Valsartan + hidrohlorothiazide Krka

Leaflet attached to 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 another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 burden on the heart and blood vessels. 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 these diseases.

2. Important information before taking Valsartan + hydrochlorothiazide Krka

When not to take Valsartan + hydrochlorothiazide Krka:

• in pregnancy over 3 months(it is also recommended to avoid taking Valsartan + hydrochlorothiazide Krka in early pregnancy - see "Pregnancy and breastfeeding");
severeliver disease, damage to the small bile ducts in the liver (biliary cirrhosis), resulting in bile stagnation in the liver (cholestasis);severekidney disease;

If any of the above situations apply to the patient, they should not take Valsartan + hydrochlorothiazide Krka. They should consult a doctor.

Warnings and precautions

Before starting treatment with Valsartan + hydrochlorothiazide Krka, the patient should discuss it with their doctor or pharmacist:

• the patient should tell their doctor if they have ever had an allergic reaction to another medicine (including ACE inhibitors), with symptoms such as swelling of the tongue and face, caused by an allergic reaction called angioedema. If such symptoms occur while taking Valsartan + hydrochlorothiazide Krka, the patient should stop taking the medicine immediately and never take it again. See also section 4 "Possible side effects".

has previously been allergic to penicillin or sulfonamides, they may be at increased risk of developing these symptoms.

• Valsartan + hydrochlorothiazide Krka may cause increased sensitivity of the skin to sunlight;
• ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney function disorders related to diabetes,
• aliskiren.

If any of the above conditions apply to the patient, they should contact their doctor.

The doctor may monitor 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 the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Valsartan + hydrochlorothiazide Krka, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Valsartan + hydrochlorothiazide Krka on their own.
The patient must inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. Valsartan + hydrochlorothiazide Krka is not recommended during the first trimester of pregnancy and 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, drink, and alcohol

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient must inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy.The doctor will usually recommend stopping Valsartan + hydrochlorothiazide Krka before becoming pregnant or as soon as pregnancy is confirmed and prescribe another medicine. Valsartan + hydrochlorothiazide Krka is not recommended during the first trimester of pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the fetus.
Breastfeeding

The patient should inform their doctor about breastfeeding or intending to breastfeed.

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

Driving and using machines

Before driving, using tools, or operating machines, or performing other activities that require concentration, the patient should make sure what effect Valsartan + hydrochlorothiazide Krka has on them. 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 the patient has been informed by their doctor that they have an intolerance to some sugars, they should consult their 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 the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. This will allow for the best treatment results and minimize 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 attend doctor's appointments, even if the patient feels well.
The doctor will prescribe the exact number of Valsartan + hydrochlorothiazide Krka tablets to be taken.
Depending on the patient's response to treatment, the doctor may recommend increasing or decreasing the dose of the medicine.

• The usual dose of Valsartan + hydrochlorothiazide Krka is one tablet per day.
• The patient should not change the dose or stop taking the tablets without consulting their 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 with a glass of water.

Taking a higher dose of Valsartan + hydrochlorothiazide Krka than recommended

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

Missing a dose of Valsartan + hydrochlorothiazide Krka

In case of a missed dose, the patient should take it as soon as they remember. However, if it is almost time for the next dose, the patient should not take the missed dose.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Valsartan + hydrochlorothiazide Krka

Stopping treatment may worsen hypertension. The patient should not stop taking the medicine unless their doctor recommends it.
In case of any further doubts about taking this medicine, the patient should consult their 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
.
The patient should contact their doctor immediately if they experience symptoms of angioedema, such as:

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

If the patient experiences any of these symptoms, they should stop taking Valsartan + hydrochlorothiazide Krka and contact their 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 thirst, dry mouth and tongue, rare urination, dark urine, 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) seizures 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)
• 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, accompanied by some of the following symptoms: fever, joint pain, joint stiffness, and (or) lymph node swelling
• rash, purple 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)
• swelling and redness
• increased liver enzyme activity
• decreased hemoglobin and red blood cell count in the blood (both of which may cause anemia in severe cases)
• kidney failure
• low sodium levels in the blood (which may cause fatigue, disorientation, muscle tremors, and (or) seizures 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
• itchy rash and other types of rash
• decreased appetite
• mild nausea and vomiting
• dizziness or fainting when standing up
• erectile dysfunction

Rare(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
• presence of sugar in the urine
• worsening of metabolic disorders in diabetes
• constipation, diarrhea, abdominal discomfort or intestinal disorders, liver function disorders, which may occur with yellowing of the skin and eyes
• irregular heartbeat
• 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 spots, fever
• allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• severe skin diseases causing rash, redness, blistering on the lips, eyes, or mucous membranes, skin peeling, fever (toxic epidermal necrolysis)
• rash, redness, blistering on the face, joint pain, muscle disorders, fever (lupus erythematosus)
• severe abdominal pain (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, frequent infections (agranulocytosis)
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fever, sore throat, or mouth ulcers due to infection (leukopenia)
• confusion, fatigue, tremors, and muscle cramps, 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, blistering on the skin, peeling, fever (possible symptoms of erythema multiforme)
• muscle cramps
• fever
• weakness (asthenia)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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:
Al. 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Valsartan + hydrochlorothiazide Krka

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The medicine should not be stored at temperatures above 30°C.
The medicine should be stored in its original packaging to protect it from light and moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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, the patient 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