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

You should carefully read the contents of this 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 your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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. Contents of the pack and other information

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

Valtap HCT contains two active substances, called 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 action 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 sufficiently controlled by taking only one substance (valsartan or hydrochlorothiazide).
High blood pressure increases the strain 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 you are 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 you are pregnant over 3 months (it is also recommended to avoid taking Valtap HCT in early pregnancy - see section Pregnancy).
• If you have severe liver disease, damage to the small bile ducts in the liver (biliary cirrhosis), resulting in bile stagnation in the liver (cholestasis).
• If you have severe kidney disease.
• If you are unable to urinate (anuria).
• If you are undergoing dialysis with an artificial kidney.
• If you have decreased potassium or sodium levels in your blood or increased calcium levels in your blood, despite treatment.
• In patients with gout.
• If you have diabetes or kidney function disorders and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above points apply to you, you should consult your doctor and not take Valtap HCT.

Warnings and precautions

Before starting treatment with Valtap HCT, you should discuss it with your doctor or pharmacist:

• If you are taking potassium-sparing medicines, potassium supplements, or salt substitutes containing potassium, or other medicines that increase potassium levels in your blood, such as heparin. Regular blood potassium level tests may be necessary.
• If you have low potassium levels in your blood.
• If you have diarrhea or severe vomiting.
• If you are taking high doses of diuretics.
• If you have severe heart disease.
• If you have heart failure or have had a heart attack. You should carefully follow your doctor's recommendations regarding the initial dose of the medicine. Your doctor may also check your kidney function.
• If you have narrowing of the renal artery.
• If you have recently had a kidney transplant.
• If you have hyperaldosteronism; this is a disease in which the adrenal glands produce too much of a hormone called aldosterone. If you have this disease, taking Valtap HCT is not recommended.
• If you have kidney or liver disease.
• If you have ever had an allergic reaction to penicillin or sulfonamides, you may be at increased risk of such symptoms.

and

• If you are taking any of the following medicines for high blood pressure:
• ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if you have kidney function disorders related to diabetes,
• aliskiren.
• If you have had breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you experience severe shortness of breath or difficulty breathing after taking Valtap HCT, you should seek medical attention immediately.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood.
See also the subsection "When not to take Valtap HCT".
If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Valtap HCT, you should discuss it with your doctor.
Your doctor will decide on further treatment. You should not stop taking Valtap HCT on your own.
Valtap HCT may cause increased sensitivity of the skin to sunlight.
You should tell your doctor if you are pregnant, suspect you are pregnant, or plan to become pregnant. It is not recommended to take Valtap HCT in early pregnancy and it should not be taken in pregnant women after the 3rd month of pregnancy, as it may seriously harm the baby if taken during this period (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

You should avoid consuming alcohol until you have consulted your doctor. Alcohol may cause additional lowering of blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy

You should tell your doctor if you are pregnant, suspect you are pregnant, or plan to become pregnant.
Your doctor will usually advise you to stop taking Valtap HCT before becoming pregnant or when pregnancy is confirmed and recommend an alternative medicine instead of Valtap HCT. It is not recommended to take Valtap HCT in early pregnancy and it should not be taken in pregnant women after the 3rd month of pregnancy, as it may seriously harm the baby if taken during this period.

Breastfeeding

You should inform your doctor if you are breastfeeding or plan to breastfeed.
Valtap HCT is not recommended for breastfeeding mothers; your doctor may choose an alternative treatment for you, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

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

Valtap HCT contains lactose, sorbitol, and sodium

Valtap HCT contains lactose and sorbitol, which are sugars. If your doctor has told you that you have an intolerance to some sugars, you should consult your 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 your doctor or pharmacist has told you. This will help you get the best results and reduce the risk of side effects. If you are unsure, you should consult your 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 your doctor, even if you feel well.
Your doctor will tell you how many Valtap HCT tablets to take. Depending on your response to treatment, your doctor may recommend increasing or decreasing the dose of the medicine.

• The recommended dose of Valtap HCT is one tablet per day.
• You should not change the dose or stop treatment without consulting your 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 you experience severe dizziness and/or fainting, you should lie down and contact your doctor immediately.
In case of accidental overdose, you should contact your doctor, pharmacist, or go to the nearest hospital.

Missing a dose of Valtap HCT

If you miss a dose, you should take it as soon as you remember. However, if it is almost time for your next dose, you should skip the missed dose.
You should not take a double dose to make up for a missed dose.

Stopping treatment with Valtap HCT

Stopping treatment with Valtap HCT may cause your blood pressure to rise again. You should not stop taking the medicine unless your doctor advises you to do so.
If you have any further doubts about taking this medicine, you should consult your 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:

• You should see a doctor immediately if you 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 (excessive accumulation of fluid between the choroid and sclera), acute angle-closure glaucoma).
• Fever, sore throat, frequent infections (agranulocytosis).

These side effects are very rare or of unknown frequency.

If you experience any of these symptoms, you should stop taking Valtap HCT and contact your 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 a feeling of thirst, dryness 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 (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 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 the use of 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: swelling in the intestine 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, feeling of discomfort in the stomach or intestines, liver disorders, which may occur with yellowing of the skin and eyes,
• irregular heartbeat,
• headache,
• sleep disturbances,
• 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 muscle cramps, 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 you experience any side effects, including those not listed in this leaflet, you should tell your 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 packaging 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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, povidence 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.

For more information about this medicine and its names in the Member States of the European Economic Area, you 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