Download IW31 A Ciplazar 25-50

CIPLAZAR 25
CIPLAZAR 50
CIPLAZAR 100
(Tablets)
IW31 A
IW31 A
General disorders:
Malaise.
Special Precautions:
Patients with volume depletion (e.g. those treated with high doses of diuretics) may
experience hypotension, which may be minimised by initiating treatment with a low
dose of CIPLAZAR.
Electrolyte imbalances occur frequently in patients with renal impairment, with or
without diabetes, and should be addressed.
Pharmacokinetic data showed significantly increased plasma concentrations of
losartan in patients with liver cirrhosis. Therefore a dose of 25 mg should be
considered in patients with a history of impaired liver function (see "DOSAGE AND
DIRECTIONS FOR USE").
Since hyperkalaemia may occur, serum potassium concentrations should be
monitored, especially in the elderly and patients with renal impairment, and the
concomitant use of potassium-sparing diuretics should generally be avoided (see
"INTERACTIONS").
In susceptible individuals with impaired renal function, changes in renal function as
a consequence of inhibiting the renin-angiotensin system, including renal failure,
have been reported. These changes in renal function may be reversible upon
discontinuation of CIPLAZAR therapy in some patients.
Where the renal function of a patient may be dependent on the activity of the
renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart
failure), treatment with ACE inhibitors has been associated with oliguria and/or
progressive azotemia and (less frequently) with acute renal failure and/or death.
Similar outcomes are possible with CIPLAZAR therapy.
Medicines affecting the renin-angiotensin system may increase serum creatinine
and blood urea in patients with bilateral renal artery stenosis or stenosis of the artery
to a solitary kidney. CIPLAZAR is contra-indicated in these patients (see
"CONTRA-INDICATIONS").
Effects on the ability to drive and use machines:
There are no data to suggest that CIPLAZAR influences the ability to drive and use
machinery.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS
TREATMENT:
The symptoms of an overdosage with CIPLAZAR would be hypotension and
tachycardia. Bradycardia could occur due to parasympathetic (vagal) stimulation.
Should symptomatic hypotension occur, institute supportive treatment. Losartan and
the active metabolite cannot be removed by haemodialysis.
IDENTIFICATION:
CIPLAZAR 25:
White, round, film-coated tablets plain on both sides.
CIPLAZAR 50:
White, oval, film-coated tablets with central break line on one
side and plain on the other side.
CIPLAZAR 100:
White, oval, film-coated tablets plain on both sides.
PRESENTATION:
CIPLAZAR 25:
Aluminium foil blister strips of 10 tablets packed in 30’s and
60’s.
CIPLAZAR 50:
Aluminium foil blister strips of 10 tablets packed in 30’s.
CIPLAZAR 100:
Aluminium foil blister strips of 10 tablets packed in 30’s.
STORAGE INSTRUCTIONS:
Store in a dry place below 25 °C.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBERS:
CIPLAZAR 25:
41/7.1.3/0820
CIPLAZAR 50:
41/7.1.3/0821
CIPLAZAR 100:
41/7.1.3/0822
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATES
OF REGISTRATION:
CIPLA MEDPRO (PTY) LTD
Rosen Heights, Pasita Street
Rosen Park, Bellville 7530 RSA
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
15 August 2008
Revised: November 2011
© CIPLA MEDPRO (PTY) LTD 2011
IW31 A
COMPOSITION:
CIPLAZAR 25:
Each tablet contains 25 mg losartan potassium.
CIPLAZAR 50:
Each tablet contains 50 mg losartan potassium.
CIPLAZAR 100:
Each tablet contains 100 mg losartan potassium.
All formulations contain colloidal anhydrous silica, croscarmellose sodium, dibasic
calcium phosphate, magnesium stearate, microcrystalline cellulose, opadry white,
and talc as inactive ingredients.
PHARMACOLOGICAL CLASSIFICATION:
A 7.1.3 Other hypotensives.
