Package Insert: Information for the User

Balzak 40 mg/10 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 who may 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 besylate). 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 the blood flow to your heart 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.
• Elevated potassium levels 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.

As with any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with altered blood flow to the heart or brain can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

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

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 at the same time as Balzak may elevate potassium levels in your blood.
• Thelithium(medication used to treat mood changes and some types of depression) used at the same time as Balzak may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in your blood.
• Thenonsteroidal anti-inflammatory drugs (NSAIDs)(medications 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 failure. The effect of Balzak may be reduced by NSAIDs.
• Colesevelam hydrochloride,a medication that lowers cholesterol levels in your 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,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 perfusion for severe body temperature abnormalities).
• Simvastatin,a medication used to lower cholesterol and triglyceride levels in your blood.
• Medications used to control the immune response of your body(e.g. tacrolimus, sirolimus, temsirolimus, everolimus, and ciclosporin), which makes it possible for 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

As with 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 when you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy.

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. It has been shown that amlodipine passes 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

During treatment of high blood pressure, 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. If in 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 small amount of 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 are likely to 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 breathing difficulties 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 forget to take Balzak

If you forget 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 pronounced 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, itching of the skin, 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 heartbeat; low blood pressure with symptoms such as dizziness, drowsiness; difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth; abdominal pain; skin rash; cramps; pain in the arms and legs; 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 in 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 ofuncomfortin thechest,knownasangina pectoris); itching;skin rash;allergic skin rash;urticaria;facial swelling;muscle pain;discomfort.

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; swelling of the ankles; feeling of sleepiness; flushing and sensation of heat in 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 ofuncomfortin thechest);irregular heartbeat;nasal secretion or congestion; hair loss;purple spotsor skin patches due to small hemorrhages(purpura);skin discoloration;excessive sweating;skin rash;itching;hives;muscle pain;problems urinating;urgency to urinate at night;increased need to urinate;enlargement of the breasts in men;chest pain;pain;sensation ofuncomfort;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 shown on the packaging (after “CAD”).The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy.Ask your pharmacist if you are unsure how to dispose of packaging and unused medications. 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 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besilate).

The other components are:

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

Tablet coating: Poly(vinyl alcohol), macrogol 3350, talc, titanium dioxide (E-171),yellow iron oxide (E-172)and red iron oxide (E-172).

Appearance of the product and contents of the package

Balzak 40 mg/10 mg film-coated tablets are brown-red, round tablets with the inscription C77 on one side.

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

Laboratorios Menarini, 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

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/10 mg

Belgium: Carlitex 40 mg/10 mg

Bulgaria: Tespadan 40 mg/10 mg

Cyprus: Orizal 40 mg/10 mg

Czech Republic: Sintonyn 40 mg/10 mg

Estonia: Sanoral 40 mg/10 mg

France: Axeler 40 mg/10 mg

Germany: Vocado 40 mg/10 mg

Greece: Orizal 40 mg/10 mg

Hungary: Duactan 40 mg/10 mg

Ireland: Konverge40 mg/10 mg

Italy: Bivis40 mg/10 mg

Latvia: Sanoral40 mg/10 mg

Lithuania: Sanoral40 mg/10 mg

Luxembourg: Carlitex40 mg/10 mg

Netherlands: Belfor 40 mg/10 mg

Malta: Tansar 40 mg/10 mg

Poland: Elestar 40 mg/10 mg

Portugal: Zolnor 40 mg/10 mg

Romania: Inovum 40 mg/10 mg

Slovakia: Folgan 40 mg/10 mg

Slovenia: Olectan 40 mg/10 mg

Spain: Balzak 40 mg/10 mg

Last review date of this leaflet:January 2025

Other sources of information

The 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/