EUCARDIC 25mg Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
09-05-2017
Summary of Product characteristics
(SPC)
07-06-2017
Active ingredient:
CARVEDILOL
Available from:
Roche Products Limited
ATC code:
C07AG02
INN (International Name):
CARVEDILOL
Dosage:
25mg Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Alpha and beta blocking agents
Authorization status:
Authorised
Authorization date:
1995-01-19
Patient Information leaflet
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 symptoms 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 Eucardic is and what it is used for
2. What you need to know before you take Eucardic
3. How to take Eucardic
4. Possible side effects
5. How to store Eucardic
6. Contents of the pack and other information
1.
WHAT EUCARDIC IS AND WHAT IT IS USED FOR
Eucardic contains a medicine called carvedilol. This belongs to
a group of medicines called ‘beta-blockers’.
Eucardic 25 mg tablets are used to treat the following:
● Congestive heart failure.
● High blood pressure (hypertension).
● Angina (chest pain or discomfort that happens when your
heart isn’t getting enough oxygen).
Eucardic works by making your blood vessels relax and widen.
● This helps to lower your blood pressure.
● If you have congestive heart failure, this makes it easier for
your heart to pump blood around your body.
● If you have angina, this will help stop the chest pain.
Your doctor may give you other medicines as well as Eucardic
to help treat your condition.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
EUCARDIC
DO NOT TAKE EUCARDIC IF:
● You are allergic (hypersensitive) to carvedilol or any of the
other ingredients of this medicine (listed in Section 6).
● You have ever had wheezing due to asthma.
● You have severe heart failure (swelling of your hands, ankles
and feet) which is being treated by medicines given into one
of your veins (intravenously).
● You have problems with your liver.
● You have problems with your heart (for example ‘heart
block’ or slow
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eucardic 25 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Carvedilol 25 mg
Excipients: each tablet contains 10mg lactose monohydrate and 25mg
sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Round, white to pale beige tablets, scored on both sides, marked BM on
one side and D5 on the other.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adjunctive therapy for the treatment of symptomatic congestive heart
failure to reduce morbidity and increase patient
well-being.
Treatment of hypertension.
Long-term management of stable angina pectoris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be taken with fluid. For Congestive Heart Failure
(CHF) patients Eucardic 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 drugs should be
stabilised prior to initiation of Eucardic treatment.
_ADULTS_
The recommended dose for the initiation of therapy is 3.125 mg 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 (187 lbs) 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 o
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