Balzak Plus 40 mg/5 mg/12.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Balzak Plus 40 mg/5 mg/12.5 mg film-coated tablets

Olmesartan medoxomil / Amlodipine / 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Balzak Plus is and what it is used for

Balzak Plus contains three active substances: olmesartan medoxomil, amlodipine (as amlodipine besilate), and hydrochlorothiazide. These three substances help 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 also lowers blood pressure by relaxing blood vessels.

• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

The action of these substances contributes to lowering your blood pressure.

Balzak Plus is used to treat high blood pressure:

• in adult patients whose blood pressure is not adequately controlled with the combination of olmesartan medoxomil and amlodipine taken as a fixed-dose combination, or
• in patients who are already taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide, together with tablets containing amlodipine only, or a fixed-dose combination of olmesartan medoxomil and amlodipine, together with tablets containing hydrochlorothiazide only.

2. What you need to know before taking Balzak Plus

Do not take Balzak Plus

• If you are allergic to olmesartan medoxomil, amlodipine, or a specific group of calcium channel blockers (dihydropyridines), hydrochlorothiazide, or substances similar to hydrochlorothiazide (sulfonamides), 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 Plus.

• If you have severe kidney problems.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood that do not improve with treatment.
• If you are more than 3 months pregnant. (Balzak Plus should also be avoided in early pregnancy – see section “Pregnancy and breastfeeding”).
• If you have severe liver problems, bile secretion disorders, or obstruction of bile drainage from the gallbladder (e.g., due to gallstones), or have jaundice (yellowing of the skin and eyes).
• If you have inadequate blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, meaning shock due to serious heart problems).
• If you have very low blood pressure.
• If blood flow from your heart is slow or blocked. This may occur if blood vessels or heart valves that carry blood away from the heart are narrowed (aortic stenosis).
• If you have low cardiac output following a heart attack (acute myocardial infarction). Low cardiac output may cause shortness of breath or swelling in the feet and ankles.

Do not take Balzak Plus if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Balzak Plus.

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), particularly if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes in your blood (e.g., potassium) at regular intervals.

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

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 output (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).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• Skin reactions such as sunburn or rash after sun exposure or use of sunbeds.
• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Balzak Plus.
• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Balzak Plus, seek medical attention immediately.

Contact your doctor if you experience any of the following symptoms:

• Severe, persistent diarrhea leading to significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.
• 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 and may occur from hours to weeks after taking Balzak Plus. This may lead to permanent vision loss if not treated.

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

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

Balzak Plus may cause increased levels of lipids and uric acid (which causes gout – painful joint swelling) in the blood. Your doctor may want to perform blood tests from time to time to monitor these possible changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor may want to perform blood tests periodically to monitor this possible change. Some signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, drowsy, or restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

If you are scheduled for parathyroid function tests, you must stop taking Balzak Plus before the tests are performed.

Athletes should be aware that this medicine contains a component that may result in a positive doping test.

You must inform your doctor if you are pregnant (or think you might be). The use of Balzak Plus 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 at this stage (see section “Pregnary and breastfeeding”).

Children and adolescents (under 18 years of age)

The use of Balzak Plus is not recommended in children and adolescents under 18 years of age.

Use of Balzak Plus with other medicines

Inform 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 increase the effect of Balzak Plus.

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

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

• Lithium (a medicine used to treat mood disorders and certain types of depression) may have increased toxicity when used together with Balzak Plus. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Diltiazem, verapamil, used for heart rhythm problems and high blood pressure.
• Rifampicin, erythromycin, clarithromycin, tetracyclines or sparfloxacin, antibiotics used for tuberculosis and other infections.
• St. John’s Wort (Hypericum perforatum), a herbal remedy used to treat depression.
• Cisapride, used to increase the movement of food through the stomach and intestine.
• Difemanyl, used to treat slow heart rate or to reduce sweating.
• Halofantrine, used to treat malaria.
• Vincamine IV, used to improve blood circulation in the nervous system.
• Amantadine, used for Parkinson’s disease.
• Potassium supplements, potassium-containing salt substitutes, diuretics (medicines that increase urine elimination), heparin (to thin the blood and prevent blood clots), angiotensin-converting enzyme (ACE) inhibitors (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), sodium G penicillin (an antibiotic also known as sodium benzylpenicillin), some painkillers such as acetylsalicylic acid (“aspirin”) or salicylates. Taking these medicines together with Balzak Plus may alter potassium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used together with Balzak Plus, may increase the risk of kidney failure. The effect of Balzak Plus may be reduced by NSAIDs. High doses of salicylates may increase the toxic effects on the central nervous system.
• Sleep-inducing medicines, sedatives, and antidepressants, when used together with Balzak Plus, may cause a sudden drop in blood pressure upon standing.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of Balzak Plus. Your doctor may advise you to take Balzak Plus at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion and heartburn), as they may slightly reduce the effect of Balzak Plus.
• Some muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and biperiden.
• Calcium supplements.
• Dantrolene (administered by infusion for severe disturbances in body temperature).
• Simvastatin, 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 might need to take any of the following medicines for:

