BISOPROLOL ORION 10 MG TABLETS

Active substance: BISOPROLOL FUMARATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Bisoprolol Orion 2.5 mg Tablets
Bisoprolol Orion 5 mg Tablets
Bisoprolol Orion 10 mg Tablets

Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.

• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What [Bisoprolol Orion] Tablets are and what they are used for.
Before you take [Bisoprolol Orion] Tablets
How to take [Bisoprolol Orion] Tablets
Possible side effects
How to store [Bisoprolol Orion] Tablets
Further Information.

1.

What Bisoprolol Orion Tablets are and what they are used for

The active substance in this medicine is Bisoprolol fumarate. [Bisoprolol Orion] belongs to a group of
medicines called beta-blockers. These medicines work by affecting the body’s response to some nerve
impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and makes the heart more
efficient at pumping blood around the body. Heart failure occurs when the heart muscle is weak and unable to
pump enough blood to supply the body's needs.
Bisoprolol is used:





2.

To treat stable chronic heart failure. It is used in combination with other medicines suitable for this
condition (such as ACE-inhibitors, diuretics, and heart glycosides).
In treatment of coronary heart disease and chest pain (angina pectoris) caused by shortage of
oxygen in the heart muscle.
In treatment of high blood pressure (hypertension).

Before you take Bisoprolol Orion Tablets

Do not take [Bisoprolol Orion] Tablets:
Do not take Bisoprolol Orion Tablets if one of the following conditions applies to you:
• allergic (hypersensitive) to bisoprolol fumarate or any of the other ingredients of [Bisoprolol Orion] tablets.
• severe asthma or severe chronic lung disease
• severe blood circulation problems in your limbs (such as Raynaud’s syndrome), which may
cause your fingers and toes to tingle or turn pale or blue
• untreated phaeochromocytoma, which is a rare tumour of the adrenal gland
• metabolic acidosis, which is a condition when there is too much acid in the blood.
Do not take [Bisoprolol Orion] Tablets if you have one of the following heart problems:
• acute heart failure
• worsening heart failure requiring injection of medicines into a vein, that increase the force of
contraction of the heart
• slow heart rate
• low blood pressure
• certain heart conditions causing a very slow heart rate or irregular heartbeat
• cardiogenic shock, which is an acute serious heart condition causing low blood pressure and
circulatory failure.

Take special care with [Bisoprolol Orion] Tablets:
If you have any of the following conditions tell your doctor before taking this medicine; he or she may want to
take special care (for example give additional treatment or perform more frequent checks):
• diabetes
• strict fasting
• certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest (Prinzmetal’s
angina)
• kidney or liver problems
• less severe blood circulation problems in your limbs
• less severe asthma or chronic lung disease
• history of a scaly skin rash (psoriasis)
• tumour of the adrenal gland (phaeochromocytoma)
• thyroid disorder.
In addition, tell your doctor if you are going to have:
• desensitization therapy (for example for the prevention of hay fever), because Bisoprolol may make it more
likely that you experience an allergic reaction, or such reaction may be more severe

• anaesthesia (for example for surgery), because this medicine may influence how your body reacts to this
situation
Taking other medicines:
Please 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 without
special advice from your doctor:
• Certain medicines used to treat irregular or abnormal heartbeat (Class I antiarrhythmic medicines 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, moxonodine,
rilmenidine. However, do not stop taking these medicines without checking with your doctor first.
Check with your doctor before taking the following medicines with [Bisoprolol Orion]; your doctor may
need to check your condition more frequently:
• Certain medicines used to treat high blood pressure or angina or abnormal heart beat (dihydropyridinederivative calcium antagonists such as nifedipine)
Certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine-type calcium
antagonists such as felodipine and amlodipine)
• Certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic medicines such as
amiodarone)
• Beta-blocking agents applied locally (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 carbachol) or medicines that are used to treat acute heart problems (sympathomimetics such
as isoprenaline and dobutamine)
• Antidiabetic medicines including insulin
• Anaesthetic agents (for example during surgery)
• Digitalis, used to treat heart failure
• Non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain or inflammation (for
example ibuprofen or diclofenac)
• Any medicine, which can lower blood pressure as a desired or undesired effect such as antihypertensives,
certain medicines for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain
medicines used to treat epilepsy or during anaesthesia (barbiturates such as phenobarbital), or certain
medicines to treat mental illness characterized by a loss of contact with reality (phenothiazines such as
levomepromazine)
• Moxisylate, used for treatment raynauds disease (poor circulation which makes toes and fingers numb and
pale.
• Mefloquine, used for prevention or treatment of malaria
• Depression treatment medicines called monoamine oxidase inhibitors (except MAO-B inhibitors) such as
moclobemide.
Taking [Bisoprolol Orion] Tablets with food and drink:
[Bisoprolol Orion] Tablets should be taken in the morning, before, with or after breakfast. They should be
swallowed whole with liquid and should not be chewed or crushed.
Avoid drinking excessive alcohol, since it may increase the blood pressure-lowering effect of Bisoprolol. Avoid
drinking alcohol altogether, if it makes you more dizzy or more light-headed than usual.
Pregnancy and breast-feeding:
There is a risk that use of [Bisoprolol Orion] during pregnancy may harm the baby. If you are pregnant or
planning to become pregnant, tell your doctor. He or she will decide whether you can take this medicine during

pregnancy. It is not known whether bisoprolol passes into human breast milk. Therefore, breastfeeding is not
recommended during therapy with Bisoprolol Orion.
Driving and using machines:
Your ability to drive or use machinery may be affected depending on how well you tolerate the medicine.
Please be especially cautious at the start of treatment, when the dose is increased or the medication is
changed, as well as in combination with alcohol.

