Vanatex Hct

Leaflet accompanying the packaging: patient information

Vanatex HCT, 80 mg + 12.5 mg, film-coated tablets

Vanatex HCT, 160 mg + 12.5 mg, film-coated tablets

Vanatex HCT, 160 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.
• 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 Vanatex HCT and what is it used for
• 2. Important information before taking Vanatex HCT
• 3. How to take Vanatex HCT
• 4. Possible side effects
• 5. How to store Vanatex HCT
• 6. Contents of the packaging and other information

1. What is Vanatex HCT and what is it used for

Vanatex HCT contains two active substances: valsartan and hydrochlorothiazide. Both of these substances help control high blood pressure (hypertension).

• Valsartanbelongs to a group of medicines called angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance produced in the human body that causes blood vessels to constrict, thereby increasing blood pressure. Valsartan works by blocking the activity of angiotensin II. As a result, blood vessels dilate and blood pressure decreases.
• Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics. Hydrochlorothiazide increases the amount of urine excreted, which also lowers blood pressure.

Vanatex HCT is used to treat high blood pressure that cannot be controlled by taking only one 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 result in stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal values can reduce the risk of these disorders.

2. Important information before taking Vanatex HCT

When not to take Vanatex HCT:

• if the patient is allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemical substances similar to hydrochlorothiazide) or any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant over 3 months (it is also recommended to avoid taking Vanatex HCT in early pregnancy - see subsection "Pregnancy and breastfeeding");
• if the patient has severe liver 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 severe kidney disease;
• if the patient is unable to urinate (anuria);
• if the patient is undergoing dialysis using an artificial kidney;
• if the patient has low potassium or sodium levels in the blood or high 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 conditions apply to the patient, they should not take Vanatex HCT - they should consult a doctor.

Warnings and precautions

Before starting to take Vanatex HCT, the patient should discuss it with their doctor:

• if the patient is taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium, or other medicines that increase potassium levels in the blood, such as heparin - the doctor may recommend regular monitoring of potassium levels in the blood;
• 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;
• if the patient has severe heart disease;
• if the patient has heart failure or has had a heart attack - they should carefully follow the doctor's recommendations for the initial dose of the medicine, and the doctor may also check 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 (a disease in which the adrenal glands produce too much of a hormone called aldosterone) - in such cases, it is not recommended to take Vanatex HCT;
• if the patient has liver or kidney disease;
• if the patient has ever had swelling of the tongue and face caused by an allergic reaction, known as angioedema, after taking another medicine (including ACE inhibitors) - if such symptoms occur while taking Vanatex HCT, the patient should stop taking it immediately and never take it again (see also section 4 "Possible side effects");
• if the patient has fever, rash, and joint pain, which may be symptoms of systemic lupus erythematosus (SLE, an autoimmune disease);
• if the patient has a history of malignant skin tumors 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 malignant skin tumors and lip tumors (non-melanoma skin cancer). During treatment with Vanatex HCT, the patient should protect their skin from sunlight and UV radiation;
• if the patient has diabetes, has had gout, has high cholesterol or triglyceride levels in the blood;
• if the patient has a history of allergic reactions after taking 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 experiences vision loss 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 inside the eye - they may occur within a few hours to weeks after taking Vanatex HCT. If left untreated, they can lead to permanent vision loss. If the patient has previously been allergic to penicillin or sulfonamides, they may be at increased risk of developing these symptoms;
• 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 diabetic kidney disease,
• aliskiren;
• 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 Vanatex HCT, they should seek medical help immediately.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.

See also subsection "When not to take Vanatex HCT".

The medicine may cause increased sensitivity of the skin to sunlight.

Vanatex HCT is not recommended for children and adolescents (under 18 years of age).

The patient should tell their doctor about pregnancy, suspected pregnancy, or planned pregnancy. Vanatex HCT is not recommended in early pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the fetus if taken during this period (see subsection "Pregnancy and breastfeeding").

Vanatex HCT 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.

