Valsartan + hidrohlorothiazide Krka

Leaflet accompanying the packaging: patient information

Valsartan + hydrochlorothiazide Krka, 80 mg + 12.5 mg, film-coated tablets

Valsartan + hydrochlorothiazide Krka, 160 mg + 12.5 mg, film-coated tablets

Valsartan + hydrochlorothiazide Krka, 160 mg + 25 mg, film-coated tablets

Valsartan + hydrochlorothiazide Krka, 320 mg + 12.5 mg, film-coated tablets

Valsartan + hydrochlorothiazide Krka, 320 mg + 25 mg, film-coated tablets

valsartan + hydrochlorothiazide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Valsartan + hydrochlorothiazide Krka and what is it used for
• 2. Important information 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 packaging and other information

1. What is Valsartan + hydrochlorothiazide Krka and what is it used for

Valsartan + hydrochlorothiazide Krka contains two active substances, valsartan and hydrochlorothiazide.
Both substances help control high blood pressure (hypertension).

• Valsartanbelongs to a group of medicines known as "angiotensin II receptor antagonists", used to treat high blood pressure. Angiotensin II is a substance produced in the human body that causes blood vessels to constrict and thus increases blood pressure. Valsartan works by blocking angiotensin II. As a result, blood vessels dilate and blood pressure decreases.
• Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics (also known as "water pills"). Hydrochlorothiazide increases urine production, which also lowers blood pressure.

Valsartan + hydrochlorothiazide Krka is used to treat high blood pressure,
which cannot be adequately controlled by a single active substance.
High blood pressure increases the strain on the heart and arteries. If left untreated, it can lead to
damage to blood vessels in the brain, heart, and kidneys, which can cause stroke,
heart failure, or kidney failure. High blood pressure increases the risk of heart attack.
Lowering blood pressure to normal values reduces the risk of developing these diseases.

2. Important information before taking Valsartan + hydrochlorothiazide Krka

When not to take Valsartan + hydrochlorothiazide Krka:

• if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically similar to hydrochlorothiazide) or any of the other ingredients of this medicine (listed in section 6);
• in pregnancy over 3 months(you should also avoid taking Valsartan + hydrochlorothiazide Krka in early pregnancy - see "Pregnancy and breastfeeding");
• if you have severe liver disease, damage to the small bile ducts in the liver (biliary cirrhosis), resulting in bile stagnation in the liver (cholestasis);
• if you have severe kidney disease;
• if you are unable to produce urine (anuria);
• if you are being treated with dialysis;
• if you have low potassium or sodium levels in the blood or increased calcium levels in the blood, despite treatment;
• if you have gout;
• if you have diabetes or kidney function disorders and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to you, do not take Valsartan + hydrochlorothiazide Krka. Consult a doctor.

Warnings and precautions

Before starting treatment with Valsartan + hydrochlorothiazide Krka, you should discuss it with your doctor or pharmacist:

• if you are taking potassium-sparing medicines, potassium supplements, or salt substitutes containing potassium, or other medicines that increase potassium levels in the blood, such as heparin; regular monitoring of potassium levels in the blood by your doctor may be necessary;
• if you have low potassium levels in the blood;
• if you have diarrhea or severe vomiting;
• if you are taking high doses of diuretics (diuretics);
• if you have severe heart disease;
• if you have heart failure or have had a heart attack. You should carefully follow your doctor's recommendations regarding the initial dose of the medicine. Your doctor may also check your kidney function.
• if you have narrowing of the renal artery;
• if you have had a kidney transplant;
• if you have hyperaldosteronism; this is a disease in which the adrenal glands produce too much of a hormone called aldosterone; if you have this disease, taking Valsartan + hydrochlorothiazide Krka is not recommended;
• if you have liver or kidney disease;
• you should tell your doctor if you have ever had an allergic reaction to another medicine (including ACE inhibitors), such as swelling of the tongue and face, caused by an allergic reaction called angioedema. If such symptoms occur while taking Valsartan + hydrochlorothiazide Krka, you should stop taking Valsartan + hydrochlorothiazide Krka immediately and never take it again. See also section 4 "Possible side effects".
• if you have had fever, rash, and joint pain, which may indicate systemic lupus erythematosus (SLE, an autoimmune disease);
• if you have diabetes, gout, high cholesterol or triglycerides in the blood;
• if you have had allergic reactions to other blood pressure-lowering medicines from this group of medicines (angiotensin II receptor antagonists) or if you have an allergy or asthma;
• if you have impaired vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure in the eye and may occur within a few hours to weeks after starting treatment with Valsartan + hydrochlorothiazide Krka. Without treatment, these symptoms can lead to complete loss of vision. If you have previously been allergic to penicillin or sulfonamides, you may be at increased risk of developing these symptoms.

