Package Leaflet: Information for the User

Kalpress 160mg Coated Tablets

valsartán

Read this 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 pass it on to others even if their symptoms are the same. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What Kalpress is and what it is used for

2.What you need to know before you start taking Kalpress

3.How to take Kalpress

4.Possible side effects

5.Storage of Kalpress

6.Contents of the pack and additional information

Kalpress contains the active ingredient: valsartan and belongs to a class of medications 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 constrict, resulting in increased blood pressure. Kalpress acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Kalpress 160mg film-coated tabletscan be used to treat three different conditions:

• to treat high blood pressure in adults and in children and adolescents from6 toless than 18years of age.High blood pressure 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.
• to treat adult patients after a recent heart attack(myocardial infarction).“Recent” here means between 12hours and 10days.
• to treat symptomatic heart failure in adult patients.Kalpress is used when it is not possible to use a group of medications called Angiotensin-Converting Enzyme Inhibitors (ACEIs) (a medication for treating heart failure), or it can be used in addition to ACEIs when other medications for treating heart failure cannot be used.
  Among the symptoms of heart failure are difficulty breathing and swelling of feet and legs due to fluid retention. This is because the heart muscle is not strong enough to pump blood with sufficient force to provide all the blood needed by the body.

Do not take Kalpress:

• if you areallergic(hypersensitive) to valsartan or any of the other components of this medication (listed in section 6).
• if you have aserious liver disease.
• if you arepregnantover 3 months(it is better to avoid Kalpress during the first months of pregnancy – see Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.

If any of the above situations apply to you, inform your doctor and do not takeKalpress.

Warnings and precautions:

Consult your doctor

• if you have liver disease.
• if you have a serious kidney disease or if you are undergoing dialysis.
• if you have a narrowing of the renal artery.
• if you have recently undergone a kidney transplant (received a new kidney).
• if you have a serious heart disease other than heart failure or myocardial infarction.
• 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, stop taking Kalpress immediately and never take it again. See also section 4 “Possible side effects”.
• if you are using medications that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin. You may need to regularly monitor 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 (medications to increase urine production).
• 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, etc.,)
  • aliskirén
• if you are being treated with an ACE inhibitor along with other medications specifically used to treat your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

Your doctor may regularly monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood.

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

You should inform your doctor if you think you are (or could be) pregnant. Kalpress is not recommended at the beginning of pregnancy, and it should not be taken if you are pregnant for more than3months, as it could cause serious harm to your baby if you use it during this period (see Pregnancy section).

Use of Kalpress with other medications

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

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

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

Additionally:

• if you are being treated aftera myocardial infarction,it is not recommended to combine withACE inhibitors(a medication for treating a myocardial infarction).
• if you are being treated forheart failure,it is not recommended to take the triple combination withACE inhibitors and other medications specifically used to treat your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers(such as metoprolol).

Pregnancy and breastfeeding

• You should inform your doctor if you are pregnant(or if you suspect that you might be).Your doctor will usually recommend that you stop taking Kalpress before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Kalpress. Kalpress is not recommended at the beginning of pregnancy, and it should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point on.

• Inform your doctor if you are breastfeeding or are about to start. Kalpress is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

Before driving a vehicle, using tools or operating machinery, or performing other activities that require concentration, make sure you know how Kalpress affects you. Like many other medications used to treat high blood pressure, Kalpress may cause dizziness and affect concentration.

To get the best results and reduce the risk of adverse effects, take this medication exactly as your doctor tells you to.In case of doubt, ask yourdoctor or pharmacist. People with high blood pressure often do not notice any signs of the disease; many feel normal. This makes it very important to attend your appointments with the doctor, even if you feel well.

Adult patients with high blood pressure:The recommended dose is 80mg per day. In some cases, your doctor may prescribe higher doses (e.g. 160mg or 320mg). You may also combine Kalpress with another medication (e.g. a diuretic).

Use in children and adolescents from 6 to less than 18 years of age with high blood pressure:

In patients weighing less than 35kg, the recommended starting dose for valsartan tablets is 40mg once a day.

In patients weighing 35kg or more, the recommended starting dose for Kalpress tablets is 80mg once a day.

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

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

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

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

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

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

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

Take Kalpress approximately at the same time every day.

Uncovered dosage with the available Kalpress presentations

The available Kalpress presentations (80 mg, 160 mg, and 320 mg) do not allow for the recommended starting dose for the treatment of recent myocardial infarction or heart failure in adults, nor for the treatment of hypertension in children <35>

If you take more Kalpress than you should

If you experience severe 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication 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 compensate for the missed doses.

If you interrupt treatment withKalpress

If you stop taking Kalpress, your condition may worsen. Do not stop taking the medication unless your doctor tells you to.

If you have any other doubts 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 may require immediate medical attention:

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

• swelling in 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:

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

• dizziness
• low blood pressure with or without symptoms such as dizziness and fainting when standing up
• reduction in kidney function (signs of renal deterioration)

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

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

Unknown frequency(cannot be estimated from available data):

• blistering on the skin (sign of dermatitis herpetiformis)
• may occur allergic reactions with skin rash, itching, and hives; symptoms of serum sickness, such as fever, swelling, and joint pain, muscle pain, swelling of lymph nodes, and/or symptoms similar to the flu
• red-purple spots, fever, itching (signs of inflammation of blood vessels, also known as vasculitis)
• more frequent bleeding or bruising than usual (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat, or ulcers in the mouth due to infections (symptoms of low white blood cell count, also known as neutropenia)
• reduction in hemoglobin level and reduction in percentage of red blood cells in the blood (which, in severe cases, can cause anemia)
• increase in potassium level 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 level in the blood (which, in severe cases, can cause the skin and eyes to turn yellow)
• increase in urea nitrogen level in the blood and increase in serum creatinine level (which may indicate renal anomalies)
• low sodium level in the blood (which, in severe cases, can cause fatigue, confusion, muscle fasciculations, and/or seizures)

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and kidney function reduction 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 side effects

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

• Keep out of sight and reach of children.
• Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.
• Do not store above 86°F (30°C). Store in the original packaging to protect it from moisture.
• Do not use this medication if 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 containers and medicines you no longer need at theSIGREcollection pointofthe pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofKalpress

• The active ingredient is valsartán. Each film-coated tablet contains 160 mg of valsartán.
• The other components are microcrystalline cellulose, crospovidone type A, anhydrous colloidal silica, magnesium stearate. The coating of the tablet 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 contents of the package

Kalpress 160 mg film-coated tablets are light orange, oval-shaped, with a notch on one side. They have the mark “DX” on one side of the notch and “DX” on the other side of the notch and “NVR” on the opposite side of the tablet.The notch is only for splitting and facilitating swallowing, but not for dividing into equal doses..

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

Only some package 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

Responsible for manufacturing

Novartis Farmacéutica, S.A.

Gran Vía de les Corts Catalanes, 764
08013 Barcelona

Spain

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 Farma S.p.A.

Viale Luigi Sturzo 43

20154 Milano (MI)

Italy

Novartis Farma S.p.A.

Via Provinciale, Schito131

80058 Torre Annunziata (NA)

Italy

You can request more information about this medication 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 medication is authorized in themember states of the European Economic Area withthe following names:

Last review date of this leaflet:October 2020

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) htpp://www.aemps.gob.es/