VALSARTAN/HYDROCHLOROTHIAZIDE KRKA 160 mg/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Valsartan/Hydrochlorothiazide Krka 160mg/25mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Valsartan/Hydrochlorothiazide Krka and what is it used for
2. What you need to know before taking Valsartan/Hydrochlorothiazide Krka
3. How to take Valsartan/Hydrochlorothiazide Krka
4. Possible side effects
5. Storage of Valsartan/Hydrochlorothiazide Krka

Contents of the pack and additional information

1. What is Valsartan/Hydrochlorothiazide Krka and what is it used for

Valsartan/Hydrochlorothiazide Krka film-coated tablets contain two active substances, valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartanbelongs to a class of medications known as "angiotensin II receptor antagonists" that 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.
• Hydrochlorothiazidebelongs to a class of medications known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also decreases blood pressure.

Valsartan/Hydrochlorothiazide Krka is used to treat high blood pressure that is not adequately controlled with the use of a single component.

Hypertension 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 values reduces the risk of developing these disorders.

2. What you need to know before taking Valsartan/Hydrochlorothiazide Krka

Do not take Valsartan/Hydrochlorothiazide Krka

• if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related to hydrochlorothiazide), or any of the other components of this medication (listed in section 6);
• if you are pregnant for more than 3 months(in any case, it is best to avoid Valsartan/Hydrochlorothiazide Krka also at the beginning of your pregnancy – see section Pregnancy, breastfeeding, and fertility);
• if you have severe liver disease, destruction of the small bile ducts in the liver (biliary cirrhosis) leading to a buildup of bile 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 low potassium or sodium levels in your blood, or if your blood calcium levels are higher than normal despite treatment;
• if you have gout;
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication containing aliskiren.

If any of these situations apply to you, do not take this medication and consult your doctor.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take valsartan/hydrochlorothiazide

• if you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium, or other medications that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly monitor your potassium levels;
• if you have low potassium levels in your blood;
• if you experience severe diarrhea or vomiting;
• if you are taking high doses of a diuretic;
• if you have severe heart disease;
• if you are suffering from heart failure or have a history of heart attack. Follow your doctor's instructions to start the dose with caution. Your doctor may also monitor your kidney function;
• if you have a narrowing of the kidney artery;
• if you have recently undergone a kidney transplant;
• if you have hyperaldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, Valsartan/Hydrochlorothiazide Krka is not recommended;
• if you have kidney or liver disease;
• 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 Valsartan/Hydrochlorothiazide Krka, stop treatment with Valsartan/Hydrochlorothiazide Krka immediately and never take it again. See also section 4 "Possible side effects";
• if you have fever, rash, and joint pain, which can be signs of systemic lupus erythematosus (SLE, a known autoimmune disease);
• if you have diabetes, gout, high cholesterol or lipid levels in your blood;
• if you have previously experienced an allergic reaction with the use of another medication in this class to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma;
• if you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a time frame of several hours to a week after taking Valsartan/Hydrochlorothiazide Krka. If left untreated, this can lead to permanent vision loss. You may be at higher risk of developing it if you have previously experienced an allergy to penicillin or sulfonamides;
• it may cause increased sensitivity of the skin to the sun;
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Valsartan/Hydrochlorothiazide Krka.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Valsartan/Hydrochlorothiazide Krka, see your doctor immediately;
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have diabetes-related kidney problems.
  • aliskiren.

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

If any of these situations apply to you, consult your doctor.

Your doctor may monitor 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 Valsartan/Hydrochlorothiazide Krka".

You should consult your doctor if you think you are (or might be) pregnant. Valsartan/hydrochlorothiazide is not recommended in the early stages of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used at that stage (see section Pregnancy, breastfeeding, and fertility).

Children and Adolescents

The use of Valsartan/Hydrochlorothiazide Krka is not recommended in children and adolescents (under 18 years of age).

Other Medications and Valsartan/Hydrochlorothiazide Krka

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medication.