PHARMACOLOGICAL ACTION:
Losartan is a non-peptide angiotensin II receptor antagonist with high affinity and
selectivity for the AT1 receptor, without binding to or blocking other hormone
receptors or ion channels involved in cardiovascular regulation. Angiotensin II is a
potent vasoconstrictor, a primary active hormone of the renin-angiotensin system,
and therefore a major determinant of the pathophysiology of hypertension. Losartan
blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by
inhibiting the binding of angiotensin II to the AT1 receptor.
Pharmacokinetics:
Following oral administration, bioavailability is approximately 33 %. It undergoes
first-pass metabolism to form an active carboxylic acid metabolite (which has greater
pharmacological activity than losartan) and some inactive metabolites. About 14 %
of an intravenously or orally administered dose is converted to its active metabolite.
The mean peak concentrations of losartan are reached in 1 hour and that of its active
metabolite in 3 – 4 hours.
Both losartan and the carboxylic acid metabolite are ≥ 99 % bound to plasma
proteins, and the distribution volume of losartan is 34 litres. The terminal half-life of
losartan is 2 hours and that of its active metabolite 6 – 9 hours.
Losartan is excreted in the urine, and in the faeces, as unchanged medicine and
metabolites. Following oral dosing, about 35 % of the dose is excreted in the urine
and about 60 % in the faeces. Losartan and the active metabolite cannot be
removed by haemodialysis.
Plasma concentrations of losartan are not altered in patients with impaired renal
function and a creatinine clearance above 10 ml/min. The AUC for losartan is
approximately 2-fold greater in patients on haemodialysis, compared to those with
normal renal function.
Pharmacodynamics:
Losartan is a specific antagonist of the angiotensin II receptor type AT1. Losartan
does not inhibit the angiotensin-converting enzyme (ACE) (kininase II), which
degrades bradykinin. Due to the removal of angiotensin II negative feedback on
renin secretion, increased plasma renin activity takes place during losartan
administration. A 2- to 3-fold increase in angiotensin II levels in plasma is due to
increases in plasma renin activity. However, effective angiotensin II receptor
blockade is indicated by antihypertensive activity and suppression of plasma
aldosterone concentration. Plasma renin activity and angiotensin levels decline after
discontinuation of losartan.
INDICATIONS:
CIPLAZAR is indicated for the treatment of hypertension.
CONTRA-INDICATIONS:
• Hypersensitivity to losartan or any of the components of CIPLAZAR.
• A history of angioedema related to previous therapy with ACE inhibitors or
angiotensin receptor blockers (ARBs): these patients must never again be given
these medicines.
• Hereditary or idiopathic angioedema.
• Hypertrophic obstructive cardiomyopathy (HOCM).
• Moderate to severe renal function impairment (creatinine clearance less than 30
ml/min).
• Bilateral renal artery stenosis.
• Renal artery stenosis in patients with a single kidney.
• Aortic stenosis.
• Concomitant therapy with potassium sparing diuretics, such as spironolactone,
triamterene, and amiloride.
• Porphyria.
• Thiazide diuretics in combination with CIPLAZAR should not be given to
concentrations, neutropenia.
Immune system disorders:
The following side-effects have been reported and
frequencies are unknown: Angioedema (involving swelling of the face, lips, and/or
tongue) has been reported.
Psychiatric disorders:
Less frequent:
Insomnia.
Nervous system disorders:
Frequent:
Headache.
Less frequent:
Dizziness, migraine.
The following side-effects have been reported and
frequencies are unknown: Taste disturbances, complete taste loss.
Cardiac disorders:
The following side-effects have been reported and
frequencies are unknown: Palpitations, tachycardia.
Vascular disorders:
The following side-effects have been reported and
frequencies are unknown: Hypotension.
Respiratory, thoracic and mediastinal disorders:
Less frequent:
Nasal congestion, sinus disorder, pharyngitis, cough,
upper respiratory infection.
Gastrointestinal disorders:
Less frequent:
Nausea, dyspepsia, diarrhoea.
The following side-effects have been reported and
frequencies are unknown: Acute pancreatitis.
