Coriol 6,25 mg

Package Leaflet: Information for the User

Coryol, 6.25 mg, Tablets

Carvedilol

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

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Coryol and what is it used for
• 2. Important information before taking Coryol
• 3. How to take Coryol
• 4. Possible side effects
• 5. How to store Coryol
• 6. Contents of the pack and other information

1. What is Coryol and what is it used for

Coryol contains the active substance carvedilol. It belongs to a group of medicines called beta-blockers.
Coryol is used to treat:
chronic heart failure;
high blood pressure (hypertension);
angina pectoris (chest pain or discomfort, occurring when the heart does not receive enough oxygen).
Coryol works by reducing the tension in the blood vessel walls and dilating the blood vessels:
this helps to lower blood pressure;
in the case of chronic heart failure, it makes it easier for the heart to pump blood to the vessels of the whole body;
in the case of angina pectoris, it relieves chest pain.
In addition to Coryol, your doctor may also prescribe other medicines to help treat your condition.

2. Important information before taking Coryol

When not to take Coryol:

• if you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6);
• in case of worsening heart failure in the recent past (significant fluid retention or breathing difficulties, even when sitting) and taking intravenous medicines that support heart function;
• if you have asthma or chronic obstructive pulmonary disease (COPD) with wheezing;
• if you have liver function disorders;
• if you have heart conduction disorders (e.g., "2nd or 3rd degree AV block" or slow heart rate - below 50 beats per minute) - Coryol is not suitable for patients with certain heart diseases;
• in patients with sick sinus syndrome, including sinoatrial block (these are heart conduction disorders);
• in case of cardiogenic shock (severe heart function disorder);
• if you have very low blood pressure (systolic blood pressure <85 mmhg);< li>
• if you have too high a level of acids in the blood ("metabolic acidosis");
• if you have an untreated adrenal gland tumor ("pheochromocytoma");
• if you have Prinzmetal's angina (chest pain caused by coronary artery spasm);
• in case of severe peripheral artery disease (arteries are damaged or blocked and cannot distribute blood);
• in case of intravenous treatment with verapamil or diltiazem.

In case of doubts before taking Coryol, consult your doctor or pharmacist.

Warnings and precautions

Before starting treatment with Coryol, discuss with your doctor or pharmacist if:

• you have chronic heart failure;
• you have kidney function disorders;
• you have left ventricular function disorders after a recent heart attack;
• you have ever had wheezing associated with asthma or other lung diseases - carvedilol can only be used if the expected benefits outweigh the potential risk;
• you have diabetes;
• you wear contact lenses;
• you have peripheral vascular disease - beta-blockers may accelerate or worsen the symptoms of arteriolar insufficiency;
• you have ever had thyroid function disorders;
• you have ever had a severe allergic reaction (e.g., sudden swelling causing breathing or swallowing difficulties, swelling of hands, feet, and ankles, or severe rash) or if you are undergoing desensitization treatment, or such treatment is planned for you;
• you have Raynaud's syndrome (circulatory disorders in the fingers and toes);
• you are to undergo surgery under general anesthesia - in such a case, inform the anesthesiologist that you are taking Coryol;
• your heart rate is below 55 beats per minute (bradycardia);
• you have 1st degree AV block;
• you have ever had psoriasis after taking beta-blockers;
• you have Prinzmetal's angina, as there is no experience with carvedilol in these patients;
• you have an adrenal gland tumor - before starting treatment with Coryol, your doctor will prescribe a medicine that blocks alpha-adrenergic receptors.

If any of the above situations apply to you, or if you have any doubts, consult your doctor or pharmacist before taking Coryol.

