Vabinxo

Patient Information Leaflet

Vabinxo, 80 mg + 1.5 mg, modified-release tablets
valsartan + indapamide
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Vabinxo is and what it is 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 Vabinxo is and what it is 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 narrow, thereby increasing blood pressure. Valsartan works by blocking the effects of angiotensin II, leading to relaxation of blood vessels and lowering of blood pressure.
Indapamide is a diuretic medicine. Most diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it only slightly increases urine production.
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 at the same dose, but as 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 disorder),
• if the patient is more than 3 months pregnant (it is also better to avoid using Vabinxo early in pregnancy – see section "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 treatment with Vabinxo, discuss the following with your doctor or pharmacist:

• if the patient has liver disease,
• if the patient has severe kidney disease or is undergoing dialysis,
• in patients with renal artery stenosis,
• 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 has ever experienced swelling of the face and tongue due to an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), inform the doctor. If such symptoms occur while taking Vabinxo, stop taking Vabinxo immediately and do 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 blood potassium levels may be necessary.
• in patients with hyperaldosteronism, a condition in which the adrenal glands produce excessive amounts of a hormone called aldosterone. Vabinxo is not recommended for patients with hyperaldosteronism.
• in patients who have lost large amounts of fluid (dehydration) due to diarrhoea, vomiting, or use of high doses of diuretic medicines,
• if the patient is taking any of the following medicines used to treat high blood pressure:
• ACE inhibitors (e.g. 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 scheduled for tests assessing parathyroid function.

Inform the doctor if the patient has a light-sensitive allergic reaction.
If the patient experiences blurred vision or eye pain, inform the doctor immediately. These may be symptoms of fluid accumulation in the avascular membrane surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure. These symptoms may occur from several hours to weeks after taking indapamide. If left untreated, they may lead to permanent vision loss.
Patients who previously had an allergic reaction to penicillin or sulfonamides may be at increased risk of developing this condition.
The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Vabinxo, discuss this with the doctor. The doctor will decide on further treatment. Do not make independent decisions about stopping Vabinxo.
See also information under the heading "When not to take Vabinxo".
Inform the doctor about pregnancy, suspected pregnancy, or plans to become pregnant. Vabinxo is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the unborn child (see section "Pregnancy and breastfeeding").
If any of the above situations apply to the patient, inform the doctor before starting Vabinxo.
Important information for athletes
Athletes should be aware that this medicine contains an active substance that may lead to a positive result in doping tests.
Children and adolescents
Due to lack of data on safety and efficacy, Vabinxo is not recommended for use in children and adolescents.
Vabinxo and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
The effect of Vabinxo may change when taken simultaneously with certain other medicines. This may require dose adjustments, additional precautions, or in some cases, discontinuation of one of the medicines. This applies to both prescription and over-the-counter medicines.
Inform the doctor if the patient is taking any of the following medicines, as special precautions may be required:

• other blood pressure-lowering medicines, particularly diuretics (water tablets), ACE inhibitors (e.g. enalapril, lisinopril, etc.) or aliskiren (see also information under the headings "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 known as non-steroidal anti-inflammatory drugs (NSAIDs),
• certain antibiotics (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 effect of Vabinxo.
• lithium (a medicine used to treat certain psychiatric disorders),
• medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis glycosides),
• medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics, neuroleptics),
• bepridil (used to treat angina pectoris, a condition causing chest pain),
• cisapride, difenoxin (used to treat gastrointestinal disorders),
• sparfloxacin, moxifloxacin, intravenous erythromycin (antibiotics used to treat bacterial infections),
• intravenous vinpocetine (used for symptomatic treatment of cognitive disorders in elderly patients, 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 for pain relief (e.g. ibuprofen) or high doses of acetylsalicylic acid,
• angiotensin-converting enzyme (ACE) inhibitors (used to treat hypertension and heart failure),
• intravenous amphotericin B (an antifungal medicine),
• oral corticosteroids used to treat various conditions, including severe asthma and rheumatoid arthritis,
• stimulant laxatives,
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis),
• potassium-sparing diuretics (e.g. amiloride, spironolactone, triamterene),
• allopurinol (used to treat gout),
• metformin (used to treat diabetes),
• iodine-containing contrast agents (used in diagnostic imaging procedures with X-rays),
• calcium tablets or other calcium supplements,
• cyclosporine, tacrolimus, or other immunosuppressive medicines used after organ transplantation, or to treat autoimmune diseases, severe rheumatic or dermatological conditions,
• 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, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before taking this medicine.

• It is essential to inform the doctor about pregnancy, suspected pregnancy, or plans to become pregnant. The doctor will usually recommend discontinuing Vabinxo before becoming pregnant or immediately after pregnancy is confirmed, and will advise using an alternative medicine to Vabinxo. Vabinxo is not recommended during early pregnancy and must not be used in women who are more than 3 months pregnant, as it may seriously harm the unborn child if used beyond the third month of pregnancy.
• Inform the doctor about breastfeeding or plans to breastfeed. Vabinxo is not recommended for breastfeeding mothers. The doctor may choose a different medicine if the patient intends to breastfeed, especially if breastfeeding a newborn or premature infant.

