Bisoprolol Doc Generici

Package leaflet: Information for the patient

Bisoprololo Doc Generics 1.25 mg tablets

Bisoprololo Doc Generics 2.5 mg tablets
Bisoprololo Doc Generics 3.75 mg tablets
Bisoprololo Doc Generics 5 mg tablets
Bisoprololo Doc Generics 10 mg tablets
Bisoprolol fumarate
Generic medicinal product

Read this entire 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including 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 taking 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 substance bisoprolol fumarate. Bisoprolol belongs to a group of medicines called beta-blockers. Bisoprolol prevents irregular heartbeat (arrhythmia) during physical exertion and reduces the workload on the cardiovascular system. Bisoprolol also dilates blood vessels, thereby facilitating blood flow.

Bisoprololo Doc Generics is used for:

• Treating high blood pressure (hypertension).
• Treating coronary heart disease and chest pain (angina pectoris). This pain is caused by lack of oxygen in the heart muscle.
• Treating heart failure in combination with other medicines. 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 taking Bisoprololo Doc Generics

Do not take Bisoprololo Doc Generics:

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• If you have heart failure that has just developed or has recently worsened, or if you are receiving intravenous treatment for circulatory shock caused by acute heart failure (and thus to help your heart function);
• If you have very low blood pressure or slow heart rate due to severe heart dysfunction (called cardiogenic shock);
• If you have conduction disorders of the heart, such as sick sinus syndrome, 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 tumour that can increase blood pressure (called phaeochromocytoma);
• If you suffer from symptoms of severe asthma or chronic obstructive pulmonary disease;
• If you have severe circulation problems in the extremities, such as intermittent claudication (leg pain that occurs easily when walking) or Raynaud's syndrome (with fingers and toes turning pale, then bluish, and finally red, accompanied by pain);
• If you have so-called metabolic acidosis, a disturbance in 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 (for example, provide additional treatment or more frequent monitoring):

• If you have heart failure without symptoms and well controlled;
• If you have liver or kidney problems;
• If you have heart valve problems or congenital heart disease;
• If you have had a heart attack within the last three months;
• If you suffer from asthma or chronic pulmonary obstruction (if you use bronchodilator medicines, the dosage of these medicines may need adjustment and lung function monitoring may be required);
• If you are undergoing surgery or another procedure requiring sedation or spinal anaesthesia (you must inform the anaesthetist that you are taking Bisoprololo Doc Generics);
• If you have diabetes mellitus and your blood sugar levels are highly variable, Bisoprololo Doc Generics may mask the symptoms of hypoglycaemia and slow the recovery of blood sugar levels;
• If you are fasting strictly;
• If your thyroid gland is overactive, Bisoprololo Doc Generics may mask the symptoms of hyperthyroidism;
• If you are undergoing desensitisation therapy, Bisoprololo Doc Generics may worsen allergic reactions and require higher doses of medication to treat the allergic reaction;
• If you have a mild conduction disorder of the heart (first-degree atrioventricular block);
• If you have chest pain caused by spasm of the heart (coronary) arteries (known as Prinzmetal's angina);
• If you wear contact lenses, Bisoprololo Doc Generics may reduce tear production and cause dry eyes;
• If you suffer from scaly skin eruptions (psoriasis). Bisoprololo Doc Generics may lead to positive 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 medicines.

Do not take the following medicines with Bisoprololo Doc Generics without first obtaining specific advice from your doctor:

• Quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone (used to treat irregularities or abnormalities of heartbeat);
• Verapamil and diltiazem (used to treat irregular heartbeat and blood pressure);
• Clonidine, methyldopa, guanfacine, moxonidine and rilmenidine (for treating blood pressure and certain neurological conditions). However, do not stop taking these medicines without first consulting your doctor.

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

• Nifedipine, felodipine and amlodipine (used to treat high blood pressure, 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 preparations, 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 causing muscle weakness);
• Physostigmine for treating high eye pressure (glaucoma);
• Medicines called ergot alkaloids (for treating migraine or low blood pressure);
• Other antihypertensive medicines;
• Other medicines that may reduce blood pressure, such as tricyclic antidepressants (e.g., imipramine or amitriptyline), phenothiazines such as levomepromazine (for treating psychosis), or barbiturates such as phenobarbital (for treating epilepsy);
• Adrenaline for treating allergic reactions;
• Baclofen and tizanidine (muscle relaxants);
• Amifostine (a protective agent used in some anticancer therapies);
• Mefloquine (an antimalarial);
• Rifampicin (an antibiotic);
• Insulin and other medicines for the treatment of diabetes mellitus;
• Oral or intravenous corticosteroids;
• So-called monoamine oxidase inhibitors (MAO inhibitors) (except MAO-B inhibitors), such as moclobemide or phenelzine (for depression).

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

Bisoprololo Doc Generics with food and drink

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

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Bisoprololo Doc Generics should not be used during pregnancy unless clearly necessary. If you are planning a pregnancy or become pregnant while taking Bisoprololo Doc Generics, consult your doctor about continuing treatment.

It is not known whether bisoprolol is excreted in breast milk. Therefore, breastfeeding should be avoided during treatment with Bisoprololo Doc Generics.

Driving and using machines

Bisoprololo Doc Generics has little or no effect on the ability to drive. Side effects due to reduced blood pressure may include dizziness, headache, fatigue, or other side effects (see section 4), which could impair the ability to drive and/or operate machinery. If such effects occur, you should avoid driving and performing other activities requiring alertness. 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 engaged in sports activities: using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Bisoprololo Doc Generics

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Instructions for use
Swallow the tablet with a sufficient amount of liquid (e.g. a glass of water), usually once daily in the morning. The tablets must not be chewed. Food does not affect the absorption of the medicine.

The recommended dose is:
Adults:
Treatment of hypertension and angina pectoris

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

Treatment of stable chronic heart failure
Treatment with bisoprolol must start at the lowest dose and be gradually increased. Your doctor will decide how to increase the dose, usually as follows:

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

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how well you tolerate the medicine, your doctor may decide to extend the time intervals between dose increases. If your condition worsens or you are no longer able to tolerate the medicine, a dose reduction or discontinuation of treatment may be necessary. In some patients, a maintenance dose lower than 10 mg may be sufficient. Your doctor will advise you accordingly. If you need to stop treatment completely, your doctor will usually recommend gradually reducing the dose; otherwise, your condition could worsen.

Use in children and adolescents (under 18 years of age):
There is insufficient experience regarding the use of Bisoprololo Doc Generics in children; therefore, its use should be avoided in children and adolescents under 18 years of age.

Elderly patients:
Dosage adjustment is not necessary in elderly patients unless they have renal or hepatic impairment; see below.

Patients with renal or hepatic impairment:
The dose should be increased very gradually and cautiously in patients with severe kidney or liver problems. The dose must not exceed 10 mg once daily in patients with severe renal or hepatic impairment.

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 department.
In case of nausea or dizziness, lie the patient down and seek medical help. If the patient is unconscious, place them in the recovery position (on their side), with legs elevated.

If you forget to take Bisoprololo Doc Generics
Take the next tablet at the usual time. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Bisoprololo Doc Generics
Treatment with Bisoprololo Doc Generics must not be stopped abruptly, especially if the patient has coronary heart disease. The dosage must be gradually reduced according to your doctor's instructions, for example over 1 or 2 weeks. Otherwise, symptoms of heart disease may worsen.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
To prevent serious adverse reactions, inform your doctor immediately if a side effect is severe, has occurred suddenly, or worsens rapidly. The most serious side effects are related to heart function; the most common of these include slowing of the heartbeat, excessive reduction in blood pressure, dizziness, and fatigue.
Other side effects are listed below, according to how frequently they may occur:

Very common (affects at least 1 in 10 patients):

• Slow heartbeat (in patients with heart failure).

Common (affects from 1 to 10 in 100 patients):

• Dizziness and headache.
• Worsening of heart failure symptoms (in patients with pre-existing heart failure).
• Cold sensation or numbness in extremities.
• Low blood pressure (in patients with heart failure).
• Gastrointestinal disorders such as nausea, vomiting, diarrhoea or constipation.
• Astenia (in patients with heart failure), fatigue.

Uncommon (affects from 1 to 10 in 1,000 patients):

• Depression, sleep disorders.
• Heart block (disturbances in the heart's electrical conduction).
• Slow heartbeat (in patients with hypertension or coronary artery disease).
• Bronchospasm (shortness of breath in patients with asthma or chronic obstructive pulmonary disease).
• Muscle weakness, muscle cramps.
• Astenia (in patients with hypertension or angina pectoris).
• Low blood pressure when standing (orthostatic hypotension).

Rare (affects from 1 to 10 in 10,000 patients):

• Nightmares and hallucinations.
• Fainting (syncope).
• Reduced tear production (patients who wear contact lenses should take note).
• Hearing disturbances.
• Hepatitis (causes upper abdominal pain).
• Hypersensitivity reactions such as itching, redness or urticaria.
• Sexual dysfunction.
• Increased levels of liver enzymes (laboratory tests ALT or AST).
• Allergic rhinitis (stuffy, runny and itchy nose).

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

• Conjunctivitis (inflammation of the eye).
• Hair loss (alopecia), worsening of psoriasis or psoriasis-like skin rash.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via 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 Bisoprolol Doc Generics

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

6. Package contents and other information

What Bisoprololo Doc Generics contains
The active substance 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 components are: microcrystalline cellulose, anhydrous colloidal silicon dioxide, sodium croscarmellose,
sodium carboxymethylstarch (Type A), and magnesium stearate.

Description of the appearance of Bisoprololo Doc Generics and contents of the pack
Bisoprololo Doc Generics 1.25 mg are white or almost white, round, biconvex tablets.
Bisoprololo Doc Generics 2.5 mg are white or almost white, round, biconvex tablets with a score line on one side.
Bisoprololo Doc Generics 3.75 mg 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 Authorization Holder:
Doc Generici s.r.l.
Via Turati, 40
20121 Milano - Italy

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