CIPLA BISOPROLOL

CIPLA BISOPROLOL

Active ingredient(s): Bisoprolol fumarate

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Consumer Medicine Information (CMI)

This leaflet provides important information about using CIPLA BISOPROLOL. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using CIPLA BISOPROLOL.

Where to find information in this leaflet:

1. Why am I using CIPLA BISOPROLOL?
2. What should I know before I use CIPLA BISOPROLOL?
3. What if I am taking other medicines?
4. How do I use CIPLA BISOPROLOL?
5. What should I know while using CIPLA BISOPROLOL?
6. Are there any side effects?
7. Product details

1. Why am I using CIPLA BISOPROLOL?

CIPLA BISOPROLOL contains the active ingredient bisoprolol fumarate. CIPLA BISOPROLOL 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, it decreases the heart’s need for blood and oxygen and therefore reduces the amount of work the heart has to do.

CIPLA BISOPROLOL is used to treat heart failure. It is usually used in combination with other medicines.

Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body’s needs. Heart failure may start off with no symptoms, but as the condition progresses patients may feel short of breath and notice swelling of the feet and ankles due to fluid build up.

CIPLA BISOPROLOL also slows your heart rate, which in turn increases the efficiency of your heart.

CIPLA BISOPROLOL can help to reduce the number of heart failure episodes needing hospital admission and also the risk of sudden death.

Your doctor may have prescribed CIPLA BISOPROLOL for another reason. Ask your doctor if you have any questions about why CIPLA BISOPROLOL has been prescribed for you.

2. What should I know before I use CIPLA BISOPROLOL?

Warnings

Do not use CIPLA BISOPROLOL if:

• you are allergic to bisoprolol, or any of the ingredients listed at the end of this leaflet.
  Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.
  Always check the ingredients to make sure you can use this medicine.
• you have any of the following heart problems:
  – severe heart failure that is not controlled medically
  – worsening heart failure requiring injection of medicines into a vein
  – cardiogenic shock, a serious heart condition causing low blood pressure and circulatory failure
  – certain heart conditions where the electrical activity controlling your heart rate does not work properly, causing a very slow heart rate or uneven heart beating
  – low blood pressure
• you have any of the following medical conditions:
  – severe asthma or severe chronic obstructive 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, a rare tumour of the adrenal gland
  – metabolic acidosis, a condition when there is too much acid in the blood.

CIPLA BISOPROLOL is not recommended for use in children, as the safety and efficacy in children have not been established.

Check with your doctor if you:

• have asthma, difficulty breathing or other lung problems
• have heart diseases (such as disturbances in heart rhythm or Prinzmetal angina)
• have diabetes
• have any allergic conditions
• have psoriasis, a skin disease with thickened patches of red skin, often with silvery scales
• have a thyroid disorder
• have any blood vessel disorder causing poor circulation in the arms and legs
• have kidney problems
• have liver problems
• have phaeochromocytoma, a rare tumour of the adrenal gland.
• are going to have anaesthesia (for example for surgery).

CIPLA BISOPROLOL may influence how your body reacts to this situation.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

CIPLA BISOPROLOL may affect your developing baby if you take it during pregnancy. Your doctor will discuss the risks and benefits of taking CIPLA BISOPROLOL during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Like most beta-blocker medicines, CIPLA BISOPROLOL is not recommended while you are breastfeeding. Your doctor will discuss the risks and benefits of taking CIPLA BISOPROLOL when breastfeeding.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with CIPLA BISOPROLOL and affect how it works. You may need different amounts of your medicines, or you may need to take different medicines. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking CIPLA BISOPROLOL.

Do not take the following medicines with CIPLA BISOPROLOL without special advice from your doctor:

• certain anti-arrhythmic medicines such as disopyramide, lidocaine, phenytoin or flecainide (used to treat irregular or abnormal heartbeat)
• certain calcium antagonists such as diltiazem or verapamil (used to treat high blood pressure and angina)
• certain medicines used to treat high blood pressure such as clonidine, methyldopa or moxonidine.

