CARVEDILOL 6.25 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Carvedilol Orion, 6.25 mg, coated tablets
3. Carvedilol Orion, 12.5 mg, coated tablets
4. Carvedilol Orion, 25 mg, coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Carvedilol Orion and what is it used for
   1. Carvedilol Orion is used in:
6. Important information before taking Carvedilol Orion
   1. When not to take Carvedilol Orion:
   2. Warnings and precautions
   3. Carvedilol Orion and other medicines
   4. Taking carvedilol:
   5. Carvedilol Orion with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
7. How to take Carvedilol Orion
   1. Hypertension
   2. Angina pectoris
   3. Heart failure
   4. Patients with liver function disorders
   5. Children and adolescents (under 18 years of age)
   6. Overdose of Carvedilol Orion
   7. Missed dose of Carvedilol Orion
   8. Stopping treatment with Carvedilol Orion
8. Possible side effects
   1. Very common: may affect more than 1 in 10 people
   2. Common: may affect up to 1 in 10 people
   3. Uncommon: may affect up to 1 in 100 people
   4. Rare: may affect up to 1 in 1,000 people
   5. Very rare: may affect up to 1 in 10,000 people
   6. Reporting side effects
9. How to store Carvedilol Orion
10. Contents of the packaging and other information
    1. What Carvedilol Orion contains
    2. What Carvedilol Orion looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: information for the user

Carvedilol Orion, 6.25 mg, coated tablets

Carvedilol Orion, 12.5 mg, coated tablets

Carvedilol Orion, 25 mg, coated tablets

Carvedilol

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• You should consult a doctor or pharmacist if you have any doubts.
• 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 you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Carvedilol Orion and what is it used for

Carvedilol Orion belongs to a group of medicines called beta-blockers, which have a relaxing and vasodilating effect, making it easier for the heart to pump blood into the body and lowering blood pressure and reducing the resistance that the heart has to overcome when pumping blood.

Carvedilol Orion is used in:

• treatment of high blood pressure (hypertension),
• treatment of chest pain that occurs when the arteries that supply oxygenated blood to the heart become narrowed, resulting in less oxygen being delivered to the heart muscle (angina pectoris),
• treatment of weakened heart muscle (heart failure), in combination with other medicines.

2. Important information before taking Carvedilol Orion

When not to take Carvedilol Orion:

• if the patient is allergicto carvedilol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has had breathing difficulties due to asthma or other lung disease,
• if the patient has had severe chronic heart failure and has been treated with certain intravenous medicines,
• if the patient has liver disease,
• if the patient has a slow heart rate,
• if the patient has very low blood pressure,
• if the patient has a blood clot in the lungs, causing chest pain and shortness of breath (pulmonary embolism),
• if the patient has a condition called Prinzmetal's angina,
• if the patient has a tumor of the adrenal gland (pheochromocytoma) that has not been treated,
• if the patient has had severe skin reactions with blistering of the skin, mouth, eyes, and genitals (toxic epidermal necrolysis, TEN) and Stevens-Johnson syndrome (SJS) while taking carvedilol,
• if the patient has severe metabolic acidosis,
• if the patient has very poor blood circulation in the hands and feet, causing a feeling of coldness and pain,
• if the patient has certain types of heart conduction disorders (e.g., second- or third-degree atrioventricular block [unless the patient has a pacemaker] or sick sinus syndrome),
• if the patient is taking monoamine oxidase inhibitors (MAOIs) (used to treat depression),
• if the patient is currently being treated with intravenous verapamil or diltiazem (used to treat high blood pressure or heart disease),
• if the patient is breastfeeding.

If any of the above situations apply to the patient, they should not take Carvedilol Orion.

Warnings and precautions

Before starting to take Carvedilol Orion, the patient should discuss it with their doctor or pharmacist

• if the patient has other heart diseases,
• if the patient has or has had liver, kidney, or thyroid disease,
• if the patient has diabetes. Carvedilol Orion may mask the symptoms of low blood sugar,
• if the patient has a skin disease called psoriasis,
• if the patient has poor circulation affecting the hands, feet, or lower legs or Raynaud's syndrome,
• if the patient has had a severe allergic reaction or is undergoing desensitization treatment for any allergy,
• if the patient wears contact lenses, as Carvedilol Orion may cause increased dryness of the eyes.

Carvedilol Orion and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.

Taking carvedilol:

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those bought without a prescription or herbal products. It is especially important to inform the doctor if the patient is currently being treated with any of the following medicines:

