KORANDIL Tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Korandil 5 mg tablets. Korandil 10 mg tablets. Korandil 20 mg tablets.
2. Qualitative and quantitative composition
Korandil 5 mg tablets: Each tablet contains 5 mg of enalapril maleate. Korandil 10 mg tablets: Each tablet contains 10 mg of enalapril maleate. Korandil 20 mg tablets: Each tablet contains 20 mg of enalapril ...
3. Pharmaceutical form
Tablet. <u>Korandil 5 mg tablets:</u> White, scored, normal convex, barrel shaped tablets with Remedicas logo on one side. <u>Korandil 10 mg tablets:</u> Light red, scored, normal convex, barrel shaped ...
4.1. Therapeutic indications
Treatment of Hypertension. Treatment of Symptomatic Heart Failure. Prevention of Symptomatic Heart Failure in patients with asymptomatic left ventricular dysfunction (ejection fraction 35%) (see section ...
4.2. Posology and method of administration
Posology The absorption of enalapril maleate is not affected by food. The dose should be individualised according to patient profile (see section 4.4) and blood pressure response. Paediatric population ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or any other ACE inhibitor. History of angioedema associated with previous ACE-inhibitor therapy. Hereditary or ...
4.4. Special warnings and precautions for use
Symptomatic Hypotension Symptomatic hypotension is rarely seen in uncomplicated hypertensive patients. In hypertensive patients receiving Korandil, symptomatic hypotension is more likely to occur if the ...
4.5. Interaction with other medicinal products and other forms of interaction
Medicines increasing the risk of angioedema Concomitant use of ACE inhibitor with sacubitril/valsartan is contraindicated as this increase the risk for angioedema (see sections 4.3 and 4.4). Concomitant ...
4.6. Pregnancy and lactation
Pregnancy ACE inhibitors The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 4.4). The use of ACE inhibitors is contra-indicated during the second and third ...
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 weariness may occur.
4.8. Undesirable effects
The following undesirable effects have been reported for enalapril in clinical studies and in post-marketing experience: <b>Table 3. Undesirable effects of Korandil:</b> <br /> System organ class ...
4.9. Overdose
Limited data are available for overdosage in humans. The most prominent features of overdosage reported to date are marked hypotension, beginning some six hours after ingestion of tablets, concomitant ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Agents acting on the renin-angiotensin system, ACE Inhibitors, plain <b>ATC Code:</b> C09AA02 Korandil (enalapril maleate) is the maleate salt of enalapril, a derivative ...
5.2. Pharmacokinetic properties
Absorption Oral enalapril is rapidly absorbed, with peak serum concentrations of enalapril occurring within one hour. Based on urinary recovery, the extent of absorption of enalapril from oral enalapril ...
5.3. Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. Reproductive toxicity studies ...
6.1. List of excipients
<u>Korandil 5 mg tablets:</u> Lactose Maleic acid Zinc Stearate <u>Korandil 10 mg tablets:</u> Lactose Maleic acid Zinc Stearate Quinoline Yellow aluminium lake E104 Ponceau 4R aluminium lake E124 <u> ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light and moisture.
6.5. Nature and contents of container
<u>Korandil 5 mg tablets:</u> PVC/PVDC-Aluminium blisters. Pack sizes of 30, 50 and 100 tablets. <u>Korandil 10 mg tablets:</u> PVC/PVDC-Aluminium blisters. Pack sizes of 30, 50 and 100 tablets. <u>Korandil ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
Korandil 5 mg tablets: 12841 Korandil 10 mg tablets: 12842 Korandil 20 mg tablets: 12843
9. Date of first authorization / renewal of the authorization
<u>Korandil 5 mg tablets:</u> Date of first authorization: 25 July 1990 Date of latest renewal: 12 July 2012 <u>Korandil 10 mg tablets:</u> Date of first authorization: 25 July 1990 Date of latest renewal: ...
10. Date of revision of the text
09/2021
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