The effect of treatment with Valsartan/Hydrochlorothiazide Krka may be altered if taken with certain medications. Your doctor may need to modify your dose and/or take other precautions or, in some cases, stop treatment with one of the medications. This is especially applicable to the following medications:

• lithium, a medication used to treat certain psychiatric disorders,
• medications or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin,
• medications that can decrease the amount of potassium in the blood, such as diuretics (medications to urinate), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G,
• certain antibiotics (rifamycin group), a medication used to protect against transplant rejection (cyclosporine), or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Valsartan/Hydrochlorothiazide Krka,
• medications that can induce "torsades de pointes" (irregular heartbeats), such as anti-arrhythmics (medications used to treat heart problems) and some antipsychotics,
• medications that can reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics,
• medications for treating gout, such as allopurinol, probenecid, sulfinpyrazone,
• therapeutic vitamin D and calcium supplements,
• medications for treating diabetes (oral antidiabetics such as metformin or insulin),
• other medications for lowering blood pressure, including methyldopa,
• medications that increase blood pressure, such as noradrenaline or adrenaline,
• digoxin or other digitalis glycosides (medications used to treat heart problems),
• medications that can increase blood sugar levels, such as diazoxide or beta-blockers,
• cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide,
• medications for pain, such as non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid in doses above 3 g,
• muscle relaxants, such as tubocurarine,
• anticholinergic medications (medications used to treat a wide range of disorders, such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia),
• amantadine (a medication used to treat Parkinson's disease and also to treat or prevent certain viral diseases),
• cholestyramine and colestipol (medications primarily used to treat high lipid levels in the blood),
• cyclosporine, a medication used to prevent organ rejection after transplantation,
• alcohol, sleeping medications, and anesthetics (medications with a sedative effect or for pain used, for example, in surgery),
• iodinated contrast media (used for diagnostic imaging tests),
• if you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings "Do not take Valsartan/Hydrochlorothiazide Krka" and "Warnings and Precautions").

Taking Valsartan/Hydrochlorothiazide Krka with Food, Drinks, and Alcohol

You can take Valsartan/Hydrochlorothiazide Krka with or without food.

Avoid taking alcohol until you have consulted your doctor. Alcohol can further lower your blood pressure and/or increase the possibility of dizziness and weakness.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You must inform your doctor if you are pregnant (or might be) pregnant.

Generally, your doctor will advise you to stop taking Valsartan/Hydrochlorothiazide Krka before becoming pregnant or as soon as you become pregnant and recommend taking another anti-hypertensive medication instead. Valsartan/Hydrochlorothiazide Krka is not recommended at the start of pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby when administered from that point on.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding.

Valsartan/Hydrochlorothiazide Krka is not recommended for women during this period, and your doctor may decide to administer a treatment that is more suitable if you wish to breastfeed, especially newborns or premature babies.

Driving and Using Machines

Before driving a vehicle, using tools, or operating machines, or performing other activities that require concentration, make sure you know how you react to the effects of Valsartan/Hydrochlorothiazide Krka. Like many other medications used to treat high blood pressure, Valsartan/Hydrochlorothiazide Krka can cause, in rare cases, dizziness and affect your ability to concentrate.

Valsartan/Hydrochlorothiazide Krka contains Lactose and Sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to Take Valsartan/Hydrochlorothiazide Krka

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. This will help you achieve the best results and reduce the risk of side effects. If in doubt, 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 appointments with your doctor, even if you feel well.

Your doctor will tell you exactly how many Valsartan/Hydrochlorothiazide Krka tablets you should take.

Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

• The usual dose of Valsartan/Hydrochlorothiazide Krka is one tablet per day.
• Do not change the dose or stop treatment without consulting your doctor.
• This medication should be taken at the same time every day, usually in the morning.
• You can take this medication with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan/Hydrochlorothiazide Krka than you should

If you notice a strong dizziness and/or fainting, lie down and contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Valsartan/Hydrochlorothiazide Krka

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 treatment with Valsartan/Hydrochlorothiazide Krka

If you stop your treatment with Valsartan/Hydrochlorothiazide Krka, your hypertension may worsen. Do not stop taking the medication unless your doctor tells you to.

If you have any other questions about the use of this medication, 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.

Some adverse effects can be serious and require immediate medical attention:

You should visit your doctor immediately if you notice symptoms of angioedema, such as:

• swelling in the face, tongue, or pharynx
• difficulty swallowing
• hives and difficulty breathing

If you experience any of these symptoms, stop taking Valsartan/Hydrochlorothiazide Krka and contact your doctor immediately (see also section 2 "Warnings and Precautions").

