Package Insert: Information for the User

Balzak 20 mg/5 mg

Film-coated Tablets

Olmesartán medoxomilo/Amlodipino

Read this package insert carefully before starting to take this medication, as it contains important information for you.

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this package insert. See section 4.

Balzakcontains two substances called olmesartan medoxomil and amlodipine (as amlodipine besilate). The two substances help control high blood pressure.

• Olmesartan medoxomil belongs to a group of medications called “angiotensin II receptor antagonists”, which decrease blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medications called “calcium channel blockers”. Amlodipine prevents calcium from entering the blood vessel wall, preventing blood vessel constriction, thereby also decreasing blood pressure.

The action of both substances contributes to preventing blood vessel constriction, allowing blood vessels to relax and blood pressure to decrease.

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

Do not take Balzak

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

Inform your doctor if you think you may be allergic before taking Balzak.

• If you are more than 3 months pregnant. It is best to avoid Balzak at the beginning of pregnancy (see section “Pregnancy and breastfeeding”).
• If you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.
• If you have severe liver problems, if your bile secretion is altered, or if your bile release is blocked (for example, by gallstones), or if you have jaundice (yellow skin and eyes).
• If you have very low blood pressure.
• If you have inadequate blood flow to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heart rate (shock, including cardiogenic shock). Cardiogenic shock means shock due to severe heart problems.
• If your heart's blood flow is blocked (for example, due to aortic stenosis).
• If you have poor heart function (producing difficulty breathing, or peripheral edema) 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 medications used to treat high blood pressure (hypertension):

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in your blood (such as 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 heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-sodium diet.
• High levels of potassium in your blood.
• Problems with the adrenal glands (glands that produce hormones located above the kidneys).

Contact your doctor if you experience severe diarrhea, persistent, and causing significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your treatment for high blood pressure.

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.

Like any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with heart or brain blood flow abnormalities can cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You should inform your doctor if you are pregnant or think you may be pregnant. Balzak is not recommended for use at the beginning 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 used during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years)

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

Use of Balzak with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications:

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

Your doctor may need to adjust 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 containing potassium, medications that increase urine production (diuretics), orheparin(to thin the blood and prevent blood clots). The use of these medications with Balzak may elevate potassium levels in the blood.
• Thelithium(medication used to treat mood changes and some types of depression) used with Balzak may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• Thenonsteroidal anti-inflammatory drugs (NSAIDs)(medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) used with Balzak may increase the risk of kidney failure. The effect of Balzak may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, 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.
• Medications used to treat HIV/AIDS(e.g. ritonavir, indinavir, nelfinavir)or fungal infections(e.g. ketoconazole, itraconazole).
• Diltiazem,verapamil(medications used to treat heart rhythm problems and high blood pressure).
• Rifampicin,erythromycin, clarithromycin(antibiotics), medications used to treat tuberculosis or other infections.
• St. John's Wort(Hypericum perforatum), herbal remedy.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, a medication used to lower cholesterol and triglyceride levels in the blood.
• Medications used to control the immune response of thebody(e.g. tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine), which allows your body to accept the transplanted organ.

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

Taking Balzak with food and drinks

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

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

Older patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure each time you increase the dose, to ensure that it does not decrease too much.

Black patients

Like other similar medications, the blood pressure-lowering effect of Balzak is somewhat less in black patients.

Pregnancy and breastfeeding

Pregnancy

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

Your doctor will advise you to stop taking Balzak before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of Balzak. Balzak is not recommended for use at the beginning 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 used during this period.

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

Breastfeeding

Inform your doctor if you are breastfeeding or planning to start breastfeeding. Amlodipine has been shown to pass into breast milk in small amounts. Balzak is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature.

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

Driving and operating machinery

During high blood pressure treatment, you may experience drowsiness, feel sick, or dizzy, or have a headache. If this occurs, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially “sodium-free”.

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 of Balzak is one tablet per day.
• Tablets can be taken with or without food. Take the tablets with a little liquid (such as a glass of water). Do not chew the tablet. Do not take Balzak with grapefruit juice.
• Try to take your daily dose at the same time each day, for example at breakfast time.

If you take more Balzak than you should

If you take more tablets than you should, you will probably experience a drop in blood pressure, accompanied by symptoms such as dizziness, and a rapid or slow heart rate.

If you take more tablets than you should or a child accidentally ingests some tablets, contact your doctor immediately or go to the nearest emergency center and bring the medication packaging or this leaflet 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 Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Balzak

If you forgot to take a dose, take the usual dose the next day.Do nottake a double dose to make up for the missed doses.

If you interrupt treatment with Balzak

It is essential to continue taking Balzak, unless your doctor tells you to stop treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If they occur, they are often mild and do not require interrupting treatment.

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

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

Balzak can cause a significant drop in blood pressure in susceptible patients, or as a result of an allergic reaction. This can cause dizziness or severe drowsiness.If this happens, 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 high blood pressure.

