Coryol 3,125 mg

Package leaflet: Information for the patient

Coryol 3.125 mg, tablets
Coryol 12.5 mg, tablets
Coryol 25 mg, tablets
Carvedilolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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 an active substance called carvedilol. It belongs to a group of medicines known as 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 relaxing and widening blood vessels.
This helps lower blood pressure.
In chronic heart failure, it helps the heart pump blood more effectively around the body.
In angina pectoris, it helps relieve chest pain.
In addition to Coryol, your doctor may prescribe other medicines to help treat your condition.

2. Important information before using Coryol

When not to use Coryol

• if the patient is allergic to carvedilol or to 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);
• if the patient has previously experienced breathing difficulties associated with asthma or obstructive lung disease;
• if the patient has liver problems;
• if the patient has certain specific heart abnormalities [called second- or third-degree atrioventricular (AV) block (unless a permanent pacemaker has been implanted) or sinoatrial block];
• if the patient has severe cardiac dysfunction (cardiogenic shock);
• if the patient has a very slow heart rate;
• if the patient has very low blood pressure;
• if the patient has disturbances in blood acid levels ("metabolic acidosis");
• if the patient has a tumor of one of the adrenal glands ("pheochromocytoma") that is untreated;
• if the patient has a condition called Prinzmetal's angina (chest pain occurring at rest);
• if the patient has severe peripheral arterial disorders (arteries are damaged or blocked and unable to distribute blood);
• when receiving intravenous verapamil or diltiazem.

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

Warnings and precautions

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

• the patient has unstable cardiovascular function after a heart attack;
• the patient has kidney problems;
• the patient has diabetes (high blood sugar levels);
• the patient wears contact lenses;
• the patient has blood vessel problems (peripheral vascular disease);
• the patient has previously had thyroid problems;
• the patient has previously experienced a severe allergic reaction (e.g. sudden swelling causing breathing or swallowing difficulties, swelling of hands, feet and ankles, or severe rash);
• the patient has allergies or is undergoing desensitization treatment;
• the patient has poor blood circulation in fingers and toes (Raynaud's phenomenon);
• the patient has developed psoriasis after taking beta-blockers;
• the patient has angina pectoris known as Prinzmetal's angina;
• the patient has been diagnosed with poor metabolism of debrisoquine (a substance that lowers blood pressure by acting on nerves); the doctor will closely monitor the patient at the beginning of treatment.

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

Coryol and other medicines

Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take. This includes over-the-counter medicines and herbal products. 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:

• other medicines used for heart conditions or high blood pressure, including: diuretics, calcium channel blockers (e.g. diltiazem, verapamil), or medicines regulating irregular heartbeat (e.g. amiodarone and digoxin);
• medicines that reduce catecholamine levels (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 flushes 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 drugs (NSAIDs);
• estrogens (used in hormone replacement therapy);
• corticosteroids (used to reduce inflammation or allergic reactions);
• ergotamine (used to treat migraine);
• bronchodilators (used to treat chest tightness and breathlessness associated with asthma or other respiratory diseases).

Coryol with food, drink, and alcohol

Avoid consuming grapefruit or grapefruit juice at the same time or immediately before or after taking Coryol. Grapefruit or grapefruit juice may increase the blood concentration of the active substance carvedilol and cause unpredictable adverse effects.

Do not drink alcohol while taking Coryol. Alcohol may cause excessive lowering of blood pressure and increase the risk of adverse effects.

Surgery

Before undergoing surgery, inform the doctor that you are taking Coryol. This is because some painkillers may lower blood pressure, and its level may become too low.

Pregnancy and breastfeeding

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

Unless otherwise advised by a doctor, Coryol should not be used during pregnancy, when planning pregnancy, or during breastfeeding.

Breastfeeding should not be undertaken while taking Coryol.

Driving and using machines

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

Coryol contains monohydrate lactose and sucrose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Coryol

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
The tablet should be swallowed with a drink.
The 12.5 mg and 25 mg tablets may be divided into equal doses.

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, together with food.
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 (187 lbs), the dose may be increased to 50 mg twice daily.
If treatment with Coryol has been interrupted for more than two weeks, you should consult your doctor.
Treatment must be restarted with the initial dose (see section "Stopping Coryol").

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 sufficiently 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 (chest pain):
Adults
The usual starting dose is 12.5 mg twice daily for two days.
After two days, the dose is usually 25 mg twice daily.

