1.25 mg and 2.5 mg tablets 
Bisoprolol fumarate

Read all of this leaflet carefully before you start taking 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 you will find information about: 
1. What Bisostad is and what it is used for 
2. What you need to know before you use Bisostad 
3. How to use Bisostad 
4. Possible side effects 
5. How to store Bisostad 
6. Contents of the packaging and other information 

1. What Bisostad is and what it is used for

The active substance in Bisostad 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 slows down the heart rate and makes the heart pump around the blood in the body more efficiently.

Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body’s needs. Bisostad is used in the treatment of stable chronic heart failure. The drug is used in combination with other drugs that are suitable for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

Bisoprolol contained in Bisostad 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.

2. What you need to know before using Bisostad

Do not use Bisostad

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

  • if you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6).
  • severe asthma or severe chronic lung disease.
  • severe blood circulation problems in the arms and legs (eg Raynaud’s syndrome) which causes tingling in the fingers and toes or causes them to turn pale or blue.
  • untreated pheochromocytoma, which is a rare tumor of the adrenal gland.
  • metabolic acidosis, which is a condition in which the blood is too acidic.

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

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

Warnings and cautions

If you have any of the following conditions, talk to your doctor before taking this medicine. He or she may want to take special precautions (eg give additional treatment or perform 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
  • mild blood circulation problems in arms and legs
  • mild asthma or chronic lung disease
  • scaly skin rash ( psoriasis )
  • an adrenal tumor ( pheochromocytoma )
  • thyroid disease.

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

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

Children and young people

Bisostad is not recommended for use in children.

Other medicines and Bisostad

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 Bisostad unless specifically advised by a doctor:

  • Some medicines used to treat irregular or abnormal heart rhythms (class I antiarrhythmics, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone )
  • Some 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, brimonidine. Do not stop taking these medicines without first consulting a doctor.

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

  • Certain medicines used to treat high blood pressure or angina (dihydropyridine-type calcium channel blockers such as felodipine and amlodipine)
  • Some 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 drugs used to treat for example Alzheimer’s disease or glaucoma(parasympathomimetics example tacrine or carbachol) or drugs used for treating acute heart problems ( sympathomimetics as isoprenaline and dobutamine )
  • Medicines 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 medicines that can lower blood pressure as a desired or unwanted effect, such as blood pressure-lowering medicines, certain antidepressants ( tricyclic antidepressants such as imipramine and amitriptyline), certain medicines used to treat epilepsy or used under anesthesia ( barbiturates such as phenobarbital), or certain drugs for the treatment of mental illness characterized by lost contact with reality (phenothiazines such as levomepromazine)
  • Mefloquine, which is used to prevent or treat malaria
  • Some medicines for the treatment of depression, so-called monoamine oxidase inhibitors (with the exception of MAO-B inhibitors) such as moclobemide.

Bisostad with food, drink, and alcohol

Bisostad should be taken the morning before, with, or after breakfast. The tablets should be swallowed whole with liquid and should not be chewed or crushed.

Avoid large amounts of alcohol as this may potentiate the antihypertensive effect of bisoprolol. Avoid drinking alcohol completely if you feel more dizzy and affected than usual.

Pregnancy, breastfeeding, and fertility

There is a risk that Bisostad may harm the 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 this medication during pregnancy.

It is not known if bisoprolol passes into breast milk. Therefore, breast-feeding is not recommended during treatment with Bisostad.

Driving and using machines

The ability to drive or use machines may be affected, depending on how well you tolerate the medicine. Take special care at the beginning of treatment, when increasing the dose or changing the medication, 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.

3. How to use Bisostad

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

Treatment with Bisostad requires regular medical check-ups. This is especially important at the beginning of treatment, during dose escalation, and at the end of treatment.

Take the tablet with a little water in the morning, with or without food. The tablets must not be chewed or crushed.

Treatment with Bisostad is usually long-lasting.

Adults, including the elderly:

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 bisoprolol once daily for one week
  • then 2.5 mg bisoprolol once daily for one week
  • then 3.75 mg bisoprolol once daily for one week
  • then 5 mg bisoprolol once daily for four weeks
  • then 7.5 mg bisoprolol once daily for four weeks

The highest recommended daily dose is 10 mg bisoprolol.

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.

Patients with renal or hepatic impairment

The dose should be increased gradually and with great caution in patients with renal or hepatic impairment.

Symptoms of overdose may include slow heartbeat, difficulty breathing, dizziness, or tremors (due to decreased blood sugar).

If you forget to use Bisostad

Do not take a double dose to make up for a forgotten dose . Take your usual dose the next morning.

If you stop using Bisostad

Never stop taking Bisostad other than on the advice of a doctor. Otherwise, your condition may worsen sharply.

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 more than 1 user in 10)
  • 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, rash
  • impaired erection
  • nightmares, hallucinations.
  • fainting

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

  • irritation and red eyes ( 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 Bisostad should be stored

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 card and the carton after the abbreviation EXP. The expiration date is the last day of the specified month.

No special storage 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 Bisostad 1.25 mg tablet contains 1.25 mg bisoprolol fumarate.

Each Bisostad 2.5 mg tablet contains 2.5 mg bisoprolol fumarate.

The other ingredients are microcrystalline cellulose, colloidal silica, croscarmellose sodium, sodium starch glycolate (type A), and magnesium stearate.

What the medicine looks like and contents of the pack

Bisostad 1.25 mg tablets are white to off-white, round, and biconvex tablets.

Bisostad 2.5 mg tablets are white to off-white, round, and biconvex tablets with a scoreline on one side.

Bisostad tablets are available in the following packs: 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 and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

Alternative manufacturer

Chanelle Medical, Loughrea, Co. Galway, Ireland

Centrafarm Services BV, Nieuwe Donk 9, 4879 AC Etten Leur, The Netherlands

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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