Carvedilol 12.5 mg. 28 tablets

What is Carvedilol and what is it used for?
Carvedil belongs to a group of medicines called beta blockers. They act by expanding blood vessels (vasodilators).

Carvedilol is used:

For the treatment of high blood pressure (essential hypertension)
For the treatment of chronic angina pectoris (pain in the heart area due to a lack of blood to the heart muscle)
In combination with other medicines for the treatment of moderate to severe chronic heart failure. Moderate to severe heart failure occurs when the heart fails to function well and the symptoms are:
o Swelling of the ankles
O breathless

2. What should you know before you take Carvedilol ?

Do not take Carvedilol

if you are allergic (hypersensitive) to carvedilol or any of the other ingredients of this medicine listed in section 6.
if you have severe heart failure requiring intravenous (intravenous) treatment. Such treatment is done in a hospital and your doctor will determine the medications you should take.
if you have difficulty breathing or asthma
If you have a lung disease called Chronic Obstructive Pulmonary Disease (COPD) with bronchial obstruction (shortness of breath) and shortness of breath.
If you have a liver disease for which treatment is needed If you have heart failure impulses. Your doctor will monitor your heartbeat to find out if you have such a disorder.
If you have severe bradycardia (when the heart rate is very low)
If you have a sick sinus syndrome (a heart disease where the rhythm is incorrect)
If you have a slow heartbeat (bradycardia) - just under 50 beats per minute
In cardiogenic shock (very low blood pressure due to heart disease)
If you have very low blood pressure (systolic blood pressure below 85 mmHg)
If you have Pritchmetal angina (heart pain caused by spasm of the blood vessels of the heart)
If you have metabolic acidosis (when the blood is lower than the normal pH, and when blood sugar levels are very high in diabetic patients). Your doctor will tell you if you have this problem
If you are treated with intravenous verapamil or diltiazem (see "Taking other medicines") Warnings and precautions
Please tell your doctor if you have or have ever had any of the following conditions:

Heart failure (when the heart is not functioning properly and this is the reason for symptoms such as swollen ankles or difficulty in breathing)
Impaired renal function
Fresh myocardial infarction
Chronic Obstructive Pulmonary Disease (COPD) with a tendency to bronchospasm (narrowing of the respiratory tract
Diabetes (high blood sugar): If you are a diabetic, you should regularly check your blood sugar. The dose of the antidiabetic medicine should be changed.
Thyroid problems: Carvedil may mask the symptoms of thyrotoxicosis (thyroid hyperfunction). These symptoms include sweating, increased heart rhythm, insomnia, weight loss.
Delayed heart beat (bradycardia): If your heart rate is too slow and causes symptoms such as dizziness and seizures, your doctor should reduce the dose.
If you are taking the following medicines:
Calcium antagonists - for example verapamil, diltiazem
Antiarrhythmics (for irregular heart rhythm, for example amiodarone), your blood pressure and cardiac conduction should be monitored. No intravenous treatment with these medicines should be given at the same time.
If you use contact lenses, you should be aware that you may experience slight dry eyes
Serious hypersensitivity reactions such as:
• Angioedema (swelling of the skin of the face, tongue and throat, which may make breathing difficult)

• Difficulty breathing due to narrowing of the airways

• Erythema (reddening of the skin), which can cause scaling

• Rash (urticaria)

Severe hypotension (very low blood pressure)
Tachycardia (accelerated heart rhythm)
Skin disease, known as psoriasis: Carvedil therapy may worsen skin reactions.
Diseases of the blood vessels that lead to poor circulation in the limbs, especially the lower limbs and the feet. Beta blockers such as Carvedil may worsen the condition.
Raynaud's phenomenon (a rare condition characterized by a change in color and pain in the fingers and / or legs). Beta blockers (such as Carvedil) may worsen the symptoms of this disease.
If you have:

• Very variable blood pressure

• Low blood pressure caused by another condition

• Orthostatic hypotension (significant decrease in blood pressure when standing up)

- Proven other diseases of the heart and blood vessels, including:

• Inflammatory heart disease

• Impaired blood flow through or outside of the heart due to impaired hemodynamics. This leads to a reduced ability of the heart to pump the blood around the body due to heart valve disease
Cardiac glycosides (e.g., digoxin, digoxetine)
• Barbiturates (to treat epilepsy)
• Phenothiazines in nausea or vomiting, certain disorders of the nervous system such as vertigo and mental illness (eg schizophrenia).
• Tricyclic antidepressants
• Medicinal products used to enlarge the blood vessels
• Inhaled anesthetics. Always tell your doctor if you are going to use anesthetics.
• Non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain such as acetylsalicylic acid or ibuprofen
• Estrogens (female sex hormones in menopausal and contraceptive symptoms)
• Corticosteroids (against inflammation)
• Sympathomimetics (medicines with a stimulating effect)
• Muscle relaxants (neuromuscular blocking agents) used during surgery. You should tell your anesthetist if you are taking Carvedil.
• Alpha-1 antagonists (for example, prostate or high blood pressure or alpha-2 antagonists (for circulatory problems or for the treatment of certain types of pain).

Take Carvedil with food and drink
Carvedil may increase the effects of alcohol. Therefore, the use of alcohol during treatment should be avoided.

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Carvedil is not recommended during pregnancy. You should consult your doctor immediately if you become pregnant while taking this medicine.
Women who are breast-feeding should not take Carvedil.

Driving and using machines
Because of side effects that may affect your alertness (see section 4, Possible side effects), you should not drive or use machines. These reactions are more likely to occur at the start of treatment or after an increase in the dose.

Carvedil contains lactose (milk sugar) and sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Carvedilol ?
Always take Carvedil exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The tablets should be swallowed whole with a glass of water while eating. The tablets should not be chewed.

Treatment of high blood pressure (hypertension)
Carvedil can be taken alone or in combination with other medicines to treat high blood pressure. The medicinal product should be taken once daily. The recommended maximum single dose is 25 mg.
The recommended maximum daily dose is 50 mg.

Adults:
The recommended initial dose is 12.5 mg once a day for the first two days. Treatment should then continue at a dose of 25 mg once daily. If necessary, the dose may be increased at intervals of not less than two weeks. The dose is increased only at the discretion of your doctor.

Elderly patients

The recommended starting dose is 12.5 mg once a day. This dose is sufficient to control your blood pressure. If a higher dose is recommended, it may be increased at intervals of not less than two weeks. Dose increases only at the discretion of your treating physician.

Treatment of chronic stable angina
It is recommended that you take this medicine twice a day.

Adults:
The starting dose is 12.5 mg twice daily for the first two days. Treatment should be continued at a dose of 25 mg twice daily. If necessary, the dose may be increased at intervals of not less than two weeks. The recommended maximum daily dose is 100 mg per day, divided into two 50 mg doses. The dose is increased only at the discretion of your doctor.

Elderly patients
The recommended starting dose is 12.5 mg twice a day for the first two days. Treatment should then continue at a dose of 25 mg twice daily, which is the maximum recommended dose.

Treatment of heart failure
If you have moderate to severe heart failure (according to doctor's tests), your doctor may prescribe Carvedil as an add-on therapy.

Treatment starts with a dose of 3,125 mg twice daily for two weeks. If this dose is well tolerated by you for at least two weeks, it may be increased to 6.25 mg twice daily. A further dose increase can be made at least two weeks apart, depending on how you are taking this medicine. The maximum dose you can take depends on your weight. If your weight is below 85 kg, the maximum dose is 25 mg twice a day. If your weight is over 85 kg, the maximum dose is 50 mg twice a day. Symptoms of heart failure may temporarily get worse at the start of treatment or during
If you ever need to stop treatment for more than two weeks, you should start with it at the lowest (starting) dose. The dose may then be gradually increased.

Impaired renal function
Your doctor will tell you what dose to take. It is possible that you can take the usual doses as stated above.

Impaired liver function
Dose adjustment is necessary. Your doctor will tell you what dose to take.

