Leaflet: Information for the User

Valsartan/hydrochlorothiazide Kern Pharma 320 mg/12.5 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even 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.

1. What is Valsartan/hydrochlorothiazide Kern Pharma and what it is used for

2. What you need to know before taking Valsartan/hydrochlorothiazide Kern Pharma

3. How to take Valsartan/hydrochlorothiazide Kern Pharma

4. Possible side effects

5. Storage of Valsartan/hydrochlorothiazide Kern Pharma

6. Contents of the pack and additional information

Valsartán/hidroclorotiazida Kern Pharma 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 (also known as urine-producing medications). Hidroclorotiazida increases diuresis, which also decreases blood pressure.

Valsartán/hidroclorotiazida Kern Pharma 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 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 Kern Pharma

• if you are allergic to valsartan, hidroclorotiazida, sulfonamide derivatives (chemical substances related to hidroclorotiazida) or to any of the other components of this medication (listed in section 6),
• if you aremore than 3 months pregnant(in any case, it is better to avoid taking this medication also at the beginning of your pregnancy – see Pregnancy section),
• if you have a severe liver diseaseorsmall bile duct destruction in the liver (biliary cirrhosis) that leads to bile accumulation in the liver (cholestasis),
• if you have a severe kidney disease,
• if you are unable to 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 apply to you, do not take this medication and consult your doctor.

Warnings and precautions

Inform your doctor or pharmacist before taking Valsartán/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 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 a severe heart disease.
• if you have heart failure or have had a heart attack. Follow your doctor's instructions carefully to start treatment. 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 disease in which the adrenal glands produce too much aldosterone hormone. In this case, Valsartán/hidroclorotiazida is not recommended.
• if you have kidney or liver disease.
• inform your doctor if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema while taking other medications (including ACE inhibitors). If you have these symptoms, stop taking Valsartán/Hidroclorotiazida Kern Pharma immediately and do not 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 (a known autoimmune disease called LES).
• if you have diabetes, gout, high levels of cholesterol or triglycerides 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 several hours to weeks after taking valsartán/hidroclorotiazida. If left untreated, this can lead to permanent vision loss. You may be at higher risk of developing it if you have had an allergy to penicillin or sulfonamides previously.
• 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 Kern Pharma.
• if you 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 Kern Pharma, 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.

Your doctor may regularly monitor your renal function, blood pressure, and electrolyte levels in the blood (such as potassium).

See also the information under the heading “Do not take Valsartán/hidroclorotiazida Kern Pharma”.

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 apply to you, consult your doctor.

You must inform your doctor if you suspect you are pregnant (or could be). Valsartán/Hidroclorotiazida Kern Pharma is not recommended for use at the beginning 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 during this period (see Pregnancy section).

Children and adolescents

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

Use in athletes

This medication contains hidroclorotiazida, which may produce a positive result in doping control tests (see section 4.4 of the technical data sheet).

Use of other medications

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

The effect of treatment with Valsartán/hidroclorotiazida may be altered if taken with certain medications. You may need to change the dose, take other precautions, or, in some cases, discontinue treatment with one of the medications. This is especially applicable to the following medications:

• lithium, a medication used to treat certain types of psychiatric diseases;
• medications that may affect or be affected by potassium levels, such as digoxin, a medication to control heart rhythm, some antipsychotics;
• medications or substances that may increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin;
• medications that may decrease potassium levels in the blood, diuretics (medications to urinate), corticosteroids, some laxatives, carbenoxolona, anfotericina, or penicillin G;
• some antibiotics (of the rifampicin group), a medication used to protect against rejection after a transplant (ciclosporina), or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Valsartán/Hidroclorotiazida Kern Pharma;
• medications that may induce »torsades de pointes« (irregular heartbeats), such as antiarrhythmics (medications used to treat heart problems) and some antipsychotics;
• medications that may decrease sodium levels 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 antidiabetics, such as metformin or insulin);
• other medications to lower blood pressure, including metildopa;
• medications to increase blood pressure, such as norepinephrine or epinephrine;
• digoxin or other digitalis glycosides (medications used to treat heart problems);
• medications to 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 more than 3 g of aspirin;
• muscle relaxants, such as tubocurarina;
• anticholinergic medications (medications used to treat different disorders such as gastrointestinal cramps, urinary tract spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia);
• amantadina (a medication used to treat Parkinson's disease and to prevent certain diseases caused by viruses);
• colestiramina and colestipol (medications used mainly to treat high levels of lipids in the blood);
• ciclosporina, a medication used to prevent organ rejection after transplantation;
• alcohol, sleep medications, and anesthetics (medications with sedative or pain-relieving effects used, for example, in surgical cases);
• 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 Kern Pharma” and “Warnings and precautions”.

Taking Valsartán/hidroclorotiazida Kern Pharma with food, drinks, and alcohol

You can take Valsartán/hidroclorotiazida 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 and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you are pregnant, or if you plan to become pregnant.

Generally, your doctor will advise you to stop taking Valsartán/hidroclorotiazida before becoming pregnant or as soon as you become pregnant, and will recommend taking another antihypertensive medication instead. Valsartán/hidroclorotiazida is not recommended for use at the beginning 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 during this period (see Pregnancy section).

