Bisoprolol and hydrochlorothiazide Aurobindo: detailed information

Patient Information Leaflet: Information for the User

Bisoprolol and Hydrochlorothiazide 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
Please read all of 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist (see section 4).

Contents of this leaflet

What Bisoprolol and Hydrochlorothiazide Aurobindo is and what it is used for
What you need to know before taking Bisoprolol and Hydrochlorothiazide Aurobindo
How to take Bisoprolol and Hydrochlorothiazide Aurobindo
Possible side effects
How to store Bisoprolol and Hydrochlorothiazide Aurobindo
Package contents and other information

1. What Bisoprolol and Hydrochlorothiazide Aurobindo is and what it is used for

The active substances are bisoprolol and hydrochlorothiazide.
Bisoprolol belongs to a family of medicines called beta-blockers and is used to reduce blood pressure.
Hydrochlorothiazide belongs to a family of medicines known as thiazide diuretics (also known as "fluid tablets"). This medicine helps lower blood pressure by increasing urine elimination.
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 chemically related to hydrochlorothiazide) or to any of the other ingredients of this medicine (listed in section 6);
you suffer from severe asthma or any other breathing problems such as chronic respiratory disorders;
you have untreated heart failure or cardiogenic shock (a serious heart condition causing a drop in blood pressure and circulatory failure);
you have heart rhythm disorders, particularly a slow heart rate, conduction disorders, or a condition known as sick sinus syndrome;
you have very low blood pressure;
you have an untreated tumour of the adrenal gland (pheochromocytoma);
you suffer from severe circulatory problems in the limbs (such as Raynaud's syndrome, which may cause paleness, bluish discoloration, or tingling in the fingers or toes);
you have increased levels of acid in the blood (metabolic acidosis) due to a serious illness;
you have severe kidney or liver problems;
you have low potassium levels in the blood that do not respond to treatment (persistent hypokalaemia).

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

you suffer from any heart disease, such as heart failure, heart rhythm disorders, or Prinzmetal's angina;
you have circulatory problems in the fingers or toes, arms or legs (Raynaud's syndrome), or experience cramp-like pain in the calves during exercise or walking. These conditions may worsen, especially at the beginning of treatment;
you have a tumour of the adrenal gland (pheochromocytoma) that is under treatment. Bisoprolol and Hydrochlorothiazide Aurobindo should only be used in combination with certain medicines (alpha-blockers);
you suffer from asthma or any other chronic respiratory disorder that may cause symptoms (bronchospasm). Your treatment may need to be adjusted;
you have diabetes; Bisoprolol and Hydrochlorothiazide Aurobindo may mask the symptoms of low blood sugar (hypoglycaemia);
you have a thyroid disorder; Bisoprolol and Hydrochlorothiazide Aurobindo may mask the symptoms of an overactive thyroid;
you have (or have had) recurrent skin disorders causing peeling or dryness of the skin (psoriasis);
you are on a strict diet;
you are scheduled for surgery. When anaesthetics are used together with Bisoprolol and Hydrochlorothiazide Aurobindo, heart rate and blood pressure may change. Inform your anaesthetist that you are taking Bisoprolol and Hydrochlorothiazide Aurobindo;
you have reduced blood volume (hypovolaemia);
you have mild to moderate kidney or liver problems;
you have high levels of uric acid in the blood (hyperuricaemia), as Bisoprolol and Hydrochlorothiazide Aurobindo may 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. Furthermore, your usual treatment may be less effective;
you plan to be exposed to sunlight or artificial UV radiation, as some patients have developed skin rashes after sun exposure. In this case, protect your skin during treatment with Bisoprolol and Hydrochlorothiazide Aurobindo;
you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Bisoprolol and Hydrochlorothiazide Aurobindo;
you experience vision disturbances or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to several weeks after taking Bisoprolol and Hydrochlorothiazide Aurobindo. This condition may lead to permanent vision loss if not treated. The risk may be higher if you are allergic to penicillin or sulfonamide drugs;
you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If, after taking

Bisoprolol and Hydrochlorothiazide Aurobindo, you develop severe shortness of breath or difficulty breathing,
contact a doctor immediately.
Do not stop treatment suddenly, especially if you have certain heart conditions (e.g. angina). If you need to stop treatment, your doctor will gradually reduce the dose over several days.
It is not advisable to combine this medicine with lithium, used in the treatment of certain psychiatric disorders, or with medicines used for treating hypertension, angina pectoris, or cardiac arrhythmia (such as verapamil, diltiazem or bepridil) (see section “Other medicines and Bisoprolol and Hydrochlorothiazide Aurobindo”).
Inform your doctor immediately if you have chronic lung disease or mild asthma and develop new breathing difficulties, cough, or shortness of breath after exercise while using Bisoprolol and Hydrochlorothiazide Aurobindo.

