BISOPROLOLO 1.25 mg Tablet

Зміст інструкції

1. Bisoprololo Doc Generics 1.25 mg tablets, Generics2.5 mg tablets, Generics3.75 mg tablets, Generics5 mg tablets, Generics10 mg tablets
   1. What is Bisoprololo Doc Generics and what is it used for
   2. How to take Bisoprololo Doc Generics
   3. Possible side effects
   4. How to store Bisoprololo Doc Generics
   5. Contents of the pack and other information

Bisoprololo Doc Generics 1.25 mg tablets, Generics2.5 mg tablets, Generics3.75 mg tablets, Generics5 mg tablets, Generics10 mg tablets

Bisoprolol fumarate

Equivalent Medicinal Product

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Bisoprololo Doc Generics is and what it is used for
• 2. What you need to know before you take Bisoprololo Doc Generics
• 3. How to take Bisoprololo Doc Generics
• 4. Possible side effects
• 5. How to store Bisoprololo Doc Generics
• 6. Contents of the pack and other information

1. What is Bisoprololo Doc Generics and what is it used for

Bisoprololo Doc Generics contains the active ingredient bisoprolol fumarate. Bisoprololo belongs to a
group of drugs called beta-blockers. Bisoprololo prevents irregular heartbeat (arrhythmia) during exertion and reduces cardiovascular workload. Bisoprololo also dilates the
blood vessels and therefore facilitates blood flow.
Bisoprololo Doc Generics is used for:

• To treat high blood pressure (hypertension).
• To treat coronary heart disease and chest pain (angina pectoris). This pain is caused by a lack of oxygen in the heart muscle.
• To treat heart failure together with other medications. Heart failure is the inability of the heart to pump enough blood to meet the body's needs, causing swelling (edema) of the extremities and shortness of breath.
• 2.What you need to know before you takeBisoprololo Doc Generics Do not takeBisoprololo Doc Generics :
• If you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• If you suffer from heart failure that has just developed or has recently worsened, or if you are receiving treatment via intravenous infusion for shock caused by acute heart failure (and to help your heart work);
• If you have very low blood pressure or a slow heartbeat due to a severe heart malfunction (called cardiogenic shock);
• If you have heart conduction disorders, such as sinus node disease, sino-atrial block, or second or third-degree atrioventricular block;
• If you have a very slow heart rate;
• If you have very low blood pressure;
• If you have an untreated tumor that can raise blood pressure (called pheochromocytoma);
• If you suffer from symptoms of severe asthma or chronic obstructive pulmonary disease;
• If you suffer from severe circulatory disorders in the extremities, such as intermittent claudication (leg pain that easily occurs when walking) or Raynaud's syndrome (where the fingers and toes become white, bluish, and then red and accompanied by pain);
• If you have so-called metabolic acidosis, a disturbance of acid/base balance as occurs in diabetic patients when blood sugar levels rise too high.

Warnings and precautions:
Talk to your doctor or pharmacist before taking Bisoprololo Doc Generics, they may decide to
take special precautions (e.g., give you additional treatment or subject you to more frequent checks):

• If you suffer from heart failure without symptoms and well controlled;
• If you have liver or kidney problems;
• If you have problems with heart valves or a congenital heart disease;
• If you have had a heart attack in the last three months;
• If you suffer from asthma or chronic pulmonary obstruction (if you are using bronchodilator drugs, the dosage of these drugs may need to be adjusted and it may be necessary to check lung function);
• If you are going to undergo surgery or another procedure requiring sedation or spinal anesthesia (you must inform the anesthesiologist that you are using Bisoprololo Doc Generics);
• If you suffer from diabetes mellitus and blood sugar levels are very variable, Bisoprololo Doc Generics, this can mask the symptoms of hypoglycemia and slow down the rise in blood sugar levels);
• If you are fasting;
• If your thyroid is overactive, Bisoprololo Doc Generics can mask the symptoms of hyperthyroidism);
• If you are undergoing desensitization therapy, Bisoprololo Doc Generics may worsen allergic reactions and require an increase in the dose of medication needed to treat the allergic reaction);
• If you have a mild heart conduction disorder (first-degree atrioventricular block);
• If you have chest pain caused by spasm of the coronary arteries (Prinzmetal's angina);
• If you use contact lenses, Bisoprololo Doc Generics can reduce tear production and cause dry eyes);
• If you suffer from scaly skin rashes (psoriasis). Bisoprololo Doc Generics can determine positivity to doping tests.

Other medicines and Bisoprololo Doc Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Do not take the following medicines with Bisoprololo Doc Generics without receiving specific
advice from your doctor:

• quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone (used to treat irregularities or abnormalities of the heartbeat);
• verapamil and diltiazem (used to treat irregular heartbeat and blood pressure);
• clonidine, methyldopa, guanfacine, moxonidine and rilmenidine (to treat blood pressure and some neurological diseases). However, do not stop taking these medicineswithout first consulting your doctor.

Consult your doctor before taking the following medicines with Bisoprololo Doc Generics: the
doctor may need to check you more frequently:

• nifedipine, felodipine and amlodipine (used to treat high blood pressure or angina or abnormal heartbeat);
• amiodarone (used to treat irregular or abnormal heartbeat);
• beta-blockers, including eye drops containing beta-blockers, such as timolol for the treatment of glaucoma;
• digitalis, such as digoxin, used to treat heart failure;
• donepezil or tacrine (for the treatment of dementia);
• neostigmine or pyridostigmine (for the treatment of myasthenia gravis, a disease that causes muscle weakness);
• physostigmine to treat high eye pressure (glaucoma);
• drugs called ergot alkaloids (for the treatment of migraine or low blood pressure);
• other antihypertensive drugs;
• other drugs that can lower blood pressure, such as tricyclic antidepressants (e.g., imipramine or amitriptyline), phenothiazines such as levomepromazine (for the treatment of psychosis), or barbiturates such as phenobarbital (for the treatment of epilepsy);
• adrenaline to treat allergic reactions;
• baclofen and tizanidine (muscle relaxants);
• amifostine (a protective substance used in some cancer therapies);
• mefloquine (an antimalarial);
• rifampicin (an antibiotic);
• insulin and other drugs for the treatment of diabetes mellitus;
• oral or intravenous corticosteroids;
• so-called monoamine oxidase inhibitors, i.e. MAO inhibitors (except MAO-B inhibitors) such as moclobemide or phenelzine (for depression).

Non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid, diclofenac, ibuprofen,
ketoprofen, naproxen, celecoxib, or etoricoxib (especially if used long-term and regularly)
can reduce the effectiveness of Bisoprololo Doc Generics in the treatment of hypertension. However
small daily doses of acetylsalicylic acid, e.g. 100 mg, can be used safely
concurrently with the use of Bisoprololo Doc Generics to prevent the formation of blood clots.

Bisoprololo Doc Generics with food and drink.
The tablets of Bisoprololo Doc Generics should be taken in the morning with or without food. The
tablets should be swallowed with some liquid and should not be chewed.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Bisoprololo Doc Generics should not be used during pregnancy unless clearly
necessary. If you are planning a pregnancy or if you become pregnant while taking
Bisoprololo Doc Generics, ask your doctor about continuing therapy.
It is not known whether bisoprolol is excreted in breast milk. Therefore, breastfeeding during
treatment with Bisoprololo Doc Generics should be avoided.

Driving and using machines
Bisoprololo Doc Generics has little or no effect on the ability to drive. Side effects
following a reduction in blood pressure may include dizziness, headache, fatigue
or other side effects (see section 4) that may reduce the ability to drive and/or use
machinery. If these effects occur, you should avoid driving and other activities
that require attention. This is particularly important at the beginning of treatment and
when the dose is increased. Bisoprololo Doc Generics usually does not affect the ability to
drive if the therapy is well balanced.

For those who play sports: the use of the drug without therapeutic need constitutes doping and may
still result in positive doping tests.

3. How to take Bisoprololo Doc Generics

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

How to use
Swallow the tablet with a sufficient amount of liquid (e.g. a glass of water), usually
once a day in the morning. The tablets must not be chewed. Food does not affect
the absorption of the drug.
The recommended dose is:
Adults:
Treatment of hypertension and angina pectoris

• The initial dose is 5 mg once a day.
• The doctor may gradually increase the dose (usually within a few weeks) to 10 mg or a maximum of 20 mg, if necessary.

Treatment of stable chronic heart failure
Treatment with bisoprolol must begin at the lowest dose and increase gradually. The doctor
will decide how to increase the dose, and this is usually done as follows:

• 1.25 mg of bisoprolol once a day for one week;
• 2.5 mg of bisoprolol once a day for one week;
• 3.75 mg of bisoprolol once a day for one week;
• 5 mg of bisoprolol once a day for four weeks;
• 7.5 mg of bisoprolol once a day for four weeks;
• 10 mg of bisoprolol once a day as maintenance therapy.

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how well you are able to tolerate the drug, the doctor may decide to
extend the time between an increase in one dose and the next. If your condition
worsens or you are no longer able to tolerate the drug, a reduction
of the dose or discontinuation of treatment may be necessary. In some patients, a maintenance dose of
less than 10 mg may be sufficient. The doctor will tell you what to do. If you need to completely stop
treatment, the doctor will usually advise you to gradually reduce the dose, otherwise your
condition may worsen.
Use in children and adolescents (under 18 years of age):
There is insufficient experience with the use of Bisoprololo Doc Generics in children, so use must
be avoided in children or adolescents under 18 years of age.
Elderly patients:
It is not necessary to adjust the dosage in the elderly, unless they suffer from renal
or hepatic insufficiency, see below.
Patients with renal or hepatic insufficiency:
The dose must be increased very gradually and with caution in patients with severe problems
with the kidneys or liver. The dose should not exceed 10 mg once a day in patients with severe
kidney or liver problems.

