Atasart 8mg Tablet

Land: Filippinerne

Sprog: engelsk

Kilde: FDA (Food And Drug Administration)

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Hent Produktets egenskaber (SPC)
15-06-2024

Aktiv bestanddel:

Candesartan Cilexetil

Tilgængelig fra:

N/A; Importer: Getz Pharma (Phils.), Inc.; Distributor: N/A

INN (International Name):

Candesartan Cilexetil

Dosering:

8mg

Lægemiddelform:

Tablet

Enheder i pakken:

Alu/Alu Blister Pack x 7's (Box of 14's), Alu/Alu Blister pack x 7 tablets (box of 14 tablets)

Fremstillet af:

Getz Pharma Pvt. Ltd., Pakistan

Terapeutisk område:

Anti-Hypertensive

Terapeutiske indikationer:

For the treatment of Hypertension. It may be used alone or in combination with other anti-hypertensive agents.

Autorisation dato:

2023-01-05

Produktets egenskaber

                                attributed to treatment, with an incidence of 0.5% cannot be
determined whether these events were causally related to
candesartan cilexetil.
_BODY AS A WHOLE:_ asthenia, fever
_CENTRAL AND PERIPHERAL NERVOUS SYSTEM:_ paresthesia, vertigo
_GASTROINTESTINAL SYSTEM DISORDERS: _dyspepsia, gastroenteritis
_HEART RATE AND RHYTHM DISORDERS:_ tachycardia, palpitation
_METABOLIC AND NUTRITIONAL DISORDERS:_ creatinine phosphokinase
increased, hyperglycemia, hypertriglyceridemia, hyperuricemia
_MUSCULOSKELETAL SYSTEM DISORDERS:_ myalgia
_PLATELET/BLEEDING-CLOTTING DISORDERS: _epistaxis
_PSYCHIATRIC DISORDERS:_ anxiety, depression, somnolence;
_RESPIRATORY SYSTEM DISORDERS:_ dyspnea
If symptomatic hypotension should occur, symptomatic treatment
should be instituted and vital signs monitored. The patient should
be placed supine with the legs elevated. If this is not sufficient
plasma volume should be increased by infusion of for example,
isotonic saline solution. Sympathomimetic medicinal products may
by administered if the above mentioned measures are not sufficient.
CONTRAINDICATIONS
Candesartan cilexetil is contraindicated in patients who are
hypersensitive to this drug or any component of this product.
Severe hepatic impairment and/or cholestasis.
WARNINGS / PRECAUTIONS
Avoid drinking alcohol. It can lower your blood pressure and may
increase some of the adverse effects of candesartan cilexetil.
_Hypotension _
_in _
_Volume- _
_and _
_Salt-Depleted _
_P ati ents_
In patients with an activated renin-angiotensin system, such as
volume and/or salt-depleted patients (eg., those being treated with
diuretics), symptomatic hypotension may occur. These conditions
should be corrected prior to administration of candesartan cilexetil,
or the treatment should start under close medical supervision. If
hypotension occurs, the patients should be placed in the supine
position and, if necessary, given an intravenous infusion of normal
saline. A transient hypotensive response is not a contraindication
to further treatment, which usually ca
                                
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