Carvedilol 6.25 Mg Film-Coated Tablets
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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.
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 (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.
Warnings and precautions
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 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.
Other medicines and Carvedilol
Tell your doctor or pharmacist if you are taking or have recently taking, have recently taken or might take any other medicines.
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),
• 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 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 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.
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The frequency of possible side effects is shown in the table below:
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Very common: |
occur in more than 1 in 10 users |
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Common: |
occur in less than 1 in 10, but more than 1 in 100 users |
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Uncommon: |
occur in less than 1 in 100 users but more than 1 in 1.000 users |
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Rare: |
occur in less than 1 in 1.000, but more than 1 in 10.000 users |
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Very rare: |
occur in less than 1 in 10.000 users, including isolated cases |
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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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
Very common:
• Dizziness
• Headache
• Tiredness
• Low blood pressure
• Heart failure
Common:
• 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:
• Sleep disturbance
• Confusion
• Fainting
• 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
Rare:
• Lowered blood platelet count (thrombocytopenia)
• Mouth dryness (dryness of the mouth)
• Stuffy nose
Very rare:
• Low numbers of white blood cells
• Allergic reactions
• Changes in the liver function test
• Involuntary leakage of urine in women (urinary incontinence).
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
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.
PVC/PE /PVDC - Aluminum:
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 film-coated tablets.
Bottle of hioh density polyethylene (HDPE1 with a white cap, opaque polypropylene
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 approved in 07/2012.