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BIBLOC as 5 mg. 30 tablets

Product Code: BIBLOC as 5 mg. 30 tablets
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What is Bibloc and what it is used
Bibloc belongs to a group of medicines that are called beta-blockers. They protect the heart from too much activity.

Bibloc be applied for the treatment of:
high blood pressure;
angina (heart pain);
Heart failure causes breathlessness on exertion and fluid retention, bisoprolol can be used as adjunctive therapy to other treatments for heart failure.

2. What you need to know before taking Bibloc
Do not take Bibloc
if you are allergic to bisoprololov fumarate or any of the other ingredients of this medicine (listed in section 6);
if you have cardiogenic shock, a serious heart condition causing a rapid, weak pulse; low blood pressure, cold, clammy skin; fatigue and fainting;
If you have ever suffered from severe wheezing or severe asthma, as they can affect your breathing;
if you have slow heart rate (under 60 beats per minute). Ask your doctor if you are unsure;
if you have very low blood pressure;
if you have severe circulation problems (which may cause the fingers or thumbs you numb or turn white or bruising);
if you have certain serious heart rhythm problems;
if you have new onset heart failure or heart failure that is not stabilized and need hospital treatment;
if you have a condition in which there is an accumulation of an excessive amount of acid in the body known as metabolic acidosis. Your doctor can give you advice;
if you have an adrenal gland tumor, known as pheochromocytoma, which is not cured.
Tell your doctor if you are unsure of any of the foregoing.

Warnings and Precautions
Talk to your doctor before taking Bibloc:
If you suffer from wheezing or difficulty breathing (asthma). It is concomitant bronchodilator therapy. It may need a higher dose beta2-mimetic;
if you have diabetes. Tablets can mask the symptoms of low blood sugar (such as increased heart rate, palpitations or sweating);
if fasting (not taking oily food);
if you are being treated for hypersensitivity (allergic). Biblok may increase the hypersensitivity to the substances you are allergic to and increase the severity of hypersensitivity reactions. Treatment with adrenaline then can not produce the desired result. It may need a higher dose of adrenaline (epinephrine);
with I-st degree heart block (conduction disorder in the heart);
if you suffer from angina Prinzmetal, which is a type of chest pain caused by spasm of the coronary arteries that supply blood to the heart muscle;
If you have any circulation problems in the extremities - hands and feet;
in case of operation requiring administration of anesthetic: if you consulted a doctor, visit a hospital or dentist for surgery requiring administration of anesthetic, tell them about the medicines you are taking;
in combination with calcium antagonists such as verapamil and diltiazem. Concomitant use is not recommended, see also section "Other medicines and Biblok"
if you suffer (or have suffered) from psoriasis (a recurrent skin disorder involving scaling and dry skin rash);
if you have pheochromocytoma (a tumor of the adrenal glands). You will need your doctor to cure it before you prescribe Bibloc;
if you have thyroid problems. The tablets may mask symptoms of overactive thyroid gland.
So far, no therapeutic experience in the treatment of heart failure with Biblok in patients with the following diseases and conditions:
diabetes treated with insulin (Type I);
severe kidney disease;
severe liver disease;
certain heart diseases;
heart attack in the previous three months.
Treatment of heart failure with Bibloc requires regular monitoring by a doctor. This is absolutely necessary, especially at the start and discontinuation of treatment.
Bibloc treatment should not be stopped abruptly, except for compelling reasons.
In patients with hypertension or angina pectoris with concomitant heart failure treatment should not be stopped suddenly. The dose should be reduced by slowly reduced to half within one week.
Consult your doctor if any of the above warnings applies to you or applied to you in the past.

Other medicines and Bibloc
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines. This includes medicines obtained without a prescription. Some drugs can not be used simultaneously, while other drugs require specific changes (in the dose, for example).

