BALZAK 40mg/5mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Balzak 40 mg/5 mg

film-coated tablets

Olmesartan medoxomil/Amlodipine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Balzak and what is it used for
2. What you need to know before you take Balzak
3. How to take Balzak
4. Possible side effects
5. Storage of Balzak
6. Contents of the pack and other information

1. What is Balzak and what is it used for

Balzak contains two active substances called olmesartan medoxomil and amlodipine (as amlodipine besylate). Both substances help to control high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor antagonists”, which lower blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines called “calcium channel blockers”. Amlodipine prevents calcium from entering the blood vessel wall, which prevents the blood vessels from narrowing, and thus also lowers blood pressure.

The action of both substances contributes to preventing the narrowing of blood vessels, so they relax and blood pressure decreases.

Balzak is used to treat high blood pressure in patients whose blood pressure is not adequately controlled with olmesartan medoxomil or amlodipine alone.

2. What you need to know before you take Balzak

Do not take Balzak

• If you are allergic to olmesartan medoxomil, or amlodipine, or a special group of calcium channel blockers called dihydropyridines, or to any of the other ingredients of this medicine (listed in section 6).

If you think you may be allergic, inform your doctor before taking Balzak.

• If you are more than 3 months pregnant. It is better to avoid Balzak at the start of pregnancy (see section “Pregnancy and breast-feeding”).
• If you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren.
• If you have severe liver problems, if bile secretion is altered, or its release by the gallbladder is blocked (e.g. by gallstones), or if you have jaundice (yellowing of the skin and eyes).
• If you have very low blood pressure.
• If you have insufficient blood supply to the tissues, with symptoms such as low blood pressure, weak pulse, rapid heart rate (shock, including cardiogenic shock). Cardiogenic shock means shock due to serious heart problems.
• If the blood flow to your heart is blocked (e.g. due to narrowing of the aorta (aortic stenosis)).
• If you have poor heart performance (causing difficulty breathing, or swelling) after a heart attack (acute myocardial infarction).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Balzak.

Tell your doctorif you are taking any of the following medicines used to treat high blood pressure:

• a medicine called an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Balzak”.

Tell your doctorif you have any of the following health problems:

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medicines that increase urine production (diuretics), or if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands (hormone-producing glands located above the kidneys).

Contact your doctor if you suffer from severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Balzak. Your doctor will decide whether to continue treatment. Do not stop taking Balzak on your own.

As with any other medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You must inform your doctor if you are pregnant or think you may be pregnant. The use of Balzak is not recommended at the start of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage (see section “Pregnancy and breast-feeding”).

Children and adolescents (under 18 years)

Balzak is not recommended for children and adolescents under 18 years.

Using Balzak with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• Other blood pressure-lowering medicines, as they may increase the effect of Balzak.

Your doctor may need to change your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Balzak” and “Warnings and precautions”).

• Potassium supplements, salt substitutes that contain potassium, medicines that increase urine production(diuretics), or heparin(to thin the blood and prevent blood clots). The use of these medicines at the same time as Balzak may increase potassium levels in the blood.
• Lithium(a medicine used to treat mood changes and some types of depression) used at the same time as Balzak may increase its toxicity. If you have to take lithium, your doctor will measure lithium levels in your blood.
• Non-steroidal anti-inflammatory medicines(NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) used at the same time as Balzak may increase the risk of kidney problems. The effect of Balzak may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of Balzak. Your doctor may advise you to take Balzak at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of Balzak.
• Medicines used for HIV/AIDS(e.g. ritonavir, indinavir, nelfinavir) or for the treatment of fungal infections(e.g. ketoconazole, itraconazole).
• Diltiazem, verapamil(medicines used for heart rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin(antibiotics), medicines used for tuberculosis or other infections.
• St. John's Wort(Hypericum perforatum), a herbal remedy.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, a medicine used to lower blood cholesterol and fat (triglyceride) levels.
• Medicines used to control the body's immune response(e.g. tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporin), which allows your body to accept a transplanted organ.

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

Taking Balzak with food and drink

Balzak can be taken with or without food. Take the tablets with a little liquid (e.g. a glass of water). If possible, take your daily dose at the same time each day, e.g. at breakfast time.

People taking Balzak should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active ingredient amlodipine in the blood, which can cause an unpredictable increase in the blood pressure-lowering effect of Balzak.

Elderly patients

If you are over 65 years old, your doctor will regularly check your blood pressure whenever your dose is increased, to make sure it does not decrease too much.

Black patients

As with other similar medicines, the blood pressure-lowering effect of Balzak is somewhat smaller in black patients.

Pregnancy and breast-feeding

Pregnancy

You must inform your doctor if you are pregnant or think you may be pregnant.

Your doctor will advise you to stop taking Balzak before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Balzak. The use of Balzak is not recommended at the start of pregnancy, and it should not be taken when you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage.

If you become pregnant while taking Balzak, inform and consult your doctor immediately.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. It has been shown that amlodipine passes into breast milk in small amounts. Balzak is not recommended for breast-feeding mothers, and your doctor may choose another treatment if you wish to breast-feed, especially if your baby is newborn or premature.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

During treatment for high blood pressure, you may feel drowsy, feel sick, or have headaches, or feel dizzy. If this happens, do not drive or use machines until the symptoms have gone away. Consult your doctor.

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e. it is essentially “sodium-free”.

3. How to take Balzak

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

• The recommended dose of Balzak is one tablet per day.
• The tablets can be taken with or without food. Take the tablets with a little liquid (e.g. a glass of water). Do not chew the tablet. Do not take Balzak with grapefruit juice.
• If possible, take your daily dose at the same time each day, e.g. at breakfast time.

If you take more Balzak than you should

If you take more tablets than you should, you will probably suffer from low blood pressure, accompanied by symptoms such as dizziness, and rapid or slow heart rate.

If you take more tablets than you should, or a child accidentally swallows some tablets, contact your doctor or go to the nearest hospital casualty department immediately and take this leaflet and the medicine pack with you.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that may develop up to 24-48 hours after ingestion.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Balzak

If you forget to take a dose, take your normal dose the next day. Do nottake a double dose to make up for forgotten doses.

If you stop taking Balzak

It is important to continue taking Balzak unless your doctor tells you to stop.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. If they occur, they are often mild and do not require interruption of treatment.

The following adverse effects may be serious, although they affect only a small group of people:

During treatment with Balzak, allergic reactions can occur, which can affect the whole body, with inflammation of the face, mouth, and/or larynx (vocal cords), along with itching and skin rash. If this happens to you, stop taking Balzak and consult your doctor immediately.

Balzak can cause a pronounced decrease in blood pressure, in susceptible patients, or as a result of an allergic reaction. This can cause fainting or severe dizziness. If this happens to you, stop taking Balzak, consult your doctor immediately, and remain lying down in a horizontal position.

Unknown frequency: If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with Balzak a long time ago, contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for blood pressure.

Other possible adverse effects with Balzak:

Frequent (may affect up to 1 in 10 people):

Dizziness; headache; swelling of the ankles, feet, legs, hands, or arms; fatigue.

Infrequent (may affect up to 1 in 100 people):

Dizziness when standing up; lack of energy; tingling or numbness of the hands or feet; vertigo; perception of heartbeats; rapid heartbeat; low blood pressure with symptoms such as dizziness, dizziness; difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth; pain in the upper abdomen; skin rash; cramps; pain in the arms and legs; back pain; urge to urinate; sexual inactivity; inability to have or maintain an erection; weakness.

Some changes in the results of certain blood tests have also been observed:

Increased, as well as decreased levels of potassium in the blood, increased levels of creatinine in the blood, increased levels of uric acid, increased values of liver function tests (gamma glutamyl transferase levels).

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

Hypersensitivity to the medicine; fainting; flushing and feeling of heat in the face; red hives with itching (urticaria); facial inflammation.

Adverse effects reported with the use of olmesartan medoxomil or amlodipine alone, but not with Balzak, or with a higher frequency:

Olmesartan medoxomil

Frequent (may affect up to 1 in 10 people):

Bronchitis; sore throat; nasal congestion and secretion; cough; abdominal pain; viral gastroenteritis; diarrhea; indigestion; nausea; joint and bone pain; back pain; blood in the urine; urinary tract infection; chest pain; flu-like symptoms; pain. Changes in blood test results, such as increased levels of a type of fat (hypertriglyceridemia); increased uric acid and urea in the blood, and increased values of liver and muscle function tests.

Infrequent (may affect up to 1 in 100 people):

Reduction in the number of a type of blood cells called platelets, which can cause easy bruising or prolonged bleeding time; rapid allergic reactions, which can affect the whole body and cause respiratory problems, as well as a rapid drop in blood pressure, which can even cause fainting (anaphylactic reactions); angina (chest pain or discomfort known as angina pectoris); itching; skin rash; allergic skin rash; urticaria; facial swelling; muscle pain; discomfort.

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

Inflammation of the face, mouth, and/or larynx (vocal cords); acute renal failure and renal insufficiency; lethargy; intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Amlodipine

Very frequent (may affect more than 1 in 10 people):

Edema (fluid retention).

