Carvedilol Aurobindo

Patient Information Leaflet: Information for the User

Carvedilolo Aurobindo 6.25 mg film-coated tablets, 25 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist.

Contents of this leaflet:

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

1. What Carvedilolo Aurobindo is and what it is used for

Carvedilolo Aurobindo belongs to a group of medicines called alpha and beta-blockers. Carvedilolo Aurobindo is used in the treatment of high blood pressure and in the treatment of angina pectoris. Carvedilolo Aurobindo is also used as supplementary treatment for heart failure.

2. What you need to know before taking Carvedilolo Aurobindo

Do not take Carvedilolo Aurobindo:

• if you are allergic to carvedilol or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe heart failure (swelling of the hands, ankles and feet) being treated with medicines administered intravenously (by IV)
• if you have had shortness of breath due to asthma
• if you have decompensated heart failure or certain types of heart conduction disorders (called second- or third-degree atrioventricular block or sick sinus syndrome)
• if you have heart problems (e.g. "heart block" or slow heartbeat); Carvedilolo Aurobindo is not suitable for some people with certain types of heart problems
• if you have very low blood pressure
• if you suffer from a severe disturbance in the body's acid-base balance (metabolic acidosis, acidemia)
• if you have an unusual form of angina called Prinzmetal's angina caused by spasms of the coronary arteries
• if you have overactive adrenal glands (pheochromocytoma) and this condition is not being treated with medication
• if you have severely reduced circulation in the hands and feet or episodes of limping and leg pain (intermittent claudication)
• if you have liver problems
• if you are currently being treated with intravenous medicines used to treat irregular heartbeat (verapamil or diltiazem).

Warnings and precautions
Tell your doctor or pharmacist before taking Carvedilolo Aurobindo:

• if you have a type of angina called "Prinzmetal's variant angina"
• if you suffer from any other heart problems
• if you have a tumour of one of the adrenal glands ("pheochromocytoma")
• if you have kidney problems. Kidney function should be monitored. A dose reduction may be necessary
• if you have diabetes (high blood sugar). Treatment with Carvedilolo Aurobindo may mask the symptoms of low blood sugar levels. You must monitor your blood sugar levels regularly.
• if you have lung problems or severe breathing difficulties for which you are not taking medication, as Carvedilolo Aurobindo may worsen these breathing difficulties
• if you wear contact lenses. Carvedilolo Aurobindo may reduce tear production.
• if you have circulation problems in the hands and feet such as, for example, Raynaud's phenomenon (fingers and toes first turn bluish, then white, then red and become painful). Carvedilolo may worsen these symptoms.
• if you have had thyroid gland problems with excessive production of thyroid hormone, as Carvedilolo Aurobindo may mask the symptoms.
• if you are taking Carvedilolo Aurobindo and are scheduled for surgery involving the use of anaesthetics. You must discuss this in advance with the doctor responsible for the anaesthesia.
• if your heart rate is very low (less than 55 beats per minute)
• if you have ever had a severe allergic reaction (e.g. sudden swelling causing difficulty breathing or swallowing, swelling of the hands, feet and ankles, or a severe skin rash), as Carvedilolo Aurobindo may reduce the effectiveness of medicines used to treat these allergic reactions.
• if you have an allergy and are about to undergo desensitisation treatment
• if you have ever had a skin disorder called "psoriasis" after taking beta-blockers
• if you are currently receiving intravenous medicines used to treat irregular heartbeat (verapamil or diltiazem).

Other medicines and Carvedilolo Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. Carvedilolo Aurobindo may affect how some medicines work. In addition, some medicines may affect how carvedilol works.
It is particularly important that your doctor knows if you are already being treated with:

• Other medicines for the heart or blood pressure, including diuretics, "calcium channel blockers" (e.g. diltiazem or verapamil), medicines to control irregular heartbeat (e.g. digoxin and amiodarone)
• Rifampicin (an antibiotic used to treat tuberculosis)
• Fluoxetine (a medicine used to treat depression)
• Cyclosporine (a medicine used to suppress the immune system, to prevent transplant rejection after organ transplantation, also used, for example, for certain rheumatic or dermatological conditions)
• Clonidine (to treat high blood pressure, migraine, or hot flushes during menopause)
• Medicines for diabetes, such as insulin and metformin
• Non-steroidal anti-inflammatory drugs (NSAIDs, e.g. aspirin, indometacin and ibuprofen), as these may in some cases reduce the blood pressure-lowering effect of carvedilol
• Agents that reduce catecholamines, e.g. reserpine, guanethidine, methyldopa, guanfacine, and monoamine oxidase inhibitors (MAOIs) such as isocarboxazid and phenelzine (medicines used to treat depression), as these may lead to a further increase in heart rate
• Beta-agonist bronchodilators (used to treat chest tightness and shortness of breath due to asthma and other chest conditions (e.g. salbutamol and terbutaline sulfate)).

