BISOPROLOLO 2.5 mg/6.25 mg Film-coated tablets

Зміст інструкції

1. Bisoprololo e Idroclorotiazide Mylan Generics 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 Mylan Generics and what it is used for
   2. What you need to know before taking Bisoprolol and Hydrochlorothiazide Mylan Generics
   3. How to take Bisoprololo and Idroclorotiazide Mylan Generics
   4. Possible side effects
   5. How to store Bisoprololo e Idroclorotiazide Mylan Generics
   6. Package Contents and Other Information

Bisoprololo e Idroclorotiazide Mylan Generics 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

bisoprolol fumarate

hydrochlorothiazide

Generic medicine
Read this leaflet carefully before taking this medicine because 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. What is Bisoprololo and Idroclorotiazide Mylan Generics and what it is 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. This component helps
to reduce blood pressure by increasing the elimination of urine.
The medicine is indicated for the treatment of mild to moderate high blood pressure.

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

Do not take Bisoprolol and Hydrochlorothiazide Mylan Generics:

• 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).
• If you have severe asthma.
• If you have uncontrolled heart failure or cardiogenic shock (a severe heart condition that causes a drop in blood pressure and circulatory failure).
• If you have heart rhythm disorders, in particular a slowed heart rate, conduction disturbances and a condition called sick sinus syndrome.
• If you have very low blood pressure.
• If you have a tumor of the adrenal gland (pheochromocytoma) that is not being treated.
• If you have severe circulatory problems in the limbs (such as Raynaud's syndrome which can cause paleness, bluish discoloration or tingling of the fingers or toes).
• If you have an increase in blood acidity (metabolic acidosis) caused by a serious illness.
• If you have severe kidney or liver problems.
• If you have low levels of potassium in your blood that do not respond to treatment (persistent hypokalemia).

Warnings and precautions
Talk to your doctor or pharmacist before taking Bisoprolol and Hydrochlorothiazide Mylan Generics:

• If you have had breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Bisoprolol and Hydrochlorothiazide Mylan Generics, consult a doctor immediately.
• If you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain 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 Mylan Generics.
• If you suffer from any heart condition, such as heart failure, heart rhythm disorders or Prinzmetal's angina.
• If you have circulatory problems in your fingers or toes, arms or legs (Raynaud's syndrome) or have cramp-like pain in your calves that occurs with exercise or walking. These conditions may worsen, especially at the beginning of treatment.
• If you have a tumor of the adrenal gland (pheochromocytoma) that is being treated. Bisoprolol and Hydrochlorothiazide Mylan Generics must be used in combination only with certain medicines (alpha-blockers).
• If you have asthma or any other chronic respiratory condition that can cause symptoms (bronchospasm). The treatment you are receiving may need to be modified.
• If you have diabetes. Bisoprolol and Hydrochlorothiazide Mylan Generics may mask the symptoms of low blood sugar (hypoglycemia).
• If you have thyroid problems, Bisoprolol and Hydrochlorothiazide Mylan Generics may mask the symptoms of an overactive thyroid.
• If you suffer from or have suffered from recurrent skin disorders that cause scaling, dry skin (psoriasis).
• If you are following a strict diet.
• If you have high levels of uric acid in your blood (hyperuricemia), because Bisoprolol and Hydrochlorothiazide Mylan Generics tends to increase the risk of gout attacks.
• If you are planning to undergo surgery. Heart rate and blood pressure may change when an anesthetic is used together with Bisoprolol and Hydrochlorothiazide Mylan Generics. Tell the anesthesiologist that you are taking Bisoprolol and Hydrochlorothiazide Mylan Generics.
• If you have a reduced blood volume (hypovolemia).
• If you have mild to moderate kidney or liver problems.
• If you suffer from high levels of uric acid in your blood (hyperuricemia), as Bisoprolol and Hydrochlorothiazide Mylan Generics tends to increase the risk of gout attacks.
• If you are elderly.
• If you are receiving treatment for allergic reactions. Bisoprolol and Hydrochlorothiazide Mylan Generics may increase the severity of allergic reactions. In addition, your usual treatment may be less effective.
• If 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 Mylan Generics.
• If you have blurred vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur from a few hours to a few weeks after taking Bisoprolol and Hydrochlorothiazide Mylan Generics.

Treatment should never be stopped suddenly, 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 recommended to combine this medicine with lithium used to treat certain psychiatric disorders, or with medicines used to treat high blood pressure, angina pectoris or cardiac arrhythmia (such as verapamil, diltiazem or bepridil) (see section “Other medicines and Bisoprolol and Hydrochlorothiazide Mylan Generics”).

Further examinations
Bisoprolol and Hydrochlorothiazide Mylan Generics works by affecting the body's salt and fluid 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-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 your blood.

Other medicines and Bisoprolol and Hydrochlorothiazide Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines.
Bisoprolol and Hydrochlorothiazide Mylan Generics 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 disturbances.
• lithium, a medicine used to treat certain types of mental illness.