Driving and operating machinery
Before driving, using tools, operating mechanical equipment, or performing any activity requiring concentration, the patient should ensure how Vabinxo affects them. Like many other medicines used to treat high blood pressure, Vabinxo may cause dizziness and affect the ability to concentrate. In such cases, avoid driving or performing other activities requiring concentration.

3. How to take Vabinxo

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult 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 each day.
Tablets may be taken independently of meals. Swallow them whole with water.
Do not crush or chew the tablets.
People with high blood pressure often do not notice any symptoms. Many of them feel quite well. For this reason, it is especially important to attend regular check-ups
with your doctor, even if you feel well. Treatment for high blood pressure usually lasts for life.
Taking more Vabinxo than recommended
If too many tablets have been taken, contact your doctor or pharmacist immediately.
If severe dizziness or (and) fainting occurs, 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.
Missing a dose of Vabinxo
If you miss a dose of Vabinxo, take the next dose as usual.
Do not take a double dose to make up for a missed dose.
Stopping Vabinxo treatment
Since high blood pressure treatment usually lasts for life, you should consult your doctor before stopping the medicine. Do not discontinue treatment unless instructed by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur in the patient, treatment must be discontinued and
medical advice must be sought immediately:

• Angioedema and (or) urticaria. Angioedema is characterized by swelling of the skin of the limbs or face, swelling of the lips or tongue, or of the mucous membranes of the throat or airways, causing breathlessness or difficulty swallowing. If such symptoms occur, immediate medical attention must be sought. (Very rare – may occur in no more than 1 in 10,000 patients)
• Severe skin reactions, including severe rash, redness of the entire body's skin, intense itching, formation of blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions. (Very rare – may occur in no more than 1 in 10,000 patients)
• Life-threatening disturbances in heart rhythm. (Very rare – may occur in no more than 1 in 10,000 patients)
• Pancreatitis, which may cause severe upper abdominal pain radiating to the back and very poor general condition. (Very rare – may occur in no more than 1 in 10,000 patients)
• Brain disease caused by liver disorder (hepatic encephalopathy). (Frequency unknown)
• Hepatitis (inflammation of the liver). (Frequency unknown)

If any of these symptoms occur, stop taking the medicine Vabinxo and contact a doctor immediately
(see also section 2 "Warnings and precautions").
Other adverse reactions include:
Common (may occur in no more than 1 in 10 patients):

• low blood potassium levels
• allergic reactions, mainly dermatological, such as skin rashes in patients with predisposition to hypersensitivity reactions or asthma
• red, raised rash

Uncommon (may occur in no more than 1 in 100 patients):

• low blood sodium levels, which may cause dehydration and low blood pressure
• sensation 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 no more than 1 in 1,000 patients):

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

Very rare (may occur in no more than 1 in 10,000 patients):

• changes in blood cell counts, such as thrombocytopenia (reduced platelet count leading to easier bruising and nosebleeds), leukopenia (reduced white blood cell count, which may cause unexplained fever, sore throat or flu-like symptoms – if these occur, contact a doctor), and anemia (reduced red blood cells)
• high blood calcium levels
• low blood pressure
• abnormal liver function
• kidney disorders (causing extreme fatigue, increased frequency of urination, itching, nausea, limb swelling)
• intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• decreased hemoglobin concentration and reduced number of red blood cells in blood (in severe cases may lead to anemia)
• increased blood potassium levels (in severe cases may cause muscle cramps and disturbances in heart rhythm)
• sudden loss of consciousness (fainting)
• myopia
• blurred vision
• visual disturbances
• decreased vision or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the vascular membrane surrounding the eye – excessive fluid accumulation between 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 (may indicate liver damage), including increased blood bilirubin levels (in severe cases may cause yellowing of the skin and eyes)
• in patients with systemic lupus erythematosus (an autoimmune disease leading to inflammation and damage of joints, tendons, and organs, with symptoms such as skin rash, fatigue, loss of appetite, weight gain, and joint pain), symptoms may worsen
• photosensitivity reactions (skin changes) after exposure to sunlight or artificial UVA light have also been reported
• skin rash
• skin itching
• muscle pain
• increased serum creatinine levels (may indicate impaired kidney function)
• increased blood glucose levels in diabetic patients
• increased blood uric acid levels, a substance that may cause occurrence or exacerbation of gout (pain in one or more joints, especially in the feet)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Vabinxo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the word
EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light and moisture.
There are no special temperature storage requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the packaging and other information

What Vabinxo contains

• The active substances in this medicine 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, and iron oxide red (E 172).

What Vabinxo looks like and contents of the pack
80 mg + 1.5 mg, modified-release tablets: round, biconvex,
bilateral, two-layer tablets. One layer is light pink, mottled, with the imprint VI1. The other
layer is white to yellowish-white. Tablet dimensions: approximately 11 mm in diameter.
Vabinxo is available in the following pack sizes:

• 10, 14, 28, 30, 56, 60, 84, 90 or 100 modified-release tablets in blister packs, contained in a cardboard carton.
• 14, 28, 56 or 84 modified-release tablets in blister packs, calendar pack, contained in a cardboard carton.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicine is authorised in the European Economic Area under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. +48 22 57 37 500