Vabinxo

Leaflet accompanying the packaging: patient information

Vabinxo, 80 mg + 1.5 mg, modified-release tablets

valsartan + indapamide

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 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 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 packaging 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 present in the body that causes blood vessels to narrow, resulting in increased blood pressure. The action of the medicine involves blocking the action of angiotensin II, leading to the relaxation 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. The doctor may prescribe Vabinxo if the patient is 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 the patient is allergic to valsartan, indapamide, any other sulfonamide, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver disease or a condition called hepatic encephalopathy (a degenerative brain disease),
• if the patient is pregnant for more than 3 months (it is also recommended to avoid taking Vabinxo in early pregnancy - see "Pregnancy"),
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren,
• if the patient has severe kidney disease,
• if the patient has low potassium levels in the blood.

Warnings and precautions

Before starting to take Vabinxo, the patient should discuss it with their doctor or pharmacist:

• if the patient has liver disease,
• if the patient has severe kidney disease or is 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 myocardial infarction,
• if the patient taking another medicine (including ACE inhibitors) has ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema, they should inform their doctor. If such symptoms occur while taking Vabinxo, the patient should stop taking Vabinxo immediately 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 potassium-containing salt substitutes, 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 large amount of fluid (dehydrated) due to diarrhea, vomiting, or taking high doses of diuretics,
• if the patient is taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes,
• aliskiren.
• if the patient has diabetes,
• if the patient has gout,
• if the patient has any heart rhythm disorders,
• if the patient is to undergo a test to assess parathyroid function.

The patient should inform their doctor if they have a hypersensitivity reaction to light.
If the patient experiences 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 the patient has previously been allergic to penicillin or sulfonamides, they may be more prone to developing this disease.
The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood.
If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Vabinxo, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Vabinxo on their own.
See also the information under the heading "When not to take Vabinxo".
The patient should tell their doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Vabinxo in early pregnancy, and it should not be taken by patients who are pregnant for more than 3 months, as it may cause serious harm to the fetus (see "Pregnancy and breastfeeding").

If any of the above situations apply to the patient, they should inform their 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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.
The patient should inform their doctor about taking any of the following medicines, as special caution may be required:

• other blood pressure-lowering medicines, especially diuretics, 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 potassium-containing salt substitutes, potassium-sparing medicines, and heparin,
• certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs),
• certain antibiotics (from the rifampicin group), 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 disorders (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 given by injection (antibiotics used to treat bacterial infections),
• vinkamine given by injection (used to treat symptomatic 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 used to treat pain (such as ibuprofen) or high doses of acetylsalicylic acid,
• ACE inhibitors (used to treat hypertension and heart failure),
• amphotericin B given by 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 response 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 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.

• The patient must inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy.The doctor will usually recommend stopping Vabinxo before becoming pregnant or as soon as pregnancy is confirmed and advise taking a different medicine. It is not recommended to take Vabinxo in early pregnancy, and it should not be taken by patients who are pregnant for more than 3 months, as it may cause serious harm to the fetus.
• The patient should inform their doctor about breastfeeding or intending to breastfeed.It is not recommended to take Vabinxo in breastfeeding mothers. The doctor may choose a different medicine if the patient intends to breastfeed, especially when breastfeeding a newborn or premature baby.

Driving and using machines

Before driving, using tools, or operating machinery, or performing other activities that require concentration, the patient should make sure how Vabinxo affects them. Like many other medicines used to treat high blood pressure, Vabinxo can cause dizziness and affect concentration. In such a case, the patient should refrain from driving or performing other activities that require concentration.

3. How to take Vabinxo

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their 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. They should be swallowed whole, with a glass of water.
They should not be crushed or chewed.
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 they feel well. Treatment of hypertension usually lasts for the rest of their life.

Taking a higher dose of Vabinxo than recommended

If too many tablets are taken, the patient should contact their doctor or pharmacist immediately.
In case of severe dizziness and (or) fainting, the patient should lie down.
Very high doses of Vabinxo can cause nausea, vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, and changes in the amount of urine produced by the kidneys.

Missing a dose of Vabinxo

If a dose of Vabinxo is missed, the next dose should be taken as usual.
A double dose should not be taken to make up for the missed dose.

Stopping Vabinxo treatment

Because hypertension treatment usually lasts for the rest of their life, the patient should consult their doctor before stopping the medicine. The patient should not stop taking Vabinxo 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, Vabinxo can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should stop taking Vabinxo and contact their 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, causing shortness of breath or difficulty swallowing. If such symptoms occur, the patient should see their doctor immediately. (Very rare - may occur in fewer than 1 in 10,000 patients)
• severe skin reactions, including severe rash, redness of the skin all over the body, severe itching, blistering, and peeling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions. (Very rare - may occur in fewer than 1 in 10,000 patients)
• life-threatening heart rhythm disorders. (Very rare - may occur in fewer 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 fewer than 1 in 10,000 patients)
• liver disease caused by liver disease (hepatic encephalopathy). (Frequency not known)
• hepatitis. (Frequency not known)

If the patient experiences any of these symptoms, they should stop taking Vabinxo and contact their doctor immediately (see also section 2 "Warnings and precautions").

Other side effects include:

Frequent(may occur in up to 1 in 10 patients):

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

Uncommon(may occur in up to 1 in 100 patients):

• low sodium levels in the blood, which can cause dehydration and low blood pressure
• feeling of spinning (vertigo 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 up to 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 fewer than 1 in 10,000 patients):

• changes in blood cell count, such as thrombocytopenia (decrease in platelet count, causing easy bruising and nosebleeds), leukopenia (decrease in white blood cell count, which can cause unexplained fever, sore throat, or other flu-like symptoms - if these occur, the patient should contact their 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 frequency, itching, nausea, swelling of the limbs)
• angioedema of the intestines: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• decrease in hemoglobin levels 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 disorders in severe cases)
• sudden loss of consciousness (fainting)
• myopia
• blurred vision
• vision disorders
• 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 disorders visible on an 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, 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 hypersensitivity reactions to light (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 the patient experiences any side effects, including those 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:
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 gather more information on the safety of the medicine.

5. How to store Vabinxo

The medicine should be stored out of sight and reach of children.
Do not take 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 the medicine.
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 Vabinxo contains

• The active substances of Vabinxo are valsartan and indapamide. Each modified-release tablet contains 80 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, red iron oxide (E 172).

What Vabinxo looks like and contents of the packaging

80 mg + 1.5 mg, modified-release tablets: round, biconvex, two-layer tablets. One layer is pink, speckled, with the marking VI1. The other layer is white to off-white. The tablet dimensions are approximately 11 mm in diameter.
Vabinxo is available in:

• 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 packaging, 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 the Member States of the European Economic Area under the following names:

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