CARDICOR 1.25 MG Tabletki powlekane

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1. Cardicor 1.25 mg film-coated tablets, 2.5 mg film-coated tablets, 3.75 mg film-coated tablets, 5 mg film-coated tablets, 7.5 mg film-coated tablets, 10 mg film-coated tablets
   1. What Cardicor is and what it is used for
   2. What you need to know before taking Cardicor
   3. How to take Cardicor
   4. Possible side effects
   5. How to store Cardicor
   6. Package contents and other information

Cardicor 1.25 mg film-coated tablets, 2.5 mg film-coated tablets, 3.75 mg film-coated tablets, 5 mg film-coated tablets, 7.5 mg film-coated tablets, 10 mg film-coated tablets

bisoprolol fumarate

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Cardicor is and what it is used for

The active substance contained in Cardicor is bisoprolol. Bisoprolol belongs to the group of
medicines called beta-blockers. These medicines work by influencing the body's response
to certain nerve impulses, especially in the heart. As a result, bisoprolol
slows down the heart rate and makes the heart more efficient in pumping blood throughout the body.
Heart failure occurs when the heart muscle is weak and unable to pump
blood in sufficient quantity to meet the body's needs. Cardicor is used in the
treatment of chronic stable heart failure.
The medicine is used in association with other medicines available for this condition (such as
ACE inhibitors, diuretics and cardiac glycosides).

2. What you need to know before taking Cardicor

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

• allergy (hypersensitivity) to bisoprolol or any of the other ingredients (see section 6 ‘What Cardicor contains’)
• severe asthma
• serious circulatory problems of the extremities (such as Raynaud's syndrome), which can cause tingling or changes in the colour of the fingers (pale or blue) of the hands and feet
• untreated pheochromocytoma, a rare tumour of the adrenal gland
• metabolic acidosis, a condition characterised by too much acid in the blood.

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

• acute heart failure
• worsening heart failure requiring injection of medicines intravenously, which increases the force of heart contraction
• low heart rate
• low blood pressure
• certain heart conditions that cause a very low heart rate or irregular heartbeat
• cardiogenic shock, a severe acute heart condition that causes low blood pressure and circulatory failure.

Warnings and precautions
If you have any of the following conditions, tell your doctor before taking Cardicor; the doctor
may take special measures (e.g. prescribing additional treatment or performing
more frequent checks):

• diabetes
• strict fasting
• certain heart diseases, such as heart rhythm disturbances or severe chest pain at rest (Prinzmetal's angina)
• kidney or liver problems
• less severe circulatory problems of the extremities
• chronic lung disease or less severe asthma
• history of scaling skin rashes (psoriasis)
• tumour of the adrenal gland (pheochromocytoma)
• thyroid disorder.

Also, tell your doctor if you are going to receive:

• a desensitisation therapy (e.g. for the prevention of hay fever), because Cardicor can facilitate an allergic reaction or make it more severe
• an anaesthetic (e.g. for surgery), because Cardicor can affect the body's reaction to this situation.

If you have chronic lung disease or less severe asthma, tell your doctor immediately if you start
to experience new difficulty in breathing, cough, wheezing after exercise, etc.
when using Cardicor.

Children and adolescents
The use of Cardicor is not recommended in children and adolescents.
For those who play sports: the use of the drug without therapeutic need constitutes doping and may
still result in positive doping tests.

Other medicines and Cardicor
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take the following medicines together with Cardicor without special instructions from your doctor:

• certain medicines used in the treatment of irregular or abnormal heartbeat (class I antiarrhythmic medicines, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone)
• certain medicines used in the treatment of high blood pressure, angina pectoris or irregular heartbeat (calcium antagonists, such as verapamil and diltiazem)
• certain medicines used in the treatment of high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking thesemedicineswithout first consulting your doctor.

Before taking Cardicor together with the following medicines, consult your doctor, who may require more
frequent checks of your condition:

• certain medicines used in the treatment of high blood pressure or angina pectoris (dihydropyridine calcium antagonists, such as felodipine and amlodipine)
• certain medicines used in the treatment of irregular or abnormal heartbeat (class III antiarrhythmic medicines, such as amiodarone)
• betablockers applied locally (such as eye drops containing timolol for the treatment of glaucoma)
• certain medicines used in the treatment, for example, of Alzheimer's disease or in the treatment of glaucoma (parasympathomimetics such as tacrine or carbacol) or medicines used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine)
• antidiabetic medicines, including insulin
• anaesthetic agents (e.g. during surgery)
• digitoxin, used in the treatment of heart failure
• non-steroidal anti-inflammatory drugs (NSAIDs), used in the treatment of arthritis, pain or inflammation (e.g. ibuprofen or diclofenac)
• any medicine that can lower blood pressure as a desired or undesired effect, such as antihypertensives, certain medicines for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used in the treatment of epilepsy or during anaesthesia (barbiturates such as phenobarbital) or certain medicines used to treat mental disorders characterised by loss of contact with reality (phenothiazines such as levomepromazine)
• mefloquine, used in the prevention and treatment of malaria
• medicines for the treatment of depression called monoamine oxidase inhibitors (except MAO-B inhibitors), such as moclobemide.

Pregnancy and breastfeeding

Pregnancy
There is a risk that using Cardicor during pregnancy may harm the unborn baby. If you are
pregnant or planning a pregnancy, consult your doctor, who will decide whether you can take Cardicor in
pregnancy.

Breastfeeding
It is not known whether bisoprolol passes into breast milk. Therefore, it is recommended not to breastfeed during
therapy with Cardicor.

Driving and using machines
Your ability to drive and use machines may be affected depending on how
you tolerate the medicine. Use particular caution at the beginning of treatment, when the dose is
increased, when switching from another medicine and in association with alcohol.

3. How to take Cardicor

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Treatment with Cardicor requires periodic monitoring by your doctor. This is necessary in
particular at the beginning of treatment, during dose increases and when stopping treatment.
Take the tablets with a little water in the morning, independently of food. Do not crush or
chew the tablet.
Tablets with a score line can be divided into two equal doses.
Treatment with Cardicor is usually long-term.

Adults, including the elderly
Treatment with bisoprolol should be started at low doses, which are gradually increased.
The doctor will decide how to increase the dose, usually as follows:

• 1.25 mg of bisoprolol once a day for one week
• 2.5 mg of bisoprolol once a day for one week
• 3.75 mg of bisoprolol once a day for one week
• 5 mg of bisoprolol once a day for four weeks
• 7.5 mg of bisoprolol once a day for four weeks
• 10 mg of bisoprolol once a day for maintenance therapy (long-term)

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how well the medicine is tolerated, the doctor may decide to extend the interval between
dose increases. If your condition worsens or if you no longer tolerate the medicine, it may be
necessary to reduce the dose again or stop treatment. In some patients, a lower maintenance dose than 10 mg of bisoprolol may be sufficient.
The doctor will tell you what to do.
If you have to stop treatment completely, the doctor will probably advise you to reduce the
dose gradually, otherwise your condition may worsen.

If you take more Cardicor than you should
If you have taken more Cardicor tablets than you should, tell your doctor immediately, who
will decide what measures need to be taken.
Symptoms of an overdose may include slow heartbeat, severe difficulty breathing,
dizziness and tremors (due to decreased blood sugar).

If you forget to take Cardicor
Do not take a double dose to make up for a missed dose. Take your usual dose the
next morning.

If you stop taking Cardicor
Never stop taking Cardicor without first consulting your doctor: your condition
may worsen.
If you have any doubts about the use of this medicine, 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, contact your doctor immediately if a side effect is severe,
appears suddenly or worsens rapidly.
The most serious side effects affect cardiac function:

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

If you experience dizziness, feel weak or have difficulty breathing, contact your doctor as soon as possible.
Below is a list of other side effects, depending on how frequently they occur:

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
• stomach or intestinal problems such as nausea, vomiting, diarrhea or constipation.

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

• sleep disturbances
• depression
• dizziness when moving to an upright position
• breathing problems 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
• inflammatory process of the liver that can cause yellowing of the skin or whites of the eyes
• results of certain blood tests for liver function or fat levels that are different from normal
• allergy-like reactions such as itching, flushing, skin rashes. You should consult your doctor immediately if you experience more severe allergic reactions, which may include swelling of the face, neck, tongue, mouth or throat, or difficulty breathing.
• erectile dysfunction
• nightmares, hallucinations
• fainting.

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

• eye irritation and redness (conjunctivitis)
• hair loss
• appearance or worsening of a scaly skin rash (psoriasis); psoriasis-like rash.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Cardicor

• 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”. The expiry date refers to the last day of that month.

Cardicor 1.25 mg film-coated tablets:

Cardicor 2.5 mg film-coated tablets:

Cardicor 3.75 mg film-coated tablets:

• Do not store at a temperature above 25°C.

Cardicor 5 mg film-coated tablets:

Cardicor 7.5 mg film-coated tablets:

Cardicor 10 mg film-coated tablets:

• Do not store at a temperature above 30°C.

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cardicor contains

Cardicor 1.25 mg film-coated tablets

• The active ingredient is bisoprolol fumarate. Each film-coated tablet contains 1.25 mg.
• The other ingredients are: Tablet core: colloidal anhydrous silica; magnesium stearate; crospovidone; pregelatinized corn starch; corn starch; microcrystalline cellulose; calcium hydrogen phosphate (anhydrous). Film coating: dimethicone; talc; macrogol 400; titanium dioxide (E171); hypromellose.

Cardicor 2.5 mg film-coated tablets

• The active ingredient 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.

Cardicor 3.75 mg film-coated tablets

• The active ingredient 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.

Cardicor 5 mg film-coated tablets

• The active ingredient 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.

Cardicor 7.5 mg film-coated tablets

• The active ingredient is bisoprolol fumarate. Each film-coated tablet contains 7.5 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.

Cardicor 10 mg film-coated tablets

• The active ingredient 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.

Description of Cardicor and package contents
Cardicor 1.25 mg film-coated tablets are white and round.
Cardicor 2.5 mg film-coated tablets are white and heart-shaped, with a fracture line on
both sides.
Cardicor 3.75 mg film-coated tablets are off-white in color and heart-shaped, with a
fracture line on both sides.
Cardicor 5 mg film-coated tablets are light yellowish in color and heart-shaped, with a
fracture line on both sides.
Cardicor 7.5 mg film-coated tablets are pale yellow in color and heart-shaped, with a fracture line
on both sides.
Cardicor 10 mg film-coated tablets are light orange-yellow in color and heart-shaped,
with a fracture line on both sides.
Each pack contains 10, 20, 28, 30, 50, 56, 60, 90 or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Marketing authorization holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via M. Civitali, 1 – 20148 Milan.

Manufacturer
MERCK KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany.
Merck S.L., Polìgono Merck, 08100 Mollet del Vallès (Barcelona), Spain.

This medicinal product is authorized in the Member States of the European Economic Area with the
following denominations:
Belgium: Isoten *
Denmark: Cardicor
France: Cardiocor
Italy: Cardicor
Netherlands: Bisoprololfumaraat Deco Mylan
Sweden: Cardicor
United Kingdom: Congescor
*film-coated tablets 2.5 mg: Isoten Minor