Bisoprolol Aurovitas

Leaflet included in the packaging: patient information

Bisoprolol Aurovitas, 5 mg, film-coated tablets

Bisoprolol Aurovitas, 10 mg, film-coated tablets

Bisoprolol fumarate
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 blood vessels that supply the heart muscle) or high blood pressure(high blood pressure).

2. Important information before taking Bisoprolol Aurovitas

When NOT to take Bisoprolol Aurovitas:

• in patients with cardiogenic shock.

In case of doubt about the above conditions, the patient should consult a doctor.

Warnings and precautions

Before taking Bisoprolol Aurovitas, the patient should discuss with their doctor or pharmacist if:

• the patient has liver or kidney problems.
• the patient has diabetes. Bisoprolol tablets may mask the symptoms of low blood sugar.
• the patient has had psoriasis (a recurring skin disease characterized by scaling and dry rash on the skin).
• the patient is being treated for an allergic reaction. Bisoprolol may exacerbate this condition or make it difficult to treat.
• the patient has been treated for a pheochromocytoma (a rare tumor of the adrenal gland).
• the patient has thyroid function disorders. The tablets may mask the symptoms of hyperthyroidism.
• the patient has asthma or chronic lung disease.
• the patient does not eat solid food.
• the patient has any irregularity in the conduction system of the heart.
• the patient has Prinzmetal's angina, a type of chest pain caused by spasm of the coronary arteries that supply the heart muscle.
• the patient has any circulatory disorders in the upper and lower limbs.
• the patient has low blood pressure.
• the patient has a slow heart rate.
• the patient has heart failure.
• the patient is an athlete (bisoprolol may give positive results in doping tests).

Bisoprolol Aurovitas with food, drink, and alcohol

Bisoprolol Aurovitas can be taken with or without food.
The tablet should be swallowed whole, with a glass of water.
Alcohol may exacerbate the dizziness and lightheadedness caused by Bisoprolol Aurovitas. In this case, the patient should avoid consuming alcohol.

Pregnancy, breastfeeding, and fertility

Bisoprolol Aurovitas may be harmful to 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. For this reason, Bisoprolol Aurovitas should not be taken during pregnancy.
It is not known whether bisoprolol passes into breast milk, and therefore it is not recommended during breastfeeding.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

These tablets may cause fatigue, drowsiness, or dizziness. If these side effects occur, the patient should not drive vehicles or operate machines.
The patient should be aware that these symptoms may occur, especially at the beginning of treatment, when changing the medicine, or when consuming alcohol.

3. How to take Bisoprolol Aurovitas

This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of doubt, the patient should consult their doctor or pharmacist.
The tablets should be swallowed whole, with a glass of water.
The doctor will determine the appropriate dose for the patient. Treatment usually starts with the lowest dose (5 mg). The maximum recommended dose is 20 mg. The tablets should be taken daily at approximately the same time.
In severe cases, the dose may be increased to 20 mg once a day.

Patients with kidney disease

Patients with severe kidney disease should not take a dose higher than 10 mg of bisoprolol once a day. Before starting treatment with this medicine, the patient should consult their doctor.

Patients with liver disease

Patients with severe liver disease should not take a dose higher than 10 mg of bisoprolol once a day. Before starting treatment with this medicine, the patient should consult their doctor.

Children under 12 years old and adolescents

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

Taking a higher dose of Bisoprolol Aurovitas than recommended

In case of accidental ingestion of a higher dose of the medicine than recommended, the patient should immediately contact their doctor or pharmacist. The patient should take the remaining tablets or this leaflet with them, so that the medical staff knows exactly which medicine was taken.
Symptoms of overdose may include dizziness, lightheadedness, 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 a dose of the medicine is missed, the patient should take it as soon as they remember, if it is within 12 hours of the time when they usually take the medicine. If more than 12 hours have passed, the patient should not take the missed tablet, but take the next one at the scheduled time.
The patient should not take a double dose to make up for the missed tablet.

Stopping treatment with Bisoprolol Aurovitas

Treatment with Bisoprolol Aurovitas should not be stopped suddenly, especially in patients with angina pectoris or after a heart attack. If bisoprolol fumarate is stopped suddenly, 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, according to the doctor's instructions.
In case of any further doubts about the use of the medicine, the patient should consult their 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:
Common(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 upper and/or lower limbs,
• nausea, vomiting,
• diarrhea,
• constipation,
• low blood pressure.

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

• sleep disorders,
• depression,
• slow or irregular heart rate (bradycardia),
• worsening of heart failure, causing 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.

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

• nightmares,
• hallucinations,
• hearing disorders,
• nasal congestion with irritation, causing a runny nose,
• allergic reactions (hives, facial flushing, rash). The patient should immediately consult their doctor if they experience severe allergic reactions, which may include facial, neck, tongue, mouth, or throat swelling, or difficulty breathing.
• dryness of the eyes due to reduced tear secretion (may be very troublesome if the patient wears contact lenses),
• liver inflammation 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 rare(may affect up to 1 in 10,000 people):

• exacerbation of psoriasis or development of a similar dry, scaly rash,
• hair loss,
• conjunctivitis.

Reporting side effects
If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Bisoprolol Aurovitas

The medicine should be stored out of sight and reach of children.
Store in the original packaging 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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, 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 side.
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 side.
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.
Sokratesa 13D, local 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: 01/2023