Kalpress Plus 160 mg/12.5 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Kalpress Plus 160mg/12.5mg film-coated tablets

Valsartan/hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

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

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

• Valsartan belongs to a class of medicines known as "angiotensin II receptor antagonists" which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, leading to increased blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazide belongs to a class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also helps lower blood pressure.

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

Hypertension increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these complications.

2. What you need to know before taking Kalpress Plus

Do not take Kalpress Plus

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant (in any case, it is better to avoid taking this medicine also during early pregnancy – see Pregnancy section).
• if you have severe liver disease, destruction of the small bile ducts in the liver (primary biliary cirrhosis) leading to bile accumulation in the liver (cholestasis).
• if you have severe kidney disease.
• if you are unable to produce urine (anuria).
• if you are undergoing dialysis.
• if you have abnormally low levels of potassium or sodium in the blood, or if your blood calcium levels are higher than normal despite treatment.
• if you have gout.
• if you have diabetes or renal impairment and are being treated with an aliskiren-containing medicine to lower blood pressure.

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

Warnings and precautions

Consult your doctor

• if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium, or other medicines that increase blood potassium levels, such as heparin. Your doctor may consider regular monitoring of potassium levels necessary.
• if you have low potassium levels in the blood.
• if you experience severe diarrhoea 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 when starting treatment. Your doctor may also monitor your kidney function.
• if you have narrowing of the artery to the kidney (renal artery stenosis).
• if you have recently undergone a kidney transplant.
• if you have hyperaldosteronism, a condition 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 previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If you develop these symptoms while taking Kalpress Plus, stop treatment immediately and never take it again. See also section 4 “Possible side effects”.
• if you develop abdominal pain, nausea, vomiting, or diarrhoea 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, or high cholesterol or triglyceride levels in the blood.
• if you have previously had an allergic reaction to another medicine of this class used to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.
• if you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from several hours to weeks after taking Kalpress Plus. If untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulphonamides.
• if you are taking any of the following medicines used to treat high blood pressure:
  • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.
• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Kalpress Plus.
• if you have previously had breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop 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 blood electrolyte levels (e.g., potassium) at regular intervals.

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

Kalpress Plus may increase skin sensitivity to sunlight.

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

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Use of Kalpress Plus is not recommended during early pregnancy (first 3 months) and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby. See section Pregnancy.

Taking Kalpress Plus with other medicines

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

The effect of Kalpress Plus may be altered when taken with certain medicines. Your doctor may need to adjust your dose and/or take other precautions, or in some cases discontinue treatment with one of the medicines. This particularly applies to the following medicines:

• lithium, a medicine used to treat certain psychiatric conditions
• medicines or substances that may increase blood potassium levels, including potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin
• medicines that may decrease blood potassium levels, such as diuretics (medicines to increase urine production), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G
• certain antibiotics (rifampicin group), a drug used to prevent transplant rejection (cyclosporine), or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of Kalpress Plus
• medicines that may cause "torsades de pointes" (irregular heartbeats), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics
• medicines for gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic vitamin D and calcium supplements
• medicines for diabetes (insulin or oral antidiabetics such as metformin)
• other blood pressure-lowering medicines including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also information under the headings “Do not take Kalpress Plus” and “Warnings and precautions”)
• medicines that increase blood pressure, such as noradrenaline or adrenaline
• digoxin or other digitalis glycosides (medicines used to treat heart problems)
• medicines that may increase blood sugar levels, such as diazoxide or beta-blockers
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide
• pain medicines such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) and acetylsalicylic acid at doses above 3 g
• muscle relaxants such as tubocurarine
• anticholinergic medicines (used to treat a wide range of disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, travel sickness, muscle spasms, Parkinson's disease, and as an aid in anaesthesia)
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral infections)
• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels)
• cyclosporine, a medicine used to prevent rejection of transplanted organs
• alcohol, sleeping medicines, and anaesthetics (medicines with sedative or pain-relieving effects, used, for example, during surgery)
• iodinated contrast media (used in diagnostic imaging procedures)

Taking Kalpress Plus with food, drinks, and alcohol

Avoid drinking alcohol until you have discussed it with your doctor. Alcohol may further lower your blood pressure and/or increase the likelihood of dizziness and weakness.

Pregnancy and breastfeeding

• You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking Kalpress Plus before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Kalpress Plus is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby when used from that time.

• Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Kalpress Plus is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable if you wish to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

Before driving a vehicle, operating tools, handling machinery, or performing other activities requiring concentration, make sure you are aware of how you react to Kalpress Plus. Like many other medicines used to treat high blood pressure, Kalpress Plus may rarely cause dizziness and affect concentration ability.

3. How to take Kalpress Plus

Always take this medicine exactly as your doctor has told you. This will help you achieve the best results and reduce the risk of adverse effects. If in doubt, consult your doctor or pharmacist again.

People with high blood pressure often do not experience any symptoms and may feel perfectly normal. This makes it very important to attend your medical appointments regularly, even if you feel well.

Your doctor will tell you exactly how many Kalpress Plus tablets 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 daily.
• Do not change the dose or stop treatment without consulting your doctor.
• This medicine should be taken at the same time every day, usually in the morning.
• You may 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 accidentally taken too many tablets, contact your doctor, pharmacist, or hospital. You may also contact the toxicology information service at telephone number 91 562 04 20, indicating the medicine 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 your next dose, skip the missed dose.

Do not take a double dose to make up for forgotten doses.

If you stop taking Kalpress Plus

If you stop treatment with Kalpress Plus, your hypertension may worsen. Do not stop taking the medicine unless your doctor tells you to do so.

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.

Some adverse effects may be serious and require immediate medical attention:

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

• swelling of the face, tongue or pharynx

• difficulty swallowing

• hives and difficulty breathing

• Serious skin disease causing skin rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)

• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)

• Fever, sore throat, increased frequency of infections (agranulocytosis)

• Severe breathing difficulty, fever, weakness and confusion (acute respiratory distress)

These adverse 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 adverse effects include:

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

• cough
• low blood pressure
• dizziness
• dehydration (with symptoms of thirst, dry mouth and tongue, reduced frequency of urination, dark-colored urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• noises (e.g. ringing or buzzing) in the ears

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

• dizziness
• diarrhea
• joint pain

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

• difficulty breathing
• severe decrease in urine output
• 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 cramps, irregular heartbeat)
• low white blood cell count (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 blood urea nitrogen and creatinine levels (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 adverse effects have been observed with medicines containing valsartan or hydrochlorothiazide separately:

Valsartan

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

• sensation of spinning
• abdominal pain

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

• intestinal angioedema: swelling in the intestine accompanied by symptoms such as abdominal pain, nausea, vomiting and diarrhea.

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

• blisters on the skin (sign of bullous dermatitis)
• skin rash with or without itching together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
• skin rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
• low platelet count (sometimes with increased bleeding or bruising)
• high potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
• 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
• elevated liver function test values
• decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anemia)
• renal failure
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations and/or seizures)

Hydrochlorothiazide

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

• low potassium levels in the blood
• increased blood lipids

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

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• itchy skin rash and other types of rashes
• decreased appetite
• mild vomiting and nausea
• dizziness, dizziness upon standing
• inability to achieve or maintain an erection

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

• swelling and blisters on the skin (due to increased sensitivity to sunlight)
• high calcium levels in the blood
• high blood sugar levels
• sugar in the urine
• worsening of diabetic metabolic status
• constipation, diarrhea, stomach or intestinal discomfort, liver disorders that may occur along with yellowing of the skin and eyes
• irregular heartbeat
• headache
• sleep disturbances
• sadness (depression)
• low platelet count (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• vision disturbances

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

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• severe pain in the upper abdomen (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory difficulty including pneumonitis and pulmonary edema)
• pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)
• fever, sore throat or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, muscle twitching and cramps, rapid breathing (hypochloremic alkalosis)

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

• weakness, bruising and frequent infections (aplastic anemia)
• marked decrease in urine production (possible signs of kidney dysfunction or kidney failure)
• skin rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle cramps
• fever (pyrexia)
• weakness (asthenia)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Kalpress Plus

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
• Do not store above 30°C. Store in the original packaging to protect from moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Kalpress Plus

• The active substances are valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other components are: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate.
• The tablet film-coating contains: hypromellose, macrogol 8000, talc, iron oxide red (E 172), titanium dioxide (E 171).

Nature of the product and pack contents

Kalpress Plus 160 mg/12.5 mg film-coated tablets are oval-shaped, dark red tablets, marked “HHH” on one side and “CG” on the other.

The tablets are available in blister packs containing 14 tablets, calendar packs containing 28 tablets, 56 tablets, 98 tablets (calendar pack) or 280 tablets. Also available are pre-cut unit-dose blister packs of 56x1, 98x1 or 280x1 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Manufacturer

Novartis Farma S.p.A.

Via Provinciale Schito, 131

80058 Torre Annunziata (NA)

Italy

Novartis Farma – Produtos Farmacêuticos, S.A.

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

Oeiras Parish. 2740 255

Portugal

Novartis Sverige AB

Torshamnsgatan 48

164 40 Kista

Sweden

Novartis Pharma B.V.

Haaksbergweg 16

1101 BX Amsterdam

The Netherlands

Novartis Pharma GmbH

Jakov-Lind-Straße 5, Top 3.05

1020 Vienna

Austria

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

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

12 km National Road

Athens-Lamia. GR-14451. Metamorphoses

Greece

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 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 further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo, 29

08022 Barcelona, Spain

Tel: +34 93 205 86 86

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Sweden	Angiosan Comp
Germany	Cordinate plus
Greece	Co-Dalzad
Spain	Kalpress Plus

Date of the last revision of this leaflet: 11/2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/