VALSARTAN/HYDROCHLOROTHIAZIDE KERN PHARMA 320 mg/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valsartan/Hydrochlorothiazide Kern Pharma 320 mg/25 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Valsartan/Hydrochlorothiazide Kern Pharma and what is it used for
2. What you need to know before you take 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 other information

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

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

• Valsartanbelongs to a class of medicines 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 narrow, leading to an increase in blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazidebelongs to a class of medicines known as thiazide diuretics (also known as water pills). Hydrochlorothiazide increases urine production, which also decreases blood pressure.

Valsartan/Hydrochlorothiazide 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 lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these disorders.

2. What you need to know before you take Valsartan/Hydrochlorothiazide Kern Pharma

Do not take Valsartan/Hydrochlorothiazide Kern Pharma

• if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6),
• if you are pregnant more than 3 months(in any case, it is better to avoid taking this medicine also at the beginning of your pregnancy – see section Pregnancy),
• if you have severe liver disease, destruction of the 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 low potassium or sodium levels in your blood, or if your blood calcium levels are higher than normal despite treatment,
• if you have gout.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

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

Warnings and precautions

Tell your doctor or pharmacist before taking Valsartan/Hydrochlorothiazide

• if you are using potassium-sparing medicines, potassium supplements, salt substitutes that contain potassium, or other medicines that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly check 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 have heart failure or have had a heart attack. Follow your doctor's instructions carefully when starting treatment. Your doctor may also monitor your kidney function.
• if you have a narrowing of the kidney artery.
• if you have recently undergone a kidney transplant.
• if you have hyperaldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, Valsartan/Hydrochlorothiazide is not recommended.
• if you have kidney or liver disease.
• tell your doctor if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema while taking other medicines (including ACE inhibitors). If you have these symptoms, stop taking Valsartan/Hydrochlorothiazide Kern Pharma immediately and never take it again. See also section 4. Possible side effects.
• if you have fever, rash, and joint pain, which can be signs of systemic lupus erythematosus (an autoimmune disease known as SLE).
• if you have diabetes, gout, high cholesterol or triglyceride levels in your blood.
• if you have previously had an allergic reaction with the use of another medicine in this class to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.
• if you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur within a period of time ranging from several hours to weeks after taking valsartan/hydrochlorothiazide. If left untreated, this can lead to permanent vision loss. You may be at higher risk of developing it if you have previously been allergic to penicillin or sulfonamides.
• it may cause increased sensitivity of the skin to the sun.
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular its long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Valsartan/Hydrochlorothiazide Kern Pharma.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Valsartan/Hydrochlorothiazide Kern Pharma, seek medical attention immediately.
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Valsartan/Hydrochlorothiazide Kern Pharma”.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking this medicine. Your doctor will decide whether to continue treatment. Do not stop taking Valsartan/Hydrochlorothiazide on your own.

If any of these situations apply to you, consult your doctor.

You must inform your doctor if you suspect you are pregnant (or might be). Valsartan/Hydrochlorothiazide Kern Pharma is not recommended for use at the start of pregnancy, and it must not be taken if you are pregnant more than 3 months, as it may cause serious harm to your baby if used during this period (see section Pregnancy).

Children and adolescents

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

Athletes

This medicine contains hydrochlorothiazide, which may produce a positive result in doping tests (see references to section 4.4 of the technical sheet).

