AMIAS Tablet (2021)
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Περιεχόμενα
Name of the medicinal product
Amias 2 mg Tablets. Amias 4 mg Tablets. Amias 8 mg Tablets. Amias 16 mg Tablets. Amias 32 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 2 mg candesartan cilexetil. Each tablet contains 95.4 mg lactose monohydrate. Each tablet contains 4 mg candesartan cilexetil. Each tablet contains 93.4 mg lactose monohydrate. Each ...
Pharmaceutical form
Tablet. Amias 2 mg Tablets are round white tablets. Amias 4 mg Tablets are round white tablets with a single score line on both sides. The tablet can be divided into equal doses. Amias 8 mg Tablets are ...
Therapeutic indications
Amias is indicated for the: Treatment of essential hypertension in adults. Treatment of hypertension in children and adolescents aged 6 to <18 years. Treatment of adult patients with heart failure and ...
Posology and method of administration
Posology in Hypertension The recommended initial dose and usual maintenance dose of Amias is 8 mg once daily. Most of the antihypertensive effect is attained within 4 weeks. In some patients whose blood ...
Contraindications
Hypersensitivity to candesartan cilexetil or to any of the excipients listed in section 6.1. Second and third trimesters of pregnancy (see sections 4.4 and 4.6). Severe hepatic impairment and/or cholestasis. ...
Special warnings and precautions for use
Dual block ade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, ...
Interaction with other medicinal products and other forms of interaction
Compounds which have been investigated in clinical pharmacokinetic studies include hydrochlorothiazide, warfarin, digoxin, oral contraceptives (i.e. ethinylestradiol/levonorgestrel), glibenclamide, nifedipine ...
Fertility, pregnancy and lactation
Pregnancy The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4). The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections ...
Effects on ability to drive and use machines
No studies on the effects of candesartan on the ability to drive and use machines have been performed. However, it should be taken into account that occasionally dizziness or weariness may occur during ...
Undesirable effects
Treatment of Hypertension In controlled clinical studies adverse reactions were mild and transient. The overall incidence of adverse events showed no association with dose or age. Withdrawals from treatment ...
Overdose
Symptoms Based on pharmacological considerations, the main manifestation of an overdose is likely to be symptomatic hypotension and dizziness. In individual case reports of overdose (of up to 672 mg candesartan ...
Pharmacodynamic properties
Pharmacotherapeutic group: Angiotensin II antagonists, plain ATC code: C09CA06 Mechanism of action Angiotensin II is the primary vasoactive hormone of the renin-angiotensin-aldosterone system and plays ...
Pharmacokinetic properties
Absorption and distribution Following oral administration, candesartan cilexetil is converted to the active substance candesartan. The absolute bioavailability of candesartan is approximately 40% after ...
Preclinical safety data
There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses. In preclinical safety studies candesartan had effects on the kidneys and on red cell parameters at high ...
List of excipients
Carmellose calcium Hydroxypropyl cellulose Iron oxide red (E172) (8, 16 and 32 mg tablets only) Lactose monohydrate Magnesium stearate Maize starch Macrogol
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Polypropylene blisters (7, 10 or 14 tablets/blister). 2 mg tablets: Blister packs of 7 and 14 tablets. 4 mg, 8 mg and 16 mg tablets: Blister packs of 7, 14, 20, 28, 50, 56, 98, 98x1 (single dose unit), ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Neon Healthcare Limited, 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom
Marketing authorization number(s)
PL 45043/0077 PL 45043/0078 PL 45043/0079 PL 45043/0080 PL 45043/0081
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 December 1998 Date of latest renewal: 29 April 2002
Date of revision of the text
20/12/2021
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