Cardicor

PACKAGE LEAFLET

Package leaflet: information for the patient

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
Please read all of this leaflet carefully before taking this medicine because 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 in Cardicor is bisoprolol. Bisoprolol belongs to a group of medicines called beta-blockers. These medicines work by affecting the body's response to certain nerve impulses, especially in the heart. As a result, bisoprolol slows the heart rate and makes the heart more efficient at pumping blood throughout the body.
Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs. Cardicor is used in the treatment of stable chronic heart failure.
The medicine is used in combination with other available medicines for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you should know before taking Cardicor

Do not take Cardicor
Do not take Cardicor if any of the following apply to you:

• allergy (hypersensitivity) to bisoprolol or to any of the other ingredients (see section 6 ‘What Cardicor contains’)
• severe asthma
• severe circulatory problems in the extremities (such as Raynaud's syndrome), which may cause tingling or changes in skin color (pale or blue fingers) of hands and feet
• untreated pheochromocytoma, a rare tumor of the adrenal gland
• metabolic acidosis, a condition characterized by excessive acidity in the blood.

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

• acute heart failure
• worsening heart failure requiring intravenous injection of medicines that increase the heart's pumping strength
• slow heart rate (bradycardia)
• low blood pressure (hypotension)
• certain heart conditions causing very slow heart rate or irregular heartbeat
• cardiogenic shock, a severe acute heart condition causing low blood pressure and circulatory failure.

Warnings and precautions
If you have any of the following conditions, inform your doctor before taking Cardicor; your doctor may take special measures (for example, prescribing additional treatment or performing more frequent check-ups):

• diabetes
• prolonged fasting
• certain heart diseases, such as heart rhythm disorders or severe chest pain at rest (Prinzmetal's angina)
• kidney or liver problems
• less severe circulatory problems in the extremities
• chronic lung disease or less severe asthma
• history of scaly skin eruptions (psoriasis)
• tumor of the adrenal gland (pheochromocytoma)
• thyroid disorders.

Additionally, inform your doctor if you are due to receive:

• desensitization therapy (e.g., for prevention of hay fever), because Cardicor may trigger or worsen allergic reactions
• anesthesia (e.g., for surgery), because Cardicor may affect your body's response to anesthesia.

If you have chronic lung disease or less severe asthma, inform your doctor immediately if you develop new breathing difficulties, cough, wheezing after physical exertion, etc., while using Cardicor.

Children and adolescents
The use of Cardicor is not recommended in children and adolescents.
For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

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 specific instructions from your doctor:

• certain medicines used to treat irregular or abnormal heartbeats (Class I antiarrhythmics, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone)
• certain medicines used to treat high blood pressure, angina pectoris, or irregular heartbeat (calcium channel blockers such as verapamil and diltiazem)
• certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking these medicines without first consulting your doctor.

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

• certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine-type calcium channel blockers such as felodipine and amlodipine)
• certain medicines used to treat irregular or abnormal heartbeats (Class III antiarrhythmics such as amiodarone)
• locally applied beta-blockers (such as eye drops containing timolol for glaucoma treatment)
• certain medicines used, for example, in Alzheimer’s disease or glaucoma (parasympathomimetics such as tacrine or carbachol), or medicines used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine)
• antidiabetic medicines, including insulin
• anesthetic agents (e.g., during surgical procedures)
• digitalis, used in the treatment of heart failure
• non-steroidal anti-inflammatory drugs (NSAIDs), used to treat arthritis, pain, or inflammation (e.g., ibuprofen or diclofenac)
• any medicine that may lower blood pressure as either a desired or unwanted effect, such as antihypertensives, certain antidepressants (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used for epilepsy or anesthesia (barbiturates such as phenobarbital), or certain medicines used to treat mental disorders characterized by loss of contact with reality (phenothiazines such as levomepromazine)
• mefloquine, used for prevention and treatment of malaria
• medicines for depression called monoamine oxidase inhibitors (excluding MAO-B inhibitors), such as moclobemide.

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

Breastfeeding
It is not known whether bisoprolol passes into breast milk. Therefore, breastfeeding is not recommended during treatment with Cardicor.

Driving and using machines
Your ability to drive or operate machinery may be affected depending on how well you tolerate the medicine. Exercise particular caution at the beginning of treatment, when the dose is increased, when switching from another medicine, and when consuming alcohol.

3. How to take Cardicor

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Treatment with Cardicor requires periodic monitoring by your doctor. This is particularly necessary at the beginning of treatment, during dose escalation, and when stopping treatment.
Take the tablets with a glass of water in the morning, regardless of food intake. Do not crush or chew the tablet.
Tablets with a score line may be divided into two equal doses.
Treatment with Cardicor is usually long-term.

Adults, including elderly patients
Treatment with bisoprolol should be initiated at low doses, which are gradually increased.
Your doctor will decide how to increase the dose, usually as follows:
1.25 mg of bisoprolol once daily for one week
2.5 mg of bisoprolol once daily for one week
3.75 mg of bisoprolol once daily for one week
5 mg of bisoprolol once daily for four weeks
7.5 mg of bisoprolol once daily for four weeks
10 mg of bisoprolol once daily for long-term maintenance therapy
The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how well you tolerate the medicine, your doctor may decide to extend the intervals between dose increases. If your condition worsens or you no longer tolerate the drug, it may be necessary to reduce the dose again or discontinue treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient.
Your doctor will advise you accordingly.
If you need to completely stop treatment, your doctor will likely instruct you to gradually reduce the dose, otherwise your condition could worsen.

If you take more Cardicor than you should
If you have taken more Cardicor tablets than prescribed, inform your doctor immediately. The doctor will determine the necessary measures to take.
Symptoms of overdose may include slow heartbeat, severe breathing difficulties, dizziness, and tremors (due to low blood sugar).

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

If you stop taking Cardicor
Never stop taking Cardicor without first consulting your doctor: your condition may worsen.

If you have any questions about the use of this medicine, consult 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, occurs suddenly, or worsens rapidly.

The most serious side effects affect heart 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 feel dizzy, weak, or have breathing difficulties, contact your doctor as soon as possible.

Other side effects are listed below, according to how frequently they occur:

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

• Tiredness, feeling weak, dizziness, headache
• Feeling cold or numbness in hands or feet
• Low blood pressure
• Stomach or intestinal problems such as nausea, vomiting, diarrhoea or constipation

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

• Sleep disorders
• Depression
• Dizziness upon standing
• 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 liver disorder which may cause yellowing of the skin or the whites of the eyes (jaundice)
• Abnormal results in certain blood tests for liver function or fat levels
• Allergy-like reactions such as itching, flushing, skin rashes. You should contact 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 experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: 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 stated on the blister and 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 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 above 30°C.
Do not dispose of any medicine via 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 substance is bisoprolol fumarate. Each film-coated tablet contains 1.25 mg.
The other components are:
Tablet core: anhydrous colloidal 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 substance is bisoprolol fumarate. Each film-coated tablet contains 2.5 mg.
The other components are:
Tablet core: anhydrous colloidal 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 substance is bisoprolol fumarate. Each film-coated tablet contains 3.75 mg.
The other components are:
Tablet core: anhydrous colloidal 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 substance is bisoprolol fumarate. Each film-coated tablet contains 5 mg.
The other components are:
Tablet core: anhydrous colloidal 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 substance is bisoprolol fumarate. Each film-coated tablet contains 7.5 mg.
The other components are:
Tablet core: anhydrous colloidal 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 substance is bisoprolol fumarate. Each film-coated tablet contains 10 mg.
The other components are:
Tablet core: anhydrous colloidal 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 the appearance 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, heart-shaped, with a break line on both sides.
Cardicor 3.75 mg film-coated tablets are cream-white, heart-shaped, with a break line on both sides.
Cardicor 5 mg film-coated tablets are light yellowish, heart-shaped, with a break line on both sides.
Cardicor 7.5 mg film-coated tablets are pale yellow, heart-shaped, with a break line on both sides.
Cardicor 10 mg film-coated tablets are light pale orange, heart-shaped, with a break line on both sides.
Each package 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
Merck Serono S.p.A., Via Flaminia 970-972, 00189 Rome, Italy

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

This medicinal product is authorized in the European Economic Area countries under the
following names:
Belgium: Isoten *
Italy: Cardicor
Sweden: Cardicor
* 2.5 mg film-coated tablets: Isoten Minor