Vabinxo

Package Leaflet: Information for the Patient

Vabinxo, 160 mg + 1.5 mg, Modified Release Tablets

valsartan + indapamide

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Vabinxo and what is it used for
• 2. Important information before taking Vabinxo
• 3. How to take Vabinxo
• 4. Possible side effects
• 5. How to store Vabinxo
• 6. Contents of the pack and other information

1. What is Vabinxo and what is it used for

Vabinxo contains two active substances: valsartan and indapamide.
Valsartan belongs to a group of medicines called angiotensin II receptor antagonists, which help
control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to
constrict, which in turn increases blood pressure. The action of the medicine is to block the action of
angiotensin II, which leads to the dilation of blood vessels and a decrease in blood pressure.
Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However,
indapamide differs from other diuretics, as it only causes a slight increase in the amount of urine produced.
This medicine is used to treat high blood pressure (hypertension) in adults. Your doctor may prescribe
Vabinxo if you are already taking valsartan and indapamide in the same dose, but in the form of separate
tablets.

2. Important information before taking Vabinxo

When not to take Vabinxo

• if you are allergic to valsartan, indapamide, any other sulfonamide, or any of the other ingredients of this medicine (listed in section 6),
• if you have liver disease or a condition called hepatic encephalopathy (a degenerative brain disease),
• if you are pregnant for more than 3 months (it is also recommended to avoid taking Vabinxo in early pregnancy - see section "Pregnancy and breastfeeding"),
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if you have severe kidney disease,
• if you have low potassium levels in your blood.

Warnings and precautions

Before starting to take Vabinxo, you should discuss it with your doctor or pharmacist:

• if you have liver disease,
• if you have severe kidney disease or are undergoing dialysis,
• in patients with narrowing of the renal artery,
• in patients who have recently undergone kidney transplantation (received a new kidney),
• in patients with severe heart disease, other than heart failure or heart attack,
• if you have ever had an allergic reaction called angioedema (swelling of the face, lips, tongue, or throat) while taking another medicine (including ACE inhibitors). If such symptoms occur while taking Vabinxo, you should stop taking the medicine and not take it again. See also section 4 "Possible side effects".
• in patients taking medicines that increase potassium levels in the blood, such as potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin. Periodic monitoring of potassium levels in the blood may be necessary.
• in patients with aldosteronism. This is a disease in which the adrenal glands produce too much of a hormone called aldosterone. It is not recommended to take Vabinxo in patients with aldosteronism.
• in patients who have lost a lot of fluid (dehydrated) due to diarrhea, vomiting, or taking high doses of diuretics,
• if you are taking any of the following medicines for high blood pressure:
• ACE inhibitors (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren.
• if you have diabetes,
• if you have gout,
• if you have any heart rhythm disturbances,
• if you are to undergo a test to assess parathyroid function.

You should inform your doctor if you have a history of allergic reactions to sunlight.
If you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive accumulation of fluid between the choroid and sclera) or increased pressure inside the eye – they can occur within a few hours to weeks after taking indapamide. If left untreated, they can lead to permanent vision loss.
If you have previously had an allergic reaction to penicillin or sulfonamides, you may be more likely to develop this condition.
Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood.
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Vabinxo, you should discuss it with your doctor. The doctor will decide on further treatment. Do not stop taking Vabinxo on your own.
See also the information under the heading "When not to take Vabinxo".
You should inform your doctor about pregnancy, suspected pregnancy, or planning pregnancy. It is not recommended to take Vabinxo in early pregnancy and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the baby (see section "Pregnancy and breastfeeding").

If any of the above situations apply to you, you should inform your doctor before starting to take Vabinxo.

Important information for athletes

Athletes should be aware that this medicine contains an active substance that may give a positive result in doping tests.

Children and adolescents

Due to the lack of data on safety and efficacy, it is not recommended to take this medicine in children and adolescents.

