Carvedilol 3.125mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Carvedilol

Saatavilla:

Arrow Generics Ltd

ATC-koodi:

C07AG02

INN (Kansainvälinen yleisnimi):

Carvedilol

Annos:

3.125mg

Lääkemuoto:

Oral tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 02040000; GTIN: 5060034832454

Pakkausseloste

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
CARVEDILOL 3.125 MG, 6.25 MG, 12.5 MG & 25 MG TABLETS
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 further questions, please ask your doctor or your
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 side effects not listed in this
leaflet.
IN THIS LEAFLET:
1. What Carvedilol Tablets are and what they are used for
2. What you need to know before you take Carvedilol Tablets
3. How to take Carvedilol Tablets
4. Possible side effects
5. How to store Carvedilol Tablets
6. Contents of the pack and further information
1. WHAT CARVEDILOL TABLETS ARE AND WHAT THEY ARE USED FOR
Carvedilol is a type of medicine called a beta blocker and
vasodilator.
Carvedilol Tablets are used for the treatment of angina (pains in the
chest caused by blockages in the arteries
leading to the heart) and mild to moderate heart failure (when the
heart cannot pump blood properly to the
rest of the body). Carvedilol is also used to treat hypertension (high
blood pressure).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARVEDILOL TABLETS
DO NOT TAKE CARVEDILOL TABLETS IF YOU:
• are ALLERGIC (HYPERSENSITIVE) to CARVEDILOL, other BETA BLOCKERS
or any of the other ingredients in the
tablets (these are listed in Section 6, Further Information)
• have a history of WHEEZING due to ASTHMA or other LUNG DISEASES
• have SEVERE FLUID RETENTION (swelling of your hands, ankles and
feet) which is being treated by medicines
given into your veins (intravenously)
• have very SEVERE HEART FAILURE and are breathless even when
sitting
• have LIVER disease
• suffer from a condition called PHAEOCHROMOCYTOMA (high blood
pressure due to a tumour near the kidney)
unless this

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carvedilol 3.125 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 3.125 mg of carvedilol.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Light peach, round flat tablet. Scored on one side, debossed on the
other side
with “CVL” on top and “T1” on bottom. The score line is only
to facilitate
breaking for ease of swallowing and not to divide into equal doses.
4
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
_CHRONIC HEART FAILURE_
Carvedilol is adjunctive therapy for the treatment of moderate to
severe stable chronic
heart failure.
_HYPERTENSION _
Carvedilol is indicated for the treatment of hypertension.
_ANGINA _
Carvedilol is indicated for the prophylactic treatment of stable
angina
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be taken with fluid.
_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.
_Adults _
The recommended dose for initiation of therapy is 12.5 mg once a day
for the first
two days. Thereafter the recommended dosage is 25 mg once a day.
Although this is
an adequate dose in most patients, if necessary the dose may be
titrated up to a
recommended daily maximum dose of 50 mg given once a day or in divided
doses.
Dose titration should occur at intervals of at least two weeks.
_ _
_Elderly _
An initial dose of 12.5 mg daily is recommended. This has provided
satisfactory
control in some cases. If the response is inadequate the dose may be
titrated up to the
recommended daily maximum dose of 50 mg given once a day or in divided
doses.
_ _
_Paediatric population_
Safety and efficacy in children (under 18 years) has not been
established.
_ANGINA_
A twice-daily regimen is recommended.
_ _
_Adults_
The recommended dose for initiation of therapy is 12.5 mg twice a day
for the first
two days. Thereafter, the recommend