BISOPROLOLO 2.5 mg/6.25 mg Film-coated tablets

Зміст інструкції

1. Bisoprololo e Idroclorotiazide Aurobindo 2.5 mg/6.25 mg film-coated tablets, 5 mg/6.25 mg film-coated tablets, 10 mg/6.25 mg film-coated tablets
   1. What is Bisoprololo and Idroclorotiazide Aurobindo and what is it used for
   2. What you need to know before taking Bisoprolol and Hydrochlorothiazide Aurobindo
   3. How to take Bisoprololo and Idroclorotiazide Aurobindo
   4. Possible side effects
   5. How to store Bisoprololo e Idroclorotiazide Aurobindo
   6. Package contents and other information

Bisoprololo e Idroclorotiazide Aurobindo 2.5 mg/6.25 mg film-coated tablets, 5 mg/6.25 mg film-coated tablets, 10 mg/6.25 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start 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 e Idroclorotiazide Aurobindo is and what it is used for
• 2. What you need to know before you take Bisoprololo e Idroclorotiazide Aurobindo
• 3. How to take Bisoprololo e Idroclorotiazide Aurobindo
• 4. Possible side effects
• 5. How to store Bisoprololo e Idroclorotiazide Aurobindo
• 6. Contents of the pack and other information

1. What is Bisoprololo and Idroclorotiazide Aurobindo and what is it used for

The active ingredients are bisoprolol and hydrochlorothiazide.
Bisoprolol belongs to the family of medicines called beta-blockers and is used to reduce
blood pressure.
Hydrochlorothiazide belongs to the family of medicines called thiazide diuretics (also known as
“water pills”). This medicine helps to lower blood pressure
by increasing the elimination of urine.
This medicine is recommended for the treatment of mild to
moderate high blood pressure.

2. What you need to know before taking Bisoprolol and Hydrochlorothiazide Aurobindo

Do not take Bisoprolol and Hydrochlorothiazide Aurobindo if

• you are allergic to bisoprolol, hydrochlorothiazide, other thiazides, sulfonamides (substances related to hydrochlorothiazide from a chemical point of view) or any of the other ingredients of this medicine (listed in section 6);
• you suffer from a severe form of asthma or any other breathing problem such as chronic respiratory disorders;
• you suffer from uncontrolled heart failure or cardiogenic shock (a serious heart condition that causes a drop in blood pressure and circulatory failure);
• you suffer from heart rhythm disorders, in particular have a slowed heart rate, conduction disturbances and a disease called sick sinus syndrome;
• you suffer from very low blood pressure;
• you have a tumor of the adrenal gland (pheochromocytoma) that is not being treated;
• you suffer from severe circulatory problems in the limbs (such as Raynaud's syndrome which can cause paleness, bluish discoloration or tingling in the fingers of the hands or feet);
• you have an increase in the concentration of acids in the blood (metabolic acidosis) due to a serious illness;
• you suffer from severe kidney or liver problems;
• you have low levels of potassium in the blood that do not respond to treatment (persistent hypokalemia).

Warnings and precautions
Talk to your doctor or pharmacist before taking Bisoprolol and Hydrochlorothiazide Aurobindo if:

• you suffer from any heart condition, such as heart failure, heart rhythm disorders or Prinzmetal's angina;
• you suffer from circulatory problems in the fingers of the hands or feet, arms or legs (Raynaud's syndrome) or have pain similar to cramps in the calves, which appear with exercise or walking. These disorders may worsen, especially at the beginning of treatment;
• you have a tumor of the adrenal gland (pheochromocytoma) that is being treated. Bisoprolol and Hydrochlorothiazide Aurobindo must be used in combination only with certain medicines (alpha-blockers);
• you suffer from asthma or any other chronic respiratory disorder that can cause symptoms (bronchospasm). The treatment you are receiving may need to be modified;
• you suffer from diabetes, Bisoprolol and Hydrochlorothiazide Aurobindo may mask the symptoms of low blood sugar (hypoglycemia);
• you suffer from a thyroid problem, Bisoprolol and Hydrochlorothiazide Aurobindo may mask the symptoms of an overactive thyroid;
• you suffer from (or have suffered from) recurrent skin disorders that cause scaling, dry skin (psoriasis);
• you are following a strict diet;
• you have high levels of uric acid in the blood (hyperuricemia), because Bisoprolol and Hydrochlorothiazide Aurobindo tends to increase the risk of gout attacks;
• you are planning to undergo surgery. When an anesthetic is used together with Bisoprolol and Hydrochlorothiazide Aurobindo, heart rate and blood pressure may change. Inform the anesthesiologist that you are taking Bisoprolol and Hydrochlorothiazide Aurobindo;
• you have a reduced blood volume (hypovolemia);
• you have mild to moderate kidney or liver problems;
• you suffer from high levels of uric acid in the blood (hyperuricemia), as Bisoprolol and Hydrochlorothiazide Aurobindo tends to increase the risk of gout attacks;
• you are elderly;
• you are receiving treatment for allergic reactions. Bisoprolol and Hydrochlorothiazide Aurobindo may increase the severity of allergic reactions. Also, your usual treatment may be less effective;
• you are planning to be exposed to sunlight or artificial UV radiation, because some patients have developed a skin rash after exposure to the sun. In this case, you should protect your skin during treatment with Bisoprolol and Hydrochlorothiazide Aurobindo;
• you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Bisoprolol and Hydrochlorothiazide Aurobindo;
• you have blurred vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a few hours to a few weeks after taking Bisoprolol and Hydrochlorothiazide Aurobindo. This condition can lead to permanent vision loss if left untreated. If you are allergic to penicillin or sulfonamide drugs, this risk may be increased;
• if you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Bisoprolol and Hydrochlorothiazide Aurobindo, consult a doctor immediately. The treatment should never be stopped abruptly, especially if you suffer from certain heart conditions (e.g. angina). If you need to stop treatment, your doctor will reduce the dose over several days.

It is not advisable to combine this medicine with lithium used in the treatment of some psychiatric disorders, or with medicines used to treat hypertension, angina pectoris or cardiac arrhythmia (such as verapamil, diltiazem or bepridil) (see section “Other medicines and Bisoprolol and Hydrochlorothiazide Aurobindo”).
Immediately inform your doctor if you have a chronic lung disease or less severe asthma, and if you begin to experience new breathing difficulties, cough, shortness of breath after exercise, etc., while using Bisoprolol and Hydrochlorothiazide Aurobindo.

Further examinations

• Bisoprolol and Hydrochlorothiazide Aurobindo works by influencing the body's fluid and electrolyte balance. Your doctor will monitor this regularly. These examinations are particularly important if you suffer from other illnesses that may be aggravated if the fluid and electrolyte balance is altered. In addition, your doctor may decide to occasionally check the levels of lipids, potassium, sodium, calcium, urea, uric acid or glucose in the blood.

Other medicines and Bisoprolol and Hydrochlorothiazide Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Bisoprolol and Hydrochlorothiazide Aurobindo can only be taken with the following medicines if prescribed by your doctor, because they are generally not recommended:

• some medicines used to treat high blood pressure, angina or cardiac arrhythmia (such as verapamil, diltiazem or bepridil) which may increase the risk of heart rhythm disorders,
• lithium, a medicine used to treat some types of psychiatric illnesses.

Tell your doctor or pharmacist if you are taking any of the following medicines. Their use with Bisoprolol and Hydrochlorothiazide Aurobindo must be carried out with caution:

• some medicines used to treat high blood pressure (e.g. clonidine, methyldopa, moxonidine, rilmenidine),
• propafenone, cibenzoline, flecainide, used to treat heart rhythm abnormalities,
• lidocaine, used as an anesthetic during minor surgery and to treat heart rhythm abnormalities,
• medicines that mimic the action of some nerves such as pilocarpine or carbacol (parasympathomimetics),
• medicines to treat diabetes (e.g. insulin, sulfonamide hypoglycemic agents, glinides),
• medicines that can cause a slowing of the heartbeat (e.g. anticholinergic agents, digitalis glycosides, mefloquine, etc.),
• medicines that lower blood pressure by dilating blood vessels (ACE inhibitors (e.g. captopril, enalapril, quinapril), sartans (e.g. losartan, irbesartan, valsartan), dihydropyridine calcium antagonists (e.g. nifedipine, amlodipine)),
• eye drops to treat glaucoma (topical beta-blockers),
• medicines to treat pain and inflammation (e.g. NSAIDs, acetylsalicylic acid),
• medicines to treat high blood pressure by increasing urine production (potassium-sparing diuretics),
• medicines to reduce potassium levels in the blood, can cause excessive potassium loss (hypokalemizing agents, e.g. amphotericin, corticosteroids, tetracosactide, stimulant laxatives),
• medicines that affect or may be affected by potassium levels in the blood, such as digoxin, a medicine to control heart rhythm, some antipsychotic medicines,
• carbamazepine, used to treat epilepsy and some mood disorders,
• medicines used in hospitals to examine blood vessels (iodinated contrast media),
• medicines used to treat gout by reducing uric acid levels in the blood,
• calcium salts, can increase calcium in the blood to dangerous levels,
• cyclosporine, used after organ transplants and to treat disorders such as psoriasis and arthritis,
• medicines used to reduce the absorption of hydrochlorothiazide (e.g. cholestyramine, colestipol).

Bisoprolol and Hydrochlorothiazide Aurobindo with food and drink
Bisoprolol and Hydrochlorothiazide Aurobindo coated tablets should be taken in the morning and with food. The tablet should be swallowed with liquid and should not be chewed.
It is recommended to maintain an adequate fluid intake and eat more potassium-rich foods during the intake of this medicine, to avoid potential potassium deficiency, e.g. bananas, vegetables and nuts. Potassium loss can also be reduced or prevented by means of medicines (potassium-sparing diuretics). Talk to your doctor if you are concerned.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Usually, your doctor will advise you to take another medicine instead of Bisoprolol and Hydrochlorothiazide Aurobindo, because Bisoprolol and Hydrochlorothiazide Aurobindo is not recommended during pregnancy. This is because both hydrochlorothiazide and bisoprolol cross the placenta and their use during pregnancy can be dangerous for your baby. If Bisoprolol and Hydrochlorothiazide Aurobindo is used during pregnancy, your baby should be monitored for the 5 days following birth.
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Bisoprolol and Hydrochlorothiazide Aurobindo is not recommended in breastfeeding mothers. Hydrochlorothiazide can impair milk production.
Like other medicines, Bisoprolol and Hydrochlorothiazide Aurobindo can rarely affect the ability to have an erection.

Sport
Athletes should be informed that this medicine contains a substance that can give a positive result in doping tests.

Driving and operating machinery
Bisoprolol and Hydrochlorothiazide Aurobindo generally does not affect the ability to drive vehicles or operate machinery. However, the way you react to the medicine may have an effect on your ability to concentrate or on your reactions. In this case, you should not drive or operate machinery.

3. How to take Bisoprololo and Idroclorotiazide Aurobindo

Dosage
Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended initial dose is one 2.5 mg/6.25 mg tablet of Bisoprololo and
Idroclorotiazide Aurobindo per day.
If at this dose the decrease in blood pressure is not sufficient, the dose may be
increased to one 5 mg/6.25 mg tablet of Bisoprololo and Idroclorotiazide Aurobindo per day
and, if the response is still insufficient, the dose may be increased to one 10 mg/6.25
mg tablet of Bisoprololo and Idroclorotiazide Aurobindo per day.

Use in children
The use of Bisoprololo and Idroclorotiazide Aurobindo is not recommended because there is insufficient
experience with the use of this medicine in children.

Method and route of administration
Oral use.
The tablets should be taken in the morning, with or without food. The tablets can be
swallowed with liquid and should not be chewed.

Frequency of administration
The usual frequency of administration is 1 tablet per day.

Duration of treatment
Treatment with Bisoprololo and Idroclorotiazide Aurobindo is a long-term treatment. You should not
suddenly stop treatment because this may worsen your condition. Discontinuation of treatment must first be discussed with your doctor.

If you take more Bisoprololo and Idroclorotiazide Aurobindo than you should
If you take more Bisoprololo and Idroclorotiazide Aurobindo than you should, contact a
doctor or the Emergency Room immediately. Bring the package and any remaining tablets with you. The most common signs of
overdose are mental confusion, feeling of fainting, malaise, drowsiness and slow or irregular
heartbeat.

If you forget to take Bisoprololo and Idroclorotiazide Aurobindo
Do not take a double dose to make up for a missed dose. Take the next dose
according to the prescribed schedule. If you have forgotten several doses, contact your doctor.

If you stop taking Bisoprololo and Idroclorotiazide Aurobindo
Do not stop taking this medicine unless your doctor tells you to do so. Your condition
may worsen significantly if you stop treatment. If you need to stop treatment, in
general your doctor will tell you to gradually reduce the dose.
If you have any doubts 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 everyone will experience them.

Common: may affect up to 1 in 10 people

• feeling of cold or numbness in the hands and feet;
• fatigue, dizziness, headache. These symptoms mainly occur at the beginning of treatment. The effects are generally mild and usually disappear within 1 or 2 weeks of starting treatment;
• nausea, vomiting, diarrhea or constipation.

Uncommon: may affect up to 1 in 100 people

• muscle weakness and muscle cramps;
• feeling tired or weak;
• slow heartbeat, irregular heartbeat, worsening of heart failure;
• dizziness or lightheadedness when getting up;
• sleep disturbances, depression;
• loss of appetite and weight loss (anorexia);
• breathing problems in subjects affected by asthma or chronic bronchopneumopathy;
• increased levels of creatinine or urea in the blood;
• abdominal discomfort;
• increased amylase (enzymes involved in digestion);
• increased levels of lipids, cholesterol, uric acid or glucose in the blood; increased levels of glucose in the urine;
• abnormal levels of body fluids and electrolytes (hypokalemia, hypomagnesemia, hyponatremia, hypochloremia, hypercalcemia).

