Avedol

Leaflet accompanying the packaging: patient information

Avedol, 6.25 mg, film-coated tablets

Avedol, 12.5 mg, film-coated tablets

Avedol, 25 mg, film-coated tablets

Carvedilol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not mentioned in this leaflet, tell your doctor. See section 4.

Table of contents of the leaflet

• 1. What is Avedol and what is it used for
• 2. Important information before taking Avedol
• 3. How to take Avedol
• 4. Possible side effects
• 5. How to store Avedol
• 6. Package contents and other information

1. What is Avedol and what is it used for

Avedol contains carvedilol, which belongs to a group of medicines called alpha- and beta-adrenergic blockers. Avedol is used to treat high blood pressure and angina pectoris. Avedol is also indicated as adjunctive treatment in heart failure, improving its function.

2. Important information before taking Avedol

When not to take Avedol:

• if you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6).
• if you have severe heart failure that is being treated mainly with intravenous medications.
• if you have had asthma or other lung disease in the past.
• if you have untreated heart failure or certain types of heart conduction disorders (called second- or third-degree atrioventricular block, or sick sinus syndrome).
• if you have severe heart dysfunction (cardiogenic shock).
• if you have significant bradycardia or very low blood pressure.
• if you have severe acid-base balance disorders (metabolic acidosis).
• if you have increased adrenal gland activity (pheochromocytoma) and it is not being treated with any medications.
• if you have decreased blood circulation in your hands and feet, resulting in coldness, pain, or intermittent claudication.
• if you have severe liver disease.
• if you are being treated with intravenous medications for high blood pressure or heart disease (verapamil or diltiazem).

Warnings and precautions

Before taking Avedol, discuss it with your doctor.

• if you have heart failure with accompanying low blood pressure, coronary artery disease, and/or kidney dysfunction. In such cases, your doctor should monitor your kidney function. It may be necessary to reduce the dose of the medicine.
• if you have diabetes. Taking Avedol may mask the symptoms of low blood sugar. Therefore, you should regularly check your blood sugar levels.
• if you have severe respiratory problems that are not being treated, as Avedol may worsen breathing difficulties.
• if you have peripheral vascular disease.
• if you wear contact lenses. Avedol may decrease tear production.
• if you have Raynaud's syndrome (initially, fingers or toes become blue, then pale, and finally red with accompanying pain). Avedol may exacerbate existing symptoms.
• if you have hyperthyroidism - increased production of thyroid hormones, Avedol may mask the symptoms of this hyperthyroidism.
• if you are taking Avedol and are planning to have surgery with general anesthesia. Inform your anesthesiologist about taking Avedol.
• if you have a heart rate below 55 beats per minute.
• if you have had severe allergic reactions (e.g., after insect bites or food consumption) or if you have undergone or are undergoing desensitization treatment, as Avedol may reduce the effectiveness of medications used to treat allergic reactions.
• if you have psoriasis.
• if you have Prinzmetal's angina.
• if you have a pheochromocytoma.

Avedol and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take. It is especially important to inform your doctor about the use of the following medicines:

• Digoxin(a medicine used to treat heart failure)
• Rifampicin(an antibiotic used to treat tuberculosis)
• Cimetidine(a medicine used to treat stomach ulcers, heartburn, and acid reflux)
• Cyclosporin(a medicine that weakens the immune system to prevent organ rejection after transplantation, also used for rheumatological or dermatological problems)
• Clonidine(a medicine used to lower blood pressure or treat migraines)
• Verapamil, diltiazem, amiodarone(medicines used to treat irregular heartbeats)
• Quinidine, disopyramide, mexiletine, propafenone, flecainide(medicines used to treat irregular heartbeats)
• Other medicines that lower blood pressure. Avedol may enhance the effect of other blood pressure-lowering medicines through similar action (e.g., alpha-receptor antagonists)
• Insulinor oral antidiabetic medicines(medicines that lower blood sugar levels), as the blood sugar-lowering effect may be enhanced and the symptoms of low blood sugar may be masked
• Anesthetics(medicines used for anesthesia)
• Sympathomimetics(medicines that increase the activity of the sympathetic nervous system)
• Dihydropyridine derivatives(medicines used to treat high blood pressure and heart disease)
• Nitrates(medicines used to treat heart disease), as they may cause a sudden decrease in blood pressure, reducing the effect of Avedol
• Medicines that block nerve-muscle conduction(medicines that reduce muscle tension)
• Ergotamine(a medicine used to treat migraines)
• Certain painkillers(nonsteroidal anti-inflammatory drugs), estrogens(hormones), and corticosteroids(adrenal hormones), as they may, in some cases, lower blood pressure, reducing the effect of Avedol
• Medicines containing reserpine, guanethidine, methyldopa, guanfacine, monoamine oxidase inhibitors (MAOIs)- medicines used to treat depression, as they may cause further slowing of the heart rate
• Fluoxetine(a medicine used to treat depression)
• Beta-adrenergic receptor agonists with bronchodilatory effects(medicines used to treat asthma), e.g., salbutamol and formoterol.

