Carvedilol 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Carvedilol

Available from:

IVAX Pharmaceuticals UK Ltd

ATC code:

C07AG02

INN (International Name):

Carvedilol

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Page No.
Version No.
Date
Software
140519/1
Ennogen
Carvedilol Leaflet
UK
English
240 x 400 mm
9 pt
1 of 1
4
10-12-19
Coreldraw 12
Packaging Development
Quality Assurance (QA)
Quality Control (QC)
Production
e-mail : [e-mail]
Ph : [phone]
Colours Used
Black
Keyline
EN V01
!
have very LOW BLOOD PRESSURE
Talk to your doctor or pharmacist before taking Carvedilol Tablets if
you:
TAKING OTHER MEDICINES
!
suffer from any other HEART PROBLEMS
!
Carvedilol Tablets can affect the results of some blood, urine or
other
tests. If you have a blood or urine test done, tell the doctor or
medical
staff that you are taking Carvedilol Tablets
!
suffer from RAYNAUD'S disease (very poor circulation in the hands and
feet) or another form of peripheral vascular disease
!
wear CONTACT LENSES. Carvedilol can make your eyes become drier
!
suffer from SERIOUS ALLERGIC REACTIONS (abnormal sensitivity to insect
bites or stings, severe eczema, hayfever)
!
suffer from any lung diseases
!
have any problems with your KIDNEYS
!
have problems with the ACID LEVELS in your blood (metabolic acidosis)
!
have a THYROID problem
!
have a condition called PRINZMETAL'S angina
!
have DIABETES and are taking INSULIN or ANTI-DIABETIC tablets. You may
need to monitor your glucose (sugar) levels more closely when you
take Carvedilol Tablets.
!
have severe BLOOD CIRCULATION problems (which may cause your
fingers and toes to tingle or turn pale or blue)
WARNINGS AND PRECAUTIONS
Tell your doctor or pharmacist if you are taking or, have recently
taken or
might take any other medicines. This includes medicines that you buy
without a prescription and herbal medicines. This is because
Carvedilol
Tablets can affect the way some medicines work. Also some medicines
can
affect the way carvedilol works.
!
have PSORIASIS (a skin condition)
!
have an ALLERGY and are having treatment to desensitise you
TAKE SPECIAL CARE WITH CARVEDILOL TABLETS:

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carvedilol 25 mg tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 25 mg carvedilol.
Excipient with known effect: Each tablet contains 100mg lactose
monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
White, oval, scored on both sides and marked "25" on one side. The
tablet can
be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Essential hypertension.
Chronic stable angina pectoris
Adjunctive treatment in moderate to severe stable heart failure._ _
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
Posology
Carvedilol is available in 4 strengths: 3.125 mg, 6.25 mg, 12.5 mg and
25 mg
_Essential hypertension _
Carvedilol may be used for the treatment of hypertension alone or in
combination
with other antihypertensives, especially thiazide diuretics. Once
daily dosing is
recommended, however the recommended maximum single dose is 25 mg and
the
recommended maximum daily dose is 50 mg.
_Adults _
The recommended initial dose is 12.5 mg once a day for the first two
days. Thereafter,
the treatment is continued at the dose 25 mg/day. If necessary, the
dose may be further
increased gradually at intervals of two weeks or more rarely.
_Elderly_
The recommended initial dose in hypertension is 12.5 mg once a day,
which may also
be sufficient for continued treatment. However, if the therapeutic
response is
inadequate at this dose, the dose may be further increased gradually
at intervals of two
weeks or more rarely.
_Chronic stable angina pectoris _
_Adults_
The recommended initial dose is 12.5 mg twice daily for two days.
Thereafter, the
treatment is continued at the dose 25 mg twice daily. If necessary,
the dose may be
further increased gradually at intervals of two weeks or more rarely.
The
recommended maximum daily dose is 100 mg in divided doses (50mg twice
daily).
_Elderly_
The recommended initial dose is 12.5 mg twice daily for two days.
Thereafter