Rare: may affect up to 1 in 1,000 people

• nightmares, hallucinations;
• allergic reactions such as irritation, sudden flushing of the face or skin rash, skin sensitization to the sun, hives, red spots on the skin due to bleeding under the skin (purpura);
• increased levels of certain liver enzymes, liver inflammation, yellowing of the skin or eyes (jaundice);
• erectile dysfunction;
• hearing disorders;
• fainting;
• runny nose;
• reduced tear flow (may be a problem if you wear contact lenses);
• vision disturbances;
• decreased number of white blood cells (leukopenia) or platelets (thrombocytopenia) in the blood. You should immediately consult a doctor if you experience more severe allergic reactions, which may include swelling of the face, neck, tongue, mouth or throat, or difficulty breathing.

Very rare: may affect up to 1 in 10,000 people

• eye irritation and redness (conjunctivitis), hair loss;
• appearance or worsening of pre-existing scaly skin rashes (psoriasis); appearance of thick scaly patches (cutaneous lupus erythematosus);
• chest pain;
• severe reduction in the number of white blood cells (agranulocytosis);
• inflammation of the pancreas;
• severe loss of acids in the blood (metabolic alkalosis);
• allergic reactions (anaphylactic reactions), severe blistering reactions (Lyell's syndrome);
• acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Not known: frequency cannot be estimated based on available data

• rapid onset of distance vision impairment (acute myopia), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma);
• severe shortness of breath or worsening shortness of breath, which may be signs of a lung disorder (interstitial lung disease);
• skin and lip cancer (non-melanoma skin carcinoma).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Bisoprololo e Idroclorotiazide Aurobindo

Keep this medicine out of the sight and reach of children.
Store the blisters in the packaging to protect the medicine from light.
Store at a temperature below 30 °C.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Bisoprololo e Idroclorotiazide Aurobindo contains
Bisoprololo e Idroclorotiazide Aurobindo 2.5 mg/6.25 mg film-coated tablets
Each film-coated tablet contains 2.5 mg of bisoprolol fumarate and 6.25 mg of
hydrochlorothiazide.
Bisoprololo e Idroclorotiazide Aurobindo 5 mg/6.25 mg film-coated tablets
Each film-coated tablet contains 5 mg of bisoprolol fumarate and 6.25 mg of
hydrochlorothiazide.
Bisoprololo e Idroclorotiazide Aurobindo 10 mg/6.25 mg film-coated tablets
Each film-coated tablet contains 10 mg of bisoprolol fumarate and 6.25 mg of
hydrochlorothiazide.
The other ingredients are:

Tablet core: calcium hydrogen phosphate, microcrystalline cellulose (grade-112), crospovidone
(type-A), anhydrous colloidal silica, magnesium stearate.

Tablet coating:
Bisoprololo e Idroclorotiazide Aurobindo 2.5 mg/6.25 mg and 5 mg/6.25 mg film-coated
tablets
Hypromellose 2910 (6 cPs), titanium dioxide (E171), macrogol 400, yellow iron oxide, polysorbate
80 and red iron oxide.
Bisoprololo e Idroclorotiazide Aurobindo 10 mg/6.25 mg film-coated tablets
Hypromellose 2910 (6 cPs), titanium dioxide (E171), macrogol 400 and polysorbate 80.

Description of the appearance of Bisoprololo e Idroclorotiazide Aurobindo and contents of the
pack
Film-coated tablets.
Bisoprololo e Idroclorotiazide Aurobindo 2.5 mg/6.25 mg film-coated tablets
Film-coated tablets, yellow, round (diameter 5.21 mm), biconvex, with ‘L1’ inscribed on one
side and smooth on the other side.
Bisoprololo e Idroclorotiazide Aurobindo 5 mg/6.25 mg film-coated tablets
Film-coated tablets, pink, round (diameter 7.03 mm), biconvex, with ‘L2’ inscribed on one
side and smooth on the other side.
Bisoprololo e Idroclorotiazide Aurobindo 10 mg/6.25 mg film-coated tablets
Film-coated tablets, white, round (diameter 7.02 mm), biconvex, with ‘L3’ inscribed on one
side and smooth on the other side.
The tablets of Bisoprololo e Idroclorotiazide Aurobindo are available in blister packs
PVC/PE/PVdC - aluminium transparent.

Pack sizes:
Blister packs: 30 and 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102

• 21047 – Saronno (VA)

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, 19, Venda Nova, 2700-487 Amadora, Portugal
Arrow Génériques- Lyon
26 avenue Tony Garnier, 69007 – Lyon, France

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
France: Bisoprolol/Hydrochlorothiazide Arrow Lab 2.5 mg/6.25 mg, coated tablet
Bisoprolol/Hydrochlorothiazide Arrow Lab 5 mg/6.25 mg, coated tablet
Bisoprolol/Hydrochlorothiazide Arrow Lab 10 mg/6.25 mg, coated tablet
Italy: Bisoprololo e Idroclorotiazide Aurobindo
Portugal: Bisoprolol + Hidroclorotiazida Generis