2.5 mg, 5 mg and 10 mg film-coated tablets 
bisoprolol

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Bisoprolol Krka is and what it is used for 
2. What you need to know before you use Bisoprolol Krka 
3. How to use Bisoprolol Krka 
4. Possible side effects 
5. How to store Bisoprolol Krka 6. Contents of the pack 
and other information 

1. What Bisoprolol Krka is and what it is used for

The active substance in Bisoprolol Krka is bisoprolol. Bisoprolol belongs to a group of medicines called beta-blockers . These drugs work by affecting the body’s response to certain nerve impulses, especially in the heart. This effect means that bisoprolol lowers heart rate and makes the heart pump around the blood in the body more efficiently. At the same time, the heart’s need for blood and oxygenation decreases. Heart failure occurs when the heart muscle is weakened and unable to pump enough blood to meet the body’s needs.

Bisoprolol Krka is used to treat:

  • high blood pressure ( hypertension )
  • angina pectoris (angina)
  • stable chronic heart failure . It is used in combination with other medicines that are suitable for this condition (eg ACE inhibitors , diuretics and cardiac glycosides).

Bisoprolol contained in Bisoprolol Krka may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you use Bisoprolol Krka

Do not use Bisoprolol Krka

Do not use Bisoprolol Krka if you have any of the following problems:

  • you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6)
  • you have severe asthma
  • you have severe circulatory problems in your arms and legs (eg Raynaud’s syndrome) that cause tingling in the fingers and toes or make them pale or blue
  • you have untreated pheochromocytoma , which is a rare tumor of the adrenal gland
  • You have metabolic acidosis , which is a condition in which the blood is too acidic

Do not use Bisoprolol Krka if you have any of the following heart problems:

  • acute heart failure
  • worsening heart failure that requires injection of drugs into a vein that increases the contractile force of the heart
  • low blood pressure
  • certain heart conditions that cause very slow heart rate or irregular heartbeat
  • cardiogenic shock , which is an acute , severe heart condition that causes low blood pressure and circulatory failure .

Warnings and cautions

Talk to your doctor or pharmacist before using Bisoprolol Krka.

If you have any of the following conditions, tell your doctor before taking Bisoprolol Krka. He or she may want to take special precautions (eg also give other treatment or carry out more frequent checks):

  • diabetes
  • strictly fixed
  • certain heart diseases, such as disturbed heart rhythm, or severe chest pain at rest (Prinzmetal’s angina)
  • kidney or liver problems
  • less severe circulatory problems in the arms and legs
  • less severe asthma or chronic lung disease
  • previously had problems with scaly skin rash ( psoriasis )
  • adrenal tumor ( pheochromocytoma )
  • thyroid disease
  • in first-degree heart block (a condition with disturbances in the heart’s nerve signals, which may cause the heart to skip a beat or beat irregularly)

You should also tell your doctor if you are going to undergo:

  • desensitization treatment (eg for the prevention of hay fever) as Bisoprolol Krka may increase the likelihood of an allergic reaction or that such a reaction becomes more severe
  • anesthesia (eg during surgery), as Bisoprolol Krka can affect how the body reacts to this situation

Children and young people

Bisoprolol Krka is not recommended for use in children and adolescents.

Other medicines and Bisoprolol Krka

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 Bisoprolol Krka unless specifically advised by a doctor:

  • certain medicines used to treat irregular or abnormal heart rhythms (class I antiarrhythmics such as quinidine , disopyramide , lidocaine , phenytoin , flecainide , propafenone )
  • certain medicines used to treat high blood pressure , angina or irregular heartbeat (calcium channel blockers such as verapamil and diltiazem )
  • Some drugs used to treat high blood pressure such as clonidine, methyldopa, moxonidine, and rilmenidine. Do not stop taking these medicines without first consulting a doctor.

Ask your doctor before taking the following medicines with Bisoprolol Krka: you may need to go for more frequent check-ups for your condition:

  • certain medicines used to treat high blood pressure , angina or abnormal heart rhythm (dihydropyridine-type calcium channel blockers such as nifedipine, felodipine and amlodipine)
  • certain medicines used to treat irregular or abnormal heart rhythms (class III antiarrhythmics such as amiodarone )
  • beta blockers applied topically (eg timolol – eye drops for the treatment of glaucoma )
  • certain medicines used to treat Alzheimer’s disease or glaucoma(parasympatomimetics such as tacrine and carbacol) or medicines used to treat acute heart problems ( sympathomimetics such as isoprenaline and dobutamine )
  • drugs for diabetes , including insulin
  • anesthetics (eg for surgery)
  • digitalis used to treat heart failure
  • non-steroidal anti-inflammatory drugs ( NSAIDs ) used to treat joint inflammation, pain or inflammation (eg ibuprofen or diclofenac )
  • all drugs that can lower blood pressure as a desired or unwanted effect, such as antihypertensive drugs, certain antidepressants ( tricyclic antidepressants such as imipramine and amitriptyline), certain drugs for the treatment of epilepsy or used under anesthesia ( barbiturates such as phenobarbital) or certain drugs for the treatment of mental illnesses characterized by lost contact with reality (phenothiazines such as levomepromazine)
  • mefloquine, which is used to prevent or treat malaria
  • certain drugs for the treatment of depression, so-called monoamine oxidase inhibitors (with the exception of MAO-B inhibitors) such as moclobemide
  • moxisylyt, which is used to treat circulatory problems such as Raynaud’s syndrome

Pregnancy, breastfeeding and fertility

There is a risk that Bisoprolol Krka may harm your baby if used during pregnancy. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. He or she will determine if you can take Bisoprolol Krka during pregnancy.

It is not known whether Bisoprolol Krka is excreted in human milk. Therefore, breast-feeding is not recommended during treatment with Bisoprolol Krka.

Driving and using machines

The ability to drive or use machines may be affected, depending on how well you tolerate the medicine. Be especially careful at the beginning of treatment, when changing dose , as well as when combined with alcohol.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Bisoprolol Krka contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose , ie essentially ‘sodium-free’.

3. How to use Bisoprolol Krka

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The tablets should be swallowed with liquid and should be taken in the morning, with or without food. The tablets must not be crushed or chewed.

Treatment with Bisoprolol Krka requires regular medical check-ups. This is especially important at the beginning of treatment, during dose escalation, and at the end of treatment. Treatment with Bisoprolol Krka is usually a long-term treatment.

High blood pressure and angina pectoris (angina)

Adult and elderly patients

Dose one should be adjusted individually. The usual dose is 10 mg once a day. Depending on how you respond to the drug treatment, your doctor may reduce the dose one to 5 mg or increase the dose one to 20 mg. The maximum dose should not exceed 20 mg daily.

Stable chronic heart failure

Adult and elderly patients

Bisoprolol treatment must be started at a low dose and gradually increased. Your doctor will decide how to increase your dose , and this will normally be done as follows:

  • 1.25 mg once daily for one week
  • 2.5 mg once daily for another week
  • 3.75 mg once daily for an additional week
  • 5 mg once daily for the following 4 weeks
  • 7.5 mg once daily for the following 4 weeks
  • 10 mg once daily as maintenance treatment.

The recommended maximum dose is 10 mg bisoprolol per day.

Depending on how well you tolerate the medicine, your doctor may also extend the time between dose increases. If the condition worsens or you can no longer tolerate the medicine, it may be necessary to lower the dose again or to stop treatment. For 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 completely, your doctor will normally instruct you to reduce the dose gradually, as the condition may worsen.

Hepatic or renal insufficiency

Normally, no dose adjustment is required for patients with mild to moderate renal or hepatic impairment. In case of severe renal impairment ( creatinine clearance <20 ml / min) or severe hepatic impairment, the daily dose should not exceed 10 mg bisoprolol.

Use for children and adolescents

Bisoprolol Krka is not recommended for use in children.

Symptoms of overdose may include slow heart rate , difficulty breathing, dizziness and tremors (due to low blood sugar).

If you forget to use Bisoprolol Krka

Do not take a double dose to make up for a forgotten dose , but take your regular dose as usual the next morning.

If you stop using Bisoprolol Krka

Never stop taking Bisoprolol Krka other than on the advice of a doctor. Otherwise, your condition may worsen sharply. It is especially important for patients being treated for ischemic heart disease that treatment not be stopped abruptly. If treatment needs to be stopped, your doctor may suggest a gradual reduction of doseone.

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, talk to a doctor immediately if a side effect is severe, occurs suddenly or worsens quickly. The most serious side effects are related to heart function:

  • slow heart rate (may affect up to 1 in 10 people)
  • aggravated 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 or weak, or have difficulty breathing, contact your doctor as soon as possible.

Additional side effects are listed below according to how common they are:

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
  • gastrointestinal upset such as nausea, vomiting, diarrhea or constipation

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

  • sleep disorders
  • Depression
  • dizziness when traveling to a standing position
  • respiratory distress 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
  • hepatitis that can cause yellowing of the skin or whites of the eyes
  • Some results of blood tests to check liver function or fat content may differ from normal
  • allergy-like reactions such as itching , redness and rash
  • impaired erection
  • nightmares, hallucinations
  • fainting

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

  • irritation and redness of the eye ( inflammation of the conjunctiva )
  • hair loss
  • onset or worsening of scaly rash ( psoriasis ); psoriasis-like rash.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Bisoprolol Krka

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Store in the original package. Sensitive to light. Moisture sensitive.

No special temperature instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is bisoprolol fumarate. Each Bisoprolol Krka 2.5 mg film-coated tablet contains 2.5 mg bisoprolol fumarate. Each Bisoprolol Krka 5 mg film-coated tablet contains 5 mg bisoprolol fumarate. Each Bisoprolol Krka 10 mg film-coated tablet contains 10 mg bisoprolol fumarate.
  • The other ingredients are microcrystalline cellulose, sodium starch glycolate type A, povidone K30, colloidal anhydrous silica, and magnesium stearate (E470b) in the tablet core. Hypromellose 2910, macrogol 400, titanium dioxide (E171), talc, yellow iron oxide (E172) only for 5 mg and 10 mg film-coated tablets and red iron oxide (E172) only for 5 mg and 10 mg film-coated tablets, in the film-coating.See section 2 “Bisoprolol Krka contains sodium”.

What the medicine looks like and contents of the pack

2.5 mg: white to off-white, oval, slightly biconvex film-coated tablet, with a scoreline on one side (length 8.3 – 8.7 mm, width 5.5 mm, thickness 2.8 – 3.6 mm). The tablet can be divided into two equal doses .

5 mg: light brownish yellow, oval, slightly biconvex film-coated tablet, with a scoreline on one side (length 8.3 – 8.7 mm, width 5.5 mm, thickness 2.8 – 3.6 mm). The tablet can be divided into two equal doses .

10 mg: light brownish yellow, round, slightly biconvex film-coated tablet with bevelled edges and a break notch on one side (diameter 10.0 – 10.3 mm, thickness 2.8– 3.6 mm). The tablet can be divided into two equal doses .

Blister (Alu / Alu foil): 10, 20, 28, 30, 50, 56, 60, 84, 90 and 100 tablets in a carton.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA Sverige AB, Göta Ark 175, 118 72 Stockholm,

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Muhammad Nadeem

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