Package Insert: Information for the User

Valsartan/Hydrochlorothiazide Kern Pharma 160 mg/25 mg Film-Coated Tablets

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others who may 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.

The active ingredients of Valsartán/hidroclorotiazida Kern Pharma coated tablets are valsartán and hidroclorotiazida. These components help control high blood pressure (hypertension).

• Valsartánbelongs to a group of medications known as “angiotensin II receptor antagonists” that help control high blood pressure. Angiotensin II is a substance produced by the body that causes blood vessels to constrict, resulting in an increase in 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 Kern Pharma coated tablets are used to treat high blood pressure (hypertension) that is not adequately controlled with the use of valsartán alone.

Hypertension increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal levels reduces the risk of suffering these disorders.

Do not take Valsartán/hidroclorotiazida Kern Pharma:

• if you are allergic to valsartán, hidroclorotiazida, sulfonamide derivatives (chemical substances 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. It is recommended to avoid Valsartán/hidroclorotiazida Kern Pharma in early stages of pregnancy (see Pregnancy section),
• if you have severe liver disease, destruction of small bile ducts in the liver (biliary cirrhosis) that leads to the accumulation 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 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 the above situations apply to you, do not take this medication and inform your doctor.

Warnings and precautions

Inform your doctor or pharmacist before taking Valsartán/hidroclorotiazida Kern Pharma

• 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 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 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 renal artery stenosis.
• if you have recently undergone a kidney transplant.
• if you have hyperaldosteronism. This is a disease in which the adrenal glands produce too much aldosterone hormone. If this is your case, the use of Valsartán/hidroclorotiazida Kern Pharma 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 suffer from 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 at any time from several hours to several 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 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. 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 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, seek medical attention immediately.
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• a renin-angiotensin-aldosterone system (RAAS) inhibitor (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 may be). Valsartán/Hidroclorotiazida Kern Pharma is not recommended in early stages of pregnancy, and 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 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 Kern Pharma 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 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 your blood, such as diuretics (urine-producing medications), corticosteroids, some laxatives, carbenoxolona, anfotericina or penicillin G;
• some antibiotics (from 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 antiarrhythmic medications (heart medications) and some antipsychotics;
• medications that may decrease the amount of sodium 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 metfomina or insulins);
• 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 medications);
• medications used to increase blood sugar levels, such as diazoxida or beta-blockers;
• cytotoxic medications (used to treat cancer), such as metotrexato or ciclofosfamida;
• pain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, and more than 3 g of acetylsalicylic acid;
• 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 (ACE) inhibitor 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 Kern Pharma with or without food.

Avoid taking alcohol until consulting with 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

Inform your doctor if you are pregnant or think you may be.Normally, your doctor will advise you to stop treatment with Valsartán/hidroclorotiazida Kern Pharma before becoming pregnant or as soon as you know you are pregnant and will prescribe another medication in place of Valsartán/hidroclorotiazida Kern Pharma. Valsartán/hidroclorotiazida Kern Pharma is not recommended in early stages of pregnancy, and should not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Lactation

Inform your doctor if you are breastfeeding or plan to start breastfeeding.Valsartán/hidroclorotiazida Kern Pharma is not recommended for 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 performing other activities that require concentration, make sure you know your reactions to the effects of Valsartán/hidroclorotiazida Kern Pharma. Like many other medications used to treat high blood pressure, Valsartán/hidroclorotiazida Kern Pharma may cause, in rare cases, dizziness and affect concentration.

Valsartán/hidroclorotiazida Kern Pharma contains lactose and sodium

Valsartán/hidroclorotiazida Kern Pharma contains lactose. If you have been told that you have a certain sugar intolerance, consult your doctor 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. In cases of doubt, consult your doctor or pharmacist.

People with high blood pressure often do not notice any specific signs of this disease. Many do not feel unwell. This makes it very important to keep your appointments with your doctor even when you feel well.

Your doctor will indicate exactly how many tablets of Valsartán/hidroclorotiazida Kern Pharma 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 Kern Pharma 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 Kern Pharma 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 to take the next dose, do not take the missed dose.

Do not take a double dose to compensate 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 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
• Rash and difficulty breathing
• Severe skin disease that causes a 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
• Mild headache
• Dehydration (with symptoms such as thirst, dry mouth and tongue, reduced urine output, 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 available data)

• Difficulty breathing
• Severe reduction in urine output
• Low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or seizures)
• Low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, cardiac arrhythmias)
• 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 may, in severe cases, cause yellow skin and eyes)
• 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 may, in severe cases, trigger a gout attack)
• Syncope (fainting)

The following side effects have been observed with valsartan or hydrochlorothiazide-containing medications separately:

Valsartan

Uncommon (may affect up to 1 in 100 people)

• Dizziness
• 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 available data)

• Rash with or without itching, along with some of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or flu-like symptoms
• Rash, red-purple spots, fever, pruritus (signs of blood vessel inflammation)
• Low platelet count (sometimes with unusual bleeding or bruising)
• High potassium levels in the blood (sometimes with muscle spasms, cardiac arrhythmias)
• Allergic reactions (with symptoms such as rash, itching, urticaria, difficulty breathing or swallowing, dizziness)
• Swelling mainly of the face and throat; rash; itching
• Elevated liver function values
• Decreased hemoglobin and red blood cell percentage in the blood (which may, in severe cases, trigger anemia)
• Renal insufficiency
• Low sodium levels in the blood (which, in severe cases, may 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
• Reduced appetite
• Mild nausea and vomiting
• 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 of 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 abnormalities that may appear with yellow skin and eyes
• Irregular heart rhythm
• 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 blood vessels, with symptoms such as rash, red-purple spots, fever (vasculitis)
• Rash, itching, urticaria, 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 available data)

• Skin cancer and lip cancer (non-melanoma skin cancer)
• Weakness, bruises, and frequent infections (aplastic anemia)
• Severe reduction in urine output (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 it 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 medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Valsartán/Hidroclorotiazida Kern Pharma

• The active principles are valsartán and hidroclorotiazida.

Each film-coated tablet contains 160 mg of valsartán and 25 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, iron oxide red (E172), and iron oxide yellow (E172) in the coating. See section 2 "Valsartán/Hidroclorotiazida Kern Pharma contains lactose and sodium"

Appearance of the product and contents of the package

Film-coated tablets are light brown, oval, and biconvex.

They are presented in blisters containing 14, 28, 30, 56, 60, 84, 90, 98, 280 56 x 1, 98 x 1, 280 x 1 tablets.

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 medicinal product has been authorized in the Member States of the Economic Area with the following names:

Last review date of this leaflet: March 2025

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