Coryol 6.25 mg

Package leaflet: Information for the user

Coryol 6.25 mg tablets
Carvedilolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist immediately. See section 4.

Contents of the leaflet:

1. What Coryol is and what it is used for
2. What you need to know 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 Coryol is and what it is 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 tone of blood vessel walls and by dilating blood vessels:
this helps lower blood pressure;
in chronic heart failure, it helps the heart pump blood throughout the body;
in angina pectoris, it helps relieve chest pain.
In addition to Coryol, the doctor may also prescribe other medicines to help treat the patient's condition.

2. Important information before using Coryol

When not to use Coryol:

• if the patient is allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6);
• in case of recent worsening of heart failure (significant fluid retention or breathing difficulties, even while sitting) and intravenous administration of drugs supporting heart function;
• if the patient currently has or has previously had wheezing due to bronchial asthma or chronic obstructive pulmonary disease;
• if the patient has liver function disorders;
• if the patient without a cardiac pacemaker has cardiac conduction disorders (e.g. second- or third-degree atrioventricular block) or slow heart rate (less than 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 disorders in impulse conduction in the heart);
• in cardiogenic shock (severe heart dysfunction);
• if the patient has very low blood pressure (systolic blood pressure <85 mmHg);
• if the patient has excessive blood acid levels ("metabolic acidosis");
• if the patient has untreated adrenal gland tumor ("pheochromocytoma");
• if the patient has been diagnosed with Prinzmetal's angina (chest pain caused by coronary artery spasm);
• in severe peripheral arterial circulation disorders (arteries are damaged or blocked and unable to distribute blood);
• during intravenous treatment with verapamil or diltiazem.

If in doubt, consult a doctor or pharmacist before taking Coryol.

Warnings and precautions

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

• the patient has chronic congestive heart failure;
• the patient has kidney function disorders;
• the patient has left ventricular dysfunction after acute myocardial infarction;
• the patient has ever had wheezing related to asthma or other lung diseases – carvedilol may be used only if expected benefits outweigh potential risks;
• the patient has diabetes;
• the patient wears contact lenses;
• the patient has peripheral vascular disease – beta-blockers may accelerate or worsen symptoms of arterial insufficiency;
• the patient has ever had thyroid disorders;
• the patient has previously experienced severe allergic reactions (e.g. sudden swelling causing breathing or swallowing difficulties, swelling of hands, feet and ankles, or severe rash), or if the patient is undergoing or planned for desensitization therapy;
• the patient has poor blood circulation in fingers and toes (Raynaud's syndrome);
• the patient is scheduled for surgery under general anesthesia – in such case, inform the anesthesiologist that the patient is taking Coryol;
• heart rate is below 55 beats per minute (bradycardia);
• the patient has first-degree atrioventricular block;
• the patient developed psoriasis after taking beta-blockers;
• the patient has angina pectoris known as Prinzmetal's angina, due to lack of experience with carvedilol in these patients;
• the patient has adrenal pheochromocytoma – before starting treatment with Coryol, the doctor will recommend using an alpha-adrenergic receptor blocker.

If any of the above conditions apply to the patient, or if in doubt, consult a doctor or pharmacist before taking Coryol.

Coryol and other medicines

Tell your doctor or pharmacist about all medicines currently taken, recently used, or planned for use. 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 migraine);
• calcium channel blockers (medicines used to treat heart rhythm disorders, e.g. verapamil or diltiazem) – when used concomitantly with Coryol, the doctor will recommend regular ECG and blood pressure monitoring;
• blood pressure-lowering medicines, so-called alpha-blockers (e.g. doxazosin or indoramine), or medicines that may cause hypotension as an adverse 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 drugs (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;
• drugs stimulating the central nervous system, e.g. rifampicin (used to treat tuberculosis), and drugs inhibiting hepatic metabolism, e.g. cimetidine (used to treat peptic ulcer and "hyperacidity");
• drugs reducing catecholamine levels, e.g. reserpine, used to treat high blood pressure, and monoamine oxidase inhibitors (MAO), 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 in heart rhythm disorders, e.g. amiodarone);
• ergotamine (used to treat migraine);
• anesthetic medicines.

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 blood concentration of the active substance carvedilol and cause unexpected adverse effects.

Do not drink alcohol during treatment, as alcohol may affect the action of Coryol.

Surgical procedures

Before undergoing surgery, inform the doctor about taking Coryol. This is because some anesthetic medicines may lower blood pressure, potentially causing it to become too low.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Do not use Coryol during pregnancy, when planning pregnancy, or during breastfeeding, unless otherwise advised by a doctor.

Coryol should not be used during breastfeeding.

Driving and operating machinery

Dizziness may occur while taking Coryol. This is most likely at the beginning of treatment, when dosage is changed, or after drinking alcohol. In such cases, do not drive or operate machinery. If other disturbances occur while taking Coryol that may negatively affect driving or operating machinery, consult a doctor.

