Kalpress Plus 320 mg/12.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Kalpress Plus 320mg/12.5mg film-coated tablets

Valsartan/hydrochlorothiazide

Read the entire 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 give it to others, even if they have the same symptoms as you, because it could 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.

Contents of the leaflet

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 side 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, resulting in 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 lowers 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 the blood vessels of 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 conditions.

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 components of this medicine (listed in section 6).

• if you are more than 3 months pregnant (in any case, it is best 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 (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 your blood, or if your blood calcium levels are higher than normal despite treatment.

• if you have gout.

• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

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 your potassium levels necessary.

• if you have low blood potassium levels.

• 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 your 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 loss of vision 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 (ACEI) (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, especially 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 rays while taking Kalpress Plus.

• if you have previously had respiratory 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 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 information under the heading “Do not take Kalpress Plus”.

Kalpress Plus may increase skin sensitivity to sunlight.

The use of Kalpress Plus is not recommended 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 serious harm to your baby; see Pregnancy section.

Taking Kalpress Plus with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

The effect of treatment with Kalpress Plus may be altered if taken together 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 is especially relevant for the following medicines:

• lithium, a medicine used to treat certain psychiatric conditions
• medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin
• medicines that may decrease blood potassium levels, such as diuretics (medicines that 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 (ritonavir). These drugs may increase the effect of Kalpress Plus
• medicines that may induce “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 used to treat gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic vitamin D and calcium supplements
• medicines used to treat 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 may 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 variety 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 diseases)
• 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 consulted your doctor. Alcohol may further lower your blood pressure and/or increase the likelihood of dizziness and weakness.

Pregnancy and breastfeeding

• Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally 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 serious 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 more suitable treatment if you wish to breastfeed, especially if you have a newborn or premature infant.

Driving and using machines

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

3. How to take Kalpress Plus

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

People with high blood pressure often do not notice any signs of the condition and frequently feel perfectly well. Therefore, it is very important to keep your doctor's appointments, even if you feel fine.

Your doctor will tell you exactly how many Kalpress Plus tablets you should take. Depending on your response to treatment, your doctor may recommend 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.

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 will experience 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 rash, redness of the skin, blisters on 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-coloured 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
• diarrhoea
• 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 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 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 presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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 inflammation of blood vessels)
• low platelet count (sometimes with more frequent bleeding or bruising than usual)
• high potassium levels in 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 haemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may cause anaemia)
• renal failure
• low sodium levels in 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 blood
• increased blood lipid levels

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

• low sodium levels in blood
• low magnesium levels in blood
• high uric acid levels in blood
• itchy rash and other types of skin rash
• 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 blood
• high blood sugar levels
• sugar in urine
• worsening of diabetic metabolic status
• constipation, diarrhoea, stomach or intestinal discomfort, liver disorders which may occur 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 oedema)
• pale skin, fatigue, shortness of breath, dark urine (haemolytic anaemia)
• fever, sore throat or mouth ulcers due to infections (leucopenia)
• confusion, fatigue, muscle twitching and cramps, rapid breathing (hypochloraemic alkalosis)

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

• weakness, bruising and frequent infections (aplastic anaemia)
• marked decrease in urine production (possible signs of kidney impairment or kidney failure)
• skin rash, redness of the skin, blisters on 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 type of adverse effect, talk to 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 (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 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. Unused medicines and their packaging should be returned to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. 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 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other components are: microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate.
• The tablet coating 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 pack

Kalpress Plus 320 mg/12.5 mg film-coated tablets are oval-shaped, bevelled-edged, pink tablets, with the imprint “NVR” on one side and “HIL” on the other.

The tablets are available in blister packs containing 7, 14, 28 tablets in calendar pack, 56, 98 tablets in calendar pack, or 280 tablets. Single-dose pre-cut blister packs are also available containing 56x1, 98x1 or 280x1 tablets.

Only certain pack sizes may be commercially available.

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 – 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 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 about 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:

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/