Valsartan/hydrochlorothiazide Krka 80 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Valsartan/Hydrochlorothiazide Krka 80 mg/12.5 mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given 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 it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Valsartan/Hydrochlorothiazide Krka is and what it is used for
2. What you need to know before taking Valsartan/Hydrochlorothiazide Krka
3. How to take Valsartan/Hydrochlorothiazide Krka
4. Possible side effects
5. How to store Valsartan/Hydrochlorothiazide Krka
6. Contents of the pack and other information

1. What Valsartán/Hidroclorotiazida Krka is and what it is used for

Valsartán/Hidroclorotiazida Krka 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. Hydrochlorothiazide increases urine production, which also lowers blood pressure.

Valsartán/Hidroclorotiazida Krka is used to treat high blood pressure that is not adequately controlled with a single component.

Hypertension increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also 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/Hidroclorotiazida Krka

Do not take Valsartán/Hidroclorotiazida Krka

• if you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide), or any of the other ingredients of this medicine (listed in section 6);
• if you are more than 3 months pregnant (in any case, it is better to avoid Valsartán/Hidroclorotiazida Krka also during early pregnancy – see section Pregnancy, breastfeeding and fertility);
• if you have severe liver disease, destruction of the small bile ducts in the liver (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 your 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

Talk to your doctor or pharmacist before taking valsartan/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 it necessary to monitor your potassium levels regularly;
• if you have low potassium levels in your blood;
• 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 a history of 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/Hidroclorotiazida Krka is not recommended;
• if you have kidney or liver disease;
• 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), inform your doctor. If you develop these symptoms while taking Valsartán/Hidroclorotiazida Krka, stop treatment immediately and never 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 (SLE, a known autoimmune disease);
• if you have diabetes, gout, or high cholesterol or lipid 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 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 eye pressure, which may occur within a period ranging from several hours to one week after taking Valsartán/Hidroclorotiazida Krka. If left untreated, this may lead to permanent vision loss. Your risk may be higher if you previously had an allergy to penicillin or sulphonamides;
• it may increase skin sensitivity to sunlight;
• if you have had skin cancer or 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 and UV exposure while taking Valsartán/Hidroclorotiazida Krka.
• if you have previously had respiratory 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/Hidroclorotiazida Krka, 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.

Talk to 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 valsartan/hydrochlorothiazide on your own.

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

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/Hidroclorotiazida Krka”.

Consult your doctor if you think you are (or might be) pregnant. Valsartan/hydrochlorothiazide 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 at that stage (see section Pregnancy, breastfeeding and fertility).

Children and adolescents

The use of Valsartán/Hidroclorotiazida Krka is not recommended in children and adolescents (under 18 years of age).

Other medicines and Valsartán/Hidroclorotiazida Krka

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/Hidroclorotiazida Krka may be altered if taken together with certain medicines. Your doctor may need to adjust your dose and/or take other precautions, or in some cases discontinue treatment with one of the medicines. This is especially relevant 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, laxatives, carbenoxolone, amphotericin, or penicillin G;
• certain antibiotics (rifamycin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartán/Hidroclorotiazida Krka;
• 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, and antiepileptics;
• medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone;
• therapeutic vitamin D and calcium supplements;
• medicines used to treat diabetes (oral antidiabetics such as metformin or insulin);
• other blood pressure-lowering medicines, including methyldopa;
• medicines that may increase blood pressure, such as noradrenaline or adrenaline;
• digoxin or other digitalis glycosides (medicines used to treat heart problems);
• medicines that may 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 acetylsalicylic acid at doses above 3 g;
• muscle relaxants, such as tubocurarine;
• anticholinergic medicines (used to treat a wide range of 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 also to treat or prevent certain viral diseases);
• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels);
• cyclosporine, a medicine used to prevent rejection of transplanted organs;
• 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 inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Valsartán/Hidroclorotiazida Krka” and “Warnings and precautions”).

Taking Valsartán/Hidroclorotiazida Krka with food, drinks and alcohol

You may take Valsartán/Hidroclorotiazida Krka with or without food.

Avoid drinking 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, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you are pregnant (or might be pregnant).

Generally, your doctor will advise you to stop taking Valsartán/Hidroclorotiazida Krka before becoming pregnant or as soon as you become pregnant, and will recommend an alternative antihypertensive medicine. Valsartán/Hidroclorotiazida Krka 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 when used from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed.

