CARVEDILOL 12.5 MG TABLETS

Active substance: CARVEDILOL

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PATIENT INFORMATION LEAFLET

Please 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 further questions, please ask your doctor or pharmacist
This medicine has been prescribed for you personally and you should not pass it on to other people. It may
harm them even if their symptoms are the same as yours
If any of the side effects become serious or you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist
In this leaflet:
1
2
3

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4
5

What Carvedilol is and what it is used for
Before you take Carvedilol
How to take Carvedilol

What Carvedilol is and what it
is used for

Possible side effects
How to store Carvedilol
Further information

Taking other medicines
Please inform your doctor or pharmacist if you are
taking, or have recently taken any other medicines,
including medicines obtained without a prescription.

Carvedilol belongs to a group of medicines called Beta- Medicines which may interact with Carvedilol:
Blockers. These work by blocking the transmission of
Medicines used to treat heart problems and high
certain nerve impulses. Carvedilol works by dilating
blood pressure e.g. Verapamil, Diltiazem, (during
blood vessels and decreasing heart rate.
treatment with Carvedilol, Verapamil and Diltiazem
must not be injected into a vein), Amlodipine,
Carvedilol is used to treat the following:
Felodipine, Lacidipine, Nifedipine, Nicardipine,
High blood pressure (Hypertension)
Nimodipine, Nitrendipine (Calcium Channel Blockers)
Chronic stable Angina Pectoris (a condition marked
Clonidine for high blood pressure or migrane.
by chest pain)
If combined treatment with Carvedilol and Clonidine
Moderate to severe heart failure
is to be stopped, you should stop taking Carvedilol
several days before gradually decreasing the dose
of Clonidine
Before you take Carvedilol
Other medicines used to treat heart problems and
high blood pressure e.g. Reserpine, Guanethidine,
Methyldopa, Guanfacin
Do not take Carvedilol if:
Medicines used to treat high blood pressure and/or
You are allergic (hypersensitive) to Carvedilol or any
increased prostate e.g. Prazosine, Terazosine,
other Beta Blocker or any of the other ingredients in
Doxazosine, Alfuzosine, Urapidil, Tamsulosine
the tablets (these are listed in Section 6, Further
Medicines used to treat heart rhythm disorders e.g.
information)
Amiodarone, Quinidine, Hydroquinidine, Cibenzoline,
You suffer from unstable/decompensated
Flecainide, Disopyramide, Lidocaine, Mexiletine,
heart failure
Propafenone
You have difficulty in breathing or wheezing
Digoxin for heart failure or irregular heart beat
(Bronchospasm or Asthma)
Medicines used to treat epileptic attacks or sleep
You suffer from liver problems
disturbances e.g. Phenobarbitone (Barbiturates)
You have an irregular heart beat, unless you have a
Medicines used to treat mood disorders e.g.
pacemaker (Second or Third Degree Heart Block)
Chlorpromazine (Phenothiazines), Haloperidol (AntiYou have a very slow heart beat
Psychotics)
You are in shock caused by heart problems
Medicines used to treat depression e.g.
(Cardiogenic Shock)
Amitriptyline, Imipramine (Tricyclic Antidepressants)
You have an abnormal heart rhythm (Sick Sinus
Other medicines used to treat depression e.g.
Syndrome)
Trancypramine, Moclobemide (Monoamine-Oxidase
You have very low blood pressure
Inhibitors), Fluoxetine (Selective Serotonin
You have an untreated growth in the adrenal glands
Reuptake Inhibitor (SSRI)
You have excessive acid in the blood (Metabolic
Medicines which dilate the blood vessels e.g.
Acidosis)
Nitroglycerin (Vasodilators)
You suffer from very poor circulation (Raynaud´s
Medicines used to treat chest pain (Angina) e.g.
Phenomenon, Claudication Intermittens)
Nitrates
Medicines used to treat diabetes e.g. Insulin (Anti
Take special care with Carvedilol - Tell your doctor
Diabetics)
if any of the following apply to you:
Medicines used to treat pain and inflammation e.g.