Hepatobiliary disorders:
The following side-effects have been reported and
frequencies are unknown: Raised liver enzyme values, severe acute
hepatotoxicity, cholestasis.
Skin and subcutaneous tissue disorders:
The following side-effects have been reported and
frequencies are unknown: Urticaria, rash, atypical cutaneous lymphoid infiltrates.
Musculoskeletal, connective tissue and bone disorders:
Less frequent:
Back pain, muscle cramps, leg pain, myalgia.
Renal and urinary disorders:
The following side-effects have been reported and
frequencies are unknown: Impaired renal function.
General disorders:
Less frequent:
Asthenia, fatigue, chest pain, abdominal pain, and
oedema/swelling.
Post-marketing experience:
The following adverse reactions were spontaneously reported in post-marketing
experience. The precise incidence cannot be determined and therefore the
frequency is unknown:
Blood and lymphatic system disorders:
Anaemia, thrombocytopenia.
Immune system disorders:
Anaphylactic reactions, angioedema (including swelling of the larynx and glottis
causing airway obstruction) and/or swelling of the face, lips, pharynx and/or tongue
have been reported rarely in patients who received losartan, as in CIPLAZAR; some
of these patients previously developed angioedema with ACE inhibitors and
angiotensin receptor blockers.
Nervous system disorders:
Migraine, dysgeusia.
Vascular disorders:
Vasculitis, including Henoch-Schönlein purpura.
Respiratory, thoracic and mediastinal disorders:
Cough.
Gastrointestinal disorders:
Vomiting.
Hepatobiliary disorders:
Hepatitis.
Skin and subcutaneous tissue disorders:
Urticaria, pruritus, erythroderma, photosensitivity.
Musculoskeletal, connective tissue and bone disorders:
Myalgia, arthralgia.
Reproductive system and breast disorders:
Erectile dysfunction/impotence.
(Tablets)
CIPLAZAR 25 (Tablets)
CIPLAZAR 50 (Tablets)
CIPLAZAR 100 (Tablets)
patients with Addison’s disease. This therapy is also contra-indicated in patients
with severe renal impairment or anuria, and in patients who show
hypersensitivity to other sulphonamide-derived medicines.
• Lithium therapy: concomitant administration with CIPLAZAR may lead to toxic
blood concentrations of lithium.
The use of CIPLAZAR during pregnancy is contra-indicated (see "WARNINGS"
and "PREGNANCY AND LACTATION"). CIPLAZAR should be discontinued as
soon as possible when pregnancy is suspected.
Safety and efficacy have not been established in children.
WARNINGS:
Should a woman become pregnant while taking CIPLAZAR, the treatment should
be stopped promptly and switched to a different medicine (see
"CONTRA-INDICATIONS" and "PREGNANCY AND LACTATION"). If she is
contemplating pregnancy, a different class of medicine should be administered.
Adequate contraception should be utilised by women of childbearing age.
CIPLAZAR is contra-indicated in patients with bilateral renal artery stenosis or
stenosis of an artery to a single kidney, aortic valve stenosis or hypertrophic
obstructive cardiomyopathy.
Symptomatic hypotension may occur after initiation of CIPLAZAR.
Reduced doses must be considered in patients with hepatic impairment.
Serum potassium levels require regular monitoring.
INTERACTIONS:
Combinations containing any of the following medications, depending on the amount
present, may also interact with CIPLAZAR:
• Non-steroidal anti-inflammatory agents (NSAIDs) may antagonise the
antihypertensive effect of CIPLAZAR.
• Concurrent use with sympathomimetics may reduce the antihypertensive effects
of CIPLAZAR.
• Potassium-sparing diuretics, potassium-containing medication or potassium
supplements used concurrently with CIPLAZAR may result in hyperkalaemia,
since reduction of aldosterone production induced by CIPLAZAR may lead to
elevation of serum potassium.
PREGNANCY AND LACTATION:
Pregnancy (see "CONTRA-INDICATIONS" and "WARNINGS"):
- CIPLAZAR should be discontinued as soon as possible when pregnancy is
suspected.
