COROSAN 75 MG

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

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Vara einkenni Vara einkenni (SPC)
07-11-2021

Virkt innihaldsefni:

DIPYRIDAMOLE

Fáanlegur frá:

RAZ PHARMACEUTICS LTD, ISRAEL

ATC númer:

B01AC07

Lyfjaform:

TABLETS

Samsetning:

DIPYRIDAMOLE 75 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

LABORATORIO FARMACOLOGICO MILANESE SRL, ITALY

Lækningarsvæði:

DIPYRIDAMOLE

Ábendingar:

Corosan is indicated for:• As an adjunct to oral anticoagulation for prophylaxis of thromboembolism associated with prosthetic heart valves.• As an alternative to exercise stress in thallium myocardial imaging particularly in patients unable to exercise or in those for whom exercise may be contraindicated.

Leyfisdagur:

2021-06-17

Upplýsingar fylgiseðill

                                PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
This medicine is to be supplied with doctor’s prescription only
COROSAN 75 MG TABLETS
ACTIVE INGREDIENT:
Each tablet contains Dipyridamole 75mg.
For the list of inactive ingredients - see section 6, "Additional
information" in
this leaflet.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains essential information about this medicine. If
you have any
further questions, refer to the doctor or the pharmacist.
This medicine has been prescribed for you. Do not pass it to others.
It may
harm them even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
-
As an adjunct to oral anticoagulation for prophylaxis of
thromboembolism
associated with prosthetic heart valves.
- As an alternative to exercise stress in thallium myocardial imaging
particularly in patients unable to exercise or in those for whom
exercise may
be contraindicated.
THERAPEUTIC GROUP: platelet aggregation inhibitors excluding heparin.
2. BEFORE USING THIS MEDICINE:
DO NOT USE THIS MEDICINE IF:
- you are sensitive (allergic) to the active ingredient Dipyridamole
or to any of
the other ingredients that this medicine contains (see section 6,
"Additional
information").
-you suffer from serious heart problems (acute heart attack).
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE:
Talk to your doctor or pharmacist before taking COROSAN.
Take COROSAN with caution if you suffer from low blood pressure
(hypotension), since excessive doses may cause dilation in the small
arteries
and veins (peripheral vasodilation) with consequent excessive drop in
blood
pressure.
DRUG INTERACTIONS
IF YOU ARE TAKING OR HAVE RECENTLY TAKEN OTHER MEDICINES, INCLUDING
NON-
PRESCRIPTION MEDICINES AND FOOD SUPPLEMENTS, INFORM YOUR DOCTOR OR
PHARMACIST.
Especially if you are taking COROSAN together with other medicines
used to
prevent coagulation (anticoagulants), in this case, it is advised to
undergo a

                                
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                                SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
COROSAN 75 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg of dipyridamole.
Excipients with known effect: lactose
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablets.
4.
CLINICAL INFORMATION
4.1
THERAPEUTIC INDICATIONS
Corosan is indicated:

As an adjunct to oral anticoagulation for prophylaxis of
thromboembolism associated with
prosthetic heart valves.

As an alternative to exercise stress in thallium myocardial imaging
particularly in patients
unable to exercise or in those for whom exercise may be
contraindicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
4-6 capsules per day in divided doses.
Method of administration
The medicine must be ingested on an empty stomach one hour before
meals.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Acute heart attack.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The medicine should be used with caution in hypotensive patients
because excessive doses can
induce peripheral vasodilatation.
This product contains lactose. Patients with rare hereditary problems
of galactose intolerance,
Lapp lactase deficiency or glucose-galactose malabsorption should not
take this medicine.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Interferences may occur with anticoagulant treatments: check the blood
coagulation parameters
carefully.
4.6
FERTILITY, PREGNANCY AND LACTATION
No toxic effects for mother and child following the use of
dipyridamole during pregnancy are
found in the literature.
4.7
EFFECTS ON ABILITY TO DRIVE AND OPERATE MACHINERY
COROSAN does not affect your ability to drive or operate machinery.
4.8
UNDESIRABLE EFFECTS
The following side effects are possible and are listed by frequency:
_Very common_
(may affect more than 1in 10 patients)
headache, dizziness, diarrhoea, nausea.
_Common_
(may affect up to 1 in 10 patients)
angina pectoris (chest pa
                                
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