1.25 mg, 2.5 mg, 3.75 mg, 5 mg, and 10 mg film-coated tablets. Bisoprolol fumarate. 

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

1. What Emconcor CHF is and what it is used for

The active substance in Emconcor CHF is bisoprolol. Bisoprolol belongs to a group of medicines called beta-blockers. These drugs work by affecting the body’s response to certain nerve impulses, especially in the heart. This effect means that bisoprolol slows down the heart rate and makes the heart pump around the blood in the body more efficiently.

Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body’s needs. Emconcor CHF is used to treat stable chronic heart failure. The drug is used in combination with other drugs that are suitable for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

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

What you need to know before taking Emconcor CHF

Do not take Emconcor CHF

Do not take Emconcor CHF if you have any of the following conditions:

  • allergy (hypersensitivity) to bisoprolol or any of the other ingredients of Emconcor CHF (see section 6, “Contents of contents”)
  • severe asthma
  • severe blood circulation problems in the arms and legs (eg Raynaud’s syndrome) that cause tingling in the fingers and toes or make them pale or blue
  • untreated pheochromocytoma, which is a rare tumor of the adrenal gland
  • metabolic acidosis, which is a condition in which the blood is too acidic.

Do not take Emconcor CHF if you have any of the following heart problems:

  • acute heart failure
  • worsening heart failure requiring an injection of drugs that increase the contractile force of the heart into a vein
  • slow heart rate
  • low blood pressure
  • certain heart conditions that cause very slow heartbeat or irregular heartbeat
  • cardiogenic shock, which is an acute, severe heart condition that causes low blood pressure and circulatory failure.

Warnings and cautions

If you have any of the following conditions, tell your doctor before taking Emconcor CHF. He or she may want to take special precautions (eg also give other treatment or carry out more frequent checks):

  • diabetes
  • strictly fixed
  • certain heart diseases, such as disturbed heart rhythm, or severe chest pain at rest (Prinzmetal’s angina)
  • kidney or liver problems
  • less severe circulatory problems in the arms and legs
  • chronic lung disease or less severe asthma
  • scaly skin rash ( psoriasis )
  • an adrenal tumor ( pheochromocytoma )
  • thyroid disease.

You should also tell your doctor if you are going to undergo:

  • desensitization treatment (eg for the prevention of hay fever) as Emconcor CHF may increase the likelihood of an allergic reaction or that such a reaction becomes more severe
  • anesthesia (eg during surgery), as Emconcor CHF can affect how the body responds to this situation.

If you have chronic lung disease or less severe asthma and are being treated with Emconcor CHF, contact your doctor immediately if you experience new symptoms such as difficulty breathing, coughing, wheezing after exercise, or other respiratory symptoms.

Children and young people

Emconcor CHF is not recommended for use in children and adolescents.

Other medicines and Emconcor CHF

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

Do not take the following medicines with Emconcor CHF unless specifically advised by your doctor:

  • certain medicines used to treat irregular or abnormal heart rhythms (class I antiarrhythmics, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone )
  • certain medicines used to treat high blood pressure, angina, or irregular heartbeat (calcium channel blockers such as verapamil and diltiazem )
  • Some drugs used to treat high blood pressure such as clonidine, methyldopa, moxonidine, cimetidine. Do not stop taking these medicines without first consulting a doctor.

Ask your doctor before taking the following medicines with Emconcor CHF; you may need to go for more frequent medical check-ups for your condition:

  • certain medicines used to treat high blood pressure or angina (dihydropyridine-type calcium antagonists such as felodipine and amlodipine)
  • certain medicines used to treat irregular or abnormal heart rhythms (class III antiarrhythmics such as amiodarone )
  • beta-blockers applied topically (eg timolol – eye drops for the treatment of glaucoma )
  • certain medicines used to treat eg Alzheimer’s disease or glaucoma(parasympathomimetics like tacrine or carbachol) or medicines used to treat acute heart problems ( sympathomimetics like isoprenaline and dobutamine )
  • drugs for diabetes, including insulin
  • anesthetics (eg in the case of surgery)
  • digitalis used to treat heart failure
  • non-steroidal anti-inflammatory drugs ( NSAIDs ) used to treat joint inflammation, pain, or inflammation (eg ibuprofen or diclofenac )
  • all drugs that can lower blood pressure as a desired or unwanted effect, e.g. antihypertensives, certain antidepressants ( tricyclic antidepressants such as imipramine and amitriptyline), certain medicines used to treat epilepsy or used under anesthesia ( barbiturates such as phenobarbital), or certain medicines for the treatment of mental illnesses characterized by lost touch with reality (phentomazines)
  • mefloquine, which is used to prevent or treat malaria
  • certain drugs for the treatment of depression, so-called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.

Pregnancy and breastfeeding

Pregnancy

There is a risk that Emconcor CHF may harm your baby if used during pregnancy. If you are pregnant or planning to become pregnant, tell your doctor. He or she will determine if you can take Emconcor CHF during pregnancy.

Breast-feeding

It is not known if bisoprolol passes into breast milk. Therefore, breast-feeding is not recommended during treatment with Emconcor CHF.

Driving and using machines

The ability to drive or use machines may be affected, depending on how well you tolerate the medicine. Take special care at the beginning of treatment, when increasing the dose or changing the medication, as well as when combined with alcohol.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

3. How to take Emconcor CHF

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. 
Treatment with Emconcor CHF requires regular medical check-ups. This is especially important at the beginning of treatment, during dose escalation, and at the end of treatment.

Take the tablet with a little water in the morning, with or without food. The tablets must not be chewed or crushed. The scored tablets can be divided into two equal doses.

Treatment with Emconcor CHF is usually long-lasting.

Adults, including the elderly 
Treatment with bisoprolol must be initiated at a low dose and gradually increased. 
Your doctor will decide how to increase your dose, and this will normally be done as follows:

  • 1.25 mg bisoprolol once daily for one week
  • 2.5 mg bisoprolol once daily for one week
  • 3.75 mg bisoprolol once daily for one week
  • 5 mg bisoprolol once daily for four weeks
  • 7.5 mg bisoprolol once daily for four weeks
  • 10 mg bisoprolol once daily for maintenance treatment.

The highest recommended daily dose is 10 mg bisoprolol.

Depending on how well you tolerate the medicine, your doctor may also extend the time between dose increases. If the condition worsens or you can no longer tolerate the medicine, it may be necessary to lower the dose again or to stop treatment. For some patients, a maintenance dose lower than 10 mg bisoprolol may be sufficient. 
Your doctor will tell you what to do.

If you need to stop treatment completely, your doctor will normally instruct you to reduce the dose gradually, as the condition may worsen.

If you take more Emconcor CHF then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. 
Symptoms of overdose may include slow heartbeat, difficulty breathing, dizziness, or tremors (due to lowered blood sugar).

If you forget to take Emconcor CHF

Do not take a double dose to make up for a forgotten dose. Take your usual dose the next morning.

If you stop taking Emconcor CHF

Never stop taking Emconcor CHF unless your doctor tells you to. Otherwise, your condition may worsen sharply.

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.

To prevent serious reactions, talk to a doctor immediately if a side effect is severe, occurs suddenly, or worsens quickly.

The most serious side effects are related to heart function:

  • slow heart rate (may affect more than 1 in 10 people)
  • worsening heart failure (may affect up to 1 in 10 people)
  • slow or irregular heartbeat (may affect up to 1 in 100 people)

If you feel dizzy or weak, or have difficulty breathing, contact your doctor as soon as possible.

Additional side effects are listed below according to how common they are:

Common (may affect up to 1 in 10 people)

  • fatigue, feeling weak, dizziness, headache
  • feeling cold or numbness in the hands or feet
  • low blood pressure
  • gastrointestinal upset such as nausea, vomiting, diarrhea, or constipation.

Uncommon (may affect up to 1 in 100 people)

  • sleep disorders
  • Depression
  • dizziness when traveling to a standing position
  • respiratory distress in patients with asthma or chronic lung disease
  • muscle weakness, muscle cramps.

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

  • hearing problems
  • allergic rhinitis
  • reduced tear flow
  • hepatitis that can cause yellowing of the skin or whites of the eyes
  • Some results of blood tests to check liver function or fat content may differ from normal
  • allergy-like reactions such as itching, redness, rash. You should contact a doctor immediately if you experience more severe allergic reactions, which may include swelling of the face, throat, tongue, mouth, or throat, or difficulty breathing.
  • impaired erection
  • nightmares, hallucinations
  • fainting.

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

  • irritation and redness of the eye ( inflammation of the conjunctiva )
  • hair loss
  • onset or worsening of scaly rash ( psoriasis ); psoriasis-like rash.

5. How to store Emconcor CHF

  • 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 the carton after EXP and EXP. The expiration date is the last day of the specified month.

Storage instructions for blister packaging of PVC / Alu

Emconcor CHF 1.25 mg film-coated tablets: 
Emconcor CHF 2.5 mg film-coated tablets: 
Emconcor CHF 3.75 mg film-coated tablets:

  • Do not store above 25 ° C.

Emconcor CHF 5 mg film-coated tablets: 
Emconcor CHF 10 mg film-coated tablets:

  • Do not store above 30 ° C.

Storage instructions for blister packs of Alu / Alu

Emconcor CHF 1.25 mg film-coated tablets:

Emconcor CHF 2.5 mg film-coated tablets:

Emconcor CHF 3.75 mg film-coated tablets:

Emconcor CHF 5 mg film-coated tablets:

Emconcor CHF 10 mg film-coated tablets:

  • This medicine has no special storage 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

Emconcor CHF 1.25 mg film-coated tablets

  • The active substance is bisoprolol fumarate. Each film-coated tablet contains 1.25 mg.
  • The other ingredients are 
    Tablet core: Colloidal anhydrous silica, magnesium stearate, crospovidone, pregelatinized maize starch, maize starch, microcrystalline cellulose, calcium hydrogen phosphate (anhydrous). 
    Film coating: Dimethicone, Talc, macrogol 400, titanium dioxide (E171), hypromellose.

Emconcor CHF 2.5 mg film-coated tablets

  • The active substance is bisoprolol fumarate. Each film-coated tablet contains 2.5 mg.
  • The other ingredients are 
    Tablet core: Colloidal anhydrous silica, magnesium stearate, crospovidone, corn starch, microcrystalline cellulose, calcium hydrogen phosphate (anhydrous). 
    Film coating: Dimethicone, macrogol 400, titanium dioxide (E171), hypromellose.

Emconcor CHF 3.75 mg film-coated tablets

  • The active substance is bisoprolol fumarate. Each film-coated tablet contains 3.75 mg.
  • The other ingredients are 
    Tablet core: Colloidal anhydrous silica, magnesium stearate, crospovidone, corn starch, microcrystalline cellulose, calcium hydrogen phosphate (anhydrous). 
    Film coating: Yellow iron oxide (E172), dimethicone, macrogol 400, titanium dioxide (E171), hypromellose.

Emconcor CHF 5 mg film-coated tablets

  • The active substance is bisoprolol fumarate. Each film-coated tablet contains 5 mg.
  • The other ingredients are 
    Tablet core: Colloidal anhydrous silica, magnesium stearate, crospovidone, corn starch, microcrystalline cellulose, calcium hydrogen phosphate (anhydrous). 
    Film coating: Yellow iron oxide (E172), dimethicone, macrogol 400, titanium dioxide (E171), hypromellose.

Emconcor CHF 10 mg film-coated tablets

  • The active substance is bisoprolol fumarate. Each film-coated tablet contains 10 mg.
  • The other ingredients are 
    Tablet core: Colloidal anhydrous silica, magnesium stearate, crospovidone, corn starch, microcrystalline cellulose, calcium hydrogen phosphate (anhydrous). 
    Film coating: Red iron oxide (E172), yellow iron oxide (E172), dimethicone, macrogol 400, titanium dioxide (E171), hypromellose.

What the medicine looks like and the contents of the pack

Emconcor CHF 1.25 mg film-coated tablets are white and round. 
Emconcor CHF 2.5 mg film-coated tablets are white and heart-shaped with a scoreline on both sides. 
Emconcor CHF 3.75 mg film-coated tablets are off-white and heart-shaped with a scoreline on both sides. 
Emconcor CHF 5 mg film-coated tablets are yellowish-white and heart-shaped with a scoreline on both sides. 
Emconcor CHF 10 mg film-coated tablets are bleached to light orange and heart-shaped with a scoreline on both sides. 
Each pack contains 20, 28, 30, 50, 56, 60, 90 or 100 tablets. 
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Merck AB, Solna

Manufacturer

Merck Healthcare KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany 
P&G Health Austria GmbH & Co. OG, Hösselgasse 20, 9800 Spittal / Drau, Austria

Famar Lyon, 29 Avenue Charles de Gaulle, 69230 Saint Genis Laval, France

This medicinal product is authorized under the European Economic Area under the names:

Belgium: Emconcor Minor
Finland: Emconcor CHF
France: Cardensiel
Ireland: Cardicor
Italy: Senator
Croatia: Concor COR
Luxembourg: Concor Cor
Netherlands: Emcor Deco
Portugal: Concor IC
Spain: EMCONCOR COR
UK: Cardicor
Germany: Concor COR
Austria:

Muhammad Nadeem

Leave a Reply