Carvedilol orion

Package leaflet: Information for the user

Carvedilol Orion, 6.25 mg, film-coated tablets
Carvedilol Orion, 12.5 mg, film-coated tablets
Carvedilol Orion, 25 mg, film-coated tablets
Carvedilolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Carvedilol Orion is and what it is used for
2. What you need to know before you take Carvedilol Orion
3. How to take Carvedilol Orion
4. Possible side effects
5. How to store Carvedilol Orion
6. Contents of the pack and other information

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

Carvedilol Orion belongs to a group of medicines called beta-blockers, which also have blood vessel relaxing and dilating effects. These effects make it easier for the heart to pump blood around the body, lower blood pressure, and reduce the resistance the heart must overcome when pumping blood.
Carvedilol Orion is used for:

• treatment of high blood pressure (hypertension),
• treatment of chest pain caused by narrowing of the arteries supplying oxygen-rich blood to the heart, resulting in reduced oxygen supply 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 allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has previously experienced breathing difficulties due to asthma or another lung disease,
• if the patient has severe chronic heart failure and has experienced fluid retention (oedema) requiring treatment with certain intravenous (i.v.) medications,
• if the patient has liver disease,
• if the patient has a slowed 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 (acute pulmonary embolism),
• if the patient has been diagnosed with a condition called Prinzmetal's angina,
• if the patient has an untreated phaeochromocytoma (an adrenal gland tumour causing high blood pressure),
• if the patient has ever previously experienced severe skin reactions with blistering of the skin, mouth, eyes, and genital organs (toxic epidermal necrolysis, TEN) or Stevens-Johnson syndrome (SJS) while taking carvedilol,
• if the patient has severe acid-base balance disorders (metabolic acidosis),
• if the patient has very poor blood circulation in the hands and feet, causing coldness and pain,
• if the patient has certain types of heart conduction disorders (so-called second- or third-degree atrioventricular block [unless the patient has a cardiac pacemaker], or sick sinus syndrome),
• if the patient is taking monoamine oxidase inhibitors (MAO inhibitors) (used to treat depression),
• if the patient is currently receiving intravenous verapamil or diltiazem (used to treat high blood pressure or heart conditions),
• if the patient is breastfeeding.

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

Warnings and precautions

Before starting treatment with Carvedilol Orion, discuss this with your doctor or pharmacist:

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

Carvedilol Orion and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Use of carvedilol:

Tell your doctor or pharmacist about all medicines currently or recently taken, including over-the-counter medicines or herbal supplements. It is particularly important to inform your doctor if the patient is currently being treated with any of the following medicines:

• medicines used to treat heart rhythm disorders (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 indoramine),
• medicines used to treat depression and other psychiatric disorders (e.g., fluoxetine, paroxetine, tricyclic antidepressants, barbiturates, phenothiazine derivatives, haloperidol, or monoamine oxidase inhibitors (MAO inhibitors)),
• medicines used to prevent rejection of transplanted organs (e.g., cyclosporine or tacrolimus),
• medicines that reduce blood sugar levels, such as oral antidiabetic medicines or insulin,
• medicines used to lower blood pressure or treat migraine (e.g., clonidine or ergotamine),
• certain painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen and diclofenac),
• medicines used in hormone replacement therapy (e.g., estrogens),
• corticosteroids used to suppress inflammatory 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),
• decongestants sometimes used to treat cough and colds (e.g., ephedrine and pseudoephedrine).

Before undergoing any surgical procedure involving anaesthetics, inform the doctor that the patient is taking Carvedilol Orion.

Carvedilol Orion with food, drink, and alcohol

Take Carvedilol Orion with water.

If the patient is taking Carvedilol Orion for the treatment of heart failure, the medicine should be taken with food and water (see section 3: "How to take Carvedilol Orion").

Avoid drinking grapefruit juice at the same time or immediately after taking Carvedilol Orion. Grapefruit or its juice may increase the blood concentration of the active substance carvedilol and cause unpredictable increases in the frequency of adverse effects.

Do not drink alcohol while taking Carvedilol Orion, as this may enhance the effects of alcohol.

Pregnancy, breastfeeding, and fertility

Do not use this medicine without first consulting your doctor if the patient is pregnant or breastfeeding.

Contact your doctor immediately if the patient becomes pregnant while taking this medicine.

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

Driving and using machines

Dizziness or fatigue may occur while taking Carvedilol Orion. This is most likely at the beginning of treatment or when the dose is changed. In such cases, the patient should not drive or operate machinery. Avoid drinking alcohol, as it may worsen these symptoms. If the patient is unsure or wants more information, they should speak with their doctor.

Carvedilol Orion contains lactose and sucrose (certain types of sugars). If the patient has been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Carvedilol Orion

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your 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, followed by 25 mg once daily. If necessary, your doctor may gradually increase the dose at intervals of two weeks or longer. The recommended maximum daily dose is 50 mg (the recommended maximum single dose is 25 mg).
Elderly patients: Your doctor will usually prescribe an initial dose of 12.5 mg once daily and continue treatment at this unchanged dose throughout the treatment period. If necessary, your doctor may gradually increase the dose at intervals of two weeks or longer.

Angina pectoris
Adults: The usual starting dose is 12.5 mg twice daily for the first two days, followed by 25 mg twice daily. If necessary, your doctor may gradually increase the dose at intervals of two weeks or longer, up to a maximum daily dose of 100 mg, divided into two doses.
Elderly patients: The recommended starting dose is 12.5 mg twice daily for the first two days, followed by 25 mg twice daily, which represents the recommended maximum daily dose.

Heart failure
Adults and elderly patients: For the treatment of stable heart failure, tablets should be taken twice daily, in the morning and evening. Tablets should be taken with food to reduce the risk of adverse effects.
The starting dose is 3.125 mg twice daily for two weeks. Your doctor may gradually increase the dose at intervals of two weeks or longer until an optimal dose for the patient is established.
If the patient weighs less than 85 kg, the recommended maximum dose of Carvedilol Orion is 25 mg twice daily; if the patient weighs more than 85 kg, your doctor may increase the dose to 50 mg twice daily.
For the treatment of heart failure, it is recommended that Carvedilol Orion therapy be initiated and managed cautiously by a physician experienced in hospital practice.
If a patient has discontinued Carvedilol Orion for more than two weeks, treatment should be restarted at the initial dose, followed by gradual dose escalation.
Sometimes, heart failure may worsen during treatment with Carvedilol Orion, especially at the beginning of therapy. This may worsen subjective symptoms (e.g. fatigue, difficulty breathing) and objective signs of fluid retention (e.g. weight gain, leg swelling).
If such symptoms occur or the patient's condition worsens during treatment with Carvedilol Orion, the doctor should be informed, as this may require adjustment of the dosage of other medications or of Carvedilol Orion.
While taking Carvedilol Orion, the patient should ensure that other medications for heart failure are taken as prescribed by the doctor.

Patients with hepatic impairment
Depending on the patient's condition, the doctor may reduce the dose compared to the doses recommended above.

Children and adolescents (under 18 years of age)
Carvedilol Orion is not intended for use in this age group.

Taking more Carvedilol Orion than recommended
If an overdose is taken by accident, contact your doctor immediately or go to the nearest hospital emergency department. Symptoms may include dizziness, nausea, fainting, breathing difficulties or shortness of breath, sinus arrest, extreme drowsiness, or seizures.