Use of other medicines

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

The effect of treatment with Valsartan/Hydrochlorothiazide may be altered if taken with certain medicines. It may be necessary to change the dose, take other precautions, or, in some cases, stop treatment with one of the medicines. This is especially applicable to the following medicines:

• lithium, a medicine used to treat certain psychiatric disorders;
• medicines that may affect or be affected by potassium levels, such as digoxin, a medicine to control heart rhythm, and some antipsychotic medicines;
• medicines or substances that may increase potassium levels in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin;
• medicines that may decrease potassium levels in the blood, diuretics (water pills), corticosteroids, some laxatives, carbenoxolone, amphotericin, or penicillin G;
• certain antibiotics (of the rifampicin group), a medicine used to protect against rejection after a transplant (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartan/Hydrochlorothiazide Kern Pharma;
• medicines that may induce “torsades de pointes” (irregular heartbeats), such as anti-arrhythmics (medicines used to treat heart problems) and some antipsychotics;
• medicines that may reduce sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics;
• medicines for treating gout, such as allopurinol, probenecid, sulfinpyrazone;
• therapeutic vitamin D and calcium supplements, medicines for treating diabetes (oral antidiabetics, such as metformin or insulin);
• other medicines for lowering blood pressure, including methyldopa;
• medicines for increasing blood pressure, such as noradrenaline or adrenaline;
• digoxin or other digitalis glycosides (medicines used to treat heart problems);
• medicines for increasing blood sugar levels, such as diazoxide or beta-blockers,
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
• medicines for pain, such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors, and more than 3 g of acetylsalicylic acid;
• muscle relaxants, such as tubocurarine,
• anticholinergic medicines (medicines used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia);
• amantadine (a medicine used to treat Parkinson's disease and to prevent certain viral diseases);
• cholestyramine and colestipol (medicines used primarily to treat high lipid levels in the blood);
• cyclosporin, a medicine used to prevent organ rejection after transplantation;
• alcohol, sleeping medicines, and anesthetics (medicines with a sedative effect or for pain used, for example, in surgical cases);
• iodinated contrast media (used for diagnostic imaging tests);
• if you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Valsartan/Hydrochlorothiazide Kern Pharma” and “Warnings and precautions”.

Taking Valsartan/Hydrochlorothiazide Kern Pharma with food, drinks, and alcohol

You can take Valsartan/Hydrochlorothiazide with or without food.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you are planning to become pregnant.

Generally, your doctor will advise you to stop taking Valsartan/Hydrochlorothiazide before you become pregnant or as soon as you find out you are pregnant, and will recommend taking another anti-hypertensive medicine instead. Valsartan/Hydrochlorothiazide is not recommended for use at the start of pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby when administered after this time.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding.Valsartan/Hydrochlorothiazide Kern Pharma is not recommended for breastfeeding mothers, and your doctor will prescribe another medicine if you wish to continue breastfeeding, especially if the baby is newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or engaging in other activities that require concentration, make sure you know how you react to the effects of Valsartan/Hydrochlorothiazide. Like many other medicines used to treat high blood pressure, Valsartan/Hydrochlorothiazide may occasionally cause dizziness and affect your ability to concentrate.

Valsartan/Hydrochlorothiazide Kern Pharma contains lactose and sodium

Valsartan/Hydrochlorothiazide Kern Pharma contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially “sodium-free”

3. How to take Valsartan/Hydrochlorothiazide Kern Pharma

Follow the instructions for administration of this medicine exactly as indicated by your doctor. This will help you get the best results and reduce the risk of side effects. If you are 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 tell you exactly how many Valsartan/Hydrochlorothiazide tablets you should take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

• The usual dose of Valsartan/Hydrochlorothiazide is one tablet per day.
• Do not change the dose or stop treatment without consulting your doctor.
• This medicine should be taken at the same time every day, usually in the morning.
• You can take Valsartan/Hydrochlorothiazide with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan/Hydrochlorothiazide Kern Pharma than you should

If you notice a strong dizziness and/or fainting, lie down and contact your doctor immediately.

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

If you forget to take Valsartan/Hydrochlorothiazide 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 missed doses.

If you stop taking Valsartan/Hydrochlorothiazide Kern Pharma

Stopping treatment with Valsartan/Hydrochlorothiazide Kern Pharma may cause your blood pressure to worsen. Do not stop taking this medicine unless your doctor tells you to.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some adverse effects can be serious and require immediate medical attention:

• You should visit your doctor immediately if you notice symptoms of angioedema, such as:

• swelling in the face, tongue, or pharynx
• difficulty swallowing
• hives and difficulty breathing.
• 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 pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

• Fever, sore throat, increased frequency of infections (agranulocytosis).
• Acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

These adverse effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop taking Valsartan/Hydrochlorothiazide Kern Pharma and contact your doctor immediately (see also section 2"Warnings and Precautions").

Other adverse 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 frequency of urination, dark-colored urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness sensation
• blurred vision
• noises (e.g., whistling or buzzing) in the ears

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

• dizziness
• diarrhea
• joint pain

Frequency not known (frequency cannot be estimated from available data)

• breathing difficulties
• severe decrease in urine production
• low sodium levels in the blood (which, in severe cases, can 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 in the blood (with symptoms such as fever, skin infections, sore throat, or mouth ulcers due to infections, weakness)
• increased bilirubin in the blood (which, in severe cases, can cause yellowing of the skin and eyes)
• increased urea and creatinine levels in the blood (which may indicate abnormal kidney function)
• increased uric acid levels in the blood (which, in severe cases, can trigger a gout attack)
• fainting (syncope).

Adverse effects have been observed with medicines containing valsartan or hydrochlorothiazide 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

Frequency not known (frequency cannot be estimated from available data)

• skin 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
• skin rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
• low platelet count (sometimes with bleeding or bruising more frequently than usual)
• high potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)
• allergic reactions (with symptoms such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling mainly of the face and throat; skin rash; itching
• elevated liver function values
• decrease in hemoglobin and red blood cell percentage in the blood (which, in severe cases, can cause anemia)
• renal failure
• low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle twitching, and/or convulsions).

Hydrochlorothiazide

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

• low potassium levels in the blood
• increased lipids in the blood

Common (may affect up to 1 in 10 people)

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• skin rash with itching and other types of rash
• decreased appetite
• mild vomiting and nausea
• dizziness, dizziness when standing up
• inability to achieve or maintain an erection.

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

• swelling and blisters on the skin (due to increased sun sensitivity)
• 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 along with yellowing of the skin and eyes
• irregular heartbeat
• headache
• sleep disturbances
• sadness (depression)
• low platelet count (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• vision disturbances.

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

• blood vessel inflammation with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• severe pain in the upper abdomen (pancreatitis)
• breathing difficulties with fever, cough, wheezing, shortness of breath (breathing difficulties including pneumonitis and pulmonary edema)
• pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)
• fever, sore throat, or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, muscle twitching, and/or spasms, rapid breathing (hypochloremic alkalosis)

Frequency not known (frequency cannot be estimated from available data)

• skin and lip cancer (non-melanoma skin cancer)
• weakness, bruising, and frequent infections (aplastic anemia)
• severe decrease in urine production (possible signs of kidney disorder or renal failure)
• rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle spasms
• fever (pyrexia)
• weakness (asthenia)

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Valsartan/Hydrochlorothiazide Kern Pharma

Keep this medicine out of the sight and reach of children.

Do not store above 30°C. Store in the original packaging to protect from light and moisture.

Do not use this medicine 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 via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Valsartan/Hydrochlorothiazide Kern Pharma

• The active ingredients are valsartan and hydrochlorothiazide.

Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.

• The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, magnesium stearate (E470b), sodium croscarmellose, povidone, and anhydrous colloidal silica in the tablet core, and hypromellose, titanium dioxide (E171), macrogol 4000, and yellow iron oxide (E172) in the coating. See section 2 "Valsartan/Hydrochlorothiazide Kern Pharma contains lactose and sodium"

Appearance of the Product and Package Contents

Light yellow, oval, biconvex, film-coated tablets with a score line on one side. The tablets can be divided into two equal halves.

They are available in packs containing 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 280, 56x1, 98x1, and 280x1 tablets in blister packs.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

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 under the following names:

Date of the last revision of this leaflet: March 2025

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