CARVEDILOL 3.125MG TABLETS

Active substance: CARVEDILOL

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Package Leaflet: Information for the user

Carvedilol 3.125 mg, 6.25 mg, 12.5 mg & 25 mg Tablets
(Carvedilol)

Read all of this leaflet carefully before you start taking
this medicine.
• 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. Do not

pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice

any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

In this leaflet:
W
1  hat Carvedilol is and what it is used for
B
2  efore you take Carvedilol
H
3  ow to take Carvedilol
4  ossible side effects
P
5  ow to store Carvedilol
H
6 Further information
1  HAT CARVEDILOL IS AND WHAT IT IS USED
W
FOR
The name of your drug is Carvedilol 3.125 mg or 6.25 mg or
12.5 mg or 25 mg Tablets. Carvedilol Tablets contain the active
ingredient Carvedilol. Carvedilol is one of a group of medicines
which act as a beta blocker and it dilates blood vessels
(vasodilator).
Carvedilol is used for the treatment of angina and mild,
moderate or severe heart failure. Carvedilol is also used to treat
high blood pressure. Tablets of higher strengths are required
when Carvedilol is used to treat high blood pressure or angina.

B
2  EFORE YOU TAKE CARVEDILOL
Do not take Carvedilol if

• you are allergic (hypersensitive) to carvedilol or any of the

other ingredients of Carvedilol (listed in Section 6)
• you have a history of wheezing due to asthmatic or other

lung diseases.
• you have severe fluid retention (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 heart beat).
• you have very low blood pressure.

• you have a problem with the acid levels in your blood

(‘metabolic acidosis’).
• you have a growth on one of your adrenal glands

(‘phaeochromocytoma’)
Do not take Carvedilol if any of the above applies to you. If you
are not sure consult your doctor or pharmacist first.

Take special care with Carvedilol if

• you have problems with your kidneys.

• you have diabetes (high blood sugar).

• you wear contact lenses.

• you have ever had problems with your thyroid

• you have ever had a serious allergic reaction (for example,

sudden swelling, causing difficulty breathing or swallowing,
swelling of the hands, feet and ankles or a severe rash).
• you have an allergy and are having treatment to desensitise

you.
• you have problems with blood circulation in your fingers and

toes (‘Raynaud’s phenomenon’).
• you have had a skin disorder called ‘psoriasis’, after taking

beta-blocker medicines.
• you have a type of angina called ‘Prinzmetal’s variant angina’.

• Monoamine oxidase inhibitors (MAOIs) such as isocarboxide

and phenelzine (used to treat depression)
• Medicines for diabetes, such as insulin or metformin.

Carvedilol may lower your blood sugar amounts. Check your
blood sugar amounts closely while taking Carvedilol.
• Clonidine (used to treat high blood pressure, migraine,

flushing in the menopause).
• Rifampicin (used to treat infections)

• Cimetidine (used to treat indigestion, heartburn and

stomach ulcers).
• Cyclosporin (used after an organ transplant).


Operations

If you are going to have an operation, tell the doctor that you
are taking Carvedilol. This is because some anaesthetics can
lower your blood pressure, and it may become too low.

Pregnancy and breast-feeding

Do not take Carvedilol if you are pregnant, trying to get
pregnant or breast-feeding, unless your doctor has told you to.

Driving and using machines

You may feel dizzy while taking Carvedilol. This is more likely
when you start treatment or if your treatment is changed, and
when you drink alcohol. If this happens to you, do not drive or
use any tools or machines.
Talk to your doctor if you notice any other problems that might
affect driving, using tools or machines while you are taking
Carvedilol.

Important information about some of the
ingredients of Carvedilol

This medicinal product contains lactose. If you have been
told by your doctor that you have intolerance to some sugars,
contact your doctor before taking this medicinal product.

3  OW TO TAKE CARVEDILOL
H
It is important to take your medicine as your doctor has told
you to. The pharmacist’s label will tell you how many tablets
to take.
Carvedilol is not suitable for children under the age of 18 year.
Swallow each tablet with a drink.

Chronic heart failure:

When used for heart failure, treatment with Carvedilol should
be started by a specialist doctor.
• You should take your tablets at the same time as eating some

food.
• The usual starting dose is one 3.125 mg tablet twice a day for

two weeks.
• Your doctor will then increase the dose slowly, over several

weeks, up to 25 mg twice a day.
• If you weigh more than 85 kg (187 lb) the dose may be

increased up to 50 mg twice a day.
• If you have stopped taking Carvedilol for more than two

weeks you should talk to your doctor. They will need you to
go back to the starting dose again (see section ‘If you stop
taking Carvedilol’).

