6.25 mg, 12 mg, 25 mg film-coated tablet 
Karvedilol

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4

This leaflet contains information about: 
1. What Carvedilol Aurobindo is and what it is used for 
2. What you need to know before you use Carvedilol Aurobindo 
3. How to use Carvedilol Aurobindo 
4. Possible side effects 
5. How to store Carvedilol Aurobindo 6. Contents of the pack 
and other information 

What Carvedilol Aurobindo is and what it is used for

Carvedilol Aurobindo belongs to a group of medicines called beta-blockers, which have a relaxing and dilating effect on the blood vessels. This makes it easier for the heart to pump around the blood in the body and reduces blood pressure and stress on the heart.

Carvedilol Aurobindo is used:

  • in the treatment of hypertension ( hypertension )
  • in the treatment of chest pain that occurs when the arteries that supply the heart with oxygen-rich blood are narrowed, which leads to less oxygen reaching the heart muscle (angina)
  • in the treatment of weakening of the heart muscle ( heart failure ), in combination with other drugs.

Carvedilol contained in Carvedilol Aurobindo may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Carvedilol Aurobindo

Do not use Carvedilol Aurobindo

  • if you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6).
  • if you have previously had wheezing due to asthma or other lung diseases
  • if you have been informed that you have very severe heart failure and have fluid retention (swelling) that is being treated with drug injections into a vein ( intravenously )
  • if you have liver disease
  • if you have been informed that you have a very slow heart rate
  • if you have very low blood pressure
  • if you have been informed that you have a condition called Prinzmetal’s angina
  • if you suffer from untreated pheochromocytoma (a tumor of the adrenal gland that causes high blood pressure )
  • if you suffer from severe disorders of the body’s acid-base balance (metabolic acidosis )
  • if you have very poor blood circulation in your hands and feet, which leads to cold and pain
  • if you have a special conduction defect in the heart (so-called AV block grade II or III [if no pacemaker is available] or an SA block)
  • if you are currently being treated with verapamil or diltiazem injections (used to treat high blood pressure or heart problems).
    Do not take Carvedilol if any of the above apply to you.

Warnings and cautions

  • have been informed that you are suffering from some other heart problem
  • have or have had problems with the liver, kidneys, or thyroid gland
  • have diabetes. Carvedilol Aurobindo can mask your common symptoms of low blood sugar.
  • have a skin condition called psoriasis
  • have poor blood circulation affecting the hands, feet, or lower legs, or Raynaud’s phenomenon
  • has or has had a severe allergic reaction or is undergoing hyposensitization treatment for allergies for any form of severe allergy
  • wear contact lenses, as Carvedilol may make your eyes drier than normal.

Other medicines and Carvedilol Aurobindo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Administration of carvedilol:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and herbal medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

  • drugs for the treatment of irregular heartbeat (eg diltiazem, verapamil, or amiodarone )
  • nitrates against angina (eg isosorbide mononitrate or glyceryl trinitrate )
  • drugs for the treatment of heart failure (eg digoxin )
  • other medicines to treat high blood pressure (eg doxazosin, reserpine, amlodipine or indoleamine)
  • medicines to treat depression or other mental illnesses (eg fluoxetine, tricyclic antidepressants, barbiturates, phenothiazines, haloperidol or monoamine oxidase inhibitors ( MAOIs ))
  • drugs that prevent the body from rejecting organs after transplantation (eg cyclosporine)
  • medicines that lower blood sugar, such as oral medicines for diabetes or insulin
  • medicines used to lower blood pressure or treat migraines (eg clonidine or ergotamine )
  • certain painkillers, e.g. non-steroidal anti-inflammatory drugs ( NSAIDs ) (eg ibuprofen or diclofenac )
  • hormones for hormone therapy (eg estrogen )
  • corticosteroids that inhibit inflammation or allergic reactions (eg prednisolone )
  • drugs for the treatment of bacterial infections (eg rifampicin or erythromycin)
  • medicines to treat stomach ulcer, heartburn, and acid reflux (eg cimetidine)
  • medicines to treat fungal infections (eg ketoconazole )
  • medicines sometimes used in decongestants for coughs and colds (eg ephedrine or pseudoephedrine).
    Tell your doctor that you are taking Carvedilol Aurobindo if you are going to receive anesthetics before an operation.

