1.25 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 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: 
1. What Bisoprolol Sandoz is and what it is used for 
2. What you need to know before taking Bisoprolol Sandoz 
3. How to take Bisoprolol Sandoz 
4. Possible side effects 
5. How to store Bisoprolol Sandoz 
6. Package contents and other information

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

Bisoprolol Sandoz belongs to a group of medicines called beta-blockers . They protect the heart from working too hard.

Bisoprolol Sandoz is used to treat:

  • Heart failure that causes shortness of breath during exertion or fluid retention. In these cases, Bisoprolol Sandoz can be given as an adjunct to other heart failuremedications .

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

What you need to know before you take Bisoprolol Sandoz

Do not take Bisoprolol Sandoz

  • if you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6)
  • if you have a cardiogenic shock , a serious condition of the heart that causes a fast, weak pulse; low blood pressure; cold, moist skin; weakness and fainting
  • if you have ever had severe wheezing or severe asthma because the medicine may affect your breathing
  • if you have a slow heart rate (below 60 beats per minute). Ask your doctor if you are unsure.
  • if you have very low blood pressure
  • if you have severe problems with your blood circulation (which may make you feel tingling in your fingers or toes or pale or bluish)
  • if you have some serious problems with your heart rhythm
  • if you have heart failure that has just occurred or has not stabilized and that requires hospital treatment
  • If you have a condition with the accumulation of too much acid in the body, it is called metabolic acidosis . Your doctor will advise you
  • if you have an adrenal tumor called pheochromocytoma that is untreated.

Talk to your doctor if you are unsure about any of the above.

Warnings and cautions

Talk to your doctor before taking Bisoprolol Sandoz

  • if you have wheezing or difficulty breathing ( asthma ).Bronchodilator therapy is given concomitantly. A higher dose of beta2-stimulator may be needed.
  • if you have diabetes. The tablets may mask symptoms of low blood sugar (eg fast heartbeat, palpitations, or sweating)
  • if you fast and do not eat solid food
  • if you are being treated for hypersensitivity reactions (allergic reactions). Bisoprolol Sandoz may increase the hypersensitivity to the substances you are allergic to and may increase the severity of the hypersensitivity reactions . Treatment with adrenaline in such cases may not give the desired result. A higher dose of adrenaline ( epinephrine ) may be needed
  • in first-degree heart block (conduction disturbance in the heart)
  • if you have Prinzmetal’s angina, which is a type of chest pain caused by cramps in the coronary arteries of the heart that support the heart muscle
  • If you have any problems with the circulation to the extremities of your body, such as your hands and feet
  • if you are going to have surgery under anesthesia: If you visit a doctor, hospital, or dentist for a surgical procedure that involves anesthesia, tell them which medicines you are taking.
  • if you have (or have had) psoriasis (a recurring skin condition with flaking and dry skin rash)
  • if you have a pheochromocytoma (a tumor of the adrenal medulla). Your doctor needs to treat this before you are prescribed Bisoprolol Sandoz
  • if you have thyroid problems. The tablets may mask symptoms of an overactive thyroid gland.

To date, there is no experience with Bisoprolol Sandoz for heart failure in patients with the following diseases and conditions:

  • diabetes mellitus treated with insulin (type I)
  • severe kidney disease
  • severe liver disease
  • certain heart diseases
  • heart attack within 3 months.

The treatment of heart failure with Bisoprolol Sandoz requires regular medical follow-up. This is absolutely necessary, especially when starting treatment and when it ends.

Treatment with Bisoprolol Sandoz must not be stopped abruptly unless there are compelling reasons.

Ask your doctor if any of the above warnings apply to you, or have been reported to you in the past.

Other medicines and Bisoprolol Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines. Some medicines cannot be used at the same time, and other medicines require specific adjustments (eg of dose one).

Always tell your doctor if you are taking or using any of the following medicines besides Bisoprolol Sandoz:

  • medicines for blood pressure control or medicines for heart problems (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil)
  • sedatives and treatment for psychosis (a mental illness), e.g. barbiturates (also used for epilepsy ), phenothiazines (also used for vomiting and nausea) 
  • medicines for depression, e.g. tricyclic antidepressants, MAO-A inhibitors
  • medicines used for anesthesia during surgery (see also section “Warnings and precautions”)
  • certain painkillers (eg acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen )
  • medicines for asthma, nasal congestion, or certain eye diseases such as glaucoma(increased pressure in the eye) or dilation of the pupil en
  • certain drugs for the treatment of shock (eg adrenaline, dobutamine, norepinephrine )
  • mefloquine, a drug for malaria
  • rifampicin, an antibiotic
  • ergotamine derivatives for migraines.

All of these medicines like Bisoprolol Sandoz can affect your blood pressure and/or your heart function.

  • insulin or other medicines for diabetes. The blood sugar lowering effect can be enhanced. Symptoms of low blood sugar can be hidden.

Bisoprolol Sandoz with alcohol

The dizziness and dizziness that can be caused by Bisoprolol Sandoz can get worse if you drink alcohol. If this happens to you, avoid drinking alcohol.

Pregnancy and breastfeeding

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. Bisoprolol Sandoz may be harmful to the pregnancy and/or the unborn baby. There is an increased risk of premature birth, miscarriage, low blood sugar and slow heart rate in the baby.

