Prospect: information for the patient

Bisoprolol/Hydrochlorothiazide Aurovitas 10 mg/25 mg film-coated tablets EFG

bisoprolol fumarate/hydrochlorothiazide

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1. What isBisoprolol/Hydrochlorothiazide Aurovitasand for what it is used

2. What you need to know before starting to takeBisoprolol/Hydrochlorothiazide Aurovitas

3. How to takeBisoprolol/Hydrochlorothiazide Aurovitas

4. Possible adverse effects

5. Storage ofBisoprolol/Hydrochlorothiazide Aurovitas

6. Contents of the package and additional information

Bisoprolol/Hidroclorotiazida Aurovitascontains the active ingredients bisoprolol fumarate and hydrochlorothiazide.

Bisoprolol belongs to a group of medications called beta blockers that are used to lower blood pressure.

Hydrochlorothiazide belongs to a group of medications called thiazide diuretics. This medication helps lower blood pressure by facilitating the elimination of urine.

This combination is used for the treatment of essential hypertension (high blood pressure), in patients whose blood pressure is not adequately controlled with bisoprolol or hydrochlorothiazide separately.

Do not takeBisoprolol/HidroclorotiazidaAurovitas:

-if you are allergic to bisoprolol, hidroclorotiazida, other thiazides, sulfonamides (medicines chemically related to hidroclorotiazida) or to any of the other components of this medicine, listed in section 6,

-if you have acute heart muscle weakness (acute heart failure) or if your heart muscle weakness is not under control (decompensated heart failure),

-if you have shock due to a heart attack (cardiogenic shock),

-if you have significant heart rhythm disturbances (second and third-degree AV block, sick sinus syndrome, sinoatrial block without pacemaker),

-if your heart rate is very slow (less than 60 beats per minute) before starting treatment,

-if you have severe asthma or any other chronic respiratory problem

-if you have severe circulatory disorders affecting the extremities (such as Raynaud's syndrome that could cause paleness, blue discoloration or tingling in the fingers and toes),

-if you have untreated phaeochromocytoma (rare adrenal gland tumor),

-if you have metabolic acidosis (an increase in blood acid concentration) due to a serious disease,

-if you have severe kidney function disorder (renal insufficiency) with little or no urine production or liver,

-if you have acute kidney inflammation (glomerulonephritis),

-if you have low potassium levels in the blood that do not respond to treatment,

-if you are breastfeeding,

-if you have hyponatremia (low sodium levels),

-if you have hypercalcemia (elevated calcium levels in the blood),

-if you have gout,

-if you are taking floctafenina used for pain and inflammation (seeother medicines and Bisoprolol/Hidroclorotiazida Aurovitas).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

•if you have heart failure. Your doctor may adjust your bisoprolol dose before starting bisoprolol/hidroclorotiazida,

•if you are planning to undergo surgery. Heart rate and blood pressure may change when anesthetics are taken with bisoprolol/hidroclorotiazida. Inform the anesthetist that you are taking this medicine,

•if you have asthma or any other chronic respiratory disorder that may cause breathing difficulties or tracheal hardening (bronchospasm). In these cases, your doctor may increase your existing respiratory treatment dose or add some more medicines for respiratory problems,

•if you have diabetes, this medicine may mask the symptoms caused by low blood sugar (hypoglycemia), increased heart rate,

•if you are fasting or engaging in physically demanding activities,

•if you have adrenal gland tumor (pheochromocytoma) and are under treatment: this medicine should only be used in combination with certain medicines (alpha-blockers),

•if you are under treatment for allergic reactions. Bisoprolol/hidroclorotiazida may increase the severity of your allergic reactions and also may reduce the effectiveness of your treatment,

•if you have thyroid disorders (bisoprolol may mask thyroid hyperactivity symptoms),

•if you have heart conduction disorders (first-degree AV block),

•if you experience chest pressure or pain at rest (Prinzmetal's angina). This medicine may increase the number and duration of these attacks,

