Prospect: information for the user

Kalpress Plus 320mg/12,5mg coated tablets

Valsartan/hydrochlorothiazide

Read this prospect carefully before starting to take this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you, and you must not give it to other people even if they have the same symptomsas you, as it may harm them.
• Ifyou experienceadverse effects, consult your doctor or pharmacist, even if they are not listedin this prospect.See section 4.

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

2.What you need to know before starting to take Kalpress Plus

3.How to take Kalpress Plus

4.Possible adverse effects

5.Storage of Kalpress Plus

6.Contents of the package and additional information

Kalpress Plus film-coated tablets contain two active ingredients known as valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartanbelongs to a class of medications known as “angiotensin II receptor antagonists” that help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to constrict, resulting in increased blood pressure. Valsartan acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazidebelongs to a class of medications known as thiazide diuretics. Hydrochlorothiazide increases diuresis, which also decreases blood pressure.

Kalpress Plus is used to treat high blood pressure that is not adequately controlled with the use of a single component.

Hypertension increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys and may cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

Do not takeKalpress Plus

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemical substances related to hydrochlorothiazide) or to any of the other components ofthis medication (listed in section 6).

• if you are more than 3months pregnant(in any case, it is better to avoid taking this medication also at the beginning of your pregnancy – see Pregnancy section).
• if you have a severe liver diseaseorbile duct destruction in the liver (biliary cirrhosis) that leads to a buildup of bile in the liver (cholestasis).
• if you have a severe kidney disease.
• if you are unable to produce urine (anuria).
• if you are undergoing dialysis.
• if you have lower-than-normal levels of potassium or sodium in your blood, or if your blood calcium levels are higher than normal despite treatment.
• if you have gout.
• if you have diabetes or kidney insufficiency and are being treated with a medication to reduce blood pressure that contains aliskiren.

If any of these situations affect you, inform your doctor and do not take Kalpress Plus.

Warnings and precautions

Consult your doctor

• if you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium, or other medications that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly monitor your potassium levels.
• if you have low levels of potassium in your blood.
• if you experience severe diarrhea or vomiting.
• if you are taking high doses of a diuretic.
• if you have severe heart disease.
• if you have heart failure or have had a heart attack. Follow your doctor's instructions carefully to start treatment. Your doctor may also monitor your kidney function.
• if you have a narrowing of the renal artery.
• if you have recently undergone a kidney transplant.
• if you have primary aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, Kalpress Plus is not recommended.
• if you have kidney or liver disease.
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACE inhibitors), inform your doctor. If you have these symptoms when taking Kalpress Plus, stop taking it immediately and never take it again. See also section 4 “Possible side effects”.
• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Kalpress Plus. Your doctor will decide whether to continue treatment. Do not stop taking Kalpress Plus on your own.
• if you have fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (a known autoimmune disease).
• if you have diabetes, gout, high levels of cholesterol or triglycerides in your blood.
• if you have previously experienced an allergic reaction with the use of another medication of this class to reduce blood pressure (angiotensin II receptor antagonists), or if you have any type of allergy or asthma.
• if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased eye pressure, which can occur within a few hours to several weeks after taking Kalpress Plus. If left untreated, this can lead to permanent vision loss. You may be at higher risk of developing it if you have previously been allergic to penicillin or sulfonamides.

• if you are taking any of the following medications used to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.
• if you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Kalpress Plus.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Kalpress Plus, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

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

Kalpress Plusmay cause increased sensitivity to the sun.

Kalpress Plus is not recommended for use in children and adolescents (under 18years).

If you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant, inform your doctor. Kalpress Plus is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy because it may cause serious harm to your baby, see Pregnancy section.

Use ofKalpress Plus withother medications

Inform your doctor or pharmacist if you are using, have used recentlyor may need to useany other medication.

The effect of treatment withKalpress Plusmay be altered if taken with certain medications. Your doctor may need to modify your dose and/or take other precautions or, in some cases, discontinue treatment with one of the medications. This is particularly applicable to the following medications:

• lithium, a medication used to treat certain types of psychiatric disorders
• medications or substances that may increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin
• medications that may decrease the amount of potassium in the blood, such as diuretics (urine-producing medications), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G
• some antibiotics (of the rifampicin group), a medication used to protect against rejection in a transplant (ciclosporin) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Kalpress Plus
• medications that may induce “torsades de pointes” (irregular heartbeats), such as antiarrhythmics (medications used to treat heart problems) and some antipsychotics
• medications that may reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics
• medications used to treat gout, such as allopurinol, probenecid, sulfinpyrazone
• vitamin D therapy and calcium supplements
• medications used to treat diabetes (insulin or oral antidiabetic medications such as metformin)
• other medications to reduce blood pressure, including methyldopa, ACE inhibitors(such as enalapril, lisinopril, etc.,) or aliskiren(see also the information under the headings“Do not take Kalpress Plus” and “Warnings and precautions”)
• medications that increase blood pressure, such as norepinephrine or epinephrine
• digoxin or other digitalis glycosides (medications used to treat heart problems)
• medications that may increase blood sugar levels, such as diazoxide or beta-blockers
• chemotherapy medications (used to treat cancer), such as methotrexate or cyclophosphamide
• pain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors and aspirin in doses above3 g
• muscle relaxants, such as tubocurarine
• anticholinergic medications (medications used to treat a wide range of disorders such as gastrointestinal cramps, urinary tract spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia)
• amantadine (a medication used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses)
• cholestyramine and colestipol (medications used primarily to treat high levels of lipids in the blood)
• ciclosporin, a medication used to prevent organ rejection after transplantation
• alcohol, sleep medications, and anesthetics (medications with sedative or pain-relieving effects used, for example, in surgery)
• iodinated contrast media (used for diagnostic imaging tests)

TakingKalpress Pluswith food, drinks, and alcohol

Avoid drinking alcohol until you have consulted your doctor. Alcohol may further lower your blood pressure and/or increase the risk of dizziness and weakness.

Pregnancy and breastfeeding

• You must inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant.Generally, your doctor will advise you to stop taking Kalpress Plus before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Kalpress Plus is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to your baby when administered from that point on.

• Inform your doctor if you are planning to initiate or are in a breastfeeding periodsince Kalpress Plus is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machinery

Before driving a vehicle, using tools, or operating machinery, or engaging in other activities that require concentration, make sure you know your reactions to the effects of Kalpress Plus. Like many other medications used to treat high blood pressure, Kalpress Plus may cause, in rare cases, dizziness and affect concentration.

Always take this medication exactly as your doctor tells you to.This will help you get the best results and reduce the risk of side effects.If you are unsure, consult your doctor or pharmacist.

People with high blood pressure often do not notice any symptoms of the disease; many feel normal.This makes it very important to attend your appointments with your doctor, even if you feel well.

Your doctor will tell you exactly how many tablets of Kalpress Plus you should take.Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

• The recommended dose of Kalpress Plus is one tablet per day.
• Do not change the dose or stop treatment without consulting your doctor.
• This medication should be taken at the same time every day, usually in the morning.
• You can take Kalpress Plus with or without food.
• Swallow the tablet with a glass of water.

If you take more Kalpress Plus than you should

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.

If you have taken too many tablets by accident, contact your doctor, pharmacist, or hospital.You can also call the toxicology information service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Kalpress Plus

If you forget to take a dose, take it as soon as you remember.However, if it is almost time for the next dose, skip the missed dose.

Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Kalpress Plus

If you stop taking Kalpress Plus, your high blood pressure may worsen.Do not stop taking the medication unless your doctor tells you to.

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.

Some side effects can be serious and require immediate medical attention:

• You should visit your doctor immediately if you notice symptoms of angioedema, such as:

• hinchazón en la cara, lengua o faringe swelling in the face, tongue, or throat
• dificultad para tragar difficulty swallowing
• urticaria y dificultad para respirar hives and difficulty breathing

• Enfermedad grave de la piel que causa erupción cutánea, enrojecimiento de la piel, ampollas en los labios, ojos o boca, descamación de la piel, fiebre (necrólisis tóxica de la piel) Severe skin disease that causes skin rash, redness of the skin, blisters on the lips, eyes, or mouth, peeling of the skin, fever (toxic epidermal necrolysis)
• Disminución de la visión o dolor en los ojos debido a la presión alta (posibles signos de acumulación de líquido en la capa vascular del ojo (derrame coroideo) o glaucoma de ángulo cerrado agudo) Decreased vision or eye pain due to high blood pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma)
• Fiebre, dolor de garganta, mayor frecuencia de infecciones (agranulocitosis) Fever, sore throat, increased frequency of infections (agranulocytosis)
• Dificultad respiratoria grave, fiebre, debilidad y confusión (dificultad respiratoria aguda) Severe respiratory difficulty, fever, weakness, and confusion (acute respiratory distress)