However, do not stop taking these medicines without checking with your doctor.

Check with you doctor before taking the following medicines:

• anti-arrhythmic medicines such as amiodarone (used to treat irregular or abnormal heartbeat)
• calcium antagonists such as felodipine or amlodipine (used to treat high blood pressure and angina)
• certain medicines used to treat arthritis, pain or inflammation, such as ibuprofen or diclofenac
• eye drops for glaucoma treatment
• insulin and oral drugs for diabetes
• anaesthetic agents used in surgery
• digoxin, a medicine used to treat heart failure
• ergot derivatives, medicines commonly used to treat migraines
• rifampicin, a medicine used to treat tuberculosis
• tricyclic antidepressants
• barbiturates, medicines used to treat epilepsy
• phenothiazines, medicines used to treat some mental conditions
• mefloquine, a medicine used to treat malaria
• adrenaline (epinephrine), a medicine used to treat allergic reactions
• certain medicines used to treat depression called monoamine oxidase inhibitors, such as phenelzine or tranylcypromine.

Your doctor may need to check your condition more frequently.

However, do not stop taking these medicines without checking with your doctor.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CIPLA BISOPROLOL.

4. How do I use CIPLA BISOPROLOL?

How much to take

• The usual starting dose is 1.25 mg once daily for a week. If well tolerated, your doctor will gradually increase your dose over the next ten weeks.
• The usual dose for maintenance therapy is 10 mg once daily.
• If your conditions 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 may be sufficient. Your doctor will tell you what to do.
• Your doctor will monitor your blood pressure, heart rate and other vital signs carefully after you start treatment with CIPLA BISOPROLOL and during dose increase.
• Follow all directions given to you by your doctor and pharmacist carefully.
• Swallow the tablets with a glass of water.
• Do not crush or chew the tablets.
• If you crush or chew CIPLA BISOPROLOL tablets, they will not work as well.

When to take CIPLA BISOPROLOL

• Take CIPLA BISOPROLOL in the morning, with or without food.
• To properly control your condition, CIPLA BISOPROLOL must be taken every day, usually as a long-term treatment.
• Keep taking CIPLA BISOPROLOL for as long as your doctor recommends.
• It is very important that you do not stop taking CIPLA BISOPROLOL suddenly.

If you forget to use CIPLA BISOPROLOL

CIPLA BISOPROLOL should be used regularly at the same time each day.

If you miss your dose at the usual time and if it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you use too much CIPLA BISOPROLOL

If you think that you have used too much CIPLA BISOPROLOL you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

Symptoms of an overdose may include slowed heart rate, difficulty breathing, marked drop in blood pressure, severe heart failure, or a decrease in blood sugar.

5. What should I know while using CIPLA BISOPROLOL?

Things you should do

Before starting any new medicine, tell your doctor or pharmacist that you are taking CIPLA BISOPROLOL.

Visit your doctor regularly so they can check on your progress. Your doctor may check your eyes, thyroid, lipid and blood glucose levels.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Your doctor may think it is not working effectively and change your treatment unnecessarily.

If you are being treated for diabetes, make sure you check your blood sugar level regularly and report any changes to your doctor.

CIPLA BISOPROLOL may change how well your diabetes is controlled. It may also cover up some of the symptoms of low blood sugar, called If you hypoglycaemia, such as fast heartbeat. CIPLA BISOPROLOL may make hypoglycaemia last longer. Your dose of diabetic medicines, including insulin, may need to change.

If you are to have any medical tests. CIPLA BISOPROLOL may affect the results of some tests.

CIPLA BISOPROLOL may affect the results of some tests.

If plan to have surgery, including dental surgery, tell your doctor or dentist that you are taking CIPLA BISOPROLOL.

Call your doctor straight away if you:

• become pregnant while taking CIPLA BISOPROLOL

Remind any doctor, dentist or pharmacist when you visit that you are using CIPLA BISOPROLOL.

