COZAAR Film-coated tablets (2018)
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Περιεχόμενα
Name of the medicinal product
Cozaar 12.5 mg film-coated tablets. Cozaar 25 mg film-coated tablets. Cozaar 50 mg film-coated tablets. Cozaar 100 mg film-coated tablets.
Qualitative and quantitative composition
Each COZAAR 12.5 mg tablet contains 12.5 mg of losartan potassium. Each COZAAR 25 mg tablet contains 25 mg of losartan potassium. Each COZAAR 50 mg tablet contains 50 mg of losartan potassium. Each COZAAR ...
Pharmaceutical form
Film-coated tablets. COZAAR 12.5 mg tablet: Blue, oval film-coated tablets marked 11 on one side and plain on the other. COZAAR 25 mg tablet: White, oval unscored film-coated tablets marked 951 on one ...
Therapeutic indications
Treatment of essential hypertension in adults and in children and adolescents 6-18 years of age. Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ...
Posology and method of administration
Posology Hypertension The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. Some patients ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in sections 4.4 and 6.1. 2<sup>nd</sup> and 3<sup>rd</sup> trimester of pregnancy (see sections 4.4 and 4.6). Severe hepatic ...
Special warnings and precautions for use
Hypersensitivity Angiooedema Patients with a history of angiooedema (swelling of the face, lips, throat, and/or tongue) should be closely monitored (see section 4.8). Hypotension and Electrolyte/Fluid ...
Interaction with other medicinal products and other forms of interaction
Other antihypertensive agents may increase the hypotensive action of losartan. Concomitant use with other substances which may induce hypotension as an adverse reaction (like tricyclic antidepressants, ...
Pregnancy and lactation
Pregnancy The use of losartan is not recommended during the first trimester of pregnancy (see section 4.4). The use of losartan is contraindicated during the 2<sup>nd</sup> and 3<sup>rd</sup> trimester ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, when driving vehicles or operating machines it must be borne in mind that dizziness or drowsiness may occasionally ...
Undesirable effects
Losartan has been evaluated in clinical studies as follows: In a controlled clinical trial in >3,000 adult patients 18 years of age and older for essential hypertension. In a controlled clinical trial ...
Overdose
Symptoms of intoxication Limited data are available with regard to overdose in humans. The most likely manifestation of overdose would be hypotension and tachycardia. Bradycardia could occur from parasympathetic ...
Pharmacodynamic properties
Pharmacotherapeutic group: Angiotensin II antagonists, plain ATC code: C09CA01 Losartan is a synthetic oral angiotensin-II receptor (type AT<sub>1</sub>) antagonist. Angiotensin II, a potent vasoconstrictor, ...
Pharmacokinetic properties
Absorption Following oral administration, losartan is well absorbed and undergoes first-pass metabolism, forming an active carboxylic acid metabolite and other inactive metabolites. The systemic bioavailability ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, genotoxicity and carcinogenic potential. In repeated dose toxicity studies, the administration ...
List of excipients
Microcrystalline cellulose (E460) Lactose monohydrate Pregelatinized maize starch Magnesium stearate (E572) Hyprolose (E463) Hypromellose (E464) COZAAR 12.5 mg, 25 mg, 50 mg and 100 mg contain potassium ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Blisters: Store in the original package in order to protect from light and moisture. HDPE bottle: Do not store above 25°C. Store in original container in order to protect from light. Keep the bottle tightly ...
Nature and contents of container
COZAAR 12.5 mg: PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 14, 21, 28, 50, 98, 210 or 500 tablets and a unit-dose package of 28 tablets for hospital use. HDPE bottles ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Herts, EN11 9BU
Marketing authorization number(s)
12.5 mg: PL 0025/0515 25 mg: PL 0025/0336 50 mg: PL 0025/0324 100 mg: PL 0025/0416
Date of first authorization / renewal of the authorization
12.5 mg: 6 January 2009/22 December 2009 25 mg: 15 December 1994/27 August 2009 50 mg: 15 December 1994/22 December 2009 100 mg: 28 November 2001/22 December 2009
Date of revision of the text
22 March 2018
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