These side effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop taking Kalpress Plus and contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other side effects include:

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

• cough
• low blood pressure
• dizziness
• deshidratación (con síntomas de sed, boca y lengua secas, reducción de la frecuencia de urinación, orina de color oscuro, piel seca) dehydration (with symptoms of thirst, dry mouth and tongue, reduced urine frequency, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• ringing in the ears

Very rare (may affect fewer than 1 in 10,000 people):

• dizziness
• diarrhea
• joint pain

Unknown frequency (cannot be estimated from available data):

• severe difficulty breathing
• severe decrease in urine production
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or seizures)
• low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• low white blood cell count in the blood (with symptoms such as fever, skin infections, sore throat, or mouth ulcers due to infections, weakness)
• increased bilirubin levels in the blood (which, in severe cases, may cause yellowing of the skin and eyes)
• increased urea and creatinine levels in the blood (which may indicate abnormal kidney function)
• increased uric acid levels in the blood (which, in severe cases, may trigger a gout attack)
• syncope (fainting)

The following side effects have been observed with valsartan or hydrochlorothiazide-containing medications separately:

Valsartan

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

• feeling of rotation
• abdominal pain

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

• intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown frequency (cannot be estimated from available data)::

• blistering of the skin (sign of dermatitis bullosa)
• skin rash with or without itching, along with one or more of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or symptoms similar to the flu
• skin rash, red-purple spots, fever, itching (signs of vasculitis)
• low platelet count (sometimes with bleeding or bruising more frequently than usual)
• high potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)
• allergic reactions (with symptoms such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling mainly of the face and throat; skin rash; itching
• increased liver function values
• decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may cause anemia)
• renal insufficiency
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or seizures)

Hidroclorotiazida

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

• niveles bajos de potasio en sangre low potassium levels in the blood
• aumento de lípidos en sangre increased lipids in the blood

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

• niveles bajos de sodio en sangre low sodium levels in the blood
• niveles bajos de magnesio en sangre low magnesium levels in the blood
• niveles altos de ácido úrico en sangre high uric acid levels in the blood
• erupción cutánea con picor y otros tipos de erupción skin rash with itching and other types of rash
• disminución del apetito decreased appetite
• vómitos y náuseas leves light vomiting and nausea
• mareos, mareo al levantarse dizziness, dizziness when standing up
• incapacidad de alcanzar o mantener una erección inability to achieve or maintain an erection

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

• hinchazón y ampollas en la piel (debido a una mayor sensibilidad al sol) swelling and blisters on the skin (due to increased sensitivity to the sun)
• niveles altos de calcio en sangre high calcium levels in the blood
• niveles altos de azúcar en sangre high blood sugar levels
• azúcar en la orina sugar in the urine
• empeoramiento del estado metabólico diabético worsening of diabetic metabolic state
• estreñimiento, diarrea, molestias en el estómago o intestinos, alteraciones del hígado que pueden aparecer junto con la piel y los ojos amarillos constipation, diarrhea, stomach or intestinal discomfort, liver changes that may appear with yellow skin and eyes
• latido irregular del corazón irregular heartbeat
• dolor de cabeza headache
• alteraciones del sueño sleep disturbances
• tristeza (depresión) depression
• nivel bajo de plaquetas (a veces con sangrado o contusiones bajo la piel) low platelet count (sometimes with bleeding or bruising under the skin)
• mareos dizziness
• hormigueo o adormecimiento tingling or numbness
• alteración de la visión vision disturbances

Very rare (may affect fewer than 1 in 10,000 people)::

• inflamación de los vasos sanguíneos con síntomas como erupción cutánea, manchas rojo púrpura, fiebre (vasculitis) vasculitis with symptoms such as skin rash, red-purple spots, fever
• erupción, picor, urticaria, dificultad al respirar o tragar, mareos (reacciones de hipersensibilidad) skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• erupción en la cara, dolor en las articulaciones, trastornos musculares, fiebre (lupus eritematoso) skin rash, joint pain, muscle disturbances, fever (lupus erythematosus)
• dolor fuerte en la parte superior del estómago (pancreatitis) severe pain in the upper abdomen (pancreatitis)
• dificultad para respirar con fiebre, tos, respiración sibilante, falta de aliento (dificultad para respirar que incluye neumonitis y edema pulmonar) difficulty breathing with fever, cough, wheezing, shortness of breath (difficulty breathing that includes pneumonia and pulmonary edema)
• piel pálida, fatiga, falta de aliento, orina de color oscuro (anemia hemolítica) paleness of the skin, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fiebre, dolor de garganta o úlceras en la boca debido a infecciones (leucopenia) fever, sore throat, or mouth ulcers due to infections (leukopenia)
• confusión, fatiga, tirones musculares y espasmos, respiración rápida (alcalosis hipoclorémica) confusion, fatigue, muscle fasciculations, and spasms, rapid breathing (hypochloremic alkalosis)