Taking Vanatex HCT with certain other medicines may affect treatment. It may be necessary to change the dose, take other precautions, or, in some cases, stop taking one of the medicines. This applies in particular to the following medicines:

• lithium (a medicine used to treat certain mental illnesses);
• medicines or substances that may increase potassium levels in the blood. These include potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, and heparin.
• medicines that may decrease potassium levels in the blood, such as diuretics (including thiazide diuretics), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G;
• certain antibiotics (from the rifamycin group), medicines used to prevent rejection of a transplanted organ (cyclosporine), or antiretroviral medicines used to treat HIV/AIDS (ritonavir). These medicines may enhance the effect of Vanatex HCT.
• medicines that may cause "torsade de pointes" (irregular heart rhythm), such as anti-arrhythmic medicines (used to treat heart diseases) and certain antipsychotic medicines;
• medicines that may decrease sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics;
• medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone;
• therapeutic doses of vitamin D and calcium supplements;
• medicines used to treat diabetes (oral medicines, such as metformin, or insulin);
• other blood pressure-lowering medicines, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also subsections "When not to take Vanatex HCT" and "Warnings and precautions");
• medicines that increase blood pressure, such as noradrenaline or adrenaline;
• digoxin or other digitalis glycosides (medicines used to treat heart diseases);
• medicines that may increase blood sugar levels, such as diazoxide and beta-blockers;
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
• painkillers, such as non-steroidal anti-inflammatory medicines (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid >3 g;
• muscle relaxants, such as tubocurarine;
• anticholinergic medicines (used to treat various disorders, such as gastrointestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an adjunct during anesthesia);
• amantadine (a medicine used to treat Parkinson's disease and to treat and prevent certain viral diseases);
• cholestyramine and colestipol (medicines used mainly to treat high lipid levels in the blood);
• alcohol, sedatives, and anesthetics (medicines that have a sedative or analgesic effect, used, for example, during surgical procedures);
• contrast agents containing iodine (used in imaging tests).

Vanatex HCT with food, drink, and alcohol

Vanatex HCT can be taken with or without food.

The patient should avoid consuming alcohol until they have consulted their doctor. Alcohol may cause further lowering of blood pressure 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.

The patient should tell their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Vanatex HCT before planned pregnancy or immediately after confirming pregnancy and recommend taking a different medicine instead of Vanatex HCT. Vanatex HCT is not recommended in early pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the fetus if taken during this period.

The patient should inform their doctor if they are breastfeeding or plan to breastfeed.

Vanatex HCT is not recommended for breastfeeding mothers. The doctor may recommend taking a different medicine if the patient plans to breastfeed, especially if they have a newborn or premature baby.

Driving and using machines

Before driving, using tools, operating machines, or performing other activities that require concentration, the patient should know how Vanatex HCT affects them.

Like many other medicines used to treat high blood pressure, Vanatex HCT may rarely cause dizziness and affect concentration.

Vanatex HCT contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Vanatex HCT contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Vanatex HCT

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

Following these instructions will help achieve the best results and reduce the risk of side effects.

People with high blood pressure often do not notice any symptoms. Many of them feel quite well. Therefore, it is especially important to attend doctor's appointments, even if the patient feels well.

The doctor will determine the exact number of Vanatex HCT tablets the patient should take. Depending on the response to treatment, the doctor may recommend increasing or decreasing the dose of the medicine.

• The recommended dose of Vanatex HCT is one tablet per day.
• The patient should not change the dose or stop treatment without consulting their doctor.
• The medicine should be taken every day at the same time, usually in the morning.
• Vanatex HCT can be taken with or without food.
• The tablet should be swallowed with a glass of water.

Taking a higher dose of Vanatex HCT than recommended

If the patient experiences severe dizziness and (or) fainting, they should lie down and immediately consult their doctor.

If the patient has accidentally taken too many tablets, they should consult their doctor or go to the emergency department of the nearest hospital.

Missing a dose of Vanatex HCT

If the patient misses a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, they should skip the missed dose.

The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Vanatex HCT

Stopping treatment with Vanatex HCT may cause high blood pressure to worsen. The patient should not stop taking the medicine unless their doctor recommends it.

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, Vanatex HCT can cause side effects, although not everybody gets them.

Some side effects may be serious and require immediate medical attention

The patient should immediately consult their doctor if they experience symptoms such as:

• swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing (symptoms of angioedema);
• severe skin disease causing a rash, redness of the skin, blisters on the lips, eyes, or mucous membranes of the mouth, peeling of the skin, fever (toxic epidermal necrolysis);
• worsening vision or eye pain due to increased pressure (possible symptoms of acute angle-closure glaucoma);
• fever, sore throat, frequent infections (agranulocytosis).

The above side effects are very rare or their frequency is unknown.

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

Other side effects include:

Uncommon (occurring in less than 1 in 100 patients):

• cough;
• low blood pressure;
• feeling of "emptiness" in the head;
• dehydration (with a feeling of thirst, dryness of the mucous membranes of the mouth and tongue, infrequent urination, dark urine, dry skin);
• muscle pain;
• feeling of fatigue;
• tingling or numbness;
• blurred vision;
• ringing in the ears (e.g., hissing, buzzing).