- CIPLAZAR should not to be used in pregnancy as teratogenicity has been
shown in experimental animals.
Women of childbearing age should make use of adequate contraception.
Lactation (see "CONTRA-INDICATIONS"):
− Safety has not been established.
DOSAGE AND DIRECTIONS FOR USE:
For most patients the usual starting and maintenance dose is 50 mg once daily. The
maximum antihypertensive effect is achieved 3 – 6 weeks after initiation of therapy.
The dose may be increased to 100 mg once daily, if required.
For patients who are volume depleted (e.g. those treated with high doses of
diuretics), an initial dose of 25 mg once daily should be considered (see "Special
Precautions").
Elderly patients or patients with renal impairment, including patients on dialysis, do
not require initial dose adjustments.
A dose reduction should be considered for patients with hepatic impairment (see
"Special Precautions").
Renal protection in patients with type 2 diabetes with hypertension and
proteinuria:
Usually the starting dose is 50 mg once daily. The dose may be increased to 100 mg
once a day dependent on blood pressure response. CIPLAZAR may be given with
antihypertensive agents (e.g. diuretics, calcium channel blockers, alpha- or
beta-blockers, and centrally acting medicines) as well as with insulin and other
commonly used hypoglycaemic agents (e.g. sulphonylureas, glitazones and
glucosidase inhibitors).
CIPLAZAR may be administered with other antihypertensives of a different class.
CIPLAZAR can be administered with or without meals.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-Effects:
The following side-effects may occur:
Blood and lymphatic system disorders:
The following side-effects have been reported and
frequencies are unknown: Symptomatic anaemia, decreased haemoglobin
CIPLAZAR 25
CIPLAZAR 50
CIPLAZAR 100
SCHEDULING STATUS: S3
PROPRIETARY NAME (AND DOSAGE FORM):
CIPLAZAR 25 (Tablette)
CIPLAZAR 50 (Tablette)
CIPLAZAR 100 (Tablette)
SAMESTELLING:
CIPLAZAR 25:
Elke tablet bevat 25 mg losartankalium.
CIPLAZAR 50:
Elke tablet bevat 50 mg losartankalium.
CIPLAZAR 100:
Elke tablet bevat 100 mg losartankalium.
Onaktiewe bestanddele in al die formulerings sluit kolloïdale anhidriese silika,
natriumkroskarmellose, dibasiese kalsiumfosfaat, magnesiumstearaat, mikrokristallyne
sellulose, opadriewit en talk in.
FARMAKOLOGIESE KLASSIFIKASIE:
A 7.1.3 Ander hipotensiewe middels.
FARMAKOLOGIESE WERKING:
Losartan is ‘n nie-peptied angiotensien II reseptorantagonis met hoë affiniteit en
selektiwiteit vir die AT1 reseptor, sonder om ander hormoonreseptore of ioonkanale
betrokke by kardiovaskulêre regulasie te bind of te blokkeer. Angiotensien II is ‘n
potente vasokonstriktor, ‘n primêre aktiewe hormoon van die renien-angiotensien
sisteem, en speel dus ‘n groot rol in die patofisiologie van hipertensie. Losartan
blokkeer die vasokonstriktor en aldosteroonsekreterende effekte van angiotensien II
deur die binding van angiotensien II aan die AT1 reseptor te inhibeer.
Farmakokinetika:
Na orale toediening is biobeskikbaarheid ongeveer 33 %. Dit ondergaan
eerstedeurgangsmetabolisme om ‘n aktiewe karboksielsuurmetaboliet te vorm (wat
meer farmakologiese aktiwiteit as losartan het), asook ‘n paar onaktiewe
metaboliete. Ongeveer 14 % van ‘n intraveneuse of oraal toegediende dosis word
omgesit na die aktiewe metaboliet. Die gemiddelde piekkonsentrasies van losartan
word bereik binne 1 uur en dié van die aktiewe metaboliet binne 3 – 4 uur.
