BLOPRESS Tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Blopress 2 mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 2 mg candesartan cilexetil. Each tablet contains 95.4 mg lactose monohydrate. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. Blopress 2 mg Tablets are round white tablets.
4.1. Therapeutic indications
Blopress 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 ...
4.2. Posology and method of administration
Posology in Hypertension The recommended initial dose and usual maintenance dose of Blopress is 8 mg once daily. Most of the antihypertensive effect is attained within 4 weeks. In some patients whose blood ...
4.3. 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. ...
4.4. Special warnings and precautions for use
Dual blockade 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, ...
4.5. 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 ...
4.6. 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 ...
4.7. 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 ...
4.8. 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 orage. Withdrawals from treatment ...
4.9. Overdose
Symptoms Based on pharmacological considerations, the main manifestation of an overdose is likely to be symptomatic hypotension and dizziness. In individualcase reports of overdose (of up to 672 mg candesartan ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Angiotensin II antagonists, plain <b>ATC code:</b> C09CA06 Mechanism of action Angiotensin II is the primary vasoactive hormone of the renin-angiotensin-aldosterone system ...
5.2. 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 ...
5.3. 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 ...
6.1. List of excipients
Carmellose calcium Hydroxypropylcellulose Lactose monohydrate Magnesium stearate Maize starch Macrogol
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
Polypropylene blister. Blister packs of 7, 14 and 28 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany
8. Marketing authorization number(s)
PA2239/014/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 14<sup>th</sup> November 1997 Date of last renewal: 28<sup>th</sup> April 2007
10. Date of revision of the text
July 2021
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