• Treating certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• Treating low blood sugar (e.g., diazoxide) or high blood pressure (e.g., beta-blockers, methyldopa), since Balzak Plus may affect the mechanism of action of these medicines.
• Treating heart rhythm problems, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injections.
• Treating HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir).
• Treating fungal infections (e.g., ketoconazole, itraconazole, amphotericin).
• Treating heart problems, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis.
• Treating cancer, such as amifostine, cyclophosphamide, or methotrexate.
• Increasing blood pressure and decreasing heart rate, such as noradrenaline.
• Treating gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Lowering blood fat levels, such as cholestyramine and colestipol.
• Lowering blood sugar levels, such as metformin or insulin.

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

Taking Balzak Plus with food and drink

Balzak Plus may be taken with or without food.

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

Be cautious when drinking alcohol while taking Balzak Plus, as some people may feel faint or dizzy. If this happens, do not consume alcohol.

Elderly patients

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

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you to stop taking Balzak Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of Balzak Plus is not recommended during pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.

If you become pregnant while being treated with Balzak Plus, inform and consult your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. Balzak Plus is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

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

Driving and operating machinery

You may feel drowsy, sick, dizzy, or experience headache while undergoing treatment for high blood pressure. If this occurs, 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 Plus

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

• The recommended dose of Balzak Plus is one tablet daily.
• Tablets may be taken with or without food. Swallow the tablets with some liquid (such as a glass of water). Do not chew the tablet. Do not take the tablets 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 Plus 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 department, and take the medicine packaging or this leaflet with you.

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

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.

If you forget to take Balzak Plus

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 Plus

It is important to continue taking Balzak Plus 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 may 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 Plus, allergic reactions may occur, 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 Plus and consult your doctor immediately.

Balzak Plus may cause a marked drop in blood pressure in susceptible patients. This may lead to fainting or severe dizziness. If this happens to you, stop taking Balzak Plus, 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 Plus some time ago, contact your doctor immediately, who will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Balzak Plus is a combination of three active substances. The following information first describes the adverse effects reported so far with the combination Balzak Plus (in addition to those already mentioned), and secondly, the known adverse effects of each of the active substances individually, or when two of the substances are taken together.

To give you an idea of the number of patients who may experience adverse effects, these have been classified as common, uncommon, rare, and very rare.

These are other known adverse effects with Balzak Plus so far:

If these effects occur, they are often mild and it is not necessary to discontinue treatment.

Common

(may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat and nose, urinary tract infection, dizziness, headache, awareness of heartbeat, low blood pressure, nausea, diarrhea, constipation, cramps, joint swelling, urgency to urinate, weakness, ankle swelling, fatigue, abnormal laboratory test results.

Uncommon

(may affect up to 1 in 100 people)

Dizziness upon standing, vertigo, rapid heartbeat, feeling faint, flushing and sensation of warmth in the face, cough, dry mouth, muscle weakness, inability to achieve or maintain an erection.

These are the known adverse effects for each of the active substances individually or when two of the substances are taken together:

These may be adverse effects due to Balzak Plus, even if they have not been observed so far with Balzak Plus.

Very common

(may affect more than 1 in 10 people)

Edema (fluid retention).

Common

(may affect up to 1 in 10 people)

Bronchitis, stomach and intestinal infection, vomiting, increased blood sugar, sugar in urine, confusion, drowsiness, visual disturbances (including double vision and blurred vision), nasal discharge or congestion, sore throat, difficulty breathing, cough, abdominal pain, heartburn, stomach discomfort, flatulence, joint or bone pain, back pain, bone pain, blood in urine, flu-like symptoms, chest pain, pain.

Uncommon

(may affect up to 1 in 100 people)

Reduction in the number of a type of blood cells called platelets, which may cause easy bruising or prolonged bleeding time, anaphylactic reactions, abnormal decrease in appetite (anorexia), sleep problems, irritability, mood changes including anxiety, feeling depressed, chills, sleep disorders, altered sense of taste, loss of consciousness, decreased sense of touch, tingling sensation, worsening of myopia, ringing in the ears (tinnitus), angina (chest pain or discomfort, known as angina pectoris), irregular heartbeat, rash, hair loss, allergic skin inflammation, skin redness, purple spots or patches on the skin due to small hemorrhages (purpura), skin discoloration, itchy red welts (urticaria), increased sweating, pruritus, skin rash, skin reactions to light such as sunburn or skin eruption, muscle pain, problems urinating, feeling of needing to urinate at night, breast enlargement in men, decreased sex drive, facial swelling, feeling unwell, weight gain or loss, exhaustion.