High blood pressure:

• The usual starting dose is 12.5 mg once a day for two days.

• After two days the dose is usually 25 mg, once a day.

• If your blood pressure is not under control, your doctor may

increase your dose slowly, over several weeks up to 50 mg
a day.
• If you are elderly, you may not need any more than 12.5 mg a

day to control your blood pressure.

Angina:

Adults
• The usual starting dose is 12.5 mg twice a day for two days.

• After two days the dose is usually 25 mg, twice a day.


Elderly

If any of the above apply to you, or if you are not sure, talk to
your doctor or pharmacist before you take Carvedilol.

• Your doctor will decide both your starting dose and the best

dose for you to take in the longer term.
• The usual maximum dose is 50 mg each day, taken in smaller

amounts (divided doses).

Taking other medicines

If you take more Carvedilol than you should

Please tell your doctor if you are taking or have recently taken
any other medicines. This includes medicines that you buy
without a prescription and herbal medicines. This is because
Carvedilol can affect the way some medicines work. Also some
other medicines can affect the way Carvedilol works.
In particular, tell your doctor or pharmacist if you are taking
any of the following medicines:
• Other medicines for your heart or blood pressure, including

diuretics (water tablets), calcium channel blockers (e.g.
diltiazem or verapamil), and digoxin
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AAAG8254

• If you take too many tablets (overdose) or someone else

takes your Carvedilol tablets, you may feel dizzy, light
headed, breathless, wheezy or extremely tired.
• Contact your nearest hospital casualty department or tell

your doctor immediately. Take the medicine pack with you.

If you forget to take your medicine

• If you forget to take a dose, take it as soon as you remember.

However, if it is nearly time for the next dose, skip the missed
dose.
Continued over page

• Do not take a double dose to make up for a forgotten dose.If

you are worried, ask your doctor or pharmacist for advice.

• Problems with your sight.

• Being unable to get an erection (erectile dysfunction).


If you stop taking Carvedilol

Rare (affect less than 1 in 1,000 people):
• Low numbers of platelets in your blood. The signs include

bruising easily and nose bleeds.
• Low numbers of all types of white blood cells. The signs
include infections of the mouth, gums, throat.
• Changes in your blood shown up by a blood test.
• A stuffy nose, wheezing and flu-like symptoms.

• A dry mouth.

• Sore eyes.

• Changes to how often you pass urine.


Do not stop taking your tablets, even if you are feeling well,
unless your doctor tells you. They may want you to stop taking
Carvedilol slowly over 1 to 2 weeks.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

P
4  OSSIBLE SIDE EFFECTS
Like all medicines, Carvedilol can cause side effects, although
not everybody gets them. The possible side effects and how
likely you are to get them, will depend on the reason you are
being treated with Carvedilol.
If you think you may have any of the following side
effects contact your doctor or go to your nearest hospital
emergency room immediately:
Allergic reactions signs may include difficulty breathing or
swallowing caused by sudden swelling of the throat, or face or
swelling of your hands, feet and ankles.
Breathing problems signs may include wheezing, shortness of
breath and chest tightness.
Low numbers of all types of white blood cells signs may
include infections of the mouth, gums, throat and lungs.

Possible side effects when used to treat chronic
heart failure

Very common (affect more than 1 in 10 people):
• Feeling dizzy.

• Headache (this is usually mild and happens at the start of

your treatment).
• Feeling weak and tired.

Common (affect less than 1 in 10 people):
• Increase in weight.

• Increase in cholesterol levels (shown by a blood test).

• Loss of control of blood sugar in people with diabetes.

• A slow heart beat.

• Low blood pressure. The signs include feeling dizzy or light
headed, in particular after you stand up.
• Fluid retention. The signs include: overall swelling of your

body, swelling of parts of your body for example your hands,
feet, ankles and legs and an increase in how much blood you
have in your body.
• Feeling sick or being sick.

• Diarrhoea.

• Problems with your sight

Uncommon (affect less than 1 in 100 people)
• Fainting.

