Tensart Hct

Leaflet accompanying the packaging: information for the user

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

Tensart 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.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others. It 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, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Tensart HCT and what is it used for
• 2. Important information before taking Tensart HCT
• 3. How to take Tensart HCT
• 4. Possible side effects
• 5. How to store Tensart HCT
• 6. Contents of the pack and other information

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

Tensart HCT film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).

• Valsartanbelongs to a class of medicines known as “angiotensin II receptor antagonists”, which help to control high blood pressure. Angiotensin II is a substance produced in the human body, which 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, which also lowers blood pressure.

Tensart HCT is used to treat high blood pressure, which cannot be controlled by taking each component separately.

2. Important information before taking Tensart HCT

When not to take Tensart HCT:

Tensart HCT in early pregnancy – see the section on pregnancy);

• in patients with gout.

If any of the above conditions are met, do not take this medicine and consult a doctor.

Warnings and precautions

Before starting to take Tensart HCT, discuss it with your doctor or pharmacist.

The medicine may cause increased sensitivity of the skin to the sun;

• ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) in your blood at regular intervals.

Children and adolescents

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

Tell your doctor if you are pregnant (or think you may be pregnant). Tensart HCT is not recommended in early pregnancy and should not be taken by pregnant women after the third month of pregnancy, as it may seriously harm the baby if taken at this stage of pregnancy (see the section on pregnancy).

If you experience stomach pain, nausea, vomiting, or diarrhea after taking Tensart HCT, discuss it with your doctor. The doctor will decide on further treatment. Do not stop taking Tensart HCT on your own.

Tensart HCT with food and alcohol

Tensart HCT can be taken with or without food.

Avoid drinking alcohol until you have consulted your doctor. Alcohol may cause further lowering of blood pressure and/or increase the risk of dizziness and fainting.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

• Tell your doctor if you think you are pregnant (or may become pregnant)Your doctor will usually advise you to stop taking Tensart HCT before becoming pregnant or as soon as you find out you are pregnant, and will recommend taking a different medicine instead of Tensart HCT. Tensart HCT is not recommended in early pregnancy and should not be taken by pregnant women after the third month of pregnancy, as it may seriously harm the baby if taken after the third month of pregnancy.
• Tell your doctor if you are breastfeeding or plan to breastfeedTensart HCT is not recommended for breastfeeding mothers; your doctor may choose a different treatment for a breastfeeding mother, especially for newborns or premature babies.

Driving and using machines

Before driving, using tools, or operating machinery, or performing other activities that require concentration, each patient should determine how Tensart HCT affects them. Like many other medicines used to treat high blood pressure, Tensart HCT can cause dizziness and affect concentration.

Tensart HCT contains lactose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicinal product.

Tensart HCT contains soybean oil

In case of peanut or soy allergy, do not take this medicinal product.

Tensart HCT contains sodium

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

Tensart HCT 160 mg + 12.5 mg also contains orange yellow FCF (E110)

which may cause allergic reactions.

3. How to take Tensart HCT

Always take this medicine exactly as your doctor or pharmacist has told you. This will help you get the best results and reduce the risk of side effects.

• The recommended dose of Tensart HCT is one tablet per day.
• Do not change the dose or stop treatment without consulting your doctor.
• Take the medicine at the same time every day, usually in the morning.
• Tensart HCT can be taken with or without food.
• Swallow the tablet with a glass of water.

Taking a higher dose of Tensart HCT than recommended

If you experience severe dizziness and/or fainting, lie down and seek medical attention immediately.

If you have taken too many tablets, contact your doctor, pharmacist, or hospital.

Missing a dose of Tensart HCT

If you miss a dose, take it as soon as you remember. If it is already time for your next dose, skip the missed dose.

Do not take a double dose to make up for a missed dose.

Stopping treatment with Tensart HCT

Stopping treatment with Tensart HCT may worsen hypertension. Do not stop taking the medicine unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• very common: occurs in more than 1 in 10 patients,
• common: occurs in 1 to 10 patients in 100;
• uncommon: occurs in 1 to 10 patients in 1,000;
• rare: occurs in 1 to 10 patients in 10,000;
• very rare: occurs in less than 1 in 10,000 patients;
• not known: frequency cannot be estimated from the available data.

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

Tell your doctor if you experience symptoms of angioedema, such as:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing

If you experience any of these symptoms, stop taking Tensart HCT and consult your doctor (see also section 2 “Warnings and precautions”).

Other side effects include:

Uncommon

• cough
• low blood pressure
• dizziness
• dehydration (with thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• ringing in the ears (e.g. hissing, buzzing)

Very rare

• dizziness
• diarrhea
• joint pain

Frequency not known

• breathing difficulties
• significantly reduced urine output
• low sodium levels in the blood (sometimes with nausea, fatigue, confusion, malaise, seizures)
• low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, heart rhythm disturbances)
• low white blood cell count (sometimes with fever, skin infections, sore throat or mouth ulcers caused by infections, weakness)
• 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

Side effects reported with valsartan or hydrochlorothiazide alone

Valsartan

Uncommon

• dizziness
• abdominal pain

Very rare

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

Frequency not known

• blisters on the skin (symptom of bullous pemphigoid)
• 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, redness of the skin, blisters on the lips, eyelids, or mouth, peeling skin, fever (symptoms of vasculitis)
• low platelet count (sometimes with 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, redness, swelling)
• increased liver enzyme activity
• decreased hemoglobin and hematocrit levels in the blood (both of which can cause anemia in severe cases)
• kidney failure
• low sodium levels in the blood (sometimes with nausea, fatigue, confusion, malaise, seizures)

Hydrochlorothiazide

Very common

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

Common

• low sodium levels in the blood
• low potassium levels in the blood
• high uric acid levels in the blood
• itching rash and other types of rash
• decreased appetite
• mild nausea and vomiting
• fainting, fainting when standing up
• impotence

Rare

• swelling and blistering of the skin (due to increased sensitivity to the sun)
• high calcium levels in the blood
• high blood sugar levels
• presence of sugar in the urine
• worsening of diabetic metabolic balance
• constipation, diarrhea, discomfort in the stomach or intestines, liver function disorders, which may be accompanied by 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

• vasculitis with symptoms such as rash, purple-red spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness, redness, swelling (hypersensitivity reactions)
• rash on the face, joint pain, muscle disease, fever (symptoms of 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)
• fever, sore throat, or mouth ulcers due to infection (agranulocytosis)
• pallor, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fever, sore throat, or mouth ulcers due to infection (leukopenia)
• confusion, fatigue, muscle tremors, and muscle cramps (hypochloremic alkalosis)

Frequency not known

• weakness, bruising, and frequent infections (aplastic anemia)
• significantly reduced urine output (symptoms of kidney function disorders or kidney failure)
• 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)
• rash, redness of the skin, blisters on the lips, eyelids, or mouth, peeling skin, fever (symptoms of erythema multiforme)
• muscle cramps
• fever
• weakness

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to

the Department of Drug Safety Monitoring

Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Jerozolimskie Avenue 181C, 02-222 Warsaw

tel.: +48 22 49 21 301, fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tensart HCT

Blister packs: do not store above 30°C

Container: no special storage requirements.

Keep the medicine out of the sight and reach of children.

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

Do not use Tensart HCT if you notice damage to the packaging or signs of attempted opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tensart HCT contains

The active substances of Tensart HCT are valsartan and hydrochlorothiazide.

Each film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.

Each film-coated tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.

The other ingredients are:

• core of the tablet: microcrystalline cellulose, lactose monohydrate, sodium carboxymethylcellulose, povidone K29-K32, talc, magnesium stearate, silica colloidal anhydrous
• coating:
• for 160 mg + 12.5 mg - Opadry Red II 85G25455with the composition: polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E171), iron oxide, red (E172), orange yellow FCF (E110), lake;
• for 160 mg + 25 mg - Opadry Orange II 85G23675with the composition: polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, iron oxide, yellow (E172), soybean lecithin, iron oxide, red (E172), iron oxide, black (E172).

What Tensart HCT looks like and contents of the pack

Tensart HCT, 160 mg + 12.5 mg: red, oval, biconvex film-coated tablet, 15 x 6 mm in size, with the inscription "V" on one side and "H" on the other side.

Tensart HCT, 160 mg + 25 mg: orange, oval, biconvex film-coated tablet, 15 x 6 mm in size, with the inscription "V" on one side and "H" on the other side

Packaging

Blister pack:

7, 14, 28, 30, 56, 98, and 280 film-coated tablets.

Container:

7, 14, 28, 30, 56, 98, and 280 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Egis Pharmaceuticals PLC

1106 Budapest, Keresztúri út 30-38

Hungary

Manufacturer

Actavis Ltd.

BLB 016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Tel.: +356 2169 3533, fax: +356 2169 3604

e-mail: [email protected]

Egis Pharmaceuticals PLC

1165 Budapest Bökényföldi út 118-120.

Hungary

Balkanpharma – Dupnitsa AD

3 Samokovsko Schosse Str.

Dupnitsa 2600

Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 9.04.2025