natgillin/translations-raw huggingface dataset:
CHMP vedtog således en harmoniseret formulering i henhold til arbejdsgruppen vedrørende lægemiddelovervågnings anbefalinger: "Tritazide anbefales ikke under graviditetens første trimester (se pkt.
In conclusion, the CHMP adopted a harmonised wording according to the PhVWP recommendations: “Tritazide is not recommended during the first trimester of pregnancy (see section 4.4) and contraindicated during the second and third trimesters of pregnancy (see section 4.3).
Lægemiddelform Administrationsvej
Route of administration
Irland: Tritazide tablets 2.5 mg/12.5 g
Ireland: Tritazide tablets 2.5 mg/12.5 g
Hos patienter med nedsat nyrefunktion kan thiazider fremskynde uræmi.
In patients with renal disease, thiazides may precipitate uraemia.
Dosis bør individualiseres alt efter patientprofilen (se pkt.
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
ANGIVELSE AF DET AKTIVE STOF/AKTIVE STOFFER [Udfyldes nationalt]
STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally]
Hydrochlorthiazid kan forårsage føto-placental iskæmi og risiko for væksthæming i tilfælde af forlænget eksponering under tredje trimester af graviditeten.
Hydrochlorothiazide, in cases of prolonged exposure during the third trimester of pregnancy, may cause a foeto-placental ischaemia and risk of growth retardation.
D-65926 Frankfurt am Main Tyskland
D-65926 Frankfurt am Main Germany
• Hvis du drikker alkohol samtidig med at du anvender TRITAZIDE kan du blive svimmel.
• Drinking alcohol with TRITAZIDE may make you feel dizzy or light-headed.
Prøver: Tal med din læge eller dit apotek før du tager TRITAZIDE, hvis du:
Check with your doctor or pharmacist before taking your medicine:
Akut leverinsufficiens eller kolestatisk gulsot, hepatocellulær skade
Acute hepatic failure, jaundice cholestatic, hepatocellular damage
Udskillelsen af elektrolytter og vand starter ca. 2 timer efter administration og maksimum nås efter 3-6 timer og varer 6-12 timer.
With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6 to 12 hours.
Frankrig: Cotriatec 5 mg/25 mg comprimés
France: Cotriatec 5 mg/25 mg comprimés
4.4) og er kontraindiceret under graviditetens andet og tredje trimester (se pkt.
TRITAZIDE is not recommended during the first trimester of pregnancy (see section 4.4) and contraindicated during the second and third trimesters of pregnancy (see section 4.3).
Forhøjet antal af visse hvide blodlegemer i blodet (pancytopenia) Blodprøveresultater der viser en ændring i indholdet af salte som f.eks. natrium, kalcium, magnesium og klor i dit blod
• Blood tests showing a change in the amount of salts such as sodium, calcium, magnesium and chloride in your blood
Tør hoste eller bronkitis
• Dry tickly cough or bronchitis
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE [Udfyldes nationalt]
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Det er kendt, at eksponering for ACE-hæmmere/Angiotensin II Receptor Antagonister i graviditetens andet og tredje trimester forårsager human føtotoksicitet (nedsat nyrefunktion, oligohydramnion, forsinket ossifikation af kraniet) og neonatal toksicitet (nyreinsufficiens, hypotension, hyperkaliæmi) (se også pkt.
ACE inhibitor/ Angiotensin II Receptor Antagonist (AIIRA) therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
De kan nemlig mindske virkningen af TRITAZIDE:
They can make TRITAZIDE work less well:
Dette anvendes i forbindelse med scanninger eller røntgenfotografering på hospitalet.
• Medicines that contain iodine, these may be used when you are having a scan or X-ray in hospital
Opkast, aphtous stomatitis, glossitis, diarré, abdominal smerter mundtørhed i overmunden
Vomiting, aphtous stomatitis, glossitis, diarrhoea, abdominal pain upper, dry mouth
De er dog ikke kontraindikationer, men snarere ikkeindikationer i Europa.
There were other contraindications in local SPC-s like acute hypertension or primary aldosteronism but they are not contraindications but rather non-indication in Europe.
Lettere tendens til blå mærker, længere blødningsperioder, tegn på blødninger (f.eks. blødning fra tandkødet), lilla mærker på huden, lettere tendens til at få infektioner, halsbetændelse, feber, træthedsfornemmelse, svimmel eller bleghed.
• Bruising more easily, bleeding for longer than normal, any sign of bleeding (e.g. bleeding from the gums), purple spots, blotching on the skin or getting infections more easily than usual, sore throat and fever, feeling tired, faint, dizzy or having pale skin.
• Hvis du er gravid i anden og tredje trimester (se afsnittet nedenfor om graviditet og amning)
• If you are breast-feeding (see section below on “Pregnancy and breast-feeding”).
Træthed, asteni
Headache, dizziness
Forbigående erektil dysfunktion
Transient erectile impotence
Vasopressor sympatomimetika og andre stoffer (f.eks. isoproterenol, dobutamin, dopamin, epinephrin) der kan reducere den antihypertensive effekt af TRITAZIDE: Der anbefales monitorering af blodtrykket.
Vasopressor sympathomimetics and other substances (epinephrine) that may reduce the antihypertensive effect of ramipril: Blood pressure monitoring is recommended.
Grækenland: Triatec Plus 2.5 mg/12.5 mg δισκία, Triatec Plus 5 mg/25 mg δισκία
Greece: Triatec Plus 2.5 mg/12.5 mg δισκία, Triatec Plus 5 mg/25 mg δισκία
Hypercalkæmi
Hypercalcaemia
- Produktresumé etikettering og indlægsseddel, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den indsendte dokumentation og udvalgets faglige drøftelse anbefaler CHMP at ændre markedsføringstilladelsen(rne) for Tritazide og tilknyttede navne (se bilag I).
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Allopurinol, immunosuppressiva, kortikosteroider, procainamid, cytostatika og andre stoffer der kan ændre antallet af blodlegemer: Øget risiko for hæmatologiske reaktioner (se pkt.
Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count.
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt] {Navn}
NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - to be completed nationally] {Name}
Regelmæssig monitorering af serumkalium anbefales hvis samtidig behandling med de ovenfor nævnte midler vurderes passende (se pkt.
If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended (see section 4.5).
Intestinalt angioødem er blevet rapporteret hos patienter i behandling med ACE-hæmmere inklusive TRITAZIDE (se pkt.
Intestinal angioedema has been reported in patients treated with ACE inhibitors including TRITAZIDE (see section 4.8).
Fald i hvide blodlegemer, fald I rode blodlegemer, fald i haemoglobin, haemolytisk anæmi, fald i antal blodplade
White blood cell count decreased, red blood cell count decreased, haemoglobin decreased, haemolytic anaemia, platelet count decreased
Blodprøveresultater der viser højere indhold af urinsyre eller fedtindhold end norrmalt i blodet
• Blood test showing a higher amount of uric acid or more fat than usual in your blood
Blod natrium nedsat
Blood sodium decreased
Hvis du har du har taget for meget TRITAZIDE
If you forget to take TRITAZIDE
Danmark: Triatec Comp 5 mg/25 mg tabletter
Denmark: Triatec Comp 5 mg/25 mg tabletter
4.2 Dosering og indgivelsesmåde
4.2 Posology and Method of Administration
• Medicin der nedsætter mængden af kalium i blodet såsom medicin mod forstoppelse, vanddrivende medicin, amphotericin B (mod svampeinfektioner) og ACTH (der bruges til at teste at binyrerne fungerer)
These include medicines for constipation, diuretics (water tablets), amphotericin B (used for fungal infections) and ACTH (used to test if your adrenal glands are working properly)
Patienter med alvorlig hypertension
Patients with hepatic impairment
• Er overfølsom over for de aktive stoffer ramipril eller hydrochlorthiazid eller et eller flere af de øvrige indholdsstoffer i TRITAZIDE.
