KALPRESS 320 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Kalpress 320mg film-coated tablets

valsartan

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.,it is important for you to know..

• 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 pass it on to others, it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Kalpress and what is it used for

Kalpress contains the active substance: valsartan and belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, leading to an increase in blood pressure. Kalpress works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Kalpress 320 mg film-coated tablets can be used

• 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 can 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 disorders.

2. What you need to know before taking 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 a severe liver disease.
• if you are pregnantmore than 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 blood pressure-lowering medicine that contains aliskiren.

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

Warnings and precautions:

Tell your doctor

• if you have liver disease.
• if you have severe kidney disease or are on dialysis.
• if you have narrowing of the renal 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), tell your doctor. If you have these symptoms when taking Kalpress, 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. 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 that increase urine production).
• if you are taking any of the following medicines used to treat high blood pressure:
• • a medicine called an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes
  • aliskiren

Your doctor may check 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”.

You must tell 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 during this period (see section Pregnancy).

Using Kalpress with other medicines

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

The effect of treatment with Kalpress may be altered if taken with certain 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 that 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-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs).
• certain antibiotics (from 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 illnesses.

Pregnancy and breastfeeding

• Tell your doctor if you are pregnant(or if you think you might be).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 during the first trimester of pregnancy, and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

• Tell your doctor if you are breastfeeding or plan to breastfeed. 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 using machines

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 blood pressure-lowering medicines, 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 tells you. If you are unsure, ask your doctor 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 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 to less than18years 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.

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

Take Kalpress approximately at the same time each day.

Dosing 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 <35 kg. in these cases, other medicinal products that allow for the administration of 20 mg or 40 valsartan should be used.< p>

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, phone 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 missed doses.

If you stop taking Kalpress

If you stop taking Kalpress, your condition 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 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 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:

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 an abnormal heart rhythm)
• increase in liver function values (which may indicate liver damage), including an increase in bilirubin levels in the blood (which, in severe cases, can cause yellowing of the skin and eyes)
• increase in urea nitrogen and creatinine levels in the blood (which may indicate kidney problems)
• 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 they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring 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 the sight and reach of children.
• Do not use this medicine after the expiry date stated on the pack. The expiry date is the last day of the month stated.
• Do not store above 30°C. Store in the original package 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. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition ofKalpress

• The active ingredient is valsartan. Each film-coated tablet contains 320 mg of valsartan.
• The other components 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 Container Content

The film-coated tablets of Kalpress 320 mg are dark violet grey, oval, with beveled edges and a score on one side. They have the mark “DC” on one side of the score and “DC” on the other side of the score and “NVR” on the opposite face of the tablet. The score is only to allow breaking and to facilitate swallowing, but not to divide 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. Also available are 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, 76408013 Barcelona

Tel: 93-306 42 00

Manufacturer

Novartis Farmacéutica, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

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

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 theMember States of the European Economic Area underthe following names:

Date of the Last Revision of this Leaflet:October 2020

Detailed and updated 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/