If you are due to have a surgical procedure. You
Ketoprofen, Aspirin
should make sure that the anaesthetist is aware you
Medicines used to treat migraine and low blood
are taking Carvedilol
pressure e.g. Ergotamine, Dihydroergotamine
If you suffer from severe heart failure
(Ergot Alkaloids)
If you suffer from salt or fluid deficiency
Medicines used to prevent transplant rejection e.g.
If you are elderly as you may be more susceptible
Cyclosporin (Immunosuppressants)
to the effects of Carvedilol
Female hormones e.g. Oestrogen
If you have low blood pressure before treatment
Medicines used to reduce inflammation e.g.
If you are being treated for heart failure and suffer
Prednisolone, Methylprednisolone, Dexamethasone
from low blood pressure, reduced blood supply to
(Corticosteroids)
the heart, general hardening and narrowing of the
Medicines used to treat severe and acute allergic
arteries, kidney problems
reactions e.g. Epinephrine (Adrenaline)
If you suffer from Diabetes. Carvedilol may mask
(Sympathomimetics)
signs of low blood sugar level (Hypoglycaemia)
Medicines used to treat tuberculosis e.g. Rifampicin
If you suffer from a mild respiratory disorder with
(Antibiotics)
narrowed airways, not requiring medical treatment
Medicines used to treat stomach ulcers e.g.
If you have an overactive thyroid gland
Cimetidine (H2-antagonists)
(Thyrotoxicosis). Carvedilol may mask signs of
Medicines used to treat fungal infection e.g.
hyperactivity such as trembling or fast pulse rate
Ketoconazole (Antifungals)
If you have a mild heart stimulus disorder, known as
Medicines used to treat bacterial infections e.g.
1st degree AV-block
Erythromycin (Antibiotics)
If you have or have had Psoriasis as Carvedilol may
Medicines used to induce muscle relaxtion e.g.
aggravate this condition
Suxamethonium (Neuromuscular Blockers)
If you wear contact lenses. Carvedilol can cause dry
Medicines used to treat certain muscular disorders
eyes
e.g. Ibuprofen (Non-Steroidal Anti-Inflammatory
If you have an enzyme deficiency
Drugs - NSAIDs)
If you have a history of serious allergic reactions
and if you are undergoing desensitisation treatment Taking Carvedilol with food and drink
Carvedilol should be taken with a glass of water
If you have problems with your blood vessels
Carvedilol can be taken with or without meals,
(Peripheral vascular disease)
however if you are taking this medicine for heart
If you have poor blood circulation which makes the
failure you should preferably take the tablets with
toes and fingers numb and pale (Raynaud's
meals to allow slower absorption
phenomenon)
During treatment with Carvedilol, it is advisable not
If your doctor thinks you may have a tumour of the
to drink alcohol
adrenal glands (Pheochromocytoma)
If you have severe chest pain, even whilst resting
Pregnancy and Breastfeeding
(Prinzmetal's variant angina)
If you are pregnant, thinking of becoming pregnant or
suspect you are pregnant, Carvedilol should not be
Only take Carvedilol under the following conditions if
taken, unless you are told to do so by your doctor.
your doctor indicates that this medicine is absolutely
If you are breast-feeding, Carvedilol should not be
necessary:
taken.
Blood pressure that repeatedly fluctuates abruptly
High blood pressure caused by another disease
Ask your doctor for advice before taking any medicine.
A fall in blood pressure when you stand up
Driving or using machinery
Acute heart inflammation
Carvedilol may make you feel tired or dizzy. This is
Narrowed heart valves or heart outflow tract,
more likely to happen at the start of treatment after a
influencing the hearts blood output
dose increase or if you drink alcohol. If this happens
If any of the above apply to you or you are not sure do not drive or operate machinery.
you should seek advice from a doctor or
Important information about some of the
pharmacist.
ingredients of Carvedilol
Carvedilol contains Lactose. If you have been told by
your doctor that you have intolerance to some sugars,
contact your doctor before taking this medicine.