•if you have or have had recurrent skin disorders with dry, scaly skin rash (psoriasis),

•if you have circulatory disorders in the fingers of hands and feet, arms and legs or calf cramps with pain caused by exercise or walking. These episodes may worsen, especially at the beginning of treatment,

•if you have low blood volume (hypovolemia),

•if you have mild or moderate liver and kidney function disorders,

•if you have high uric acid levels in the blood (hyperuricemia), as this medicine may increase the risk of gout attacks,

•if you are elderly,

•if you plan to expose yourself to the sun or artificial ultraviolet light, some patients have presented a skin rash after sun exposure. In that case, you must protect your skin during treatment with this medicine,

•do not stop treatment suddenly, especially if you have certain heart diseases (e.g. angina). If you need to interrupt treatment, your doctor will gradually reduce the dose over a few days,

•if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe breathing difficulties or difficulty breathing after taking bisoprolol/hidroclorotiazida, see your doctor immediately,

•if you wear contact lenses, bisoprolol/hidroclorotiazida may reduce tear production, which may cause irritation,

•this medicine affects the body's electrolyte balance. Your doctor will monitor you regularly. These tests are particularly important if you have other diseases that may worsen if the electrolyte balance is altered. Your doctor may occasionally check blood concentrations of lipids, potassium, sodium, calcium, uric acid, urea or glucose,

•if you have had skin cancer or if a skin lesion appears unexpectedly during treatment. Treatment with hidroclorotiazida, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking this medicine,

•this medicine may cause eye disorders that may start with vision loss or eye pain, such as transient myopia or acute angle-closure glaucoma,

• cases of acute gallbladder inflammation (cholecystitis) have been reported in patients with gallstones,
• if you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the eye's vascular layer (choroidal effusion) or increased eye pressure and may occur within a few hours to weeks after taking bisoprolol/hidroclorotiazida. This may lead to permanent vision loss if not treated. If you are allergic to penicillin or sulfonamides, you may have a higher risk of developing this.

While taking bisoprolol/hidroclorotiazida, make sure to drink enough fluids and eat foods rich in potassium (e.g. bananas, vegetables, nuts) to compensate for the increased potassium loss.

Low potassium levels may cause heart rhythm problems, sometimes fatal.

The benefits of diuretics (hidroclorotiazida) for the treatment of high blood pressure are only obtained when the kidneys function correctly. There may be a decrease in kidney function in patients with pre-existing kidney problems.

Other medicines andBisoprolol/Hidroclorotiazida Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

Do not take Bisoprolol/Hidroclorotiazida Aurovitas with:

-floctafenina, used for pain and inflammation,

-sultoprida, used for schizophrenia.

Be careful if you are taking bisoprolol/hidroclorotiazida with any of the following medicines:

• some medicines used to treat high blood pressure, angina or heart arrhythmia (e.g. verapamilo, diltiazem, bepridil, amlodipino, felodipino) that may increase the risk of heart rhythm disorders or low blood pressure.
• medicines for treating high blood pressure (such as clonidina, moxonodina, amlodipino, metildopa, reserpina, rilmenidina and ACE inhibitors).
• other medicines for treating high blood pressure or that may reduce blood pressure (such as barbiturates or phenothiazines).
• litio, used to treat psychiatric diseases.
• antiarrhythmic medicines (quinidina, disopiramida, amiodarona, sotalol).
• digitalis glycosides, used to control heart rate.
• anti-inflammatory medicines, used to treat pain, swelling or redness.
• topical beta-blockers (e.g. eye drops for glaucoma).
• insulin or oral treatments for diabetes.
• if you are to undergo surgery that requires anesthetics, inform your doctor that you are taking bisoprolol/hidroclorotiazida.
• tricyclic antidepressants, used to treat depression.
• rifampicina, an antibiotic: it shortens the effect of bisoprolol slightly in duration. Usually, no dose adjustment is needed.
• medicines that affect the Nervous System, e.g. epinephrine, norepinephrine (sympathomimetics).
• medicines that reduce uric acid levels in the blood.
• medicines that affect or may be affected by potassium levels in the blood, such as digoxina, a medicine for controlling heart rate, some antipsychotics.
• glucocorticoids, carbenoxolona, amphotericin, furosemida, laxatives. These medicines may cause potassium deficiency.
• colestiramina, colestipol, these medicines may reduce the effect of this medicine.
• metildopa, this medicine may cause blood problems.
• mefloquina, used to prevent malaria: it increases the risk of low heart rate.
• antidepressants (monoamine oxidase inhibitors) may affect blood pressure control.

