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

1. What Emconcor is and what it is used for

The active substance in Emconcor 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. At the same time, the heart’s need for blood and oxygenation decreases. Emconcor is used to treat high blood pressure and angina in the heart ( angina pectoris ).

Bisoprolol contained in Emconcor 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 Emconcor

Do not take Emconcor

Do not take Emconcor:

  • if you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6)
  • if you have severe asthma
  • if you have severe blood circulation problems in your arms and legs (eg Raynaud’s syndrome) which causes tingling in the fingers and toes or causes them to turn pale or blue
  • if you have untreated pheochromocytoma, which is a rare tumor of the adrenal gland
  • if you have metabolic acidosis, which is a condition in which the blood is too acidic.

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

  • acute heart failure
  • worsening heart failure that requires injection of drugs that increase the contractile force of the heart in 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. 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)
  • 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 may increase the likelihood of an allergic reaction or that such a reaction becomes more severe
  • anesthesia (eg during surgery), as Emconcor may affect how the body responds to this situation.

If you have chronic lung disease or less severe asthma and are being treated with Emconcor, 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 is not recommended for use in children and adolescents.

Other medicines and Emconcor

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 except on the special advice of a doctor:

  • Some 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; you may need to go for more frequent medical check-ups for your condition:

  • Some medicines are used to treat high blood pressure or angina (dihydropyridine-type calcium antagonists such as felodipine and amlodipine)
  • Some medicines used to treat irregular or abnormal heart rhythms (class I antiarrhythmics, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone, and class III antiarrhythmics such as amiodarone )
  • Beta-blockers applied topically (eg timolol – eye drops for the treatment of glaucoma )
  • Some drugs used to treat for example Alzheimer’s disease or glaucoma (as carbachol) or medicines used to treat acute heart problems ( sympathomimetics isoprenaline and dobutamine )
  • Medicines for diabetes, including insulin
  • Anesthetics (eg for 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. antihypertensive drugs, certain antidepressants ( tricyclic antidepressants such as amitriptyline), certain medicines used to treat epilepsy or used under anesthesia ( barbiturates such as phenobarbital), or certain medicines used to treat mental illnesses characterized by lost touch with reality (phenothiazines such as levomepromazine)
  • Mefloquine, which is used to prevent or treat malaria
  • Some medicines 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 may harm the 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 during pregnancy.

Breast-feeding 
It is not known whether bisoprolol is excreted in human milk. Therefore, breast-feeding is not recommended during treatment with Emconcor.

Driving and using machines

The ability to drive or use machines may be affected, depending on how well you tolerate the medicine. Be especially careful at the beginning of treatment, when changing the dose 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 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.

3. How to take Emconcor

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Bisoprolol treatment must be started at a low dose and gradually increased. Dose one should be adjusted individually and adjusted according to heart rate and achieved effect.

The recommended dose for adults is 1 tablet 5 mg daily. If necessary, the dose can be increased to 10 mg daily and in rare cases to 20 mg daily.

The recommended maximum dose is 20 mg per day.

Treatment with Emconcor is usually long-lasting.

The tablets can be taken with food and should be taken in the morning. The tablets should be swallowed with liquid and should not be chewed.

The tablet can be divided into two equal doses.

Renal or hepatic insufficiency 
No dose adjustment is normally required for patients with mild to moderate renal or hepatic impairment. In case of severe renal impairment or hepatic impairment, the daily dose should not exceed 10 mg bisoprolol.

Elderly 
No dose adjustment is required.

If you take more Emconcor 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

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

Never stop taking Emconcor 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. These side effects are listed below according to how common they are:

Common (may affect up to 1 in 10 users)

  • fatigue, dizziness, headache: These symptoms occur especially at the beginning of treatment. They are usually mild and usually disappear within 1-2 weeks.
  • 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)

  • slow heart rate
  • worsening heart failure
  • feeling weak
  • sleep disorders
  • Depression
  • slow or irregular heartbeat
  • 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 users)

  • hearing loss
  • 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 users)

  • 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

Keep this medicine out of the sight and reach of children. 
Do not store above 30 ° C. 
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. 
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 bisoprolol fumarate. Each film-coated tablet contains 5 mg bisoprolol fumarate.
  • Other ingredients are:

Tablet core: Colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, anhydrous calcium hydrogen phosphate. 
Film coating: Dimethicone, macrogol, hypromellose, titanium dioxide (dye E171), yellow iron oxide (dye E 172).

What the medicine looks like and the contents of the pack

Emconcor 5 mg film-coated tablets are off-white, heart-shaped with a scoreline on both sides. 
Each pack contains 30 or 100 tablets.

Marketing Authorisation Holder

Merck AB, Box 3033, 169 03 Solna

Manufacturer

Merck Healthcare KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany

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

Muhammad Nadeem

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