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CARVEDILOL 25 MG FILM-COATED TABLETS

Active substance(s): CARVEDILOL

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Package leaflet: information for the user

Carvedilol 3.125 mg film-coated tablets
Carvedilol 6.25 mg film-coated tablets
Carvedilol 12.5 mg film-coated tablets
Carvedilol 25 mg film-coated tablets
Carvedilol
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 Carvedilol is and what it is
used for
2. What you need to know before you
take Carvedilol
3. How to take Carvedilol
4. Possible side effects
5. How to store Carvedilol
6. Contents of the pack and other
information
1. What Carvedilol is and what it is
used for
Carvedilol belongs to a group of
medicines called beta-blockers that work
by relaxing and widening the blood
vessels. This makes it easier for your
heart to pump blood around the body
and reduces blood pressure and strain
on your heart.

















Carvedilol is used: • for the treatment of high blood
pressure (hypertension),
• for the treatment of chest pain that
occurs when the arteries that supply
your heart with blood carrying
oxygen are narrowed which results in
less oxygen reaching your heart
muscles (angina),
• for the treatment of weakening of the
heart muscle (heart failure), in
combination with other medicines.
2. What you need to know before you
take Carvedilol
DO NOT TAKE Carvedilol:
• if you are allergic to carvedilol or
any of the other ingredients of this
medicine (listed in section 6).
• if you have a history of wheezing due
to asthma or other lung diseases,
• if you have been told you have very
severe heart failure and you have
fluid retention (swelling) which is
being treated with injections of
medicines into your
veins
(intravenously),
• if you have liver
disease,
• if you have been
told that you have a
very slow
heartbeat,
• if you have very
low blood pressure,
• if you have been told you have a
condition called Prinzmetal's angina,
• if you have phaeochromocytoma (a
tumour of the adrenal gland causing
high blood pressure) which is not
being treated,
• if you are suffering from serious
disturbances in the body’s acid-base
balance (metabolic acidosis),
• if you have very poor blood circulation
in the hands and feet resulting in
coldness and pain in them,
• if you have a particular conduction
defect of the heart (called an AV
heart block Grade II or III (unless a
pacemaker is fitted) or a SA block),
• if you are currently being treated with
injections of verapamil or diltiazem
(used in the treatment of high blood
pressure or heart problems),



nitrate medicines for angina (e.g.
isosorbide mononitrate or glyceryl
trinitrate),
medicines used to treat heart failure
(e.g. Digoxin),
any other medicine used to treat high
blood pressure (e.g. doxazosin,
reserpine, amlodipine or indoramin),
medicines used to treat depression
or other mental health conditions
(e.g. fluoxetine, tricyclic
antidepressants, barbiturates,
phenothiazines, haloperidol or
monoamine oxide inhibitors (MAOIs),
medicines used to prevent your body
rejecting organs after transplant
operations (e.g. ciclosporin),
medicines to reduce blood sugar
such as oral antidiabetic medicines
or insulin,
medicines used to reduce blood
pressure or to treat migraine (e.g.
clonidine or ergotamine),
certain painkilling agents such as
non-steroidal anti-inflammatory
medicines (NSAIDs) (e.g. ibuprofen
or diclofenac),
medicines used for hormone
replacement therapy (e.g.
estrogens),
corticosteroids used to suppress
inflammatory or allergic reactions
(e.g. prednisolone),
medicines used to treat bacterial
infections (e.g. rifampicin or
erythromycin),
medicines used to treat stomach
ulcers, heartburn and acid reflux (e.g.
cimetidine),
medicines used to treat fungal
infections (e.g. ketoconazole),
medicines sometimes used in
decongestant cough and cold
remedies (e.g. ephedrine or
pseudoephedrine),

If you need to have an anaesthetic for an
operation, tell your hospital doctor you
are taking Carvedilol.
Carvedilol with food, drink and
alcohol
You should take Carvedilol with water.
If you are taking Carvedilol to treat heart
failure, you should take this medicine
with water at your mealtime (see section
3 ‘How to take Carvedilol)
Do not drink alcohol whilst taking
Carvedilol as it might worsen the effects
of alcohol.
Pregnancy, breast-feeding and
fertility
If you are pregnant or breast-feeding, do
not take this medicine until you have
talked to your doctor. Consult your
doctor immediately if you become
pregnant while taking this medicine.
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
this medicine.
Driving and using machines
You may experience dizziness or
tiredness whilst taking Carvedilol. This is
more likely to occur when you first begin
treatment, or when the dose is
increased. If this occurs, you should not
drive or operate machinery. You should
avoid drinking alcohol, as it may make
these symptoms worse. If you are
concerned or want more information,
you should talk to your doctor.
Carvedilol contains lactose and
sucrose (types of sugar). If you have
been told by your doctor that you have
an intolerance to some sugars, contact
your doctor before taking this medicine.
3. How to take Carvedilol
Always take this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are not
sure.

