Valsartan/hydrochlorothiazide Kern Pharma 320 mg/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Valsartan/hydrochlorothiazide Kern Pharma 320 mg/12.5 mg film-coated tablets EFG

Read the entire 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Valsartan/hydrochlorothiazide Kern Pharma is 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. How to store Valsartan/hydrochlorothiazide Kern Pharma
6. Contents of the pack and other information

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

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

• Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists” which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, resulting in increased blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazide belongs to a class of medicines known as thiazide diuretics (also known as "water pills"). Hydrochlorothiazide increases urine production, which also lowers blood pressure.

Valsartan/hydrochlorothiazide Kern Pharma is used to treat high blood pressure that is not adequately controlled with only one of the components.

Hypertension increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may 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 conditions.

2. What you need to know before taking Valsartán/Hydrochlorothiazide Kern Pharma

Do not take Valsartán/Hydrochlorothiazide Kern Pharma

• if you are allergic to valsartán, hydrochlorothiazide, sulfonamide derivatives (substances chemically related to hydrochlorothiazide), or to any of the other components of this medicine (listed in section 6),
• if you are more than 3 months pregnant (in any case, it is better to avoid taking this medicine also during early pregnancy – see Pregnancy section),
• if you have severe liver disease, destruction of the small bile ducts in the liver (primary biliary cirrhosis), leading to bile accumulation 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 abnormally low levels of potassium or sodium in the blood, or if your blood calcium levels are higher than normal despite treatment,
• if you have gout,
• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing 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 Valsartán/Hydrochlorothiazide

• if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium, or other medicines that increase blood potassium levels, such as heparin. Your doctor may consider regular monitoring of potassium levels necessary.
• if you have low blood potassium levels.
• if you experience severe diarrhoea 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 narrowing of the artery to the kidney (renal artery stenosis).
• 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/Hydrochlorothiazide is not recommended.
• if you have kidney or liver disease.
• inform your doctor if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors). If you develop these symptoms, stop taking Valsartán/Hydrochlorothiazide Kern Pharma immediately and never take it again. See also section 4. Possible side effects.
• if you develop fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (an autoimmune disease known as SLE).
• if you have diabetes, gout, high cholesterol, or high triglyceride levels in the blood.
• if you previously had an allergic reaction to another medicine of this class used 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 could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from several hours to weeks after taking valsartán/hydrochlorothiazide. If untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulfonamides.
• it may cause increased skin sensitivity to sunlight.
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Valsartán/Hydrochlorothiazide Kern Pharma.
• if you have previously experienced breathing or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Valsartán/Hydrochlorothiazide Kern Pharma, seek medical attention immediately.
• if you are taking any of the following medicines 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.
• 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 Valsartán/Hydrochlorothiazide Kern Pharma”.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking this medicine. Your doctor will decide whether to continue treatment. Do not stop taking Valsartán/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 could be). Use of Valsartán/Hydrochlorothiazide Kern Pharma is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Children and adolescents

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

Use in athletes

This medicine contains hydrochlorothiazide, which may result in a positive doping test (see references in section 4.4 of the Summary of Product Characteristics).

Taking other medicines

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

The effect of treatment with Valsartán/Hydrochlorothiazide may be altered if taken together with certain medicines. It may be necessary to adjust the dose, take additional precautions, or, in some cases, discontinue one of the medicines. This is especially important for the following medicines:

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

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

You may take Valsartán/Hydrochlorothiazide with or without food.

Avoid alcohol until you have discussed it 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 medicine.

Pregnancy

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

Generally, your doctor will advise you to stop taking Valsartán/Hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Valsartán/Hydrochlorothiazide is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby if used from this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Valsartán/Hydrochlorothiazide Kern Pharma is not recommended for breastfeeding mothers, and your doctor will prescribe an alternative medicine if you wish to continue breastfeeding, especially if the baby is a newborn or premature.

Driving and using machines

Before driving, operating tools, or handling machinery, or engaging in other activities requiring concentration, ensure you are aware of how Valsartán/Hydrochlorothiazide affects you. Like many other medicines used to treat high blood pressure, Valsartán/Hydrochlorothiazide may occasionally cause dizziness and affect your ability to concentrate.

Valsartán/Hydrochlorothiazide Kern Pharma contains lactose and sodium

Valsartán/Hydrochlorothiazide Kern Pharma contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Valsartán/Hidroclorotiazida Kern Pharma

Follow exactly the instructions for administering this medicine as given 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 symptoms of the condition. Many feel perfectly normal. This makes it very important to attend your medical appointments regularly, even if you feel well.

Your doctor will tell 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 stop treatment without consulting your doctor.
• This medicine should be taken at the same time every day, usually in the morning.
• You may 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 contact your doctor immediately.

If you have accidentally taken too many tablets, contact your doctor, pharmacist, hospital, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine 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 your next dose, do not take the missed dose.

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

If you stop taking Valsartán/Hidroclorotiazida Kern Pharma

Stopping treatment with Valsartán/Hidroclorotiazida 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 further questions about using this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

• swelling of the face, tongue, or pharynx

• difficulty swallowing

• hives and difficulty breathing.

• Serious skin disease causing skin rash, redness of the skin, 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 breathing difficulty (signs include severe shortness of breath, 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., ringing, buzzing) in the ears

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

• dizziness
• diarrhea
• joint pain

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

• difficulty breathing
• severely decreased urine production
• 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 cramps, irregular heartbeat)
• 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 may, in severe cases, cause yellowing of the skin and eyes)
• increased blood urea nitrogen and creatinine levels in the blood (which may indicate abnormal kidney function)
• increased uric acid levels in the blood (which may, in severe cases, trigger a gout attack)
• syncope (fainting).

Adverse effects have been observed with medicines containing valsartan or hydrochlorothiazide separately:

Valsartan

Uncommon (may affect up to 1 in 100 people)

• sensation of spinning
• abdominal pain

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

• intestinal angioedema: swelling in the intestine causing 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 together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
• skin rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
• low platelet count (sometimes with increased bleeding or bruising)
• high potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
• 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 test values
• decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anemia)
• kidney failure
• 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 blood lipid levels

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
• itchy rash and other types of skin rash
• decreased appetite
• mild vomiting and nausea
• dizziness, dizziness upon standing
• inability to achieve or maintain an erection.

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

• swelling and blisters on the skin (due to increased sensitivity to sunlight)
• 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 disorders that may appear 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)

• inflammation of blood vessels 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)
• difficulty breathing with fever, cough, wheezing, shortness of breath (breathing difficulty including 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 twitches and 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 impairment or kidney failure)
• rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle cramps
• fever (pyrexia)
• weakness (asthenia)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartan/Hydrochlorothiazide Kern Pharma

Keep this medicine out of sight and reach of children.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are in doubt, please consult your pharmacist on how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartan/Hydrochlorothiazide Kern Pharma

• The active substances are valsartan and hydrochlorothiazide.

Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.

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

Appearance of the product and contents of the pack

Pink, oval-shaped, biconvex film-coated tablets.

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

Only certain pack sizes may be commercially available.

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. Równoległa 5,

02-235 Warszawa,

Poland

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the last review of this leaflet: March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/