Vanatex hct

Package leaflet: Information for the patient

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
Valsartanum + Hydrochlorothiazidum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Vanatex HCT is and what it is 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 pack and other information

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

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

• Valsartan belongs 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 narrow, thereby increasing blood pressure. Valsartan works by blocking the action of angiotensin II. As a result, blood vessels widen and blood pressure decreases.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (water pills). Hydrochlorothiazide increases the amount of urine produced, which also helps lower blood pressure.

Vanatex HCT is used to treat high blood pressure that cannot be controlled with only one active substance.
High blood pressure increases the workload on the heart and arteries. If left untreated, it may lead to damage of blood vessels in the brain, heart, and kidneys, potentially resulting in stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these complications.

2. Important Information Before Using Vanatex HCT

When not to use Vanatex HCT:

• if the patient is allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemicals similar to hydrochlorothiazide), or any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant beyond the 3rd month (it is also better to avoid using Vanatex HCT during early pregnancy - see section “Pregnancy and breastfeeding”);
• if the patient has severe liver disease, damage to the small bile ducts in the liver (biliary cirrhosis), leading to bile accumulation in the liver (cholestasis);
• if the patient has severe kidney disease;
• if the patient is unable to pass urine (anuria);
• if the patient is undergoing dialysis treatment with an artificial kidney;
• if the patient has low blood potassium or sodium levels, or high blood calcium levels, despite treatment;
• if the patient has gout;
• if the patient has diabetes or kidney function impairment and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply to the patient, Vanatex HCT must not be used – the patient should contact a doctor.
Warnings and precautions
Before starting to take Vanatex HCT, discuss this with a doctor:

• if the patient is taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, or other medicines that increase blood potassium levels, such as heparin – the doctor may recommend regular monitoring of blood potassium levels;
• if the patient has low blood potassium levels;
• if the patient experiences diarrhoea or severe vomiting;
• if the patient is taking high doses of diuretic medicines;
• if the patient has severe heart disease;
• if the patient has heart failure or has had a heart attack – the patient should carefully follow the doctor’s advice regarding the initial dose; the doctor may also check kidney function;
• if the patient has renal artery stenosis;
• if the patient has recently received a kidney transplant;
• if the patient has hyperaldosteronism (a condition in which the adrenal glands produce excessive amounts of a hormone called aldosterone) – in such cases, Vanatex HCT is not recommended;
• if the patient has liver or kidney disease;
• if the patient has ever experienced swelling of the tongue and face due to an allergic reaction, known as angioedema, after taking another medicine (including ACE inhibitors) – if such symptoms occur during treatment with Vanatex HCT, the medicine must be stopped immediately and never used again (see also section 4 “Possible side effects”);
• if the patient develops fever, rash, and joint pain, which may be symptoms of systemic lupus erythematosus (SLE, an autoimmune disease);
• if the patient has previously had skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially in high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. During treatment with Vanatex HCT, the skin should be protected from sunlight and UV radiation;
• if the patient has diabetes, a history of gout, or high blood cholesterol or triglyceride levels;
• if the patient has previously experienced allergic reactions after using other blood pressure-lowering medicines from this class (angiotensin II receptor antagonists), or if the patient has allergies or asthma;
• if the patient develops visual disturbances or eye pain. These may be symptoms of fluid accumulation in the uvea (the vascular layer surrounding the eye) or increased intraocular pressure (fluid accumulation between the choroid and sclera). These may occur from several hours to weeks after taking Vanatex HCT. If left untreated, they may lead to permanent vision loss. Patients who previously had an allergy to penicillin or sulfonamides 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 kidney dysfunction related to diabetes,
• aliskiren;
• if the patient has previously experienced breathing problems or lung issues (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If severe shortness of breath or difficulty breathing occurs after taking Vanatex HCT, immediate medical help should be sought.

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section “When not to use Vanatex HCT”.
The medicine may increase skin sensitivity to sunlight.
Use of Vanatex HCT is not recommended in children and adolescents (under 18 years of age).
Inform the doctor if the patient is pregnant, suspects pregnancy, or is planning pregnancy. Use of Vanatex HCT is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child if used during this period (see section “Pregnancy and breastfeeding”).

Vanatex HCT and other medicines
Inform the doctor or pharmacist about all medicines currently being taken, recently taken, or planned for use.
Taking Vanatex HCT together with certain other medicines may affect treatment. Dose adjustments, additional precautions, or in some cases discontinuation of one of the medicines may be necessary. This particularly applies to the following medicines:

• lithium (a medicine used to treat certain psychiatric disorders);
• medicines or substances that may increase blood potassium levels, including potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• medicines that may decrease blood potassium levels, such as diuretics, corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G;
• certain antibiotics (rifamycin group), medicines used to prevent rejection of transplanted organs (cyclosporine), or antiretroviral medicines used in the treatment of HIV/AIDS (ritonavir). These medicines may enhance the effect of Vanatex HCT;
• medicines that may cause “torsade de pointes” (an irregular heart rhythm), such as antiarrhythmic medicines (used to treat heart conditions) and certain antipsychotic medicines;
• medicines that may decrease blood sodium levels, such as antidepressants, antipsychotics, and anticonvulsants;
• medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone;
• therapeutic doses of vitamin D and calcium supplements;
• medicines used to treat diabetes (oral antidiabetics such as metformin or insulin);
• other blood pressure-lowering medicines, including methyldopa, angiotensin-converting enzyme (ACE) inhibitors such as enalapril, lisinopril, etc., or aliskiren (see also sections “When not to use Vanatex HCT” and “Warnings and precautions”);
• medicines that may increase blood pressure, such as noradrenaline or adrenaline;
• digoxin or other cardiac glycosides (medicines used to treat heart conditions);
• medicines that may increase blood glucose levels, such as diazoxide and beta-blockers;
• cytotoxic medicines (used in cancer treatment), such as methotrexate or cyclophosphamide;
• painkillers, such as non-steroidal anti-inflammatory drugs (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 anaesthesia);
• amantadine (a medicine used to treat Parkinson’s disease and to treat or prevent certain viral infections);
• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels);
• alcohol, sedatives, and anaesthetics (medicines with sedative or pain-relieving effects, used, for example, during surgical procedures);
• iodine-containing contrast agents (used in imaging procedures).

Vanatex HCT with food, drink, and alcohol
Vanatex HCT may be taken with or without food.
Alcohol consumption should be avoided until discussed with a doctor. Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Inform the doctor if the patient is pregnant, suspects pregnancy, or is planning pregnancy. The doctor will usually advise discontinuing Vanatex HCT before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Use of Vanatex HCT is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child if used during this period.
Inform the doctor if the patient is breastfeeding or intends to breastfeed.
Use of Vanatex HCT is not recommended in breastfeeding mothers. The doctor may recommend an alternative medicine if the patient intends to breastfeed, particularly if the infant is a newborn or premature.

Driving and operating machinery
Before driving, using tools, operating machinery, or performing any other tasks requiring concentration, the patient should be aware of how Vanatex HCT affects them. Like many other medicines used to treat high blood pressure, Vanatex HCT may rarely cause dizziness and affect the ability to concentrate.

Vanatex HCT contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
Vanatex HCT contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. How to use Vanatex HCT

This medicine should always be used as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
Following these instructions will help achieve the best results and reduce the risk of adverse effects.
People with high blood pressure often do not notice any symptoms. Many of them feel quite well.
Therefore, it is all the more important to attend regular check-ups with your doctor, even if you feel well.
Your doctor will determine the exact number of Vanatex HCT tablets to 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.
• Do not change the dose or stop treatment without consulting your doctor.
• The medicine should be taken daily at the same time, usually in the morning hours.
• Vanatex HCT may be taken with or without food.
• Swallow the tablet with a glass of water.

Taking more Vanatex HCT than recommended
If severe dizziness and/or fainting occur, lie down immediately and contact your doctor without delay.
If an overdose is taken by accident, contact your doctor or go to the emergency department of the nearest hospital.
Missing a dose of Vanatex HCT
If a dose is missed, take it as soon as you remember. However, if it is almost time for the next dose,
skip the missed dose.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Vanatex HCT
Discontinuing treatment with Vanatex HCT may cause worsening of high blood pressure. Do not stop taking
the medicine unless advised 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 everybody will experience them.
Some adverse reactions may be serious and require immediate medical attention – you should seek immediate medical advice if you experience any of the following symptoms:

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

The above adverse reactions are very rare or their frequency is unknown.
If any of these symptoms occur, treatment with Vanatex HCT must be stopped immediately
and a doctor should be contacted (see also section 2 "Warnings and precautions").
Other adverse reactions include:
Uncommon (occur in less than 1 in 100 patients):

• cough;
• low blood pressure;
• sensation of "emptiness" in the head;
• dehydration (with sensation 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;
• tinnitus (e.g. ringing, buzzing in the ears).

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

• dizziness;
• diarrhoea;
• joint pain.

Frequency unknown (frequency cannot be estimated from available data):

• breathing difficulties;
• marked decrease in urine output;
• low sodium levels in the blood (which may cause fatigue, confusion, muscle tremors and/or seizures in severe cases);
• low potassium levels in the blood (which may sometimes be accompanied by muscle weakness, cramps, heart rhythm disturbances);
• low white blood cell count (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness);
• increased bilirubin levels in the blood (which may, in severe cases, cause yellowing of the skin and eyes);
• increased blood urea and creatinine levels (which may indicate impaired kidney function);
• increased blood uric acid levels (which may, in severe cases, trigger gout);
• fainting.

Adverse reactions reported with walsartan or hydrochlorothiazide alone, but not observed with Vanatex HCT:

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

• sensation of spinning (vertigo);
• abdominal pain.

Frequency unknown (frequency cannot be estimated from available data):

• blisters on the skin (symptoms of bullous dermatitis);
• skin rash with or without itching, associated with one or more of the following objective or subjective 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 atypical 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);
• swelling, especially of the face and throat; rash; itching;
• increased liver enzyme activity;
• decreased haemoglobin levels and reduced proportion of red blood cells in the blood (both factors may lead to anaemia in severe cases);
• kidney failure;
• decreased sodium levels in the blood (which may cause fatigue, confusion, muscle tremors and/or seizures in severe cases).

Hydrochlorothiazide
Very common (occur in at least 1 in 10 patients):

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

Common (occur 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;
• itchy rash and other types of skin rash;
• decreased appetite;
• mild nausea and vomiting;
• dizziness, fainting upon standing;
• inability to achieve or maintain erection.

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

• swelling 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 disturbances in diabetes;
• constipation, diarrhoea, discomfort in the stomach or intestines, liver disorders which may occur together with yellowing of the skin and eyes;
• irregular heartbeat;
• headache;
• sleep disturbances;
• low mood (depression);
• low platelet count (sometimes with bleeding or bruising under the skin);
• dizziness;
• tingling or numbness;
• visual disturbances.

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

• vasculitis with symptoms such as rash, purple-red spots, fever;
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions);
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus);
• severe upper abdominal pain (pancreatitis);

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

• paleness of the skin, fatigue, shortness of breath, dark urine (haemolytic anaemia);
• fever, sore throat or mouth ulcers due to infection (leukopenia);
• confusion, fatigue, tremors and muscle cramps, rapid breathing (hypochloraemic alkalosis).

Unknown (frequency cannot be estimated from available data):

• weakness, bruising and frequent infections (aplastic anaemia);
• marked decrease in urine output (possible symptoms of impaired kidney function or kidney failure);
• rash, redness of the skin, formation of blisters on the lips, eyes or mucous membranes of the mouth, skin peeling, fever (possible symptoms of erythema multiforme);
• muscle cramps;
• fever;
• weakness (asthenia);
• malignant tumours of the skin and lips (non-melanoma skin cancer);
• decreased vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye – excessive accumulation of fluid between choroid and sclera – or acute angle-closure glaucoma).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Vanatex HCT

Do not store above 30°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vanatex HCT contains

• The active substances in this 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.
• Other ingredients are: Tablet core: monohydrate lactose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate. Tablet coating: Vanatex HCT 80 mg + 12.5 mg: hypromellose 6 cP, polyethylene glycol 400, titanium dioxide (E 171), iron oxide red (E 172). Vanatex HCT 160 mg + 12.5 mg: hypromellose 6 cP, polyethylene glycol 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, polyethylene glycol 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, elongated, biconvex.
Vanatex HCT 160 mg + 12.5 mg film-coated tablets are rust-brown, elongated, biconvex.
Vanatex HCT 160 mg + 25 mg film-coated tablets are light brown, elongated, biconvex.
Packs contain 14 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01