Aurovalsart Hct

Leaflet attached to the packaging: information for the user

AuroValsart HCT, 80 mg + 12.5 mg, film-coated tablets

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

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

AuroValsart HCT, 320 mg + 12.5 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.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any 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 AuroValsart HCT and what is it used for
• 2. Important information before taking AuroValsart HCT
• 3. How to take AuroValsart HCT
• 4. Possible side effects
• 5. How to store AuroValsart HCT
• 6. Contents of the packaging and other information

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

AuroValsart 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 group of medicines called "angiotensin II receptor antagonists", which help to 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.

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

2. Important information before taking AuroValsart HCT

When not to take AuroValsart HCT:

• if the patient is allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemical substances 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 AuroValsart 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) resulting in bile stagnation in the liver (cholestasis);
• if the patient has severe kidney disease;
• if the patient is unable to produce urine (anuria);
• if the patient is being dialyzed using an artificial kidney;
• if the patient has low potassium or sodium levels in the blood or high 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

The patient should inform their doctor:

• if the patient has been diagnosed with skin cancer or has experienced unexpected skin damage during treatment. Treatment with hydrochlorothiazide, especially long-term use in high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). The patient should protect their skin from the sun and UV rays while taking AuroValsart HCT.
• 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;
• if the patient has severe heart disease;
• if the patient has heart failure or has had a heart attack. The doctor should be careful when prescribing the initial dose of the medicine. The doctor may also check the patient's kidney function;
• if the patient has narrowing of the renal artery;
• if the patient has recently 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 AuroValsart HCT is not recommended;
• if the patient has liver or kidney disease;
• if the patient has ever had swelling of the tongue and face, caused by an allergic reaction called angioedema, after taking another medicine (including ACE inhibitors). If such symptoms occur while taking AuroValsart HCT, the patient should stop taking the medicine immediately and never take it 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 triglyceride levels in the blood;
• if the patient has a history of allergic reactions to other blood pressure lowering medicines from this group of medicines (angiotensin II receptor antagonists) or if the patient has an allergy or asthma;
• if the patient has impaired vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive accumulation of fluid between the choroid and sclera) or symptoms of increased eye pressure and may occur within a few hours to a few weeks after starting treatment with AuroValsart HCT. Without treatment, the symptoms may lead to complete loss of vision. If the patient has previously had

an allergy to penicillin or sulfonamides, they may be at increased risk of developing these symptoms;

• 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 associated with diabetes.
• aliskiren;
• if the patient has previously experienced 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 AuroValsart HCT, they should seek medical attention immediately.

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

See also the information under the heading "When not to take AuroValsart HCT".

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

AuroValsart 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). AuroValsart 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 fetus if taken at this stage of pregnancy (see the section on pregnancy).

AuroValsart HCT with food, drink, and alcohol

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, breastfeeding, and fertility

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 AuroValsart HCT before becoming pregnant or as soon as they find out they are pregnant, and will recommend taking a different medicine instead of AuroValsart HCT. AuroValsart 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 fetus if taken after the 3rd month of pregnancy.

The patient should inform their doctor if they are breastfeeding or plan to breastfeed

AuroValsart HCT is not recommended for breastfeeding mothers. The doctor may choose a different treatment for the patient who plans to breastfeed, especially if the patient is 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 AuroValsart HCT affects them. Like many other medicines used to treat high blood pressure, this medicine can rarely cause dizziness and affect concentration.

AuroValsart HCT contains lactose

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

AuroValsart HCT contains sodium

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

3. How to take AuroValsart HCT

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

Patients with high blood pressure often do not notice any symptoms of the condition. 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 determine the exact number of AuroValsart HCT tablets the patient should take. The doctor may suggest increasing or decreasing the dose of the medicine, depending on the patient's response to treatment.

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

Taking a higher dose of AuroValsart 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 accidentally taken too many tablets, they should contact their doctor, pharmacist, or hospital.

Missing a dose of AuroValsart HCT

If the patient misses a dose, they 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 AuroValsart HCT

Stopping treatment with AuroValsart HCT may cause high blood pressure to worsen. The patient should not stop taking the medicine 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, AuroValsart HCT can cause side effects, although not everybody gets them.

Some side effects can be serious and may 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,
• severe skin diseases causing rash, redness of the skin, blistering of the lips, eyes, or mucous membranes, peeling of the skin, fever (toxic epidermal necrolysis),
• sudden worsening of vision (acute angle-closure glaucoma), worsening of vision, or eye pain due to increased eye pressure,
• fever, sore throat, and frequent infections (agranulocytosis).

The above side effects are very rare or their frequency is unknown.

If the patient experiences any of these symptoms, they should stop taking AuroValsart HCT immediately and consult 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
• 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., buzzing, ringing)

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,
• significant decrease in 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 (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 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

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

• blistering of the skin (symptoms of blistering skin disease)
• rash, redness of the skin, itching, or no itching, accompanied by 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 swelling, 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 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
• impotence

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

• 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 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 disorders
• depression
• low platelet count (sometimes with bleeding or bruising under the skin)
• 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 (systemic lupus erythematosus)
• severe abdominal pain (pancreatitis)
• 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)
• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

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

• weakness, bruising, and frequent infections (aplastic anemia)
• significant decrease in urine output (possible symptoms of kidney function disorders or kidney failure)
• rash, redness of the skin, blistering of the lips, eyes, or mucous membranes, peeling of the skin, fever (possible symptoms of erythema multiforme)
• muscle cramps
• fever
• weakness (asthenia)
• skin cancer and lip cancer (non-melanoma skin cancer)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store AuroValsart HCT

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

The medicine should not be taken after the expiry date stated on the packaging after "Expiry date". The expiry date refers to the last day of the month stated.

The medicine should be stored at a temperature below 30°C.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What AuroValsart HCT contains

The active substances of the medicine are valsartan and hydrochlorothiazide.

AuroValsart HCT, 80 mg + 12.5 mg

Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide as active substances.

AuroValsart HCT, 160 mg + 12.5 mg

Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide as active substances.

AuroValsart HCT, 160 mg + 25 mg

Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide as active substances.

AuroValsart HCT, 320 mg + 12.5 mg

Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide as active substances.

Other ingredients are:

Tablet core:

Microcrystalline cellulose, lactose monohydrate, crospovidone (Type B), colloidal anhydrous silica, hypromellose (5 cP), sodium lauryl sulfate, magnesium stearate, talc.

Coating:

AuroValsart HCT, 80 mg + 12.5 mg and 160 mg + 12.5 mg

Hypromellose (6 cP), titanium dioxide (E 171), talc, macrogol 8000, yellow iron oxide (E 172), red iron oxide (E 172)

AuroValsart HCT, 160 mg + 25 mg

Hypromellose (6 cP), titanium dioxide (E 171), talc, macrogol 4000, yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (E 172)

AuroValsart HCT, 320 mg + 12.5 mg

Hypromellose (6 cP), titanium dioxide (E 171), talc, macrogol 4000, red iron oxide (E 172), black iron oxide (E 172)

What AuroValsart HCT looks like and contents of the pack

Film-coated tablet

AuroValsart HCT, 80 mg + 12.5 mg

Light orange, oval, with beveled edges, biconvex film-coated tablets with "I" engraved on one side and "61" on the other side.

AuroValsart HCT, 160 mg + 12.5 mg

Dark red, oval, with beveled edges, biconvex film-coated tablets with "I" engraved on one side and "62" on the other side.

AuroValsart HCT, 160 mg + 25 mg

Brown-orange, oval, with beveled edges, biconvex film-coated tablets with "I" engraved on one side and "63" on the other side.

AuroValsart HCT, 320 mg + 12.5 mg

Pink, oval, with beveled edges, biconvex film-coated tablets with "I" engraved on one side and "64" on the other side.

AuroValsart HCT is available in blisters.

Package sizes:

Blisters: 14, 28, 56, 98 film-coated tablets

Not all package sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warsaw

Manufacturer/Importer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Poland:

AuroValsart HCT

Portugal:

Valsartan + Hidroclorotiazida Aurovitas

Spain:

Valsartán/Hidroclorotiazida Aurovitas 80 mg/12.5 mg; 160 mg/12.5 mg; 160 mg/25 mg; 320 mg/12.5 mg & 320 mg/25 mg comprimidos recubiertos con película EFG

Date of last revision of the leaflet: 02/2022