Always tell your doctor if you are using or receiving any of the following medicines in addition to Bibloc:
Medicines for controlling blood pressure or medicines for heart problems (such as amiodarone, amlodipine, clonidine, digitalis, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil);
Sedatives and drugs to treat psychosis (mental illness) eg. barbiturates (also used in epilepsy), phenothiazines (also used in vomiting and nausea);
Medicines for depression eg. tricyclic antidepressants, MAO-A inhibitors;
Medicines used for anesthesia during surgery (see. Also "Warnings and Precautions");
certain analgesics (e.g., acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen);
Medicines for asthma, blocked nose or certain eye disorders such as glaucoma (increased eye pressure) or dilation (widening) of the pupil;
certain drugs for the treatment of shock (eg. adrenaline, dobutamine, norepinephrine);
mefhlohin, a medicament for treatment of malaria;
antibiotic rifampicin;
ergot derivatives migraine.
All these drugs as well as bisoprolol may affect blood pressure and / or cardiac function.
insulin or other medicines for diabetes. You can enhance the effect of lowering blood sugar. Can mask the symptoms of low blood sugar.
Biblok alcohol
Dizziness, which can be caused by Biblok may get worse if you drink alcohol. If this happens, you should avoid drinking alcohol.

Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, talk to your doctor before taking this medicine. Biblok can be harmful to the pregnancy and / or the unborn child. There is a greater likelihood of premature birth, miscarriage, low blood sugar level and reduced heart rate of the child. Growth of the child may also be affected. Therefore, bisoprolol should not be taken during pregnancy.
It is not known whether bisoprolol is excreted in human milk and therefore is not recommended during lactation.

Driving and using machines
No studies on the effects on ability to drive and use machines. These tablets may make you feel tired, sleepy or dizzy.
If you have these side effects do not drive or operate machinery. You must be aware of the possibility of these side effects, especially early in treatment, in case of the drug and in concomitant use with alcohol.

Biblok contains lactose
If your doctor told you that you have an intolerance to some sugars, contact him before taking this medicine.

3. How to take Bibloc
Always take this medicine exactly as your doctor has told you. If you're not sure, ask your doctor or pharmacist.
Your doctor will tell you how many tablets to take. You should take Biblok morning before, with or after breakfast. Swallow the tablet / s with some water and do not chew or crush.

High blood pressure / angina pectoris:
The dose is determined individually.
The recommended starting dose is 5 mg once daily.
The usual dose for adults and 10 mg once daily. Your doctor may decide to increase or decrease the dose.
The maximum dose is 20 mg once daily.

Severely impaired renal or hepatic function
If you suffer from severely impaired renal or hepatic function maximum dose is 10 mg daily.

Normally there is no need dose adjustment. Your doctor will start with the lowest possible dose.

Heart failure (reduced pumping strength of the heart)
Before you start taking Bibloc you are already taking an ACE inhibitor, a diuretic or cardiac glycoside (medicines for heart / blood pressure).
The dose will be increased gradually until reaching the right dose for you:
1,25 mg once daily for 1 week. If well tolerated, the dose may be increased to:
2,5 mg once daily for the next week. If well tolerated, the dose may be increased to:
3,75 mg once daily for the next week. If well tolerated, the dose may be increased to:
5 mg once daily for the next four weeks. If well tolerated, the dose may be increased to:
7,5 mg once daily for the next 4 weeks. If well tolerated, the dose may be increased to:
10 mg once daily as a maintenance dose.
Maximum dose: once daily 10 mg.
The doctor will determine the optimal dose among the rest for you based on possible side effects.
After the first dose of 1,25 mg doctor will check your blood pressure, heart rate, cardiac dysfunction.

Violations of liver function or kidney
The doctor will be more careful when increasing the dose.

Normally there is no need dose adjustment.

If you notice that the effect of Bibloc is too strong or not strong enough, please consult your doctor or pharmacist.

To break the tablets
Put the tablet on a hard, flat surface with the score facing upwards.
Press thumb middle of a tablet and the tablet will break into two halves. Press thumb middle of each half and get quarters.

Duration of treatment
Bibloc will normally be administered long-term.

Use in children and adolescents
There is no experience with Bibloc in children and adolescents, therefore its use in children is not recommended.

