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.
• In case of any doubts, consult a 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 the patient experiences any side effects, including any side effects not mentioned in this leaflet, they should tell their 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 the patient is allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe heart failure, which is treated mainly with intravenously administered medicines.
• if the patient has a history of bronchial asthma or other lung disease.
• if the patient has untreated heart failure or certain types of conduction disorders (called second- or third-degree atrioventricular block, or sick sinus syndrome).
• if the patient has severe heart dysfunction (cardiogenic shock).
• if the patient has significant bradycardia or very low blood pressure.
• if the patient has severe acid-base balance disorders (metabolic acidosis).
• if the patient has increased adrenal gland activity (pheochromocytoma) and it is not being treated with any medicines.
• if the patient has decreased blood circulation in the hands and feet, resulting in coldness, pain, or intermittent claudication.
• if the patient has severe liver disease.
• if the patient is being treated with intravenously administered medicines used to treat high blood pressure or heart disease (verapamil or diltiazem).

Warnings and precautions

Before starting to take Avedol, discuss it with your doctor.

• if the patient has heart failure with accompanying:
• low blood pressure
• disorders of blood and oxygen supply to the heart (ischemic heart disease) and vascular disease
• and (or) kidney function disorders. In such cases, the doctor should monitor kidney function. It may be necessary to reduce the dose of the medicine.
• if the patient has diabetes. Taking Avedol may mask the symptoms of low blood sugar. For this reason, blood sugar levels should be regularly monitored.
• if the patient has severe respiratory disorders that are not being treated, as Avedol may worsen breathing difficulties.
• if the patient has peripheral vascular disease.
• if the patient wears contact lenses. Avedol may reduce tear production.
• if the patient has Raynaud's syndrome (initially, bluish discoloration of the fingers or toes, then pallor, and finally redness with accompanying pain). Avedol may exacerbate existing symptoms.
• if the patient has hyperthyroidism - increased production of thyroid hormones, Avedol may mask the symptoms of this hyperthyroidism.
• if Avedol is being taken and a surgical procedure is planned with the use of general anesthetics. The anesthesiologist should be informed about the use of Avedol.
• if the patient has a heart rate below 55 beats per minute.
• if the patient has had severe hypersensitivity reactions (e.g., after insect bites or food intake) or if the patient has undergone or is undergoing desensitization treatment, as Avedol may reduce the effectiveness of medicines used to treat hypersensitivity reactions.
• if the patient has psoriasis.
• if the patient has Prinzmetal's angina.
• if the patient has a pheochromocytoma.

Avedol and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
It is especially importantto 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 protect against organ rejection after transplantation, also used in rheumatic or dermatological problems)
• Clonidine(a medicine used to lower blood pressure or treat migraines)
• Verapamil, diltiazem, amiodarone(medicines used to treat irregular heartbeat)
• Quinidine, disopyramide, mexiletine, propafenone, flecainide(medicines used to treat irregular heartbeat)
• Other medicines that lower blood pressure. Avedol may enhance the effect of other medicines that lower blood pressure 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, weakening the effect of Avedol
• Medicines that block neuromuscular conduction(medicines that reduce muscle tension)
• Ergotamine(a medicine used to treat migraines)
• Certain painkillers(nonsteroidal anti-inflammatory medicines), estrogens(hormones), and corticosteroids(adrenal hormones), as they may, in some cases, lower blood pressure, weakening 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 bronchodilating action(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 the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
There is a risk of harmful effects of the medicine on the unborn child. Avedol may be used during pregnancy only if the doctor considers it necessary. Always consult a doctor before taking Avedol during pregnancy.
Based on the results of studies conducted on breastfeeding animals, it was found that Avedol may pass into breast milk, and therefore, the medicine should not be taken during 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 during its change, dizziness and fatigue may occur.
In case of dizziness or weakness after taking the tablet, avoid driving or performing work that requires special concentration.

Avedol contains lactose

If the patient has been diagnosed with intolerance to some sugars, the patient should contact a doctor before taking the medicine.

3. How to take Avedol

This medicine should always be taken according to the doctor's recommendations. In case of doubts, consult a doctor or pharmacist.
Swallow the film-coated tablets with at least half a glass of water. The film-coated tablets can be taken independently of meals. However, it is recommended that patients with heart failure take the film-coated tablets during meals to reduce the risk of dizziness when getting up quickly.

Avedol tablets are available in the following doses: 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 doses of Avedol can 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 doses of Avedol can 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 the doctor, usually at 2-week intervals.
However, in some cases, the dose may be reduced or increased, which will be decided by the doctor.

Taking a higher dose of Avedol than recommended

In case of taking a higher dose of Avedol than recommended or if a child has swallowed the medicine, inform a doctor or go to the nearest hospital for advice on further action.
The symptoms of overdose include fainting caused by excessive lowering of blood pressure, slowed heart rate, and in severe cases, cardiac arrest.
Difficulty breathing, narrowing of the airways, malaise, decreased consciousness, and seizures may occur.

Missing a dose of Avedol

In case of missing 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 of the medicine.

Stopping treatment with Avedol

Do not stop treatment without consulting the attending doctor. The doctor will recommend gradual withdrawal of Avedol, slowly reducing the dose over a period of about 2 weeks.
In case of any further doubts related to the use of this medicine, consult a 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 treatment discontinuation. 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 getting up quickly), headache
• heart disease. Symptoms may include chest pain, fatigue, shortness of breath, and swelling of the hands and feet
• low blood pressure. Symptoms may include fainting and dizziness
• feeling of weakness and fatigue.

Dizziness, headache, and feeling of weakness and fatigue are usually mild and their occurrence is more likely 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 can cause problems with urination
• decreased red blood cell count (anemia). Symptoms include feeling of fatigue, pale skin, feeling of 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 of depression
• vision disorders, eye pain, or dry eye, due to reduced tear production
• slow heart rate
• fainting or dizziness when getting 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
• circulation problems in the hands and feet. Symptoms include cold hands and feet, pallor, tingling, and pain in the fingers and toes, as well as pain in the leg that worsens during walking
• breathing difficulties
• nausea, vomiting
• diarrhea
• stomach upset and (or) indigestion
• hand and foot pain
• kidney problems, including changes in urination.

Uncommon(occurring in 1 to 10 patients in 1000):

• sleep disorders
• fainting
• tingling or numbness of the hands and feet
• skin problems, including rashes that can cover a large part 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 easily occurring bruises and nosebleeds
• nasal 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 caused by sudden swelling of the throat or face, or swelling of the hands, feet, and ankles
• dry mouth
• liver function disorders (shown in blood tests)
• in some women, problems with urine retention may occur. After stopping treatment, this condition improves
• impotence
• skin rashes or redness that can 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, called "latent diabetes".

Reporting side effects

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

5. How to store Avedol

Store the medicine in a place 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 inscription 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 containers. 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.
• 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.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +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: