Carvedilol® Each Tablet contains 25 mg

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Carvedilol®

Carvedilol

Tablet 6.25 mg & 12.5 mg and 25 mg

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. 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. t

it is used f

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.

Before use this drug, ask your doctor:

Do not take Carvedilol:

  • if you are allergic to carvedilol or any of the other ingredients of this medicine.
  • 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.

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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Carvedilol:

  • 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, have recently taken or might take any other medicines.
  • 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.

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.

Method of administration

  • Take this medicine by mouth.
  • Swallow tablets whole with a drink of water.
  • If you are taking Carvedilol to treat heart failure, you should take this medicine with water at your
  • Do not drink alcohol whilst taking Carvedilol as it might worsen the effects of alcohol.
  • Always take Carvedilol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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.

Adverse reactions

Like all medicines, Carvedilol 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.

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.

 

Special precautions for storage

  • 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 30 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.

 

 

Carvedilol®

Each Tablet contains: 6.25 mg & 12.5 mg and 25 mg Carvedilol

 

Manufacture by Afa chemie pharmaceutical co. Tehran-Iran.

  • Release date : 2020/12/10
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