Elderly patients
Your doctor will decide the appropriate starting dose and the optimal long-term maintenance dose.
The usual maximum dose is 50 mg daily, administered in divided doses.

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

Taking more Coryol than you should
If you take more Coryol than prescribed, or if someone else takes this medicine by mistake, you should contact your doctor or go to a hospital immediately. Bring the medicine package with you.
If too many tablets are taken, the following symptoms may occur: slowing of the heartbeat, dizziness or lightheadedness, shallow breathing, wheezing, or severe fatigue.

If you forget to take 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 discontinue Coryol over a period of 1 to 2 weeks.
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 experiences them.

Very common adverse reactions (may occur in more than 1 in 10 patients):
Dizziness.
Headache.
Feeling of weakness and fatigue.
Heart problems. Symptoms include: chest pain, fatigue, shortness of breath, swelling of hands and feet.
Low blood pressure. Symptoms include: dizziness or a feeling of "emptiness in the head".
Dizziness, headache, weakness or fatigue are usually mild and most likely to occur at the beginning of treatment.

Common adverse reactions (may occur in up to 1 in 10 patients):
Respiratory tract infections (bronchitis), pneumonia, nose and throat infections (upper respiratory tract infections). Symptoms include: wheezing, shortness of breath, chest tightness, and sore throat.
Urinary tract infections, which may cause difficulty eliminating water from the body.
Low number of red blood cells (anaemia). Symptoms include: feeling of fatigue, pale skin, sensation of heart fluttering (palpitations), and shortness of breath.
Increase in body weight.
Increased cholesterol levels (confirmed by blood test).
Loss of blood sugar control in people with diabetes.
Depression.
Fainting.
Vision problems, eye pain or dryness due to reduced tear production.
Slowing of heart rate.
Dizziness or a feeling of "emptiness in the head" upon standing.
Fluid retention. Symptoms include: generalized body swelling, swelling of body parts (e.g.: hands, feet, ankles and legs), and increased blood volume in the body.
Circulatory problems in arms and legs. Symptoms include: cold hands and feet, paleness, tingling and pain in fingers, and leg pain worsening during walking.
Breathing difficulties.
Nausea or vomiting.
Diarrhoea.
Indigestion.
Pain, probably in the hands and feet.
Kidney problems, including changes in frequency of urination.
High blood pressure.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):
Sleep disturbances.
Tingling or numbness of hands or feet.
Skin problems, including rashes which may affect large areas of the body, urticaria, itching, and dry skin.
Hair loss.
Erectile dysfunction.
Constipation.

Rare adverse reactions (may occur in up to 1 in 1000 patients):
Low number of platelets. Symptoms include: bruising and nosebleeds.
Swelling of the nasal mucosa (feeling of blocked nose).
Dryness in the mouth.
Flu-like symptoms.
Urination disorders.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):
Low number of white blood cells. Symptoms include: infections of the mouth, gums, throat and lungs.
Allergic (hypersensitivity) reactions. Symptoms may include: difficulty breathing or swallowing due to sudden swelling of the throat or face, or swelling of hands, feet and ankles, or severe skin reactions.
Liver problems confirmed by 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 (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 appear as round spots, often with central blisters, which may lead to extensive peeling of the skin 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 available data)

• The medicine Coryol may also cause the development of diabetes symptoms 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.

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

5. How to store Coryol

Keep this 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 specified month.
Store in the original packaging.
Medicines must 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 is carvedilol. Each tablet contains 3.125 mg, 12.5 mg, or 25 mg of carvedilol.
• The other ingredients are monohydrate lactose, sucrose, crospovidone, povidone K25, anhydrous colloidal silicon dioxide, and magnesium stearate (see section 2: Coryol contains monohydrate lactose and sucrose).

What Coryol looks like and contents of the pack
3.125 mg: round, slightly biconvex, white tablets with bevelled edges.
12.5 mg: oval, slightly biconvex, white tablets with the code S3 on one side and a division groove on the other side.
25 mg: round, slightly biconvex, white tablets with bevelled edges and a division groove on one side.
Tablets of 12.5 mg and 25 mg can be divided into equal doses.
Packaging: 20 or 30 tablets in blister packs, in a cardboard carton.
Marketing Authorisation 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
tel. 22 57 37 500