The child’s growth can also be affected. Therefore, Bisoprolol Sandoz should not be taken during pregnancy.

It is not known if Bisoprolol Sandoz is excreted in human milk and therefore use during breast-feeding is not recommended.

Driving and using machines

There are no studies performed on how the effect affects the ability to drive or use machines.

These tablets can make you tired, drowsy, or dizzy. If you get any of these side effects, do not drive or use machines. Consider the risk of these effects, especially at the beginning of treatment, with dose changes, and when used in combination with alcohol.

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

Bisoprolol Sandoz contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

How to take Bisoprolol Sandoz

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

Your doctor will tell you how many tablets to take. You should take this medicine in the morning, before, during, or after breakfast. Do not swallow the tablet (s) with water and do not chew or crush them.

The usual dose is:

Heart failure (decreased pumping capacity of the heart)

Before you start taking Bisoprolol Sandoz, you are already taking an ACE inhibitor, a diuretic, or a cardiac glycoside (medicine for heart/blood pressure).

Dose one is gradually increased until a dose suitable for you is found:

1.25 mg once daily for 1 week, if well tolerated, the dose may be increased to:

2.5 mg once daily for another week, if tolerated well, the dose may be increased to:

3.75 mg once daily for an additional week, if well tolerated, the dose may be increased to:

5 mg once daily for the following 4 weeks, if tolerated well, the dose may be increased to:

7.5 mg once daily for the following 4 weeks, if tolerated well, the dose may be increased to:

10 mg once daily as a maintenance treatment.

The highest dose is 10 mg once daily.

Your doctor will decide on the most suitable dose for you, which is based on possible side effects.

After the very first dose of 1.25 mg, your doctor will check your blood pressure, heart rate, and heart function.

Hepatic or renal impairment

The doctor will be extra careful when increasing the dose.

Older

Normally no dose adjustment is required.

If you notice that the effect of Bisoprolol Sandoz is too strong or not strong enough, contact your doctor or pharmacist.

Duration of treatment

Bisoprolol Sandoz is commonly used for a long time.

Use for children and adolescents

There is no experience with the use of Bisoprolol Sandoz in children and adolescents and the medicine is therefore not recommended for children.

If you forget to take Bisoprolol Sandoz

Do not take a double dose to make up for a forgotten dose. Take the usual dose as soon as you remember and then continue with the usual dose the next day.

If you stop taking Bisoprolol Sandoz

Treatment with Bisoprolol Sandoz must not be stopped quickly. If you suddenly stop taking this medicine, your condition may get worse. Dose one must instead be reduced gradually over a few weeks according to the doctor’s instructions.

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.

Side effects that can occur are:

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

  • slow heartbeat.

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

  • fatigue, exhaustion
  • dizziness
  • headache
  • feeling of cold or numbness in the extremities (fingers or toes, ears, and nose); more often a cramp-like pain occurs in the legs when walking
  • worsening heart failure
  • very low blood pressure ( hypotension ), especially in patients with heart failure
  • feeling sick (nausea), vomiting
  • diarrhea
  • constipation.

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

  • dizziness due to a drop in blood pressure after sitting upright, dizziness or fainting
  • sleep disorders
  • Depression
  • irregular heartbeats
  • Patients with asthma or previous breathing problems may have difficulty breathing
  • muscle weakness and muscle cramps.

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

  • nightmares
  • hallucinations (imagining things)
  • fainting
  • impaired hearing
  • inflammation of the nasal mucosa which causes runny nose with irritation
  • allergic reactions (such as itching, redness, and rash)
  • dry eyes due to reduced tear flow (which can be very troublesome if you wear contact lenses)
  • inflammation of the liver ( hepatitis ), which causes abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the whites of the eyes and skin and dark-colored urine
  • decreased sexual ability (potency disorders)
  • increased levels of blood fats ( triglycerides ) and liver enzymes.

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

  • chest pain
  • aggravated psoriasis (skin disease) or causing a similar condition with dry, flaky skin rash and hair loss
  • itching or redness of the eyes ( conjunctivitis ).

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 Sandoz

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. or EXP.

The expiration date is the last day of the specified month.

Do not use this medicine after 6 months from the first opening of the tablet can.

Blister: No special storage instructions.

Tablet jar: Do not store above 30 ° C

After first opening the jar: Do not store above 25 ° 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 film-coated tablet contains 1.25 mg bisoprolol fumarate.
  • The other ingredients are Anhydrous calcium hydrogen phosphate, microcrystalline cellulose, pregelatinized maize starch, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E171).

What the medicine looks like and the contents of the pack

White, round film-coated tablets marked “BIS 1.25” on one side.

The film-coated tablets are packaged in OPA / Al / PVC / Al blisters and inserted in a carton or packed in an HDPE bottle with a PE cap.

Pack sizes:

Blisters: 7, 10, 20, 28, 30, 50, 56, 60, 90, 98, 100, 10×20 or 10×30 film-coated tablets.

Tablet cans: 10, 20, 30, 50, 60, 100, 250 or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

or

ROWA Pharmaceuticals Limited, Newtown, Bantry, Co. Cork, Ireland

or

Lek Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia

or

Lek SA, Ul. Domaniewska 50 C, 02-672 Warsaw, Poland

Muhammad Nadeem

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