Beide losartan en die karboksielsuurmetaboliet is ≥ 99 % gebonde aan
plasmaproteïene en die distribusie volume van losartan is 34 liter. Die terminale
halflewe van losartan is 2 uur en dié van die aktiewe metaboliet 6 – 9 uur.
Losartan word uitgeskei in die uriene, en in die feses, beide as onveranderde middel
en metaboliete. Na orale dosering word ongeveer 35 % van die dosis uitgeskei in die
uriene en ongeveer 60 % in die feses. Losartan en die aktiewe metaboliet kan nie
deur hemodialise verwyder word nie.
Plasmakonsentrasies van losartan is nie verander in pasiënte met ingekorte
nierfunksie en ‘n kreatinienopruiming bo 10 ml/min nie. Die AOK van losartan is
ongeveer 2-voudig meer in pasiënte op hemodialise, in vergelyking met pasiënte
met normale nierfunksie.
Farmakodinamika:
Losartan is ‘n spesifieke antagonis van die angiotensien II reseptor tipe AT1.
Losartan inhibeer nie die angiotensienomsettingsensiem (AOE) (kininase II), wat
bradikinien afbreek, nie. Weens die verwydering van angiotensien II negatiewe
terugvoer op reniensekresie, vind verhoogde plasmarenien aktiwiteit plaas tydens
losartan toediening. ‘n Twee- tot 3-voudige toename in angiotensien II plasmavlakke
vind plaas weens die verhoging in plasmarenien aktiwiteit. Effektiewe
angiotensienreseptor blokkade word egter aangedui deur antihipertensiewe
aktiwiteit en onderdrukking van plasma aldosteroonkonsentrasie. Plasmarenien
aktiwiteit en angiotensienvlakke daal na staking van losartan.
INDIKASIES:
CIPLAZAR word aangedui vir die behandeling van hipertensie.
KONTRA-INDIKASIES:
• Hipersensitiwiteit vir losartan of enige van die ander bestanddele in CIPLAZAR.
• ‘n Geskiedenis van angio-edeem verwant aan vorige behandeling met AOE
inhibeerders of angiotensien reseptorblokkers (ARBs): hierdie pasiënte moet
nooit weer hierdie middels ontvang nie.
• Oorerflike of idiopatiese angio-edeem.
• Hipertrofiese obstruktiewe kardiomiopatie (HOKM).
• Matige tot erge inkorting van nierfunksie (kreatinienopruiming minder as 30 ml/min).
• Bilaterale renale arterie stenose.
• Renale arterie stenose in pasiënte met slegs een nier.
• Aorta stenose.
• Gepaardgaande behandeling met kaliumbesparende diuretika, soos
spironolaktoon, triamtereen en amiloried.
• Porfirie.
• Tiassieddiuretika in kombinasie met CIPLAZAR moenie aan pasiënte met
Addison se siekte gegee word nie. Hierdie terapie is ook teenaangedui in
pasiënte met erge nierinkorting of anurie en in pasiënte wie hipersensitiwiteit vir
ander sulfonamied-afgeleide middels getoon het.
• Litiumterapie: gepaardgaande toediening met CIPLAZAR mag tot toksiese
bloedkonsentrasies van litium lei.
Die gebruik van CIPLAZAR tydens swangerskap is teenaangedui (sien
"WAARSKUWINGS" en "SWANGERSKAP EN LAKTASIE"). CIPLAZAR behoort
so gou moontlik gestaak te word sodra swangerskap vermoed word.
Die veiligheid en effektiwiteit is nog nie in kinders vasgestel nie.
WAARSKUWINGS:
Indien ‘n vrou sou swanger raak terwyl sy CIPLAZAR gebruik, moet behandeling
spoedig gestaak en daar na ‘n ander middel oorgeskakel word (sien
"KONTRA-INDIKASIES" en "SWANGERSKAP EN LAKTASIE"). Indien sy
swangerskap oorweeg, moet ‘n middel vanuit ‘n ander klas toegedien word.
Vroue in hulle voortplantingsjare moet voldoende voorbehoeding tref.
