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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

bisoprolol fumarate/hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again. If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Bisoprolol/Hydrochlorothiazide Aurovitas is and what it is used for
2. What you need to know before taking Bisoprolol/Hydrochlorothiazide Aurovitas
3. How to take Bisoprolol/Hydrochlorothiazide Aurovitas
4. Possible side effects
5. How to store Bisoprolol/Hydrochlorothiazide Aurovitas
6. Contents of the pack and other information

1. What Bisoprolol/Hydrochlorothiazide Aurovitas is and what it is used for

Bisoprolol/Hydrochlorothiazide Aurovitas contains the active substances bisoprolol fumarate and hydrochlorothiazide.

Bisoprolol belongs to a group of medicines called beta-blockers, which are used to lower arterial blood pressure.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. This medicine helps lower blood pressure by increasing urine elimination.

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

2. What you need to know before taking Bisoprolol/Hydrochlorothiazide Aurovitas

Do not take Bisoprolol/Hydrochlorothiazide Aurovitas:

• if you are allergic to bisoprolol, hydrochlorothiazide, other thiazides, sulfonamides (medicines chemically related to hydrochlorothiazide), or any of the other ingredients of this medicine, listed in section 6,
• if you have acute weakness of the heart muscle (acute heart failure) or if your heart muscle weakness is not under control (decompensated heart failure),
• if you are suffering from shock due to a heart attack (cardiogenic shock),
• if you have significant heart rhythm disorders (second- or third-degree AV block, sick sinus syndrome, sinoatrial block without a pacemaker),
• if your heart rate is very slow (less than 60 beats per minute) before starting treatment,
• if you have severe forms of asthma or any other chronic respiratory disorder,
• if you have severe circulatory disorders affecting the limbs (such as Raynaud's syndrome, which may cause paleness, bluish discoloration, or tingling in the fingers and toes),
• if you have untreated pheochromocytoma (a rare adrenal gland tumor),
• if you have metabolic acidosis (increased blood acidity) due to a serious illness,
• if you have severe kidney (renal failure) or liver dysfunction, especially with little or no urine production,
• if you have acute inflammation of the kidney (glomerulonephritis),
• if you have low blood potassium levels that do not respond to treatment,
• if you are breastfeeding,
• if you have hyponatremia (low sodium levels),
• if you have hypercalcemia (high calcium levels),
• if you suffer from gout,
• if you are taking floctafennine used for pain and inflammation (see Other medicines and Bisoprolol/Hydrochlorothiazide Aurovitas).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have heart failure. Your doctor may adjust your bisoprolol dose before starting bisoprolol/hydrochlorothiazide,
• if you are scheduled for surgery. Heart rate and blood pressure may change when anesthetics are used together with bisoprolol/hydrochlorothiazide. Inform your anesthesiologist that you are taking this medicine,
• if you have asthma or any other chronic respiratory disorder that may cause breathing difficulties or airway constriction (bronchospasm). In such cases, your doctor may increase the dose of your existing respiratory treatment or add additional medications for respiratory problems,
• if you have diabetes, as this medicine may mask symptoms of low blood sugar (hypoglycemia), such as increased heart rate,
• if you are fasting or engaging in physically strenuous activities,
• if you have a tumor of the adrenal gland (pheochromocytoma) and are under treatment: this medicine should only be used in combination with certain drugs (alpha-blockers),
• if you are undergoing treatment for allergic reactions. Bisoprolol/hydrochlorothiazide may increase the severity of your allergic reactions and may also reduce the effectiveness of your treatment,
• if you have a thyroid disorder (bisoprolol may mask symptoms of hyperactive thyroid),
• if you have cardiac conduction disorders (first-degree AV block),
• if you experience chest pressure or pain at rest (Prinzmetal's angina). This medicine may increase the frequency and duration of such attacks,
• if you have or have had recurrent skin disorders with dry, scaly rash (psoriasis),
• if you have poor blood circulation in fingers, toes, arms, or legs, or experience painful leg cramps during exercise or walking. These episodes may worsen, especially at the beginning of treatment,
• if you have reduced blood volume (hypovolemia),
• if you have mild or moderate liver or kidney dysfunction,
• if you have high blood uric acid levels (hyperuricemia), as this medicine may increase the risk of gout attacks,
• if you are elderly,
• if you plan to be exposed to sunlight or artificial ultraviolet light, as some patients have developed skin rashes after sun exposure. In such cases, protect your skin during treatment with this medicine,
• treatment should not be stopped suddenly, especially if you have certain ischemic heart diseases (e.g., angina). If you need to discontinue treatment, your doctor will gradually reduce the dose over several days,
• if you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulty after taking bisoprolol/hydrochlorothiazide, contact your doctor immediately,
• if you wear contact lenses, bisoprolol/hydrochlorothiazide may reduce tear production, which could cause irritation,
• this medicine affects the body's electrolyte balance. Your doctor will monitor you regularly. These tests are especially important if you have other conditions that may worsen if water-electrolyte balance is disturbed. Your doctor may occasionally check blood levels of lipids, potassium, sodium, calcium, uric acid, urea, or glucose,
• if 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 and UV exposure while taking this medicine,
• this medicine may cause eye disorders that may begin with vision loss or eye pain, such as transient myopia or acute angle-closure glaucoma,
  • cases of acute inflammation of the gallbladder (cholecystitis) have been reported in patients with gallstones,
  • if you experience decreased vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks after taking bisoprolol/hydrochlorothiazide. 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 condition.

While taking bisoprolol/hydrochlorothiazide, you should ensure you drink enough fluids and eat potassium-rich foods (e.g., bananas, vegetables, nuts) to compensate for increased potassium loss.

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

The benefits of diuretic medicines (hydrochlorothiazide) for treating high blood pressure are only achieved when the kidneys are functioning properly. Kidney function may decrease in patients with pre-existing kidney problems.

Other medicines and Bisoprolol/Hydrochlorothiazide Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

You must not take Bisoprolol/Hydrochlorothiazide Aurovitas with:

• floctafennine, used to treat pain or inflammation,
• sultopride, used to treat schizophrenia.

Take special care if you are taking bisoprolol/hydrochlorothiazide with any of the following medicines:

• Some medicines used to treat high blood pressure, angina, or heart arrhythmia (e.g., verapamil, diltiazem, bepridil, amlodipine, felodipine), which may increase the risk of heart rhythm disorders or low blood pressure.
• Medicines for high blood pressure (such as clonidine, moxonidine, amlodipine, methyldopa, reserpine, rilmenidine, and ACE inhibitors).
• Other medicines for high blood pressure or that may lower blood pressure (such as barbiturates or phenothiazines).
• Lithium, used to treat psychiatric disorders.
• Antiarrhythmic medicines (quinidine, disopyramide, amiodarone, sotalol).
• Digitalis glycosides, used to control heart rate.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used to treat pain, swelling, or redness.
• Topical beta-blockers (e.g., eye drops for glaucoma).
• Medicines for diabetes such as insulin, glinides, and sulfonylureas (e.g., glibenclamide, gliquidone, gliclazide, glipizide, glimepiride, or tolbutamide). Bisoprolol may increase the risk of severe hypoglycemia when used with these medicines.
• If you are undergoing surgery requiring anesthetics, inform your doctor that you are taking bisoprolol/hydrochlorothiazide.
• Tricyclic antidepressants, used to treat depression.
• Rifampicin, an antibiotic: it slightly shortens the duration of bisoprolol’s effect. Dose adjustment is usually not necessary.
• Medicines affecting the nervous system, e.g., epinephrine, norepinephrine (sympathomimetics).
• Medicines that reduce blood uric acid levels.
• Medicines that affect or may be affected by blood potassium levels, such as digoxin (a medicine to control heart rhythm), and some antipsychotics.
• Glucocorticoids, carbenoxolone, amphotericin, furosemide, laxatives. These medicines may cause potassium deficiency.
• Colestipol, cholestyramine: these medicines may reduce the effect of this medicine.
• Methyldopa: this medicine may lead to blood disorders.
• Mefloquine, used to prevent malaria: increases the risk of slow heart rate.
• Antidepressants (monoamine oxidase inhibitors) may affect your ability to control blood pressure.

If you are allergic to penicillin or sulfonamides, your risk of developing an allergic reaction to this medicine is higher. Your doctor will advise you whether to stop or change your treatment.

Use in athletes

This medicine contains hydrochlorothiazide, which may result in a positive doping test.

Taking Bisoprolol/Hydrochlorothiazide Aurovitas with food and drink

Bisoprolol/Hydrochlorothiazide Aurovitas tablets should be taken in the morning and may be taken with food. Swallow the tablets with sufficient liquid and do not chew them.

Pregnancy, breastfeeding, and fertility

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

Usually, your doctor will advise you to take another medicine instead of Bisoprolol/Hydrochlorothiazide 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/hydrochlorothiazide should not be used by breastfeeding mothers. Hydrochlorothiazide may affect breast milk production.

