VALSARTAN/HYDROCHLOROTHIAZIDE KRKA 160 MG/12.5 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Valsartan/Hydrochlorothiazide Krka 160mg/12.5mgfilm-coated tabletsEFG

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 pack

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

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

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

• Valsartanbelongs to a class of medicines known as “angiotensin II receptor antagonists” that 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.

• Hydrochlorothiazidebelongs to a class of medicines 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 the blood vessels in the brain, heart, and kidneys, and can lead to a 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 you take Valsartan/Hydrochlorothiazide Krka

Do not take Valsartan/Hydrochlorothiazide Krka

• if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide) or to any of the other ingredients of this medicine (listed in section 6);
• if you are more than 3 months pregnant(in any case, it is better to avoid Valsartan/Hydrochlorothiazide Krka also at the beginning of your pregnancy – see section Pregnancy, breast-feeding 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 levels of potassium or sodium 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 medicine that contains aliskiren.

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with valsartan/hydrochlorothiazide

• if you are using potassium-sparing medicines, potassium supplements, salt substitutes that contain potassium, or other medicines 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 levels of potassium 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 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 medicines (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 suffered an allergic reaction with the use of another medicine 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 an increase in eye pressure 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 been allergic 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, in particular its 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 lung 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 medicines used to treat high blood pressure (hypertension):
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking this medicine. 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 become) pregnant. Valsartan/hydrochlorothiazide is not recommended in the early stages 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, breast-feeding and fertility).

Children and adolescents

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

Other medicines and Valsartan/Hydrochlorothiazide Krka

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

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

• lithium, a medicine used to treat certain types of psychiatric disorders,
• medicines or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin,
• medicines that can decrease the amount of potassium in the blood, such as diuretics (medicines to urinate), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G,
• certain antibiotics (rifamycin group), a medicine used to protect against transplant rejection (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartan/Hydrochlorothiazide Krka,
• medicines that can induce “torsades de pointes” (irregular heartbeats), such as anti-arrhythmics (medicines used to treat heart problems) and some antipsychotics,
• medicines that can reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics,
• medicines for treating gout, such as allopurinol, probenecid, sulfinpyrazone,
• therapeutic vitamin D and calcium supplements,
• medicines for treating diabetes (oral antidiabetics such as metformin or insulin),
• other medicines for lowering blood pressure, including methyldopa,
• medicines that increase blood pressure, such as noradrenaline or adrenaline,
• digoxin or other digitalis glycosides (medicines used to treat heart problems),
• medicines that can increase blood sugar levels, such as diazoxide or beta-blockers,
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide,
• medicines 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 medicines (medicines used to treat a wide range of disorders, such as gastrointestinal cramps, bladder spasms, asthma, travel sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia),
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases),
• cholestyramine and colestipol (medicines primarily used to treat high lipid levels in the blood),
• cyclosporin, a medicine used to prevent organ rejection after transplantation,
• alcohol, sleeping medicines, and anesthetics (medicines with a sedative effect or for pain used, for example, in the case of 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 risk of dizziness and weakness.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

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 you become pregnant or as soon as you find out you are pregnant, and will recommend taking another blood pressure-lowering medicine instead. Valsartan/Hydrochlorothiazide Krka is not recommended for use at the start of pregnancy and should not be taken after the third month of pregnancy, as it can cause serious harm to your baby when administered from that time on.

Breast-feeding

Tell your doctor if you are about to start or are breast-feeding.

Valsartan/Hydrochlorothiazide Krka is not recommended for use in women during breast-feeding, and your doctor may decide to prescribe a treatment that is more suitable if you wish to breast-feed, especially for newborns or premature babies.

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 you react to the effects of Valsartan/Hydrochlorothiazide Krka. Like many other medicines 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 medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine 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 medicine 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 medicine should be taken at the same time every day, usually in the morning.
• You can take this medicine 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 medicine and the amount taken.

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 taking Valsartan/Hydrochlorothiazide Krka

If you stop your treatment with Valsartan/Hydrochlorothiazide Krka, your hypertension may worsen. Do not stop taking the 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.

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 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 medicines 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 available data)

• blistering of the skin (sign of bullous dermatitis)
• rash with or without itching along with any of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or flu-like symptoms
• rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
• 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 rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling mainly of the face and throat; 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
• 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 sugar levels in the blood
• 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)

• inflammation of blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• severe skin disease that causes 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 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 pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• 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 12.5 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, and red 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/12.5 mg are oval, biconvex, and reddish-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/.