Avedol with food, drink, and alcohol

Avedol may enhance the effect of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. There is a risk of harmful effects on the unborn child. Avedol may only be used during pregnancy if your doctor considers it necessary. Always consult your doctor before taking Avedol during pregnancy. Based on the results of studies conducted on breastfeeding animals, it has been found that Avedol may pass into breast milk, and therefore, you should not take the medicine while breastfeeding.

Driving and using machines

The medicine has a minor effect on the ability to drive and use machines. At the beginning of treatment or when changing it, dizziness and fatigue may occur. If you experience dizziness or weakness after taking the tablet, avoid driving or performing tasks that require special concentration.

Avedol contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Avedol

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. The film-coated tablets should be swallowed with at least half a glass of water. The film-coated tablets can be taken with or without food. However, it is recommended that patients with heart failure take the film-coated tablets during meals to reduce the risk of dizziness when standing up suddenly.

Avedol tablets are available in the following strengths: 6.25 mg, 12.5 mg, 25 mg

High blood pressure:

The usual dose is 1 tablet of Avedol 12.5 mg (equivalent to 12.5 mg of carvedilol) for the first 2 days of treatment, and then 2 tablets of Avedol 12.5 mg (equivalent to 25 mg of carvedilol) once a day. Other available strengths of Avedol may also be used.

Angina pectoris:

The usual dose is 1 tablet of Avedol 12.5 mg (equivalent to 12.5 mg of carvedilol) twice a day for 2 days, and then 2 tablets of Avedol 12.5 mg (equivalent to 25 mg of carvedilol) twice a day. Other available strengths of Avedol may also be used.

Heart failure:

The usual dose is half a tablet of Avedol 6.25 mg (equivalent to 3.125 mg of carvedilol) twice a day for 2 weeks. The dose may be gradually increased by your doctor, usually at 2-week intervals. However, in some cases, the dose may be decreased or increased, which will be decided by your doctor.

Taking more than the recommended dose of Avedol

If you take more than the recommended dose of Avedol or if a child accidentally swallows the medicine, inform your doctor or go to the nearest hospital for advice on what to do next. Symptoms of overdose include fainting due to excessive lowering of blood pressure, slowed heart rate, and in severe cases, cardiac arrest. Breathing difficulties, narrowing of airways, malaise, decreased consciousness, and seizures may occur.

Missing a dose of Avedol

If you miss a dose (or several doses) of the medicine, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Avedol

Do not stop treatment without consulting your doctor. Your doctor will advise you to stop taking Avedol gradually, by slowly reducing the dose over a period of about 2 weeks. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Avedol can cause side effects, although not everybody gets them. Most side effects are dose-dependent and symptoms disappear after dose reduction or discontinuation of treatment. Some side effects may occur at the beginning of treatment and disappear spontaneously during treatment. Very common(occurring in more than 1 in 10 patients):

• dizziness (e.g., when standing up), headache
• heart disease. Symptoms may include chest pain, fatigue, shortness of breath, and swelling of hands and feet
• low blood pressure. Symptoms may include fainting and dizziness
• feeling weak and tired.

