6.25 mg; 12.5 mg and 25 mg tablets of 
carvedilol

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Carveratio is and what it is used for 
2. What you need to know before you take Carveratio 
3. How to take Carveratio 
4. Possible side effects 
5. How to store Carveratio 
6. Contents of the packaging and other information 

1. What Carveratio is and what it is used for

Carveratio belongs to a group of medicines with both alpha- and beta-blocking effects. Carveratio is used to treat high blood pressure and to treat angina. Carveratio is also used as an adjunctive treatment for heart failure .

Carvedilol contained in Carveratio may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before taking Carveratio

Do not take Carveratio:

  • if you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6).
  • if you have untreated or unstable heart failure or certain types of disorders of the cardiac conduction system (so-called AV blocks of type II and III if you do not have a pacemaker, or so-called diseased sinus node).
  • if you suffer from severe liver disease.
  • if you have a very low heart rate (less than 50 beats per minute) or very low blood pressure .
  • if you suffer from severe cardiac impairment (cardiogenic shock ).
  • if you suffer from a severe disturbance in the body’s acid-base balance(metabolic acidosis , acidemia).
  • if you have or have had asthma or a sudden blockage of your airways.

Warnings and cautions

Talk to your doctor or pharmacist before taking Carveratio

  • if you have heart failure along with
    • low blood pressure,
    • deficient blood and oxygen supply to the heart (ischemic heart disease) and atherosclerosis (atherosclerosis)
    • and / or kidney problems,
  • your kidney function should then be checked. It may be necessary to lower your dose.
  • if you have had a heart attack . This condition must be adequately treated before Carveratio is taken.
  • if you have a certain type of disorder in the heart’s conduction system (so-called AV block type I).
  • if you have high blood pressure due to organic causes.
  • if you have severe breathing problems and do not receive any treatment for the problems. Carveratio may aggravate these breathing difficulties.
  • if you have diabetes . Treatment with Carveratio may mask signs of low blood sugar. Your blood sugar should therefore be checked regularly.
  • if you have very poor blood circulation in your hands and feet .
  • if you have Raynaud’s phenomenon (fingers or toes first turn bluish, then whitish and then reddish along with pain). Carveratio may worsen the symptoms.
  • if you have increased thyroid function , with increased production of thyroid hormone. Carveratio may mask the symptoms.
  • if you are using Carveratio and are about to undergo surgery and where you are going to be anesthetized ( anesthesia ). You should discuss this with the doctor responsible for anesthesia well in advance.
  • if you have a very low heart rate (less than 55 beats per minute) .
  • if you have had a severe allergic reaction (eg to insect bites or certain foods) or if you are or should be undergoing desensitization treatment as Carveratio may reduce the effect of medicines used to treat such allergic reactions.
  • if you have psoriasis.
  • if you have an adrenal insufficiency ( pheochromocytoma ) and this is not treated with medicine.
  • if you suffer from an unusual form of angina pectoris called Prinzmetal’s angina caused by spasm of the coronary arteries of the heart .
  • if you wear contact lenses . Carveratio can reduce the production of tear fluid.

Other medicines and Carveratio

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Other concomitant medications may affect or be affected by Carveratio.

It is especially important that your doctor knows if you are already being treated with:

  • Digoxin or digitoxin (for the treatment of heart failure )
  • Insulin or oral antidiabetic medicines (blood sugar-lowering agents) as their blood sugar lowering effect may be increased and symptoms of low blood sugar may be hidden.
  • Rifampicin (an antibiotic used to treat tuberculosis )
  • Carbamazepine(for the treatment of epilepsy )
  • Fluconazole (a medicine used to treat fungal infections)
  • Paroxetine , fluoxetine or bupropion (medicines used to treat depression)
  • Drugs containing reserpine, guanethidine, methyldopa, guanfacine and monoamine oxidase inhibitors ( MAOIs ) for the treatment of depression and Parkinson’s disease , as these may lead to a further decrease in heart rate.
  • Ciclosporin (medicine to suppress the immune system to prevent rejection reactions after organ transplantation). Also used for certain rheumatic or dermatological disorders.
  • Drugs used to treat irregular heartbeat (eg verapamil, diltiazem, quinidine, amiodarone ).
  • Clonidine (medicines to lower blood pressure or to treat migraines )
  • Sympathomimetics (drugs that increase the function of the sympathetic nervous system)
  • Medicines for the treatment of respiratory problems (eg salbutamol , formoterol ).
  • Dihydropyridines (medicines used to treat high blood pressure and heart disease)
  • Other antihypertensive drugs. Carveratio may potentiate the effect of other antihypertensive drugs given concomitantly (eg alpha 1 receptor antagonists, nitrates ) and drugs for which a decrease in blood pressure occurs as a side effect , e.g. barbiturate s (in the treatment of epilepsy ), phenothiazines (for the treatment of psychosis ), tricyclic antidepressants (for treating depression), and vasodilators (drugs to dilate blood vessels) .
  • Neuromuscular blockers (drugs that reduce muscle tension)
  • Ergotamine (a drug for migraines )
  • Anesthetics (medicines used for anesthesia)
  • Some analgesics ( NSAIDs -preparat), estrogen s ( hormone s) and corticosteroid s (adrenal hormone), then these may in some cases reduce the blood pressure-lowering effect of Carveratio.
  • Cinacalcet (for the treatment of diseases of the parathyroid gland).

