Package Leaflet: Information for the Patient

Valsartan/Hydrochlorothiazide Krka 160mg/12.5mgCoated TabletsEFG

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

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

Valsartán/Hidroclorotiazida Krka coated tablets contain two active principles known as valsartán and hidroclorotiazida. These components help control high blood pressure (hypertension).

• Valsartánbelongs 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 constrict, resulting in increased blood pressure. Valsartán acts by blocking the effect of angiotensin II. As a consequence, blood vessels relax and blood pressure decreases.

• Hidroclorotiazidabelongs to a class of medications known as thiazide diuretics. Hidroclorotiazida increases diuresis, which also decreases blood pressure.

Valsartán/Hidroclorotiazida 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 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.

Do not take Valsartán/Hidroclorotiazida Krka

• if you are allergic to valsartan, hidroclorotiazida, sulfonamide derivatives (substances chemically related to hidroclorotiazida) or to any of the other components of this medication (listed in section 6);
• if you are more than 3 months pregnant(in any case, it is better to avoid Valsartán/Hidroclorotiazida Krka also at the beginning of your pregnancy – see Pregnancy, breastfeeding and fertility section);
• if you have a severe liver disease, destruction of small bile ducts in the liver (biliary cirrhosis) that leads to a buildup of bile in the liver (cholestasis);
• if you have a severe kidney disease;
• if you cannot produce urine (anuria);
• if you are undergoing dialysis;
• if you have lower than normal 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 insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

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

Warnings and precautions

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

• if you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium or other medications that increase the amount of potassium in the blood, such as heparin. Your doctor may consider it necessary to regularly control 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 experiencing heart failure or have a history of heart attack. Follow your doctor's instructions to start the dose carefully. Your doctor may also control your renal function;
• if you have a narrowing of the renal 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, Valsartán/Hidroclorotiazida 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 Valsartán/Hidroclorotiazida Krka, stop taking it immediately and never take it again. See also section 4 “Possible side effects”;
• if you have fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (LES, a known autoimmune disease);
• if you have diabetes, gout, high levels of cholesterol or lipids in your blood;
• if you have previously experienced an allergic reaction with the use of another medication of this class to lower blood pressure (angiotensin II receptor antagonists), or if you have any type of allergy or asthma;
• if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur during a period of time ranging from several hours to a week after taking Valsartán/Hidroclorotiazida Krka. If not treated, this can lead to permanent vision loss. You may have a 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 a skin lesion appears unexpectedly during treatment. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Valsartán/Hidroclorotiazida Krka;
• ifyou have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking Valsartán/Hidroclorotiazida Krka, see your doctor immediately;
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• • a converting enzyme inhibitor (IECA) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskirén.

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/hidroclorotiazida on your own.

If any of these situations affect you, consult your doctor.

Your doctor may control your renal function, blood pressure, and electrolyte levels in your blood (such as potassium), at regular intervals.

See also the information under the heading “Do not take Valsartán/Hidroclorotiazida Krka”.

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

Children and adolescents

Valsartán/Hidroclorotiazida Krka is not recommended for use in children and adolescents (under 18 years old).

Other medications and Valsartán/Hidroclorotiazida Krka

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

The effect of treatment with Valsartán/Hidroclorotiazida 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, discontinue treatment of one of the medications. This is especially applicable to the following medications:

• lithium, a medication used to treat some types of psychiatric diseases,
• medications or substances that may increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin,
• medications that may decrease the amount of potassium in the blood, such as diuretics (urine medications), corticosteroids, laxatives, carbenoxolona, amfotericina, or penicillin G,
• some antibiotics (rifamicin group), a medication used to prevent rejection of transplants (ciclosporina) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Valsartán/Hidroclorotiazida Krka,
• medications that may induce “torsades de pointes” (irregular heartbeats), such as antiarrhythmics (medications used to treat heart problems) and some antipsychotics,
• medications that may reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics,
• medications to treat gout, such as alopurinol, probenecid, sulfinpirazona,
• vitamin D therapy and calcium supplements,
• medications to treat diabetes (oral antidiabetic medications such as metformin or insulin),
• other medications to lower blood pressure, including metildopa,
• medications that increase blood pressure, such as noradrenaline or adrenaline,
• digoxin or other digitalis glycosides (medications used to treat heart problems),
• medications that may increase blood sugar levels, such as diazoxida or beta-blockers,
• cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide,
• pain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors and aspirin in doses above 3 g,
• muscle relaxants, such as tubocurarina,
• anticholinergic medications (medications used to treat a wide range of disorders such as gastrointestinal cramps, urinary retention, asthma, travel sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia),
• amantadina (a medication used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses),
• colestiramina and colestipol (medications used primarily to treat high levels of lipids in the blood),
• ciclosporina, a medication used to prevent rejection of transplanted organs,
• alcohol, sleep medications, and anesthetics (medications with sedative or pain-relieving effects used, for example, in surgery),
• contrast agents containing iodine (used for diagnostic imaging tests),
• if you are taking an angiotensin-converting enzyme inhibitor (IECA) or aliskirén (see also the information under the headings “Do not take Valsartán/Hidroclorotiazida Krka” and “Warnings and precautions”).