Vabinxo and other medicines

You should inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The action of the medicine may change if Vabinxo is taken at the same time as certain other medicines. It may then be necessary to change the dose, take other precautions, or, in some cases, stop taking one of the medicines. This applies to both prescription and over-the-counter medicines.
You should inform your doctor about taking any of the following medicines, as special caution may be required:

• other blood pressure-lowering medicines, especially diuretics (such as hydrochlorothiazide), ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under the heading "When not to take Vabinxo" and "Warnings and precautions"),
• medicines that increase potassium levels in the blood, such as potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin,
• certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs),
• certain antibiotics (such as rifampicin), a medicine used to prevent transplant rejection (cyclosporine) or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may enhance the action of Vabinxo.
• lithium (a medicine used to treat certain mental illnesses),
• medicines used to treat heart rhythm disturbances (such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, glycosides),
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (such as tricyclic antidepressants, antipsychotics, neuroleptics),
• bepridil (used to treat angina pectoris, a disease that causes chest pain),
• cisapride, difemanil (used to treat gastrointestinal disorders),
• sparfloxacin, moxifloxacin, erythromycin injection (antibiotics used to treat bacterial infections),
• vincamine injection (used to treat cognitive disorders in the elderly, including memory loss),
• halofantrine (an antiparasitic medicine used to treat certain types of malaria),
• pentamidine (used to treat certain types of pneumonia),
• mizolastine (used to treat allergic reactions, such as hay fever),
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain (such as ibuprofen) or high doses of acetylsalicylic acid,
• ACE inhibitors (used to treat high blood pressure and heart failure),
• amphotericin B injection (a medicine used to treat fungal infections),
• oral corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis,
• laxatives that stimulate peristalsis,
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),
• potassium-sparing diuretics (such as amiloride, spironolactone, triamterene),
• allopurinol (used to treat gout),
• metformin (used to treat diabetes),
• iodine-containing contrast agents (used in diagnostic tests using X-rays),
• calcium-containing tablets or other calcium supplements,
• cyclosporine, tacrolimus, or other medicines that suppress the immune system after organ transplantation, in the treatment of autoimmune diseases or severe rheumatic or dermatological diseases,
• tetracosactide (used to treat Crohn's disease).

Vabinxo with food and drink

Vabinxo can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• You must inform your doctor about pregnancy, suspected pregnancy, or planning pregnancy.Your doctor will usually recommend stopping Vabinxo before becoming pregnant or as soon as pregnancy is confirmed, and will advise you to take a different medicine. It is not recommended to take Vabinxo in early pregnancy and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the baby.
• You should inform your doctor about breastfeeding or intending to breastfeed.It is not recommended to take Vabinxo while breastfeeding. Your doctor may choose a different medicine if you intend to breastfeed, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

Before driving, using tools, or operating machinery, or performing other activities that require concentration, you should make sure what effect Vabinxo has on you. Like many other medicines used to treat high blood pressure, Vabinxo can cause dizziness and affect your ability to concentrate. In such a case, you should avoid driving or performing other activities that require concentration.

3. How to take Vabinxo

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Vabinxo is one tablet per day, preferably in the morning. Vabinxo should be taken at the same time every day.
The tablets can be taken with or without food. You should swallow them whole with a glass of water.
Do not crush or chew them.
People with high blood pressure often do not notice any symptoms of this problem. Many of them feel quite well. Therefore, it is especially important to attend doctor's appointments, even if you feel well. Treatment of high blood pressure usually lasts for the rest of your life.

Take more than the recommended dose of Vabinxo

If you have taken too many tablets, you should contact your doctor or pharmacist immediately.
If you experience severe dizziness and/or fainting, you should lie down.
Very high doses of Vabinxo may cause nausea, vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, disorientation, and changes in the amount of urine produced by the kidneys.

Miss a dose of Vabinxo

If you miss a dose of Vabinxo, you should take the next dose as usual.
You should not take a double dose to make up for a missed dose.

Stop taking Vabinxo

Because the treatment of high blood pressure usually lasts for the rest of your life, you should consult your doctor before stopping the medicine. You should not stop taking Vabinxo unless your doctor tells you to.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vabinxo can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking Vabinxo and contact your doctor immediately:

• angioedema and/or urticaria. Angioedema is characterized by swelling of the skin of the limbs or face, swelling of the lips or tongue, mucous membranes of the throat or respiratory tract, which can cause difficulty breathing or swallowing. If such symptoms occur, you should contact your doctor immediately. (Very rare - may occur in less than 1 in 10,000 patients)
• severe skin reactions, including severe rash, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions. (Very rare - may occur in less than 1 in 10,000 patients)
• life-threatening heart rhythm disturbances. (Very rare - may occur in less than 1 in 10,000 patients)
• pancreatitis, which can cause severe abdominal pain, radiating to the back, and very poor general condition. (Very rare - may occur in less than 1 in 10,000 patients)
• liver disease caused by liver disease (hepatic encephalopathy). (Frequency not known)
• hepatitis. (Frequency not known)

If you experience any of these symptoms, stop taking Vabinxo and contact your doctor immediately (see also section 2 "Warnings and precautions").

