħala pilloli bojod (tondi:
20 mg; oblong:
20 mg; rettangulari:
40 and 80 mg).
40 u 80 mg).
What is Kinzalmono used for?
Għalxiex jintuża Kinzalmono?
Kinzalmono is used in adults who have essential hypertension (high blood pressure). ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
Kinzalmono jintuża f’ adulti li jkollhom pressjoni għolja essenzjali (pressjoni għolja tad- demm). ‘ Essenzjali ’ tfisser li l- pressjoni għolja tad- demm ma tkunx ikkawżata minn xi kundizzjoni oħra.
How is Kinzalmono used?
Kif jintuża Kinzalmono?
Kinzalmono is taken by mouth, with or without food.
Kinzalmono jittieħed oralment, ma ’ jew mingħajr l- ikel.
The usual recommended dose is 40 mg once a day, but some patients may benefit from using a 20-mg dose.
Id- doża li normalment tiġi rrakkomandata hija 40 mg darba kuljum, iżda xi pazjenti jistgħu jibbenefikaw mill- użu ta ’ doża ta ’ 20- mg.
If the target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Jekk il - pressjoni tad- demm mixtieqa ma tintlaħaqx, id- doża tista ’ tiżdied għal 80 mg, jew inkella tista ’ tiżdied mediċina oħra għall- pressjoni għolja, bħal hydrochlorothiazide.
How does Kinzalmono work?
Kif jaħdem Kinzalmono?
The active substance in Kinzalmono, telmisartan, is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Is- sustanza attiva f’ Kinzalmono, telmisartan, huwa ‘ antagonist tar- riċettur ta ’ angiotensin II ’, li jfisser li jimblokka l- azzjoni ta ’ ormon fil- ġisem magħruf bħala angiotensin II.
Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Angiotensin II huwa vażokonstrittur (sustanza li ddejjaq il- vini u l- arterji) qawwi.
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 normalment angiotensin II jeħel magħhom, telmisartan iwaqqaf l- ormon milli jkollu effett, u jħalli lill- arterji u lill - vini jitwessgħu.
This allows the blood pressure to drop, reducing the risk caused by high blood pressure, such as having a stroke.
Dan iwassal għal tnaqqis fil- pressjoni tad- demm, u b’ hekk inaqqas ir- riskju kkawżat minn pressjoni għolja tad- demm, fosthom il- puplesija.
How has Kinzalmono been studied?
Kif ġie studjat Kinzalmono?
Kinzalmono has been studied in 1,647 patients who were treated with telmisartan either alone or in combination with hydrochlorothiazide.
Kinzalmono ġie studjat f’ 1, 647 pazjent li ġew ittrattati b’ telmisartan waħdu jew flimkien ma ’ hydrochlorothiazide.
Kinzalmono was compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine).
Kinzalmono tqabbel ma ’ plaċobo (trattament finta) u ma ’ mediċini oħra għall - pressjoni għolja tad- demm (atenolol, lisinopril, enalapril u amlodipina).
The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Il- mezz ewlieni tal- effikaċja kien it- tnaqqis fil- pressjoni dijastolika tad- demm (il- pressjoni tad- demm mkejla bejn żewġ taħbitiet tal- qalb).
What benefit has Kinzalmono shown during the studies?
Liema benefiċċju wera Kinzalmono waqt l- istudji mwettqa?
Kinzalmono was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Kinzalmono kien iktar effettiv mill- plaċebo fit- tnaqqis tal- pressjoni dijastolika tad- demm u kellu effetti simili għall- mediċini l- oħrajn tat- tnaqqis tal- pressjoni.
What is the risk associated with Kinzalmono?
X’ inhu r- riskju assoċjat ma ’ Kinzalmono?
Side effects with Kinzalmono are not common.
L- effetti sekondarji b' Kinzalmono m’ humiex komuni.
However, the following side effects are seen in between 1 and 10 patients in 1,000: hyperkalaemia (high blood potassium levels), syncope (fainting), insomnia (difficulty sleeping), vertigo (a spinning sensation), hypotension (low blood pressure), dyspnoea (difficulty breathing), abdominal (tummy) pain, diarrhoea, dry mouth, dyspepsia (heartburn), flatulence (gas), hyperhidrosis (excessive sweating), pruritus (itching), myalgia (muscle pain), renal impairment (kidney problems) including renal failure (kidney failure), and chest pain.
Madanakollu, l- effetti sekondarji li ġejjin dehru f' bejn pazjent 1 u 10 minn 1000, iperkalemija (livelli għolja ta ’ potassju fid- demm), sinkope (tħossok ħażin), insomnja (diffikultà biex torqod), vertiġni (sensazzjoni li tħoss rasek iddur), ipotensjoni (pressjoni tad- demm baxxa), dispnea (diffikultà fit- teħid tan- nifs), uġigħ addominali (fiż- żaqq), dijarrea, ħalq niexef, dispepsja (qrusa tal- istonku), flatulenza (gass), iperidrożi (għaraq eċċessiv), prurite (ħakk), mijalġja (uġigħ fil- muskolu), indeboliment renali (problemi fil- kliewi) inkluża l - insuffiċjenza renali (insuffiċjenza tal- kliewi) u uġigħ fis- sider.
For the full list of all side effects reported with Kinzalmono, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati b' Micardis, ara l- Fuljett ta 'Tagħrif.
Kinzalmono should not be used in people who may be hypersensitive (allergic) to telmisartan or any of the other ingredients.
Kinzalmono ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal telmisartan jew għal xi ingredjent ieħor tiegħu.
Its use during the first three months of pregnancy is not recommended.
Mhuwiex irakkomandat l- użu tagħha waqt l- ewwel tliet xhur tat- tqala.
Kinzalmono must not be used in people who have severe liver problems or bile problems.
Kinzalmono ma għandux jintuża f' persuni li jkollhom problemi gravi fil- fwied jew problemi biljari.
Why has Kinzalmono been approved?
Għaliex ġie approvat Kinzalmono?
The Committee for Medicinal Products for Human Use (CHMP) decided that Kinzalmono’ s benefits are greater than its risks for the treatment of essential hypertension in adults.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Kinzalmono huma ikbar mir- riskji tiegħu għat- trattament ta ’ pressjoni għolja essenzjali tad- demm fl - adulti.
The Committee recommended that Kinzalmono be given marketing authorisation.
Il- Kumitat irrakkomanda li Kinzalmono jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Kinzalmono:
Informazzjoni oħra dwar Kinzalmono:
The European Commission granted a marketing authorisation valid throughout the European Union for Kinzalmono on 16 December 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq madwar l- Unjoni Ewropea, għal Kinzalmono fis- 16 ta ’ Diċembru 1998.
The marketing authorisation was renewed on 16 December 2003 and on 16 December 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 16 ta ’ Diċembru 2003 u fis- 16 ta ’ Diċembru 2008.