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Emconcor Chf

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Document: Emconcor CHF film-coated tablet ENG PL change

PACKAGE LEAFLET

Package leaflet: Information for the user


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 7.5 mg film-coated tablets

Emconcor CHF 10 mg film-coated tablets


Bisoprolol fumarate


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


What is in this leaflet:


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

2. What you need to know before you take Emconcor CHF

3. How to take Emconcor CHF

4. Possible side effects

5. How to store Emconcor CHF

6. Contents of the pack and other information


1. WhatEmconcorCHF 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 medicines work by affecting the body`s response to some nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and makes the heart more efficient at pumping blood around the body.


Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body's needs. Emconcor CHF is used to treat stable chronic heart failure.

It is used in combination with other medicines suitable for this condition (such as ACE-inhibitors, diuretics, and heart glycosides).


2. What you need to know before you take Emconcor CHF


Do not take Emconcor CHF


Do not take Emconcor CHF if one of the following conditions applies to you:



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



Warnings and precautions


If you have any of the following conditions tell your doctor before taking Emconcor CHF; he or she may want to take special care(for example give additional treatment or perform more frequent checks):


In addition, tell your doctor if you are going to have:


If you have chronic lung disease or less severe asthma please inform your doctor immediately if you start to experience new difficulties in breathing, cough, wheezing after exercise, etc. when using Emconcor CHF.


Children and adolescents


Emconcor CHF is not recommended for use in children or 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 without special advice from your doctor:



Check with your doctor before taking the following medicines with Emconcor CHF; your doctor may need to check your condition more frequently:



Pregnancy and breast-feeding


Pregnancy

There is a risk that use of Emconcor CHF during pregnancy may harm the baby. If you are pregnant or planning to become pregnant, tell your doctor. He or she will decide whether you can take Emconcor CHF during pregnancy.

Breast-feeding

It is not known whether bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during therapy with Emconcor CHF.


Driving and using machines


Your ability to drive or use machinery may be affected depending on how well you tolerate the medicine. Please be especially cautious at the start of treatment, when the dose is increased or the medication is changed, as well as in combination with alcohol.


3. How to take Emconcor CHF


Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Treatment with Emconcor CHF requires regular monitoring by your doctor. This is particularly necessary at the start of treatment, during dose increase, and when you stop treatment.


Take the tablet with some water in the morning, with or without food. Do not crush or chew the tablet.

The scored tablets can be divided into two equal doses.


Treatment with Emconcor CHF is usually long-term.


Adults including the elderly


Treatment with bisoprolol must be started at a low dose and increased gradually.

Your doctor will decide how to increase the dose, and this will normally be done in the following way:



The maximum recommended daily dose is 10 mg bisoprolol.

Depending on how well you tolerate the medicine, your doctor may also decide to lengthen the time between dose increases. If your condition gets worse or you no longer tolerate the drug, it may be necessary to reduce the dose again or to interrupt treatment. In some patients a maintenance dose lower than 10 mg bisoprolol may be sufficient.

Your doctor will tell you what to do.


If you have to stop treatment entirely, your doctor will usually advise you to reduce the dose gradually, as otherwise your condition may become worse.


If you take more Emconcor CHF than you should


If you have taken more Emconcor CHF tablets than you should, tell your doctor immediately. Your doctor will decide what measures are necessary.

Symptoms of an overdose may include slowed heart rate, severe difficulty in breathing feeling dizzy, or trembling (due to decreased 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 on your doctor’s advice. Otherwise your condition could become much worse.


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, speak to a doctor immediately if a side effect is severe, occurred suddenly or gets worse rapidly.


The most serious side effects are related to the heart function:

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


Further side effects are listed below according to how frequently they may occur:


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


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


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


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


If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report the side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Emconcor CHF



Storage conditions for PVC/Alu blister


Emconcor CHF1.25 mg film-coated tablets:

Emconcor CHF2.5 mg film-coated tablets:

Emconcor CHF3.75 mg film-coated tablets:

Do not store above 25°C.

Emconcor CHF 5 mg film-coated tablets:

Emconcor CHF7.5 mg film-coated tablets:

Emconcor CHF10 mg film-coated tablets:

Do not store above 30°C.


Storage conditions for Alu/Alu blister


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 7.5 mg film-coated tablets:

Emconcor CHF 10 mg film-coated tablets:

This medicine does not require any special storage conditions.


Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


6. Contents of the pack and other information


What Emconcor CHF contains


Emconcor CHF 1.25 mg film-coated tablets

Tablet core: Silica, colloidal anhydrous; magnesium stearate; crospovidone; pregelatinised 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

Tablet core: Silica, colloidal anhydrous; magnesium stearate; crospovidone; maize starch; microcrystalline cellulose; calcium hydrogen phosphate (anhydrous).

Film coating: dimethicone; macrogol 400; titanium dioxide (E171); hypromellose.


Emconcor CHF 3.75 mg film-coated tablets

Tablet core: Silica, colloidal anhydrous; magnesium stearate; crospovidone; maize starch; microcrystalline cellulose; calcium hydrogen phosphate (anhydrous).

Film coating; Iron oxide yellow (E172);dimethicone; macrogol 400; titanium dioxide (E171); hypromellose.


Emconcor CHF 5 mg film-coated tablets

Tablet core: Silica, colloidal anhydrous; magnesium stearate; crospovidone; maize starch; microcrystalline cellulose; calcium hydrogen phosphate (anhydrous).

Film coating: Iron oxide yellow (E172); dimethicone; macrogol 400; titanium dioxide (E171); hypromellose.


Emconcor CHF 7.5 mg film-coated tablets

Tablet core: Silica, colloidal anhydrous; magnesium stearate; crospovidone; maize starch; microcrystalline cellulose; calcium hydrogen phosphate (anhydrous).

Film coating: Iron oxide yellow (E172);dimethicone; macrogol 400; titanium dioxide (E171); hypromellose.


Emconcor CHF 10 mg film-coated tablets

Tablet core: Silica, colloidal anhydrous; magnesium stearate; crospovidone; maize starch; microcrystalline cellulose; calcium hydrogen phosphate (anhydrous).

Film coating: Iron oxide red (E172); Iron oxide yellow (E172);dimethicone; macrogol 400; titanium dioxide (E171); hypromellose.


What Emconcor CHF looks like and 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 break-line on both sides.

Emconcor CHF 3.75 mg film-coated tablets are off-white and heart-shaped with a break-line on both sides.

Emconcor CHF 5 mg film-coated tablets are yellowish-white and heart-shaped with a break-line on both sides.

Emconcor CHF 7.5 mg film-coated tablets are pale yellow and heart-shaped with a break-line on both sides.

Emconcor CHF 10 mg film-coated tablets are pale orange – light orange and heart-shaped with a break-line 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 KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany


Manufacturer


Merck KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany

Merck KGaA & Co., Hösslgasse 20, 9800 Spittal/Drau, Austria

Tjoapack Netherlands B.V. Nieuwe Donk 9, 4879 AC Etten-Leur, The Netherlands

Merck S.L., Polígono Merck, Mollet del Vallés, 08100 Barcelona, Spain

[To be completed nationally]


This medicinal product is authorised in the Member States of the EEA under the following names:


Austria: Concor COR

Belgium: Emconcor Minor *

Croatia: Concor COR

Finland: Emconcor CHF

France: Cardensiel

Germany: Concor COR

Ireland Cardicor

Italy: Sequacor

Luxemburg: Concor Cor

Netherlands: Emcor Deco

Portugal: Concor IC

Spain: EMCONCOR COR

Sweden: Emconcor CHF

United Kingdom: Cardicor


This leaflet was last revised in 2016-04-20


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