2.5 mg, 5 mg and 10 mg film-coated 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 may harm them, even if they show symptoms 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 Accord is and what it is used for 
2. What you need to know before taking Bisoprolol Acord 
3. How to take Bisoprolol Accord 
4. Possible side effects 
5. How to store Bisoprolol Accord 
6. Contents of the packaging and other information 

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

The active substance in this medicine is bisoprolol fumarate. Bisoprolol belongs to a group of medicines called beta-blockers. Beta-blockers protect the heart from working too hard. This drug works by affecting the body’s response to certain nerve impulses, especially in the heart. This effect means that Bisoprolol Accord slows 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 Accord 2.5 mg, 5 mg and 10 mg tablets are used in combination with other medicines to treat stable heart failure .

Bisoprolol Accord 5 mg and 10 mg tablets are also used to treat high blood pressure ( hypertension ) and angina (angina pectoris; chest pain caused by a blockage in the arteries that supply the heart muscle).

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

2. What you need to know before you take Bisoprolol Acord

Do not take Bisoprolol Accord

  • if you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6)
  • if you have severe asthma or a serious chronic lung disease
  • if you have severe problems with blood circulation in your arms or legs (such as Raynaud’s syndrome), which can cause it to stick to your fingers and toes or make them pale or blue)
  • if you have untreated pheochromocytoma, which is a rare tumor of the adrenal gland (marrow)
  • if you have metabolic acidosis, which is a condition where there is too much acid in the blood
  • if you have acute heart failure that suddenly gets worse and/or that may need to be treated in hospital
  • if you have a low heart rate
  • if you have low blood pressure
  • if you have a type of heart condition that causes very low heart rate or irregular heartbeat
  • if you have cardiogenic shock, which is an acute and severe heart condition that causes low blood pressure and circulatory failure

Warnings and cautions

Talk to your doctor or pharmacist before taking this medicine if you have any of the following. Your doctor may want to be extra careful (eg give you additional treatment or check your condition more often).

  • if you have diabetes
  • if you are strictly fasting (do not eat solid food)
  • if you have certain heart diseases, such as disturbed heart rhythm or severe chest pain at rest (Prinzmetal’s angina)
  • if you have kidney or liver disease
  • if you have less severe problems with blood circulation in your arms and/or legs
  • if you have less severe asthma or lung disease
  • if you have previously had scaly skin rash ( psoriasis )
  • if you have a tumor in the adrenal gland [pheochromocytoma]
  • if you have a thyroid disease

Also, tell your doctor

  • if you are going to undergo desensitization treatment (to prevent hay fever for example), as Bisoprolol Accord may increase the risk of an allergic reaction or make such a reaction more serious
  • if you are going to be anesthetized (eg for an operation), as this medicine may affect how your body reacts in this situation

Other medicines and Bisoprolol Accord

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 Accord without special advice from a doctor:

  • medicines to control blood pressure or medicines for heart problems (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, cimetidine, verapamone)
  • antidepressants, e.g. imipramine, amitriptyline, moclobemide
  • drugs for the treatment of mental illness, e.g. phenothiazines, such as levomepromazine
  • medicines used for anesthesia during an operation (see also “Warnings and precautions”)
  • drugs used to treat epilepsy, e.g. barbiturate is, like phenobarbital
  • certain painkillers (eg acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen )
  • medicines for asthma or nasal congestion
  • drugs used for certain eye diseases, such as glaucoma (increased pressure in the eye) or for dilating the pupil a
  • certain drugs for the treatment of clinical shock (eg adrenaline, dobutamine, noradrenaline )
  • mefloquine, a drug for malaria
  • rifampin for treatment of infection s
  • medicines to treat severe headaches or migraines (ergotamine derivatives)

Pregnancy and breastfeeding

Pregnancy

There is a risk that Bisoprolol Accord 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 for advice before using this medicine. Your doctor will decide if you can take Bisoprolol Accord during pregnancy.

Breast-feeding

It is not known whether Bisoprolol Accord is excreted in human milk. therefore breast-feeding is not recommended during treatment with Bisoprolol Accord.

Driving and using machines

The ability to drive and 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 in case of changes in medication and in combination 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. A description 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 take Bisoprolol Accord

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Treatment with Bisoprolol Accord requires regular medical check-ups. This is especially important at the beginning of treatment and when increasing the dose. Bisoprolol Accord should be taken in the morning and can be taken with or without food. Swallow the tablet whole with a little water. The tablet should not be crushed or chewed. The tablet can be divided into two equal doses. Bisoprolol Accord is usually given as a long-term treatment.

Use for adults

Chest pain and high blood pressure:

Your doctor will start treatment with the lowest possible dose (5 mg). Your doctor will monitor you closely at the beginning of treatment and increase the dose gradually to achieve the dose that is best for you.

The highest recommended dose is 20 mg once daily.

Patients with kidney disease:

Patients with severe kidney disease should not exceed 10 mg once daily. Talk to your doctor before taking this medicine.

Patients with liver disease:

Patients with severe liver disease should not exceed 10 mg once daily. Ask your doctor for advice before taking this medicine.

