Valtap Hct

Leaflet accompanying the packaging: patient information

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

VALTAP HCT, 160 mg + 25 mg, film-coated tablets

Valsartan + Hydrochlorothiazide

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and should not be given to others. It may harm them, 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Valtap HCT and what is it used for
• 2. Important information before taking Valtap HCT
• 3. How to take Valtap HCT
• 4. Possible side effects
• 5. How to store Valtap HCT
• 6. Package contents and other information

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

Valtap HCT contains two active substances, valsartan and hydrochlorothiazide.
Both 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.

Valtap HCT is used to treat high blood pressure that is not adequately controlled by taking only one substance (valsartan or hydrochlorothiazide).
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 increases the risk of heart attack. Lowering blood pressure to normal values reduces the risk of these disorders.

2. Important information before taking Valtap HCT

When not to take Valtap HCT

• If the patient is allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically 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 Valtap HCT in early pregnancy - see section Pregnancy).
• If the patient has severe liver disease, damage to the small bile ducts in the liver (biliary 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 decreased potassium or sodium levels in the blood or increased calcium levels in the blood, despite treatment.
• In patients with 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 points apply to the patient, they should consult a doctor and not take Valtap HCT.

Warnings and precautions

Before starting Valtap HCT, the patient should discuss the following with their doctor or pharmacist:

• If the patient is taking potassium-sparing medicines, potassium supplements, or salt substitutes containing potassium, or other medicines that increase potassium levels in the blood, such as heparin. Regular blood potassium level tests may be necessary.
• 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. The doctor will carefully monitor the patient's condition and may check their kidney function.
• If the patient has narrowing of the renal artery.
• If the patient has had a kidney transplant.
• If the patient has hyperaldosteronism; this is a disease in which the adrenal glands produce too much of a hormone called aldosterone. If the patient has this disease, taking Valtap HCT is not recommended.
• If the patient has kidney or liver disease.
• If the patient has ever had an allergic reaction to penicillin or sulfonamides, they may be at increased risk of such symptoms.

The patient should tell their doctor if they are taking any of the following medicines used to treat high blood pressure:

• ACE inhibitors (such as enalapril, lisinopril, ramipril), especially if the patient has kidney function disorders related to diabetes,
• 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 Valtap HCT, they should seek medical help immediately.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood.
See also the section "When not to take Valtap HCT".
If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Valtap HCT, they should discuss this with their doctor.
The doctor will decide on further treatment. The patient should not stop taking Valtap HCT without consulting their doctor.
Valtap HCT may cause increased sensitivity of the skin to sunlight.
The patient should inform their doctor if they are pregnant, suspect they may be pregnant, or are planning to become pregnant. Valtap HCT is not recommended in early pregnancy and should not be taken by pregnant women after the 3rd month of pregnancy, as it may seriously harm the unborn baby (see section Pregnancy).

Children and adolescents

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

Valtap HCT with food, drink, and alcohol

The patient should avoid drinking alcohol until they have consulted their doctor. Alcohol may cause additional lowering of blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

The patient should inform their doctor if they are pregnant, suspect they may be pregnant, or are planning to become pregnant.
The doctor will usually advise the patient to stop taking Valtap HCT before becoming pregnant or as soon as pregnancy is confirmed and recommend an alternative medicine instead of Valtap HCT. Valtap HCT is not recommended in early pregnancy and should not be taken by pregnant women after the 3rd month of pregnancy, as it may seriously harm the unborn baby.

Breastfeeding

The patient should inform their doctor if they are breastfeeding or plan to breastfeed.
Valtap HCT is not recommended for breastfeeding mothers; the doctor may choose an alternative treatment for the patient who plans to breastfeed, especially for newborns or premature babies.

Driving and using machines

Before driving, using tools, or operating machinery, or performing other activities that require concentration, the patient should establish how Valtap HCT affects them. Like many other blood pressure-lowering medicines, Valtap HCT may rarely cause dizziness and affect concentration.

Valtap HCT contains lactose, sorbitol, and sodium

Valtap HCT contains lactose and sorbitol, which are sugars. If the doctor has told the patient that they have an intolerance to some sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially 'sodium-free'.

3. How to take Valtap HCT

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. This will help the patient get the best results and reduce the risk of side effects. If the patient has any doubts, they should consult their doctor or pharmacist.
People with high blood pressure often do not notice any symptoms. Many people feel quite well. Therefore, it is especially important to attend follow-up appointments with their doctor, even if they feel well.
The doctor will inform the patient how many Valtap HCT tablets to take. Depending on the patient's response to treatment, the doctor may recommend increasing or decreasing the dose.

• The recommended dose of Valtap 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.
• Valtap HCT can be taken with or without food.
• The tablet should be swallowed with a glass of water.

Taking a higher dose of Valtap HCT than recommended

If the patient experiences severe dizziness and/or fainting, they should lie down and contact their doctor immediately.
If the patient has taken too many tablets, they should contact their doctor, pharmacist, or go to the nearest hospital.

Missing a dose of Valtap 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 a missed dose.

Stopping Valtap HCT treatment

Stopping Valtap HCT treatment may cause high blood pressure to return. The patient should not stop taking Valtap HCT unless their doctor advises them to do so.
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, Valtap HCT can cause side effects, although not everybody gets them.

Some side effects may be serious and may require immediate medical attention:

• The patient should see their doctor immediately if they experience symptoms of angioedema (allergic reaction), such as:
• swelling of the face, tongue, or throat,
• difficulty swallowing,
• hives and difficulty breathing.
• Severe skin disease that causes a rash, redness of the skin, blistering of the lips, eyes, or mouth, peeling of the skin, and fever (toxic epidermal necrolysis).
• Blurred vision or eye pain due to increased pressure in the eyeball (possible symptoms of fluid accumulation in the vascular layer surrounding the eye, acute angle-closure glaucoma).
• Fever, sore throat, frequent infections (agranulocytosis).

These side effects are very rare or of unknown frequency.

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

Other side effects include:

Uncommon (may affect up to 1 in 100 people):

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

Rare (may affect up to 1 in 1,000 people):

• dizziness,
• diarrhea,
• joint pain.

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

• breathing difficulties,
• significantly reduced urine output,
• low sodium levels in the blood (which may cause fatigue, disorientation, muscle tremors, and/or seizures in severe cases),
• low potassium levels in the blood (which may sometimes be accompanied by muscle weakness, muscle cramps, heart rhythm disturbances),
• low white blood cell count (sometimes with unexplained bleeding or bruising),
• increased bilirubin levels in the blood (which may, in rare 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 rare cases, cause gout),
• fainting.

The following side effects have been reported with valsartan or hydrochlorothiazide alone.

Valsartan

Uncommon (may affect up to 1 in 100 people):

• dizziness,
• abdominal pain.

Uncommon (may affect up to 1 in 100 people):

• angioedema of the intestine: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• blisters on the skin (symptom of bullous pemphigoid),
• rash with itching or without, occurring with some of the following 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 unexplained 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, mainly of the face and throat; rash; itching,
• increased liver enzyme activity,
• decreased hemoglobin and red blood cell count in the blood (both of which may cause anemia in severe cases),
• kidney failure,
• low sodium levels in the blood (which may cause fatigue, disorientation, muscle tremors, and/or seizures in severe cases).

Hydrochlorothiazide

Very common (may affect more than 1 in 10 people):

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

Common (may affect up to 1 in 10 people):

• 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,
• inability to achieve or maintain an erection.

Rare (may affect up to 1 in 1,000 people):

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

Very rare (may affect up to 1 in 10,000 people):

• vasculitis with symptoms such as rash, purple-red spots, fever,
• rash, itching, hives, difficulty breathing or swallowing, dizziness (allergic reactions),
• rash on the face, joint pain, muscle disorders, fever (lupus erythematosus)
• severe abdominal pain (pancreatitis),
• breathing difficulties with fever, cough, wheezing, shortness of breath (respiratory failure, including pneumonia and pulmonary edema); acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion),
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia),
• fever, sore throat, or mouth ulcers due to infection (leukopenia),
• confusion, fatigue, tremors, and rapid breathing (hypochloremic alkalosis).

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

• malignant skin tumors and lip tumors (non-melanoma skin cancer),
• weakness, bruising, and frequent infections (aplastic anemia),
• significantly reduced urine output (possible symptoms of kidney function disorders or kidney failure),
• rash, redness of the skin, blistering of the lips, eyes, or mouth, peeling of the skin, fever (possible symptoms of erythema multiforme),
• muscle cramps,
• fever,
• weakness (asthenia).

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform 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
Phone: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Valtap HCT

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 after: Expiry date. The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Store in the original package to protect from moisture.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Valtap HCT contains

• The active substances of Valtap HCT are valsartan and hydrochlorothiazide. Valtap HCT, 160 mg + 12.5 mg: each film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide. Valtap HCT, 160 mg + 25 mg: each film-coated tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
• Other ingredients are: tablet core: microcrystalline cellulose, sorbitol (E 420), heavy magnesium carbonate, povidone K-25, maize starch, sodium stearyl fumarate, sodium lauryl sulfate, crospovidone (type A), colloidal anhydrous silica; tablet coating: lactose monohydrate, hypromellose, talc, macrogol 6000, indigo carmine (E 132) Valtap HCT, 160 mg + 12.5 mg: iron oxide red (E 172) Valtap HCT, 160 mg + 25 mg: iron oxide yellow and brown (E 172).

What Valtap HCT looks like and contents of the pack

Valtap HCT, 160 mg + 12.5 mg: red, round, biconvex film-coated tablets.
Valtap HCT, 160 mg + 25 mg: brown, round, biconvex film-coated tablets.
The medicine is available in packs of 14 (only Valtap HCT, 160 mg + 25 mg), 28, 30, 56, 84, 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the leaflet:January 2025