CORDAMIL 80 MG

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

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Prenos Navodilo za uporabo (PIL)
31-08-2023
Prenos Lastnosti izdelka (SPC)
31-08-2023
Prenos Javno poročilo o oceni (PAR)
22-05-2022

Aktivna sestavina:

VERAPAMIL HYDROCHLORIDE

Dostopno od:

TRUSTPHARM LTD, ISRAEL

Koda artikla:

C08DA01

Farmacevtska oblika:

FILM COATED TABLETS

Sestava:

VERAPAMIL HYDROCHLORIDE 80 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

S.C. AC HELCOR S.R.L., ROMANIA

Terapevtsko območje:

VERAPAMIL

Terapevtske indikacije:

Treatment of coronary heart disease, including:- chronic stable angina pectoris (effort angina), - unstable angina pectoris: - aggravated angina, resting angina, vasospastic angina (Prinzmetal angina) - post heart-attack angina in patients without heart failure, when adrenergic beta-blockers are contraindicated. Prevention of ventricular fast heart rate disorders not controlled by tonic-cardiac glycosides or beta-blockers (for example supraventricular paroxysmal tachycardia, atrial fibrillation/ flutter with rapid ventricular response, except for Wolff-Parkinson-White syndrome.) Moderate to mild essential hypertension

Datum dovoljenje:

2021-12-30

Navodilo za uporabo

                                PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor's prescription only
CORDAMIL 40 MG
CORDAMIL 80 MG
FILM-COATED TABLETS
ACTIVE INGREDIENT
Cordamil 40 mg: Each tablet contains 40 mg verapamil hydrochloride
Cordamil 80 mg: Each tablet contains 80 mg verapamil hydrochloride
Inactive ingredients and allergens: see section 2 under ‘Important
information about some of
this medicine’s ingredients’, and section 6
‘Additional information'.
Read the entire leaflet carefully before you start using this
medicine. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor
or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if it seems to you that their medical condition is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
1.
Cordamil is used for treatment of coronary heart disease, including:
-
chronic stable angina pectoris (effort angina);
-
unstable angina pectoris:
-
aggravated angina, resting angina, vasospastic angina (Prinzmetal
angina
adrenergic);
-
post-heart attack angina in patients without heart failure, when
beta-blockers
are contraindicated;
2.
Prevention of ventricular fast heart rate disorders not controlled by
Cardiac glycosides
with cardiotonic effector
beta-blockers (for example supraventricular paroxysmal
tachycardia, atrial fibrillation/flutter with rapid ventricular
response, except for Wolff-
Parkinson-White syndrome).
3.
Treatment of moderate to mild blood pressure.
THERAPEUTIC GROUP: selective calcium channel blockers, calcium
blockers with direct cardiac
effects, phenylalkylamines.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
-
you are sensitive (allergic) to the active ingredients or to any of
the other ingredients in this
medicine (listed in section 6).
-
you have cardiogenic shock.
-
you had an acute myocardial infarction with complications such as a
slower heartbeat
(bradycardi
                                
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Lastnosti izdelka

                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CORDAMIL 40 mg film-coated tablets
CORDAMIL 80 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CORDAMIL 40 mg
Each film-coated tablet contains 40 mg verapamil hydrochloride.
Excipients: lactose monohydrate 35.60 mg, tartrazine (E 102) 0.002 mg.
CORDAMIL 80 mg
Each film-coated tablet contains 80 mg verapamil hydrochloride.
Excipients: lactose monohydrate 71.20 mg, tartrazine (E 102) 0.015 mg.
For the list of all excipients, see point 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
CORDAMIL 40 mg
Film-coated, light yellow lenticular tablets with a uniform
appearance, compact and
homogeneous structure, intact edges, engraved on one of the sides "V
40", with a
diameter of 7 mm.
CORDAMIL 80 mg
Film-coated
tablets,
yellow
lenticular
with
uniform
appearance,
compact
and
homogeneous structure, intact edges, engraved with "V 80" on one side
and breaking
line on the other, with a diameter of 9 mm.
The breaking line is intended to ease swallowing of the tablet and not
for dose
modification (equivalence of the two parts was not demonstrated).
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of coronary heart disease, including:
- chronic stable angina pectoris (effort angina),
- unstable angina pectoris:
- aggravated angina, resting angina, vasospastic angina (Prinzmetal
angina),
- post heart-attack angina in patients without heart failure, when
-
adrenergic beta-
blockers are contraindicated.
Prevention
of
ventricular
fast
heart
rate
disorders
not
controlled
by
tonic-cardiac
glycosides or beta-blocker (for example supraventricular paroxysmal
tachycardia, atrial
fibrillation/flutter
with
rapid
ventricular
response,
except
for
Wolff-Parkinson-White
syndrome).
Moderate to mild essential hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dose of verapamil hydrochloride should be adjusted individually
according to the
severity of the condition. Long-term clinical experience demonstrates
that the average
dose for all indica
                                
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