Children and adolescents under 18 years of age
Carvedil should not be used in these patients due to insufficient clinical experience in this group.

Elderly patients
Particular attention should be paid by your doctor as you may be more sensitive to the effects of Carvedil.

If you take more Carvedilol than you should
Contact your nearest hospital or your doctor immediately. Take the pack, this leaflet, and any other tablets with you.

Symptoms of overdose may include:
- very low blood pressure
- Delayed heart rate
- heart failure
- cardiogenic shock (very low blood pressure in which you lose consciousness)
- stopping the heart
- difficulty breathing
- loss of consciousness
- vomiting
- convulsions
If necessary, treatment should be initiated by a doctor.

If you forget to take Carvedilol
Do not take a double dose to make up for the forgotten tablet. Take the next dose as prescribed.

If you stop taking Carvedilol
Do not stop taking Carvedil unless your doctor tells you. If you stop taking Carvedil suddenly, the symptoms you have been treated with may be worse. Your doctor will tell you how to reduce and then stop taking this medicine. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Carvedil can cause side effects, although not everyone gets them:
Very common: More than 1 user in 10
Common: 1 to 10 users out of 100
Uncommon: 1 to 10 users of 1,000
Rare: 1 to 10 users in 10,000
Very rare: Less than 1 user in 10,000
Frequency not known: Frequency can not be calculated from available data

Very common:

low blood pressure (hypotension) dizziness, headache
worsening of heart failure (shortness of breath, swelling of the ankles) fatigue
Common:

mild thrombocytopenia (decreased number of blood platelets)
bronchitis, pneumonia, respiratory infections, urinary tract infections increased weight, increased cholesterol levels, impaired glucose tolerance, elevated blood glucose levels (in diabetic patients), anemia (decreased red blood cell count)
depression, mood swings
hyperglycaemia (elevated blood sugar levels in diabetics)
hypervolaemia (increased blood volume)
fluid retention (when the body can not remove excess fluid from urine)
visual disturbance, decreased eye irritation, eye irritation Bradycardia (slow heart rate), edema (swelling of the organ or tissue due to accumulation of tissue fluid), orthostatic hypotension (sudden drop in blood pressure when standing up)
Impaired blood circulation in extremities (cold toes and hands, intermittent claudication)
Raynaud's syndrome (change of fingers and toes from red, bluish, and finally white)
Difficulty breathing (dyspnoea)
nausea (feeling tired)
diarrhea
vomiting
stomach ache
general pain, pain in limbs
impaired kidney function, impaired urination
Uncommon:

sleep disturbance
feeling sick, tingling of the limbs (paresthesia)
heart block, chest pain (angina)
allergic skin reactions, exanthema, urticaria, pruritus
psoriasis, psoriatic lesions
hair loss
Potency Disorders Rare
decreased number of platelets (may occur as an easy bruising or bleeding from the nose)
stuffy nose
Very rare:

decrease in white blood cell count (symptoms of infection, unexplained fever, red throat)
hypersensitivity reactions (allergic reactions)
increase in serum transaminase levels (blood tests to monitor liver function)
urinary disorders (especially in women)
serious reactions such as blistering of the skin, mouth, eyes and genitals (eg erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis)
How to store Carvedilol ?
Keep out of the reach and sight of children.
Do not use Carvedilol  after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of your unnecessary medicines. These help me to protect the environment.

6. Package Contents and Additional Information
What Carvedel contains:

The active substance is carvedilol.
• Carvedilol 12.5 mg tablets contain 12.5 mg carvedilol

The other ingredients are:
• Sucrose
• Lactose monohydrate
• Povidone K25
• Crospovidone
• Silica, colloidal anhydrous
• Magnesium stearate (Ph.Eur.)

What does Carvedilol look like and what does the package contain?
Carvedil 12.5 mg: Round, slightly convex, white tablets with one line and S3 on the opposite side.

The tablets are packed in blisters:
Carvedilol 12.5 mg tablets: 28, 50 and 100 tablets

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