Unknown frequency (cannot be estimated from available data)::

• debilidad, contusiones e infecciones frecuentes (anemia aplásica) weakness, bruising, and frequent infections (aplastic anemia)
• disminución importante de la producción de orina (posibles signos de alteración renal o fallo renal) significant decrease in urine production (possible signs of renal impairment or renal failure)
• erupción cutánea, enrojecimiento de la piel, ampollas en los labios, ojos o boca, descamación de la piel, fiebre (posibles signos de eritema multiforme) skin rash, redness of the skin, blisters on the lips, eyes, or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
• espasmos musculares muscle spasms
• fiebre (pirexia) fever
• debilidad (astenia) weakness
• cáncer de piel y labios (cáncer de piel no-melanoma) skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use (www.notificaRAM.es). By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

• Keep out of sight and reach of children.
• Do not usethis medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.
• Do not store at a temperature above30°C. Store in the original packaging to protect it from moisture.
• Do not usethis medicationif you observe that the packaging is damaged or shows signs of handling.
• Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines that you no longer need at theSIGREcollection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need.This will help protect the environment.

Composition ofKalpress Plus

• The active principles are valsartán and hidroclorotiazida. Each tablet contains 320 mg of valsartán and 12.5 mg of hidroclorotiazida.
• The other components are: microcrystalline cellulose, crospovidona, anhydrous colloidal silica, magnesium stearate.
• The coating of the tablet contains: hypromellose, macrogol 4000, talc, iron oxide red (E 172), iron oxide black (E 172), titanium dioxide (E 171).

Appearance of the product and contents of the package

The coated tablets of Kalpress Plus 320 mg/12.5 mg are oval, with beveled edges, pink in color, with the imprint “NVR” on one face and “HIL” on the other.

The tablets are presented in blister packs with 7 tablets, 14 tablets, 28 tablets in a calendar pack, 56 tablets, 98 tablets in a calendar pack, or 280 tablets. Blister packs precut in single doses of 56x1, 98x1, or 280x1 tablets are also available.

Only some package sizes may be marketed.

Holder of the marketing authorization

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Responsible for manufacturing

Novartis Farma S.p.A.

Via Provinciale Schito, 131

80058 Torre Annunziata (NA)

Italy

Novartis Farma – Productos Farmacêuticos, S.A.

Avenida Professor Doutor Cavaco Silva, n.° 10E (Taguspark, Porto Salvo).

Oeiras Parish. 2740 255

Portugal

Novartis Sverige AB

Torshamnsgatan 48

164 40 Kista

Sweden

Novartis Pharma GmbH

Roonstrasse 25

DE-90429 Nuremberg

Germany

Novartis Pharma B.V.

Haaksbergweg 16,

1101 BX Amsterdam

Netherlands

Novartis Pharma GmbH

Jakov-Lind-Straße 5, Top 3.05

1020 Vienna

Austria

Novartis Pharma nv

Medialaan 40/Bus 1

BE-1800 Vilvoorde

Belgium

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis (Hellas) S.A.C.I.

12 km National Road

Atenas-Lamia.GR-14451. Metamorphoses

Greece

Novartis Finland Oy

Metsäneidonkuja 10

FI-02130 Espoo

Finland

Novartis Hungária Kft.

Bartók Béla út 43-47.

1114 Budapest

Hungary

Novartis s.r.o.

Na Pankráci 1724/129

CZ-140 00 Prague 4, Nusle

Czech Republic

Novartis Poland Sp. zo.o.

ul. Marynarska 15

02-674 Warsaw

Poland

Novartis Pharma S.A.S.

8-10 rue Henri Sainte-Claire Deville

92500 Rueil-Malmaison

France

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nuremberg

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo, 29

08022 Barcelona, Spain

Phone: +34 93 205 86 86

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:11/2024

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) at http://www.aemps.gob.es/