Carvedilol Krka 25 mg Tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Carvedilol

Доступна с:

KRKA, d.d., Novo mesto

код АТС:

C07AG; C07AG02

ИНН (Международная Имя):

Carvedilol

дозировка:

25 milligram(s)

Фармацевтическая форма:

Tablet

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

Alpha and beta blocking agents; carvedilol

Статус Авторизация:

Marketed

Дата Авторизация:

2003-08-22

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARVEDILOL KRKA 3.125 MG TABLETS
CARVEDILOL KRKA 6.25 MG TABLETS
CARVEDILOL KRKA 12.5 MG TABLETS
CARVEDILOL KRKA 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 Carvedilol Krka is and what it is used for
2.
What you need to know before you take Carvedilol Krka
3.
How to take Carvedilol Krka
4.
Possible side effects
5.
How to store Carvedilol Krka
6.
Contents of the pack and other information
1.
WHAT CARVEDILOL KRKA IS AND WHAT IT IS USED FOR
Carvedilol Krka contains a medicine called carvedilol. This belongs to
a group of medicines called
‘betablockers’.
Carvedilol Krka 3.125 mg and 6.25 mg tablets are used to treat the
following:
-
Congestive heart failure.
-
High blood pressure (hypertension).
Carvedilol Krka 12.5 mg and 25 mg tablets are used to treat the
following:
-
Congestive heart failure.
-
High blood pressure (hypertension).
-
Angina (chest pain or discomfort that happens when your heart isn’t
getting enough oxygen).
Carvedilol Krka works by making your blood vessels relax and widen.
-
This helps to lower your blood pressure.
-
If you have congestive heart failure, this makes it easier for your
heart to pump blood around
your body.
-
If you have angina, this will help stop the chest pain.
Your doctor may give you other medicines as well as Carvedilol Krka to
help treat your condition.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARVEDILOL KRKA
DO NOT TAKE CARVEDILOL KRKA
-
if you are allergic (hypersensitive) to carved

Характеристики продукта

Health Products Regulatory Authority
18 October 2019
CRN008JX7
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carvedilol Krka 25 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 25 mg carvedilol.
Excipients: Each tablet contains 85 mg lactose monohydrate and 60 mg
sucrose.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablets.
Appearance:
Round, slightly biconvex, white bevel edged tablet scored on one side.
The tablet can be divided into two equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adjunctive therapy for the treatment of symptomatic congestive heart
failure to reduce morbidity and increase patient
well-being.
Treatment of hypertension.
Long-term management of stable angina pectoris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_SYMPTOMATIC CONGESTIVE HEART FAILURE_
The dosage must be titrated to individual requirements and patients'
clinical status should be monitored for 2 - 3 hours after
initiation and any dose increase during up-titration. For those
patients receiving diuretics and/or digoxin and/or ACE inhibitors,
dosing of these other drugs should be stabilised prior to initiation
of Carvedilol Krka treatment.
_ADULTS_
The recommended dose for the initiation of therapy is 3.125 mg twice a
day for two weeks. If this dose is tolerated, the dosage
should be increased subsequently, at intervals of not less than two
weeks, to 6.25 mg twice daily, followed by 12.5 mg twice
daily and thereafter 25 mg twice daily. Dosing should be increased to
the highest level tolerated by the patient. The
recommended maximum daily dose is 25 mg given twice daily in patients
weighing less than 85 kg (187 lbs) and 50 mg twice
daily in patients weighing more than 85 kg. During up-titration of the
dose in patients with systolic blood pressure < 100
mmHg, deterioration of renal and/or cardiac functions may occur.
Therefore, before each dose increase, these patients should
be evaluated by the physician for renal function