3.

How to take Bisoprolol Orion tablets

Always take Bisoprolol Orion tablets exactly as your doctor has told you. You should check with your doctor or
your pharmacist if you are not sure. Bisoprolol Orion Tablets should be taken in the morning, before, with or
after breakfast. Swallow the tablet/s whole with some water and do not chew or crush them.
This treatment should be initiated by a specialist in cardiology or internal medicine.
Children and adolescents: Bisoprolol Orion Tablets are not recommended for use in children
Stable chronic heart failure
Adults including the elderly: Treatment with bisoprolol must be started at a low dose and increased
gradually. Your doctor will decide how to increase the dose, and this will normally be done in the following
way:
• 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 (on-going) therapy.
The maximum recommended daily dose is 10 mg bisoprolol.
Depending on how well you tolerate the medicine, your doctor may also decide to lengthen the time between
dose increases. If your condition gets worse or you no longer tolerate the drug, it may be necessary to reduce
the dose again or to interrupt treatment. In 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 entirely, your doctor will
usually advise you to reduce the dose gradually, as otherwise your condition may become worse.
Renal or liver disease: The dosage should be increased very gradually and cautiously in patients with severe
kidney or liver problems
Hypertension and angina
Adults and the elderly: The usual dose for adults is one tablet (10 mg) daily. Your doctor may decide to
increase or decrease this dose.
Renal or liver disease: The dosage should not exceed 10 mg once daily in patients with severe kidney or
liver problems.
If you take more [Bisoprolol Orion] Tablets than you should:
Contact your doctor or local emergency ward immediately. Take this leaflet and any tablets you still have with
you. Your doctor will decide what measures are necessary. Symptoms of an overdose may include slowed
heart rate, severe difficulty in breathing feeling dizzy, or trembling (due to decreased blood sugar).
For Spain only: En caso de sobredosis o ingestión accidental, consulte inmediatamente a su médico o
farmacéutico o llame al Servicio de Información Toxicológica, teléfono 91 562 04 20 indicando el
medicamento y la cantidad ingerida.
If you forget to take [Bisoprolol Orion] Tablets:
If you forget to take a dose, take it as soon as you remember it unless it is nearly time for your next dose. Do
not take a double dose to make up for a forgotten dose.
If you stop taking [Bisoprolol Orion] Tablets:
Do not stop treatment suddenly or 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 you doctor or pharmacist.

4.

Possible side effects

Like all medicines, Bisoprolol Orion Tablets can cause side effects, although not everybody gets them.
To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurred suddenly or
gets worse rapidly. The most serious side effects are related to the heart function:
• slowing of heart rate (affects more than 1 person in 10)
• worsening of heart failure (affects less than 1 person in 10)
• slow or irregular heartbeat (affects less than 1 person in 100)
If you feel dizzy or weak, or have breathing difficulties please contact your doctor as soon as possible.
Further side effects are listed below according to how frequently they may occur:
Very common:
Common:

affects more than 1 user in 10
affects 1 to 10 users in 100

Uncommon:

affects 1 to 10 users in 1,000

Rare:

affects 1 to 10 users in 10,000

Very rare:

affects less than 1 user in 10,000

Common (affects less than 1 person in 10):
• tiredness, feeling weak, dizziness, headache
• feeling of coldness or numbness in hands or feet
• low blood pressure
• stomach or intestine problems such as nausea, vomiting, diarrhoea, or constipation.
Uncommon (affects less than 1 person in 100):
• sleep disturbances
• depression
• dizziness when standing up
• breathing problems in patients with asthma or chronic lung disease
• muscle weakness, muscle cramps.
Rare (affects less than 1 person in 1,000):
• hearing problems
• allergic runny nose
• reduced tear flow
• inflammation of the liver which can cause yellowing of the skin or whites of the eyes
• certain blood test results for liver function or fat levels differing from normal
• allergy-like reactions such as itching, flush, rash
• impaired erection
• nightmares, hallucinations.
Very rare (affects less than 1 person in 10,000):
• irritation and redness of the eye (conjunctivitis)
• hair loss
• appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

5.

How to store Bisoprolol Orion tablets

Keep out of the reach and sight of children.

Keep out of the reach and sight of children
Do not use Bisoprolol Orion Tablets after the expiry date which is stated on the blister and the carton. The
expiry date refers to the last day of that month. This medicinal product does not require any special storage
conditions.
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.

What Bisoprolol Fumarate tablets contain: Information
6.
Further
The active substance is bisoprolol fumarate.
The active substance is bisoprolol fumarate
What Bisoprolol Orion Tablets contain
The active substance is bisoprolol fumarate
Each 2.5 mg tablet contains 2.5 mg bisoprolol fumarate.
Each 5 mg tablet contains 5 mg bisoprolol fumarate.
Each 10 mg tablet contains 10 mg bisoprolol fumarate.
The other ingredients are cellulose, microcrystalline, silica colloidal anhydrous, croscarmellose sodium,
sodium starch glycolate (type A) and magnesium stearate.
What Bisoprolol Orion Tablets look like and contents of the pack:
2.5 mg: White to off white round biconvex tablets with a break line on one side.
5 mg: White to off white round biconvex tablets with a break line on one side.
10 mg: White to off white round biconvex tablets with a break line on one side.
Bisoprolol Orion 2.5 mg, 5 mg and 10 mg Tablets only: The tablet can be divided into equal halves.
Pack sizes of 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
This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last approved in: 03/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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