Additional tests

Bisoprolol and Hydrochlorothiazide Aurobindo affects the body's fluid and electrolyte balance. Your doctor will monitor you regularly. These tests are particularly important if you have other conditions that could worsen if fluid and electrolyte balance is disturbed. Your doctor may also occasionally check blood levels of lipids, potassium, sodium, calcium, urea, uric acid, or glucose.

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 may be taken with the following medicines only if prescribed by your doctor, as they are generally not recommended:

certain 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 certain psychiatric disorders.

Inform your doctor or pharmacist if you are taking any of the following medicines. Use with Bisoprolol and Hydrochlorothiazide Aurobindo should be done with caution:

certain 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 a local anaesthetic during minor surgical procedures and to treat heart rhythm abnormalities;
medicines that mimic the action of certain nerves, such as pilocarpine or carbachol (parasympathomimetics);
diabetes medicines such as insulin, glinides, and sulfonylureas (e.g. glibenclamide, gliquidone, gliclazide, glipizide, glimepiride or tolbutamide). Bisoprolol may increase the risk of severe lowering of blood glucose levels when used with these medicines;
medicines that may slow the heart rate (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 for glaucoma (topical beta-blockers);
medicines for pain and inflammation (e.g. NSAIDs, acetylsalicylic acid);
medicines used to treat high blood pressure by increasing urine production (potassium-sparing diuretics);
medicines that reduce potassium levels in the blood, which may cause excessive potassium loss (hypokalaemic agents, e.g. amphotericin, corticosteroids, tetracosactide, stimulant laxatives);
medicines that affect or may be affected by blood potassium levels, such as digoxin (a medicine for controlling heart rhythm), certain antipsychotic medicines;
carbamazepine, used to treat epilepsy and certain mood disorders;
medicines used in hospitals to visualise blood vessels (iodinated contrast media);
medicines used to treat gout by reducing uric acid levels in the blood;
calcium salts, which may increase blood calcium levels to dangerous levels;
cyclosporine, used after organ transplants and to treat conditions such as psoriasis and arthritis;
medicines that reduce the absorption of hydrochlorothiazide (e.g. cholestyramine, colestipol).

Bisoprolol and Hydrochlorothiazide Aurobindo with food and drinks
Bisoprolol and Hydrochlorothiazide Aurobindo film-coated tablets should be taken in the morning with food. The tablet should be swallowed with liquid and not chewed.
It is recommended to maintain adequate fluid intake and consume more foods rich in potassium during treatment with this medicine, to help prevent potential potassium deficiency, such as bananas, vegetables, and nuts. Potassium loss may also be reduced or prevented with potassium-sparing diuretics. Discuss with your doctor if you are concerned.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will usually advise you to take another medicine instead of Bisoprolol and Hydrochlorothiazide Aurobindo, as it is not recommended during pregnancy. This is because both hydrochlorothiazide and bisoprolol cross the placenta, and their use during pregnancy may be harmful to your baby. If Bisoprolol and Hydrochlorothiazide Aurobindo is used during pregnancy, your baby should be monitored for 5 days after birth.
Inform your doctor if you are breastfeeding or planning to breastfeed. Bisoprolol and Hydrochlorothiazide Aurobindo is not recommended for breastfeeding mothers. Hydrochlorothiazide may reduce milk production.
As with other medicines, Bisoprolol and Hydrochlorothiazide Aurobindo may rarely affect the ability to achieve an erection.

Sports
Athletes should be aware that this medicine contains a substance that may lead to a positive result in doping tests.

Driving and using machines
Bisoprolol and Hydrochlorothiazide Aurobindo generally does not affect the ability to drive or operate machinery. However, your individual response to the medicine may affect your concentration or reaction time. In such cases, you should not drive or operate machinery.

3. How to take Bisoprolol and Hydrochlorothiazide Aurobindo

Dosage
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is one 2.5 mg/6.25 mg tablet of Bisoprolol and Hydrochlorothiazide Aurobindo daily.
If blood pressure reduction is insufficient at this dose, it may be increased to one 5 mg/6.25 mg tablet of Bisoprolol and Hydrochlorothiazide Aurobindo daily.
If the response is still inadequate, the dose may be increased to one 10 mg/6.25 mg tablet of Bisoprolol and Hydrochlorothiazide Aurobindo daily.

Use in children
Bisoprolol and Hydrochlorothiazide Aurobindo is not recommended for use in children, as there is insufficient experience with this medicine in the pediatric population.

Method and route of administration
For oral use.
Take the tablets in the morning, with or without food. The tablets should be swallowed with liquid and must not be chewed.

Frequency of administration
The usual dosage frequency is one tablet daily.

Duration of treatment
Treatment with Bisoprolol and Hydrochlorothiazide Aurobindo is intended for long-term use. Do not stop treatment suddenly, as this may worsen your condition. Discontinuation of treatment should always be discussed with your doctor beforehand.

