CARVEDEXXON 6.25

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

CARVEDILOL

Dostopno od:

DEXCEL LTD, ISRAEL

Koda artikla:

C07AG02

Farmacevtska oblika:

TABLETS

Sestava:

CARVEDILOL 6.25 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

DEXCEL LTD, ISRAEL

Terapevtska skupina:

CARVEDILOL

Terapevtsko območje:

CARVEDILOL

Terapevtske indikacije:

Treatment of symptomatic congestive heart failure. Carvedexxon may be used as adjunct to standard therapy, but may also be used in those patients unable to tolerate an ACE inhibitor, or those who are not receiving digitalis, hydralazine or nitrate therapy.

Datum dovoljenje:

2022-11-30

Navodilo za uporabo

1
PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine can be sold with a physician’s prescription only.
CARVEDEXXON TABLETS 6.25, 12.5 MG
ACTIVE INGREDIENT:
each tablet contains Carvedilol at dose of 6.25 and 12.5 mg
respectively.
Inactive ingredients and allergens in the medicine – see section 6
"Additional information" and in section 2
"Important information about some of the ingredients of the medicine".
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information
about the medicine. If you have any further questions, ask the doctor
or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if you think
that their medical condition is the same as yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
CARVEDEXXON
is used for the treatment of congestive heart failure.
THERAPEUTIC GROUP:
Alpha 1 and beta receptor blockers.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF YOU:
•
Are hypersensitive (allergic) to the active ingredient (carvedilol),
or to any of the other ingredients this
medicine contains (see section 6).
•
Have ever had wheezing or asthma.
•
Have severe heart failure (swelling of your hands, ankles and feet)
which is being treated by
medicines given into one of your veins (intravenously).
•
Have problems with your liver.
•
Have problems with your heart (for example: ‘heart block’ or slow
heartbeat).
CARVEDEXXON
is not
suitable for some people with certain types of heart problems.
•
Have very low blood pressure.
If any of the above applies to you, do not take this medicine. If you
are not sure, talk to the doctor or
pharmacist before taking this medicine.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
•
BEFORE THE TREATMENT WITH CARVEDEXXON, TELL THE DOCTOR IF YOU:
o
Have problems with your lungs.
o
Have problems with your kidneys.
o
Have diabetes (high blood sugar).
o
Wear contact lenses.
o
Have problems with your blood vessels (peripher

Lastnosti izdelka

1
SUMMARY OF PRODUCT CHARACTERITICS
1.
NAME OF THE MEDICINAL PRODUCT
CARVEDEXXON 6.25
CARVEDEXXON 12.5
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Carvedilol 6.25 mg or 12.5 mg respectively.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off white, round, biconvex tablets, scored on one side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of symptomatic congestive heart failure.
CARVEDEXXON may be used as adjunct to standard therapy, but may also
be used in those
patients unable to tolerate an ACE inhibitor, or those who are not
receiving digitalis,
hydralazine or nitrate therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be taken with fluid. CARVEDEXXON should be given
with food to slow the
rate of absorption and reduce the incidence of orthostatic effects.
SYMPTOMATIC CONGESTIVE HEART FAILURE
The dosage must be titrated to individual requirements and monitored
during up-titration.
For those patients receiving diuretics and/or digoxin and/or ACE
inhibitors, dosing of these
other medicinal products should be stabilized prior to initiation of
CARVEDEXXON treatment.
ADULTS
The recommended dose for the initiation of therapy is 3.125 mg (half a
6.25mg tablet) 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 85kg. and 50 mg twice daily in patients weighing more than 85 kg.
Before each dose increase the patient should be evaluated by the
physician for symptoms of
worsening heart failure or vasodilation. Transient worsening of heart
failure, vasodilation or
fluid retention may be treated with increased doses of diuretics or
ACE inhibitors