Bisoprolol Aurovitas

Package Leaflet: Information for the Patient

Bisoprolol Aurovitas, 5 mg, Film-Coated Tablets

Bisoprolol Aurovitas, 10 mg, Film-Coated Tablets

Bisoprolol Fumarate
Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Bisoprolol Aurovitas and what is it used for
• 2. Important information before taking Bisoprolol Aurovitas
• 3. How to take Bisoprolol Aurovitas
• 4. Possible side effects
• 5. How to store Bisoprolol Aurovitas
• 6. Contents of the pack and other information

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

Bisoprolol Aurovitas belongs to a group of medicines called beta-blockers. These medicines protect the heart from excessive activity.
Bisoprolol may be used to treat angina pectoris(chest pain caused by blockage of the blood vessels that supply the heart muscle) or high blood pressure.

2. Important information before taking Bisoprolol Aurovitas

When NOT to take Bisoprolol Aurovitas:

• if you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had acute, severe asthma or chronic bronchial asthma.
• if you have a slow heart rate, which may cause problems. If in doubt, consult your doctor.
• if you have very low blood pressure (less than 100 mmHg).
• if you have severe circulatory problems (which may cause tingling, pallor, or cyanosis of the fingers and toes).
• if you have severe heart rhythm disorders.
• if you have heart failure, which has recently worsened or requires hospital treatment.
• if you have metabolic acidosis - a condition where there is an excessive accumulation of acids in the body. Your doctor will inform you about this.
• if you have an untreated pheochromocytoma, a rare tumor of the adrenal gland.
• in patients with cardiogenic shock.

In case of doubts about the above conditions, consult your doctor.

Warnings and precautions

Before taking Bisoprolol Aurovitas, discuss with your doctor or pharmacist if:

• you have liver or kidney problems.
• you have diabetes. Bisoprolol tablets may mask the symptoms of low blood sugar.
• you have had psoriasis (a recurring skin disease characterized by scaling and dry rash on the skin).
• you are being treated for allergic reactions. Bisoprolol may worsen this condition or make it difficult to treat.
• you have been treated for pheochromocytoma (a rare tumor of the adrenal gland).
• you have thyroid function disorders. The tablets may mask the symptoms of hyperthyroidism.
• you have asthma or chronic lung disease.
• you do not eat solid foods.
• you have any irregularities in the conduction of impulses in the heart.
• you have Prinzmetal's angina, a type of chest pain caused by spasm of the coronary arteries that supply the heart muscle.
• you have circulatory problems in the upper and lower limbs.
• you have low blood pressure.
• you have a slow heart rate.
• you have heart failure.
• if you are going to have surgery, inform your doctor, hospital staff, or dentist about all the medicines you are taking.
• you are an athlete (bisoprolol may give positive results in doping tests).

Bisoprolol Aurovitas with other medicines:

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
It is especially important to inform about the use of any of the following medicines, as their effect may change:

• medicines used to control blood pressure or treat heart-related disorders, such as: amlodipine, amiodarone, clonidine, diltiazem, disopyramide, lidocaine, phenytoin, flecainide, propafenone, digoxin, dobutamine, isoprenaline, methyldopa, moxonidine, nifedipine, quinidine, rilmenidine, verapamil, and beta-blockers,
• medicines used to treat depression and mental disorders, such as: tricyclic antidepressants, phenothiazine derivatives, monoamine oxidase inhibitors, and barbiturates,
• medicines used for anesthesia during surgical procedures,
• anti-inflammatory medicines known as NSAIDs (e.g., diclofenac, indomethacin, ibuprofen, naproxen),
• medicines used to treat diabetes,
• medicines used to treat malaria, e.g., mefloquine,
• medicines used to treat migraines, e.g., ergotamine,
• medicines used to treat asthma,
• medicines used to treat a "stuffy" nose,
• medicines used to treat glaucoma (increased eye pressure),
• medicines used to dilate the pupils,
• fingolimod. All of the above medicines may affect blood pressure and/or heart function.

Bisoprolol used together with insulin or other diabetes medicines may mask the symptoms of low blood sugar.

Bisoprolol Aurovitas with food, drink, and alcohol

Bisoprolol Aurovitas can be taken with or without food.
Swallow the tablet whole with water.
Alcohol may increase the feeling of dizziness and drowsiness caused by Bisoprolol Aurovitas. In this case, you should avoid consuming alcohol.

Pregnancy, breastfeeding, and fertility

Bisoprolol Aurovitas may harm the pregnancy and/or the fetus. There is an increased risk of premature birth, miscarriage, low blood sugar, and slow heart rate in the baby. The medicine may also affect the development of the baby. Therefore, you should not take Bisoprolol Aurovitas during pregnancy.
It is not known whether bisoprolol passes into breast milk, and therefore, it is not recommended during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

These tablets may cause fatigue, drowsiness, or dizziness. If you experience any of these side effects, do not drive or operate machinery.
Be aware that such effects may occur, especially at the beginning of treatment, when changing to another medicine, or when consuming alcohol.

3. How to take Bisoprolol Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
Swallow the tablets whole with water.
Your doctor will determine the appropriate dose for you. Treatment usually starts with the lowest dose (5 mg). The maximum recommended dose is 20 mg. Take the tablets once a day at about the same time.

