Coriol 3,125 mg

Package Leaflet: Information for the Patient

Coryol 3.125 mg, tablets

Coryol 12.5 mg, tablets

Coryol 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 tell your doctor or pharmacist. See section 4.

Table of Contents of the 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 that occurs when the heart does not receive enough oxygen).
Coryol works by relaxing and widening 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 body.
In the case of angina pectoris, it helps to stop 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);
• if you have severe heart failure that has recently worsened (significant fluid retention or difficulty breathing, even when sitting) and are taking intravenous medicines to support heart function;
• if you have had breathing difficulties related to asthma or chronic obstructive pulmonary disease in the past;
• if you have liver problems;
• if you have certain specific heart defects [called atrioventricular (AV) block II or III degree (unless a permanent pacemaker has been implanted) or sinoatrial block];
• if you have severe heart function disorders (cardiogenic shock);
• if you have a very slow heart rate;
• if you have very low blood pressure;
• if you have acid-base balance disorders in the blood (metabolic acidosis);
• if you have a tumor on one of the adrenal glands (pheochromocytoma) that is not being treated;
• if you have a condition called Prinzmetal's angina (chest pain that occurs at rest);
• if you have severe peripheral artery disease (the arteries have been damaged or blocked and cannot distribute blood);
• if you are taking verapamil or diltiazem intravenously.

If you are unsure before taking Coryol, consult your doctor or pharmacist.

Warnings and precautions

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

• you have unstable heart function after a heart attack;
• you have kidney problems;
• you have diabetes (high blood sugar levels);
• you wear contact lenses;
• you have blood vessel problems (peripheral vascular disease);
• you have had thyroid problems in the past;
• you have had a severe allergic reaction (e.g., sudden swelling causing difficulty breathing or swallowing, swelling of the hands, feet, and ankles, or severe rash);
• you have an allergy or are undergoing desensitization treatment;
• you have circulation problems in your fingers and toes (Raynaud's phenomenon);
• you have had psoriasis after taking beta-blockers;
• you have Prinzmetal's angina;
• you have poor metabolism of debrisoquine (a substance that acts on nerves to lower blood pressure); your doctor will monitor you closely at the start of treatment.

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

Coryol with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. This includes medicines that are available without a prescription and herbal medicines. This is because Coryol may affect the action of other medicines, and some other medicines may affect the action of Coryol.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
other medicines for heart disease or high blood pressure, including diuretics, calcium channel blockers (e.g., diltiazem, verapamil), or medicines that regulate irregular heartbeat (e.g., amiodarone and digoxin);
medicines that reduce the level of catecholamines (e.g., reserpine and monoamine oxidase inhibitors (MAOIs) such as isocarboxazid and phenelzine [used to treat depression]), fluoxetine, and paroxetine (used to treat depression);
antidiabetic medicines, such as insulin or metformin;
clonidine (used to treat high blood pressure, migraine, and hot flashes during menopause);
rifampicin (used to treat infections);
cimetidine (used to treat indigestion, heartburn, and stomach ulcers);
cyclosporine or tacrolimus (used after organ transplants);
non-steroidal anti-inflammatory medicines (NSAIDs);
estrogens (used in hormone replacement therapy);
corticosteroids (used to reduce inflammation or allergic reactions);
ergotamine (used to treat migraine);
medicines that dilate the airways (used to treat chest tightness and shortness of breath associated with asthma or other respiratory diseases).

Coryol with food, drink, and alcohol

Avoid taking Coryol with grapefruit or grapefruit juice. Grapefruit or grapefruit juice may increase the level of the active substance carvedilol in the blood and cause unpredictable side effects.
Do not drink alcohol while taking Coryol. This may cause too great a decrease in blood pressure and increase the risk of side effects.

Surgery

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Unless your doctor advises otherwise, do not take Coryol during pregnancy, planning a pregnancy, or breastfeeding.
Do not breastfeed while taking Coryol.

Driving and using machines

While taking Coryol, dizziness may occur. This is most likely to happen at the start of treatment, when changing the dose, or after drinking alcohol. In this case, do not drive or operate machinery. If you experience other problems that may have a negative impact on driving or operating machinery while taking Coryol, consult your doctor.

Coryol contains lactose monohydrate and sucrose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Coryol

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.
Swallow the tablet with a drink of water.
The 12.5 mg and 25 mg tablets can be divided into equal doses.