If any of these apply to you, do not take
Carvedilol.

Carvedilol should be swallowed with a
drink of water.

Warnings and precautions
Talk to your doctor or pharmacist before
taking Carvedilol:
• have been told you suffer from any
other heart problems,
• have or have ever had any problems
with your liver, kidneys or thyroid,
• have diabetes. Carvedilol may hide
your usual symptoms of low blood
sugar,
• have a skin condition known as
psoriasis,
• have poor circulation affecting hands,
feet or lower legs, or Raynaud's
phenomenon,
• have or have ever had a serious
allergic reaction or you are
undergoing allergic desensitisation
therapy for any type of severe
allergy,
• wear contact lenses because
carvedilol may cause the eyes to be
drier than normal.

High blood pressure
Adults: The usual starting dose is
12.5 mg once a day for the first two
days. After this, the dose is increased to
25 mg once a day. If necessary, your
doctor may gradually increase the dose
further at intervals of two weeks or more.
The maximum recommended daily dose
is 50 mg (the maximum recommended
single dose is 25 mg).

The administration of carvedilol:
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines, including
medicines obtained without a
prescription or herbal medicines. Take
particular care and tell your doctor or
pharmacist, if you are taking any of the
following medicines:
• medicines used to treat an irregular
heartbeat (e.g. diltiazem, verapamil
or amiodarone),

Black

Angina
Adults: The usual starting dose is
12.5 mg twice a day for the first two
days. After this, the dose is increased to
25 mg twice a day. If necessary, your
doctor may gradually increase the dose
further at intervals of two weeks or more
to a maximum of 100 mg a day in two
doses.
Elderly: The recommended starting dose
is 12.5 mg twice a day for two days.
After this, the dose may be increased to
25 mg twice a day, which is the
recommended maximum daily dose.
Heart failure
Adults and elderly: For the treatment of
stable heart failure, the tablets should be
taken twice a day, in the morning and in
the evening, and should be taken with
food in order to reduce the risk of side
effects.
The starting dose is 3.125 mg twice a
day for two weeks. Your doctor will

P15xxxxx

Other medicines and Carvedilol
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.

Elderly: Your doctor will usually start you
on 12.5 mg once a day and continue
with this dose for the length of your
treatment. If necessary, your doctor may
increase your dose gradually at intervals
of two weeks or more.

then gradually increase the strength of
tablets you take at intervals of two weeks
or more until you receive the dose that
suits you best.




If you weigh less than 85 kg, the
maximum recommended dose of
Carvedilol is 25 mg twice a day, if you
weigh more than 85 kg, your doctor may
increase your dose to 50 mg twice a day.



If you have stopped taking Carvedilol for
more than two weeks, you will need to
return to the starting dose and increase
the dose gradually again.
Sometimes, your heart failure may
worsen while taking Carvedilol,
particularly at the start of your treatment.
This may result in increased symptoms
(e.g. tiredness, shortness of breath) and
signs of fluid retention (e.g. weight gain
and swelling of the legs).
If your symptoms or condition worsen
whilst taking Carvedilol you should tell
your doctor, as he or she may need to
change the dose of your other
medications or of Carvedilol.
While taking Carvedilol, make sure that
you continue with your other treatments
for heart failure as advised by your
doctor.
Patients with liver problems
Depending on your condition, your
doctor may reduce your dose compared
to those recommended above.
Children and adolescents (under 18
years old)
Carvedilol are not recommended in this
age group.
If you take more Carvedilol than you
should
If you accidentally take too many tablets,
contact your doctor immediately or go to
the nearest hospital casualty
department. You may feel dizzy, sick,
faint, breathless/wheezy, very drowsy, or
experience convulsions.
If you forget to take Carvedilol
If you forget to take a dose, do not worry.
Take another as soon as you remember,
provided it is not nearly time for your
next dose. Take your next tablet at the
normal time, but do not take a double
dose to make up for a forgotten tablet.
If you stop taking Carvedilol
Do not suddenly stop taking Carvedilol
before you have spoken to your doctor
about it. You may have side effects if
you suddenly stop the tablets. Your
doctor will tell you how to reduce the
dosage gradually and then stop this
medicine. If you are also taking a
medicine called clonidine, never stop
either treatment unless told to by your
doctor.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.
4. Possible side
effects
Like all medicines, this
medicine can cause
side effects, although
not everybody gets
them.
The frequency of
possible side effects is
shown in the table
below:
The majority of side effects are doserelated and disappear when the dose is
reduced or the treatment discontinued.
Some side effects can occur at the
beginning of treatment and resolve
spontaneously as the treatment
continues.
Very common may affect more than
1 in 10 people:
• Dizziness
• Headache
• Tiredness
• Low blood pressure
• Heart failure
Common may affect up to 1 in 10
people:
• Bronchitis, pneumonia, upper
respiratory tract infection
• Infections of the urinary tract
• Low numbers of red blood cells
• Increase in weight
• Elevated cholesterol levels
• Loss of control of blood sugar in
people with diabetes
• Depression, depressed mood
• Visual disturbance
• Reduced lacrimation, eye irritation
• Slow heart rate
• Oedema (swelling of the body or
parts of the body), fluid overload,
increased volume of blood in the
body
• Dizziness when standing up quickly
• Problems with blood circulation
(signs include cold hands and feet),
hardening of the arteries
(atherosclerosis) worsening of
symptoms in patients with Raynaud’s
disease (fingers or toes turn first
bluish, then whitish, and then reddish
together with pain) or claudication
(pain in the legs which worsens when
walking)
• Asthma and breathing problems
• Fluid accumulation in the lungs
• Diarrhoea
• Malaise, vomiting, stomach pains,
indigestion
• Pains (e.g. in the arms and legs)
• Acute renal insufficiency and
disturbances in renal function in
patients with hardening of the
arteries and/or impaired renal
function
• Difficulty in passing urine
Uncommon may affect up to 1 in 100
people:
• Sleep disturbance
• Confusion
• Fainting