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

Driving and using machines

This medicine usually has no effect on the ability to drive or operate machinery. However, it may affect your concentration or reaction time. If so, do not drive or use machines.

3. How to take Bisoprolol/Hydrochlorothiazide Aurovitas

Dosage

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Use in children

The use of Bisoprolol/Hydrochlorothiazide Aurovitas is not recommended in children, as there is insufficient clinical experience with this medicine in pediatric patients.

Use in elderly patients

Dosage adjustment is not necessary. It is recommended to start treatment with the lowest possible dose.

Renal impairment

In patients with mild or moderate renal impairment, your doctor may prescribe a lower dose. Bisoprolol/hydrochlorothiazide tablets must not be taken if the patient has severe renal impairment (see section 2.).

Method of administration

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

Frequency of administration

The tablet(s) should be taken once daily.

Duration of treatment

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

If you take more Bisoprolol/Hydrochlorothiazide Aurovitas than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine package and leaflet to the healthcare professional.

If you forget to take Bisoprolol/Hydrochlorothiazide Aurovitas

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

If you stop taking Bisoprolol/Hydrochlorothiazide Aurovitas

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

If you discontinue treatment, it should be done gradually, as abrupt discontinuation may lead to acute worsening of the disease.

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

4. Possible adverse effects

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

Frequent: may affect more than 1 in 10 people

• abnormal body fluid and electrolyte levels (increased triglycerides, increased cholesterol, hypokalemia, hypomagnesemia, hyponatremia, hypochloremia, hypercalcemia),
• dizziness*, headache*,
• feeling cold or numbness in hands and feet,
• nausea, vomiting, diarrhea, or constipation,
• glucose in urine,
• feeling tired or weak*.

Uncommon: may affect up to 1 in 100 people

• loss of appetite,
• sleep disorders, depression,
• slow heart rate, irregular heartbeat, worsening of heart failure,
• feeling dizzy or lightheaded when standing up,
• breathing difficulty in people with asthma or respiratory diseases,
• abdominal pain, pancreatitis,
• increased amylase levels (enzymes involved in digestion),
• muscle weakness and cramps,
• increased levels of creatinine and urea in blood,
• loss of physical strength.

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

• decrease in white blood cells (leukopenia) or platelets (thrombocytopenia) in blood,
• nightmares, hallucinations,
• fainting,
• decreased tear flow (may cause problems if you wear contact lenses),
• visual disturbances,
• hearing problems,
• rhinorrhea,
• increase in certain liver enzymes in blood tests, liver inflammation (hepatitis), yellowing of the skin and eyes (jaundice),
• allergic reactions such as itching, facial redness, or skin rash, skin sensitivity to sunlight, hives, red spots on the skin due to small subcutaneous bleeding (purpura),
• erectile dysfunction,
• you should consult your doctor immediately 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

• severe decrease in white blood cells (agranulocytosis),
• increased alkalinity of the blood (metabolic alkalosis),
• inflammation of the eye or eyelid (conjunctivitis),
• hair loss,
• onset or worsening of pre-existing skin rash (psoriasis),
• development of hard crusts on the skin (cutaneous lupus erythematosus),
• chest pain,
• acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Frequency not known: cannot be estimated from available data

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

• interstitial lung disease,

  • sudden decrease in distance vision (acute myopia), decreased vision or eye pain due to elevated intraocular pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

• These symptoms usually occur at the beginning of treatment. They are generally mild and usually disappear within 1 or 2 weeks.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisoprolol/Hydrochlorothiazide Aurovitas

Keep this medicine 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 medicine after the expiry date stated on the outer carton and blister pack, following “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol/Hydrochlorothiazide Aurovitas

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

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

The other components are:

Tablet core: calcium hydrogen phosphate, microcrystalline cellulose (Grade-112), crospovidone (Type-A), colloidal anhydrous 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 pack

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

Pink, round (diameter 9.07 mm), biconvex, film-coated tablets, engraved with 'L' and '6' separated by a score line on one side and smooth on the other.

Bisoprolol/Hydrochlorothiazide Aurovitas film-coated tablets EFG are available in PVC/PE/PVdC - Aluminium blister packs.

Pack sizes:

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid,

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorised in the European Economic Area member states under the following names:

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

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

Portugal: Bisoprolol + Hydrochlorothiazide Generis

Date of the most recent review of this leaflet: February 2026

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).