Other possible side effects with Balzak:

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

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

Infrequent (can 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 heartbeats; low blood pressure with symptoms such as dizziness, drowsiness; difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth; abdominal pain; skin rash; cramps; arm and leg pain; back pain; sensation of urgency to urinate; sexual inactivity; inability to achieve or maintain an erection; weakness.

Also, some changes have been observed in the results of certain blood tests:

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 (can affect up to 1 in 1,000 people):

Medication hypersensitivity; fainting; flushing and sensation of heat on the face; red itchy patches (urticaria); facial inflammation.

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

Olmesartan medoxomil

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

Bronchitis; sore throat; congestion and nasal 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 (can affect up to 1 in 100 people):

Reduction in the number of a type of blood cell, called platelets, which can cause easy bruising or prolong bleeding time; rapid allergic reactions, which can affect the entire body and cause respiratory problems, as well as rapid drop in blood pressure, which can even cause fainting (anaphylactic reactions);angina (painorsensation ofdiscomfortin thechest,knownasangina pectoris); itching;skin rash;allergic skin rash;urticaria;facial swelling;muscle pain;malaise.

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

Facial, mouth, and/or laryngeal (vocal cord) inflammation; acute renal failure and renal insufficiency; lethargy; intestinal angioedema: swelling in the intestine accompanied by symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Amlodipine

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

Edema (fluid retention).

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

Abdominal pain; nausea; ankle swelling; drowsiness; flushing and sensation of heat on the face; visual disturbances (including double vision and blurred vision); perception of heartbeats; diarrhea; constipation; indigestion; cramps; weakness; difficulty breathing.

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

Difficulty sleeping; sleep disorders; mood changes, including anxiety;depression;irritability;shakiness;alterations in taste; fainting;ringing in the ears(tinnitus);exacerbationof angina pectoris(painorsensation ofdiscomfortin thechest);irregular heartbeats;nasal secretion or congestion; hair loss;purple spotsor patcheson the skin due to small hemorrhages(purpura);skin discoloration;excessive sweating;skin rash;itching;red itchy patches (urticaria);joint or muscle pain;urinary problems;need to urinate at night;increased need to urinate;enlarged breasts in men;chest pain;pain;sensation ofdiscomfort;weight gain or loss.

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

Confusion.

Very rare (can 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 cell called platelets, which could cause bruising and prolong bleeding time; increased glucose in the blood; increased muscle tensionorincreased resistanceto 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; yellow skin and eyes; increased sensitivity of the skin to light; severe allergic reactions, including itching, rash, facial, mouth, and/or laryngeal (vocal cord) inflammation, along with itching and rash, and other allergy problems with inflammation and peeling of the skin, severe skin reactions including intense skin rash, urticaria, redness of the skin, severe itching, blisters, peeling, and inflammation of the skin, inflammation of 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 with dragging of the feet.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side 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.

Do not use this medication 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.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Balzak

The active principles are olmesartan medoxomil and amlodipine (as besilate).

Each tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besilate).

The other components are:

Tablet core: Pregelatinized cornstarch, microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, and magnesium stearate.

Tablet coating: Poly(vinyl alcohol), macrogol 3350, talc, and titanium dioxide (E-171).

Appearance of the product and contents of the package

Balzak 20 mg/5 mg film-coated tablets are white, round tablets with the inscription C73 on one face.

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

Not all packs are marketed.

Marketing authorization holder

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG, S.A.

1 Avenue de la Gare L-1611

Luxembourg

Local representative

MENARINI Laboratories, S.A.

Alfons XII, 587 - Badalona (Barcelona) Spain

Responsible for manufacturing

DAIICHI SANKYO EUROPE GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

or

BERLIN-CHEMIE AG

Glienicker Weg 125,

12489 Berlin

Germany

or

MENARINI Laboratories, 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 20 mg/5 mg

Belgium: Carlitex 20 mg/5 mg

Bulgaria: Tespadan 20 mg/5 mg

Cyprus: Orizal 20 mg/5 mg

Czech Republic: Sintonyn 20 mg/5 mg

Estonia: Sanoral 20 mg/5 mg

France: Axeler 20 mg/5 mg

Germany: Vocado 20 mg/5 mg

Greece: Orizal 20 mg/5 mg

Hungary: Duactan 20 mg/5 mg

Ireland: Konverge 20 mg/5 mg

Italy: Bivis 20 mg/5 mg

Latvia: Sanoral 20 mg/5 mg

Lithuania: Sanoral 20 mg/5 mg

Luxembourg: Carlitex 20 mg/5 mg

Netherlands: Belfor 20 mg/5 mg

Malta: Tansar 20 mg/5 mg

Poland: Elestar 20 mg/5 mg

Portugal: Zolnor 20 mg/5 mg

Romania: Inovum 20 mg/5 mg

Slovakia: Folgan 20 mg/5 mg

Slovenia: Olectan 20 mg/5 mg

Spain: Balzak 20 mg/5 mg

Last review date of this leaflet: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 Medical Devices (AEMPS) http://www.aemps.gob.es/