Perazodin 75mg coated tablets

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

DIPYRIDAMOLE

Disponibil de la:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

Codul ATC:

B01AC07

INN (nume internaţional):

DIPYRIDAMOLE 75 mg

Forma farmaceutică:

COATED TABLET

Compoziție:

DIPYRIDAMOLE 75 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

ANTITHROMBOTIC AGENTS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2006-11-23

Prospect

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERAZODIN 25 MG COATED TABLETS
PERAZODIN 75 MG COATED TABLETS
PERAZODIN 100 MG COATED TABLETS
Dipyridamole
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 Perazodin is and what it is used for
2. What you need to know before you take Perazodin
3. How to take Perazodin
4. Possible side effects
5. How to store Perazodin
6. Contents of the pack and other information
1.
WHAT PERAZODIN IS AND WHAT IT IS USED FOR
The name of your medicine is Perazodin. It contains a substance called
dipyridamole. This
belongs to a group of medicines called ‘anti-thrombotic agents’,
which are used to help
stop blood clots forming.
Perazodin helps stop blood clots which may occur if you have had your
heart valves
replaced.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERAZODIN
DO NOT TAKE PERAZODIN
• if you are allergic (hypersensitive) to dipyridamole or to any of
the other ingredients of
this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Perazodin if:
• you have angina or other heart problems (including heart valve or
circulation problems)
or have had a recent heart attack.
• you have myasthenia gravis (a rare muscle problem).
• you have any bleeding problems.
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• you are pregnant or planning to become pregnant or are
breast-feeding.
• you have been told by your doctor that you have an intolerance to
some sugars.
If you are not sure if any of the above apply to you, talk to your
doct

Caracteristicilor produsului

mt-spc-perazodin-75mg-sc-tabs-v02-r00-a0
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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Perazodin
75 mg coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 75 mg dipyridamole.
Excipient(s) with known effect
This product contains 40,2 mg lactose and 71,331 mg sucrose, 0,106 mg
ponceau 4R cochineal
red A E124 and 0,036 mg quinolone yellow E104.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Coated tablet.
Orange, round, sugar-coated tablets.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
An adjunct to oral anti-coagulation for prophylaxis of
thrombo-embolism associated with
prosthetic heart valves.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 300-600 mg daily in three or four doses.
Children: Dipyridamole is not recommended for children.
Method of administration
Oral administration.
Perazodin should usually be taken before meals.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
mt-spc-perazodin-75mg-sc-tabs-v02-r00-a0
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Among other properties, dipyridamole acts as a vasodilator. It should
be used with caution in
patients with severe unstable angina or recent myocardial infarction,
left ventricular outflow
obstruction or haemodynamic instability (e.g. decompensated heart
failure).
In patients with myasthenia gravis, readjustment of therapy may be
necessary after changes in
dipyridamole dosage (see ‘Interaction with other medicinal products
and other forms of
interaction’).
Perazodin should be used with caution in patients with coagulation
disorders.
A small number of cases have been reported in which unconjugated
dipyridamole was shown
to be incorporated into gallstones to a variable extent (up to 70% by
dry weight of stone). These
patients were all elderly, had evidence of ascending cholangitis and
had been treated with oral
dipyridamole for a number of years. There is no evidence t