Valsartan + hydrochlorothiazide Krka may cause increased sensitivity of the skin to sunlight;

• if you have had skin cancer or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During treatment with Valsartan + hydrochlorothiazide Krka, you should protect your skin from sunlight and UV radiation;
• if you have had breathing or lung problems (including pneumonia or fluid accumulation in the lungs). If you experience severe shortness of breath or difficulty breathing after taking Valsartan + hydrochlorothiazide Krka, you should seek medical attention immediately;
• if you are taking any of the following medicines used to treat high blood pressure:
• ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney function disorders related to diabetes,
• aliskiren.

If any of the above conditions apply to you, you should consult a doctor.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.
See also the information under the heading "When not to take Valsartan + hydrochlorothiazide Krka:".
If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Valsartan + hydrochlorothiazide Krka, you should discuss it with your doctor. Your doctor will decide on further treatment. You should not stop taking Valsartan + hydrochlorothiazide Krka on your own.
You must inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Valsartan + hydrochlorothiazide Krka during the first trimester of pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").

Children and adolescents

Valsartan + hydrochlorothiazide Krka is not recommended for children and adolescents (under 18 years of age).

Valsartan + hydrochlorothiazide Krka with food, drinks, and alcohol

Valsartan + hydrochlorothiazide Krka can be taken with or without food.
You should avoid consuming alcohol without consulting your doctor. Alcohol may enhance the blood pressure-lowering effect and (or) increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy.Your doctor will usually recommend stopping Valsartan + hydrochlorothiazide Krka before becoming pregnant or as soon as pregnancy is confirmed and recommend taking another medicine. It is not recommended to take Valsartan + hydrochlorothiazide Krka during the first trimester of pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the fetus.
Breastfeeding

You should inform your doctor about breastfeeding or intending to breastfeed.

Valsartan + hydrochlorothiazide Krka is not recommended during breastfeeding.
Your doctor may choose another medicine if you intend to breastfeed, especially in the case of newborns or premature babies.

Driving and using machines

Before starting to drive, use tools, or operate machines, or perform other activities that require concentration, you should make sure what effect Valsartan + hydrochlorothiazide Krka has on you. Like many other medicines used to treat high blood pressure, Valsartan + hydrochlorothiazide Krka may rarely cause dizziness and affect concentration.

Valsartan + hydrochlorothiazide Krka contains lactose and sodium

If you have been informed by your doctor that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, so it can be considered "essentially sodium-free".

3. How to take Valsartan + hydrochlorothiazide Krka

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. In case of doubts, you should consult a doctor or pharmacist. This will allow you to get the best treatment results and reduce the risk of side effects.
Patient with high blood pressure often do not notice any symptoms of this disease.
Many of them feel quite well. Therefore, it is very important to visit your doctor, even if you feel well.
Your doctor will tell you the exact number of Valsartan + hydrochlorothiazide Krka tablets to take.
Depending on your response to treatment, your doctor may recommend increasing or decreasing the dose of the medicine.

• The usual dose of Valsartan + hydrochlorothiazide Krka is one tablet per day.
• You should not change the dose or stop taking the tablets without consulting your doctor.
• The medicine should be taken at the same time every day, usually in the morning.
• Valsartan + hydrochlorothiazide Krka can be taken with or without food.
• The tablet should be swallowed, washed down with a glass of water.