Other side effects include:

Frequent(may occur in less than 1 in 10 patients):

• low potassium levels in the blood
• allergic reactions, mainly skin-related, such as rashes in patients with a tendency to allergic reactions or asthma
• red, raised rash

Uncommon(may occur in less than 1 in 100 patients):

• low sodium levels in the blood, which can cause dehydration and low blood pressure
• feeling of spinning (dizziness of labyrinthine origin)
• cough
• vomiting
• abdominal pain
• red spots on the skin (petechiae)
• impotence (inability to achieve or maintain an erection)
• fatigue

Rare(may occur in less than 1 in 1,000 patients):

• low chloride levels in the blood
• low magnesium levels in the blood
• headache
• tingling and numbness (paresthesia)
• gastrointestinal disorders (such as nausea, constipation)
• dry mouth

Very rare(may occur in less than 1 in 10,000 patients):

• changes in blood cell counts, such as thrombocytopenia (decrease in platelet count, which can cause easy bruising and bleeding from the nose), leukopenia (decrease in white blood cell count, which can cause unexplained fever, sore throat, or other flu-like symptoms - if these symptoms occur, you should contact your doctor) and anemia (decrease in red blood cell count)
• high calcium levels in the blood
• low blood pressure
• abnormal liver function
• kidney disease (causing fatigue, increased urination, itching, nausea, swelling of the limbs)
• angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Frequency not known(cannot be estimated from the available data):

• decrease in hemoglobin and red blood cell count in the blood (which can lead to anemia in severe cases)
• increase in potassium levels in the blood (which can cause muscle cramps and heart rhythm disturbances in severe cases)
• sudden loss of consciousness (fainting)
• myopia
• blurred vision
• vision disturbances
• vision loss or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive accumulation of fluid between the choroid and sclera - or acute angle-closure glaucoma)
• heart rhythm disturbances visible on ECG
• purple-red spots, fever, itching (symptoms of vasculitis)
• increased liver enzyme activity (which may indicate liver damage), including increased bilirubin levels in the blood (which can cause yellowing of the skin and eyes in severe cases)
• in the case of systemic lupus erythematosus (an autoimmune disease that causes inflammation and destruction of joints, tendons, and organs, along with symptoms such as skin rash, fatigue, loss of appetite, weight gain, and joint pain), the symptoms may worsen
• there have also been reports of photosensitivity reactions (changes in skin appearance) after exposure to sunlight or artificial UVA light
• skin rash
• itching
• muscle pain
• increased creatinine levels in the blood (which may indicate kidney problems)
• increased glucose levels in the blood in patients with diabetes
• increased uric acid levels, a substance that can cause gout (pain in the joint or joints, especially the feet)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 Vabinxo

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 after EXP. The expiry date refers to the last day of the month.
Store in the original packaging to protect from light and moisture.
There are no special storage temperature requirements for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Vabinxo contains

• The active substances of Vabinxo are valsartan and indapamide. Each modified-release tablet contains 160 mg of valsartan and 1.5 mg of indapamide.
• Other ingredients Valsartan layer: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, and magnesium stearate. Indapamide layer: microcrystalline cellulose, mannitol, hypromellose, anhydrous colloidal silica, magnesium stearate, carbomers, yellow iron oxide (E 172).

What Vabinxo looks like and contents of the pack

160 mg + 1.5 mg, modified-release tablets: round, biconvex, two-layer tablets. One layer is yellowish-brown, speckled, with the marking VI2.
The other layer is white to off-white. The tablet dimensions are approximately 11 mm in diameter.
Vabinxo is available in packs of:

• 10, 14, 28, 30, 56, 60, 84, 90, or 100 modified-release tablets in blisters, in a cardboard box.
• 14, 28, 56, or 84 modified-release tablets in blisters, calendar pack, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

This medicine is authorized in other European Economic Area countries under the following names:

For more information about this medicine, contact your local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:20.02.2025