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Last modified: 05/08/2010

Size:

165 x 420mm

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Reason for changes :
Tillomed Laboratories Ltd, 3 Howard Road Eaton Socon, St Neots, Cambs PE19 8ET, UK

3

Always take Carvedilol exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
Take the tablets with a glass of water with or
without meals
If you take Carvedilol for heart failure you should
preferably take the tablets with meals to allow
slower absorption
High Blood Pressure
Adults
Starting dose: 12.5mg once daily for the first 2
days.
Treatment is then continued with 25mg once daily.
Maximum dose: 25mg twice daily.
Elderly
Starting dose: 12.5mg once daily.
This dose may be gradually increased at intervals
of 2 or more weeks
Maximum dose: 25mg twice daily.
Angina
Starting dose: 12.5mg twice daily for the first 2
days.
Treatment is then continued with 25mg twice daily.
Maximum dose: 50mg twice daily.
Heart Failure
Starting dose: 3.125mg twice daily.
Depending on your response to the treatment, this
dose may be gradually increased after two or more
weeks to: 6.25mg twice daily, then to 12.5mg twice
daily followed by 25mg twice daily.
Maximum dose for patients weighing less than
85kg: 25mg twice daily.
Maximum dose for patients weighing more than
85kg: 50mg twice daily provided that the heart
failure is not severe. Your doctor will monitor you
closely after starting the treatment or increasing the
dose.
Patients with liver problems (not severe)
The dose is determined by the doctor, who adjusts it
individually for you
Patients with kidney problems
The dose is determined by the doctor, who adjusts it
individually for you
Children
Carvedilol should not be used for children under 18
years of age
Do not change your dose unless your doctor tells you
to do so.
If you have taken more Carvedilol than you should:
If you accidentally take too many tablets, contact your
doctor or nearest emergency department immediately
for advice. Remember to take this leaflet or any
remaining tablets with you.
The symptoms of overdose are: severe low blood
pressure, heart problems, breathing difficulty, being
sick, feeling light headed and fits
If you forget to take Carvedilol:
Take it as soon as you remember, unless it is nearly
time for your next dose. Do not take a double dose to
make up for a forgotten tablet.
If you stop taking Carvedilol:
It is important that you keep on taking Carvedilol until
the prescribed dose has finished. Treatment with
Carvedilol should generally not be discontinued
suddenly. Usually your doctor will reduce the dose
gradually within two weeks or replace Carvedilol with
another medicine. Do not stop or change your
treatment before talking to your doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

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Swelling and/or fluid retention around the body
(Oedema) and an increase in the amount of blood
in your body (Hypervolaemia)
Fall in blood pressure when getting up quickly*
(Orthostatic Hypotension)
Problems with the blood circulation in the arms or
legs, which can cause cold hands and feet and
pain or cramping in the lower leg or numb and pale
fingers and toes may become worse
Breathing problems
Feeling or being sick
Diarrhoea
Pain, possibly in the hands and feet
Kidney problems, including changes to how often
you pass urine
Stomach pain or indigestion

How to take Carvedilol

Possible side effects

Uncommon Side Effects (affect less than 1 in 100
users)
Sleep disturbances
Fainting* (Syncope)
Tingling or numbness in the hands or feet
Dizziness, weakness or confusion (Atrioventricular
Block)
Chest pain (Angina)
Various skin reactions such as allergic skin rash,
itching, itchy rash, and dry skin patches
Scaly pink patches on your skin (Psoriasis) which, if
already existing, may become worse
Hair loss
Unable to have an erection (Erectile Dysfunction)
Rare Side Effects (affect less than 1 in 1,000 users)
Blocked nose
Reduction in blood platelets, which increases risk of
bleeding or bruising
Swelling and/or fluid retention in the hands feet or
legs
Constipation
Increase in serum transaminase (detected through
liver function test)
Very Rare Side Effects (affect less than 1 in 10,000
users)
Dry mouth
Reduction in white blood cells, which may make
infections more likely
Increase in liver enzymes (detected through blood
test)
Problems with bladder control in women (usually
improves when treatment is stopped)
Carvedilol may cause the development of diabetes in
people who have a very mild form called 'latent
diabetes'.
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.