• If you are allergic (hypersensitive) to ramipril, hydrochlorothiazide or any of the other ingredients of TRITAZIDE (see section 6)
Nedsat libido hos mænd
• Breast enlargement in men
Blod kalium nedsat, tørst pga hydrochlorothiazide
Blood potassium decreased, thirst due to hydrochlorothiazide
TRITAZIDE indeholder [Udfyldes nationalt]
FURTHER INFORMATION What TRITAZIDE contains [To be completed nationally]
Blodprøveresultater der viser ændring i lever, bugspytkirtel og nyrernes funktion
• Blood tests showing changes in the way your liver, pancreas or kidneys are working
Lidelser I luftveje, thorax og mediastinum
Respiratory, thoracic and mediastinal disorders
Spædbørn, hvis mor har taget ACE-hæmmere, skal følges nøje med henblik på hypotension (se også pkt.
Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension (see also section 4.3 and 4.4)”.
Patienter i diuretisk behandling
Diuretic-treated patients
SÅDAN SKAL DU TAGE TRITAZIDE
HOW TO TAKE TRITAZIDE
Belgien: Tritazide 5 mg/25 mg tabletten/comprimés/Tabletten
Belgium: Tritazide 5 mg/25 mg tabletten/comprimés/Tabletten
Ikke almindelige bivirkninger (forekommer hos færre end 1 ud af 100 patienter): Hududslæt
Uncommon ( affects less than 1 in 100 people)
Sløret syn
Hearing impaired
Blodprøveresultater der viser højere sukkerindhold i blodet end normalt.
• Blood test showing a higher amount of sugar than usual in your blood.
Patienter med leversygdom
• Patients with liver disease
Systemic lupus erythematosus pga hydroklorothiazide
Systemic lupus erythematosus due to hydrochlorothiazide
Kontakt straks lægen hvis du oplever: Øget puls, hjertebanken (palpitations), brystsmerter, strammende fornemmelse i brystet eller mere alvorlige lidelser som blodprop i hjertet eller hjerteanfald.
• Faster heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness in your chest or more serious problems including heart attack and stroke
Rumænien: Tritace 2.5 Plus 2.5 mg/12.5 mg comprimate, Tritace 5 Plus 5 mg/25 mg comprimate
Romania: Tritace 2.5 Plus 2.5 mg/12.5 mg comprimate, Tritace 5 Plus 5 mg/25 mg comprimate
Hydrochlorothiazid kan svække effekten af antidiabetisk medicin.Der anbefales derfor nøje monitorering af blodglukose i den initiale fase af samtidig administration.
Particularly close blood glucose monitoring is therefore recommended in the initial phase of co-administration.
Det anbefales, at TRITAZIDE tages hver dag på samme tidspunkt, sædvanligvis om morgenen.. TRITAZIDE kan tages før, under eller efter måltider, da fødeindtag ikke ændrer biotilgængeligheden.
TRITAZIDE can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2).
Xanthopsi, nedsat tåresekretion pga hydroklothiazid
Xanthopsia, lacrimation decreased due to hydrochlorothiazide
Ved diagnosticering af graviditet skal behandling med ACE-hæmmere og AIIRA seponeres øjeblikkeligt, og der bør opstartes en alternativ behandling (se pkt.
When pregnancy is diagnosed, treatment with ACE inhibitors/ AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Holland: Tritazide 5 mg/25 mg tabletten
Netherlands: Tritazide 5 mg/25 mg tabletten
Kontakt din læge før du anvender TRITAZIDE hvis du er usikker.
If you are not sure, talk to your doctor before taking TRITAZIDE.
Da hypotension kan forekomme efter start af behandlingen, anbefales forsigtighed hos patienter der samtidigt behandles med diuretika.
In patients concurrently treated with diuretics, as hypotension may occur following initiation of the treatment, caution is recommended.
