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 them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those 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 strain 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:

• if the patient is 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(it is also recommended to avoid taking Valsartan + hydrochlorothiazide Krka in early pregnancy - see the section "Pregnancy and breastfeeding");
• if the patient has severeliver disease, damage to the small bile ducts in the liver (bile duct cirrhosis), resulting in bile stagnation in the liver (cholestasis);
• if the patient has severekidney disease;
• if the patient is unable to produce urine (anuria);
• if the patient is undergoing dialysis;
• if the patient has low potassium or sodium levels in the blood or increased calcium levels in the blood, despite treatment;
• if the patient has gout;
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

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:

• if the patient is 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 the doctor may be necessary;
• if the patient has low potassium levels in the blood;
• if the patient has diarrhea or severe vomiting;
• if the patient is taking high doses of diuretics (diuretics);
• if the patient has severe heart disease;
• if the patient has heart failure or has had a heart attack. The doctor should be careful when prescribing the initial dose of the medicine. The doctor may also check the patient's kidney function.
• if the patient has narrowing of the renal artery;
• if the patient has recently had a kidney transplant;
• if the patient has hyperaldosteronism; this is a disease in which the adrenal glands produce too much of a hormone called aldosterone; if the patient has this disease, taking Valsartan + hydrochlorothiazide Krka is not recommended;
• if the patient has liver or kidney disease;
• 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".
• if the patient has had fever, rash, and joint pain, which may indicate systemic lupus erythematosus (SLE, an autoimmune disease);
• if the patient has diabetes, gout, high cholesterol or triglyceride levels in the blood;
• if the patient has a history of allergic reactions to other blood pressure-lowering medicines from this group of medicines (angiotensin II receptor antagonists) or if the patient has an allergy or asthma;
• if the patient has 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 the patient 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;

• if the patient has 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, the patient should protect their skin from sunlight and UV radiation;
• if the patient has had breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient experiences severe shortness of breath or difficulty breathing after taking Valsartan + hydrochlorothiazide Krka, they should seek medical help immediately;
• if the patient is taking any of the following medicines for high blood pressure:
• 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 consult 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. 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 the section "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 baby, 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 usually recommends stopping Valsartan + hydrochlorothiazide Krka before becoming pregnant or as soon as pregnancy is confirmed and recommends 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

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 starting to drive, use tools, or operate machines, or perform 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 the patient to get the best results from the treatment and reduce the risk of side effects.
Patient with high blood pressure often do not notice any symptoms of the 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 tell the patient exactly how many tablets of Valsartan + hydrochlorothiazide Krka to take.
Depending on the patient's response to the 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 cause high blood pressure to worsen. The patient should not stop taking the medicine unless their doctor tells them to.
If the patient has any further doubts about taking this medicine, they 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, dryness of the 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 disorders)
• 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 kidney function disorders)
• increased uric acid levels in the blood (which in severe cases may cause gout attacks)
• 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):

• skin rash with or without itching, in combination with some of the following symptoms: fever, joint pain, muscle pain, swollen 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 disorders)
• allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling, mainly of the face and throat, rash, itching
• increased liver enzyme activity
• decreased hemoglobin and red blood cell count in the blood (both of which in severe cases may cause anemia)
• 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
• itching 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 heart rhythm
• headache
• sleep disorders
• depression
• low platelet count (sometimes with subcutaneous bleeding 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 mouth mucosa, skin peeling, fever (toxic epidermal necrolysis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• skin cancer 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)
• vision disturbances 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 mouth mucosa, skin peeling, fever (possible symptoms of erythema multiforme)
• muscle cramps
• fever
• weakness (asthenia)

Reporting side effects

If the patient experiences any side effects, including those not listed in the 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Valsartan + hydrochlorothiazide Krka

The medicine should be stored out of the 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. 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 about 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