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

• some medicines used to treat high blood pressure (e.g. clonidine, methyldopa, moxonidine, rimenidine);
• 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, sulfonylurea hypoglycemic agents, glinides);
• medicines that can cause a slowing of the heartbeat (e.g. anticholinergic agents, digitalis glycosides, mefloquine);
• 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 (beta-blockers for topical use);
• 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 (hypokaliemizing agents, e.g. amphotericin, corticosteroids, tetracosactide, stimulant laxatives);
• medicines that are affected by or can affect 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, 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 conditions such as psoriasis and arthritis;
• medicines used to reduce the absorption of hydrochlorothiazide (e.g. cholestyramine, colestipol).

Bisoprolol and Hydrochlorothiazide Mylan Generics with food and drink
Bisoprolol and Hydrochlorothiazide Mylan Generics tablets should be taken in the morning and can be taken
with food. The tablet should be swallowed with liquid and should not be chewed.
It is recommended to maintain an adequate intake of fluids 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 drugs (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 the doctor will advise you to take another
medicine instead of Bisoprolol and Hydrochlorothiazide Mylan Generics, because Bisoprolol and
Hydrochlorothiazide Mylan Generics 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 Mylan Generics is used during pregnancy, your baby should be
monitored for 5 days after delivery.
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Bisoprolol and
Hydrochlorothiazide Mylan Generics is not recommended in breastfeeding mothers. Hydrochlorothiazide can
compromise milk production.
As with other drugs, Bisoprolol and Hydrochlorothiazide Mylan Generics may rarely affect the
ability to have an erection.

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

Driving and operating machinery
Bisoprolol and Hydrochlorothiazide Mylan Generics 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.

Bisoprolol and Hydrochlorothiazide Mylan Generics contains lactose, sodium and macrogol
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.
This medicine contains macrogol which can cause stomach upset and diarrhea.

3. How to take Bisoprololo and Idroclorotiazide Mylan Generics

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

Use in children
The use of Bisoprololo and Idroclorotiazide Mylan Generics is not recommended because there is not sufficient
experience on use in children.

Method and route of administration
For 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 is 1 tablet per day.

Duration of treatment
That with Bisoprololo and Idroclorotiazide Mylan Generics is a long-term treatment. You should not
suddenly stop the treatment because this can cause a worsening of your
conditions. The suspension of treatment must first be discussed with your doctor.

If you take more Bisoprololo and Idroclorotiazide Mylan Generics than you should
If you take more Bisoprololo and Idroclorotiazide Mylan Generics than you should, contact a
doctor or the Emergency Room immediately. Take with you the container and the remaining tablets. The most common signs of
overdose are feeling lightheaded, feeling faint, nausea, vomiting, drowsiness and
slow or irregular heartbeat.

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

If you stop taking Bisoprololo and Idroclorotiazide Mylan Generics
Do not stop taking Bisoprololo and Idroclorotiazide Mylan Generics unless your
doctor tells you to. Your condition may worsen significantly if you stop treatment. If you need to
stop treatment, your doctor will generally tell you to reduce the dose gradually.
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 gets them.
If you notice any of the following serious side effects, stop taking this medicine and
contact your doctor immediately:
Uncommon (may affect up to 1 in 100 people):

• slowed heartbeat (bradycardia).

Rare (may affect up to 1 in 1,000):

• reduction in the number of white blood cells in the blood (leukopenia, agranulocytosis), which increases the risk of infections, causing fever, severe chills, sore throat or mouth ulcers;
• reduction in the number of platelets in the blood (thrombocytopenia), which causes bruising or unexpected bleeding for a longer period than normal;
• inflammation of the liver (hepatitis), with symptoms including yellowing of the skin and whites of the eyes, abdominal pain, pale stools, dark urine. Very rare (may affect up to 1 in 10,000):
• Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).
• a severe allergic reaction (anaphylactic) that can cause difficulty breathing or swallowing;
• severe skin reactions with blisters and widespread peeling (toxic epidermal necrolysis) or the appearance of scaly red patches (cutaneous lupus erythematosus);
• inflammation of the pancreas (pancreatitis) with symptoms including severe pain in the upper part of the stomach, often with a feeling of unwellness (nausea) and vomiting.

Not known (frequency cannot be estimated from available data):

• 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 cancer).

Other possible side effects:
Common (may affect up to 1 in 10 patients):

• cold or numb hands and feet;
• feeling tired (fatigue), dizziness, headache. These symptoms appear especially at the beginning of treatment. They are usually mild and usually disappear within 1 or 2 weeks of starting treatment;
• nausea, vomiting, diarrhea, constipation.

