Bisoprolol AHCL

Package leaflet: Information for the user

Bisoprolol HCl 2.5 mg film-coated tablets, 5 mg film-coated tablets, 10 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Bisoprololo AHCL is and what it is used for

The active substance in this medicine is bisoprolol fumarate. Bisoprolol fumarate
belongs to a group of medicines called beta-blockers. Beta-blockers protect the heart
from excessive activity. This medicine works by affecting the body's response to certain
nerve impulses, particularly in the heart. As a result, bisoprolol fumarate slows the
heart rate and makes the heart more efficient at pumping blood around the body.
Heart failure occurs when the heart muscle is weakened and unable to
pump enough blood to meet the body's needs.
Bisoprololo AHCL 2.5 mg, 5 mg and 10 mg tablets are used in combination
with other medicines for the treatment of stable heart failure.
Bisoprololo AHCL 5 mg and 10 mg tablets are also used for the treatment
of high blood pressure (hypertension) and angina pectoris (chest pain caused by blockages
in the arteries supplying the heart muscle).

2. What you should know before taking Bisoprolol HCl

Do not take Bisoprolol HCl if:

• you are allergic to bisoprolol fumarate or to any of the other ingredients of this medicine (listed in section 6).
• you have severe asthma.
• you have a severe circulation disorder in the limbs (such as Raynaud's syndrome), which may cause tingling in the fingers and toes or make them pale or blue.
• you have untreated phaeochromocytoma, which is a rare tumour of the adrenal gland.
• you have metabolic acidosis, a condition in which there is an excessive amount of acid in the blood.

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

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

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine. Your doctor may want to take special care (for example, prescribe additional treatment or perform more frequent checks) if you have any of the following conditions:

• diabetes
• prolonged fasting (no solid food intake)
• certain heart diseases, such as heart rhythm disorders or severe chest pain at rest (Prinzmetal's angina)
• kidney or liver disease
• milder circulation problems in the limbs
• mild asthma or chronic lung disease
• history of scaly skin rash (psoriasis)
• tumour of the adrenal medulla (phaeochromocytoma)
• thyroid disorder

Also, inform your doctor if you are about to undergo:

• desensitization therapy (e.g. for hay fever prevention), because bisoprolol fumarate may increase the likelihood of an allergic reaction or make such a reaction more severe.
• anaesthesia (e.g. for surgery), because this medicine may affect how your body responds during such procedures.

If you have chronic lung disease or mild asthma, inform your doctor immediately if you develop new breathing difficulties, cough, wheezing after physical exertion, etc., while taking Bisoprolol HCl.
For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.
Other medicines and Bisoprolol HCl
Talk to 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 Bisoprolol HCl without first consulting 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 antagonists 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.

Check with your doctor before taking the following medicines with Bisoprolol HCl; your doctor may need to monitor your condition more frequently:

• certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine calcium antagonists 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 timolol eye drops for glaucoma treatment)
• certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbacol), or medicines used to treat acute heart conditions (sympathomimetics such as isoprenaline and dobutamine)
• antidiabetic medicines, including insulin
• anaesthetic agents (e.g. during surgery)
• digitalis, used to treat 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 intended or unintended 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 illnesses characterized by loss of contact with reality (phenothiazines such as levomepromazine)
• mefloquine, used for prevention or treatment of malaria
• medicines for depression called monoamine oxidase inhibitors (except MAO-B inhibitors), such as moclobemide.

Pregnancy and breastfeeding
Pregnancy
There is a risk that Bisoprolol HCl may harm your baby if used during pregnancy. If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine. Your doctor will decide whether you can take Bisoprolol HCl during pregnancy.
Breastfeeding
It is not known whether bisoprolol fumarate passes into breast milk. For this reason, breastfeeding is not recommended during treatment with Bisoprolol HCl.
Bisoprolol HCl contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.
Driving and using machines:
Your ability to drive or operate machinery may be affected, depending on how well you tolerate the medicine. Pay particular attention at the start of treatment, when the dose is increased, when the medicine is changed, or when the medicine is taken together with alcohol.

3. How to take Bisoprolol HCl

Always take this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Treatment with Bisoprolol HCl requires regular monitoring by your doctor. This is
particularly important at the beginning of treatment, during the dose-increase phase, and when
discontinuing treatment.
Bisoprolol HCl should be taken in the morning, with or without food. Swallow the tablet or
tablets whole with a glass of water, without chewing or crushing them. The tablet may be
divided into equal doses. If it is necessary to take half a tablet, place the tablet on a flat surface
with the score line facing upwards. Then gently press on each side of the score line to break the
tablet into two equal parts.
Treatment with Bisoprolol HCl is generally long-term.
Adults:
Chest pain and high blood pressure:
Your doctor will start treatment with the lowest possible dose (5 mg). Your doctor will closely
monitor you at the beginning of treatment. Your doctor will increase your dose to achieve the
best possible dosage.
The maximum recommended dose is 20 mg once daily.
Patients with kidney disease:
Patients with severe kidney disease must not exceed a dose of 10 mg of bisoprolol once daily.
Consult your doctor before starting to use this medicine.
Patients with liver disease:
Patients with severe liver disease must not exceed a dose of 10 mg of bisoprolol once daily.
Consult your doctor before starting to use this medicine.
Heart failure:
Before starting Bisoprolol HCl, you should already be receiving treatment with other
medicines for heart failure, including an ACE inhibitor, a diuretic, and (as an added option) a
cardiac glycoside.
Treatment with Bisoprolol HCl should be initiated at a low dose and the dose should be
gradually increased. Your doctor will decide how to increase the dose, which will normally be
done as follows:

• 1.25 mg bisoprolol fumarate once daily for one week
• 2.5 mg bisoprolol fumarate once daily for one week
• 3.75 mg bisoprolol fumarate once daily for one week
• 5 mg bisoprolol fumarate once daily for four weeks
• 7.5 mg bisoprolol fumarate once daily for four weeks
• 10 mg bisoprolol fumarate once daily for maintenance therapy (ongoing).

The maximum recommended daily dose of bisoprolol fumarate is 10 mg.
Depending on how well you tolerate the medicine, your doctor may 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. For some patients, a maintenance
dose lower than 10 mg of bisoprolol fumarate may be sufficient. Your doctor will advise you on
what to do. If you need to stop treatment completely, your doctor will usually advise you to
gradually reduce the dose, as otherwise your condition could worsen.
Use in children
Bisoprolol HCl is not recommended for use in children.
Elderly patients
Dose adjustment is generally not required. It is recommended to start with the lowest possible
dose.
If you notice that the dose of bisoprolol is too strong or not effective enough, consult your doctor
or pharmacist.
If you take more Bisoprolol HCl than you should
If you have taken more Bisoprolol HCl tablets than prescribed, inform your doctor immediately.
Your doctor will decide what measures are necessary.
Symptoms of overdose may include slow heartbeat, severe breathing difficulties, dizziness, or
tremor (due to low blood sugar).
If you forget to take Bisoprolol HCl
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your
next dose. Do not take a double dose to make up for the missed dose.
If you stop taking Bisoprolol HCl
Do not stop treatment suddenly and do not change the recommended dose without first
consulting your doctor. If treatment needs to be stopped, it should be discontinued gradually to
avoid unwanted effects.
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, consult your doctor immediately if a side effect is severe, occurs suddenly, or worsens rapidly.
The most serious side effects relate to heart function:

• Slowing of the heart rate (may affect up to 1 in 10 people with chronic heart failure and may affect up to 1 in 100 people with hypertension or angina pectoris)
• Worsening of heart failure (may affect up to 1 in 10 people with chronic heart failure and may affect up to 1 in 100 people with hypertension or angina pectoris)
• Slow or irregular heartbeat (may affect up to 1 in 10 people with chronic heart failure)
• Worsening of symptoms of blockage in the main blood vessel to the legs, particularly at the beginning of treatment (frequency not known). If you experience dizziness, weakness, or have difficulty breathing, consult 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):

• Fatigue*, feeling of weakness (in patients with chronic heart failure), dizziness*, headache*
• Cold sensation or numbness in hands or feet
• Low blood pressure, particularly in patients with heart failure
• Stomach or intestinal problems, such as nausea, vomiting, diarrhoea or constipation

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

• Sleep disorders
• Depression
• Dizziness when standing up
• 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 (stuffy nose or runny nose)
• Reduced tear flow (may be a problem if you wear contact lenses)
• Inflammation of the liver which may cause yellowing of the skin or whites of the eyes
• Abnormal results in certain blood tests for liver function and fat levels
• Allergic-type reactions, such as itching, flushing, rash. You must consult your doctor immediately if you experience more severe allergic reactions, which may involve swelling of the face, neck, tongue, mouth or throat, or difficulty breathing.
• Impaired erection
• Nightmares, hallucinations
• Fainting

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

• Eye irritation and redness (conjunctivitis)
• Hair loss
• New onset or worsening of scaly skin rash (psoriasis): psoriasiform rash.

* If you are being treated for high blood pressure or angina, these symptoms occur particularly at the beginning of treatment, or if your dose is changed.
They are usually mild and often disappear within 1–2 weeks.
Reporting of side effects
If you experience any side effects, 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 for adverse reactions. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bisoprolol AHCL

• 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 following 'Exp.'. The expiry date refers to the last day of that month.
• 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 Bisoprololo AHCL contains:
The active substance is bisoprolol fumarate. Each tablet contains 2.5 mg, 5 mg or 10 mg of
bisoprolol fumarate.
The other components are microcrystalline cellulose, sodium starch glycolate (Type-A), povidone
K-30, colloidal anhydrous silica, magnesium stearate (E70b), hypromellose E-15 (E464), macrogol
400 (E553), titanium dioxide (E171), talc.

Description of the appearance of Bisoprololo AHCL and the pack contents:
Film-coated, biconvex, round tablets, white to off-white in colour,
with 'b1' engraved on one side and a break line on the other side.
Film-coated, biconvex, round tablets, white to off-white in colour,
with 'b2' engraved on one side and a break line on the other side.
Film-coated, biconvex, round tablets, white to off-white in colour,
with 'b3' engraved on one side and a break line on the other side.
Pack sizes of 20, 28, 30, 50, 56, 60, 90 and 100 tablets per pack are registered for
all strengths. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice,
Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens, Lamia, Schimatari, 32009, Greece

This medicinal product is authorised in the European Economic Area Member States under the following names:

This leaflet was approved in: 09/2025.