CIPLAZAR is teenaangedui in pasiënte met bilaterale renale arterie stenose of
stenose van ‘n arterie na ‘n enkel nier, aortaklep stenose of hipertrofiese
obstruktiewe kardiomiopatie.
Simptomatiese hipotensie kan voorkom na die aanvang van CIPLAZAR
behandeling.
Verminderde dosisse moet oorweeg word in pasiënte met lewerinkorting.
Serumvlakke van kalium behoort gereeld gemonitor te word.
INTERAKSIES:
Kombinasies wat enige van die volgende middels bevat, afhangende van die
hoeveelheid teenwoordig, kan ook ‘n interaksie met CIPLAZAR hê:
• Nie-steroïedale
anti-inflammatoriese
middels
(NSAIMs)
kan
die
antihipertensiewe effek van CIPLAZAR antagoniseer.
• Gesamentlike gebruik met simpatomimetika kan die antihipertensiewe effekte
van CIPLAZAR verminder.
• Kaliumbesparende diuretika, kaliumbevattende middels of kaliumaanvullings
wat saam met CIPLAZAR gebruik word, kan hiperkalemie tot gevolg hê,
aangesien die vermindering van aldosteroon produksie, geïnduseer deur
CIPLAZAR, tot styging van serumkalium kan lei.
SWANGERSKAP EN LAKTASIE:
Swangerskap (sien "KONTRA-INDIKASIES" en "WAARSKUWINGS"):
- CIPLAZAR behoort so gou moontlik gestaak te word wanneer swangerskap
vermoed word.
- CIPLAZAR behoort nie tydens swangerskap gebruik te word nie aangesien
teratogenisiteit in eksperimentele diere aangetoon is.
Vroue in hulle voortplantingsjare moet van voldoende voorbehoeding gebruik maak.
Laktasie (sien "KONTRA-INDIKASIES" en "WAARSKUWINGS"):
− Veiligheid is nog nie vasgestel nie.
DOSIS EN GEBRUIKSAANWYSINGS:
Vir meeste pasiënte is die gewone aanvanklike en instandhoudingsdosis 50 mg een
maal daagliks. Die maksimum antihipertensiewe effek word 3 – 6 weke na aanvang
van behandeling bereik. Die dosis kan verhoog word na 100 mg een maal daagliks,
indien nodig.
Vir pasiënte met volume-uitputting (bv. dié wie met hoë dosisse diuretika behandel
is), behoort ‘n aanvanklike dosis van 25 mg een maal daagliks oorweeg te word (sien
"Spesiale Voorsorgmaatreëls").
Bejaardes of pasiënte met nierinkorting, insluitende pasiënte op dialise, benodig nie
aanvanklike dosisaanpassings nie.
‘n Dosisvermindering behoort oorweeg te word vir pasiënte met lewerinkorting (sien
"Spesiale Voorsorgmaatreëls").
Renale beskerming in pasiënte met tipe 2 diabetes met hipertensie en
proteïenurie:
Gewoonlik is die aanvangsdosis 50 mg een maal daagliks. Die dosis mag tot 100 mg
een maal daagliks verhoog word, afhangende van die bloeddruk reaksie.
CIPLAZAR mag saam met antihipertensiewe middels (bv. diuretika,
kalsiumkanaalblokkers, alfa- en beta-blokkers en sentraal werkende middels) asook
insulien en ander algemeen gebruikte hipoglisemiese middels (bv. sulfonielureums,
glitasone en glukosidase inhibeerders) gegee word.
CIPLAZAR kan toegedien word met ander antihipertensiewe middels van ander
klasse.
CIPLAZAR kan met of sonder maaltye toegedien word.
NEWE-EFFEKTE EN SPESIALE VOORSORGMAATREËLS:
Newe-Effekte:
Die volgende newe-effekte kan voorkom:
Hematologiese en limfatiese sisteem afwykings:
Die volgende newe-effekte is gemeld en die frekwensie
daarvan is onbekend:
Simptomatiese
anemie,
verlaagde
hemoglobienkonsentrasies, neutropenie.
