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CARVEDILOL 6.25MG TABLETS

Active substance(s): CARVEDILOL

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Package Leaflet: Information for the user

Carvedilol 3.125 mg tablets
Carvedilol 6.25 mg tablets
Carvedilol 12.5 mg tablets
Carvedilol 25 mg tablets
carvedilol
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
•K
 eep this leaflet. You may need to read it again.
• I f 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 tablet is and what it is 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 other information
1 What Carvedilol tablet is and what it is used
for
Carvedilol tablets contain the active ingredient carvedilol.
Carvedilol belongs to a group of medicines called beta-blocker.
Beta-blockers make your blood vessels relax and widen and
slows your heart rate, thus causing the heart to beat more
calmly and lower blood pressure.
Carvedilol tablets is used to:
• treat angina
• control high blood pressure
• Carvedilol tablets can also be used in combination with other
therapies to treat heart failure.

2 What you need to know before you take
Carvedilol tablets
Do not take Carvedilol tablets if:
• y ou are allergic (hypersensitive) to carvedilol or any of the
other ingredients of this medicine (listed in section 6)
• y ou have a history of asthma or other lung diseases unless
you have consulted your doctor or pharmacist first
• y ou have liver problems
• y ou have problems with your heart (for example ‘heart block’
or unstable heart failure), as Carvedilol tablet is not suitable
for some people with certain types of heart problem
• y ou have an unusually slow heart beat (<50 bpm) or very low
blood pressure (systolic blood pressure below 85 mmHg)
sometimes causing dizziness, faintness or lightheadness on
standing
• y ou have a problem with the acid levels in your blood
(‘metabolic acidosis’)
• y ou are receiving verapamil or diltiazem by injection or as an
infusion (with a drip).
Do not take Carvedilol tablets if any of the above applies to
you. If you are not sure consult your doctor or pharmacist first.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:
• y ou have kidney problems
• you have diabetes, as your low blood sugar (hypo) warning
sign may be less obvious than usual
• you wear contact lenses, as Carvedilol tablets may cause dry
eyes
• you have thyroid problem
• you have previously suffered from serious allergic reactions or
you are undergoing desensitisation therapy to prevent allergy
e. g. to wasp or bee stings
• you have Raynaud’s syndrome or peripheral vascular disease
causing cold hands and feet or pins-and-needles
• you have psoriasis (patches of thickened and sore skin)
• you have a certain type of chest pain called ‘Prinzmetal’s
angina’
• you have a phaeochromocytoma (a growth on one of your
adrenal glands) unless adequately controlled by medication
• s evere bradycardia (<50 bpm).

Continued top of next column
AAAH5620

Other medicines and Carvedilol tablets
Tell your doctor or pharmacist if you are taking, 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 other medicines can affect
the way Carvedilol tablets works.
Talk to your doctor or pharmacist if you are taking any of the
following medicines:
•O
 ther medicines for your heart or high blood pressure
particularly;
• a ntiarrhythmics e. g. amiodarone,
• c alcium channel blockers e.g. amlodipine, diltiazem,
verapamil, nifedipine,
•d
 igitalis drugs e. g. digoxin,
•n
 itrates e.g. glyceryl trinitrate,
•g
 uanethidine, reserpine, methyldopa,
• c lonidine
•M
 onoamine oxidase inhibitors (used to treat depression) e.g.
moclobemide
• I nsulin or tablets to treat diabetes
•R
 ifampicin (used to treat tuberculosis)
•C
 imetidine (used to treat ulcers)
• Cyclosporin (used following an organ transplant)
• barbiturates e.g. amylobarbitone (sleeping drug)
• phenothiazines e.g. prochlorperazine (to help stop vomiting
and nausea)
• antidepressants e.g. amitriptyline, fluoxetine (used to treat
depression)
• non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen
(used for pain, stiffness and inflammation of painful bones,
joints and muscles)
• c orticosteroids (used to reduce inflammation) e.g.
beclometasone
•o
 estrogen therapies (used as contraception or hormone
replacement therapy)
• k etoconazole (used to treat fungal infections)
•h
 aloperidol (used in mental illness)
• erythromycin (an antibiotic used for bacterial infections)
• sympathomimetics (used for the nervous system) e.g.
ephedrine, or beta agonist bronchodilators
• ergotamine (used to treat migraine)
• neuromuscular blocking agents (muscle relaxants used in
anaesthesia) e.g. atracurium besilate
• vasodilating agents (these drugs open blood vessels)
•g
 uanfacine (used to treat high blood pressure).

Operations

Tell your hospital or dentist you are taking Carvedilol tablets if
you are going to have an operation needing an anaesthetic.

Carvedilol tablets with food and drink

Do not drink alcohol while you are taking Carvedilol tablets.

Pregnancy and breast-feeding

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

Driving and using machines

Carvedilol tablets may reduce your alertness and you may
feel dizzy while taking Carvedilol tablets. This is more likely
when you start treatment or if your treatment is changed and
when you drink alcohol. If affected do not drive or operate
machinery.
Carvedilol tablets contains lactose
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 How to take Carvedilol tablets
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
• The tablets should be swallowed preferably with a glass of
water.
Your doctor may monitor you at the start of treatment or if your
dose is increased. This may involve urine and blood tests.
The recommended dose is:
Heart failure:
The tablets should be taken with food to reduce the risk of a fall
in blood pressure when standing up, which causes dizziness,
light-headedness or fainting
• Adults: The usual starting dose is 3.125 mg twice a day for
2 weeks. Your doctor may gradually increase your dose to
25 mg twice a day. The maximum dose is 25 mg twice a day
for patients with a body weight of less than 85 kg. For patients
with a body weight above 85 kg, a maximum dose of 50 mg
twice a day can be taken.
Continued over page

High blood pressure:
•A
 dults: The usual starting dose is 12.5 mg once a day for the
first two days after which the recommended dose is 25 mg
once a day. If necessary your doctor may gradually increase
your dose. The maximum dose taken at one time is 25 mg
and the maximum dose taken in one day is 50 mg.
•E
 lderly: The usual starting dose is 12.5 mg once a day. If
necessary your doctor may increase your dose.

Angina:
•A
 dults: The usual starting dose is 12.5 mg twice a day for
two days after which the recommended dose is 25 mg twice
a day. If necessary your doctor may gradually increase your
dose. The maximum daily dose is 50 mg twice a day.
•E
 lderly: The usual starting dose is 12.5 mg twice a day for
two days after which the recommended dose is 25 mg twice
a day, which is the maximum daily dose.

Liver or kidney problems

If you have either liver or kidney problems your doctor may
prescribe a lower dose.

Elderly

Your doctor may want to monitor you more closely if you are
elderly.

Use in Children and adolescents (under 18 years
old)

Carvedilol tablets is not recommended for use in children and
adolescents under 18 years old.

If you take more Carvedilol tablets than you should

•P
 roblems with vision, sore or dry eyes, eye irritation
• swelling of hands, ankles or feet
•p
 roblems with circulation, fluid retention
•w
 orsening of cold extremities in patients who have Raynaud’s
disease or circulation problems
• Problems with breathing
• Pain in your hands, feet
• Problems with your kidney, including changes in passing
urine.
• faintness or dizziness on standing up (due to lowered blood
pressure)
Uncommon (may affect up to 1 in 100 people)
• Fainting, feeling faint
• problems with sleeping
• t ingling or numbness
•p
 roblems with heart, chest pain
•p
 roblems with your skin (skin rashes, itchiness, dry skin
patches)
• loss of hair
• impotence (difficulty getting or maintaining an erection).
Rare (may affect up to 1 in 1,000 people):
•d
 ecreased number of platelets in your blood (causing
unusual bleeding or unexplained bruising)
• s tuffy nose
Very rare (may affect up to 1 in 10,000 people):
• low number of white blood cells in your blood
• a llergic reactions
• c hanges in liver function (detected by tests)
•p
 roblems keeping urine (incontinence in women)

If you (or someone else) swallow a lot of the tablets all
together, or if you think a child has swallowed any of the
tablets, contact your nearest hospital casualty department or
your doctor immediately. An overdose can cause low blood
pressure (leading to feeling faint, shaky and weak), wheezing,
vomiting, fits, very slow heartbeat, heart failure/attack,
breathing problems and loss of consciousness.

Changes in blood sugar levels and a worsening of blood sugar
control in patients with diabetes can occur.

If you forget to take Carvedilol tablets

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.

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

If you stop taking Carvedilol tablets

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 tablets slowly over 1 to 2 weeks.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Side effects are less likely if you are being treated for angina or
hypertension than if you are being treated for heart failure..
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.
blistering of the skin, mouth, eyes and genitals (StevensJohnson Syndrome: rare skin condition with severe blisters
and bleeding in the lips, eyes, mouth, nose and genitals), or
severe blistering and peeling of large areas of the skin (toxic
epidermal necrolysis: severe skin reaction which starts with
painful red areas, then large blisters and ends with peeling
of layers of skin. This is accompanied by fever and chills,
aching muscles and generally feeling unwell , or erythema
multiforme: severe condition of the skin that may affect the
mouth and other parts of the body. It is seen as red, often itchy
spots, similar to the rash of measles, which starts on the limbs
and sometimes on the face and the rest of the body. The spots
may blister or may progress to form raised, red, pale-centred
marks. Those affected may have fever, sore throat, headache
and/or diarrhea.
Possible side effects in patients being treated for heart
failure:
Very common (may affect more than 1 in 10 people):
• Low blood pressure. The signs include feeling dizzy or lightheaded, in particular after you stand up.
•H
 eadache (this is usually mild and happens at the start of
your treatment)
• F eeling weak and tired
•D
 izziness
•P
 roblems with your heart.
Common (may affect up to 1 in 10 people):
• I ncrease in weight
• I ncrease in cholesterol levels (shown by a blood test)
• L oss of control of blood sugar in people with diabetes
•A
 slow heart beat
• F eeling sick or being sick, upset stomach, vomiting
•D
 iarrhoea
• infection of the airway (bronchitis), lungs (pneumonia), nose
and throat
•u
 rinary infections
• a naemia
• F eeling depressed
Continued top of next column
AAAH5620

You should report to your doctor if your symptoms or
condition worsen, as the dose of your other medications or
Carvedilol tablets may need to be changed.

Reporting of side effects

5 How to store Carvedilol tablets
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 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. Do not throw away any medicines via
wastewater or household waster. 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 tablets contains
• The active substance is carvedilol
• Each 3.125mg tablet contains 3.125mg of the active
ingredient carvedilol.
• Each 6.25mg tablet contains 6.25mg of the active ingredient
carvedilol.
• Each 12.5mg tablet contains 12.5mg of the active ingredient
carvedilol.
• Each 25mg tablet contains 25mg of the active ingredient
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)
What Carvedilol tablets 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, 20 Balderton Street, London, W1K 6TL,
United Kingdom
Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium
Distributed by:
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in 07/2015.

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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