ALAPREN Tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
ALAPREN 5 TABLETS. ALAPREN 10 TABLETS. ALAPREN 20 TABLETS.
2. Qualitative and quantitative composition
ALAPREN 5 TABLETS Each tablet contains: Enalapril maleate 5 mg Contains sugar: Lactose 40 mg per tablet Contains sodium: 0,131 mg per tablet ALAPREN 10 TABLETS Each tablet contains: Enalapril maleate 10 ...
3. Pharmaceutical form
Tablet. <u>ALAPREN 5 TABLETS:</u> White to off-white round, biconvex uncoated tablets debossed with 5 on one side and plain on other side. <u>ALAPREN 10 TABLETS:</u> Pink, round biconvex uncoated tablets ...
4.1. Therapeutic indications
Treatment of hypertension. <u>Treatment of heart failure:</u> ALAPREN TABLETS is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. ...
4.2. Posology and method of administration
Posology ALAPREN TABLETS is not available in a 2,5 mg strength. Please use an alternative enalapril 2,5 mg product available on the market, Since food does not interfere with the absorption of ALAPREN ...
4.3. Contraindications
ALAPREN TABLETS should not be used in patients with known hypersensitivity to enalapril or any of the excipients of ALAPREN TABLETS (listed in section 6.1). A history of angioedema relating to previous ...
4.4. Special warnings and precautions for use
<b>Should a woman become pregnant while receiving ALAPREN TABLETS, the treatment must be stopped promptly and switched to a different class of medicine. Should a woman contemplate pregnancy, the doctor ...
4.5. Interaction with other medicinal products and other forms of interaction
Dual blockade of the RAAS with ARBs, ACE inhibitors, or aliskiren Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE inhibitors, ...
4.6. Fertility, pregnancy and lactation
Pregnancy The use of ALAPREN TABLETS is contraindicated during pregnancy. Pregnant women should be informed of the potential hazards to the foetus and must not take ALAPREN TABLETS during pregnancy (see ...
4.7. Effects on ability to drive and use machines
ALAPREN TABLETS may cause dizziness or weariness. Patients should be warned not to drive or use machines, until their individual susceptibility to the effects of ALAPREN TABLETS is known.
4.8. Undesirable effects
System Organ Class Frequent Less frequent <b>Blood and the lymphatic system disorders</b> Anaemia (including aplastic and haemolytic), neutropenia, decreases in hemoglobin, decreases in hematocrit, ...
4.9. Overdose
Limited data are available for overdosage in humans. The most prominent feature of overdosage is hypotension, six hours after ingestion of the tablets, as well as stupor. Symptoms associated with overdosage ...
5.1. Pharmacodynamic properties
<b>Category and class:</b> A 7.1.3 Vascular medicines Other hypotensives <b>Pharmacotherapeutic group:</b> Angiotensin Converting Enzyme (ACE) inhibitor <b>ATC Code:</b> C09AA02 Following oral administration ...
5.2. Pharmacokinetic properties
Absorption Oral enalapril is absorbed, with peak serum concentrations of enalapril occurring within one hour. Based on urinary recovery, the extent of absorption of enalapril from oral enalapril tablet ...
6.1. List of excipients
<u>ALAPREN 5 TABLETS:</u> Colloidal anhydrous silica Croscarmellose sodium Lactose Maleic acid Microcrystalline cellulose Zinc stearate <u>ALAPREN 10 TABLETS:</u> Colloidal anhydrous silica Croscarmellose ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store at or below 25°C, protected from moisture.
6.5. Nature and contents of container
ALAPREN 5 TABLETS: Carton containing 4 blister strips of 7 tablets in each blister. ALAPREN 10 TABLETS: Carton containing 4 blister strips of 7 tablets in each blister. ALAPREN 20 TABLETS: Carton containing ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext. 1, Roodepoort, 1724, South Africa
8. Marketing authorization number(s)
ALAPREN 5 TABLETS: 34/7.1.3/0014 ALAPREN 1 S20 TABLETS: 34/7.1.3/0015 ALAPREN 20 TABLETS: 34/7.1.3/0016
9. Date of first authorization / renewal of the authorization
27 September 2000
10. Date of revision of the text
11 November 2022
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