Bisoprolol aurovitas

Patient Information Leaflet
Bisoprolol Aurovitas, 5 mg, film-coated tablets
Bisoprolol Aurovitas, 10 mg, film-coated tablets
Bisoprolol fumarate
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Bisoprolol Aurovitas is and what it is 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 Bisoprolol Aurovitas is and what it is 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 in the treatment of angina pectoris (chest pain caused by blockage of arteries supplying the heart muscle) or hypertension (high blood pressure).

2. Important information before taking Bisoprolol Aurovitas

When NOT to take Bisoprolol Aurovitas:

• if the patient is allergic to bisoprolol fumarate or to any of the other ingredients of this medicine (listed in section 6).
• if the patient currently has or has previously had acute, wheezing breathing difficulties or severe asthma.
• if the patient has a slow heart rate, which may cause problems. If in doubt, consult a doctor.
• if the patient has very low blood pressure (below 100 mmHg).
• if the patient has severe circulatory disorders (which may cause tingling, paleness, or blueness of fingers and toes).
• if the patient has severe heart rhythm disorders.
• if the patient has been diagnosed with heart failure that has recently occurred or recently worsened, or which requires hospital treatment.
• if the patient has been diagnosed with metabolic acidosis – a condition in which excessive acids accumulate in the body. The doctor will provide further information on this.
• if the patient has untreated phaeochromocytoma, a rare tumour of the adrenal gland.
• in patients with cardiogenic shock.

If in doubt regarding any of the above conditions, consult a doctor.

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

• the patient has impaired liver or kidney function.
• the patient has diabetes. Bisoprolol tablets may mask symptoms of low blood sugar.
• the patient currently has or has previously had psoriasis (a recurring skin disease characterised by scaling and dry skin rash).
• the patient is being treated for allergic reactions (hypersensitivity). Bisoprolol may worsen this condition or make treatment more difficult.
• the patient has previously been treated for "phaeochromocytoma" (a rare tumour of the adrenal gland).
• the patient has thyroid disorders. The tablets may mask symptoms of hyperthyroidism.
• the patient has asthma or chronic lung disease.
• the patient is not consuming solid food.
• the patient has any irregularities in the heart's electrical conduction system.
• the patient suffers from Prinzmetal's angina, a type of chest pain caused by spasm of the coronary arteries supplying the heart muscle.
• the patient has any circulatory disorders in the arms or legs.
• the patient has low blood pressure.
• the patient has a slow heart rate.
• the patient has heart failure.
• if the patient is scheduled for surgery under anaesthesia, inform the doctor, hospital staff, or dentist about all medications being taken.
• the patient is an athlete (bisoprolol may lead to positive results in anti-doping tests).

Bisoprolol Aurovitas and other medicines:
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
It is especially important to inform about the use of any of the following medicines, as their effects may be altered:

• 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 psychiatric disorders, such as tricyclic antidepressants, phenothiazine derivatives, monoamine oxidase inhibitors, and barbiturates,
• anaesthetics used during surgical procedures,
• anti-inflammatory medicines known as NSAIDs (e.g. diclofenac, indomethacin, ibuprofen, naproxen),
• medicines used in the treatment of diabetes,
• medicines used to treat malaria, e.g. mefloquine,
• medicines used to treat migraines, e.g. ergotamine,
• medicines used to treat bronchial asthma,
• medicines used to treat nasal congestion,
• medicines used to treat glaucoma (increased eye pressure),
• medicines used to dilate the pupil of the eye,
• fingolimod.

All of the above medicines may affect blood pressure and/or heart function.
Bisoprolol, when used together with insulin or other medicines used to treat diabetes, may mask symptoms of low blood sugar.

Bisoprolol Aurovitas, food, drink, and alcohol
Bisoprolol Aurovitas may be taken during or regardless of meals. Swallow the tablet whole with water.
Alcohol may worsen dizziness and drowsiness caused by Bisoprolol Aurovitas. In such cases, alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility
Bisoprolol Aurovitas may harm the unborn baby and/or the foetus. There is an increased risk of premature birth, miscarriage, low blood sugar, and slowed heart rate in the newborn. The medicine may also affect the child's development. For this reason, Bisoprolol Aurovitas should not be taken during pregnancy.
It is not known whether bisoprolol passes into human breast milk, and therefore it is not recommended during breastfeeding.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
These tablets may cause fatigue, drowsiness, or dizziness. If any of these symptoms occur, the patient should not drive or operate machinery. Be aware that such symptoms may occur, particularly at the beginning of treatment, when changing to another medicine, or when consuming alcohol concurrently.

3. How to take Bisoprolol Aurovitas

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult 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. Tablets should be taken every day at approximately
the same time.
In severe cases, the dose may be increased to 20 mg once daily.