If you take more Bisoprolol and Hydrochlorothiazide Aurobindo than you should
If you take more Bisoprolol and Hydrochlorothiazide Aurobindo than prescribed, contact a doctor or the Emergency Department immediately. Bring the package and any remaining tablets with you. The most common signs of overdose include mental confusion, feeling faint, malaise, drowsiness, and slow or irregular heartbeat.

If you forget to take Bisoprolol and Hydrochlorothiazide Aurobindo
Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time. If you have missed several doses, contact your doctor.

If you stop taking Bisoprolol and Hydrochlorothiazide Aurobindo
Do not stop taking this medicine unless instructed by your doctor. Your condition may worsen significantly if you discontinue treatment abruptly. If discontinuation is necessary, your doctor will usually advise you to gradually reduce the dose.

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 everybody gets them.
Common: may affect up to 1 in 10 people

sensation of coldness or numbness in hands and feet;
tiredness, dizziness, headache. These symptoms occur mainly at the beginning of treatment. Effects are generally mild and usually disappear within 1 or 2 weeks after starting treatment;
nausea, vomiting, diarrhoea or constipation.

Uncommon: may affect up to 1 in 100 people

muscle weakness and muscle cramps;
feeling tired or weak;
slow heartbeat, abnormal heart rhythm, worsening of heart failure;
dizziness or vertigo when standing up;
sleep disorders, depression;
loss of appetite and weight loss (anorexia);
breathing problems in patients with asthma or chronic bronchopulmonary disease;
increased levels of creatinine or urea in the blood;
abdominal discomfort;
increased amylase levels (enzymes involved in digestion);
increased levels of lipids, cholesterol, uric acid or glucose in the blood; increased glucose levels in urine;
abnormal levels of body fluids and electrolytes (hypokalaemia, hypomagnesaemia, hyponatraemia, hypochloraemia, hypercalcaemia).

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

nightmares, hallucinations;
allergic reactions such as irritation, sudden redness of the face or skin rash, increased skin sensitivity to sunlight, urticaria, red spots on the skin due to subcutaneous bleeding (purpura);
increased levels of certain liver enzymes, liver inflammation, yellowing of the skin or eyes (jaundice);
erectile dysfunction;
hearing disturbances;
fainting;
runny nose;
reduced tear flow (may be a problem if wearing contact lenses);
visual disturbances;
decrease in the number of white blood cells (leucopenia) or platelets (thrombocytopenia) in the blood. You should contact your doctor immediately if you experience more severe allergic reactions, which may include swelling of the face, neck, tongue, mouth or throat, or breathing difficulties.

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

eye irritation and redness (conjunctivitis), hair loss;
onset or worsening of pre-existing scaly skin eruptions (psoriasis); appearance of thick scaly patches (cutaneous lupus erythematosus);
chest pain;
severe reduction in white blood cells (agranulocytosis);
inflammation of the pancreas;
severe loss of acids from the blood (metabolic alkalosis);
allergic (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 from the available data

sudden-onset reduction in distance vision (acute myopia), decreased vision or eye pain due to increased 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 sudden worsening of breathing difficulties, which could be signs of a lung disorder (interstitial lung disease);
skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 Bisoprolol and Hydrochlorothiazide Aurobindo

Keep this medicine out of the sight and reach of children.
Store the blisters in the carton to protect the medicine from light.
Store below 30 °C.
Do not use this medicine after the expiry date stated on the packaging. 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 no longer required. 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 components 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 package contents
Film-coated tablets.
Bisoprololo e Idroclorotiazide Aurobindo 2.5 mg/6.25 mg film-coated tablets
Film-coated, yellow, round tablets (diameter 5.21 mm), biconvex, engraved with 'L1' on one side and smooth on the other.
Bisoprololo e Idroclorotiazide Aurobindo 5 mg/6.25 mg film-coated tablets
Film-coated, pink, round tablets (diameter 7.03 mm), biconvex, engraved with 'L2' on one side and smooth on the other.
Bisoprololo e Idroclorotiazide Aurobindo 10 mg/6.25 mg film-coated tablets
Film-coated, white, round tablets (diameter 7.02 mm), biconvex, engraved with 'L3' on one side and smooth on the other.

Bisoprololo e Idroclorotiazide Aurobindo tablets are available in PVC/PE/PVdC - transparent aluminum blister packs.
Pack sizes:
Blister packs: 30 and 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
France: Bisoprolol/Hydrochlorothiazide Arrow Lab 2.5 mg/6.25 mg, film-coated tablet
Bisoprolol/Hydrochlorothiazide Arrow Lab 5 mg/6.25 mg, film-coated tablet
Bisoprolol/Hydrochlorothiazide Arrow Lab 10 mg/6.25 mg, film-coated tablet
Italy: Bisoprololo e Idroclorotiazide Aurobindo
Portugal: Bisoprolol + Hidroclorotiazida Generis