2.5 mg, 5 mg, 10 mg tablets of 
bisoprolol fumarate

Read all of this leaflet carefully before you start taking this medicine.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist or nurse.

– 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Bisoprolol Orion is and what it is used for 
2. Before you take Bisoprolol Orion 
3. How to take Bisoprolol Orion 
4. Possible side effects 
5. How to store Bisoprolol Orion 
6. Other information

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

Bisoprolol Orion contains the active substance bisoprolol fumarate which belongs to a group of medicines called beta-blockers. Beta-blockers protect the heart from excessive activity. Bisoprolol Orion works 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.

Bisoprolol Orion is used for:

  • 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 cardiac glycosides).
  • treatment of heart disease and chest pain ( angina pectoris ) caused by lack of oxygen in the heart muscle.
  • treatment of high blood pressure ( hypertension ).

Bisoprolol contained in Bisoprolol Orion 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. Before you take Bisoprolol Orion

Do not take Bisoprolol Orion

Do not take Bisoprolol Orion if you:

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

Do not take Bisoprolol Orion 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
  • 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.

Take special care with Bisoprolol Orion

Talk to your doctor before taking Bisoprolol Orion:

  • if you have diabetes
  • if you fast strictly
  • if you suffer from certain heart diseases, such as disturbed heart rhythm, or severe chest pain at rest (Prinzmetal’s angina)
  • if you have kidney or liver problems
  • if you have less severe blood circulation problems in your arms and legs
  • if you suffer from less severe asthma or chronic lung disease
  • if you have or have had scaly skin rash ( psoriasis )
  • if you have a tumor in the adrenal gland ( pheochromocytoma )
  • if you have a thyroid disease.

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

desensitization treatment (eg for the prevention of hay fever) as Bisoprolol Orion may increase the likelihood of an allergic reaction or that such a reaction becomes more severe

anesthesia (eg during surgery), as Bisoprolol Orion may affect how the body responds to this situation.

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not take the following medicines with Bisoprolol Orion unless specifically advised by your 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 ( angina pectoris ), or irregular heartbeat (calcium channel blockers such as verapamil and diltiazem )
  • Some drugs used to treat high blood pressure such as clonidine, methyldopa, moxonidine, rilmenidine. Do not stop taking these medicines without first consulting a doctor.

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

  • certain medicines used to treat high blood pressure or angina or abnormal heart rhythm (dihydropyridine-type calcium channel blockers such as nifedipine)
  • certain medicines used to treat high blood pressure or angina (dihydropyridine-type calcium channel blockers such as felodipine or 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 drugs used to treat for example Alzheimer’s disease or glaucoma ( glaucoma ) (parasympathomimetics as tacrine or carbachol) or drugs used for treating acute heart problems ( sympathomimetics as isoprenaline and dobutamine )
  • drugs for diabetes, including insulin
  • anesthetics (eg in the case of 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, e.g. antihypertensive drugs, 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 medicines used to treat mental illnesses such as lost touch with reality (phentomazines)
  • moxisylate, which is used to treat Raynaud’s syndrome (poor blood circulation which causes fingers and toes to lose sensation and turn pale)
  • 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.
  • ergotamine used to treat migraines or low blood pressure.

Using Bisoprolol Orion with food and drink

Bisoprolol Orion should be taken in the morning, before, with, or after breakfast. The tablets should be swallowed with liquid and should not be chewed or crushed. The tablet can be divided into two equal doses.

Alcohol

Avoid drinking large amounts of alcohol, as it may increase the blood pressure-lowering effect of Bisoprolol Orion. Avoid drinking alcohol completely if the medicine makes you dizzier and affected than usual.

Pregnancy and breastfeeding

There is a risk that Bisoprolol Orion may harm your baby if used during pregnancy. If you are pregnant, think you may be pregnant, or are planning to have a baby, tell your doctor. He or she will determine if you can take Bisoprolol Orion during pregnancy.

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

Bisoprolol Orion contains sodium

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

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 Bisoprolol Orion

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Bisoprolol Orion should be taken in the morning, before, with or after breakfast. Swallow the tablet (s) with a little water. The tablets must not be chewed or crushed. The tablet can be divided into two equal doses .

This treatment should be initiated by a cardiologist or specialist in internal medicine.

Stable chronic heart failure

Adults, including the elderly: Treatment with bisoprolol, must be initiated 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
  • 2.5 mg bisoprolol once daily for one week
  • 3.75 mg bisoprolol once daily for one week
  • 5 mg bisoprolol once daily for four weeks
  • 7.5 mg bisoprolol once daily for four weeks
  • 10 mg bisoprolol once daily for maintenance treatment.

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 instruct you to reduce the dose gradually, as the condition may worsen.

Kidney or liver disease: The dose should be increased gradually and with caution in patients with severe kidney or liver failure.

Hypertension and angina

Adults, including the elderly: The most common dose for adults is one tablet daily (10 mg). Your doctor may instruct you to increase or decrease the dose.

Kidney or liver disease: The dose should not exceed 10 mg (once daily) in patients with severe kidney or liver failure.

Use for children and adolescents

Bisoprolol Orion is not recommended for use in children.

If you forget to take Bisoprolol Orion

If you forget to take Bisoprolol Orion, take your dose as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Bisoprolol Orion

Do not suddenly stop taking Bisoprolol Orion and do not change the recommended dose without talking to your doctor first. If you need to stop treatment, it must be done gradually, to avoid side effects.

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 (very common, may affect more than 1 user in 10 )
  • worsening heart failure (common, may affect up to 1 in 10 people ) Slow or irregular heartbeat (uncommon, may affect up to 1 in 100 users )

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.

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 ar

If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effectsdirectly (see details below). By reporting side effects, you can help increase drug safety information.

.

The Medical Products Agency

Box 26

751 03 Uppsala

5. How to store Bisoprolol Orion

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 and carton after 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. Other information

Content declaration

– The active substance is bisoprolol fumarate. Each tablet contains 2.5 mg, 5 mg, or 10 mg bisoprolol fumarate.

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

What the medicine looks like and the contents of the pack

Bisoprolol Orion 2.5 mg, 5 mg, and 10 mg tablets are 2.5 mg: white to off-white, round, biconvex tablets with a score line on one side.

The tablet can be divided into two equal doses .

Pack sizes: 20, 21, 28, 30, 50, 56, 60, 90 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Chanelle Medical, Loughrea, Co. Galway, Ireland

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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