Package Insert: Information for the Patient

Valsartan/Hydrochlorothiazide Krka 80mg/12.5mgCoated TabletsEFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

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

Valsartán/Hidroclorotiazida Krka coated tablets contain two active ingredients 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 result, 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 load on 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 (chemical substances related to hidroclorotiazida) or any other component 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 severe liver disease, small bile duct destruction in the liver (biliary cirrhosis) that leads to bile accumulation in the liver (cholestasis);
• if you have 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 blood pressure-lowering medication containing 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 potassium levels in the blood, such as heparin. Your doctor may need 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 experiencing heart failure or have a history of heart attack. Follow your doctor's instructions to start the dose carefully. Your doctor may also monitor 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 condition 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 experience 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 eye pressure, which can occur within a few hours to a week after taking Valsartán/Hidroclorotiazida 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 skin sensitivity to the sun;
• if you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The treatment with hidroclorotiazida, particularly 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 sun exposure 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):
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. 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 valsartán/hidroclorotiazida on your own.

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

Your doctor may regularly monitor your renal function, blood pressure, and electrolyte levels in the blood (e.g. 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. Valsartán/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 harm 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 certain types of psychiatric diseases,
• medications or substances that can increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin,
• medications that can decrease potassium levels in the blood, such as diuretics (urine-producing medications), corticosteroids, laxatives, carbenoxolona, amfotericina, or penicillin G,
• some antibiotics (rifamicin group), a medication used to prevent transplant rejection (ciclosporina) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications can increase the effect of Valsartán/Hidroclorotiazida Krka,
• medications that can induce “torsades de pointes” (irregular heartbeats), such as antiarrhythmics (heart problem medications) and some antipsychotics,
• medications that can decrease sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics,
• medications used to treat gout, such as alopurinol, probenecid, sulfinpirazona,
• vitamin D therapy and calcium supplements,
• medications used to treat diabetes (oral antidiabetic medications such as metformin or insulin),
• other medications used to lower blood pressure, including metildopa,
• medications that increase blood pressure, such as noradrenaline or adrenaline,
• digoxin or other digitalis glycosides (heart problem medications),
• medications that can 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 conditions such as gastrointestinal cramps, urinary tract spasms, 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 transplant rejection,
• 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 (ACE inhibitor) 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 can 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 harm to your baby if administered at that stage.

Breastfeeding

Inform your doctor if you plan 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 for 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 told you that you have a certain sugar intolerance, consult with them 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 dose.

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
• Urticaria 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
• Numbness or tingling
• 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 urine production
• Low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or convulsions)
• Low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• Low white blood cell count in the blood (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, may cause the skin and eyes to turn yellow)
• Increased levels of urea nitrogen and creatinine in the blood (which may indicate abnormal kidney function)
• Increased 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)

• Sensation of spinning
• 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 dermatitis bullosa)
• Rash with or without itching, along with one or more of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or symptoms similar to the flu
• Rash, red-purple patches, fever, itching (signs 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 rash, itching, urticaria, difficulty breathing or swallowing, dizziness)
• Swelling mainly of the face and throat; rash; itching
• Increased liver function values
• Decreased hemoglobin levels and reduced 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 fasciculations, 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
• Rash with itching and other types of rash
• Loss of 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 in 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 alterations that may appear with yellow skin or eyes
• Irregular heartbeat
• Headache
• Sleep disturbances
• Depression (sadness)
• Low platelet count (sometimes with bleeding or bruising under the skin)
• Dizziness
• Numbness or tingling
• Visual disturbances

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

• Inflammation of blood vessels with symptoms such as rash, red-purple patches, fever (vasculitis)
• Rash, itching, urticaria, difficulty breathing or swallowing, dizziness (allergic 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 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 cramps, 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)
• Decreased vision or eye pain due to high blood pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) 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 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 medicines you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Valsartan/Hidroclorotiazida Krka

• The active principles are valsartan andhidroclorotiazida.

Each tablet contains 80 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, iron oxide red (E172), and iron oxide yellow (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 80 mg/12.5 mg coated tablets are oval, biconvex, ofpinkcolor.

The tablets are presented in blister packs with 14, 28, 30, 56, 60, 84, 90, 98, 280, 56x1, 98x1, and 280x1coated 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 medication, 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 medication is available on the website of the Spanish AgencyofMedicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.