Surgery
If you are about to undergo surgery, inform your doctor that you are taking Carvedilolo Aurobindo, as some anaesthetics can lower blood pressure and this could drop too much.
Carvedilolo Aurobindo with food, drinks and alcohol
Carvedilolo Aurobindo may increase the effects of alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
There is a risk of harm to the fetus. Carvedilolo Aurobindo should be used during pregnancy only if your doctor considers it necessary. Therefore, always consult your doctor before using Carvedilolo Aurobindo during pregnancy.
According to animal studies, carvedilol passes into breast milk and therefore should not be used during breastfeeding.
Driving and using machines
While taking Carvedilolo Aurobindo, you may experience dizziness. This is more likely at the beginning of treatment or when treatment is changed, and when you drink alcohol. If this happens, do not drive or operate tools or machinery. Talk to your doctor if you notice any other problems that may affect your ability to drive or use tools or machinery while taking Carvedilolo Aurobindo.
Carvedilolo Aurobindo contains lactose and sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Carvedilolo Aurobindo

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
If you feel that the effects of Carvedilolo Aurobindo are too strong or too weak, speak to your doctor or
pharmacist. The tablets should be swallowed with at least half a glass of water.
You must swallow the film-coated tablets with at least half a glass of water. You may take the
film-coated tablets with or without food. However, patients with heart failure should take
the film-coated tablets with food to reduce the risk of dizziness when standing up
suddenly. The tablet may be divided into two equal doses.

High blood pressure:
Adults:
The usual dose is 1 tablet of Carvedilolo Aurobindo 12.5 mg (equivalent to 12.5 mg of carvedilol)
for the first two days, followed by 2 tablets of Carvedilolo Aurobindo 12.5 mg (equivalent to 25
mg of carvedilol) once daily. Other pack sizes of Carvedilolo Aurobindo are available for this dosage.
If necessary, the dose may be gradually increased. The maximum recommended daily dose is 50 mg.

Elderly:
The recommended dose is 1 tablet of Carvedilolo Aurobindo 12.5 mg (equivalent to 12.5 mg of
carvedilol) once daily.
If necessary, the dose may be gradually increased at two-week intervals up to the maximum recommended daily dose of 50 mg.

Angina pectoris:
Adults:
The usual dose is 1 tablet of Carvedilolo Aurobindo 12.5 mg (equivalent to 12.5 mg of carvedilol)
twice daily for the first two days, followed by 2 tablets of Carvedilolo Aurobindo 12.5 mg
(equivalent to 25 mg of carvedilol) twice daily. Other pack sizes of Carvedilolo Aurobindo are available for this dosage.
If necessary, the dose may be gradually increased. The maximum recommended daily dose is 100 mg.

Elderly:
The usual dose is 1 tablet of Carvedilolo Aurobindo 12.5 mg (equivalent to 12.5 mg of carvedilol)
twice daily for the first two days, followed by 2 tablets of Carvedilolo Aurobindo 12.5 mg
(equivalent to 25 mg of carvedilol) twice daily.
The maximum recommended daily dose is 50 mg.

Congestive heart failure:
The usual starting dose is 1 tablet of Carvedilolo Aurobindo 3.125 mg (equivalent to 3.125 mg of
carvedilol) twice daily for 2 weeks. The dose may be gradually increased, usually at intervals of 2 weeks.
However, it may be necessary to increase or reduce the dose. Your doctor will advise you accordingly.
The maximum recommended daily dose is 25 mg administered twice daily in patients weighing less than 85 kg, and 50 mg twice daily in patients weighing more than 85 kg, provided that
heart failure is not severe. Dose increases up to 50 mg twice daily must be carefully carried out under close medical supervision.

Use in children and adolescents
Carvedilolo Aurobindo is not suitable for children under 18 years of age.

If you take more Carvedilolo Aurobindo than you should
If you take more Carvedilolo Aurobindo than you should, or if children have accidentally taken the medicine,
contact your doctor, go to hospital, or call emergency services for advice on the risks or
measures to be taken.
Symptoms of overdose may include feeling faint due to excessive lowering of blood pressure, slow heartbeat, and, in severe cases, occasional missed heartbeats.
Breathing difficulties, narrowing of the airways, malaise, reduced level of consciousness, and epileptic seizures may also occur.

If you forget to take Carvedilolo Aurobindo
If you miss a dose (or more than one dose), take the next dose at your usual time. Do not take a double
dose to make up for a forgotten dose.