Carvedilol Aurobindo with food, drink, and alcohol

Carvedilol Aurobindo should be taken with water.

If you are taking Carvedilol Aurobindo as a treatment for heart failure, you should take this medicine with water at mealtime (see section 3 “How to take Carvedilol Aurobindo”).

Avoid alcohol during treatment with Carvedilol Aurobindo as this may intensify the effects of alcohol.

Pregnancy, breastfeeding, and fertility

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. Ask your doctor immediately if you become pregnant during treatment with this medicine.

Driving and using machines

During treatment with Carvedilol Aurobindo, you may experience dizziness or tiredness. This usually occurs at the beginning of treatment or when increasing the dose. If this occurs, do not drive or use machines. Avoid alcohol as this may aggravate these symptoms. If you are not sure or want more information, talk to your doctor.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Carvedilol Aurobindo contains lactose and sucrose (sugars). 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 use Carvedilol Aurobindo

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. 

Carvedilol Aurobindo should be swallowed with a glass of water.

High blood pressure

Adults: The usual starting dose is 12.5 mg once daily for the first two days. After this, the dose is increased to 25 mg once daily. If necessary, your doctor may gradually increase the dose one 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 prescribe a starting dose of 12.5 mg once daily and continue with this dose throughout your treatment. If necessary, your doctor may gradually increase the dose one at intervals of two weeks or more.

Angina pectoris

Adults: The usual starting dose is 12.5 mg twice daily for the first two days. After this, the dose is increased one to 25 mg twice daily. If necessary, your doctor may gradually increase the dose one further at intervals of two weeks or more to a maximum dose of 100 mg daily divided into two doses.

Elderly: The recommended starting dose is 12.5 mg twice daily for the first two days. After this, dose one can be increased to 25 mg twice daily, which is the recommended maximum daily dose one.

Heart failure

Adults and the elderly: When treating stable heart failure, the tablets should be taken twice daily, in the morning and in the evening, and should be taken with a meal to reduce the risk of side effects.

The starting dose is 3.125 mg twice daily for two weeks. Your doctor will then increase the strength of the tablets you take at intervals of two weeks or more until you get the dose that suits you best.

If you weigh less than 85 kg, the maximum recommended dose of Carvedilol Aurobindo is 25 mg twice daily. If you weigh more than 85 kg, your doctor may increase the dose to 50 mg twice daily.

When treating heart failure, it is recommended that treatment with Carvedilol Aurobindo be initiated and closely monitored by a specialist in a hospital.

If you have stopped taking Carvedilol Aurobindo for more than two weeks, you must return to the starting dose and gradually increase the dose again.

In some cases, heart failure may worsen during treatment with Carvedilol Aurobindo, especially at the beginning of treatment. This can lead to an increase in symptoms (eg fatigue, shortness of breath) and signs of fluid retention (eg weight gain and bone swelling).

If your symptoms or illness worsen during treatment with Carvedilol Aurobindo, you should inform your doctor, as he or she may need to adjust the dose of one of the other medicines or of Carvedilol Aurobindo.

During treatment with Carvedilol Aurobindo, you must continue with other treatments for heart failure as directed by your doctor.

Patients with liver problems

Depending on your condition, your doctor may reduce the dose compared to what is recommended above.

Use for children and adolescents

Children and adolescents (under 18 years of age): Carvedilol Aurobindo is not recommended for this age group.

You may experience dizziness, nausea, fainting, shortness of breath/wheezing, severe tiredness, or cramps.

If you forget to use Carvedilol Aurobindo

Do not worry if you forgot to take a dose. Take the next tablet as soon as you remember, provided it is not soon time for the next dose. Take the next tablet at the usual time, but do not take a double dose to make up for a forgotten dose.