Carveratio with alcohol

Carveratio may intensify the effects of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is a risk of birth defects. Carveratio should only be used during pregnancy if your doctor considers it necessary. Therefore, always consult your doctor before using Carveratio during pregnancy.

It is not known whether carvedilol passes into breast milk and therefore Carveratio should not be used during breast-feeding.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Dizziness and tiredness may occur at the beginning of treatment, after increasing the dose, when changing the product or in combination with alcohol. With the right dose, it is not known whether carvedilol reduces the ability to drive or use machines. If you feel dizzy or weak when taking the tablets, you should avoid driving or work that requires sharp attention.

Carveratio contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Carveratio

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. If you have the impression that the effect of Carveratio is too strong or too weak, talk to your doctor or pharmacist.

You should swallow the tablets with at least half a glass of water. You can take those tablets with or without food. Patients with heart failure , on the other hand, should take the tablets with food to reduce the risk of dizziness when getting up quickly.

The tablets can be divided into two equal doses.

Carveratio tablets are available in the following strengths:

6.25 mg, 12.5 mg and 25 mg

Hypertension:

Adults: The 
usual dose is 1 tablet Carveratio 12.5 mg (equivalent to 12.5 mg carvedilol) for the first two days and 2 tablets Carveratio 12.5 mg (equivalent to 25 mg carvedilol) once daily thereafter. Other strengths of carvedilol are available for this dosage . 
If necessary, the dose can be increased gradually, with an interval of at least two weeks. The recommended maximum daily dose is 50 mg.

Elderly patients: The 
recommended dose is one tablet of Carveratio 12.5 mg (equivalent to 12.5 mg carvedilol) once daily. 
If necessary, dose one can be gradually increased at least two week intervals to the maximum daily dose of 50 mg.

Vasospasm:

Adults: The 
usual dose is 1 tablet Carveratio 12.5 mg (equivalent to 12.5 mg carvedilol) twice daily for two days and 2 tablets Carveratio 12.5 mg (equivalent to 25 mg carvedilol) twice daily thereafter. Other strengths of Carveratio are available for this dosage. 
If necessary, the dose can be increased gradually, with an interval of at least two weeks. The recommended maximum daily dose is 100 mg.

Elderly patients: The 
usual dose is one tablet Carveratio 12.5 mg (equivalent to 12.5 mg carvedilol) twice daily for two days and then two tablets Carveratio 12.5 mg (equivalent to 25 mg carvedilol) twice daily. The recommended maximum daily dose is 50 mg.

Heart failure:

The usual starting dose is 3.125 mg carvedilol twice daily for two weeks. Dose one can be increased gradually, usually at two-week intervals.

However, dose one may need to be increased or decreased. Your doctor will then inform you of this.

The recommended maximum daily dose is 25 mg twice daily for patients weighing less than 85 kg and 50 mg twice daily for patients weighing more than 85 kg, provided that heart failure is not severe. If dose one is increased to 50 mg twice daily, caution should be exercised and the condition should be closely monitored by the physician.

Symptoms of overdose may include a feeling of fainting due to extremely low blood pressure , low heart rate and in severe cases temporary heart failure. Difficulty breathing, constricted airways, mild nausea, decreased consciousness and seizures may occur.