Things you should not do

• Do not stop using this medicine suddenly or lower the dose, without checking with your doctor.
  Stopping CIPLA BISOPROLOL suddenly may cause your condition to worsen or other heart complications may occur.
• If you have to stop treatment, your doctor will usually advise you to reduce the dose gradually.
• Do not use CIPLA BISOPROLOL to treat any other conditions unless your doctor tells you to.
• Do not give CIPLA BISOPROLOL to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful getting up from a sitting or lying position. Dizziness, light-headedness or fainting may occur, especially when you get up quickly. Getting up slowly may help.

Suggestions to help manage your condition

• Physical activity – regular exercise when symptoms are absent or mild helps improve heart function. Before starting any exercise, ask your doctor for advice.
• Weight reduction – your doctor may suggest losing some weight to help lessen the amount of work your heart has to do.
• Diet – eat a healthy low fat diet which includes plenty of fresh fruit and vegetables, bread, cereals and fish. Also, try to eat less fat and sugar.
• Salt restriction – too much salt can make your heart failure worse. Try to avoid using salt in cooking and at the table.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how CIPLA BISOPROLOL affects you.

CIPLA BISOPROLOL may cause tiredness, dizziness or light-headedness in some people, especially after the first dose. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.

Looking after your medicine

• CIPLA BISOPROLOL 2.5mg, 5 mg should be stored below 25 degrees C. Protect from light, store in original container.
• CIPLA BISOPROLOL 10mg should be stored below 30 degrees C. Protect from light, store in original container.
• Keep your tablets in the blister pack until it is time to take them.
• If you take the tablets out of the blister pack they may not keep well.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Heat and dampness can destroy some medicines

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If your doctor tells you to stop taking CIPLA BISOPROLOL, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
tiredness, feeling weak dizziness headache sleep disturbances, nightmares nausea, vomiting diarrhoea, constipation feeling of coldness or numbness in hands or feet allergic runny nose hair loss sexual problems	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

muscular weakness or cramps dizziness or light-headedness (sometimes with fainting), especially on standing up, which may be due to low blood pressure a very slow heart beat hallucinations depression irritation or redness of the eye skin reactions such as rash, flush, itching, worsening of psoriasis difficulty hearing. swelling of the face, lips, tongue throat which may cause difficulty breathing or swallowing signs of worsening heart failure such as shortness of breath, sometimes with tiredness or weakness, swelling of the feet or legs due to fluid build up chest tightness, wheezing, rattly breathing yellowing of the skin or eyes, dark coloured urine, itching, generally feeling unwell irregular heart beating.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. These are very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What CIPLA BISOPROLOL contains

Active ingredient (main ingredient)

Bisoprolol fumarate

Other ingredients (inactive ingredients)

Each CIPLA BISOPROLOL 2.5 mg contain: colloidal anhydrous silica magnesium stearate crospovidone maize starch microcrytalline cellulose opadry complete film coating system OY-58900 White Each CIPLA BISOPROLOL 5 mg and 10 mg tablet contains: colloidal anhydrous silica magnesium stearate crospovidone maize starch microcrystalline cellulose opadry complete film coating system OY-58900 White iron oxide yellow. CIPLA BISOPROLOL 10 mg tablets also contain: iron oxide red.

Do not take this medicine if you are allergic to any of these ingredients.

What CIPLA BISOPROLOL looks like

CIPLA BISOPROLOL comes in 3 strengths of tablets:

CIPLA BISOPROLOL 2.5 mg – white coloured, heart-shaped, film-coated tablet, scored on both sides.

(AUST R 377970)

CIPLA BISOPROLOL 5 mg – white-yellow coloured, heart-shaped, film-coated tablet, scored on both sides.

(AUST R 377971)

CIPLA BISOPROLOL 10 mg – pale orange – light orange coloured, heart-shaped, film-coated tablet, scored on both sides. (AUST R 377972)

Who distributes CIPLA BISOPROLOL

Cipla Australia Pty Ltd
Level 1, 132-136 Albert Road
South Melbourne, Victoria 3205
E-mail: drugsafety@cipla.com
Phone number: 1800-569-074

This leaflet was prepared in November 2023