VALOMINDO 160 mg/1.5 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Valomindo 160 mg/1.5 mg Modified Release Tablets

valsartan/indapamide

Read all of this 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Valomindo and what is it used for

Valomindo contains two active substances called valsartan and indapamide.

Valsartan 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. Valsartan works by blocking the effect of angiotensin II. As a result, the blood vessels relax and blood pressure decreases.

Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only produces a slight increase in the amount of urine formed.

This medicine is indicated to reduce high blood pressure in adults. Your doctor may prescribe Valomindo if you are already taking valsartan and indapamide at the same dose, but in separate tablets.

2. What you need to know before you take Valomindo

Do not take Valomindo

• if you are allergic to valsartan, indapamide or any of the other ingredients of this medicine (listed in section 6).
• if you have liver disease or suffer from a disease called hepatic encephalopathy (a degenerative brain disease).
• if you are more than 3 months pregnant (it is also better to avoid Valomindo at the start 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 you have severe kidney disease.
• if you have low potassium levels in your blood.

Warnings and precautions

Talk to your doctor or pharmacist before taking Valomindo:

• if you have liver disease.
• if you have severe kidney disease or are undergoing dialysis.
• if you have narrowing of the renal artery.
• if you have recently had a kidney transplant (have received a new kidney).
• if you have severe heart disease other than heart failure or myocardial infarction.
• if you have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking another medicine (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valomindo, stop taking it immediately and never take it again. See also section 4, "Possible side effects".
• if you are taking medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin. It may be necessary to check the amount of potassium in your blood at regular intervals.
• If you have aldosteronism. This is a disease in which the adrenal glands produce an excessive amount of the hormone aldosterone. If this is the case, the use of this medicine is not recommended.
• if you have lost a lot of fluid (dehydration) caused by diarrhea, vomiting, or high doses of medicines to increase urine production (diuretics).
• if you are taking any of the following medicines used to treat high blood pressure:
• • an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
  • aliskiren,

• if you have diabetes,
• if you have gout,
• if you have heart rhythm problems,
• if you need to have a test to check the function of your parathyroid gland.

You must inform your doctor if you have had photosensitivity reactions.

If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in your eye and may occur a few hours or weeks after taking indapamide. If left untreated, it can cause permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be at greater risk of suffering from it.

Your doctor may periodically check your kidney function, blood pressure, and the amount of electrolytes (such as potassium) in your blood.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking valsartan/indapamide. Your doctor will decide whether to continue treatment. Do not stop taking valsartan/indapamide on your own.

See also the information under the heading "Do not take Valomindo”.

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

If any of these cases apply to you, inform your doctor before taking Valomindo

Important information for athletes

Athletes should be aware that this medicine contains an active substance that may give a positive reaction in doping tests.

Children and adolescents

Due to the lack of information on safety and efficacy, the use of this medicine is not recommended in children and adolescents.

Other medicines and Valomindo

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

The effect of treatment with this medicine may be altered if taken with certain medicines. It may be necessary to change the dose, take other precautions, or, in some cases, interrupt treatment with one of the medicines. This applies to both prescription and non-prescription medicines.

Make sure to inform your doctor if you are taking any of the following medicines, as you may require special care:

• other medicines that lower blood pressure, especially those that increase urine production (diuretics), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also the information under the heading "Do not take Valomindo” and “Warnings and precautions”),
• medicines that increase the amount of potassium in the blood. This includes potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin.

• certain types of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs),
• certain antibiotics (rifamycin group), a medicine used to prevent transplant rejection (cyclosporin) or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of this medicine,
• lithium (a medicine used to treat certain types of psychiatric diseases),
• medicines used to treat heart rhythm problems (such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis),
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia... (such as tricyclic antidepressants, antipsychotics, neuroleptics),
• bepridil (used to treat angina pectoris, a condition that causes chest pain),
• cisapride, difemanil (used to treat gastrointestinal problems),
• esparfloxacino, moxifloxacino, erythromycin injectable (antibiotics used to treat infections),
• vincamine injectable (used to treat symptomatic cognitive disorders in elderly patients, including memory loss),
• halofantrine (antiparasitic medicine used to treat certain types of malaria),

• pentamidine (used to treat certain types of pneumonia),
• mizolastine (used to treat allergic reactions, such as hay fever),
• non-steroidal anti-inflammatory drugs for pain relief (such as ibuprofen) or high doses of acetylsalicylic acid,
• angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure),
• amphotericin B injectable (antifungal medicines),
• oral corticosteroids used to treat various conditions, such as severe asthma and rheumatoid arthritis,
• stimulant laxatives,
• baclofen (to treat muscle stiffness that occurs in diseases such as multiple sclerosis),
• potassium-sparing diuretics (amiloride, spironolactone, triamterene),
• allopurinol (for the treatment of gout),
• metformin (to treat diabetes),
• iodinated contrast media (used for X-ray tests),
• calcium tablets or other calcium supplements,
• cyclosporin, tacrolimus, or other medicines to suppress the immune system after an organ transplant, to treat autoimmune diseases or severe rheumatic or dermatological diseases,
• tetracosactide (to treat Crohn's disease).

Taking Valomindo with food and drinks

You can take Valomindo with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• You must inform your doctor if you are pregnant (or if you might be pregnant). Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valomindo. This medicine is not recommended during the first trimester of pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby when used after this time.

• Tell your doctor if you are breastfeeding or about to start breastfeeding. Valomindo 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 carrying out other activities that require concentration, make sure you know how Valomindo affects you. Like many other medicines used to treat high blood pressure, Valomindo can cause dizziness and fatigue and may affect your ability to concentrate. If this happens, do not drive or perform other activities that require you to be alert.

3. How to take Valomindo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose of Valomindo is one tablet a day, preferably in the morning. Take it at about the same time each day.

The tablets can be taken with or without food. They should be swallowed whole with water. Do not crush or chew them.

People with high blood pressure often do not notice any symptoms. Many may feel quite normal. That's why it's so important to see your doctor even if you feel well. Treatment for high blood pressure is usually for life.

If you take more Valomindo than you should

If you have taken too many tablets, contact your doctor or pharmacist immediately.

If you experience severe dizziness and/or fainting, lie down.

Taking a higher dose of this medicine than recommended could cause nausea, vomiting, low blood pressure, cramps, dizziness, drowsiness, confusion, and changes in the amount of urine produced by the kidneys.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valomindo

If you forget to take a dose of your medicine, take the next dose at the usual time.

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

If you stop taking Valomindo

Since treatment for high blood pressure is usually for life, you should talk to your doctor before stopping this medicine. Do not stop taking your medicine unless your doctor tells you to.

If you have any further questions on 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 all people suffer from them.

Stop taking this medicine and contact a doctor immediately if you experience any of the following adverse effects:

• Angioedema and/or urticaria. Angioedema is characterized by swelling of the skin on the extremities or face, swelling of the lips or tongue, swelling of the mucous membranes of the throat or respiratory tract, causing difficulty breathing or swallowing. If this occurs, contact your doctor immediately (Very rare) (may affect up to 1 in 10,000 people).
• Severe skin reactions, including intense skin rash, redness of the skin all over the body, intense itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions (Very rare) (may affect up to 1 in 10,000 people).
• Irregular heartbeat with life-threatening consequences (Very rare) (may affect up to 1 in 10,000 people).
• Pancreatitis that can cause severe abdominal and back pain accompanied by intense discomfort (Very rare) (may affect up to 1 in 10,000 people).
• Brain disease caused by liver disease (Hepatic encephalopathy) (Frequency not known).
• Liver inflammation (Hepatitis) (Frequency not known).

If you experience any of these symptoms, stop taking Valomindo and contact your doctor immediately (see also section 2 "Warnings and precautions")

Other adverse effects include:

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

• Low potassium levels in the blood
• Allergic reactions, mainly dermatological, in individuals with a predisposition to allergic and asthmatic reactions
• Redness of the skin

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

• Low sodium levels in the blood that can cause dehydration and low blood pressure
• Dizziness with a sensation of rotation
• Cough
• Vomiting
• Abdominal pain
• Red spots on the skin (purpura)
• Impotence (inability to obtain or maintain an erection)
• Fatigue

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

• Low chloride levels in the blood
• Low magnesium levels in the blood
• Headache
• Pins and needles (paresthesia)
• Gastrointestinal disorders (such as nausea, constipation)
• Dry mouth

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

• Changes in blood cells, such as thrombocytopenia (decrease in platelet count, which favors the appearance of hematomas and nosebleeds), leucopenia (decrease in white blood cells, which can produce fever without apparent cause, sore throat or other flu-like symptoms - if this occurs, contact your doctor) and anemia (decrease in red blood cells)
• High calcium levels in the blood
• Low blood pressure
• Abnormal liver function
• Kidney disease (which can cause symptoms of fatigue, increased need to urinate, itching of the skin, discomfort, swollen limbs)
• Intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• Decrease in hemoglobin and red blood cell percentage in the blood (which can cause anemia in severe cases)
• Increased potassium levels in the blood (which can trigger muscle spasms, abnormal heart rhythm in severe cases)
• Sudden loss of consciousness (syncope)
• Nearsightedness (myopia)
• Blurred vision
• Visual disturbances
• Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• Abnormal heart tracing on the ECG
• Purple-red spots, fever, itching (signs of inflammation of the blood vessels also called vasculitis)
• Elevation of liver function values (which can indicate liver damage) including an increase in bilirubin in the blood (which can cause yellowing of the skin and eyes in severe cases)
• If you have systemic lupus erythematosus (a disorder of the immune system that causes inflammation and damage to the joints, tendons, and organs, with symptoms such as skin rashes, fatigue, loss of appetite, weight gain, and joint pain), this may worsen
• There have also been reports of photosensitivity reactions (change in the appearance of the skin) after exposure to the sun or artificial UVA rays
• Skin rash
• Skin itching
• Muscle pain
• Increased serum creatinine levels (which can indicate abnormal kidney function)
• Increased blood glucose levels in diabetic patients
• Increased uric acid levels, a substance that can cause or worsen gout (joint pain, especially in the feet).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Valomindo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store the blister pack in the original packaging to protect it from light and moisture.

This medicine does not require any special storage temperature.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Valomindo

• The active ingredients are valsartan and indapamide.

Each modified-release tablet contains 160 mg of valsartan and 1.5 mg of indapamide.

• The other components (excipients) are:

Valsartan layer: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, and magnesium stearate.

Indapamide layer: microcrystalline cellulose, mannitol, hypromellose, anhydrous colloidal silica, magnesium stearate, carbomers, and yellow iron oxide (E172).

Appearance of the product and package contents

Valomindo 160 mg/1.5 mg modified-release tablets: round, biconvex tablets with two layers. One layer is light brownish-yellow, speckled, with the mark VI2. The other layer is white to yellowish-white. Tablet dimensions: approximate diameter 11 mm.

Valomindo 160 mg/1.5 mg modified-release tablets are available in boxes that contain:

• 10, 14, 28, 30, 56, 60, 84, 90, or 100 modified-release tablets in blisters.
• 14, 28, 56, or 84 modified-release tablets in calendarized blisters.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto, Slovenia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L.,

C/ Anabel Segura 10,

28108 Alcobendas,

Madrid, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Date of the last revision of this prospectus: April 2025

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