CAPOTEN Tablets (2017)
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Περιεχόμενα
Name of the medicinal product
Capoten 25 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 25 mg captopril. Excipient(s) with known effect: Lactose monohydrate For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White, slightly mottled, square, biconvex tablet, with 25 embossed on one side and cross scored on the other side. The score line is to facilitate breaking for ease of swallowing and to divide ...
Therapeutic indications
Hypertension Capoten is indicated for the treatment of essential hypertension. Heart Failure Capoten is indicated for the treatment of chronic heart failure. Myocardial Infarction Short-term (4 weeks) ...
Posology and method of administration
Dose should be individualised according to patients profile (see section 4.4) and blood pressure response. The recommended maximum daily dose is 150mg. Capoten may be taken before, during and after meals. ...
Contraindications
History of hypersensitivity to captopril, to any of the excipients or any other ACE inhibitor. History of angioedema associated with previous ACE inhibitor therapy. Hereditary/idiopathic angioneurotic ...
Special warnings and precautions for use
Hypotension Rarely hypotension is observed in uncomplicated hypertensive patients. Symptomatic hypotension is more likely to occur in hypertensive patients who are volume and/or sodium depleted by vigorous ...
Interaction with other medicinal products and other forms of interaction
Potassium sparing diuretics or potassium supplements ACE inhibitors attenuate diuretic induced potassium loss. Potassium sparing diuretics (e.g. spironolactone, triamterene or amiloride), potassium supplements, ...
Pregnancy and lactation
Pregnancy The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 4.4). The use of ACE inhibitors is contraindicated during the second and third trimesters of ...
Effects on ability to drive and use machines
As with other antihypertensives, the ability to drive and use machines may be reduced, namely at the start of the treatment, or when posology is modified, and also when used in combination with alcohol, ...
Undesirable effects
Frequency is defined using the following convention: common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000) and very rare (<1/10,000). Undesirable effects reported for captopril ...
Overdose
Symptoms of overdosage are severe hypotension, shock, stupor, bradycardia, electrolyte disturbances and renal failure. Measures to prevent absorption (e.g. gastric lavage, administration of adsorbents ...
Pharmacodynamic properties
Pharmacotherapeutic group: ACE inhibitors, plain ATC code: C09AA01 Captopril is a highly specific, competitive inhibitor of angiotensin-I converting enzyme (ACE inhibitors). The beneficial effects of ACE ...
Pharmacokinetic properties
Captopril is an orally active agent that does not require biotransformation for activity. The average minimal absorption is approximately 75%. Peak plasma concentrations are reached within 60-90 minutes. ...
Preclinical safety data
Animal studies performed during organogenesis with captopril have not shown any teratogenic effect but captopril has produced foetal toxicity in several species, including foetal mortality during late ...
List of excipients
Lactose monohydrate Maize starch Microcrystalline cellulose Stearic acid
Incompatibilities
None.
Shelf life
Shelf life PVC/Al foil blister presentation: 48 months. PVC/PVDC/Al foil blister presentation: 36 months.
Special precautions for storage
PVC/Al foil blister presentation: Store below 30°C. Protect from moisture. PVC/PVDC/Al foil blister presentation: Do not store above 25°C. Store in the original package to protect from moisture.
Nature and contents of container
The tablets are packaged in PVC/aluminium blisters or PVC/PVdC/aluminium blisters in packs of 28 or 84 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special instructions. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
E.R. Squibb & Sons Limited, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH
Marketing authorization number(s)
PL 00034/0193
Date of first authorization / renewal of the authorization
Date of first authorisation: 27<sup>th</sup> March 1981 Date of latest renewal: 26<sup>th</sup> November 1996
Date of revision of the text
January 2017
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