Taking a higher dose of Valsartan + hydrochlorothiazide Krka than recommended

In case of severe dizziness and (or) fainting, you should lie down and contact your doctor immediately.
In case of accidental ingestion of too many tablets, you should contact your doctor, pharmacist, or hospital.

Missing a dose of Valsartan + hydrochlorothiazide Krka

In case of a missed dose, you should take it as soon as you remember. However, if it is close to the time of the next dose, you should not take the missed dose.
You should not take a double dose to make up for the missed dose.

Stopping treatment with Valsartan + hydrochlorothiazide Krka

Stopping treatment may worsen hypertension. You should not stop taking the medicine unless your doctor recommends it.
In case of any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Valsartan + hydrochlorothiazide Krka can cause side effects, although not everybody gets them.
Some side effects may be serious and require immediate medical attention.
You should contact your doctor immediately if you experience symptoms of angioedema, such as:

• swelling of the face, tongue, or throat,
• difficulty swallowing,
• hives and difficulty breathing.

If you experience any of these symptoms, you should stop taking Valsartan + hydrochlorothiazide Krka and contact your doctor (see also section 2 "Warnings and precautions").

Other side effects include:

Uncommon(may affect up to 1 in 100 people):

• cough
• low blood pressure
• vertigo
• dehydration (with a feeling of thirst, dryness of the mouth and tongue, rare urination, dark urine color, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• tinnitus (e.g., ringing, buzzing)

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

• dizziness
• diarrhea
• joint pain

Unknown(frequency cannot be estimated from the available data):

• breathing difficulties
• very low urine output
• low sodium levels in the blood (which may cause fatigue, disorientation, muscle tremors, and (or) convulsions in severe cases)
• low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, heart rhythm disturbances)
• low white blood cell count (with symptoms such as fever, skin infections, sore throat, or mouth ulcers caused by infections, weakness)
• increased bilirubin levels in the blood (which in severe cases may cause yellowing of the skin and eyes)
• increased urea and creatinine levels in the blood (which may indicate impaired kidney function or kidney failure)
• increased uric acid levels in the blood (which in severe cases may cause a gout attack)
• fainting (syncope)

The following side effects have been reported with the use of medicines containing valsartan or hydrochlorothiazide alone:

Valsartan
Uncommon(may affect up to 1 in 100 people):

• vertigo
• abdominal pain

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

• angioedema of the intestine: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Unknown(frequency cannot be estimated from the available data):

• rash with or without itching of the skin, in combination with some of the following symptoms: fever, joint pain, muscle pain, swelling of lymph nodes, and (or) flu-like symptoms
• rash, purple-red spots, fever, itching (symptoms of vasculitis)
• low platelet count (sometimes with unusual bleeding or bruising)
• high potassium levels in the blood (sometimes with muscle cramps, heart rhythm disturbances)
• allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• edema, mainly of the face and throat, rash, itching
• increased liver enzyme activity
• decreased hemoglobin and red blood cell count in the blood (both symptoms may cause anemia in severe cases)
• impaired kidney function
• low sodium levels in the blood (which may cause fatigue, disorientation, muscle tremors, and (or) convulsions in severe cases)

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

• low potassium levels in the blood
• increased lipid levels 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
• itching rash and other types of rash
• decreased appetite
• mild nausea and vomiting
• dizziness/ fainting when standing up
• erectile dysfunction

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

• skin edema and blisters due to increased sensitivity to sunlight
• high calcium levels in the blood
• high blood sugar levels
• presence of sugar in the urine
• worsening of metabolic disorders in diabetes
• constipation, diarrhea, abdominal discomfort, or gastrointestinal disorders, which may occur with liver function disorders and yellowing of the skin and eyes
• irregular heart rhythm
• headache
• sleep disorders
• depression
• low platelet count (sometimes with bleeding under the skin or bruising)
• dizziness
• tingling or numbness
• vision disturbances