Søvnproblemer
• Sleep problems
Ramipril og hydrochlorthiazid
Ramipril and Hydrochlorothiazide
TRITAZIDE kan nemlig påvirke virkningen af dem:
They may be affected by TRITAZIDE:
CMPH vedtog den harmoniserede formulering af kontraindikationerne: - Overfølsomhed over for det aktive stof eller over for andre angiotensinkonverterende enzymhæmmere (ACE-I), hydrochlorothiazid, andre thiazid-diuretika, sulfonamider eller et eller flere af hjælpestofferne i TRITAZIDE og tilknyttede navne (se pkt.
-Hypersensitivity to the active substance or to any other ACE (Angiotensin Converting Enzyme) inhibitor, hydrochlorothiazide, other thiazide diuretics, sulphonamides or any of the excipients of TRITAZIDE and associated names (see section 6.1).
Der kan opstå hypokaliæmi og nuklear icteus ved overfølsomhed overofr sulfonamidderivater.
Hypersensitivity to sulphonamide-derived active substances, hypokalaemia and nuclear icterus might occur.
Blodprøveresultater der viser mindre kalium i blodet end normalt
• Blood tests showing less potassium than usual in your blood.
5.2), og der anbefales derfor alternativ behandling med bedre etableret sikkerhedsprofil under amning, særligt ved amning af nyfødte eller for tidligt fødte børn.
Insufficient information is available regarding the use of ramipril during breast-feeding and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Almindeligvis er der ingen større ændring i det renale plasma flow og den glomerulære filtrationsrate.Administration af ramipril til patienter med hypertension medfører en nedsættelse i det liggende og stående blodtryk uden en kompenserende stigning i hjertefrekvens.
Administration of ramipril to patients with hypertension leads to a reduction in supine and standing blood pressure without a compensatory rise in heart rate.
Sialoadenitis pga hydroklorothiazide
Sialoadenitis due to hydrochlorothiazide
Sverige: Triatec Comp Mite 2.5 mg/12.5 mg tabletter, Triatec Comp 5 mg/25 mg tabletter
Sweden: Triatec Comp Mite 2.5 mg/12.5 mg tabletter, Triatec Comp 5 mg/25 mg tabletter
Sikkerhedsprofilen for ramipril + hydrochlorothiazide inkluder bivirkninger der skyldes hypotension og/eller væskemangel efter øget diuresis.. Ramipril inducerer persistevedvarende tør hoste , mens hydrochlorothiazide kan give anledning til forværret glucose, lipid og urinsyre metabolismen.De to aktive stoffer har invers effekt på plasma kalium..
The ramipril active substance may induce persistent dry cough, while the hydrochlorothiazide active substance may lead to worsening of glucose, lipid and uric acid metabolism.
Calculous kolecystitis forårsaget af hydrochlorothiazide
Calculous cholecystitis due to hydrochlorothiazide
Termer som essentiel hypertension, arteriel hypertension og arteriel essentiel hypertension bruges dog også.
The combination is indicated for the treatment of hypertension in all Member States where licensed, although it is noted that terms including essential hypertension, arterial hypertension and arterial essential hypertension are used.
Interstitial nephritis pga hydroklorothiazide
Interstitial nephritis due to hydrochlorothiazide
Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (including herbal medicines).
Gingivitis due pga hydroklorthiazid
Gingivitis due to hydrochlorothiazide
Denne ændring af teksten skal sikre, at der ikke tilrådes til omgående provokeret abort, hvilket der ikke er grundlag for på baggrund af de kliniske erfaringer, der er indsamlet indtil nu. CHMP vedtog således en harmoniseret formulering i overensstemmelse med arbejdsgruppen vedrørende lægemiddelovervågnings formulering omkring brugen af ACE-I under graviditet.
This change of the text is to ensure it doesn't suggest an immediate artificial abortion, which is not justified by the clinical experiences collected till now.