Immuunsisteem afwykings:
Die volgende newe-effekte is gemeld en die frekwensie
daarvan is onbekend:
Angio-edeem (met swelling van die gesig, lippe en/of
tong) is gemeld.
Psigiatriese afwykings:
Minder dikwels:
Slapeloosheid.
Senusisteem afwykings:
Dikwels:
Hoofpyn.
Minder dikwels:
Duiseligheid, migraine.
Die volgende newe-effekte is gemeld en die frekwensie
daarvan is onbekend:
Smaaksteurnisse, algehele smaakverlies.
Kardiale afwykings:
Die volgende newe-effekte is gemeld en die frekwensie
daarvan is onbekend:
Hartkloppings, tagikardie.
Vaskulêre afwykings:
Die volgende newe-effekte is gemeld en die frekwensie
daarvan is onbekend:
Hipotensie.
Respiratoriese, torakale en mediastinale afwykings:
Minder dikwels:
Nasale stuwing, sinusafwyking, faringitis, hoes,
boonste lugweginfeksie.
Gastro-intestinale afwykings:
Minder dikwels:
Naarheid, dispepsie, diarree.
Die volgende newe-effekte is gemeld en die frekwensie
daarvan is onbekend:
Akute pankreatitis.
Hepatobiliêre afwykings:
Die volgende newe-effekte is gemeld en die frekwensie
daarvan is onbekend:
Verhoogde lewerensieme, erge akute hepatotoksisiteit,
cholestase.
Vel- en subkutane weefselafwykings:
Die volgende newe-effekte is gemeld en die frekwensie
daarvan is onbekend:
Urtikarieë, uitslag, atipiese kutane limfoïede infiltrate.
Muskuloskeletale, bindweefsel- en beenafwykings:
Minder dikwels:
Rugpyn, spierkrampe, beenpyn, mialgie.
Renale en urinêre afwykings:
Die volgende newe-effekte is gemeld en die frekwensie
daarvan is onbekend:
Ingekorte nierfunksie.
Algemene afwykings:
Minder dikwels:
Swakheid, moegheid, borskaspyn, buikpyn en
edeem/swelling.
Na-bemarkingsondervinding:
Die volgende ongewenste reaksies is spontaan tydens na-bemarkingsondervinding
gemeld. Die presiese insidensie kan nie bepaal word nie en derhalwe is die
frekwensie onbekend:
Hematologiese en limfatiese sisteem afwykings:
Anemie, trombositopenie.
Immuunsisteem afwykings:
Anafilaktiese reaksies, angio-edeem (insluitende swelling van die larinks en glottis
met lugwegobstruksie) en/of swelling van die gesig, lippe en farinks en/of tong is
seldsaam in pasiënte wie losartan, soos in CIPLAZAR, ontvang het gemeld;
sommige van hierdie pasiënte het vantevore angio-edeem met AOE inhibeerders en
angiotensien reseptorblokkers ontwikkel.
Senusisteem afwykings:
Migraine, smaaksteuring.
Vaskulêre afwykings:
Vaskulitis, insluitende Henoch-Schönlein purpura.
Respiratoriese, torakale en mediastinale afwykings:
Hoes.
Gastro-intestinale afwykings:
Naarheid.
Hepatobiliêre afwykings:
Hepatitis.
Vel- en subkutane weefselafwykings:
Urtikarieë, pruritus, eritroderma, fotosensitiwiteit.
Muskuloskeletale, bindweefsel- en beenafwykings:
Mialgie, artralgie.
Reproduktiewe sisteem en borsafwykings:
Erektiele disfunksie/impotensie.
Algemene afwykings:
Malaise.
Spesiale Voorsorgmaatreëls:
Pasiënte met volume-uitputting (bv. dié wie met hoë dosisse diuretika behandel is)
kan hipotensie ontwikkel, wat vermy kan word deur behandeling aanvanklik met ‘n
lae dosis van CIPLAZAR te begin.
Elektrolietwanbalanse is algemeen in pasiënte met nierinkorting, met of sonder
diabetes, en moet aangespreek word.
