Tensart hct

Package leaflet: Information for the user

Tensart HCT, 160 mg + 12.5 mg, film-coated tablets
Tensart HCT, 160 mg + 25 mg, film-coated tablets
Valsartanum + Hydrochlorothiazidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Tensart HCT is and what it is 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 Tensart HCT is and what it is 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).

• Valsartan belongs 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 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. Hydrochlorothiazide increases urine output, which also lowers blood pressure.

Tensart HCT is used to treat high blood pressure that cannot be adequately controlled with either of the components alone.
High blood pressure increases the workload on the heart and blood vessels. 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 increases the risk of heart attacks. Lowering blood pressure to normal levels helps reduce the risk of these complications.

2. Important information before using Tensart HCT

When not to use Tensart HCT:

• if the patient is allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemicals similar to hydrochlorothiazide), soybean oil, arachis oil, 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 advisable to avoid using Tensart HCT during early pregnancy – see section "Pregnancy");
• if the patient has severe liver disease. Damage to the small bile ducts within the liver (primary 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 with an artificial kidney;
• if the patient has low blood potassium or sodium levels, or high blood calcium levels, despite treatment;
• in patients with gout;
• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply, this medicine must not be used and the patient should contact their doctor.
Warnings and precautions
Before starting treatment with Tensart HCT, discuss this with your doctor or pharmacist.

• if the patient has previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If severe shortness of breath or difficulty breathing occurs after taking Tensart HCT, seek immediate medical help.
• 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. Regular monitoring of blood potassium levels by a doctor may be necessary.
• if the patient has low blood potassium levels;
• if the patient has diarrhoea or severe vomiting;
• if the patient is taking high doses of diuretics (also known as water tablets);
• if the patient has severe heart disease;
• if the patient has heart failure or has had a heart attack. Follow your doctor's advice strictly. Your doctor may also monitor 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. If this condition is present, use of Tensart HCT is not recommended.
• if the patient has liver or kidney disease;
• if the patient has previously 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, stop taking Tensart HCT immediately and contact your doctor without delay. The patient must never take Tensart HCT 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 diabetes, gout, high cholesterol or high blood fat levels;
• if the patient has previously had allergic reactions after taking other blood pressure-lowering medicines of this class (angiotensin II receptor antagonists), or if the patient has allergies or asthma;
• if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure. These may occur from several hours to a week after taking Tensart HCT. If left untreated, they may lead to permanent vision damage. If the patient has had an allergy to penicillin or sulfonamides, they may be at higher risk of developing these symptoms;
• the medicine may increase skin sensitivity to sunlight;
• if the patient is taking any of the following medicines for high blood pressure:
  • an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes;
  • aliskiren.

Your doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also information under the heading "When not to use Tensart HCT".

• if the patient has previously had skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially at high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Tensart HCT.

Children and adolescents
Tensart HCT is not recommended for use in children and adolescents (under 18 years of age).
Inform your doctor if you are pregnant (or think you might be pregnant). Tensart 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 stage of pregnancy (see pregnancy section).
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Tensart HCT, discuss this with your doctor. Your doctor will decide on further treatment. Do not stop taking Tensart HCT on your own initiative.

Tensart HCT and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Taking Tensart HCT with certain other medicines may affect treatment. Your doctor may need to adjust the dose and/or take additional precautions. This particularly applies to the following medicines:

• If the patient is taking an ACE inhibitor or aliskiren (see also information under the headings "When not to use Tensart HCT" and "Warnings and precautions").
• lithium, a medicine used to treat certain psychiatric disorders;
• medicines that affect or may be affected by blood potassium levels, such as digoxin, a medicine used to control heart rhythm, and certain antipsychotics;
• medicines that may increase blood potassium levels, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing diuretics, heparin;
• medicines that may reduce blood potassium levels, such as corticosteroids, certain laxatives;
• medicines used to treat HIV/AIDS (e.g. ritonavir). These medicines may enhance the effect of Tensart HCT;
• medicines that may cause torsades de pointes (irregular heartbeat), such as antiarrhythmics (medicines used for heart conditions) and certain antipsychotics;
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics;
• diuretics, medicines used to treat gout such as allopurinol, therapeutic doses of vitamin D and calcium supplements, and medicines used to treat diabetes (oral antidiabetics 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 may increase blood glucose 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 biperiden;
• amantadine (a medicine used to treat Parkinson's disease and to prevent influenza);
• cholestyramine and colestipol (medicines used to treat high blood fat levels);
• cyclosporine, a medicine used in organ transplant patients to prevent transplant rejection;
• certain antibiotics (e.g. tetracyclines, rifampicin);
• alcohol, anaesthetics, and sedatives;
• carbamazepine, a medicine used to treat epileptic seizures;
• iodinated contrast agents (substances used in imaging procedures).

Tensart HCT with food and alcohol
Tensart HCT can be taken with or without food.
Avoid consuming 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, breastfeeding, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

• Inform your doctor if you are pregnant (or think you might be pregnant). Your doctor will usually advise stopping Tensart HCT before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Tensart 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 beyond the third month of pregnancy.
• Inform your doctor if you are breastfeeding or plan to breastfeed. Tensart HCT is not recommended for breastfeeding mothers; your doctor may choose another treatment for you if you plan to breastfeed, especially if the infant is a newborn or premature.

Driving and operating machinery
Before driving, using tools, operating machinery, or performing any activity requiring concentration, each 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 ability.

Tensart HCT contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicinal product.

Tensart HCT contains soybean oil
This medicinal product should not be used in case of allergy to peanuts or soy.

Tensart HCT contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

Tensart HCT 160 mg + 12.5 mg also contains Sunset Yellow FCF (E110)
which may cause allergic reactions.

3. How to take Tensart HCT

This medicine should always be taken exactly as directed by your doctor or pharmacist. Doing so
will help achieve the best results and reduce the risk of unwanted side effects. If in doubt,
consult your doctor or pharmacist.
People with high blood pressure often do not notice any symptoms. Many of them feel quite well.
For this reason, it is even more important to attend regular check-ups with your doctor, even if you
feel well.
Your doctor will tell you the exact number of Tensart HCT tablets to take. Your doctor may
recommend increasing or decreasing the dose of the medicine, depending on your response to
treatment.

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

Taking more Tensart HCT than recommended
If severe dizziness and/or fainting occur, lie down and contact your doctor immediately.
If you accidentally take 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. However, if it is almost time for your next
dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.
Stopping Tensart HCT treatment
Stopping treatment with Tensart HCT may cause your high blood pressure to worsen. Do not
stop taking the medicine unless your doctor tells you to do so.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Adverse effects may occur with a defined frequency as follows:

• very common: affects more than 1 in 10 patients,
• common: affects 1 in 10 to 1 in 100 patients,
• uncommon: affects 1 in 1,000 to 1 in 10,000 patients,
• rare: affects 1 in 10,000 patients,
• very rare: affects fewer than 1 in 10,000 patients,
• unknown: frequency cannot be estimated from the available data.

Some adverse effects may be serious and require immediate medical attention:
You should consult a doctor immediately if symptoms of angioedema occur, such as:

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

If any of these symptoms occur, stop taking Tensart HCT immediately and consult a doctor
(see also section 2 “Warnings and precautions”).
Other adverse effects include:
Uncommon

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

Very rare

• dizziness
• diarrhoea
• joint pain

Frequency not known

• difficulty breathing

• significantly reduced urine output

• low sodium levels in the blood (sometimes accompanied by nausea, fatigue, confusion, malaise, seizures)

• low potassium levels in the blood (sometimes accompanied by muscle weakness, muscle cramps, irregular heartbeat)

• 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 rare cases, cause yellowing of the skin and eyes)

• increased blood urea nitrogen and increased creatinine levels in the blood
  (which may indicate impaired kidney function)

• increased blood uric acid levels (which may, in rare cases, trigger gout)

• fainting

Adverse effects reported with walsartan or hydrochlorothiazide alone
Walsartan
Uncommon

• sensation of spinning (vertigo)
• abdominal pain

Very rare

• Intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhoea

Frequency not known

• skin blisters (symptom of bullous dermatitis)
• skin rash with or without itching, occurring with some of the following objective and subjective symptoms: fever, joint pain, muscle pain, lymph node swelling 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, irregular heartbeat)
• allergic reactions (with symptoms such as rash, itching, hives, breathing difficulties or swelling, dizziness, swelling, mainly of the face and throat; rash; itching)
• increased liver enzyme activity
• decreased haemoglobin concentration and decreased percentage of red blood cells in the blood (both factors may lead to anaemia in severe cases)
• kidney failure
• low sodium levels in the blood (sometimes with accompanying 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
• itchy rash and other types of rash
• decreased appetite
• mild nausea and vomiting
• fainting, fainting upon standing
• impotence

Rare

• swelling and formation of blisters on 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 diabetic metabolic control
• constipation, diarrhoea, 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
• low mood (depression)
• low platelet count (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• visual disturbances

Very rare

• vasculitis with symptoms such as rash, purple-red spots, fever (vasculitis)
• rash, itching, hives, breathing difficulties or swallowing difficulties, dizziness (hypersensitivity reactions)
• facial rash, joint pain, muscle disorders, fever (lupus-like syndrome)
• severe pain in the upper abdomen (pancreatitis)
• breathing difficulties with fever, cough, wheezing, shortness of breath (respiratory failure, including pneumonia and pulmonary oedema)
• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion)
• fever, sore throat, increased frequency of infections (agranulocytosis)
• pale skin, fatigue, shortness of breath, dark urine (haemolytic anaemia)
• fever, sore throat or mouth ulcers due to infection (leukopenia)
• confusion, fatigue, muscle twitching and cramps, rapid breathing (hypochloraemic alkalosis)

Frequency not known

• weakness, bruising and frequent infections (aplastic anaemia)
• markedly reduced urine output (symptoms of kidney dysfunction or kidney failure)
• impaired vision or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the uvea—the membrane surrounding the eye—or excessive fluid accumulation between the choroid and sclera—or acute angle-closure glaucoma)
• rash, redness of the skin, blistering on lips, eyelids or in the mouth, skin peeling, fever (erythema multiforme)
• muscle cramps
• fever
• weakness

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack, and container after EXP. The expiry date refers to the last day of that month.
Do not use Tensart HCT if the packaging is damaged or shows any signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the pack and other information

What Tensart HCT contains
The active substances 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: tablet core: microcrystalline cellulose, lactose monohydrate,
sodium croscarmellose, povidone K29-K32, talc, magnesium stearate, colloidal anhydrous silica.
coating:

• for the 160 mg + 12.5 mg strength - Opadry Red II 85G25455 coating containing: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide (E171), iron oxide red (E172), brilliant blue FCF (E110), lac; soybean lecithin (E322);
• for the 160 mg + 25 mg strength - Opadry Orange II 85G23675 coating containing: polyvinyl alcohol, talc, titanium dioxide (E171), polyethylene glycol 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, marked with "V" on one side and "H" on the other.
Tensart HCT, 160 mg + 25 mg: orange, oval, biconvex film-coated tablet, 15 x 6 mm in size, marked with "V" on one side and "H" on the other.
Pack:
Blister packs:
7, 14, 28, 30, 56, 98 and 280 film-coated tablets.
Bottle:
7, 14, 28, 30, 56, 98 and 280 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names: