Renitec 20 mg Tablett

Ülke: İsveç

Dil: İsveççe

Kaynak: Läkemedelsverket (Medical Products Agency)

Aktif bileşen:

enalaprilmaleat

Mevcut itibaren:

Cross Pharma AB

ATC kodu:

C09AA02

INN (International Adı):

enalapril

Doz:

20 mg

Farmasötik formu:

Tablett

Kompozisyon:

laktos (vattenfri) Hjälpämne; enalaprilmaleat 20 mg Aktiv substans

Reçete türü:

Receptbelagt

Terapötik alanı:

Enalapril

Yetkilendirme durumu:

Avregistrerad

Yetkilendirme tarihi:

1999-12-29

Bilgilendirme broşürü

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
RENITEC 2.5 MG, 5 MG, 10 MG, OR 20 MG 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, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Renitec is and what it is used for
2.
What you need to know before you take Renitec
3.
How to take Renitec
4.
Possible side effects
5.
How to store Renitec
6.
Contents of the pack and other information
1.
WHAT RENITEC IS AND WHAT IT IS USED FOR
Renitec contains an active substance called enalapril maleate. This
belongs to the group of medicines
called ACE inhibitors (angiotensin converting enzyme inhibitors).
Renitec is used:
-
to treat high blood pressure (hypertension)
-
to treat heart failure (weakening of heart function). It can lower the
need to go to hospital and
can help some patients live longer
-
to prevent the signs of heart failure. The signs include: shortness of
breath, tiredness after light
physical activity such as walking, or swelling of the ankles and feet.
This medicine works by widening your blood vessels. This lowers your
blood pressure. The medicine
usually starts to work within an hour, and the effect lasts for at
least 24 hours. Some people will
require several weeks of treatment until the best effect on your blood
pressure is seen.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENITEC
DO NOT TAKE RENITEC
-
if you are allergic to enalapril maleate or any of the other
ingredients of this medicine (listed in
section 6)
-
if you have ever had an allergic reaction to a type of medicine
similar to this medicine call

Ürün özellikleri

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Renitec 2.5 mg Tablets
Renitec 5 mg Tablets
Renitec 10 mg Tablets
Renitec 20 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Renitec 2.5 mg
Each tablet contains 2.5 mg of enalapril maleate.
Excipient: each tablet contains 99 mg of lactose monohydrate.
Renitec 5 mg
Each tablet contains 5 mg of enalapril maleate.
FOR TABLETS MANUFACTURED AT THE ORGANON PHARMA (UK) LIMITED, VIANEX
S.A, OR FROSST IBERICA
S.A FACILITIES:
Excipient: each tablet contains 198 mg of lactose monohydrate.
FOR TABLETS MANUFACTURED AT THE MSD ITALIA S.P.A FACILITY:
Excipient: each tablet contains 196 mg of lactose monohydrate.
Renitec 10 mg
Each tablet contains 10 mg of enalapril maleate.
Excipient: each tablet contains 164 mg of lactose monohydrate.
Renitec 20 mg
Each tablet contains 20 mg of enalapril maleate.
FOR TABLETS MANUFACTURED AT THE ORGANON PHARMA (UK) LIMITED, VIANEX
S.A, OR FROSST IBERICA
S.A FACILITIES:
Excipient: each tablet contains 154 mg of lactose monohydrate.
FOR TABLETS MANUFACTURED AT THE MSD ITALIA S.P.A FACILITY:
Excipient: each tablet contains 147 mg of lactose monohydrate.
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Strength
Appearance
Country
2.5 mg
White, round shaped tablet, one side
marked MSD 14, the other side plain
Germany, Ireland, Sweden, United
Kingdom
5 mg
White, rounded triangle shaped tablet,
one side scored*, the other side
marked MSD 712
Austria, Finland, France, Germany,
Ireland, Portugal, The Netherlands,
Spain, Sweden, United Kingdom
White, round shaped tablet, one side
scored*, the other side marked 712
Italy
White, round flat tablet, one side
scored*, other side plain
Greece
10 mg
Rust Red, rounded triangle shaped
tablet, one side scored*, the other side
marked MSD 713
Austria, Finland, Germany, Ireland,
The Netherlands, Sweden, United
Kingdom
Peach, rounded triangle shaped tablet,
one side scored*, the other side
marked MSD 714
Austria, Belgium, Finla