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

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.
• You should consult a doctor or pharmacist if you have any doubts.
• 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 the patient experiences any side effects, including any possible 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 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 packaging 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 control high blood pressure (hypertension).

• Valsartanbelongs to a class of medicines known as “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, which also lowers blood pressure.

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

2. Important information before taking Tensart HCT

When not to take Tensart HCT:

• if the patient is allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemical substances similar to hydrochlorothiazide), soybean oil, arachidic oil, 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 the medicine in early pregnancy – see the section on pregnancy);

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

• 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 (bile stasis);
• if the patient has severe kidney disease;
• if the patient is unable to urinate (anuria);
• if the patient is being dialyzed using an artificial kidney;
• if the patient has decreased potassium and 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 conditions are met, the medicine should not be taken and a doctor should be consulted.

Warnings and precautions

Before starting to take Tensart HCT, the patient should discuss it with their doctor or pharmacist.

• if the patient has had breathing or lung problems in the past after taking hydrochlorothiazide (including pneumonia or fluid accumulation in the lungs). If the patient experiences severe shortness of breath or difficulty breathing after taking Tensart HCT, they should seek medical help immediately.
• 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 monitoring of potassium levels in the blood by a doctor 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 (also known as water pills);
• if the patient has severe heart disease;
• if the patient has heart failure or has had a heart attack. The patient should strictly follow the doctor's instructions. The doctor may also check 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 this disease is present in the patient, taking Tensart HCT is not recommended.
• if the patient has liver or kidney disease;
• if the patient has experienced swelling of the tongue or face due to an allergic reaction called angioedema after taking other medicines (including ACE inhibitors). If such symptoms occur in the patient, they should stop taking Tensart HCT immediately and seek medical help. The patient should never take Tensart HCT 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 diabetes, gout, high cholesterol or fat levels in the blood;
• if the patient has had allergic reactions to other blood pressure-lowering medicines in this class 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 a week after taking Tensart HCT. If left untreated, they can lead to permanent vision loss. If the patient has had an allergy to penicillin or sulfonamides, the patient may be at higher risk of the above;

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

• if the patient is taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if the patient has kidney function disorders related to diabetes.
• aliskiren.

The attending doctor may monitor kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood at regular intervals.

• if the patient has had cancer of the skin 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 skin cancer and lip cancer (non-melanoma skin cancer). During treatment with Tensart HCT.

Children and adolescents

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

The patient should tell their doctor if they think they are pregnant (or may become pregnant). Tensart 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 baby if taken at this stage of pregnancy (see the section on pregnancy).

If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Tensart HCT, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Tensart HCT on their own.

Tensart 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 Tensart HCT with certain other medicines may affect treatment.

The doctor may need to change the dose and/or take other precautions. This applies in particular to the following medicines:

• if the patient is taking an ACE inhibitor or aliskiren (see also the information under the heading “When not to take Tensart HCT” and “Warnings and precautions”).
• lithium, a medicine used to treat certain mental illnesses
• medicines that affect or may be affected by potassium levels in the blood, such as digoxin, a medicine that controls heart rhythm, certain antipsychotic medicines
• medicines that may increase potassium levels in the blood, such as potassium supplements, salt substitutes containing potassium, potassium-sparing diuretics, heparin
• medicines that may decrease potassium levels in the blood, such as corticosteroids, certain laxatives
• medicines used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Tensart HCT
• medicines that may cause “torsades de pointes” (irregular heartbeat), such as anti-arrhythmic medicines (medicines used to treat heart diseases) and certain antipsychotic medicines
• medicines that may decrease sodium levels in the blood, such as antidepressants,

antipsychotics, antiepileptics

• diuretics, medicines used to treat gout, such as allopurinol, therapeutic doses of vitamin D, and calcium supplements, medicines used to treat diabetes (oral or insulin)
• other blood pressure-lowering medicines, such as beta-blockers or methyldopa, or medicines that constrict blood vessels or stimulate the heart, such as noradrenaline or adrenaline
• medicines that increase blood sugar levels, such as diazoxide
• medicines used to treat cancer, such as methotrexate or cyclophosphamide
• painkillers, such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and aspirin > 3 g
• medicines used to treat arthritis
• muscle relaxants, such as tubocurarine
• anticholinergic medicines, such as atropine or bipiperidine
• amantadine (a medicine used to treat Parkinson's disease and to prevent influenza)
• cholestyramine and colestipol (medicines used to treat high fat levels in the blood)
• cyclosporine, a medicine used in patients with organ transplants to prevent rejection of the transplanted organ
• certain antibiotics (tetracycline, rifampicin)
• alcohol, anesthetics, and sedatives
• carbamazepine, a medicine used to treat epileptic seizures
• iodinated contrast agents (agents used for imaging studies)

Tensart HCT with food and alcohol

Tensart 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 and fainting.

Pregnancy and breastfeeding

In pregnancy, during breastfeeding, or if the patient thinks they may be pregnant, or are planning to become pregnant, they should consult their doctor or pharmacist before taking this medicine.

• The patient should tell their doctor if they think they are pregnant (or may become pregnant)The doctor will usually advise the patient to stop taking Tensart HCT before becoming pregnant or as soon as they find out they 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 3rd month of pregnancy, as it may seriously harm the baby if taken after the 3rd month of pregnancy.
• The patient should inform their doctor if they are breastfeeding or plan to start breastfeedingTensart HCT is not recommended for breastfeeding mothers; the doctor may choose a different treatment for the patient who plans to breastfeed, especially a newborn or premature baby.

Driving and using machines

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

Tensart HCT contains lactose

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

Tensart HCT contains soybean oil

In case of peanut or soy allergy, this medicinal product should not be taken.

Tensart HCT contains sodium

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

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

which may cause allergic reactions.

3. How to take Tensart HCT

This medicine should always be taken as directed by the doctor or pharmacist. This will help achieve the best results and minimize the risk of side effects.

In case of doubts, the patient should consult their doctor or pharmacist.

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

The doctor will prescribe the exact number of Tensart HCT tablets to be taken. The doctor may suggest increasing or decreasing the dose of the medicine, depending on the patient's response to treatment.

• The recommended dose of Tensart 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 at the same time every day, usually in the morning.
• Tensart HCT can be taken with or without food.
• The tablet should be swallowed with a glass of water.

Taking a higher dose of Tensart HCT than recommended

In case of severe dizziness and/or fainting, the patient should lie down and seek medical help immediately.

In case of accidental overdose, the patient should consult their doctor, pharmacist, or hospital.

Missing a dose of Tensart HCT

In case of a missed dose, the patient should take it as soon as they remember. If it is already time for the next dose, the patient should skip the missed dose.

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

Stopping treatment with Tensart HCT

Stopping treatment with Tensart HCT may cause blood pressure to increase. The patient should not stop taking the medicine unless their doctor advises them to do so.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tensart HCT can cause side effects, although not everybody gets them.

Side effects may occur with a certain frequency, defined as follows:

• 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;
• unknown: frequency cannot be estimated from the available data.

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

The patient should consult their doctor if they experience symptoms of angioedema, such as:

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

If any of these symptoms occur, the patient should stop taking Tensart HCT and consult their 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, rare 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

Unknown frequency

• breathing difficulties
• significantly reduced urine output
• low sodium levels in the blood (which may be accompanied by nausea, fatigue, confusion, malaise, seizures)
• low potassium levels in the blood (which may be accompanied by muscle weakness, muscle cramps, heart rhythm disturbances)
• low white blood cell count (which may be accompanied by 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 kidney function disorders)

• increased uric acid levels in the blood (which may, in rare cases, cause gout)
• fainting

Side effects reported after taking valsartan or hydrochlorothiazide alone

Valsartan

Uncommon

• dizziness
• abdominal pain

Very rare

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

Unknown frequency

• blisters on the skin (a symptom of bullous pemphigoid)
• rash, itching, or no itching, accompanied by some of the following symptoms: fever, joint pain, muscle pain, swollen lymph nodes, and flu-like symptoms
• rash, redness, fever, and 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 hematocrit levels in the blood (both of which may, in severe cases, cause anemia)
• 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 and 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 disorders
• depression
• low platelet count (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• vision disturbances

Very rare

• vasculitis with symptoms such as rash, redness, fever, and itching (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness, swelling (allergic reactions)
• rash, redness of the skin, blistering on the lips, eyelids, or in the mouth, peeling of the skin, fever (symptoms of erythema multiforme)
• muscle cramps
• fever
• weakness

Unknown frequency

• 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, blistering on the lips, eyelids, or in the mouth, peeling of the skin, fever (symptoms of erythema multiforme)
• muscle cramps
• fever
• weakness

Reporting side effects

If the patient experiences any side effects, including any possible 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

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, more information can be collected on the safety of the medicine.

5. How to store Tensart HCT

Blister packs: do not store above 30°C

Container: no special storage requirements.

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

The patient should not take this medicine after the expiry date stated on the carton, blister, and container after EXP. The expiry date refers to the last day of the month.

The patient should not take Tensart HCT if they notice that 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. Contents of the packaging and other information

What Tensart HCT contains

The active substances of the medicine 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.

Other ingredients are:

tablet core:microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, 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 S (E110), lake; soy lecithin (E322);
• for 160 mg + 25 mg - Opadry Orange II 85G23675with the composition: polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, iron oxide, yellow (E172), 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: info@actavis.com.mt

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