Coryol and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take.
This is because Coryol may affect the action of other medicines, and some other medicines may affect the action of Coryol.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:
clonidine (used to treat high blood pressure or migraines);
calcium antagonists (medicines used to treat heart rhythm disorders, e.g., verapamil or diltiazem) - during concomitant use with Coryol, your doctor will recommend performing control ECG and blood pressure measurements;
blood pressure-lowering medicines, so-called alpha-adrenergic blockers (e.g., doxazosin or indoramin), or medicines for which blood pressure lowering is an undesirable effect, e.g., tricyclic antidepressants;
dihydropyridine derivatives (used to treat high blood pressure, e.g., amlodipine);
nitrates, e.g., nitroglycerin (used in angina pectoris);
non-steroidal anti-inflammatory medicines (NSAIDs) (used to treat pain and fever), estrogens (used in hormone replacement therapy), corticosteroids (used to treat inflammatory or allergic reactions);
digoxin (used to treat heart failure);
insulin or oral antidiabetic medicines;
stimulant medicines, e.g., rifampicin (used to treat tuberculosis), and medicines that inhibit liver metabolism, e.g., cimetidine (used to treat stomach ulcers and "hyperacidity");
medicines that reduce the level of catecholamines, e.g., reserpine, used to treat high blood pressure, and monoamine oxidase inhibitors (MAOIs), such as isocarboxazid and phenelzine (used to treat depression);
fluoxetine and paroxetine (used to treat depression);
cyclosporine and tacrolimus (used after organ transplantation);
other antiarrhythmic medicines (used to treat heart rhythm disorders, e.g., amiodarone).
ergotamine (used to treat migraines);
anesthetics.

Coryol with food, drink, and alcohol

Avoid drinking grapefruit juice at the same time or immediately after taking Coryol. Grapefruit or its juice may increase the level of the active substance carvedilol in the blood and cause unexpected side effects.
During treatment, do not drink alcohol, as it affects the action of Coryol.

Surgical procedures

Before surgery, inform your doctor that you are taking Coryol. This is because some anesthetics may lower blood pressure and it may become too low.

Pregnancy, breastfeeding, and fertility

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.
Do not take Coryol during pregnancy, when planning pregnancy, or during breastfeeding, unless your doctor advises otherwise.
Coryol must not be taken during breastfeeding.

Driving and using machines

While taking Coryol, dizziness may occur. This is most likely at the beginning of treatment, when changing the dose, or after drinking alcohol. In such a situation, do not drive or operate machinery. If you experience other disorders while taking Coryol that may have an unfavorable effect on driving or operating machinery, consult your doctor.

Coryol contains lactose monohydrate and sucrose (a type of sugar).

Each tablet contains 72.25 mg of lactose monohydrate and 5 mg of sucrose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Coryol

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablet with a drink of water.

Chronic heart failure

When used in heart failure, treatment with Coryol should be initiated by a specialist doctor.
Take the tablets every day at the same time, with food.
Usually, the starting dose is one 3.125 mg tablet twice a day for two weeks.
Your doctor will then gradually increase the dose over several weeks (up to 25 mg twice a day).
In patients weighing over 85 kg, the dose may be increased to 50 mg twice a day.
If you stop taking Coryol for more than two weeks, consult your doctor. It will be necessary to restart treatment from the initial dose (see "Stopping Coryol").

High blood pressure

Usually, the starting dose is 12.5 mg once a day for two days.
After two days, the dose is usually 25 mg once a day.
If blood pressure is not sufficiently controlled, your doctor may slowly increase the dose over several weeks to 50 mg per day.
In elderly patients, a dose of 12.5 mg per day is often sufficient to control blood pressure.

Angina pectoris

Adults
Usually, the starting dose is 12.5 mg twice a day for two days.
After two days, the dose is usually 25 mg twice a day.
Elderly patients
Your doctor will decide on the starting dose and the most suitable dose for long-term use.
Usually, the maximum dose is 25 mg twice a day.

Use in children and adolescents

Coryol is not intended for use in children under 18 years of age.

Taking a higher dose of Coryol than recommended

If you take more Coryol than you should or if someone else takes your medicine, contact your doctor or go to the hospital immediately. Take the medicine package with you.
If you take more tablets than recommended, you may experience symptoms such as: slow heart rate, dizziness or feeling faint, shortness of breath, wheezing, or feeling very tired.

Missing a dose of Coryol

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

• Do not take a double dose to make up for a forgotten dose.