Heart failure:

Before you start using Bisoprolol Accord, you are already taking other medicines for heart failure , including an ACE inhibitor , a diuretic and (as an extra option) a cardiac glycoside.

Treatment with Bisoprolol Accord must be initiated at a low dose and gradually increased. The doctor will decide how to increase the dose. The increase is normally as follows:

  • 1.25 mg Bisoprolol Accord once daily for one week
  • 2.5 mg Bisoprolol Accord once daily for one week
  • 3.75 mg Bisoprolol Accord once daily for one week
  • 5 mg Bisoprolol Accord once daily for four weeks
  • 7.5 mg Bisoprolol Accord once daily for four weeks
  • 10 mg Bisoprolol Accord once daily as a maintenance treatment.

The highest recommended dose is 10 mg once daily.

Your doctor may extend the time between dose increases depending on how well you tolerate the medicine. If your condition worsens or you can no longer tolerate the medicine, it may be necessary to lower the dose again or discontinue treatment. For some patients, a maintenance dose lower than 10 mg Bisoprolol Accord may be sufficient. Your doctor will tell you what to do. If you need to stop treatment altogether, your doctor will usually advise you to reduce the dose gradually as your condition may worsen.

Use for children

Bisoprolol Accord is not recommended for use in children.

Use for the elderly

Adjusting the dose one is not usually necessary. It is recommended to start with the lowest possible dose.

Contact your doctor or pharmacist if you notice that the effect of Bisoprolol Accord is too strong or not sufficient.

If you forget to take Bisoprolol Accord

If you forget to take a dose, take it 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 Accord

Do not stop treatment abruptly and do not change the recommended dose without first talking to a doctor. 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, contact a doctor immediately if you get a side effect that is severe, that occurs suddenly, or worsens quickly. The most serious side effects associated with heart function:

  • slow heart rate (may affect up to 1 in 10 users with chronic heart failure and up to 1 in 100 users with high blood pressure or angina)
  • aggravated heart failure (may affect up to 1 in 10 users with chronic heart failure and up to 1 in 100 users with high blood pressure or angina)
  • slow or irregular heartbeat (may affect more than 1 in 10 users with chronic heart failure )
  • worsening of symptoms of blockage in the main blood vessels to the legs, especially at the beginning of treatment (no known frequency)

If you feel dizzy or weak or have difficulty breathing, contact a doctor as soon as possible.

Additional side effects are listed below according to the frequency with which they occur:

Common (may affect up to 10 users):

  • fatigue *, feeling weak (in patients with chronic heart failure ), dizziness *, headache *
  • a feeling of cold or numbness in hands or feet
  • low blood pressure, especially in patients with heart failure
  • gastrointestinal problems, such as nausea, vomiting, diarrhea, or constipation

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

  • sleep disorders
  • Depression
  • respiratory distress in patients with asthma or chronic lung disease
  • muscle weakness, muscle cramps
  • feeling weak (in patients with high blood pressure or angina)

Rare (may affect up to 1 in 1,000 people):

  • hearing problems
  • allergic rhinitis (nasal congestion or runny nose)
  • reduced tear flow (may be a problem if you wear contact lenses)
  • inflammation of the liver, which can turn skin and whites of the eyes yellow
  • Some blood tests to check liver function and blood fats differ from normal
  • allergy-like reactions, such as. itching, redness, rash
  • an impaired erection (decreased sexual ability)
  • nightmares, hallucinations
  • fainting

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

  • irritated and red eyes ( inflammation of the conjunctiva )
  • hair loss
  • onset or worsening of scaly rash ( psoriasis ): psoriasis-like rash.

* in the treatment of high blood pressure or angina, these symptoms occur especially at the beginning of treatment or when changing dose one. They are usually mild and often disappear within 1 to 2 weeks.

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 Accord

  • 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.
  • Do not store above 30 ° C.
  • 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. One tablet contains either 2.5 mg, 5 mg, or 10 mg bisoprolol fumarate.

The other ingredients are microcrystalline cellulose, sodium starch glycolate (type A), povidone K30, colloidal anhydrous silica, magnesium stearate (E470b), hypromellose E-15 (E464), macrogol 400 (E553), titanium dioxide (E171), talc.

What the medicine looks like and the contents of the pack

2.5 mg: White to off-white, round, biconvex, film-coated tablet marked with “b1” on one side and a breaker notch on the other side

5 mg: White to off-white, round, biconvex, film-coated tablet marked with “b2” on one side and a score line on the other side

10 mg: White to off-white, round, biconvex, film-coated tablet marked with “b3” on one side and a breaker notch on the other side

All strengths of Bisoprolol Accord are available in packs of 20, 28, 30, 50, 56, 60, 90 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 kV Utrecht

Netherlands

Manufacturer

Accord Healthcare Limited

Sage House, 319, Pinner Road,

North Harrow, Middlesex, HA1 4HF,

UK

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare BV,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

ACCORD-UK LTD

WHIDDON VALLEY, BARNSTAPLE, EX32 8NS,

UK

Muhammad Nadeem

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