Rare

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

Inflammation and pain of the salivary glands, decreased number of white blood cells in the blood, which could increase the risk of infections, decreased number of red blood cells (anemia), bone marrow damage, restlessness, feeling of loss of interest (apathy), attacks (seizures), yellowish perception of objects when looking at them, dry eyes, blood clots (thrombosis, embolism), fluid accumulation in the lungs, pneumonia, inflammation of blood vessels and small blood vessels in the skin, inflammation of the pancreas, yellowing of the skin and eyes, acute inflammation of the gallbladder, symptoms of systemic lupus erythematosus such as skin rash, joint pains, and coldness in hands and fingers, severe skin reactions including intense skin rash, urticaria, redness of the skin of the body, severe itching, blisters, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe, impaired movement, acute kidney failure, non-infectious inflammation of the kidney, decreased kidney function, fever; intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Very rare

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

High muscle tension, numbness of hands or feet, heart attack, inflammation of the stomach, gum thickening, intestinal obstruction, liver inflammation, acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Adverse effects of unknown frequency

(cannot be estimated from available data)

Decreased vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

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

Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any type of adverse effect, 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 Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Balzak Plus

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

Do not use this medicine after the expiry date stated on the container and blister pack (after "EXP"). The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

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

6. Contents of the pack and other information

Composition of Balzak Plus

The active substances are olmesartan medoxomilo, amlodipine (as amlodipine besilate) and hydrochlorothiazide.

Each film-coated tablet contains 40 mg of olmesartan medoxomilo, 5 mg of amlodipine (as amlodipine besilate) and 12.5 mg of hydrochlorothiazide.

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) and yellow iron oxide (E-172).

Appearance of the product and pack contents

Balzak Plus 40 mg/5 mg/12.5 mg film-coated tablets are light yellow, round tablets 9.5 mm in diameter, with the inscription “C53” on one side.

Balzak Plus film-coated tablets are available:

• in laminated blisters of polyamide/aluminum/polyvinyl chloride-aluminum in packs of:
  • 14, 28, 30, 56, 84, 90, 98 and 10 x 28, 10 x 30 tablets in blisters.
  • 10 x 1, 50 x 1 and 500 x 1 tablets in pre-perforated single-dose blisters.
• in HDPE bottles containing 7, 30 and 90 tablets.

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 – E 08918 Badalona (Barcelona)

Manufacturer

DAIICHI SANKYO EUROPE GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

or

BERLIN-CHEMIE AG

Glienicker Weg 125

12489 Berlin

Germany

or

MENARINI – VON HEYDEN GmbH

Leipziger Strasse 7-13

01097 Dresden

Germany

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

Austria: Amelior plus HCT 40 mg/5 mg/12.5 mg

Belgium: Forzaten/HCT 40 mg/5 mg/12.5 mg

Bulgaria: Tespadan HCT 40 mg/5 mg/12.5 mg

Cyprus: Orizal plus 40 mg/5 mg/12.5 mg

Czech Republic: Sintonyn Combi 40 mg/5 mg/12.5 mg

Estonia: Sanoral HCT 40 mg/5 mg/12.5 mg

Germany: Vocado HCT 40 mg/5 mg/12.5 mg

Greece: Orizal plus 40 mg/5 mg/12.5 mg

Hungary: Duactan HCT 40 mg/5 mg/12.5 mg

Ireland: Konverge Plus 40 mg/5 mg/12.5 mg

Latvia: Sanoral HCT 40 mg/5 mg/12.5 mg

Lithuania: Sanoral HCT 40 mg/5 mg/12.5 mg

Luxembourg: Forzaten HCT 40 mg/5 mg/12.5 mg

Netherlands: Belfor HCT 40 mg/5 mg/12.5 mg

Malta: Konverge Plus 40 mg/5 mg/12.5 mg

Poland: Elestar HCT 40 mg/5 mg/12.5 mg

Portugal: Zolnor HCT 40 mg/5 mg/12.5 mg

Romania: Inovum HCT 40 mg/5 mg/12.5 mg

Slovakia: Folgan HCT 40 mg/5 mg/12.5 mg

Slovenia: Olectan HCT 40 mg/5 mg/12.5 mg

Spain: Balzak Plus 40 mg/5 mg/12.5 mg

Date of the most recent revision 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/