Renil 5 mg

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

enalapril maleate 5 mg

Tillgänglig från:

Actavis h.f.

ATC-kod:

C09AA02

INN (International namn):

enalapril maleate

Läkemedelsform:

tablet

Bemyndigande status:

Authorised

Tillstånd datum:

2006-11-16

Bipacksedel

1 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

RENIL
®
 5MG, 10MG & 20MG TABLETS 
_Enalapril maleate _

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have further questions,
please ask your doctor or your pharmacist. 
- 
This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, 
even if their symptoms are the same as yours. 
- 
If  any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet, 
please tell your doctor or pharmacist. 

WHAT IS IN THIS LEAFLET:  
1. 
What Renil is and what it is used for 
2. 
What you need to know before you use Renil 
3. 
How to use Renil 
4. 
Possible side effects 
5 
How to store Renil 
6. 
Contents of the pack and other information 

1. 
WHAT RENIL IS AND WHAT IS USED FOR 

Renil belongs to a group of medicinal products called ACE
inhibitors. Renil inhibits the formation of 
blood pressure elevating substances, which contract the blood
vessels. Treatment with Renil dilates 
the blood vessels and decreases the blood pressure. In patients with
heart failure, the dilating of the 
blood vessels decreases the workload of the heart. 

This medicine is used for the treatment of hypertension and
heart failure. 

Please notice that your doctor may have prescribed the
medicinal product for a different therapeutic 
indication and/or at a different dosage that is stated in the
package leaflet. Always follow the doctor’s 
prescription and the instructions on the pharmacy label. 

2. 
WHAT YOU NEED TO KNOW BEFORE YOU USE RENIL 

DO NOT USE RENIL: 
- 
if you are allergic  to enalapril or any of the
other ingredients of this medicine (listed in section 6). 
- 
if you are allergic to any other 

Produktens egenskaper

Page 1 of 14 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Renil 5 mg tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains: Enalapril maleate 5mg,. 

For a full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Tablets. 

_5 mg tablets:_ Circular, flat, white 8 mm tablets scored on
both sides. 

4. 
CLINICAL PARTICULARS 

4.1   THERAPEUTIC INDICATIONS 

Treatment of hypertension and heart failure. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

DOSAGE FOR ADULTS: 

The absorption of enalapril is not affected by food. 

The dose should be individualized according to patient profile
(see section 4.4) and blood pressure 
response. 

Hypertension 
The usual initial dose is 5 mg to maximally 20 mg,
depending on the degree of hypertension and the 
condition of the patient (see below). Enalapril is given once
daily. In mild hypertension, the 
recommended initial dose is 5 to 10 mg. Patients with a
strongly activated renin-angiotensin-
aldosterone system (e.g.,
renovascular hypertension, salt and/or volume
depletion, cardiac 
decompensation, or severe hypertension) may experience an excessive
blood pressure fall following 
the initial dose. A starting dose of 5 mg or lower is
recommended in such patients and the initiation of 
treatment should take place under medical supervision. 

Prior treatment with high dose diuretics may result in volume
depletion and a risk of hypotension 
when initiating therapy with enalapril.
A starting dose of 5 mg or lower is recommended in such 
patients. If possible, diuretic therapy should be
discontinued for 2-3 days prior to initiation of therapy 
with enalapril. Renal function and serum potassium should be
monitored. 

The usual maintenance dose is 20 mg daily. The
maximum maintena