If you take more Bisoprololo Doc Generics than you should
If you or anyone else has taken an excessive dose of Bisoprololo Doc Generics, consult a doctor or
go immediately to the nearest emergency room.
In case of nausea or dizziness, place the patient in a lying position and seek medical assistance. If the
patient is unconscious, they should be placed on their side but the legs may be raised.

If you forget to take Bisoprololo Doc Generics
Take the next tablet normally, when it is time to take it. Do not take a double dose
to make up for the missed tablet.

If you stop taking Bisoprololo Doc Generics
Treatment with Bisoprololo Doc Generics should not be stopped abruptly, especially if
the patient has coronary heart disease. The dosage must be reduced gradually according to the
instructions provided by the doctor, e.g., over 1 or 2 weeks. Otherwise, the symptoms of heart disease
may worsen.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To prevent serious adverse reactions, tell your doctor immediately if a side effect is
severe, appears suddenly or worsens rapidly. The most serious side effects are
related to heart function and the most common among these are slowed heartbeat,
excessive reduction of blood pressure, dizziness and fatigue.
Other side effects are listed below, according to how often they may occur:
Very common (affects at least 1 in 10 people)

• heartbeat too slow (in patients with heart failure).

Common (affects 1 to 10 people in 100):

• dizziness and headache.
• worsening of heart failure symptoms (in patients with pre-existing heart failure).
• feeling of coldness or numbness in the extremities.
• blood pressure too low (in patients with heart failure).
• gastrointestinal disorders such as nausea, vomiting, diarrhea or constipation.
• asthenia (in patients with heart failure), fatigue.

Uncommon (affects 1 to 10 people in 1,000):

• depression, sleep disorders.
• heart block (disturbances in heart conduction).
• heartbeat too slow (in patients with hypertension or coronary heart disease).
• bronchospasm (shortness of breath in patients with asthma or chronic obstructive pulmonary disease).
• muscle weakness, muscle cramps.
• asthenia (in patients with hypertension or angina pectoris).
• blood pressure too low when standing up (orthostatic hypotension).

Rare (affects 1 to 10 people in 10,000):

• nightmares and hallucinations.
• fainting (syncope).
• reduced tear production (contact lens wearers should take this into account).
• hearing disorders.
• hepatitis (causes pain in the upper abdomen).
• hypersensitivity reactions, such as itching, redness or hives.
• sexual potency disorders.
• increased levels of liver enzymes (laboratory tests ALT or AST).
• allergic rhinitis (nasal congestion, runny nose and itchy nose).

Very rare (affects less than 1 in 10,000 people):

• conjunctivitis (eye inflammation).
• hair loss (alopecia), worsening of psoriasis or psoriasis-like skin rash.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly through the
national reporting system, at the website: http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Bisoprololo Doc Generics

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the label and on the package. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Bisoprololo Doc Generics contains
The active ingredient is bisoprolol fumarate.
One 1.25 mg tablet contains 1.25 mg of bisoprolol fumarate.
One 2.5 mg tablet contains 2.5 mg of bisoprolol fumarate.
One 3.75 mg tablet contains 3.75 mg of bisoprolol fumarate.
One 5 mg tablet contains 5 mg of bisoprolol fumarate.
One 10 mg tablet contains 10 mg of bisoprolol fumarate.
The other ingredients are: microcrystalline cellulose, anhydrous colloidal silicon dioxide, sodium croscarmellose,
sodium carboxymethyl starch (Type A) and magnesium stearate.

Description of the appearance of Bisoprololo Doc Generics and contents of the pack
Bisoprololo Doc Generics 1.25mg are white or almost white, round, biconvex tablets.
Bisoprololo Doc Generics 2.5mg are white or almost white, round, biconvex tablets with
a score line on one side.
Bisoprololo Doc Generics 3.75mg are white or almost white, round, biconvex tablets.
Bisoprololo Doc Generics 5 mg are white or almost white, round, biconvex tablets with
a score line on one side.
Bisoprololo Doc Generics 10 mg are white or almost white, round, biconvex tablets with
a score line on one side.
Only the 2.5 mg, 5 mg and 10 mg tablets can be divided into two equal doses
Packs of 28 tablets.

Marketing Authorisation Holder:
Doc Generici s.r.l.
Via Turati, 40
20121 Milano - Italy

Manufacturer:
Chanelle Medical,
Dublin Road, Loughrea,
Co. Galway,
Ireland.