If a dose of Carvedilol Orion is missed
If a patient forgets to take a dose, do not worry. The missed dose should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped. The next scheduled dose should be taken at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Carvedilol Orion
Do not stop taking Carvedilol Orion suddenly without consulting your doctor. Stopping treatment abruptly may cause adverse effects. Your doctor will advise how to gradually reduce the dose before stopping treatment completely. If the patient is also taking a medicine called clonidine, treatment with either of these medicines must never be stopped without consulting a doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Most adverse effects are dose-dependent and resolve after dose reduction or
discontinuation of treatment. Some adverse effects may occur at the beginning of treatment and
resolve spontaneously during continued treatment.
Carvedilol may also cause sinus depression (a heart condition leading to very
slow heartbeat or cardiac arrest) in predisposed patients (e.g. elderly patients or patients with pre-existing slow heart rate (bradycardia),
sinoatrial node dysfunction or disturbances in heart rhythm (atrioventricular block)).
Very common: may affect at least 1 in 10 people
dizziness,
headache,
fatigue,
low blood pressure,
heart failure.
Common: may affect less than 1 in 10 people
bronchitis, pneumonia, upper respiratory tract infections,
urinary tract infections,
low number of red blood cells,
weight gain,
increased cholesterol levels,
loss of blood sugar control in people with diabetes,
depression, low mood,
visual disturbances,
reduced tear production, eye irritation,
slowed heart rate,
oedema (generalised swelling, swelling of body parts), fluid overload, increased blood volume,
dizziness upon standing quickly,
circulatory problems (including cold hands and feet), arterial stiffness
(arteriosclerosis), worsening of symptoms in patients with Raynaud's syndrome (sequential bluish discoloration of fingers and toes, followed by pallor and then redness with pain) and claudication (leg pain that worsens during walking),
hypertension,
asthma and breathing difficulties,
fluid accumulation in the lungs,
diarrhoea,
malaise, vomiting, abdominal pain, indigestion,
pain (e.g. in arms and legs),
severe kidney failure and kidney function disorders in patients with arteriosclerosis and (or)
kidney function disorders,
difficulty urinating.
Uncommon: may affect less than 1 in 100 people
sleep disturbances,
nightmares,
hallucinations,
confusion,
fainting,
abnormal feelings,
conduction disorders of the heart, angina pectoris (including chest pain),
certain types of skin reactions (e.g. allergic dermatitis, urticaria, itching and skin inflammation, increased sweating, psoriatic or lichenoid skin lesions),
hair loss,
impotence,
constipation.
Rare: may affect less than 1 in 1000 people
low platelet count (thrombocytopenia),
dry mouth,
nasal mucosal swelling (nasal congestion).
Very rare: may affect less than 1 in 10,000 people
low white blood cell count,
allergic reactions,
psychoses,
changes in liver function test results,
difficulty controlling the bladder during urination in women (urinary incontinence),
skin rash which may cause blistering and resemble target lesions (a dark centre surrounded by a lighter area and a dark outer ring – erythema multiforme),
widespread blistering rash with skin peeling, mainly affecting the area around the mouth,
nose, eyes and genital organs ( Stevens-Johnson syndrome ),
a more severe form causing extensive skin detachment (affecting over 30% of body surface – toxic epidermal necrolysis ).
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Carvedilol Orion

Keep the medicine out of the 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 stated month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Carvedilol Orion contains

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

What Carvedilol Orion looks like and contents of the pack
Film-coated tablet
Carvedilol Orion 6.25 mg, film-coated tablets:
White or almost white, oval film-coated tablets, marked with the code "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, film-coated tablets:
White or almost white, oval film-coated tablets, marked with the code "F58" on one side and a score line on the other side. The tablet can be divided into equal doses.
Carvedilol Orion 25 mg, film-coated tablets:
White or almost white, oval film-coated tablets, marked with the code "F59" on one side and a score line on the other side. The tablet can be divided into equal doses.
Blister pack:
Pack sizes: 30 and 100 film-coated tablets.
HDPE bottle:
Pack sizes: 30 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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
Finland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark Carvedilol “Aurobindo”
Finland Carvedilol Orion 6.25 mg/12.5 mg/25 mg tabletti, kalvopäällysteinen
Spain Carvedilol Aurobindo 6.25 mg comprimidos recubiertos con película
Germany Carvedilol Aurobindo 3.125 mg/6.25 mg/12.5 mg/25 mg Filmtabletten
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 tabletter, filmdrasjerte
Sweden Carvedilol Aurobindo 6.25 mg/12.5 mg/25 mg filmdragerad tablett