If you take more than the amount Bibloc
If you take more than the prescribed dose, tell your doctor / pharmacist. Take the remaining tablets or this leaflet with you to allow the medical team to see what you have taken. Symptoms of overdose may include drowsiness, dizziness, fatigue, shortness of breath and / or wheezing. It also has a slow heart rate, low blood pressure, insufficient action of the heart and low blood sugar (which may involve feelings of hunger, sweating and palpitations).

If you forget to take Bibloc
Do not take a double dose to make up the missed dose. Take the normal dose as soon as you remember and then continue with your usual dose the next day.

If you stop taking Biblok
Biblok treatment should not be stopped abruptly. If you suddenly stop taking this medicine your condition may worsen. Instead, treatment should be withdrawn gradually over several weeks under your doctor's advice.

If you have any further questions on 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.

Side effects that may occur are:
Very common - can occur in more than 1 in 10 patients:
bradycardia (slow heartbeat). In the treatment of hypertension or angina pectoris this side effect occurs infrequently.
Common - can occur in 1 to 10 in every 100 patients:
fatigue. In the treatment of hypertension or angina pectoris this side effect occurs infrequently;
dizziness, fatigue and headache (especially at the beginning of treatment in patients with hypertension and angina pectoris, symptoms generally are mild and often disappear within 1-2 weeks);
feeling cold or numbness in the extremities (fingers or toes, ears and nose); often feel painful cramps in the legs when walking;
worsening of pre-existing heart failure. In the treatment of hypertension or angina pectoris this side effect occurs infrequently;
very low blood pressure (hypotension), especially in patients with heart failure;
nausea, vomiting;
Uncommon - can occur in 1 to 10 in every 1,000 patients:
fatigue. In the treatment of heart failure this side effect occurs frequently;
drop in blood pressure when standing up, which can cause dizziness, dizziness or fainting;
sleep disturbances;
slow heartbeat. In the treatment of heart failure this side effect occurs very often;
irregular heartbeat;
worsening of pre-existing heart failure. In the treatment of heart failure this side effect occurs frequently;
Patients with asthma or a history of breathing problems may have difficulty in breathing;
muscle weakness and muscle cramps.
Rare - can occur in 1 to 10 in every 10,000 patients:
hallucinations (false perceptions of thing);
hearing loss;
inflammation of the lining of the nose, causing a runny nose with inflammation;
allergic reactions (including itching, flushed appearance, rash);
dry eyes due to reduced production of tears (which can be very disturbing if you wear contact lenses);
inflammation of the liver (hepatitis), causing abdominal pain, loss of appetite and sometimes yellowing of the whites of the eyes and skin and dark urine;
decreased sexual ability (violation of potency);
increased levels of blood lipids (triglycerides) and liver enzymes.
Very rare - can occur in less than 1 in 10,000 patients:
chest pain;
deterioration of the skin condition psoriasis or cause a similar dry, scaly rash and hair loss;
itching or redness of the eye (conjunctivitis).
If you get any side effects, contact your doctor or pharmacist. This includes any possible effects not listed in this leaflet.

5. How to store Bibloc
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister after "EXP". The first two digits indicate the month, the last digits the year. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

HDPE bottles:
This medicinal product does not require any special storage conditions.

Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Bibloc
The active substance is 5 mg bisoprololov fumarate.

Other ingredients are:
calcium phosphate dibasic anhydrous;
microcrystalline cellulose;
maize starch, pregelatinised;
croscarmellose sodium;
silica colloidal anhydrous;
magnesium stearate;
lactose monohydrate;
macrogol 4000;
titanium dioxide (E171);
yellow iron oxide (E172).
Biblok looks like and contents of the pack
Biblok 5 mg film-coated tablets are yellow, oval film-coated tablets with a score in the form of a cross (split tablets of four) on one side and "BIS 5" on the other side.

The product is available in:
blisters (OPA-Al-PVC / Al) of 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 500, 10x30 film.
HDPE bottles of 10, 20, 30, 50, 60, 100, 250, 500 film-coated tablets.

Not all pack sizes may be marketed.

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