Carvsanna 12,5 mg Tablett

Kraj: Szwecja

Język: szwedzki

Źródło: Läkemedelsverket (Medical Products Agency)

Składnik aktywny:

karvedilol

Dostępny od:

ratiopharm GmbH

Kod ATC:

C07AG02

INN (International Nazwa):

carvedilol

Dawkowanie:

12,5 mg

Forma farmaceutyczna:

Tablett

Skład:

karvedilol 12,5 mg Aktiv substans; laktosmonohydrat Hjälpämne

Klasa:

Apotek

Typ recepty:

Receptbelagt

Dziedzina terapeutyczna:

Karvedilol

Podsumowanie produktu:

Förpacknings: Blister, 10 tabletter; Blister, 14 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 98 tabletter; Blister, 100 tabletter

Status autoryzacji:

Godkänd

Data autoryzacji:

2008-02-22

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARVSANNA 6.25 MG, 12.5 MG AND 25 MG TABLETS
Carvedilol
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 any 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 Carvsanna is and what it is used for
2.
What you need to know before you take Carvsanna
3.
How to take Carvsanna
4.
Possible side effects
5.
How to store Carvsanna
6.
Contents of the pack and other information
1.
WHAT CARVSANNA IS AND WHAT IT IS USED FOR
Carvsanna belongs to the group of drugs, alpha- and beta blockers.
Carvsanna is used in the treatment
of high blood pressure and the treatment of angina pectoris. Carvsanna
is also used as a supplementary
treatment in heart failure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARVSANNA
DO NOT TAKE CARVSANNA:
-
if you are allergic to carvedilol or to any of the other ingredients
of this medicine (listed in
section 6).
-
if you have UNTREATED OR UNSTABLE HEART FAILURE or certain types of
DISTURBANCES IN THE
CONDUCTION SYSTEM OF THE HEART (so-called AV-block of type II and III
unless you have a
pacemaker, or so-called sick sinus node).
-
if you are suffering from a severe LIVER DISEASE.
-
if you have a very LOW PULSE (LESS THAN 50 BEATS PER MINUTE) or very
LOW BLOOD PRESSURE.
-
if you are suffering from severely COMPROMISED CARDIAC FUNCTION
(cardiogenic shock).
-
if you are suffering from SERIOUS DISTURBANCE in THE BODY’S
ACID-BASE BALANCE (metabolic
acidosis, acidaemia).
-
if you have ASTHMA or acute obstruction of your respiratory airway.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist befo

Charakterystyka produktu

Produktinformationen för Carvsanna filmdragerad tablett 6,25, 12,5,
och 25 mg , MTnr
26019, 26020, 26021, gäller vid det tillfälle då läkemedlet
godkändes. Informationen kommer
inte att uppdateras eftersom läkemedlet inte marknadsförs i Sverige.
Av samma anledning
finns inte någon svensk produktinformation.
Den engelska produktinformationen kommer dock att uppdateras för de
produkter där Sverige
är referensland.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på
dokumentet, beror det på att läkemedlet i Sverige är godkänt under
ett annat namn.
SUMMARY OF THE PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
CARVSANNA 6.25 MG FILM-COATED TABLET
CARVSANNA 12.5 MG FILM-COATED TABLET
CARVSANNA 25 MG FILM-COATED TABLET
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
One tablet contains 6.25 mg, 12.5 mg or 25 mg carvedilol.
Excipient: 25mg/50mg/100mg of lactose monohydrate
For a full list of excipients, see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Film-coated tablet
6.25 mg film-coated tablets: white, oval, scored on both sides and
marked "6" on one side.
12.5 mg film-coated tablets: white, oval, scored on both sides and
marked "12" on one side.
25 mg film-coated tablets: white, oval, scored on both sides and
marked "25" on one side
The tablets can be divided into equal halves.
4
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Essential hypertension.
Chronic stable angina pectoris
Adjunctive treatment in moderate to severe stable heart failure.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Carvsanna is available in 3 strengths: 6.25 mg, 12.5 mg and 25 mg
ESSENTIAL HYPERTENSION:
Carvedilol may be used for the treatment of hypertension alone or in
combination with other
antihypertensives, especially thiazide diuretics. Once daily dosing is
recommended, however
the recommended maximum single dose is 25 mg and the recommended
maximum daily dose
is 50 mg.
_Adults_
The recommended initial dose is 12.5 mg once a day for the first two
days. Thereafter,
the treatment is continued