• medicines used to treat irregular heartbeats (diltiazem, verapamil, or amiodarone),
• nitrates used to treat angina (e.g., isosorbide mononitrate or glyceryl trinitrate),
• medicines used to treat heart failure (e.g., digoxin),
• other medicines that lower blood pressure (e.g., doxazosin, reserpine, amlodipine, or indoramin),
• medicines used to treat depression and other mental disorders (e.g., fluoxetine, paroxetine, tricyclic antidepressants, barbiturates, phenothiazine derivatives, haloperidol, or monoamine oxidase inhibitors [MAOIs]),
• medicines used to prevent the rejection of a transplanted organ (e.g., cyclosporine or tacrolimus),
• medicines that lower blood sugar, such as oral antidiabetic medicines or insulin,
• medicines used to lower blood pressure or treat migraines (e.g., clonidine or ergotamine),
• certain painkillers, such as nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen and diclofenac),
• hormone replacement therapy (e.g., estrogens),
• corticosteroids used to suppress inflammation or allergic reactions (e.g., prednisolone),
• medicines used to treat bacterial infections (e.g., rifampicin or erythromycin),
• medicines used to treat stomach ulcers, heartburn, and gastroesophageal reflux (e.g., cimetidine),
• medicines used to treat fungal infections (e.g., ketoconazole),
• medicines that reduce congestion, sometimes used to treat coughs and colds (e.g., ephedrine and pseudoephedrine).

Before undergoing surgery with anesthesia, the patient should inform their doctor about taking Carvedilol Orion.

Carvedilol Orion with food, drink, and alcohol

Carvedilol Orion should be taken with water.
If the patient is taking Carvedilol Orion for heart failure, they should take it with water during meals (see section 3: "How to take Carvedilol Orion").
The patient should avoid drinking grapefruit juice at the same time as or immediately after taking Carvedilol Orion.
Grapefruit or its juice may increase the levels of the active substance carvedilol in the blood and cause unpredictable increases in the frequency of side effects.
The patient should not drink alcohol while taking Carvedilol Orion, as it may increase the effects of alcohol.

Pregnancy, breastfeeding, and fertility

The patient should not takethis medicine without first consulting their doctor if they are pregnant or breastfeeding.
The patient should contact their doctor immediately if they become pregnant while taking this medicine.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

While taking Carvedilol Orion, the patient may experience dizziness or fatigue.
This is most likely to happen at the beginning of treatment or when the dose is changed.
In such cases, the patient should not drive or operate machinery.
The patient should avoid drinking alcohol, as it may worsen these symptoms.
If the patient is unsure or wants more information, they should talk to their doctor.
Carvedilol Orioncontains lactose and sucrose (certain types of sugars). If the patient has intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Carvedilol Orion

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist.
Carvedilol Orion should be swallowed with water.

Hypertension

Adults:The usual starting dose is 12.5 mg once daily for the first two days, and then 25 mg once daily. If necessary, the doctor may gradually increase the dose at intervals of at least two weeks. The recommended maximum daily dose is 50 mg (the recommended maximum single dose is 25 mg).
Elderly patients:The doctor will usually prescribe a starting dose of 12.5 mg once daily and continue treatment at an unchanged level throughout the treatment period. If necessary, the doctor may gradually increase the dose at intervals of at least two weeks.

Angina pectoris

Adults:The usual starting dose is 12.5 mg twice daily for the first two days, and then 25 mg twice daily. If necessary, the doctor may gradually increase the dose at intervals of at least two weeks to a maximum dose of 100 mg daily in two divided doses.
Elderly patients:The recommended starting dose is 12.5 mg twice daily for the first two days, and then 25 mg twice daily, which is the recommended maximum daily dose.

Heart failure

Adults and elderly patients:In the treatment of stable heart failure, the tablets should be taken twice daily, in the morning and evening. The tablets should be taken with food to reduce the risk of side effects.
The starting dose is 3.125 mg twice daily for two weeks. The doctor may gradually increase the dose at intervals of at least two weeks to determine the optimal dose for the patient.
If the patient weighs less than 85 kg, the recommended maximum dose of Carvedilol Orion is 25 mg twice daily, and if the patient weighs more than 85 kg, the doctor may increase the dose to 50 mg twice daily.
In the treatment of heart failure, it is recommended that treatment with Carvedilol Orion be initiated and monitored by a hospital doctor.
If the patient has stopped taking Carvedilol Orion for more than two weeks, they will need to return to the starting dose and gradually increase it again.
Sometimes, heart failure may worsen during treatment with Carvedilol Orion, especially at the beginning of treatment. This may worsen subjective symptoms (e.g., fatigue, difficulty breathing) and objective symptoms of fluid retention (e.g., weight gain and swelling of the legs).
If the patient experiences such symptoms or their condition worsens while taking Carvedilol Orion, they should inform their doctor, as this may require a change in the dose of other medicines or Carvedilol Orion.
While taking Carvedilol Orion, the patient should ensure that they take their other heart failure medicines as prescribed by their doctor.

Patients with liver function disorders

Depending on the patient's condition, the doctor may reduce the dose compared to the recommended dose above.

Children and adolescents (under 18 years of age)

Carvedilol Orion is not intended for use in this age group.

Overdose of Carvedilol Orion

In case of accidental ingestion of more than the recommended amount of tablets, the patient should immediately contact their doctor or go to the nearest hospital emergency department. The patient may experience dizziness, nausea, fainting, shortness of breath or difficulty breathing, sinus node inhibition, or be very sleepy or have seizures.

Missed dose of Carvedilol Orion

If the patient forgets to take a dose, they should not worry. The missed dose should be taken as soon as they remember. However, if it is almost time for the next dose, the missed dose should be skipped. The next dose that the patient would normally take should be taken at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Carvedilol Orion

The patient should not suddenly stop taking Carvedilol Orion without consulting their doctor.
In case of sudden discontinuation of treatment, side effects may occur. The doctor will advise on how to gradually reduce the dose to stop treatment. If the patient is taking a medicine called clonidine, they should never stop treatment with either of these medicines without consulting their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Carvedilol Orion can cause side effects, although not everybody gets them.
Most side effects are dose-dependent and disappear after dose reduction or discontinuation of treatment. Some side effects may occur at the beginning of treatment and disappear spontaneously during continued treatment.
Carvedilol may also cause sinus node inhibition (a heart disease that causes very slow heartbeats or cardiac arrest) in predisposed patients (e.g., elderly patients or patients with pre-existing slow heart rate [bradycardia], sinoatrial node dysfunction, or heart conduction disorders).

Very common: may affect more than 1 in 10 people

dizziness,
headache,
fatigue,
low blood pressure,
heart failure.

Common: may affect up to 1 in 10 people

bronchitis, pneumonia, upper respiratory tract infections,
urinary tract infections,
low red blood cell count,
weight gain,
increased cholesterol levels,
loss of control of blood sugar levels in people with diabetes,
depression, sadness,
vision disturbances,
reduced tear production, eye irritation,
slow heart rate,
swelling (generalized swelling of the body, swelling of body parts), fluid overload, increased blood volume in the body,
dizziness when standing up quickly,
circulation problems (including cold hands and feet), arteriosclerosis, worsening of symptoms in patients with Raynaud's syndrome (successive blanching, cyanosis, and redness of fingers and toes, accompanied by pain), and intermittent claudication (pain in the legs that worsens during walking),
high blood pressure,
asthma and breathing difficulties,
fluid accumulation in the lungs,
diarrhea,
malaise, nausea, vomiting, abdominal pain, indigestion,
pain (e.g., in the arms and legs),
severe kidney failure and kidney function disorders in patients with arteriosclerosis and/or kidney function disorders,
urination difficulties.

Uncommon: may affect up to 1 in 100 people

sleep disturbances,
nightmares,
hallucinations,
confusion,
fainting,
abnormal sensations,
heart conduction disorders, angina pectoris (including chest pain),
certain types of skin reactions (e.g., allergic dermatitis, urticaria, itching, and skin rash, increased sweating, psoriatic or lichenoid skin changes),
hair loss,
impotence,
constipation.

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

low platelet count (thrombocytopenia),
dry mouth,
nasal congestion (feeling of nasal stuffiness).

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

low white blood cell count,
allergic reactions,
psychosis,
changes in liver function test results,
difficulty controlling the bladder during urination in women (urinary incontinence),
skin rash that may cause blisters and looks like small targets (erythema multiforme),
widespread rash with blisters and peeling skin, mainly on the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome),
a more severe form causing widespread skin peeling (more than 30% of the body surface – toxic epidermal necrolysis).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their 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 181 C, 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, more information can be collected on the safety of the medicine.

5. How to store Carvedilol Orion

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label after: EXP:. The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Carvedilol Orion contains

• The active substance of the medicine is carvedilol. One tablet contains 6.25 mg, 12.5 mg, or 25 mg of carvedilol.
• The other ingredients are: lactose monohydrate, colloidal silica anhydrous, crospovidone (type A), crospovidone (type B), povidone (K-30), sucrose, magnesium stearate. Tablet coating: macrogol 400, polysorbate 80, titanium dioxide (E 171), hypromellose 5cps.

What Carvedilol Orion looks like and contents of the pack

Coated tablet
Carvedilol Orion 6.25 mg, coated tablets:
White or almost white coated tablets, oval, marked with the symbol "F57" on one side and a score line on the other side. The tablet can be divided into equal doses.
Carvedilol Orion 12.5 mg, coated tablets:
White or almost white coated tablets, oval, marked with the symbol "F58" on one side and a score line on the other side. The tablet can be divided into equal doses.
Carvedilol Orion 25 mg, coated tablets:
White or almost white coated tablets, oval, marked with the symbol "F59" on one side and a score line on the other side. The tablet can be divided into equal doses.
Blister:
Pack sizes: 30 and 100 coated tablets.
HDPE bottle:
Pack sizes: 30 and 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Orion Corporation,
Orion Pharma
Orionintie 1
FI-02200 Espoo
Finlandia
To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark
Carvedilol "Aurobindo"
Finland
Carvedilol Orion 6.25 mg/12.5 mg/25 mg tablets, coated
Spain
Carvedilol Aurobindo 6.25 mg film-coated tablets
Germany
Carvedilol Aurobindo 3.125 mg/6.25 mg/12.5 mg/25 mg film-coated tablets
Malta
Carvedilol 3.125 mg/6.25 mg/12.5 mg/25 mg film-coated tablets
Poland
Carvedilol Orion
Norway
Carvedilol Aurobindo 6.25 mg/12.5 mg/25 mg tablets, film-coated
Sweden
Carvedilol Aurobindo 6.25 mg/12.5 mg/25 mg film-coated tablets
Date of last revision of the leaflet:10.02.2023