Patients with kidney disease
Patients with severe kidney disease should not take a dose higher than 10 mg of bisoprolol once daily.
Consult your doctor before starting treatment with this medicine.

Patients with liver disease
Patients with severe liver disease should not take a dose higher than 10 mg of bisoprolol once daily.
Consult your doctor before starting treatment with this medicine.

Children under 12 years of age and adolescents
There is insufficient data on the use of this medicine in children under 12 years of age and adolescents; therefore,
its use is not recommended in this age group.

The tablet may be divided into equal doses.

Taking more Bisoprolol Aurovitas than recommended
If you accidentally take more tablets than prescribed, contact your doctor or pharmacist immediately.
Take any remaining tablets or this leaflet with you so that medical personnel know exactly which medicine has been taken.
Symptoms of overdose may include dizziness, feeling faint, tiredness, shortness of breath, and/or wheezing.
There may also be a slowing of the heart rate, low blood pressure, weakened heart muscle contraction, and low blood sugar levels (which may cause hunger, excessive sweating, and palpitations).

If you miss a dose of Bisoprolol Aurovitas
If you miss a dose, take it as soon as you remember, provided that less than 12 hours have passed since the usual time of taking the medicine.
If more than 12 hours have passed, do not take the missed tablet; instead, take the next dose at the scheduled time.
Do not take a double dose to make up for a missed tablet.

Stopping treatment with Bisoprolol Aurovitas
Treatment with Bisoprolol Aurovitas must not be stopped suddenly, especially in patients with angina or who have had a heart attack.
Sudden discontinuation of bisoprolol fumarate may worsen the patient's condition or cause a recurrence of high blood pressure.
To avoid this, the dose should be gradually reduced over several weeks, as directed by your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although they do not occur in everyone.
The following adverse effects have also been reported:

Common (may occur in less than 1 in 10 patients):

• feeling of fatigue, dizziness, headache (especially at the beginning of treatment; these symptoms are usually mild and often subside within 1–2 weeks),
• sensation of coldness or tingling in the upper and/or lower limbs,
• nausea, vomiting,
• diarrhoea,
• constipation,
• low blood pressure.

Uncommon (may occur in less than 1 in 100 patients):

• sleep disorders,
• depression,
• slow or irregular heartbeat (bradycardia),
• worsening of heart failure, causing increased breathlessness and/or fluid retention,
• in patients with bronchial asthma or a history of respiratory disorders, difficulty in breathing may occur,
• muscle weakness, cramps,
• feeling of weakness.

Rare (may occur in less than 1 in 1,000 patients):

• nightmares,
• hallucinations,
• hearing disturbances,
• inflammation of the nasal mucosa causing nasal discharge with irritation,
• allergic reactions (itching, facial flushing, rash). You should contact your doctor immediately if more severe allergic reactions occur, which may include swelling of the face, neck, tongue, mouth or throat, or difficulty breathing.
• dry eyes due to reduced tear production (may be particularly bothersome 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 darkening of the urine,
• erectile dysfunction,
• fainting,
• increased blood test results such as liver enzyme activity and triglycerides.

Very rare (may occur in less than 1 in 10,000 patients):

• exacerbation of psoriasis or induction of a similar dry, scaling rash,
• hair loss,
• conjunctivitis.

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

5. How to store Bisoprolol Aurovitas

Keep this medicine 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 under: Expiry
date. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. 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 Bisoprolol Aurovitas 5 mg film-coated tablet contains 5 mg of bisoprolol fumarate, equivalent to 4.24 mg of bisoprolol. Each Bisoprol0l Aurovitas 10 mg film-coated tablet contains 10 mg of bisoprolol fumarate, equivalent to 8.48 mg of bisoprolol.
• Other ingredients are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, anhydrous colloidal silicon dioxide, crospovidone (Type A), magnesium stearate. Tablet coating: hypromellose 6cP, titanium dioxide (E 171), polyethylene glycol 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 (6.8 mm in diameter), yellow in colour, with an embossed breakline 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 (8.9 mm in diameter), yellow in colour, with an embossed breakline and the mark "I" on one side and "13" on the other side.
Bisoprolol Aurovitas film-coated tablets are available in PA/Aluminium/PVC/Aluminium blisters and in HDPE containers with a PP closure and a desiccant sachet, packed in a cardboard box.
Pack sizes:
Blister packs: 20, 28, 30, 50, 90, 100 film-coated tablets
HDPE container: 30, 500 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
Poland
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 authorised for marketing in the Member States of the European Economic Area under the following names:
France: Bisoprolol ARROW LAB 10 mg, comprimé pelliculé
Poland: Bisoprolol Aurovitas
Romania: Bisoprolol Fumarat AUROBINDO 5 mg & 10 mg comprimate filmate
United Kingdom: BISOPROLOL FUMARATE 5 mg & 10 mg film-coated tablets