Bisoprolol aurovitas

Package leaflet: Information for the patient
Bisoprolol Aurovitas, 5 mg, film-coated tablets
Bisoprolol Aurovitas, 10 mg, film-coated tablets
Bisoprololi fumaras
Read the entire leaflet carefully before using the medicine, because it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform a 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 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 amounts of acids accumulate in the body. Your doctor will provide information on this.
• if the patient has untreated phaeochromocytoma, a rare tumour of the adrenal glands.
• in patients with cardiogenic shock.

If in doubt about 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 has or has previously had psoriasis (a recurring skin disease with scaling and dry rash on the skin).
  • the patient is being treated for hypersensitivity reactions (allergic reactions). Bisoprolol may worsen this condition or make treatment more difficult.
  • the patient has been treated for "phaeochromocytoma" (a rare tumour of the adrenal glands).
• the patient has thyroid disorders. Tablets may mask symptoms of hyperthyroidism.
• the patient has been diagnosed with bronchial asthma or chronic lung disease.
• the patient is not consuming solid food.
  • the patient has any irregularities in the heart's 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 to undergo a procedure 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, recently taken, or planned for use.

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,
• medicines used for anaesthesia during surgical procedures,
• anti-inflammatory medicines known as NSAIDs (e.g. diclofenac, indometacin, ibuprofen, naproxen),
• medicines used to treat diabetes,
• medicines used to treat malaria, e.g. mefloquine,
• medicines used to treat migraine, e.g. ergotamine,
  • medicines used to treat bronchial asthma,
• medicines used to treat nasal congestion,
• medicines used to treat glaucoma (increased pressure in the eye),
• medicines used to dilate the pupil of the eye,
• fingolimod.

All of the above medicines may affect blood pressure and/or heart function.

Bisoprolol taken 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 meals or independently of meals. Swallow the tablet whole with water.

Alcohol may intensify dizziness and drowsiness caused by Bisoprolol Aurovitas. In such cases, alcohol consumption should be avoided.

Pregnancy, breastfeeding and effect on fertility

Bisoprolol Aurovitas may harm pregnancy and/or the foetus. There is an increased risk of premature delivery, miscarriage, low blood sugar and slowed heart rate in the child. The medicine may also affect the child's development. Therefore, 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 or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 undesirable effects occur, the patient should not drive or operate machinery. Be aware that such symptoms may occur, particularly at the beginning of treatment, when changing from one medicine to another, or when consuming alcohol simultaneously.

3. How to take Bisoprolol Aurovitas

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
The tablets should be swallowed whole with water.
Your doctor will determine the appropriate dose for you. Treatment is usually started at the lowest dose
(5 mg). The maximum recommended dose is 20 mg. The 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.
Before starting treatment with this medicine, you should consult your doctor.

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

Children under 12 years of age and adolescents
There is insufficient experience with 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 medicine than recommended, contact your doctor or pharmacist immediately.
You should bring 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, reduced heart contractility, 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, you should 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 usual time.
Do not take a double dose to make up for a missed tablet.

Stopping Bisoprolol Aurovitas
Treatment with Bisoprolol Aurovitas must not be stopped suddenly, especially in patients with angina or after a heart attack. Suddenly stopping bisoprolol fumarate may worsen the patient's condition or cause high blood pressure to return. 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 reactions

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

Common (may occur in fewer 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 numbness in the upper and/or lower limbs,
• nausea, vomiting,
• diarrhoea,
• constipation,
• low blood pressure.

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

• sleep disorders,
• depression,
• slow or irregular heartbeat (bradycardia),
• worsening of heart failure, causing increased shortness of breath 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 fewer than 1 in 1,000 patients):

• nightmares,
• hallucinations,
• hearing disturbances,
• inflammation of the nasal mucosa causing a runny nose with irritation,
• allergic reactions (itching, facial flushing, rash). You should immediately consult a doctor 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 secretion (may be very bothersome if the patient wears contact lenses),
• hepatitis 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 results of blood tests, such as liver enzyme activity and triglycerides.

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

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

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also 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.: +48 22 49-21-301, fax: +48 22 49-21-309,
e-mail: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to 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 packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and bottle: Expiry
date. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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 Bisoprolol Aurovitas 10 mg film-coated tablet contains 10 mg of bisoprolol fumarate, equivalent to 8.48 mg of bisoprolol.
• Other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate, colloidal anhydrous silica, crospovidone (Type A), magnesium stearate. Tablet coating: hypromellose 6 cP, 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:
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 Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in 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