Balzak 40 mg/10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Balzak 40 mg/10 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Balzak is and what it is used for

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

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

The combined action of both substances helps prevent the narrowing of blood vessels, allowing them to relax and reducing blood pressure.

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 taking Balzak

Do not take Balzak

• If you are allergic to olmesartan medoxomil, amlodipine, or to 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 best to avoid Balzak in early pregnancy (see section “Pregnancy and breastfeeding”).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have severe liver problems, if bile secretion is impaired, or its release from the gallbladder is blocked (e.g., due to gallstones), or if you have jaundice (yellowing of the skin and eyes).
• If you have very low blood pressure.
• If you have inadequate blood supply to 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 blood flow to your heart is blocked (e.g., due to narrowing of the aorta (aortic stenosis)).
• If you have low cardiac output (causing shortness of breath or peripheral swelling) following a heart attack (acute myocardial infarction).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Balzak.

Tell your doctor if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• 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 monitor 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 doctor if you have any of the following health conditions:

• 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 medicines that increase urine elimination (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 experience severe, persistent diarrhea causing significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Consult your doctor if you develop 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 might be pregnant. Use of Balzak is not recommended in early pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years of age)

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

Taking Balzak with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the following medicines:

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

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

If you are taking an angiotensin-converting enzyme inhibitor (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, medicines that increase urine elimination (diuretics), or heparin (used to thin the blood and prevent blood clots). Taking these medicines together with Balzak may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression) taken together with Balzak may increase its toxicity. If you have to take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) taken together with Balzak may increase the risk of kidney failure. The effect of Balzak may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine 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.
• Medicines used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir) or for treating 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 (administered by infusion for severe abnormalities in body temperature).
• Simvastatin, a medicine used to lower cholesterol and fat (triglyceride) levels in the blood.
• Medicines used to control the body’s immune response (e.g., tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine), which help the body accept a transplanted organ.

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

Taking Balzak with food and drinks

Balzak can be taken with or without food. Take the tablets with some 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 must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of Balzak.

Elderly patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure each time your dose is increased, to ensure it does not drop too much.

Black patients

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you might 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 recommend another medicine instead of Balzak. Use of Balzak is not recommended in early pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

If you become pregnant while taking Balzak, inform your doctor immediately and seek medical advice.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. It has been shown that amlodipine passes into breast milk in small amounts. Balzak is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

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

Driving and using machines

During treatment for high blood pressure, you may feel drowsy, unwell, dizzy, or have headaches. If this happens, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

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

3. How to take Balzak

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 of Balzak is one tablet per day.
• The tablets can be taken with or without food. Take the tablets with some liquid (such as a glass of water). The tablet must not be chewed. Do not take Balzak with grapefruit juice.
• If possible, 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 may experience a drop in blood pressure, accompanied by symptoms such as dizziness, and fast or slow heartbeat.

If you take more tablets than prescribed or if a child accidentally ingests any tablets, contact your doctor immediately or go to the nearest emergency center and bring the medicine pack or this leaflet with you.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 24–48 hours after ingestion.

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

If you forget to take Balzak

If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for missed doses.

If you stop taking Balzak

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

If you have any further questions about 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 everyone experiences them. If they do occur, they are often mild and do not require discontinuation of treatment.

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

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

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

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you started treatment with Balzak some time ago, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

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.

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

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

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

Increase or decrease in blood potassium levels, increase in blood creatinine levels, increase in blood uric acid levels, and increased values in liver function tests (levels of gamma-glutamyl transferase).

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

Hypersensitivity to the medicine; facial flushing and sensation of warmth; itchy red welts (urticaria); facial swelling.

Adverse effects reported with olmesartan medoxomilo or amlodipine used alone, but not with Balzak, or with higher frequency:

Olmesartan medoxomilo

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

Bronchitis; sore throat; nasal congestion and discharge; cough; abdominal pain; viral gastroenteritis; diarrhea; indigestion; nausea; joint and bone pain; back pain; blood in 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 blood uric acid and urea levels; and increased values in liver and muscle function tests.

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

Reduction in the number of a type of blood cells called platelets, which may lead to easy bruising or prolonged bleeding time; rapid allergic reactions, which may affect the whole body and may cause breathing difficulties as well as a rapid drop in blood pressure, possibly leading to fainting (anaphylactic reactions); angina (chest pain or discomfort, known as angina pectoris); itching; skin rash; allergic skin rash; urticarial rash; facial swelling; muscle pain; malaise.

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

Swelling of the face, mouth and/or larynx (vocal cords); acute kidney failure and renal failure; lethargy; intestinal angioedema: swelling in the intestine presenting 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 ankles; drowsiness; facial flushing and sensation of warmth; visual disturbances (including double vision and blurred vision); awareness of heartbeat; diarrhea; constipation; indigestion; cramps; weakness; difficulty breathing.

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

Difficulty sleeping; sleep disorders; mood changes including anxiety; depression; irritability; tremor; taste disturbances; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (chest pain or discomfort); irregular heartbeat; nasal discharge or congestion; hair loss; purple spots or skin lesions due to minor bleeding (purpura); skin discoloration; excessive sweating; skin rash; itching; itchy red welts (urticaria); joint or muscle pain; urinary problems; need to urinate at night; increased need to urinate; breast enlargement in men; chest pain; pain; malaise; 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 blood cells known as platelets, which could lead to bruising and prolonged bleeding time; increased blood glucose; increased muscle tone or resistance to passive movement (hypertonia); tingling or numbness in the hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach lining; gum enlargement; elevated liver enzymes; yellowing of the skin and eyes; increased skin sensitivity to light; allergic reactions such as itching, rash, swelling of the face, mouth and/or larynx (vocal cords), together with itching and rash, and other allergy problems with skin swelling and peeling, 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.

Frequency not known (cannot be estimated from available data):

Tremors, rigid posture, mask-like facial expression, slow movements, and unbalanced gait with shuffling steps.

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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Balzak

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging (after "EXP"). The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Balzak

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

Each tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besylate).

The other components are:

Tablet core: Pregelatinized corn starch, microcrystalline cellulose, anhydrous colloidal 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 pack

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

Balzak film-coated tablets are available in OPA/Aluminium/PVC/Aluminium blisters in pack sizes 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 single-dose pre-cut blisters.

Not all pack sizes 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

or

Fine Foods & Pharmaceuticals NTM S.p.A.

Via Grignano, 43

24041 - Brembate (BG)

Italy

This medicinal product is authorized in the Member States of the European Economic Area under 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: Konverge 40 mg/10 mg

Italy: Bivis 40 mg/10 mg

Latvia: Sanoral 40 mg/10 mg

Lithuania: Sanoral 40 mg/10 mg

Luxembourg: Carlitex 40 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

Date of the most recent review of this leaflet: January 2025

Other sources of information

Detailed and up-to-date 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/