If you stop taking Carvedilolo Aurobindo
Do not stop treatment or change the dose suddenly unless instructed by your doctor. Treatment should be gradually reduced over a period of 2 weeks. Any sudden interruption may worsen your symptoms.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. However, you may experience any of the side effects listed below.
Contact your doctor immediately if you experience any of the following side effects:
Signs of severe allergic reactions may include sudden swelling of the throat, face, lips, and mouth. This may cause difficulty breathing or swallowing.
Chest pain accompanied by shortness of breath, sweating, and feeling unwell.
Passing urine less frequently, with swelling of the legs, indicating kidney problems.
Very low blood sugar levels (hypoglycaemia) which could cause seizures or unconsciousness.

Very common: may affect more than 1 in 10 people

• Dizziness
• Headache
• Feeling weak or tired
• Heart problems. Signs include chest pain, fatigue, shortness of breath, and swelling of the arms and legs.
• Low blood pressure. Signs include feeling dizzy or lightheaded.

Dizziness, headache, and feelings of weakness and tiredness are usually mild and occur more frequently at the beginning of treatment.

Common: may affect up to 1 in 10 people

• Airway infections (bronchitis), lungs (pneumonia), nose and throat (upper airways). Signs include breathlessness, shortness of breath, chest tightness, and sore throat.
• Urinary tract infections which may cause problems passing urine.
• Low red blood cell count (anaemia). Signs include feeling tired, looking pale, a sensation of heart fluttering (palpitations), and shortness of breath.
• Weight gain
• Increased cholesterol levels (shown by a blood test)
• Loss of control of blood sugar levels in people with diabetes
• Feeling depressed
• Vision problems, eye pain or dry eyes due to reduced tear production
• Slowed heart rate
• Dizziness or lightheadedness upon standing up
• Fluid retention. Signs include: general swelling of the body, swelling of certain body parts such as hands, feet, ankles and legs, and an increase in blood volume. Circulatory problems in hands and feet. Signs include cold hands and feet, paleness, tingling and pain in fingers, and leg pain that worsens when walking.
• Breathing problems
• Feeling unwell or nausea
• Diarrhoea
• Stomach ache / indigestion
• Pain, possibly in hands and feet
• Kidney problems, including changes in frequency of urination

Uncommon: may affect up to 1 in 100 people

• Tingling or numbness in hands and feet
• Skin problems, including rashes that may cover large parts of the body, blistering rash (urticaria), itching, and dry skin patches.
• Dizziness, muscle fatigue, blurred vision, and feeling faint
• Fainting
• Heart conduction system disorders, chest pain
• Hair loss
• Inability to achieve an erection (erectile dysfunction)
• Constipation
• Sleep disorders

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

• Low platelet count in the blood. Signs include easy bruising and nosebleeds.
• Stuffy nose, breathlessness, and flu-like symptoms
• Dry mouth

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

• Low count of all types of white blood cells. Signs include mouth, gum, throat and lung infections.
• Allergic reactions (hypersensitivity). Signs include difficulty breathing or swallowing due to sudden swelling of the throat or face, or swelling of hands, feet and ankles.
• Kidney problems shown by a blood test
• Some women may experience difficulty controlling the bladder during urination (urinary incontinence). This usually improves when treatment is stopped.
• Severe skin conditions may occur (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis). Redness, often associated with blisters, may appear on the skin or mucous membranes, for example inside the mouth, in the genital area, or on the eyelids. These may initially appear as circular spots, often with central blisters, which may progress to widespread skin peeling and can be life-threatening. These severe skin reactions are often preceded by headache, fever, and body aches (flu-like symptoms).

Carvedilol Aurobindo may also cause the development of signs of diabetes in people with very mild diabetes known as "latent diabetes".

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Carvedilol Aurobindo

Keep this 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 that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Carvedilolo Aurobindo contains

• The active substance is carvedilol. Each tablet contains 6.25 mg or 25 mg of carvedilol.
• The other ingredients are: monohydrate lactose, anhydrous colloidal silicon dioxide, crospovidone, povidone K30, sucrose, magnesium stearate.
  Tablet coating: Macrogol 400, polysorbate 80, titanium dioxide (E171), hypromellose.

Description of the appearance of Carvedilolo Aurobindo and package contents
Film-coated tablet.
Carvedilolo Aurobindo 6.25 mg film-coated tablets:
Film-coated tablets, white to off-white, oval-shaped, marked with "F57" on one side and a score line on the other side. The tablet can be divided into two equal doses.
Carvedilolo Aurobindo 25 mg film-coated tablets:
Film-coated tablets, white to off-white, oval-shaped, marked with "F59" on one side and a score line on the other side. The tablet can be divided into two equal doses.
PVC/PE/PVDC-aluminum blister pack: 28 and 30 film-coated tablets.
HDPE bottle: 30, 100 and 250 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Aurobindo Pharma (Italia) s.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Milpharm Limited
Ares, Odyssey Business Park, West End Road, South Ruislip HA46QD, United Kingdom

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Carvedilolo Aurobindo
Netherlands: Carvedilol Aurobindo 6.25 mg / 25 mg, filmomhulde tabletten

This leaflet was last revised on