• Problems with your heart when increasing the dose of

Carvedilol.
Rare (affect less than 1 in 1,000 people):
• Low numbers of platelets in your blood. The signs include

bruising easily and nose bleeds.
• Kidney problems. The signs include feeling tired, bruising

easily and passing water (urinating) less often.
Other side effects that can happen when you take Carvedilol
for chronic heart failure include:
• Increased sweating and a skin rash.

• Some women may have difficulty with bladder control when

they pass water (urinary incontinence).This normally will get
better when treatment is stopped.
If any of the side effects become serious or troublesome, or if
you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

Possible side effects when used to treat high blood
pressure or angina
Common (affect less than 1 in 10 people):
• Feeling dizzy, tired and having a headache (usually these

effects are mild and happen at the start of your treatment).
• A slow heart beat and feeling dizzy or light-headed after

standing up. (These effects are more common at the start of
your treatment).
• Stomach upset. The signs include feeling sick, stomach ache

and diarrhoea.
• Pain in your hands and feet.

• A feeling of dryness in your eye because fewer tears are

made.

Uncommon (affect less than 1 in 100 people)
• Feeling depressed.

• Disturbed sleep.

• Tingling or numbness of your hands or feet.

• Feeling weak and tired.

• Fainting.
• Low blood pressure. The signs include feeling dizzy or light
headed.
• Problems with blood circulation in your arms and legs. The

signs include cold hands and feet, whiteness, tingling and
pain in your fingers and a pain in your leg which gets worse
when you walk.
• Problems with your heart. The signs include chest pains,

tiredness, shortness of breath and swelling of your arms and
legs.
• Constipation.

• Being sick.

• Increased sweating.

• Problems with your skin, including skin rashes which may

cover a lot of your body, a lumpy rash (hives), feeling itchy
and dry skin patches.
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Other possible side effects that can happen when you take
Carvedilol for high blood pressure and angina include:
• Difficulty controlling your blood sugar if you have diabetes.

• Developing the signs of diabetes in people who have a very

mild form of diabetes called ‘latent diabetes’.
• Some women may have difficulty with bladder control when

they pass water (urinary incontinence). This normally will get
better when treatment is stopped

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet.
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

H
5  OW TO STORE CARVEDILOL
• Keep out of the sight and reach of children.

• Do not use Carvedilol after the expiry date which is stated on

the carton after “Exp”. The expiry date refers to the last day of
that month.
• Store in the original package in order to protect from

moisture.
• Carvedilol tablets do not require any special storage

conditions.
• Do not throw away any leftover tablets. Instead, return any

leftover tablets to the pharmacist so that they can dispose of
them properly. Only keep them if your doctor tells you to.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
protect the environment.

F
6  URTHER INFORMATION
What Carvedilol contains

• The active substance is Carvedilol

• The other ingredients are Lactose monohydrate,

Microcrystalline cellulose (Avicel PH 102), Low-Substituted
hydroxypropyl cellulose (E463), Maize starch, Yellow iron
oxide (E172), Colloidal anhydrous silica, Purified talc,
Magnesium stearate (E572)
This leaflet does not contain the complete information on
Carvedilol. If you have any questions, or are not sure about
anything, ask your doctor or pharmacist.
Remember: This medicine is for you. Only a doctor can
prescribe it for you. Never give it to someone else. It may harm
them even if their symptoms are the same as yours.
What Carvedilol looks like and contents of the pack
Carvedilol 3.125 mg tablets are cream coloured, circular,
biconvex tablets, marked ‘C3’ on one face and plain on the
reverse face.
Carvedilol 6.25 mg tablets are cream coloured, circular,
biconvex tablets, marked ‘C6’ on one face and plain on the
reverse face.
Carvedilol 12.5 mg tablets are cream coloured, circular,
biconvex tablets, marked ‘C12’ on one face and plain on the
reverse face.
Carvedilol 25 mg tablets are cream coloured, circular, biconvex
tablets, marked ‘C25’ on one face and plain on the reverse face.
Carvedilol 3.125 mg and 6.25 mg tablets are available in packs
of 28 and 56 tablets.
Carvedilol 12.5 mg and 25 mg tablets are available in packs of
14, 28, 30, 56 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher,
Surrey, KT10 9NW, United Kingdom.

Manufacturer:

Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London,
W2 6BY, United Kingdom.

Distributed by :

Actavis, Barnstaple, EX32 8NS , UK
This leaflet was last revised in August 2014

Actavis, Barnstaple, EX32 8NS, UK

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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