Perazodin 25mg coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIPYRIDAMOLE

Available from:

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

ATC code:

B01AC07

INN (International Name):

DIPYRIDAMOLE 25 mg

Pharmaceutical form:

COATED TABLET

Composition:

DIPYRIDAMOLE 25 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Authorised

Authorization date:

2006-12-29

Patient Information leaflet

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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

Summary of Product characteristics

mt-spc-perazodin-25mg-sc-tabs-v02-r00-a0
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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Perazodin 25 mg coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 25 mg dipyridamole.
Excipient(s) with known effect
This product contains 13,4 mg lactose and 37,282 mg sucrose, 0,004 mg
ponceau 4R
cochineal red A E124 and 0,041 mg sunset yellow FCF aluminium lake
E110.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Coated tablet.
Light 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-25mg-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
coronary
artery
disease,
including
unstable
angina
and/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’).
Patients being treated with regular oral doses of Perazodin should not
receive additional
intravenous dipyridamole. Clinical experience suggests that patients
being treated with oral
dipyridamole who also require pharmacological stress testing with
intravenous dipyridamole,
should discontinue drugs containing oral dipyridamole for 24 hours
prior to stress