If you stop using Carvedilol Aurobindo

Talk to your doctor before stopping Carvedilol Aurobindo. If you suddenly stop taking the tablets, you may experience side effects. Your doctor will tell you how to gradually reduce the dose one and then stop taking this medicine. If you are also taking a medicine called clonidine, never stop any of the treatments unless your doctor tells you to.

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 frequency of any side effects is listed in the table below:

Most side effects are dose-related and disappear when the dose is reduced or the treatment is stopped. Some side effects may occur at the beginning of treatment and disappear spontaneously during further treatment.

Very common: may affect more than 1 user in 10

  • Dizziness
  • Headache
  • Fatigue
  • Low blood pressure
  • Heart failure

Commonmay affect up to 1 in 10 users

  • Bronchitis, pneumonia, upper respiratory tract infection
  • Urinary tract infection
  • Low red blood cell count
  • Weight gain
  • Elevated cholesterol levels
  • Poor blood sugar control in patients with diabetes
  • Depression, depression
  • Visual disturbances
  • Reduced tear production, eye irritation
  • Slow pulse
  • Edema (swelling in the body or parts of the body), excess fluid, increased blood volume in the body
  • Dizziness when rising quickly
  • Problems with blood circulation (signs of this are cold hands and feet), narrowing of the arteries (atherosclerosis), worsening of symptoms in patients with Raynaud’s phenomenon (fingers and toes first turn blue, then white and then red, in combination with pain) or intermittent claudication (pain in the legs that gets worse when walking)
  • Asthma and difficulty breathing
  • Fluid accumulation in the lungs
  • Diarrhea
  • Nausea, vomiting, abdominal pain, indigestion
  • Pain (eg in arms and legs)
  • Acute renal insufficiency and renal impairment in patients with atherosclerosis and/or renal impairment
  • Difficulties with urination 

Uncommonmay affect up to 1 in 100 people

  • Sleep disorders
  • Confusion
  • Fainting
  • Abnormal feeling
  • Cardiac conduction system disorders, angina (including chest pain)
  • Certain skin reactions (eg allergic dermatitis, hives, itching and inflammation of the skin, increased sweating, psoriasis – or lichen planus-like skin lesions)
  • Hair loss
  • Impotence

Raremay affect up to 1 in 1,000 users

  • Decreased platelet count ( thrombocytopenia )
  • Dry mouth
  • Nasal congestion

Very rare: may affect up to 1 in 10,000 people

  • Low white blood cell count
  • Allergic reactions
  • Altered liver function values
  • Involuntary urine leakage in women (urinary incontinence).
  • Skin rash, which can turn into blisters and look like small targets (a dark dot in the middle surrounded by a paler area, with a dark ring around the edge – erythema multiforme )
  • A widespread rash with blisters and flaky skin, especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ),
  • And a severe form that causes extensive flaking of the skin (more than 30% of the body surface – toxic epidermal necrolysis )

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se

5. How to store Carvedilol Aurobindo

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month.

Do not store above 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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is carvedilol. 1 tablet contains 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 the medicine looks like and the contents of the pack

Film-coated tablet

Carvedilol Aurobindo 6.25 mg film-coated tablet

Film-coated tablets, white to off-white, oval, with “F57” embossed on one side and with a scoreline on the other side. The tablets can be divided into equal parts.

Carvedilol Aurobindo 12.5 mg film-coated tablet

Film-coated tablets, white to off-white, oval, with “F58” embossed on one side and with a scoreline on the other side. The tablets can be divided into equal parts.

Carvedilol Aurobindo 25 mg film-coated tablet

Film-coated tablets, white to off-white, oval, with “F59” embossed on one side and with a scoreline on the other side. The tablets can be divided into equal parts.

Blister:

Pack sizes: 5, 7, 10, 14, 15, 20, 28, 30, 40, 50, 56, 60, 90, 98, 100, 120, 150, 200, 250, 300, 400, 500 and 1,000 film-coated tablets .

HDPE jar:

Pack sizes: 30, 50, 60, 100, 250, 500 and 1,000 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aurobindo Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana FRN 1913

Malta

Manufacturer:

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

or

Orion Corporation,

Orion Pharma

Orionintie 1,

FI-02200 Espoo.

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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