Chronic heart failure:

Treatment with Coryol should be started by a specialist doctor.
Take the tablets at the same time every day 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 (187 pounds), the dose may be increased to 50 mg twice a day.
If you stop taking Coryol for more than two weeks, consult your doctor. You will need to return to the starting dose (see the section "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 your blood pressure is not well controlled, your doctor may slowly increase the dose over several weeks to 50 mg a day.
In elderly patients, a dose of 12.5 mg a 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 best dose for long-term treatment.
Usually, the maximum dose is 50 mg a day, given in divided doses.

Use in children and adolescents

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

Taking more than the recommended dose of Coryol

If you take more than the recommended dose of Coryol or if someone else takes your medicine, consult your doctor or go to the hospital. Take the medicine pack with you.
If you take more tablets than recommended, you may experience the following symptoms: slow heart rate, dizziness or feeling of emptiness in the head, shallow breathing, wheezing, or severe fatigue.

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 missed dose.

Stopping Coryol

Do not stop taking Coryol without consulting your doctor.Your doctor may decide to gradually stop Coryol over a period of 1 to 2 weeks.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Very common side effects (may affect more than 1 in 10 people):

Dizziness.
Headache.
Feeling weak and tired.
Heart problems. Symptoms include: chest pain, fatigue, shortness of breath, swelling of the hands and feet.
Low blood pressure. Symptoms include: dizziness or feeling of emptiness in the head.
Dizziness, headache, weakness, or fatigue are usually mild and most likely to occur at the start of treatment.

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

Respiratory tract infections (bronchitis), pneumonia, infections of the nose and throat (upper respiratory tract infections). Symptoms include: wheezing, shortness of breath, chest tightness, and sore throat.
Urinary tract infections, which can cause difficulty urinating.
Low red blood cell count (anemia). Symptoms include: feeling tired, pale skin, feeling of heart palpitations, and shortness of breath.
Weight gain.
Increased cholesterol levels (confirmed by blood tests).
Loss of control of blood sugar levels in people with diabetes.
Depression.
Fainting.
Vision problems, eye pain, or dry eyes due to reduced tear production.
Slow heart rate.
Dizziness or feeling of emptiness in the head when standing up.
Fluid retention. Symptoms include: generalized swelling of the body, swelling of parts of the body (e.g., hands, feet, ankles, and legs), and increased blood volume.
Circulation problems in the hands and feet. Symptoms include: cold hands and feet, paleness, tingling, and pain in the fingers and toes, and leg pain that worsens when walking.
Breathing problems.
Nausea or vomiting.
Diarrhea.
Indigestion.
Pain, probably in the hands and feet.
Kidney problems, including changes in urination frequency.
Hypertension

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

Sleep disorders.
Numbness or tingling of the hands or feet.
Skin problems, including rashes that can cover large areas of the body, hives, itching, and dry skin.
Hair loss.
Erectile dysfunction.
Constipation.

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

Low platelet count. Symptoms include: bruising and nosebleeds.
Nasal congestion (feeling of a blocked nose).
Dry mouth.
Flu-like symptoms.
Urination problems.

Very rare side effects (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 face, or swelling of the hands, feet, and ankles, or severe skin reactions.
Liver problems confirmed by blood tests.
Some women may experience difficulty controlling their bladder when urinating (urinary incontinence). This 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 area, or eyelids. They may initially look like round spots, often with central blisters, which can lead to widespread skin peeling and may be life-threatening. These serious skin reactions are often preceded by headache, fever, and body aches (flu-like symptoms).

Frequency 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.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please 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:
Jerozolimskie Avenue 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.
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.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store in the original packaging.
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. Contents of the pack and other information

What Coryol contains

• The active substance of Coryol is carvedilol. Each tablet contains 3.125 mg, 12.5 mg, or 25 mg of carvedilol.
• The other ingredients are lactose monohydrate, sucrose, crospovidone, povidone K25, colloidal anhydrous silica, and magnesium stearate (see section 2 Coryol contains lactose monohydrate and sucrose).

What Coryol looks like and contents of the pack

3.125 mg: round, slightly convex, white tablets with beveled edges.
12.5 mg: oval, slightly convex, white tablets with the marking S3 on one side and a score line on the other side.
25 mg: round, slightly convex, white tablets with beveled edges and a score line on one side.
The 12.5 mg and 25 mg tablets can be divided into equal doses.
Packaging:20 or 30 tablets in blisters, in a cardboard box.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
phone: 22 57 37 500
Date of last revision of the leaflet:05.08.2024