Rare (occurring in less than 1 in 1,000 patients):

• dizziness;
• diarrhea;
• joint pain.

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

• breathing difficulties;
• significant decrease in urine output;
• low sodium levels in the blood (which may cause fatigue, disorientation, muscle tremors, and (or) convulsions in severe cases);
• low potassium levels in the blood (which may be accompanied by 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 may, in severe cases, 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 may, in severe cases, cause gout);
• fainting.

Side effects reported after taking valsartan or hydrochlorothiazide alone, which were not observed after taking Vanatex HCT:

Valsartan

Uncommon (occurring in less than 1 in 100 patients):

• vertigo;
• abdominal pain.

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

• blisters on the skin (symptoms of bullous dermatitis);
• rash with itching or without, accompanied by some of the following symptoms: fever, joint pain, muscle pain, swollen lymph nodes, and (or) flu-like symptoms;
• rash, purpura, 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);
• edema, especially of the face and throat; rash; itching;
• increased liver enzyme activity;
• decrease in hemoglobin and red blood cell count in the blood (both of which may, in severe cases, cause anemia);
• kidney failure;
• decrease in sodium levels in the blood (which may cause fatigue, disorientation, muscle tremors, and (or) convulsions in severe cases).

Hydrochlorothiazide

Very common (occurring in at least 1 in 10 patients):

• low potassium levels in the blood;
• increased lipid levels in the blood.

Common (occurring in less than 1 in 10 patients):

• 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, fainting when standing up;
• erectile dysfunction.

Rare (occurring in less than 1 in 1,000 patients):

• edema and blistering of 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, feeling of discomfort in the stomach or intestines, liver disorders, which may occur with yellowing of the skin and eyes;
• irregular heart rhythm;
• headache;
• sleep disorders;
• low mood (depression);
• low platelet count (sometimes with bleeding or bruising);
• dizziness;
• tingling or numbness;
• vision disorders.

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

• vasculitis with symptoms such as rash, purpura, fever;
• rash, itching, hives, difficulty breathing or swallowing, dizziness (symptoms of hypersensitivity reactions);
• rash on the face, joint pain, muscle disorders, fever (symptoms of systemic lupus erythematosus);
• severe abdominal pain (pancreatitis);

breathing difficulties with fever, cough, wheezing, severe shortness of breath, weakness, and confusion (respiratory failure, including pneumonia and pulmonary edema, acute respiratory distress syndrome);

• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia);
• fever, sore throat, or mouth ulcers due to infection (leukopenia);
• state of confusion, fatigue, tremors, and muscle cramps, rapid breathing (hypochloremic alkalosis).

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

• weakness, bruising, and frequent infections (aplastic anemia);
• significant decrease in urine output (possible symptoms of impaired kidney function or kidney failure);
• rash, redness of the skin, blisters on the lips, eyes, or mucous membranes of the mouth, peeling of the skin, fever (possible symptoms of erythema multiforme);
• muscle cramps;
• fever;
• weakness (asthenia);
• malignant skin tumors and lip tumors (non-melanoma skin cancer);
• vision loss 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).

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

Tel.: +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 Vanatex HCT

Do not store above 30°C.

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month stated.

The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it indicates the batch number.

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 Vanatex HCT contains

• The active substances of the medicine are valsartan and hydrochlorothiazide. Each 80 mg + 12.5 mg tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide. Each 160 mg + 12.5 mg tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide. Each 160 mg + 25 mg tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
• The other ingredients are: Tablet core: lactose monohydrate, sodium carboxymethylcellulose, silicon dioxide, magnesium stearate. Tablet coating: Vanatex HCT 80 mg + 12.5 mg: hypromellose 6 cP, macrogol 400, titanium dioxide (E 171), iron oxide red (E 172). Vanatex HCT 160 mg + 12.5 mg: hypromellose 6 cP, macrogol 400, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172). Vanatex HCT 160 mg + 25 mg: hypromellose 6 cP, macrogol 400, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172).

What Vanatex HCT looks like and contents of the pack

Vanatex HCT 80 mg + 12.5 mg film-coated tablets are pink, oval, biconvex.

Vanatex HCT 160 mg + 12.5 mg film-coated tablets are reddish-brown, oval, biconvex.

Vanatex HCT 160 mg + 25 mg film-coated tablets are light brown, oval, biconvex.

The packaging contains 14 or 28 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Date of last revision of the leaflet:March 2022