If you are allergic to penicillin or sulfonamides, the risk of developing an allergy to this medicine is higher. Your doctor will inform you if you should stop or change treatment.

Use in athletes

This medicine contains hidroclorotiazida that may give a positive result in anti-doping tests.

TakingBisoprolol/Hidroclorotiazida Aurovitaswith food and drinks

Bisoprolol/Hidroclorotiazida Aurovitas tablets should be taken in the morning and may be taken with food. They should be swallowed with enough liquid and not chewed.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medicine.

Normally, your doctor will advise you to take another medicine instead of Bisoprolol/Hidroclorotiazida Aurovitas, as this medicine is not recommended during pregnancy. This is because it crosses the placenta and its use may cause harmful effects on your baby.

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Bisoprolol/hidroclorotiazida should not be used in mothers who are breastfeeding. Hidroclorotiazida may affect milk production.

Like other medicines, this medicine may occasionally affect your ability to obtain and maintain an erection.

Driving and operating machines

This medicineusually has no effect on your ability to drive or operate machines. However, it may affect your concentration or reaction time. In that case, do not drive or operate machines.

Dose

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one 5 mg/12.5 mg bisoprolol/hydrochlorothiazide tablet once a day. If the effect is not sufficient, your doctor may decide to increase the dose to one 10 mg/25 mg tablet (or two 5 mg/12.5 mg tablets) once a day.

Use in children

The use of Bisoprolol/Hydrochlorothiazide Aurovitas is not recommended in children, due to insufficient clinical experience with the use of this medication in children.

Use in elderly patients

No dose adjustment is necessary. It is recommended to start treatment with the lowest possible dose.

Renal insufficiency

In patients with mild or moderate renal insufficiency, the doctor may indicate the use of a lower dose. Bisoprolol/hydrochlorothiazide tablets should not be taken if the patient has severe renal insufficiency (see section 2).

Administration form

Bisoprolol/hydrochlorothiazidemust be taken orally, in the morning, with or without food. The tablets should be swallowed with some liquid and not chewed.

Administration frequency

The tablet/tablets should be taken once a day.

Treatment duration

The treatment duration is not limited and will depend on the severity of the disease. The treatment duration will be determined by your doctor. Do not stop taking the treatment without consulting your doctor first.

If you take moreBisoprolol/Hydrochlorothiazide Aurovitas than you should

If you take more Bisoprolol/Hydrochlorothiazide Aurovitas than you should, you should contact your doctor or go to the emergency service immediately. Bring the packaging and remaining tablets with you. The most common signs of an overdose are dizziness, feeling of fainting, discomfort, drowsiness, and slow/irregular heart rate.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication prospect to the healthcare professional.

If you forgot to takeBisoprolol/Hydrochlorothiazide Aurovitas

Do not take a double dose to compensate for the missed doses. You should take the next dose at the usual time. If you have forgotten several doses, consult your doctor.

If you interrupt the treatment with Bisoprolol/Hydrochlorothiazide Aurovitas

Do not interrupt or stop your treatment with bisoprolol/hydrochlorothiazide without consulting your doctor first.

