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CARVEDILOL 6.25 MG FILM-COATED TABLETS

Active substance(s): CARVEDILOL / CARVEDILOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Carvedilol 3.125 mg, 6.25 mg, 12.5 mg and 25 mg film-coated tablets
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:
1 What Carvedilol is and what it is used for
2 Before you take Carvedilol
3 How to take Carvedilol
4 Possible side effects
5 How to store Carvedilol
6 Further 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. Before you take Carvedilol
DO NOT TAKE Carvedilol
 if you are allergic (hypersensitive) to carvedilol or any of the other ingredients of Carvedilol (as listed
in section 6 ‘Further Information’),
 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),
If any of these apply to you, do not take Carvedilol.
Take special care with Carvedilol
It is important to tell your doctor before taking Carvedilol if you:









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 the hands, feet, 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.

Taking other medicines
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),
 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.
Taking Carvedilol with food and drink
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 and breast-feeding
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.
Ask your doctor or pharmacist for advice before taking any 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.
Important information about some of the ingredients of Carvedilol
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 Carvedilol exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Carvedilol tablets should be swallowed with a drink of water.
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).
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.
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 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.
For the treatment of heart failure, it is recommended that your treatment with Carvedilol is started and
carefully monitored by a hospital specialist.
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 tablets 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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Carvedilol can cause side effects, although not everybody gets them.
The frequency of possible side effects is shown in the table below:
Very common: Occur in more than 1 in 10 users
Common: Occur in less than 1 in 10, but more than 1 in 100 users
Uncommon: Occur in less than 1 in 100 users but more than 1 in 1,000 users
Rare: Occur in less than 1 in 1,000, but more than 1 in 10,000 users
Very rare: Occur in less than 1 in 10,000 users, including isolated cases
The majority of side effects are dose-related 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.
Side effects in patients with heart failure:
Very common:
 Dizziness
 Headache
 Tiredness
Common:
 Increase in weight
 Elevated cholesterol levels
 Loss of control of blood sugar in people with diabetes
 Slow heart rate
 Low blood pressure. Signs include dizziness (e.g. when standing up quickly)
 Oedema (including swelling of the body or parts of the body for example hand and feet, genital
oedema), fluid overload, increased volume of blood in the body
 Visual disturbance
 Diarrhoea
 Malaise, vomiting
Uncommon:
 Fainting
 Disturbances in the heart’s conduction system
 Worsening of heart failure at the beginning of treatment

Rare:
 Lowered blood platelet count (thrombocytopenia)
 Acute renal insufficiency and disturbances in renal function in patients with hardening of the arteries
and/or impaired renal function
Very rare:

Low numbers of white blood cells
Side effects in patients with raised blood pressure or chest pain:
Common:
 Slow heart rate in particular at the beginning of treatment (bradycardia)
 Dizziness (e.g. when standing up suddenly)
 Headache
 Tiredness
 Reduced lacrimation, eye irritation
 Asthma and breathing problems
 Malaise, stomach pains
 Diarrhoea
 Pains in the arms and legs
Uncommon:
 Abnormal sensation
 Fainting
 Problems with blood circulation (signs include cold hands and feet), 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)
 Disturbances in the hearts conduction system, angina pectoris (including chest pain), symptoms of
heart failure and oedema (swelling of more than one part of the body)
 Visual disturbance
 Depression
 Hallucination
 Confusion
 Impotence
Rare:
 Mouth dryness (dryness of the mouth)
 Stuffy nose
 Difficulty in passing urine
Very rare:
 Psychosis
 Altered blood picture (thrombocytopenia, leucopenia)
Isolated cases of allergic reactions.
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.
Do not use Carvedilol after the expiry date, which is stated on the carton after EXP. The expiry date refers
to the last date of that month.

Store below 250 C.
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 substance is carvedilol. Each film-coated 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 (Types A & B), povidone 30, sucrose,
magnesium stearate, macrogol 400, polysorbate 80, titanium dioxide (E171) and hypromellose.
What Carvedilol looks like and contents of the pack
Film-coated tablet.
Carvedilol 3.125 mg film-coated tablets:
White to off-white, oval shaped, film-coated tablets, debossed with ‘E’ on one side and ‘01’ on the other
side.
Carvedilol 6.25 mg film-coated tablets:
White to off-white, oval shaped, film-coated tablets, debossed with ‘F57’ on one side and deep break line
on the other side. The tablet can be divided into equal halves.
Carvedilol 12.5 mg film-coated tablets:
White to off-white, oval shaped, film-coated tablets, debossed with ‘F58’ on one side and deep break line
on the other side. The tablet can be divided into equal halves.
Carvedilol 25 mg film-coated tablets:
White to off-white, oval shaped, film-coated tablets, debossed with ‘F59’ on one side and deep break line
on the other side. The tablet can be divided into equal halves.
Carvedilol film-coated tablets are available in
PVC/PE/PVDC-Aluminium blister packs: 10, 14, 28, 30, 50, 56, 60, (Carvedilol 6.25mg and 25mg only)
and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
This leaflet was last approved in

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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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