DAPRIL Tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Dapril 5 mg tablets. Dapril 10 mg tablets. Dapril 20 mg tablets.
2. Qualitative and quantitative composition
Each Dapril 5 mg tablet contains lisinopril dihydrate equivalent to 5 mg anhydrous lisinopril. Each Dapril 10 mg tablet contains lisinopril dihydrate equivalent to 10 mg anhydrous lisinopril. Each Dapril ...
3. Pharmaceutical form
Tablet. Dapril 5 mg tablets are uncoated, peach, round, and convex. Dapril 10 mg tablets are uncoated, peach, round, and convex. Dapril 20 mg tablets are uncoated, peach, round, and convex.
4.1. Therapeutic indications
Hypertension Treatment of hypertension. Heart Failure Treatment of symptomatic heart failure. Acute Myocardial Infarction Short term (6 weeks) treatment of haemodynamically stable patients within 24 hours ...
4.2. Posology and method of administration
The dose should be individualised according to patient profile and blood pressure response (see section 4.4). Posology Hypertension Dapril may be used as monotherapy or in combination with other classes ...
4.3. Contraindications
Hypersensitivity to the active substance to any other angiotensin converting enzyme (ACE) inhibitor or to any of the excipients listed in section 6.1. History of angioedema associated with previous ACE ...
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
Antihypertensive agents When lisinopril is combined with other antihypertensive agents (e.g. glyceryl trinitrate and other nitrates, or other vasodilators), additive falls in blood pressure may occur. ...
4.6. 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 ...
4.7. Effects on ability to drive and use machines
When driving vehicles or operating machines it should be taken into account that occasionally dizziness or tiredness may occur.
4.8. Undesirable effects
The following undesirable effects have been observed and reported during treatment with lisinopril and other ACE inhibitors with the following frequencies: Very common 1/10, Common 1/100 to <1/10, Uncommon ...
4.9. Overdose
Symptoms Limited data are available for overdose in humans. Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Angiotensin converting enzyme inhibitors <b>ATC code:</b> C09AA03 Mechanism of action Lisinopril is a peptidyl dipeptidase inhibitor. It inhibits the angiotensin converting ...
5.2. Pharmacokinetic properties
Lisinopril is an orally active non–sulphydryl – containing ACE inhibitor. Absorption Following oral administration of lisinopril, peak serum concentrations occur within about 7 hours, although there was ...
5.3. Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. Angiotensin converting enzyme ...
6.1. List of excipients
Dapril tablets 5 mg, 10 mg, and 20 mg also contain mannitol (E421), dicalcium phosphate dihydrate, red iron oxide (E172), maize starch, pregelatinised maize starch, and magnesium stearate.
6.2. Incompatibilities
None known.
6.3. Shelf life
48 months.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
PVC/PVDC-Aluminium blisters of ten tablets. Packs of ten (all strengths), thirty tablets (all stregths) and twenty tablets (20 mg), with a patient information leaflet are available. Not all pack sizes ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
Dapril 5 mg: 13083 Dapril 10 mg: 13084 Dapril 20 mg: 13085
9. Date of first authorization / renewal of the authorization
Dapril 5m g: 26/11/1990 Dapril 10 mg: 26/11/1990 Dapril 20 mg: 26/11/1990
10. Date of revision of the text
07/2020
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