Lactation

You must inform your doctor if you are breastfeeding or plan to start breastfeeding.Valsartán/hidroclorotiazida Kern Pharma is not recommended for use in breastfeeding mothers, and your doctor will prescribe another medication if you wish to continue breastfeeding, especially if the baby is newborn or premature.

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. Like many other medications used to treat high blood pressure, Valsartán/hidroclorotiazida may cause, occasionally, dizziness and affect concentration.

Valsartán/hidroclorotiazida Kern Pharma contains lactose and sodium

Valsartán/hidroclorotiazida Kern Pharma contains lactose. If your doctor has indicated 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, which means it is essentially “sodium-free”

Follow exactly the administration instructions for this medication as indicated by your doctor. This will help you achieve the best results and reduce the risk of adverse effects. If in doubt, consult 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 instruct you exactly how many tablets of Valsartán/hidroclorotiazida 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 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 Valsartán/hidroclorotiazida with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartán/hidroclorotiazida Kern Pharma than you should

If you experience severe dizziness and/or fainting, lie down and immediately contact your doctor.

If you have accidentally taken too many tablets, contact your doctor, pharmacist, hospital, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Valsartán/hidroclorotiazida Kern Pharma

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, do not take the missed dose.

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

If you interrupt treatment with Valsartán/hidroclorotiazida Kern Pharma

Stopping treatment with Valsartán/Hidroclorotiazida Kern Pharma may cause a worsening of your blood pressure. Do not stop taking this medication unless your doctor tells you to.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side 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 throat
• Difficulty swallowing
• Hives and difficulty breathing.
• Severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)
• 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)
• Fever, sore throat, increased frequency of infections (agranulocytosis)
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion)

These side effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop taking Valsartán/Hidroclorotiazida Kern Pharma 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
• Dehydration (with symptoms such as thirst, dry mouth and tongue, reduced urine frequency, dark urine, dry skin)
• Muscle pain
• Fatigue
• Prickling or numbness
• Blurred vision
• Ringing in the ears (e.g., hissing, buzzing)

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

• Dizziness
• Diarrhea
• Joint pain

Unknown frequency (the frequency cannot be estimated from the available data)

• Difficulty breathing
• Severe decrease in urine production
• Low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle fasciculations, and/or seizures)
• 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, can cause yellow skin and eyes)
• Increased levels of urea nitrogen and creatinine 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).

Side effects have been observed with valsartan or hydrochlorothiazide-containing medications separately:

Valsartan

Uncommon (may affect up to 1 in 100 people)

• Vertigo
• 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

Unknown frequency (the frequency cannot be estimated from the available data)

• 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 spots, fever, itching (signs 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
• Increased liver function values
• Decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, can cause anemia)
• Renal insufficiency
• Low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle fasciculations, and/or seizures).

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 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 alterations that may appear with yellow skin and eyes
• Irregular heartbeat
• Headache
• Sleep disturbances
• Depression (sadness)
• Low platelet count (sometimes with bleeding or bruising under the skin)
• Dizziness
• Prickling or numbness
• Visual disturbances.

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

• Inflammation of the blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)
• Rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• Rash, facial pain, muscle disorders, fever (lupus erythematosus)
• Severe upper stomach pain (pancreatitis)
• Difficulty breathing with fever, cough, wheezing, shortness of breath (difficulty breathing that includes pneumonitis and pulmonary edema)
• Pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia)
• Fever, sore throat, or mouth ulcers due to infections (leukopenia)
• Confusion, fatigue, muscle cramps, rapid breathing (hypochloremic alkalosis)

Unknown frequency (the frequency cannot be estimated from the available data)

• Skin cancer and lip cancer (non-melanoma skin cancer)
• Weakness, bruises, and frequent infections (aplastic anemia)
• Severe decrease in urine production (possible signs of renal dysfunction or renal insufficiency)
• 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 not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance 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 store at a temperature above 30°C. Store in the original packaging to protect from light and humidity.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Valsartán/Hidroclorotiazida Kern Pharma

• The active principles are valsartán and hidroclorotiazida.

Each tablet contains 320 mg of valsartán and 12.5 mg of hidroclorotiazida.

• The other components are microcrystalline cellulose (E460), lactose monohydrate, magnesium stearate (E470b), croscarmellose sodium, povidone, and anhydrous colloidal silica in the core of the tablet and hypromellose, titanium dioxide (E171), macrogol 4000, and iron oxide red (E172) in the coating. See section 2 “Valsartán/Hidroclorotiazida Kern Pharma contains lactose and sodium”

Appearance of the product and contents of the package

Coated tablets with a pink film, oval, biconvex.

It is presented in boxes containing 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 280, 56x1, 98x1, and 280x1 tablets in blister packs.

Only some package sizes may be marketed.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

or

TAD Pharma GmbH

Heinz-Lohmann-Strasse 5

27472 Cuxhaven

Germany.

or

KRKA-POLSKA Sp. z o.o.

ul. Równolegla 5,

02-235 Warszawa,

Poland

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

Last review date of this leaflet: March 2025

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