Valsartán/Hidroclorotiazida Krka is not recommended for women during this period, and your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, operating machinery, or engaging in other activities requiring concentration, make sure you are aware of how you react to the effects of Valsartán/Hidroclorotiazida Krka. Like many other medicines used to treat high blood pressure, Valsartán/Hidroclorotiazida Krka may rarely cause dizziness and affect your ability to concentrate.

Valsartán/Hidroclorotiazida Krka contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Valsartan/Hydrochlorothiazide Krka

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. This will help you achieve the best results and reduce the risk of adverse effects. If in doubt, ask your doctor or pharmacist.

People with high blood pressure often do not experience any symptoms; many feel perfectly normal. Therefore, it is very important to keep your doctor's appointments, even if you feel well.

Your doctor will tell you exactly how many tablets of Valsartan/Hydrochlorothiazide Krka 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 Krka is one tablet daily.
• 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 this medicine with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan/Hydrochlorothiazide Krka than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Poison Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Valsartan/Hydrochlorothiazide Krka

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

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

If you stop taking Valsartan/Hydrochlorothiazide Krka

If you discontinue treatment with Valsartan/Hydrochlorothiazide Krka, your hypertension may worsen. Do not stop taking the medicine unless instructed by your doctor.

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

4. Possible adverse effects

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

Some adverse effects can 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

If you experience any of these symptoms, stop taking Valsartan/Hydrochlorothiazide Krka 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
• dizziness
• 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
• blurred vision
• noises (e.g. ringing or buzzing) in the ears

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

• dizziness
• diarrhea
• joint pain

Frequency not known ( cannot be estimated from available data)

• difficulty breathing
• severe decrease 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 cramps, irregular heartbeat)
• low white blood cell count (with symptoms such as fever, skin infections, sore throat, or mouth ulcers due to infections, weakness)
• increased bilirubin levels in the blood (which, in severe cases, may cause yellowing of the skin and eyes)
• increased blood urea nitrogen and creatinine levels (which may indicate abnormal kidney function)
• increased blood uric acid levels (which, in severe cases, may trigger a gout attack)
• syncope (fainting)

The following adverse effects have been reported 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 associated with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Frequency not known (cannot be estimated from available data)

• blisters on the skin (sign of bullous dermatitis)
• 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)
• renal 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

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

• skin swelling and blisters (due to increased sensitivity to sunlight)
• high calcium levels in the blood
• high blood sugar levels
• sugar in the urine
• worsening of diabetic metabolic status
• constipation, diarrhea, stomach or intestinal discomfort, liver disorders that may occur together with yellowing of the skin or 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)
• severe skin disease causing skin rash, redness of the skin, blisters on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• facial rash, joint pain, muscle disorders, fever (cutaneous 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)
• fever, sore throat, increased frequency of infections (agranulocytosis)
• pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)
• acute respiratory difficulty (signs include severe shortness of breath, fever, weakness, and confusion)
• fever, sore throat or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, muscle twitching and cramps, rapid breathing (hypochloremic alkalosis)

Frequency not known (cannot be estimated from available data)

• skin and lip cancer (non-melanoma skin cancer)
• weakness, bruising, and frequent infections (aplastic anemia)
• marked decrease in urine production (possible signs of kidney impairment or kidney failure)
• 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)
• skin rash, redness of the 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 possible adverse 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 Krka

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

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.

Do not store above 30°C.

Keep in the original packaging to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán/Hidroclorotiazida Krka

• The active substances are valsartan and hydrochlorothiazide.

Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.

• The other components are microcrystalline cellulose, lactose monohydrate, magnesium stearate, sodium croscarmellose, povidone K25 and anhydrous colloidal silica in the tablet core; and hypromellose, titanium dioxide (E171), macrogol 4000, red iron oxide (E172) and yellow iron oxide (E172) in the coating. See section 2 “Valsartán/Hidroclorotiazida Krka contains lactose and sodium”.

Appearance of the product and contents of the pack

Valsartán/Hidroclorotiazida Krka 80 mg/12.5 mg coated tablets are oval, biconvex, pink in colour.

The tablets are presented in blister packs containing 14, 28, 30, 56, 60, 84, 90, 98, 280, 56x1, 98x1 and 280x1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

Date of the most recent review of this leaflet: March 2025

Detailed 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/.