Rare may affect up to 1 in 1,000
people:
• Lowered blood platelet count
(thrombocytopenia)
• Mouth dryness (dryness of the
mouth)
• Stuffy nose
Very rare may affect up to 1 in 10,000
people:
• Low numbers of white blood cells
• Allergic reactions
• Changes in the liver function test
• Involuntary leakage of urine in
women (urinary incontinence).
·
skin rash, which may blister, and
looks like small targets (central dark
spots surrounded by a paler area,
with a dark ring around the edge erythema multiforme)
·
a widespread rash with blisters and
peeling skin, particularly around the
mouth, nose, eyes and genitals
(Stevens-Johnson syndrome)
·
a more severe form, causing
extensive peeling of the skin (more
than 30% of the body surface - toxic
epidermal necrolysis)
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet.
Also you can help to make sure that
medicines remain as safe as possible by
reporting any unwanted side effects via
the internet at
www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m.
to 2 p.m. Mondays to Fridays) or fill in a
paper form available from your local
pharmacy.
5. How to store Carvedilol
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the label after
EXP. The expiry date refers to the last
day of that month.
Do not store above 30°C.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment.
6. Contents of the pack and other
information
What Carvedilol contains
- The active substance is carvedilol.
Each tablet contains 3.125 mg,
6.25 mg, 12.5 mg or 25 mg
carvedilol.
- The other ingredients are: lactose
monohydrate, silica colloidal
anhydrous, crospovidone (Type A),
crospovidone (Type B), povidone 30,
sucrose, magnesium stearate
Tablet coating: macrogol 400,
polysorbate 80, titanium Dioxide (E
171), hypromellose
What Carvedilol looks like and
contents of the pack
Film-coated tablet
Carvedilol 3.125 mg film-coated tablets
Film-coated tablets white to off-white,
oval, engraved with "E" on one side and
"01" on the other.
Carvedilol 6.25 mg film-coated tablets
Film-coated tablets white to off-white,
oval, engraved with "F57" on one side
and scored on the other side. The tablet
can be divided into equal doses.
Carvedilol 12.5 mg film-coated tablets
Film-coated tablets white to off-white,
oval, engraved with "F58" on one side
and scored on the other side. The tablet
can be divided into equal doses.
Carvedilol 25 mg film-coated tablets
Film-coated tablets white to off-white,
oval, engraved with "F59" on one side
and scored on the other side. The tablet
can be divided into equal doses.
Blister:
Package sizes: 5, 7, 10, 14, 15, 20, 28,
30, 40, 50, 56, 60, 90, 98, 100, 120, 150,
200, 250, 300, 400, 500 and 1000 filmcoated tablets.
HDPE bottle
Package sizes: 30, 50, 60, 100, 250, 500
and 1000 film-coated tablets
It is possible that not all presentations
are marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This leaflet was last revised in
05/2017.

P15xxxxx

For the treatment of heart failure, it is
recommended that your treatment with
Carvedilol is started and carefully
monito.red by a hospital specialist.

Abnormal sensation
Disturbances in the heart’s
conduction system, angina pectoris
(including chest pain)
Certain skin reactions (e.g. allergic
dermatitis, hives, itching and skin
inflammation, increased sweating,
psoriatic or lichen planus like skin
lesions)
Hair loss
Impotence

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