3.125 mg tablets 
carvedilol

What Carvedilol HEXAL is and what it is used for

Carvedilol HEXAL is used to treat:

  • high blood pressure
  • chronic stable angina pectoris, a disease that causes chest pain (angina)
  • moderate to severe stable heart failure, in addition to regular treatment. Carvedilol HEXAL belongs to the group of medicines beta-blockers.

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

What you need to know before you take Carvedilol HEXAL

Do not take Carvedilol HEXAL:

  • if you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6).
  • if you have or have had breathing problems due to asthma or other lung diseases.
  • if you have severe heart failure (swollen hands, ankles, and feet) treated with drugs given through a vein ( intravenously ).
  • if you have liver problems.
  • if you have heart problems (eg so-called “heart block”, slow pulse, cardiogenic shock ). Carvedilol HEXAL is not suitable for some people with certain types of heart problems.
  • if you have very low blood pressure.
  • if you have a blood clot in your lungs that causes chest pain and shortness of breath ( acute pulmonary embolism ).
  • if you have a special type of rare chest pain (Prinzmetal’s angina).
  • if you have been informed that you have high blood pressure due to a tumor near your kidneys ( pheochromocytoma ).
  • if you have been told that your blood is more acidic than normal (has a lower pH, a condition called metabolic acidosis ).
  • if you are taking any of the following medicines:
  • monoamine oxidase inhibitors ( MAOIs ) (for depression)
  • verapamil and diltiazem as an injection (to treat heart problems and to lower blood pressure )
  • if you are breast-feeding.

Do not take Carvedilol HEXAL if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Carvedilol HEXAL.

Warnings and cautions

Talk to your doctor or pharmacist before taking Carvedilol HEXAL

  • you have lung problems
  • you have kidney problems
  • you have diabetes (high blood sugar)
  • you wear contact lenses (keep in mind that tear production may decrease)
  • you have problems with your blood vessels ( peripheral vascular disease)
  • you have or have ever had problems with the thyroid gland
  • you have ever had a severe allergic reaction (such as sudden swelling that makes it difficult to breathe or swallow, swollen hands, feet, or ankles, and severe rash)
  • you are allergic to something and are treated by allergy vaccination
  • you have problems with blood circulation in fingers and toes (Raynaud’s phenomenon)
  • you have psoriasis after taking beta-blockers
  • you have a type of angina (angina) called Prinzmetal’s angina
  • you have a tumor on one of the adrenal glands ( pheochromocytoma )
  • you have ever been seriously ill with blisters on your skin, mouth, eyes, and genitals ( toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome (SJS)) while taking carvedilol.

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before taking Carvedilol HEXAL.

Children and young people

Carvedilol HEXAL is not recommended for use in children and adolescents below 18 years due to insufficient data on the safety and efficacy of the drug.

Other medicines and Carvedilol HEXAL

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is especially important to tell your doctor or pharmacist if you are taking any of the following medicines:

  • other medicines for the heart or blood pressure, such as diuretics ( diuretics ), calcium channel blockers (eg diltiazem and verapamil), medicines for irregular heartbeat (eg digoxin and amiodarone )
  • catecholamine-lowering drugs (eg reserpine and monoamine oxidase inhibitors(MAOIs) such as isocarboxazid and phenelzine (used to treat depression))
  • fluoxetine and paroxetine (used for depression)
  • diabetes drugs such as insulin and metformin
  • clonidine (used to treat high blood pressure, migraines, and menopausal episodes)
  • rifampicin (used for infections )
  • ciclosporin (used after organ transplantation)
  • non-steroidal anti-inflammatory drugs ( NSAIDs such as acetylsalicylic acid, indomethacin, and ibuprofen )
  • bronchodilators beta stimulants (used in chest tightness and wheezing due to asthma or other lung diseases (such as salbutamol and terbutaline sulfate))
  • drugs that reduce the amount of stomach acid (cimetidine).

Operations

Tell your doctor if you are going to have surgery. Some anesthetics can lower your blood pressure and make it too low.

Pregnancy and breastfeeding

Do not take Carvedilol HEXAL if you are pregnant, trying to conceive, or breast-feeding, unless your doctor tells you to.

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.

Driving and using machines

You may feel dizzy while taking Carvedilol HEXAL. This occurs more often at the beginning of treatment or when treatment is changed and if you consume alcohol. If this happens to you, do not drive or use any tools or machines. Talk to your doctor if you experience other problems while taking Carvedilol HEXAL that may affect your ability to drive or use tools and 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.

Carvedilol HEXAL 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.

How to take Carvedilol HEXAL

Always take this medicine exactly as your doctor has told you. Consult your doctor if you are unsure.

This medicine is also available in tablets with higher strength.

Treatment of high blood pressure

Adults:

  • Starting dose: 4 tablets once daily for the first two days. The treatment is then continued with 8 tablets once a day.
  • Maximum dose: 8 tablets twice daily.

Older:

  • Starting dose: 4 tablets once daily. Dose one can be increased gradually as needed.
  • Maximum dose: 8 tablets twice daily.

Treatment of angina ( angina pectoris )

  • Starting dose: 4 tablets twice daily for the first two days.

The treatment is then continued with 8 tablets twice daily.

  • Maximum dose: 16 tablets twice daily.

Elderly people should take a maximum of 8 tablets twice daily

Treatment of heart failure

  • Starting dose: 1 tablet twice daily.

Depending on how you respond to treatment, the dose may be gradually increased after at least two weeks, as follows: 2 tablets twice daily, then 4 tablets twice daily, followed by 8 tablets twice daily.

  • Maximum dose: 8 tablets twice daily.

The maximum dose for people who weigh over 85 kg and do not have severe heart failure is 16 tablets twice daily.

Your doctor will closely monitor you when treatment has started and after dose increases.

Hepatic impairment (not severe) or renal impairment

Dose one is determined by the doctor and is tailored specifically for you.

How to take the tablets

Take the tablets with a glass of water, with a meal.

How to divide the tablets

Place the tablet with the notch upwards on a flat and hard surface. Press firmly with your finger in the middle of the tablet until it is divided into two parts.

Duration of treatment

Decided by the responsible doctor.

If you have taken too many tablets, the following symptoms may occur slow heart rate, dizziness or feeling unsteady, shortness of breath, wheezing, or extreme fatigue.

If you forget to take Carvedilol HEXAL

If you forget to take a dose, take it as soon as you remember. However, if there is only a short time left before it is time for the next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Carvedilol HEXAL

Do not stop taking this medicine without talking to a doctor. The doctor may want to reduce the treatment for 1 to 2 weeks.

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.

Contact your doctor immediately if you experience any of these side effects are

Signs of severe allergic reactions may include sudden swelling of the throat, face, lips, or oral cavity that makes it difficult to breathe or swallow.

Chest pain with concomitant shortness of breath, sweating, and nausea.

You urinate less frequently and your legs swell, indicating kidney problems.

Severe skin reactions, such as rash, redness, blisters on the lips, around the eyes or in the mouth, scaly skin (symptoms of erythema multiforme), sores in the mouth, on the lips and skin (signs of Stevens-Johnson syndrome ), loosening of the top layer of skin from the lower skin layers (signs of toxic epidermal

necrolysis ).

Very low blood sugar  ( hypoglycaemia ) may lead to seizures or unconsciousness.

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

  • Dizziness.
  • Headache.
  • Feeling tired and weak.
  • Heart problems. Signs of this are chest pain, fatigue, shortness of breath, and swollen arms and legs.
  • Low blood pressure. Signs of this are dizziness or a feeling of instability.

Dizziness, headache, feeling weak, and tired are usually mild side effects and usually appear at the beginning of treatment.

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

  • Infection in the respiratory tract ( bronchitis ), lungs ( pneumonia ), nose, and throat (upper respiratory tract infection). Signs of this are wheezing, shortness of breath, tightness in the chest, and sore throat.
  • Urinary tract infections can cause problems when urinating.
  • Low red blood cell count ( anemia ). Signs of this are fatigue, pale skin, palpitations, and shortness of breath.
  • Weight gain.
  • Elevated cholesterol level (detected by a blood test).
  • Poorer blood sugar control in people with diabetes .
  • Depression.
  • Fainting.
  • Problems with vision, burning, or dry eyes due to low tear production.
  • Slow pulse.
  • Dizziness or feeling of instability when getting up.
  • Fluid accumulation. Signs of this are a general swelling of the body, swelling of parts of the body e.g. hands, feet, ankles, and legs, as well as an increased amount of blood in the body.
  • Problems with blood circulation in the arms and legs. Signs of this are cold hands and feet, pallor, tingling and pain in the fingers, and pain in the legs that worsens as you walk.
  • Respiratory problems.
  • Nausea and vomiting.
  • Diarrhea.
  • Stomach pain / indigestion.
  • Pain, possibly. in hands and feet.
  • Kidney problems, including changing how often you need to urinate.

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

  • Sleeping problems.
  • Nightmares.
  • Hallucinations, confusion.
  • Tingling or numbness in the hands or feet.
  • Skin problems, e.g. skin rash over large parts of the body, hives , itching, and dry skin areas.
  • Impotence ( erectile dysfunction ).
  • Constipation.
  • Disturbed signal transmission between the upper and lower heart chambers.
  • Chest pain due to narrowed blood vessels to the heart.

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

  • Low platelet count in the blood. Signs of this are that you get bruises and nosebleeds more easily.
  • Nasal congestion, wheezing, and flu-like symptoms.
  • Dry mouth.

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

  • A low number of all types of white blood cells. Signs of this are infection of the oral cavity, gums, throat, and lungs.
  • Allergic reactions ( hypersensitivity reactions ). Signs of this may be difficulty breathing or swallowing due to a sudden swelling in the throat, or swelling of the face or hands, feet, and ankles.
  • Liver problems detected in blood samples.
  • Some women may have difficulty controlling their bladder when urinating (urinary incontinence). This problem usually disappears when treatment is stopped.
  • Certain types of mental illness ( psychosis ).

Has been reported (occurs in the unknown number of users):

  • Hair loss.

Carvedilol HEXAL can also cause signs of diabetes in people who have a very mild form of diabetes called “latent diabetes”.

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. Postal address

5. How to store Carvedilol HEXAL

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 blister and carton, or on the jar after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Store in the original package. Sensitive to light.

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.

One tablet contains 3.125 mg carvedilol.

The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K30, anhydrous colloidal silica, magnesium stearate, and red iron oxide (E172).

What the medicine looks like and the contents of the pack

Light red, round, convex tablet with a notch, marked C1 on one side.

Pack sizes: Can and lid of polyethylene (PE-HD): 28, 30, 60, 100, 250 and 500 tablets Blister (Al / PVC): 14, 20, 28, 30, 50, 50×1, 56, 60, 98, 98×1 and 100 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

HEXAL A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Salutas Pharma GmbH, Otto-von-Guericke- Allee 1, 39179 Barleben, Germany

or

LEK SA, Ul. Domaniewska 50 C, PL-02-672 Warsaw, Poland

or

Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia

Muhammad Nadeem

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