ENAP Tablet (2019)
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Περιεχόμενα
1. Name of the medicinal product
ENAP 5mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 5mg enalapril maleate. <u>Excipients with known effect:</u> Each tablet contains 129.8mg lactose monohydrate and 0.712mg sodium. For the full list of excipients, see section 6.1. ...
3. Pharmaceutical form
Tablet. White oblong tablets with EN 5' embossed and a break notch on one side. The tablets can be divided into equal halves.
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
Route of Administration Oral. Posology The absorption of Enap is not affected by food. The dose should be individualized according to patients profile (see section 4.4) and blood pressure response. Hypertension ...
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 Enap, symptomatic hypotension is more likely to occur if the patient ...
4.5. Interaction with other medicinal products and other forms of interaction
Potassium sparing diuretics or potassium supplements Although serum potassium usually remains within normal limits, hyperkalaemia may occur in some patients treated with enalapril. Potassium sparing diuretics ...
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 trimester of pregnancy ...
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. Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10000, ...
4.9. Overdose
Limited data are available for over dosage in humans. The most prominent features of over dosage reported to date are marked hypotension, beginning some six hours after ingestion of tablets, concomitant ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Angiotensin converting enzyme inhibitors <b>ATC code:</b> C09AA02: ACE inhibitors plain Enap (enalapril maleate) is the maleate salt of enalapril, a derivative of two ...
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
Sodium hydrogen carbonate Lactose monohydrate Maize starch Talc Hydroxypropylcellulose Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light and moisture.
6.5. Nature and contents of container
ENAP 5mg Tablets are packed in blisters of aluminium – aluminium welded on an internally varnished aluminium support. ENAP 5mg Tablets are available in pack sizes of 30 tablets and 50 tablets. Not all ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Rowex Ltd, Newtown, Bantry, Co. Cork, Ireland
8. Marketing authorization number(s)
PA0711/028/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 26 November 1999 Date of last renewal: 26 November 2009
10. Date of revision of the text
November 2019
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