Dizziness, headache, and feeling weak and tired are usually mild and more likely to occur at the beginning of treatment. Common(occurring in 1 to 10 patients in 100):

• respiratory tract infections (bronchitis), lung infections (pneumonia), nose and throat infections (upper respiratory tract infections). Symptoms include wheezing, shortness of breath, chest pressure, and sore throat
• urinary tract infections, which may cause problems with urination
• decreased red blood cell count (anemia). Symptoms include feeling tired, pale skin, feeling of heart palpitations, and shallow breathing
• weight gain
• increased cholesterol levels in the blood (shown in blood tests)
• loss of control over blood sugar levels in people with diabetes
• feeling depressed
• vision disturbances, eye pain, or dry eye due to decreased tear production
• slow heart rate
• fainting or dizziness when standing up
• fluid retention. Symptoms include general swelling of the body, swelling of parts of the body (e.g., hands, feet, ankles, and legs), and increased blood volume in the body
• problems with blood circulation in hands and feet. Symptoms include cold hands and feet, paleness, tingling, and pain in the fingers and toes, as well as pain in the leg that worsens when walking
• breathing problems
• nausea, vomiting
• diarrhea
• stomach upset and/or indigestion
• pain in hands and feet
• kidney problems, including changes in urination.

Uncommon(occurring in 1 to 10 patients in 1,000):

• sleep disturbances
• fainting
• tingling or numbness of hands and feet
• skin problems, including rashes that may cover a large area of the body, papular rash (hives), itching, and dry skin patches
• heart conduction disorders
• heart problems. Symptoms include chest pain and shortness of breath (angina pectoris)
• hair loss
• erectile dysfunction (difficulty achieving or maintaining an erection).

Rare(occurring in 1 to 10 patients in 10,000):

• decreased platelet count. Symptoms include easy bruising and nosebleeds
• nose congestion.

Very rare(occurring in less than 1 in 10,000 patients):

• decreased white blood cell count. Symptoms include infections of the mouth, gums, throat, and lungs
• allergic reactions (hypersensitivity). Symptoms may include difficulty breathing or swallowing due to sudden swelling of the throat or face, or swelling of hands, feet, and ankles
• dry mouth
• liver function disorders (shown in blood tests)
• some women may experience problems with urine retention. After stopping treatment, this condition improves
• impotence
• skin rashes or redness that may worsen to severe skin reactions, including widespread rash with blisters and peeling of the skin, occurring especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Avedol may also cause the development of symptoms of diabetes in patients who have a very mild form of diabetes, known as "latent diabetes".

Reporting side effects

If you experience any side effects, including those not mentioned in this leaflet, tell your doctor or pharmacist. You can report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Avedol

Keep the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. The notation on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it indicates the batch number. Do not store above 30°C. Store in the original packaging to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Avedol contains

• The active substance of the medicine is carvedilol. Each tablet contains 6.25 mg, 12.5 mg, or 25 mg of carvedilol.
• The other ingredients are tablet core: microcrystalline cellulose, lactose monohydrate, crospovidone CL, povidone K30, colloidal silicon dioxide, magnesium stearate. coating: HPMC 2910/Hypromellose 3cP, HPMC 2910/Hypromellose 6cP, HPMC 2910/Hypromellose 50cP, titanium dioxide (E 171), triethyl citrate, macrogol 8000, polydextrose Fcc.

What Avedol looks like and contents of the pack

6.25 mg film-coated tablets: white, oval, with a dividing line on both sides and "6.25" embossed on one side. 12.5 mg film-coated tablets: white, oval, with a dividing line on both sides and "12.5" embossed on one side. 25 mg film-coated tablets: white, oval, with a dividing line on both sides and "25" embossed on one side. The 6.25 mg, 12.5 mg, and 25 mg tablets can be divided into equal doses. The packaging contains 30 or 60 film-coated tablets.

Marketing authorization holder and manufacturer

Polpharma S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Date of last revision of the leaflet

How the Avedol medicine looks like and what the packaging contains

6.25 mg coated tablets: white, oval, with a dividing line on both sides and embossed "6.25" on one side.
12.5 mg coated tablets: white, oval, with a dividing line on both sides and embossed "12.5" on one side.
25 mg coated tablets: white, oval, with a dividing line on both sides and embossed "25" on one side.
The 6.25 mg, 12.5 mg, and 25 mg tablets can be divided into equal doses.
The packaging contains 30 or 60 coated tablets.

Responsible entity and manufacturer

PHARMACEUTICAL WORKS POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Date of the last update of the leaflet: