Valsartan/hydrochlorothiazide Kern Pharma 80 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Valsartan/hydrochlorothiazide Kern Pharma 80 mg/12.5 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, as you may need to read it again.
• If you have any questions, ask 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 could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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 Valsartán/Hidroclorotiazida Kern Pharma is and what it is used for

The active substances in Valsartán/hidroclorotiazida Kern Pharma film-coated tablets are valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartan belongs to a group of medicines known as “angiotensin II receptor antagonists” which help control high blood pressure. Angiotensin II is a substance produced by 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 is lowered.
• Hydrochlorothiazide belongs to a class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also lowers blood pressure.

Valsartán/hidroclorotiazida Kern Pharma film-coated tablets are used to treat high blood pressure (hypertension) that is not adequately controlled with valsartan alone.

High blood pressure 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 starting to take Valsartán/Hydrochlorothiazide Kern Pharma

Do not take Valsartán/Hydrochlorothiazide Kern Pharma:

• if you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6),
• if you are more than 3 months pregnant. Use of Valsartán/Hydrochlorothiazide Kern Pharma is not recommended during early pregnancy (see Pregnancy section),
• if you have severe liver disease, destruction of the small bile ducts in the liver (primary biliary cirrhosis), or a condition causing 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 your blood, or abnormally high levels of calcium in your blood despite treatment,
• if you have gout,
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to you, do not take this medicine and inform your doctor.

Warnings and precautions

Tell your doctor or pharmacist before taking Valsartán/Hydrochlorothiazide Kern Pharma:

• if you are taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, 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 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 such cases, use of Valsartán/Hydrochlorothiazide Kern Pharma 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, or high cholesterol or triglyceride levels in your blood.
• if you have 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 valsartan/hydrochlorothiazide. If untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergic reaction to penicillin or sulphonamides.
• it may increase skin sensitivity to sunlight.
• if you have had skin cancer or develop unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, especially 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 and UV exposure while taking Valsartán/Hydrochlorothiazide Kern Pharma.
• if you have previously experienced respiratory or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnoea 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 (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 Kern Pharma 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 at the beginning of 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

Use of Valsartán/Hydrochlorothiazide Kern Pharma is not recommended 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).

Use with 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 Kern Pharma may be altered when taken together with certain medicines. It may be necessary to adjust the dose, take additional precautions, or, in some cases, discontinue treatment with one of the medicines. This is particularly important for the following medicines:

• lithium, a medicine used to treat certain psychiatric disorders;
• medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• medicines that may decrease blood potassium levels, such as diuretics (medicines that increase urine production), corticosteroids, certain 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 certain antipsychotics;
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics;
• medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone;
• therapeutic vitamin D and calcium supplements; medicines for treating diabetes (oral antidiabetics, such as metformin, or insulin);
• other blood pressure-lowering medicines, including methyldopa;
• medicines that 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 (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 medicines, and anaesthetics (medicines with sedative or pain-relieving effects, used, for example, during surgery);
• iodinated contrast agents (used in diagnostic imaging procedures);
• if you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also the 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 Kern Pharma with or without food.

Avoid 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 taking any medicine.

Pregnancy

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. Use of 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 that point.

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, handling machinery, or engaging in other activities requiring concentration, ensure you are aware of how Valsartán/Hydrochlorothiazide Kern Pharma affects you. Like many other medicines used to treat high blood pressure, Valsartán/Hydrochlorothiazide Kern Pharma may rarely cause dizziness and affect concentration.

Valsartán/Hydrochlorothiazide Kern Pharma contains lactose and sodium

Valsartán/Hydrochlorothiazide Kern Pharma contains lactose. If your doctor has informed 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, meaning it is essentially “sodium-free”.

3. How to take Valsartan/Hydrochlorothiazide Kern Pharma

Follow exactly the administration instructions for 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 this condition. Many do not feel unwell. This makes it very important to keep your doctor's appointments even when you feel well.

Your doctor will tell you exactly how many tablets of Valsartan/Hydrochlorothiazide 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 Valsartan/Hydrochlorothiazide Kern Pharma 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 Valsartan/Hydrochlorothiazide Kern Pharma 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 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 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 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 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 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

• rash and difficulty breathing

• Serious skin disease causing rash, redness of the skin, blisters on 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
• mild headache
• dehydration (with symptoms such as thirst, dry mouth and tongue, reduced frequency of urination, dark-coloured 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
• diarrhoea
• joint pain

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

• difficulty breathing
• severe decrease in urine production
• low sodium levels in blood (which in severe cases may cause fatigue, confusion, muscle fasciculations and/or seizures)
• low potassium levels in blood (sometimes with muscle weakness, muscle cramps, irregular heart rhythm)
• low white blood cell count in blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
• increased bilirubin in blood (which may, in severe cases, cause yellowing of skin and eyes)
• increased blood urea nitrogen and creatinine levels in blood (which may indicate abnormal kidney function)
• increased levels of uric acid in blood (which may, in severe cases, trigger a gout attack)
• syncope (fainting)

The following adverse effects have been observed with medicines containing valsartan or hydrochlorothiazide separately:

Valsartan

Uncommon (may affect up to 1 in 100 people)

• dizziness
• abdominal pain

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

• intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhoea

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, lymph node swelling and/or flu-like symptoms
• skin rash, red-purple spots, fever, pruritus (symptoms of blood vessel inflammation)
• low platelet count (sometimes with unusual bleeding or bruising)
• high potassium levels in blood (sometimes with muscle cramps, irregular heart rhythm)
• allergic reactions (with symptoms such as rash, itching, urticaria, difficulty breathing or swallowing, dizziness)
• swelling mainly of face and throat; rash; itching
• increased liver function test values
• decreased haemoglobin levels and percentage of red blood cells in blood (which in severe cases may lead to anaemia)
• renal failure
• low sodium levels in 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 blood
• increased blood lipids

Common (may affect up to 1 in 10 people)

• low sodium levels in blood
• low magnesium levels in blood
• high uric acid levels in blood
• itchy rash and other types of skin rash
• decreased appetite
• mild nausea and vomiting
• dizziness, dizziness upon standing
• inability to achieve or maintain an erection

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

• skin swelling and blisters (due to increased sensitivity to sunlight)
• high calcium levels in blood
• high blood sugar levels
• sugar in urine
• worsening of diabetic metabolic status
• constipation, diarrhoea, stomach or intestinal discomfort, liver disorders which may occur together with yellowing of skin and eyes
• irregular heart rhythm
• headache
• sleep disorders
• sadness (depression)
• low platelet count (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• visual 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, urticaria, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• severe upper abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (breathing difficulty including pneumonitis and pulmonary oedema)
• pale skin, fatigue, shortness of breath, dark-coloured urine (haemolytic anaemia)
• fever, sore throat or mouth ulcers due to infections (leucopenia)
• confusion, fatigue, muscle twitches and cramps, rapid breathing (hypochloraemic 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 anaemia)
• severe decrease in urine production (possible signs of kidney impairment or renal failure)
• rash, redness of skin, blisters on 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 adverse effect, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can 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.

Store in the original packaging to protect it from light and moisture.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Pack contents and other information

Composition of Valsartan/Hydrochlorothiazide Kern Pharma

• The active substances are valsartan and hydrochlorothiazide.

Each film-coated tablet contains 80 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 anhydrous colloidal silica in the tablet core; hypromellose, titanium dioxide (E171), macrogol 4000, iron oxide red (E172), and iron oxide yellow (E172) in the coating. See section 2 “Valsartan/Hydrochlorothiazide Kern Pharma contains lactose and sodium”.

Appearance of the product and contents of the pack

Pink, oval, biconvex film-coated tablets.

Packaged in cartons containing 14, 28, 30, 56, 60, 84, 90, 98, 280, 56 x 1, 98 x 1, 280 x 1 tablets in blister packs.

Only certain 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. Równoległa 5

02-235 Warszawa

Poland

This medicinal product has been authorized in the Member States of the European Economic Area 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/