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

Each tablet contains 72.25 mg of monohydrate lactose and 5 mg of sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

3. How to take Coryol

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The tablet should be swallowed with liquid.

Chronic heart failure
When used for heart failure, treatment with Coryol should be initiated by a specialist doctor.
The tablets should be taken at the same time each day, during a meal.
The usual starting dose is one 3.125 mg tablet twice daily for two weeks.
Your doctor will then gradually increase the dose over several weeks (up to 25 mg twice daily).
In patients with body weight above 85 kg, the dose may be increased to 50 mg twice daily.
If treatment with Coryol is interrupted for more than two weeks, you should contact your doctor. Treatment will need to be restarted at the initial dose (see section "Stopping Coryol treatment").

High blood pressure
The usual starting dose is 12.5 mg once daily for two days.
After two days, the dose is usually increased to 25 mg once daily.
If blood pressure is not adequately controlled, your doctor may slowly increase the dose over several weeks up to 50 mg daily.
In elderly patients, a dose of 12.5 mg daily is often sufficient to control blood pressure.

Angina pectoris
Adults
The usual starting dose is 12.5 mg twice daily for two days.
After two days, the dose is usually increased to 25 mg twice daily.

Elderly patients
Your doctor will determine the appropriate starting dose and the most suitable long-term dose.
The usual maximum dose is 25 mg twice daily.

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

Taking more Coryol than prescribed
If you take more Coryol than prescribed, or if someone else takes this medicine, contact your doctor immediately or go to hospital. Take the medicine pack with you.
If too many tablets are taken, the following symptoms may occur, among others: slowing of the heartbeat, dizziness or feeling faint, shortness of breath, wheezing, or extreme tiredness.

If you miss 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 treatment
Do not stop taking Coryol suddenly, especially if you have ischaemic heart disease. Your doctor may decide to discontinue Coryol gradually by reducing the dose over a 2-week period.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Very common (may occur in at least 1 in 10 patients):
dizziness;
headache;
feeling of weakness and fatigue;
heart failure (a condition in which the heart does not supply enough blood 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 occur in less than 1 in 10 patients):
bronchitis, pneumonia, upper respiratory tract infections – symptoms include:
cough, wheezing, difficulty breathing, sore throat;
urinary tract infections, which may cause difficulty passing urine;
asthma (in susceptible patients), shortness of breath, pulmonary oedema (fluid accumulation in the lungs);
low number of red blood cells (anaemia) – symptoms include: feeling tired, pale skin, palpitations, and shortness of breath;
weight gain;
increased cholesterol levels (detected in blood tests);
worsening of blood sugar control in people with diabetes;
low mood (depression);
vision disorders, eye pain or dry eyes due to reduced tear production;
slowing of heart rate;
fainting, pre-syncope (near-fainting);
orthostatic hypotension (dizziness or faintness upon standing);
fluid retention in the body – symptoms include: generalized swelling of the body, swelling of body parts (e.g. hands, feet, ankles and legs), and increased blood volume;
circulatory disorders in arms and legs – symptoms include: cold hands and feet, paleness, tingling and pain in fingers, and leg pain worsening during walking;
nausea or vomiting;
diarrhoea;
indigestion;
abdominal pain;
pain, including limb pain;
kidney function disorders and kidney failure, disorders of urine excretion;
high blood pressure.

Uncommon (may occur in less than 1 in 100 patients):

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

Rare (may occur in less than 1 in 1000 patients):
low platelet count – symptoms include: bruising and bleeding, e.g. from the nose;
nasal mucosa oedema (feeling of nasal congestion);
dryness of the oral mucosa.

Very rare (may occur in less than 1 in 10,000 patients):
low 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 larynx, severe skin reactions (with skin redness, blister formation and skin peeling);
liver function disorders (detected in blood tests);
some women may experience difficulty controlling the bladder during urination (urinary incontinence). This condition usually improves after stopping treatment.

Severe skin diseases may occur (e.g. erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis). Redness, often with blisters, may appear on the skin or mucous membranes, such as inside the mouth, genital area or eyelids. These may initially look like round spots, often with central blisters, which may 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).

Unknown (frequency cannot be estimated from available data)
Coryol may also cause the development of symptoms of diabetes in people with very mild forms of diabetes (‘latent diabetes’).
There have been reports of hallucinations in patients taking Coryol.
Excessive sweating (hyperhidrosis) may occur.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Coryol

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Coryol contains

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

What Coryol looks like and contents of the pack
Oval, slightly biconvex, white tablets marked with "S2" on one side and a division line on the other side.
Available pack sizes:
30 tablets in blister packs, in a cardboard box.
Marketing Authorisation Holder and Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw, Poland
tel. 22 57 37 500