Uncommon (may affect up to 1 in 100 patients):

• muscle weakness, muscle cramps;
• feeling unusually tired;
• irregular heartbeat (atrioventricular conduction disturbances), worsening of heart failure;
• dizziness or feeling faint when standing up;
• sleep disorders, depression;
• loss of appetite;
• abdominal discomfort;
• breathing problems (difficulty breathing, wheezing, coughing), in people who suffer from asthma or have a history of obstructive airway disease;
• increased levels of creatinine, urea or uric acid in the blood;
• increased amylase in the blood;
• increased levels of fats (triglycerides and cholesterol) or sugars (glucose) in the blood;
• increases in glucose levels in the urine;
• abnormal levels of fluids and electrolytes in the body that can be detected by a blood test.

Rare (may affect up to 1 in 1,000):

• nightmares, hallucinations;
• other allergic reactions, such as itching, sudden redness of the face or skin rash, swelling of the face, lips, tongue or throat, skin sensitization to the sun (photodermatitis), hives, red spots on the skin due to bleeding under the skin (purpura);
• increased levels of liver enzymes in the blood, yellowing of the skin and/or whites of the eyes (jaundice);
• erectile dysfunction;
• hearing problems;
• fainting;
• runny nose;
• reduced tear production (may be a problem if you use contact lenses);
• vision disorders.

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

• eye irritation and redness (conjunctivitis);
• hair loss (alopecia);
• appearance or worsening of red, itchy and scaly patches (psoriasis);
• chest pain;
• loss of acids in the blood (metabolic alkalosis).

If any of these side effects occur, see your doctor or pharmacist. This

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://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 Mylan Generics

Keep this medicine out of the sight and reach of children .
Do not use this medicine after the expiry date which is stated on the packaging after the wording
“Scad.”. The expiry date refers to the last day of that month.

Storage conditions
This medicine does not require any special storage conditions.
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. Package Contents and Other Information

What Bisoprololo and Idroclorotiazide Mylan Generics 2.5 mg/6.25 mg film-coated tablets contain
The active ingredients are bisoprolol fumarate and hydrochlorothiazide.
The other ingredients are:

Tablet core
Microcrystalline cellulose (E460), Lactose, Pregelatinized maize starch, Anhydrous colloidal silica
(E551), Magnesium stearate, Sodium lauryl sulfate, Sodium croscarmellose (E468), yellow iron oxide (E172).
See section 2 “Bisoprololo e Idroclorotiazide Mylan Generics contains lactose, sodium and
macrogol”.

Film coating
Titanium dioxide (E171), Polydextrose FCC (E1200), Hypromellose (E464), Macrogol, yellow iron oxide
(E172).

What Bisoprololo and Idroclorotiazide Mylan Generics 5 mg/6.25 mg film-coated tablets contain
The active ingredients are bisoprolol fumarate and hydrochlorothiazide.
The other ingredients are:

Tablet core
Microcrystalline cellulose (E460), Lactose, Pregelatinized maize starch, Anhydrous colloidal silica
(E551), Magnesium stearate, Sodium lauryl sulfate, Sodium croscarmellose (E468), yellow iron oxide (E172).
See section 2 “Bisoprololo e Idroclorotiazide Mylan Generics contains lactose, sodium and
macrogol”.

Film coating
Titanium dioxide (E171), Polydextrose FCC (E1200), Hypromellose (E464), Macrogol, yellow iron oxide
(E172), red iron oxide (E172).

What Bisoprololo and Idroclorotiazide Mylan Generics 10 mg/6.25 mg film-coated tablets contain
The active ingredients are bisoprolol fumarate and hydrochlorothiazide.
The other ingredients are:

Tablet core
Microcrystalline cellulose (E460), Lactose, Pregelatinized maize starch, Anhydrous colloidal silica
(E551), Magnesium stearate, Sodium lauryl sulfate, Sodium croscarmellose (E468). See section 2
“Bisoprololo e Idroclorotiazide Mylan Generics contains lactose, sodium and macrogol”.

Film coating
Titanium dioxide (E171), Polydextrose FCC (E1200), Hypromellose (E464), Macrogol.

Description of the appearance of Bisoprololo and Idroclorotiazide Mylan Generics and package contents
Bisoprololo and Idroclorotiazide Mylan Generics 2.5 mg/6.25 mg film-coated tablets
Film-coated tablets, yellow, round, biconvex, with “BH1” engraved on one side and “M” on the other
side of the tablet.

Bisoprololo and Idroclorotiazide Mylan Generics 5 mg/6.25 mg film-coated tablets
Film-coated tablets, light pink, round, biconvex, with “BH2” engraved on one side and “M”
on the other side of the tablet.

Bisoprololo and Idroclorotiazide Mylan Generics 10 mg/6.25 mg film-coated tablets
Film-coated tablets, white, round, biconvex, with “BH3” engraved on one side and “M”
on the other side of the tablet.
Bisoprololo and Idroclorotiazide Mylan Generics is packaged in cartons containing blister packs with 30
film-coated tablets.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano

Responsible Manufacturer for Batch Release
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Hungary Kft.
H-2900
Komárom, Mylan utca 1
Hungary

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: