KALPRESS 160 mg FILM-COATED TABLETS

2. What you need to know before you take Kalpress

Do not take Kalpress:

• if you are allergic(hypersensitive) to valsartan or any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease.
• if you are pregnantover 3 months(it is also better to avoid Kalpress during the first months of pregnancy – see section Pregnancy).
• if you have diabetes or kidney problems and are being treated with a medicine to reduce blood pressure that contains aliskiren.

If any of the above applies to you, tell your doctor and do not takeKalpress.

Warnings and precautions:

Consult your doctor

• if you have liver disease.
• if you have severe kidney disease or are undergoing dialysis.
• if you have narrowing of the kidney artery.
• if you have recently had a kidney transplant (received a new kidney).
• if you have severe heart disease other than heart failure or heart attack.
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), inform your doctor. If you have these symptoms when taking Kalpress, stop taking Kalpress 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. Your doctor will decide whether to continue treatment. Do not stop taking Kalpress on your own.
• if you are taking medicines that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin. It may be necessary to regularly check the amount of potassium in the blood.
• if you have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to take Kalpress.
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to increase urine production).
• 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), especially if you have kidney problems related to diabetes
  • aliskiren
• if you are being treated with an ACE inhibitor along with other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

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

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

You should inform your doctor if you think you are (or might become) pregnant. Kalpress is not recommended at the start of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy (see section Pregnancy).

Using Kalpress with other medicines

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

The effect of treatment with Kalpress may be affected if taken with certain other medicines. Your doctor may need to change your dose and/or take other precautions, or in some cases, stop treatment with one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• other medicines that lower blood pressure,especially diuretics(medicines to increase urine production), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also the information under the headings “Do not take Kalpress” and “Warnings and precautions”).
• medicines that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin.
• certain pain medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs).
• certain antibiotics (of the rifampicin group), a medicine used to protect against rejection in a transplant (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Kalpress.
• lithium,a medicine used to treat certain types of psychiatric diseases.

In addition:

• if you are being treated after a heart attack,it is not recommended to combine with ACE inhibitors(a medication for treating heart attack).
• if you are being treated for heart failure,it is not recommended to combine with ACE inhibitors and other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers(e.g., metoprolol).

Pregnancy and breastfeeding

• You must inform your doctor if you are pregnant(or if you think you might be pregnant).Your doctor will normally advise you to stop taking Kalpress before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Kalpress. Kalpress is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby.

• Tell your doctor if you are breast-feeding or about to start breast-feeding. Kalpress is not recommended during breast-feeding, and your doctor will choose another treatment for you if you want to breast-feed, especially if your baby is a newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or carrying out other activities that require concentration, make sure you know how Kalpress affects you. Like many other medicines used to treat high blood pressure, Kalpress can cause dizziness and affect your ability to concentrate.

3. How to take Kalpress

To get the best results and reduce the risk of side effects, always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist. People with high blood pressure often do not feel any symptoms; many feel normal. This makes it very important to attend your doctor's appointments, even if you feel well.

Adult patients with high blood pressure:the recommended dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Kalpress can also be taken with another medicine (e.g., a diuretic).

Use in children and adolescents from6 toless than 18years of age with high blood pressure:

In patients who weigh less than 35 kg, the recommended starting dose for valsartan tablets is 40 mg once daily.

In patients who weigh 35 kg or more, the recommended starting dose for Kalpress tablets is 80 mg once daily.

In some cases, your doctor may prescribe higher doses (the dose can be increased to 160 mg and up to a maximum of 320 mg).

In children who have difficulty swallowing tablets, the oral solution is recommended.

Adult patients after a recent heart attack:treatment is usually started at 12 hours, normally with a low dose of 20 mg, given twice daily. The 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase this dose over several weeks to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Kalpress can be given with other treatments for heart attack, and your doctor will decide which treatment is suitable for you.

Adult patients with heart failure:treatment is usually started with 40 mg twice daily. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Kalpress can be given with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

You can take Kalpress with or without food. Swallow Kalpress with a glass of water.

Take Kalpress at about the same time each day.

Dosage not covered by the available presentations of Kalpress

The available presentations of Kalpress (80 mg, 160 mg, and 320 mg) do not allow for the administration of the recommended dose for the treatment of recent myocardial infarction or heart failure in adults, or for the treatment of high blood pressure in children under 35 kg. In these cases, other medicinal products that allow for the administration of 20 mg or 40 mg of valsartan should be used.

If you take more Kalpress than you should

If you notice a strong dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital. You can also call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Kalpress

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 forgotten doses.

If you stop taking Kalpress

If you stop taking Kalpress, your illness may get worse. Do not stop taking the medicine unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and may need immediate medical attention:

You may experience symptoms of angioedema (a specific allergic reaction), such as

• swelling of the face, lips, tongue, or throat
• difficulty breathing or swallowing
• hives, itching

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

Other side effects include:

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

• dizziness
• low blood pressure with or without symptoms such as dizziness and fainting when standing up
• reduced kidney function (signs of kidney impairment)

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

• angioedema (see section “Some symptoms need immediate medical attention”)
• sudden loss of consciousness (syncope)
• feeling of spinning (vertigo)
• marked reduction in kidney function (signs of acute kidney failure)
• muscle spasms, abnormal heart rhythm (signs of hyperkalemia)
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhea
• fatigue
• weakness

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

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

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

• blistering of the skin (sign of bullous dermatitis)
• allergic reactions with skin rash, itching, and hives; symptoms of fever, swelling, and joint pain, muscle pain, swelling of the lymph nodes, and/or symptoms similar to those of the flu (signs of serum sickness)
• red spots on the skin, fever, itching (signs of vasculitis)
• bleeding or bruising more often than usual (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count, also called neutropenia)
• reduction in hemoglobin and reduction in the percentage of red blood cells in the blood (which, in severe cases, can cause anemia)
• increase in potassium levels in the blood (which, in severe cases, can cause muscle spasms and abnormal heart rhythm)
• elevation of liver function values (which may indicate liver damage), including an increase in bilirubin levels in the blood (which, in severe cases, can cause the skin and eyes to turn yellow)
• increase in blood urea nitrogen and increase in serum creatinine levels (which may indicate kidney function abnormalities)
• low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle twitching, and/or convulsions)

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and reduced kidney function were observed less frequently in adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent heart attack.

Side effects in children and adolescents are similar to those observed in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Information System (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Kalpress

• Keep out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date is 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 should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofKalpress

• The active ingredient is valsartan. Each film-coated tablet contains 160 mg of valsartan.
• The other ingredients are microcrystalline cellulose, crospovidone type A, anhydrous colloidal silica, magnesium stearate. The tablet coating contains hypromellose, titanium dioxide (E 171), macrogol 8000, red iron oxide (E 172), yellow iron oxide (E 172), black iron oxide (E 172).

Appearance of the Product and Package Contents

The film-coated tablets of Kalpress 160 mg are orange-gray in color, oval in shape, with a score line on one side. They are marked with "DX" on one side of the score line and "DX" on the other side of the score line and "NVR" on the opposite face of the tablet. The score line is only for the purpose of facilitating breaking and swallowing, but not for dividing into equal doses.

The tablets are available in blister packs of 7, 14, 28, 30, 56, 90, or 98 tablets and in calendar blister packs of 14, 28, 56, 98, and 280 tablets. They are also available in single-dose blister packs of 56x1, 98x1, or 280x1 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Novartis Farmacéutica S.A., Gran Vía de les Corts Catalanes, 764, 08013 Barcelona

Tel: 93-306 42 00

Manufacturer

Novartis Farmacéutica, S.A.

Gran Vía de les Corts Catalanes, 764, 08013 Barcelona

Spain

Novartis Farma – Produtos 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 Farma S.p.A.

Viale Luigi Sturzo 43

20154 Milan (MI)

Italy

Novartis Farma S.p.A.

Via Provinciale, Schito 131

80058 Torre Annunziata (NA)

Italy

You can request more information about this medicine by contacting 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:October 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/