Stopping Coryol

Do not stop taking Coryol suddenly, especially in patients with coronary artery disease .Your doctor may decide to discontinue Coryol, gradually reducing the dose over 2 weeks.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect up to 1 in 10 people):

dizziness;
headache;
feeling weak and tired;
heart failure (a condition in which the heart does not supply blood in sufficient quantities to meet the body's needs) - symptoms include: feeling tired, shortness of breath, swelling of hands and feet;
low blood pressure - symptoms include dizziness or feeling faint.
Dizziness, headache, weakness, or feeling tired are usually mild.

Common (may affect up to 1 in 10 people):

bronchitis, pneumonia, upper respiratory tract infections - symptoms include: cough, wheezing, difficulty breathing, sore throat;
urinary tract infections, which can cause difficulty urinating;
asthma (in susceptible patients), shortness of breath, pulmonary edema (fluid accumulation in the lungs);
low red blood cell count (anemia) - symptoms include: feeling tired, pale skin, rapid heartbeat, and shortness of breath;
weight gain;
increased cholesterol level (detected in a blood test);
worsening control of blood sugar levels in people with diabetes;
depression;
vision disorders, eye pain, or dryness due to reduced tear secretion;
slow heart rate;
fainting, pre-fainting state:
orthostatic hypotension (dizziness or fainting when standing up);
fluid retention in the body - symptoms include: generalized swelling, swelling of body parts (e.g., hands, feet, ankles, and legs), and increased blood volume in the body;
circulatory disorders in the hands and feet - symptoms include: cold hands and feet, paleness, tingling, and pain in the fingers and toes, as well as pain in the legs that worsens when walking;
nausea or vomiting;
diarrhea;
indigestion;
stomach pain;
pain, including limb pain;
kidney function disorders and kidney failure, urination disorders;
high blood pressure.

Uncommon (may affect up to 1 in 100 people):

• heart conduction disorders, angina pectoris (chest pain due to insufficient blood supply to the heart);
• sleep disorders;
• tingling or numbness of hands or feet;
• skin reactions, including rash, hives, itching, skin inflammation, skin peeling;
• hair loss;
• impotence;
• constipation.

Rare (may affect up to 1 in 1,000 people):

low platelet count - symptoms include: bruising and bleeding, e.g., nosebleeds;
nasal congestion (feeling of a blocked nose);
dryness of the mucous membrane of the mouth.

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

low white blood cell count - symptoms include: mouth, gum, throat, and lung infections;
allergic reactions (hypersensitivity) - symptoms may include: difficulty breathing or swallowing due to sudden swelling of the throat or larynx, severe skin reactions (with skin redness, blistering, and peeling);
liver function disorders (detected in a blood test);
some women may experience difficulty controlling the bladder while urinating (urinary incontinence). This condition usually improves after stopping treatment.
Severe skin diseases (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) may occur. Redness, often associated with blisters, may appear on the skin or mucous membranes, such as the inside of the mouth, genital areas, or eyelids. They may initially look like round spots, often with central blisters, which can lead to widespread skin peeling and can be life-threatening. These serious skin reactions are often preceded by headache, fever, and body aches (flu-like symptoms).

Not known (frequency cannot be estimated from the available data)

Coryol may also cause the development of signs of diabetes in people with very mild diabetes ("latent diabetes").
There have been reports of hallucinations in patients taking Coryol.
Excessive sweating (hyperhidrosis) may occur.
If any of the side effects get worse or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Coryol

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Coryol contains

• The active substance of Coryol is carvedilol. Each tablet contains 6.25 mg of carvedilol.
• The other ingredients of the medicine are lactose monohydrate, sucrose, crospovidone, povidone K25, colloidal anhydrous silica, and magnesium stearate.

What Coryol looks like and contents of the pack

Oval, slightly convex, white tablets with the marking S2 on one side and a dividing line on the other side.

Pack sizes:

30 tablets in blisters, in a cardboard box.

Marketing authorization holder and manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on the medicine, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
tel. 22 57 37 500
Date of last revision of the leaflet:23.11.2023