Congescor

Patient Information Leaflet: Information for the Patient

CONGESCOR 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 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CONGESCOR is and what it is used for

The active substance in CONGESCOR 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. CONGESCOR is used for the treatment of stable chronic heart failure and is used in combination with other medicines available for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

2. What you need to know before taking CONGESCOR

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

• allergy (hypersensitivity) to bisoprolol or to any of the excipients (see section 6, 'What CONGESCOR contains')
• severe asthma
• severe circulatory problems in the extremities (such as Raynaud's syndrome), which may cause tingling or changes in skin colour (pale or blue fingers) of hands and feet
• untreated phaeochromocytoma, a rare tumour of the adrenal gland
• metabolic acidosis, a condition characterized by excessive acid in the blood.

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

• acute heart failure
• worsening heart failure requiring intravenous administration of medicines to increase the force of the heart's contraction
• 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 CONGESCOR; your doctor may take special measures (for example, prescribing additional treatment or more frequent monitoring):

• 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)
• tumour of the adrenal gland (phaeochromocytoma)
• thyroid disorder.

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

• desensitizing therapy (e.g. for prevention of hay fever), because CONGESCOR may provoke an allergic reaction or make it more severe
• anaesthesia (e.g. for surgery), because CONGESCOR may affect your body's response to this situation.

If you have chronic lung disease or less severe asthma, inform your doctor immediately if you develop worsening breathing difficulties, cough, shortness of breath during exercise, etc., while taking CONGESCOR.
Children and adolescents
The use of CONGESCOR is not recommended in children and adolescents.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Other medicines and CONGESCOR
Inform 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 CONGESCOR 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 CONGESCOR 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 conditions (sympathomimetics such as isoprenaline and dobutamine)
• antidiabetic medicines, including insulin
• anaesthetic 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 to treat epilepsy or during anaesthesia (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 in the prevention and treatment of malaria
• medicines for depression known as monoamine oxidase inhibitors (excluding MAO-B inhibitors), such as moclobemide.

Pregnancy and breastfeeding
Pregnancy
There is a risk that using CONGESCOR during pregnancy may harm the unborn child. If you are pregnant or planning a pregnancy, consult your doctor, who will decide whether you can take CONGESCOR during pregnancy.
Breastfeeding
It is not known whether bisoprolol passes into breast milk. Therefore, breastfeeding is not recommended during treatment with CONGESCOR.
Driving and using machines
Your ability to drive vehicles 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 CONGESCOR

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

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 medicine, 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 what to do.
If you need to completely stop treatment, your doctor will likely advise you to gradually reduce the
dose; otherwise, your condition could worsen.
If you take more CONGESCOR than you should
If you have taken more CONGESCOR 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 CONGESCOR
Do not take a double dose to make up for a missed dose. Take your usual dose the next morning.
If you stop taking CONGESCOR
Never stop taking CONGESCOR without first consulting your doctor: your condition may worsen.
If you have any doubts about how to use 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, appears suddenly, or worsens rapidly.
The most serious side effects involve heart function:

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

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

Listed below are other side effects, categorized according to how often they occur:
Common (may affect less than 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 less than 1 in 100 people):

• sleep disorders
• depression
• dizziness upon standing up
• breathing problems in patients with asthma or chronic lung disease
• muscle weakness, muscle cramps

Rare (may affect less than 1 in 1,000 people):

• hearing problems
• allergic rhinitis
• reduced tear flow
• inflammatory liver disorder which may cause yellowing of the skin or whites of the eyes (jaundice)
• abnormal results in certain blood tests for liver function or lipid levels
• allergic-type 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 less than 1 in 10,000 people):

• eye irritation and redness (conjunctivitis)
• hair loss
• onset or worsening of a scaly skin rash (psoriasis); psoriasiform rash

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 CONGESCOR

• 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 the month.

CONGESCOR 1.25 mg film-coated tablets:
CONGESCOR 2.5 mg film-coated tablets:
CONGESCOR 3.75 mg film-coated tablets:

• Do not store above 25 °C.

CONGESCOR 5 mg film-coated tablets:
CONGESCOR 7.5 mg film-coated tablets:
CONGESCOR 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. Contents of the pack and other information

What CONGESCOR contains
CONGESCOR 1.25 mg film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 1.25 mg.
• The excipients 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.

CONGESCOR 2.5 mg film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 2.5 mg.
• The excipients are: Tablet core: colloidal anhydrous silica; magnesium stearate; crospovidone; maize starch; microcrystalline cellulose; calcium hydrogen phosphate (anhydrous). Film coating: dimethicone; macrogol 400; titanium dioxide (E171); hypromellose.

CONGESCOR 3.75 mg film-coated tablets

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

CONGESCOR 5 mg film-coated tablets

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

CONGESCOR 7.5 mg film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 7.5 mg.
• The excipients are: Tablet core: colloidal anhydrous silica; magnesium stearate; crospovidone; maize starch; microcrystalline cellulose; calcium hydrogen phosphate (anhydrous). Film coating: yellow iron oxide (E172); dimethicone; macrogol 400; titanium dioxide (E171); hypromellose.

CONGESCOR 10 mg film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 10 mg.
• The excipients are: Tablet core: colloidal anhydrous silica; magnesium stearate; crospovidone; maize 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 CONGESCOR and pack contents
CONGESCOR 1.25 mg film-coated tablets are white and round.
CONGESCOR 2.5 mg film-coated tablets are white and heart-shaped, with a break line on both sides.
CONGESCOR 3.75 mg film-coated tablets are cream-white and heart-shaped, with a break line on both sides.
CONGESCOR 5 mg film-coated tablets are light yellowish and heart-shaped, with a break line on both sides.
CONGESCOR 7.5 mg film-coated tablets are pale yellow and heart-shaped, with a break line on both sides.
CONGESCOR 10 mg film-coated tablets are pale light orange and heart-shaped, with a break 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
MERCK SERONO S.p.A.
Via Casilina, 125, 00176 Rome, Italy (IT)

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

This medicinal product is authorized in the European Economic Area countries under the following names:
France: BisoCé Gé
Germany: Bisoprolol-CT
Italy: Congescor
Sweden: Libracor