Taking Valsartán/Hidroclorotiazida Krka with food, drinks, and alcohol

You can take Valsartán/Hidroclorotiazida Krka with or without food.

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You should inform your doctor if you are pregnant, (or may be)pregnant.

Generally, your doctor will advise you to stop taking Valsartán/Hidroclorotiazida Krka before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Valsartán/Hidroclorotiazida Krka is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy, as it may cause serious damage to your baby when administered from that moment on.

Breastfeeding

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

Valsartán/Hidroclorotiazida Krka is not recommended for use during this period, and your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in newborns or premature babies.

Driving and operating machines

Before driving a vehicle, using tools, or operating machines, or engaging in other activities that require concentration, make sure you know your reactions to the effects of Valsartán/Hidroclorotiazida Krka. Like many other medications used to treat high blood pressure, Valsartán/Hidroclorotiazida Krka may cause, in rare cases, dizziness and affect concentration.

Valsartán/Hidroclorotiazida Krka contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a intolerance to certain sugars, consult with him before taking this medication.

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

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

Your doctor will tell you exactly how many tablets of Valsartán/Hidroclorotiazida Krka you should take.

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

• The usual dose of Valsartán/Hidroclorotiazida Krka is one tablet per day.
• Do not change the dose or interrupt 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 Valsartán/Hidroclorotiazida Krka than you should

If you experience severe 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Valsartán/Hidroclorotiazida 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 compensate for the missed doses.

If you interrupt treatment with Valsartán/Hidroclorotiazida Krka

If you stop taking Valsartán/Hidroclorotiazida Krka, your high blood pressure may worsen. Do not stop taking the medication unless your doctor tells you to.

If you have any other questions about using 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 may 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 throat
• difficulty swallowing
• hives and difficulty breathing

If you experience any of these symptoms, stop taking Valsartán/Hidroclorotiazida Krka and contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other side effects include:

Uncommon (may affect up to 1 in 100 people)

• cough
• low blood pressure
• dizziness
• dehydration (with symptoms of thirst, dry mouth and tongue, reduced frequency of urination, dark-colored urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• 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 urine production
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle twitching, 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)
• high bilirubin levels in the blood (which, in severe cases, may cause the skin and eyes to turn yellow)
• high levels of urea nitrogen and creatinine in the blood (which may indicate abnormal kidney function)
• high levels of uric acid in the blood (which, in severe cases, may trigger a gout attack)
• syncope (fainting)

The following side effects have been reported with valsartan or hydrochlorothiazide-containing medicines separately:

Valsartan

Uncommon (may affect up to 1 in 100 people)

• feeling of spinning
• abdominal pain

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

• intestinal angioedema: swelling in the intestine that is accompanied by symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Frequency not known (cannot be estimated from available data)

• blistering of the skin (sign of dermatitis bullous)
• skin rash with or without itching, accompanied by one or more of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or symptoms similar to the flu
• 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
• increased liver function values
• decrease in hemoglobin level and reduction in the percentage of red blood cells in the blood (which, in severe cases, may cause anemia)
• renal insufficiency
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle twitching, and/or convulsions)

Hydrochlorothiazide

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

• low potassium levels in the blood
• increased levels of 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
• nausea and vomiting
• dizziness, dizziness when standing up
• difficulty achieving or maintaining 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 with yellow skin or eyes
• irregular heartbeat
• headache
• sleep disturbances
• depression
• low platelet count (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• vision disturbances

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

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• skin 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)
• skin rash, joint pain, muscle pain, fever (cutaneous lupus erythematosus)
• severe stomach pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (difficulty breathing that includes pneumonitis and pulmonary edema)
• fever, sore throat, increased frequency of infections (agranulocytosis)
• pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)
• acute respiratory distress (the signs include severe difficulty breathing, fever, weakness, and confusion)
• fever, sore throat, or mouth ulcers due to infections (leucopenia)
• confusion, fatigue, muscle twitching, and spasms, rapid breathing (hypochloremic alkalosis)

Frequency not known (cannot be estimated from available data)

• skin cancer and lip cancer (non-melanoma skin cancer)
• weakness, bruises, and frequent infections (aplastic anemia)
• significant decrease in urine production (possible signs of renal impairment or renal failure)
• decrease in vision or eye pain due to high blood pressure (possible signs of accumulation of fluid in the vascular layer of the eye (choroidal hemorrhage) 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 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 the Spanish System of 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 this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears 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 it from light and moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Valsartan/Hidroclorotiazida Krka

• The active principles are valsartan andhidroclorotiazida.

Each tablet contains 160 mg of valsartan and 12.5 mg ofhidroclorotiazida.

• The other components 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 iron oxide red (E172) in the coating. See section 2 “Valsartan/Hidroclorotiazida Krka contains lactose and sodium”.

Appearance of the product and contents of thepackaging

The valsartan/hidroclorotiazida Krka 160 mg/12.5 mg coated tablets are oval, biconvex, and brownish-red in color.

The tablets are presented in blister packs with 14, 28, 30, 56, 60, 84, 90, 98, 280, 56x1, 98x1, and 280x1 coated tablets.

Only some sizes of packaging may be commercially marketed.

Marketing Authorization Holder

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

Responsible for Manufacturing

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

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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

Last review date of this leaflet: March 2025

More detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.