Frequent (may affect up to 1 in 10 people):

Abdominal pain; nausea; swelling of the ankles; feeling of sleepiness; flushing and feeling of heat in the face; visual disturbances (including double vision and blurred vision); perception of heartbeats; diarrhea; constipation; indigestion; cramps; weakness; difficulty breathing.

Infrequent (may affect up to 1 in 100 people):

Difficulty sleeping; sleep disorders; mood changes including anxiety; depression; irritability; tremors; taste disturbances; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (chest pain or discomfort); irregular heartbeats; nasal secretion or congestion; hair loss; purple spots or spots on the skin due to small hemorrhages (purpura); skin discoloration; excessive sweating; skin rash; itching; red hives with itching (urticaria); joint or muscle pain; urination problems; need to urinate at night; increased need to urinate; breast enlargement in men; chest pain; pain; feeling of discomfort; weight gain or loss.

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

Confusion.

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

Reduction in the number of white blood cells, which could increase the risk of infections; reduction in the number of a type of blood cells called platelets, which could lead to bruising and prolonged bleeding time; increased blood glucose; increased muscle tension or greater resistance to passive movement (hypertonia); tingling or numbness of the hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach wall; gum thickening; elevated liver enzymes; yellowing of the skin and eyes; increased sensitivity of the skin to light; allergic reactions with itching, rash, inflammation of the face, mouth, and/or larynx (vocal cords), along with itching and rash, and other allergic problems with inflammation and peeling of the skin, severe skin reactions including intense skin rash, urticaria, redness of the body skin, severe itching, blisters, peeling, and skin inflammation, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe.

Unknown frequency (cannot be estimated from available data):

Tremors, rigid posture, mask-like face, slow movements, and unsteady gait.

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 is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Balzak

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

Do not use this medicine after the expiration date that appears on the packaging (after "CAD"). The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Balzak

The active ingredients are olmesartan medoxomil and amlodipine (as besylate).

Each tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).

The other ingredients are:

Core of the tablet: Pregelatinized cornstarch, microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, and magnesium stearate.

Coating of the tablet: Poly(vinyl alcohol), macrogol 3350, talc, titanium dioxide (E-171), and iron oxide (III) yellow (E-172).

Appearance of the product and package contents

Balzak 40 mg/5 mg film-coated tablets are cream-colored, round tablets with the inscription C75 on one side.

Balzak film-coated tablets are available in OPA/Aluminum/PVC/Aluminum blisters in packages of 14, 28, 30, 56, 90, 98, 10 x 28, 10 x 30 film-coated tablets in blisters, and in packages of 10 x 1, 50 x 1, and 500 x 1 film-coated tablets in single-dose precut blisters.

Not all packages are marketed.

Marketing authorization holder

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG, S.A.

1 Avenue de la Gare L-1611

Luxembourg

Local representative

Laboratorios Menarini, S.A.

Alfons XII, 587 - Badalona (Barcelona) Spain

Manufacturer

DAIICHI SANKYO EUROPE GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

or

BERLIN-CHEMIE AG

Glienicker Weg 125,

12489 Berlin

Germany

or

Laboratorios Menarini, S.A.

Alfons XII, 587

08918 Badalona (Barcelona),

Spain

This medicine is authorized in the Member States of the European Economic Area with the following names:

Austria: Amelior 40 mg/5 mg

Belgium: Carlitex 40 mg/5 mg

Bulgaria: Tespadan 40 mg/5 mg

Cyprus: Orizal 40 mg/5 mg

Czech Republic: Sintonyn 40 mg/5 mg

Estonia: Sanoral 40 mg/5 mg

France: Axeler 40 mg/5 mg

Germany: Vocado 40 mg/5 mg

Greece: Orizal 40 mg/5 mg

Hungary: Duactan 40 mg/5 mg

Ireland: Konverge 40 mg/5 mg

Italy: Bivis 40 mg/5 mg

Latvia: Sanoral 40 mg/5 mg

Lithuania: Sanoral 40 mg/5 mg

Luxembourg: Carlitex 40 mg/5 mg

Netherlands: Belfor 40 mg/5 mg

Malta: Tansar 40 mg/5 mg

Poland: Elestar 40 mg/5 mg

Portugal: Zolnor 40 mg/5 mg

Romania: Inovum 40 mg/5 mg

Slovakia: Folgan 40 mg/5 mg

Slovenia: Olectan 40 mg/5 mg

Spain: Balzak 40 mg/5 mg

Date of the last revision of this prospectus:January 2025

Other sources of information

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