Bulgarien Tritace 2.5 Plus 2.5 mg/12.5 mg таблетки, Tritace 5 Plus 5 mg/25 mg таблетки
Bulgaria: Tritace 2.5 Plus 2.5 mg/12.5 mg таблетки, Tritace 5 Plus 5 mg/25 mg таблетки
TRITAZIDE 2.5 5 mg/ 12,5 mg Tablettere
TRITAZIDE 2.5 5 mg/ 12,5 mg tablete
Dette kombinationspræperat er indiceret til patienter, der ikke kan behandles sufficient med monoterapi.
This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or hydrochlorothiazide alone.
Psykiske lidelser
Psychiatric disorders
Dette kunne være tegn på lungeproblemer.
These could be signs of lung problems including inflammation
Den tekst, som er vedtaget i arbejdsgruppen vedrørende lægemiddelovervågning for denne advarsel, opmuntrer ikke til eller foreslår at anvende ACE-hæmmere under graviditetens første trimester.
The text agreed in the PhVWP of this warning doesn't encourage or propose the use of ACE inhibitors during the first trimester of the pregnancy on the contrary once the pregnancy is detected the prescriber has to stop the use of ACE inhibitors and to change if it is necessary for another antihypertensive agent as soon as possible.
Spanien Sverige sanofi-aventis AB Box 14142
Spain Sweden sanofi-aventis AB
TRITAZIDE og tilhørende navne (Se bilag I) 2,5 mg/12,5 mg tabletter TRITAZIDE og tilhørende navne (Se bilag I) 5 mg/12,5 mg tabletter TRITAZIDE og tilhørende navne (Se bilag I) 5 mg/25 mg tabletter [Se bilag I - Udfyldes nationalt] ramipril/hydrochlorothiazide
NAME OF THE MEDICINAL PRODUCT TRITAZIDE and associated names (see Annex I) 2.5 mg/12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/25 mg tablets [See Annex I - to be completed nationally] ramipril/hydrochlorothiazide
Slovenien: Tritazide 2.5 mg/12.5 mg tablete, Tritazide 5 mg/25 mg tablete
Slovenia: Tritazide 2.5 mg/12.5 mg tablete, Tritazide 5 mg/25 mg tablete
TRITAZIDE and associated names (see Annex I) 2.5 mg/12.5 mg Tabletter TRITAZIDE and associated names (see Annex I) 5 mg/12.5 mg Tabletter TRITAZIDE and associated names (see Annex I) 5 mg/25 mg Tabletter
NAME OF THE MEDICINAL PRODUCT TRITAZIDE and associated names (see Annex I) 2.5 mg/12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/25 mg tablets
Polen:
Poland
(se punkterne 4.3 og 4.4).
(See also 5.3 'Preclinical safety data').
[Se bilag I - udfyldes nationalt] {Navn og adresse} {telefon} {fax} {e-mail}
{Name and address} {Tel} {fax} {e-mail}
Terapeutisk klassifikation:C 09 BA 05 - ACE-hæmmere og diuretika
Pharmacotherapeutic group: ramipril and diuretics, ATC code C09BA05
Blodprøverresultater der viser mere kalium i blodet end normalt
• Blood tests showing more potassium than usual in your blood.
Se pkt.
P.O.
Farmakokinetikken for hydrochlorthiazid er ikke væsentligt anderledes hos patienter med levercirrhose.
In patients with hepatic cirrhosis the pharmacokinetics of hydrochlorothiazide has not changed significantly.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE TRITAZIDE
BEFORE YOU TAKE TRITAZIDE
Justering af medicin til behandling af diabetes, herunder insulin, kan være nødvendig.
In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required.
Elektrolyforstyrrelser
Electrolyte imbalance
• Gør det lettere for dit hjerte at pumpe blodet rundt i din krop Hydroklorthiazid tilhører gruppen af lægemidler der kaldes ”tiazider” eller vanddrivende lægemidler.
• Making it easier for your heart to pump blood around your body.
• Skal have testet din biskjoldbruskkirtel.
• If you are having a test for parathyroid function.
Afhængigt af det apparatur der anvendes, kan det være uhensigtsmæssigt at anvende Tritace samtidig.
Depending on the machine that is used,
Patienter med eksisterende salt og væskemangel eller kan opstå (inklusive patienter som anvender diuretika) Patienter med levercirrhose og/eller ascites Patienter planlagt til større operationer, eller under anæstesi med stoffer der medfører hypotension.
Significant activation of renin-angiotensin-aldosterone system is to be anticipated and medical supervision including blood pressure monitoring is necessary, for example in: - patients with severe hypertension - patients with decompensated congestive heart failure - patients with haemodynamically relevant left ventricular inflow or outflow impediment (e.g. stenosis of the aortic or mitral valve) - patients with unilateral renal artery stenosis with a second functional kidney - patients in whom fluid or salt depletion exists or may develop (including patients with diuretics) - patients with liver cirrhosis and/or ascites - patients undergoing major surgery or during anaesthesia with agents that produce hypotension.
- Lægen har ordineret Tritazide til dig personligt.
• This medicine has been prescribed for you.
Meget sjældne bivirkninger (forekommer hos færre end 1 ud af 10.000 patienter) Kvalme, diarré eller halsbrand
Very rare (affects less than 1 in 10,000 people)
De maksimale tilladte doser er 10 mg ramipiril og 25 mg hydrochlorothiazid dagligt."
If necessary, the dose can be progressively increased to achieve target blood pressure; the maximum permitted doses are 10 mg of ramipril and 25 mg of hydrochlorothiazide daily”
Overfølsomhed over de aktive stoffer eller over for et eller flere af de øvrige hjælpestoffer, eller andre ACE (Angiotensin Converting Enzyme)-hæmmere (se pkt.
- Hypersensitivity to the active substance or to any other ACE (Angiotensin Converting Enzyme) inhibitor, hydrochlorothiazide, other thiazide diuretics, sulfonamides or any of the excipients of TRITAZIDE (see section 6.1).
• Medicin der indeholder jod.
• Swallow the tablets with liquid.
Patienter der planlægger graviditet bør skiftes til alternativ antihypertensiv behandling, der besidder en etablereret sikkerhedsprofil for gravide, medmindre fortsat behandling med ACE-hæmmere/AIIRA betragtes som essentiel.
Unless continued ACE inhibitor/ AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Hårtab
• Hair loss
Norge Polen
Norway
Slovakiet: Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety
Slovak Republic: Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety
• Medicin der kan øge indholdet af kalium i blodet såsom spironolakton, triamterene, amilorid, kalium salte og heparin (blodfortyndende middel)
• Medicines which can increase the amount of potassium in your blood such as spironolactone,
Tjekkiet: Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety
Czech Republic Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety
Indehaver af markedsføringstilladelsen [Se Bilag I - udfyldes nationalt] {Navn og adresse} {telefon} {fax} {e-mail}
What TRITAZIDE looks like and contents of the pack Tablets [To be completed nationally] Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally] {Name and address} {tel} {fax} {email}
Forstoppelse og smerter i maveregionen
vomiting and diarrhoea
Forholdsregler
Tests
Indtag medicinen gennem munden, på samme tidspunkt på dagen hver dag Slug tabletterne hele med rigelig væske Du må ikke tygge eller knuse tabletterne
• Take this medicine by mouth at the same time of day each day, usually in the morning.
Tørre øjne
Eye disorders
i anamnesen
Whereas
Dette kan være tegn på nyresygdom (interstitial nephritis) Højere sukkerindhold i urinen end normalt
This could be a sign of a kidney problem (interstitial nephritis)
Lysskyhed
PACKAGE LEAFLET
Fordøjelsesbesvær og kvalme
• Indigestion or feeling sick
Hævelser, smerter og rødmen i kinden (betændelse af spytkirtlerne) Hævelse i tarmsystemet kaldet ”intestinal angiødem” der medfører symptomer som smerter i maveregionen, opkast og diarré
• A swelling in your gut called “intestinal angioedema” presenting with symptoms like abdominal pain,