1.25 mg, 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, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. See section 4.

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

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

The active substance in this medicine is bisoprolol fumarate. Bisoprolol Orifarm 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 leads to bisoprolol causing the heart rhythm to slow down and the heart to pump around the blood in the body more efficiently. Heart failure occurs when the heart muscle is weak and cannot pump enough blood to meet the body’s needs.

Bisoprolol is used:

  • To treat stable chronic heart failure. It is taken in combination with other medicines that are suitable for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).
  • In the treatment of coronary heart disease and chest pain ( angina pectoris ) caused by a lack of oxygen in the heart muscle.
  • In the treatment of hypertension ( hypertension ).

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

What you need to know before you use Bisoprolol Orifarm

Do not take Bisoprolol Orifarm:

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

  • if you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6).
  • severe asthma
  • severe blood circulation problems in the arms and legs (such as Raynaud’s syndrome) that can cause tingling in the fingers and toes or make them 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 Bisoprolol Orifarm tablets if you have any of the following heart problems:

  • acute heart failure
  • worsening heart failure that requires injection of drugs into a vein and that increases the contraction force of the heart
  • slow heart rate
  • low blood pressure
  • certain heart conditions that cause a 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

Talk to your doctor, pharmacist, or nurse before taking Bisoprolol Orifarm.

Take special care with Bisoprolol Orifarm:

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

  • diabetes
  • strictly fixed
  • certain heart conditions, such as heart rhythm disorders 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
  • scaly skin rash ( psoriasis )
  • an adrenal tumor ( pheochromocytoma )
  • thyroid disease.

Also, tell your doctor if you are going to perform:

  • desensitization treatment (for example for the prevention of hay fever) as bisoprolol may make it more likely that you may have an allergic reaction or that such a reaction becomes more severe
  • anesthesia (for example for surgery) because this medicine can affect how the body reacts to this situation

If you have chronic lung disease or less severe asthma and are being treated with Bisoprolol Orifarm, contact your doctor immediately if you experience new symptoms such as difficulty breathing, coughing, wheezing after exercise, etc.

Other medicines and Bisoprolol Orifarm

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 Orifarm unless specifically advised by your doctor:

  • Some medicines used to treat irregular or abnormal heart rhythms (class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone )
  • Some medicines used to treat high blood pressure, 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 asking your doctor.

Ask your doctor before taking the following medicines with Bisoprolol Orifarm, your doctor may need to check your condition more often:

  • Some medicines used to treat high blood pressure or angina pectoris(dihydropyridine-type calcium channel blockers such as felodipine and amlodipine)
  • Some medicines used to treat irregular or abnormal heart rhythms (class III antiarrhythmic medicines like amiodarone )
  • Beta-blockers applied topically (eg timolol – eye drops for the treatment of glaucoma )
  • Some drugs used to treat e.g. Alzheimer’s disease or glaucoma(parasympathomimetics such as tacrine or carbachol) or medicines used to treat acute heart problems ( sympathomimetics such as isoprenaline and dobutamine )
  • Medicines for diabetes, including insulin
  • Anesthetics (for example during surgery)
  • Digitalis used to treat heart failure
  • Non-steroidal anti-inflammatory drugs ( NSAIDs ) used to treat joint inflammation, pain, and 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 medicines used to treat epilepsy or used under anesthesia ( barbiturates such as phenobarbital) or certain medicines used to treat mental illnesses characterized by lost contact with reality (phenothiazines) (phenothiazines)
  • Moxisylate (used to treat impotence )
  • Medicines containing ergotamine (used to treat migraines )
  • Mefloquine 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.

Pregnancy, breastfeeding, and fertility

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.

Driving and using machines

Bisoprolol Orifarm can cause side effects that may affect a person’s ability to drive and use machines, especially during the first weeks of treatment. You may notice that your ability to react is impaired, especially if you have also consumed alcohol. Examples of side effects include visual disturbances, drowsiness, and dizziness. If you get any of these side effects, it is advisable to refrain from driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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 Orifarm

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Bisoprolol Orifarm should be taken in the morning before, at the same time as, or after breakfast. Swallow the tablet (s) whole with a little water, they must not be chewed or crushed.

Bisoprolol Orifarm 2.5 mg tablets only: The tablet can be divided into two equal doses.

Treatment with Bisoprolol Orifarm requires regular medical check-ups. This is especially important at the beginning of treatment, during dose escalation, and at the end of treatment. This treatment should always be started by a doctor who specializes in cardiac or internal medicine.

Use for children and adolescents

Bisoprolol Orifarm is not recommended for use in children.

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 it will usually 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 as a maintenance treatment.

The highest recommended daily dose is 10 mg bisoprolol.

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

Kidney or liver disease: For patients with severe kidney or liver problems, the dose should be increased very gradually and carefully.

High blood pressure and angina ( angina pectoris )

Adults and the elderly: The usual dose for adults is 10 mg once a day. Your doctor may decide to increase or decrease this dose.

Kidney or liver disease: For patients with severe kidney or liver problems, the dose should not exceed 10 mg once daily.

Contact a doctor or emergency room immediately. Bring this leaflet and any remaining tablets. You may feel dizzy or extremely tired, or get tinnitus (ringing in the ears).

If you forget to use Bisoprolol Orifarm

If you forget to take a dose, take it as soon as you notice it unless it is time for the next dose soon. Do not take a double dose to make up for a forgotten dose.

If you stop using Bisoprolol Orifarm

Do not stop treatment suddenly and do not change the dose without discussing it with 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, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

To prevent serious reactions, talk to your doctor immediately if a side effect is severe, occurs suddenly, or gets worse quickly. The most serious side effects are related to heart function:

Very common (may affect more than 1 user in 10):

• slow heartbeat

Common (may affect up to 1 in 10 people):

• worsening heart failure

• slow or irregular heartbeat

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 and 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 standing up
  • 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
  • inflammation of the liver which can cause yellowing of the skin or whites of the eyes
  • Some results of blood tests to check liver function or fat levels 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 redness of the eye ( conjunctivitis )
  • hair loss
  • appearance 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 side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of medicines

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

5. How to store Bisoprolol Orifarm

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 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. Contents of the packaging and other information

Content declaration

  • The active substance is bisoprolol fumarate.
    Each 1.25 mg tablet contains 1.25 mg of bisoprolol fumarate.
    Each 2.5 mg tablet contains 2.5 mg of bisoprolol fumarate.

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

What the medicine looks like and the contents of the pack

1.25 mg: Diameter 5 mm, white to off-white, round, biconvex tablets.

2.5 mg: Diameter 6.5 mm, white to off-white, round, biconvex tablets with a notch on one side.

Bisoprolol Orifarm 2.5 mg tablets only: The tablet can be divided into two equal doses.

2.5 mg: Cartons of 7, 10, 28, 30, 98 and 100 tablets

1.25 mg: Cartons of 7, 10, 20, 21, 28, 30, 98 and 100 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Local representative:

Orifarm Generics AB

Box 56048

102 17 Stockholm

info@orifarm.com

Muhammad Nadeem

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