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

• vasculitis with symptoms such as rash, purple-red spots, fever
• allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• severe skin diseases causing rash, redness of the skin, blistering of the lips, eyes, or mucous membranes of the mouth, peeling of the skin, fever (toxic epidermal necrolysis)
• rash, redness of the skin, blistering of the lips, eyes, or mucous membranes of the mouth, peeling of the skin, fever (Stevens-Johnson syndrome)
• acute pain in the upper abdomen (pancreatitis)
• breathing difficulties with fever, cough, wheezing, shortness of breath (respiratory failure, including pneumonia and pulmonary edema)
• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion)
• fever, sore throat, or mouth ulcers due to infection (agranulocytosis)
• pale skin, fatigue, shortness of breath, dark urine color (hemolytic anemia)
• fever, sore throat, or mouth ulcers due to infection (leukopenia)
• confusion, fatigue, tremors, and rapid breathing (hypochloremic alkalosis)

Unknown(frequency cannot be estimated from the available data):

• malignant skin tumors and lip cancer (non-melanoma skin cancer)
• weakness, bruising, and frequent infections (aplastic anemia)
• significant decrease in urine output (possible symptoms of kidney function disorders or kidney failure)
• worsening of vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma)
• rash, redness of the skin, blistering of the lips, eyes, or mucous membranes of the mouth, peeling of the skin, fever (possible symptoms of erythema multiforme)
• muscle cramps
• fever
• weakness (asthenia)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Valsartan + hydrochlorothiazide Krka

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Valsartan + hydrochlorothiazide Krka contains

• The active substances of the medicine are valsartan and hydrochlorothiazide. Each film-coated tablet of Valsartan + hydrochlorothiazide Krka contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide. Each film-coated tablet of Valsartan + hydrochlorothiazide Krka contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide. Each film-coated tablet of Valsartan + hydrochlorothiazide Krka contains 160 mg of valsartan and 25 mg of hydrochlorothiazide. Each film-coated tablet of Valsartan + hydrochlorothiazide Krka contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide. Each film-coated tablet of Valsartan + hydrochlorothiazide Krka contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, magnesium stearate, sodium croscarmellose, povidone K-25, and anhydrous colloidal silica in the tablet core, and hypromellose 2910 6 cP, titanium dioxide (E 171), macrogol 4000, iron oxide red (E 172) - only in 80 mg + 12.5 mg, 160 mg + 12.5 mg, 160 mg + 25 mg, and 320 mg + 12.5 mg tablets, iron oxide yellow (E 172) - only in 80 mg + 12.5 mg, 160 mg + 25 mg, and 320 mg + 25 mg tablets in the tablet coating. See section 2 "Valsartan + hydrochlorothiazide Krka contains lactose and sodium".

What Valsartan + hydrochlorothiazide Krka looks like and contents of the pack

The 80 mg + 12.5 mg film-coated tablets are pink, oval, biconvex. Tablet dimensions: length: 10 mm, width: 5 mm.
The 160 mg + 12.5 mg film-coated tablets are reddish-brown, oval, biconvex. Tablet dimensions: length: 14 mm, width: 6 mm.
The 160 mg + 25 mg film-coated tablets are light brown, oval, biconvex. Tablet dimensions: length: 14 mm, width: 6 mm.
The 320 mg + 12.5 mg film-coated tablets are pink, oval, biconvex. Tablet dimensions: length: 16 mm, width: 8.5 mm.
The 320 mg + 25 mg film-coated tablets are light yellow, oval, biconvex with a dividing line on one side. Tablet dimensions: length: 16 mm, width: 8.5 mm. The tablet can be divided into equal doses.
Packaging: 28, 30, 56, or 60 film-coated tablets in blisters in a cardboard box

Marketing authorization holder:

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

Manufacturer/Importer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
To obtain more detailed information on the names of this medicine in other European Economic Area countries, you should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:14.03.2025