Farmakokinetiese data toon betekenisvolle verhoogde plasmakonsentrasies van
losartan in pasiënte met lewersirrose. Derhalwe moet ‘n dosis van 25 mg in pasiënte
met ‘n geskiedenis van ingekorte lewerfunksie oorweeg word (sien "DOSIS EN
GEBRUIKSAANWYSINGS").
Aangesien hiperkalemie kan voorkom, behoort serumkalium konsentrasies
gemonitor te word, veral in bejaardes en pasiënte met nierinkorting en die
gesamentlike gebruik van kaliumbesparende diuretika behoort oor die algemeen
vermy te word (sien "INTERAKSIES").
In vatbare individue met ingekorte nierfunksie, is veranderinge in nierfunksie,
insluitende nierversaking, weens die inhibisie van die renien-angiotensien sisteem,
gemeld. Hierdie veranderinge in nierfunksie is in sommige pasiënte omkeerbaar met
staking van CIPLAZAR behandeling.
Waar die nierfunksie van ‘n pasiënt afhanklik mag wees van die aktiwiteit van die
renien- angiotensien-aldosteroon sisteem (bv. pasiënte met erge kongestiewe
hartversaking), is behandeling met AOE inhibeerders geassosieer met oligurie en/of
progressiewe asotemie en (minder dikwels) met akute nierversaking en/of dood.
Soortgelyke uitkomste is moontlik met CIPLAZAR behandeling.
Middels wat die renien-angiotensien sisteem beïnvloed, kan serumkreatinien en
bloedureum verhoog in pasiënte met bilaterale renale arterie stenose of stenose van
die arterie na ‘n enkel nier. Behandeling met CIPLAZAR is in hierdie pasiënte
teenaangedui (sien "KONTRA-INDIKASIES").
Effekte op die vermoë om te bestuur en masjinerie te hanteer:
Daar is geen data wat daarop dui dat CIPLAZAR die vermoë om te bestuur of
masjinerie te gebruik, beïnvloed nie.
BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE
BEHANDELING DAARVAN:
Die simptome van ‘n oordosering met CIPLAZAR sal hipotensie en tagikardie wees.
Bradikardie kan ook weens parasimpatiese (vagale) stimulasie voorkom. Indien
simptomatiese hipotensie voorkom, moet ondersteunende behandeling ingestel word.
Losartan en die aktiewe metaboliet kan nie deur hemodialise verwyder word nie.
IDENTIFIKASIE:
CIPLAZAR 25: Wit, ronde, filmbedekte tablette glad aan beide kante.
CIPLAZAR 50: Wit, ovaal, filmbedekte tablette met ‘n sentrale breeklyn aan die
een kant en glad aan die ander kant.
CIPLAZAR 100: Wit, ovaal, filmbedekte tablette glad aan beide kante.
AANBIEDING:
CIPLAZAR 25: Aluminiumfoelie stulpverpakte stroke van 10 tablette verpak in
30’s en 60’s.
CIPLAZAR 50: Aluminiumfoelie stulpverpakte stroke van 10 tablette verpak in 30’s.
CIPLAZAR 100: Aluminiumfoelie stulpverpakte stroke van 10 tablette verpak in 30’s.
BERGINGSINSTRUKSIES:
Berg in ‘n droë plek benede 25 °C.
HOU BUITE BEREIK VAN KINDERS.
REGISTRASIENOMMERS:
CIPLAZAR 25:
41/7.1.3/0820
CIPLAZAR 50:
41/7.1.3/0821
CIPLAZAR 100:
41/7.1.3/0822
NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE SERTIFIKATE VAN
REGISTRASIE:
CIPLA MEDPRO (EDMS) BPK
Rosen Heights, Pasitastraat
Rosenpark, Bellville 7530 RSA
DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET:
15 Augustus 2008
Hersien: November 2011
© CIPLA MEDPRO (EDMS) BPK 2011
IW31 A
SKEDULERINGSTATUS: S3
EIENDOMSNAAM (EN DOSEERVORM):