Patients with kidney disease

Patients with severe kidney disease should not take more than 10 mg of bisoprolol once a day. Consult your doctor before starting treatment.

Patients with liver disease

Patients with severe liver disease should not take more than 10 mg of bisoprolol once a day. Consult your doctor before starting treatment.

Children under 12 years and adolescents

There is no experience with the use of this medicine in children under 12 years and adolescents, therefore, it is not recommended in this age group.
The tablet can be divided into equal doses.

Taking more than the recommended dose of Bisoprolol Aurovitas

If you have taken more than the recommended dose of the medicine, contact your doctor or pharmacist immediately.
Take the remaining tablets or this leaflet with you so that the medical staff knows exactly what medicine has been taken.
Symptoms of overdose may include dizziness, drowsiness, fatigue, shortness of breath, and/or wheezing. Slow heart rate, low blood pressure, inadequate heart contraction, and low blood sugar (which may cause hunger, excessive sweating, and palpitations) may also occur.

Missing a dose of Bisoprolol Aurovitas

If you miss a dose, take it as soon as you remember, unless it is more than 12 hours since the time you usually take the medicine. If more than 12 hours have passed, do not take the missed tablet, but take the next one at the scheduled time.
Do not take a double dose to make up for the missed tablet.

Stopping treatment with Bisoprolol Aurovitas

Do not stop treatment with Bisoprolol Aurovitas abruptly, especially in patients with angina pectoris or after a heart attack. If bisoprolol fumarate is stopped abruptly, the patient's condition may worsen or high blood pressure may recur.
To avoid this, the dose of the medicine should be gradually reduced over several weeks, as advised by your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bisoprolol Aurovitas can cause side effects, although not everybody gets them.
The following side effects have also been reported:

• Frequently(may affect up to 1 in 10 people):
• fatigue, dizziness, headache (especially at the beginning of treatment; these symptoms are usually mild and often disappear within 1-2 weeks),
• feeling of coldness or numbness in the hands and/or feet,
• nausea, vomiting,
• diarrhea,
• constipation,
• low blood pressure.
• Less frequently(may affect up to 1 in 100 people):
• sleep disorders,
• depression,
• slow or irregular heartbeat (bradycardia),
• worsening of heart failure, leading to increased shortness of breath and/or fluid retention,
• in patients with asthma or a history of respiratory disorders, breathing difficulties may occur,
• muscle weakness, cramps,
• feeling of weakness.

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

• nightmares,
• hallucinations,
• hearing disorders,
• inflammation of the nasal mucosa, causing a runny nose with irritation,
• allergic reactions (hives, facial flushing, rash). You should immediately consult your doctor if you experience severe allergic reactions, which may include swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing.
• dryness of the eyes caused by reduced tear secretion (may be very troublesome if you wear contact lenses),
• inflammation of the liver, causing abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the eyes and skin, and dark urine,
• erectile dysfunction,
• fainting,
• increased results of blood tests, such as liver enzyme activity and triglycerides.

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

• worsening of psoriasis or the occurrence of a similar dry, scaly rash,
• hair loss,
• conjunctivitis.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
e-mail: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bisoprolol Aurovitas

Keep this medicine out of the sight and reach of children.
Store in the original package to protect from light.
Do not use this medicine after the expiry date stated on the carton and bottle after: Expiry date. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bisoprolol Aurovitas contains

• The active substance is bisoprolol fumarate. Each film-coated tablet of Bisoprolol Aurovitas 5 mg contains 5 mg of bisoprolol fumarate, equivalent to 4.24 mg of bisoprolol. Each film-coated tablet of Bisoprolol Aurovitas 10 mg contains 10 mg of bisoprolol fumarate, equivalent to 8.48 mg of bisoprolol.
• The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, colloidal anhydrous silica, crospovidone (Type A), magnesium stearate. Tablet coating:hypromellose 6cP, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172).

What Bisoprolol Aurovitas looks like and contents of the pack

Film-coated tablet.
Bisoprolol Aurovitas, 5 mg, film-coated tablets
Round, biconvex, film-coated tablets (with a diameter of 6.8 mm), yellow in color with a dividing line and the mark "I" on one side and "11" on the other.
Bisoprolol Aurovitas, 10 mg, film-coated tablets
Round, biconvex, film-coated tablets (with a diameter of 8.9 mm), yellow in color with a dividing line and the mark "I" on one side and "13" on the other.
Bisoprolol Aurovitas film-coated tablets are available in blisters PA/Aluminum/PVC/Aluminum and in an HDPE container with a PP closure and a desiccant bag, in a cardboard box.
Pack sizes:
Blisters: 20, 28, 30, 50, 90, 100 film-coated tablets
HDPE container: 30, 500 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
tel.: +48 22 311 20 00

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Generis Farmacêutica S.A.,
Rua João de Deus, no 19, Venda Nova,
2700-487 Amadora
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France:
Bisoprolol ARROW LAB 10 mg, film-coated tablet
Poland:
Bisoprolol Aurovitas
Romania:
Bisoprolol Fumarat AUROBINDO 5 mg & 10 mg film-coated tablets
United Kingdom: BISOPROLOL FUMARATE 5 mg & 10 mg film-coated tablets

Date of last revision of the leaflet: 06/2022