Other adverse effectsinclude:

Uncommon (may affect up to 1 in 100 people)

• cough
• low blood pressure
• dizziness
• dehydration (with symptoms of thirst, dry mouth and tongue, reduced urination frequency, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• noises (e.g. ringing or buzzing) in the ears

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

• dizziness
• diarrhea
• joint pain

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

• difficulty breathing
• severe decrease in diuresis
• low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle fasciculation and/or convulsions)
• low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• 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 the blood (which, in severe cases, can cause yellowing of the skin and eyes)
• increased urea and creatinine levels in the blood (which may indicate abnormal kidney function)
• increased uric acid levels in the blood (which, in severe cases, can trigger a gout attack)
• syncope (fainting)

The following adverse effects have been reported with medications containing valsartan or hydrochlorothiazideseparately:

Valsartan

Uncommon(may affect up to 1 in 100 people)

• feeling of rotation
• abdominal pain

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)

• skin blisters (sign of bullous dermatitis)
• skin rash with or without itching along with some of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation and/or flu-like symptoms
• skin rash, red-purple spots, fever, itching (symptoms of vasculitis)
• low platelet count (sometimes with bleeding or bruising more frequently than usual)
• high potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)
• 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 values
• decrease in hemoglobin and red blood cell percentage in the blood (which, in severe cases, can cause anemia)
• renal failure
• low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle fasciculation and/or convulsions)

Hydrochlorothiazide

Very common(may affect more than 1 in 10 people)

• low potassium levels in the blood
• increased lipids in the blood

Common(may affect up to 1 in 10 people)

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• skin rash with itching and other types of rash
• decreased appetite
• mild vomiting and nausea
• dizziness, dizziness when standing up
• inability to achieve or maintain an erection

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

• swelling and blisters on the skin (due to increased sensitivity to the sun)
• high calcium levels in the blood
• high blood sugar levels
• sugar in the urine
• worsening of diabetic metabolic state
• constipation, diarrhea, stomach or intestinal discomfort, liver changes that may appear along with yellowing of the skin or eyes
• irregular heartbeat
• headache
• sleep disturbances
• sadness (depression)
• low platelet count (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• vision changes

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

• vasculitis with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• rash on the face, joint pain, muscle disorders, fever (cutaneous lupus erythematosus)
• severe pain in the upper abdomen (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (breathing difficulties including pneumonitis and pulmonary edema)
• fever, sore throat, increased frequency of infections (agranulocytosis)
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia)
• acute respiratory distress (signs include severe breathing difficulties, fever, weakness, and confusion)
• fever, sore throat or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, muscle twitches and spasms, rapid breathing (hypochloremic alkalosis)

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

• skin and lip cancer (non-melanoma skin cancer)
• weakness, bruising, and frequent infections (aplastic anemia)
• significant decrease in urine production (possible signs of kidney damage or kidney failure)
• decreased vision or eye pain due to high blood pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• skin rash, skin redness, blisters on the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle spasms
• fever (pyrexia)
• weakness (asthenia)

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 leaflet. You can also report them 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 Valsartan/Hydrochlorothiazide Krka

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

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

Do not store above 30°C.

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

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. 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 of Valsartan/Hydrochlorothiazide Krka

• The active ingredients are valsartan and hydrochlorothiazide.

Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.

• The other ingredients are microcrystalline cellulose, lactose monohydrate, magnesium stearate, sodium croscarmellose, povidone K25, and anhydrous colloidal silica in the tablet core, and hypromellose, titanium dioxide (E171), macrogol 4000, red iron oxide (E172), and yellow iron oxide (E172) in the coating. See section 2 "Valsartan/Hydrochlorothiazide Krka contains lactose and sodium".

Appearance of the Product and Package Contents

The film-coated tablets of Valsartan/Hydrochlorothiazide Krka 160 mg/25 mg are oval, biconvex, and light brown in color.

The tablets are available in blister packs of 14, 28, 30, 56, 60, 84, 90, 98, 280, 56x1, 98x1, and 280x1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

Date of the last revision of this leaflet: March 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/.