If you forget to take Carveratio

If you forget to take one dose (or several doses ), take the next dose at the same time as usual. Do not take a double (or higher) dose to make up for a forgotten dose .

If you stop taking Carveratio

Do not stop treatment suddenly and do not change the dose unless your doctor tells you to. The treatment should be stopped gradually over a period of two weeks. Sudden termination may worsen the symptoms.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The majority of side effects are dose-dependent and disappear when the dose is reduced or treatment is stopped. Some side effects may occur at the beginning of treatment and disappear by themselves as treatment continues.

Very common (may affect more than 1 user in 10):

  • dizziness
  • headache
  • heart failure
  • low blood pressure
  • fatigue

Common (may affect up to 1 in 10 people):

  • bronchitis ( bronchitis ), pneumonia, upper respiratory
  • urinary tract infection
  • low red blood cell count
  • weight gain
  • elevated cholesterol levels
  • impaired blood sugar balance in diabetics
  • depression, depression
  • visual disturbances
  • reduced production of tear fluid, eye irritation
  • low heart rate
  • edema (swelling in the body or parts of the body), excess fluid, increased blood volume in the body
  • dizziness when getting up quickly
  • problems with blood circulation (symptoms include cold hands and feet), atherosclerosis, aggravated symptoms of Raynaud’s syndrome (fingers and toes first turn bluish, then whitish and then reddish along with pain) or window disease (pain in the legs such as worsens when walking)
  • asthma and difficulty breathing
  • fluid accumulation in the lungs
  • diarrhea
  • malaise, nausea, vomiting, abdominal pain, indigestion
  • pain (eg in arms and legs)
  • acute renal failure and renal impairment in patients with atherosclerosis and/or renal impairment
  • urination difficulties.

Uncommon (may affect up to 1 in 100 people):

  • sleep disorder
  • confusion
  • fainting
  • abnormal feeling in the body
  • disorders of the cardiovascular system, angina pectoris (including chest pain)
  • certain skin reactions (eg allergic dermatitis, hives, itching and inflammation of the skin, increased sweating; psoriatic or lichen planus-like skin lesions)
  • hair loss
  • impotence

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

  • decreased platelet count ( thrombocytopenia )
  • dry mouth
  • stuffy nose.

Very rare (may affect up to 1 in 10,000 patients, including isolated cases):

  • decreased white blood cell count
  • allergic reactions
  • severe skin reactions, which include blisters, red or purple marks or flaky skin. It can also affect the mouth, eyes and other mucous membranes. ( Stevens-Johnson syndrome, toxic epidermal necrolysis or Erythema multiforme)
  • changes in liver function values
  • involuntary urine leakage (urinary incontinence) in women.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information

5. How to store Carveratio

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton / blister after EXP. dat. / EXP.

The expiration date is the last day of the specified month.

Blister (PVC / PVdC-Aluminum)

6.25 mg:

Do not store above 30 ° C.

Store in the original package. Sensitive to light.

12.5 mg and 25 mg:

Store in the original package. Sensitive to light.

No special temperature instructions.

Blister (OPA / Aluminum / PVC-Aluminum)

Store in the original package. Sensitive to light.

No special temperature instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is: carvedilol 
Each tablet contains 6.25 / 12.5 / 25 mg carvedilol

The other ingredients are microcrystalline cellulose, lactose monohydrate , crospovidone, povidone, silica ( colloidal , anhydrous), magnesium stearate.

What the medicine looks like and the contents of the pack

6.25 mg tablets: white, biconvex, capsule-shaped tablets with a score line, debossed with “C” and “2” on one side and smooth on the other.

12.5 mg tablets: white, biconvex, capsule-shaped tablets with a score line, debossed with “C” and “3” on one side and smooth on the other side.

25 mg tablets: white, biconvex, capsule-shaped tablets with a score line marked with “C” and “4” on one side and smooth on the other.

The tablets can be divided into two equal doses .

Pack sizes: 10, 14, 28, 30, 50, 56, 60, 98, 100 and 105 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: 
ratiopharm GmbH 
Graf-Arco-Strasse 3 
89079 Ulm 
Germany

Manufacturer: 
Merckle GmbH 
Ludwig-Merckle-Str. 3 
D-89143 Blaubeuren 
Germany

Teva Pharmaceutical Works Ltd.,

Pallagi út 13,

Debrecen H-4042

Hungary


Muhammad Nadeem

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