5

How to store Carvedilol

Keep out of the reach and sight of children.
Store in the original package.
Do not use Carvedilol after the expiry date which is
stated on the carton/bottle after "EXP". The expiry date
refers to the last date of the month.
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 to protect the environment.

6

Further information

What Carvedilol contains:
The active ingredients in each tablet are:
3.125mg: Each tablet contains 3.125mg Carvedilol
6.25mg: Each tablet contains 6.25mg Carvedilol
12.5mg: Each tablet contains 12.5mg Carvedilol
25mg: Each tablet contains 25mg Carvedilol

Other ingredients are:
Lactose Monohydrate, Microcrystalline Cellulose,
Crospovidone, Povidone K30, Colloidal Anhydrous
Contact your doctor immediately if you have the
Silica, Magnesium Stearate
following allergic reactions:
3.125mg & 12.5mg Tablets also contain Ferric Oxide
Red (E172)
Difficulty breathing or swallowing due to sudden
6.25mg & 12.5mg Tablets also contain Ferric Oxide
swelling of the throat or face
Yellow (E172)
*Side effects marked with an asterisk are usually mild
What Carvedilol looks like and contents of the
and more likely to happen at the beginning of
pack:
treatment.
3.125mg: light red, round, convex tablet divided into
Very Common Side Effects (affect more than 1 in 10
two by a break-line and marked C1
users)
6.25mg: yellow, round, convex tablet divided into two
Dizziness*
by a break-line and marked C2
Headache*
12.5mg: red/brown, round, convex tablet divided into
Heart problems which can cause shortness of
two by a break-line and marked C3
breath or ankle swelling (Cardiac Failure)
25mg: white, round, convex tablet divided into two by a
Feeling dizzy or light headed (symptoms of Low
break-line and marked C4
Blood Pressure)
Carvedilol is available in:
Tiredness*
Carvedilol tablets are available in packs of:
Common Side Effects (affect less than 1 in 10 users) 14, 20, 28, 30, 50, 56, 60, 98, 100, 250, 500
Wheezing, shortness of breath, chest tightness and Not all pack sizes may be marketed
sore throat. Symptoms of infections of the airway
Marketing Authorisation Holder
(Bronchitis), lungs (Pneumonia), nose and throat
Tillomed Laboratories Ltd
(Upper Respiratory Tract)
3 Howard Road, Eaton Socon, St. Neots
Breathlessness, coughing and wheezing in
Cambridgeshire
asthmatic patients
Difficulty passing urine (symptom of a Urinary Tract PE19 8ET, UK
Manufacturer
Infection)
Salutas Pharma GmbH
Reduction in red blood cells which can make the
Otto-Von-Guericke-Allee 1
skin pale and cause weakness or breathlessness
D-39179 Barleben
(Anaemia)
Germany
Weight increase
Like most medicines, Carvedilol tablets can cause side
effects, although not everybody gets them.

Raised cholesterol level (detected by a blood test)
Raised or lowered blood sugar levels in patients
with diabetes
Depression or depressed moods
Eyesight problems, dry eyes due to a decrease in
tears or sore eyes
Slow heart beat

Last modified: 21/01/11

Size:

165 x 420mm

Product Licence Numbers:
Carvedilol 3.125mg - PL 11311/0480
Carvedilol 6.25mg - PL 11311/0481
Carvedilol 12.5mg - PL 11311/0482
Carvedilol 25mg - PL 11311/0483
Date of last revision: January 2011

Regulatory:

Colour:
Pantone Black CVC

Amendments Required:

Signature:

Task Allocated:

Approved:

Prepared by: Fawad
PL No.

No

Amendments Required:

Signature:
ver.1.6s

Software:Adobe illustrator 9 (windows)

Date:

QA:

Information Provided by:

Keyline: Yes

Approved:

Date:

General Sales & Marketing:

Tillomed Code:

XXX

Approved:

Pharma Code:

XXX

Signature:

Amendments Required:
Date:

Reason for changes :
Tillomed Laboratories Ltd, 3 Howard Road Eaton Socon, St Neots, Cambs PE19 8ET, 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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