If you interrupt your treatment, you should do it gradually, as abrupt interruption of treatment may lead to acute deterioration of the disease.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Frequent: can affect more than 1 in 10 people

•abnormal levels of body fluids and electrolytes (increased triglycerides, increased cholesterol, hypokalemia, hypomagnesemia, hyponatremia, hypochloremia, hypercalcemia),

•dizziness*,headaches*,

•feeling of coldness or numbness in hands and feet,

•nausea, vomiting, diarrhea, or constipation,

•glucose in urine,

•feeling of fatigue or weakness.*

Not frequent: can affect up to 1 in 100 people

•loss of appetite,

•sleep disorders, depression,

•slow heart rate, abnormal heart rhythm, worsening of heart failure,

•dizziness or lightheadedness when standing up,

•difficulty breathing in people with asthma or respiratory diseases,

•abdominal pain, pancreatitis inflammation,

•increase in amylases (enzymes involved in digestion),

•muscle weakness and cramps,

•increase in creatinine and urea levels in the blood,

•loss of physical strength.

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

•decrease in the number of white blood cells (leukopenia) or platelets (thrombocytopenia) in the blood,

•nightmares, hallucinations,

•syncope,

•decrease in tear flow (may have problems if using contact lenses),

•visual disturbances,

•hearing problems,

•rhinorrhea,

•increase in certain liver enzymes in blood tests, hepatitis inflammation, jaundice (yellowing of the skin and eyes),

•allergic reactions such as itching, facial redness, or skin rash, skin sensitivity to the sun, urticaria, red spots on the skin due to small subcutaneous bleeding (purpura),

•erectile dysfunction,

•should consult a doctor immediately if experiencing more severe allergic reactions, which may include swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing.

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

•severe decrease in white blood cells (agranulocytosis),

•increase in blood alkalinity (metabolic alkalosis),

•inflammation of the eye or eyelid (conjunctivitis),

•hair loss,

•appearance or worsening of pre-existing skin rash (psoriasis),

•appearance of hard skin crusts (cutaneous lupus erythematosus),

•chest pain,

•acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Frequency unknown: cannot be estimated from available data

•skin and lip cancer (non-melanoma skin cancer),

•interstitial lung disease,

• abrupt decrease in distant vision (acute myopia), decrease in vision or eye pain due to increased intraocular pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).

* These symptoms usually appear at the beginning of treatment.Generally, they are mild and usually disappear within 1 or 2 weeks.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Keep in the original packaging to protect it from light.

Store below 30°C.

Do not use this medication after the expiration date that appears on the carton and blister packaging, after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofBisoprolol/Hidroclorotiazida Aurovitas

Bisoprolol/Hidroclorotiazida Aurovitas 10mg/25mg film-coated tablets EFG:

Each film-coated tablet contains 10 mg of bisoprolol fumarate and 25 mg of hydrochlorothiazide.

The other components are:

Core tablet:calcium hydrogen phosphate, microcrystalline cellulose (Grade-112), crospovidone (Type-A), anhydrous colloidal silica, and magnesium stearate.

Tablet coating:hypromellose 2910 (6 cPs), titanium dioxide (E171), macrogol 400, yellow iron oxide, polysorbate 80, and red iron oxide.

Appearance of the product and contents of the package

Bisoprolol/Hidroclorotiazida Aurovitas 10mg/25mg film-coated tablets EFG:

Film-coated tablets of pink color, round (diameter 9.07 mm), biconvex, engraved with ‘L and 6’ separated by a groove and smooth on the other side.

Bisoprolol/Hidroclorotiazida Aurovitasfilm-coated tablets EFG are available in PVC/PE/PVdC - Aluminum blister packs.

Package sizes:

Blister:28, 30, 50, 56, 98, and 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid,

Spain

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Bisoprolol-comp PUREN 10 mg/25 mg Filmtabletten

Spain:Bisoprolol/Hidroclorotiazida Aurovitas 10 mg/25 mg film-coated tablets EFG

Portugal:Bisoprolol + Hidroclorotiazida Generis

Last review date of this leaflet:January 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).