Aurovalsart hct

Package leaflet: 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
Valsartanum + Hydrochlorothiazidum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

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

• Valsartan belongs to a group 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 production, which also helps lower blood pressure.

AuroValsart HCT is used to treat high blood pressure that cannot be adequately controlled with either active substance given alone.
High blood pressure increases the workload on the heart and blood vessels. If left untreated, it may damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these complications.

2. Important information before using AuroValsart HCT

When not to take AuroValsart HCT:

• if the patient is allergic to valsartan, hydrochlorothiazide, sulphonamide-derived substances (chemicals similar to hydrochlorothiazide), or any of the other ingredients of this medicine (listed in section 6);
• if the patient is more than 3 months pregnant (it is also advisable to avoid using AuroValsart HCT in early pregnancy - see pregnancy section);
• if the patient has severe liver disease – damage to the small bile ducts in the liver (primary biliary cirrhosis), resulting in bile stasis in the liver (cholestasis);
• if the patient has severe kidney disease;
• if the patient is unable to produce 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 function disorders 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 a doctor.
Warnings and precautions
Tell your doctor:

• if the patient has been diagnosed with skin cancer or develops unexpected skin damage during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). The patient should protect their skin from sunlight and UV radiation while taking AuroValsart HCT.
• if the patient is taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium, or other medicines that increase blood potassium levels, such as heparin. Regular monitoring of blood potassium levels by the 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 diuretic medicines;
• if the patient has severe heart disease;
• if the patient has heart failure or has had a heart attack. The patient should carefully follow the doctor’s advice regarding the initial dose. The doctor may also check the patient’s 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 too much of a hormone called aldosterone. If this condition is present, AuroValsart HCT is not recommended;
• if the patient has liver or kidney disease;
• if the patient has previously experienced swelling of the tongue and face due to an allergic reaction known as angioedema after taking another medicine (including ACE inhibitors), the patient should inform the doctor. If such symptoms occur while taking AuroValsart HCT, the patient must stop taking AuroValsart HCT immediately and must never take it 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 triglyceride levels in the blood;
• 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 (the vascular layer surrounding the eye) or symptoms of increased intraocular pressure and may occur from a few hours to several weeks after starting treatment with AuroValsart HCT. Without treatment, these symptoms may lead to complete vision loss. If the patient previously had

an allergy to penicillin or sulphonamides, 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:
  • ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney function disorders related to 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 develops severe shortness of breath or difficulty breathing after taking AuroValsart HCT, seek immediate medical help.

The treating 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 AuroValsart HCT”.
This medicine may increase skin sensitivity to sunlight.
If the patient develops abdominal pain, nausea, vomiting, or diarrhoea after taking AuroValsart HCT, discuss this with the doctor. The doctor will decide whether treatment should continue. Do not make independent decisions about stopping AuroValsart HCT.
The use of AuroValsart HCT is not recommended in children and adolescents (under 18 years of age).
Inform the doctor if the patient thinks she is pregnant (or might become pregnant). AuroValsart HCT is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used during this stage of pregnancy (see pregnancy section).
AuroValsart HCT and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Taking AuroValsart HCT with certain other medicines may affect treatment. Dose adjustments, additional precautions, or in some cases discontinuation of one of the medicines may be necessary. This particularly applies to the following medicines:

• lithium, a medicine used to treat certain types of psychiatric disorders;
• medicines or substances that may increase blood potassium levels, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, heparin;
• medicines that may reduce blood potassium levels, such as diuretics, glucocorticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G;
• certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may enhance the effect of AuroValsart HCT;
• medicines that may cause “torsade de pointes” (irregular heart rhythm), such as antiarrhythmic medicines (used to treat heart conditions) and certain antipsychotic medicines;
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, anticonvulsants;
• medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone;
• therapeutic doses of vitamin D and calcium supplements;
• medicines used to treat diabetes (oral antidiabetics such as metformin or insulin);
• other blood pressure-lowering medicines, including methyldopa, angiotensin-converting enzyme (ACE) inhibitors such as enalapril, lisinopril, etc., or aliskiren (see also information under the headings “When not to use AuroValsart HCT” and “Warnings and precautions”);
• medicines that may increase blood pressure, such as noradrenaline or adrenaline;
• digoxin or other cardiac glycosides (medicines used to treat heart conditions);
• medicines that may increase blood glucose levels, such as diazoxide, and beta-blockers;
• cytotoxic medicines (used in cancer treatment), such as methotrexate or cyclophosphamide;
• painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid > 3 g;
• muscle relaxants such as tubocurarine;
• anticholinergic medicines (used to treat various disorders such as gastrointestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as adjuncts during anaesthesia), amantadine (a medicine used to treat Parkinson’s disease and to treat and prevent certain viral infections);
• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels);
• cyclosporine, a medicine used in organ transplant patients to prevent transplant rejection;
• alcohol, sedatives, and anaesthetics (medicines with sleep-inducing or pain-relieving effects, used, for example, during surgical procedures);
• iodine-containing contrast agents (used in imaging procedures).

AuroValsart HCT with food, drink, and alcohol
Avoid consuming alcohol until consulting with a doctor. Alcohol may further lower blood pressure and/or increase the risk of dizziness and fainting.
Pregnancy, breastfeeding, and fertility

• Inform the doctor if the patient thinks she is pregnant (or might become pregnant) The doctor will usually advise stopping AuroValsart HCT before becoming pregnant or as soon as pregnancy is confirmed and will recommend an alternative medicine. AuroValsart HCT is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used beyond the third month of pregnancy.
• Inform the doctor if the patient is breastfeeding or plans to breastfeed AuroValsart HCT is not recommended for breastfeeding mothers. In such cases, the doctor may choose an alternative treatment for a patient who intends to breastfeed, especially if the infant is a newborn or premature.

Driving and using machines
Before driving, operating tools, or using machinery or performing any activity requiring concentration, each patient should determine how AuroValsart HCT affects them. Like many other medicines used to treat high blood pressure, this medicine may rarely cause dizziness and affect the ability to concentrate.
AuroValsart HCT contains lactose
If the patient has been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
AuroValsart HCT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dosage unit, meaning it is considered "sodium-free".

3. How to use AuroValsart HCT

This medicine should always be taken exactly as your doctor has instructed. Following these instructions will help you achieve the best results and reduce the risk of unwanted side effects. If you have any doubts, you should consult your doctor or pharmacist again.
People with high blood pressure often do not experience any symptoms of this condition. Many of them feel quite well. For this reason, it is especially important to keep regular appointments with your doctor, even when feeling well.
Your doctor will tell you exactly how many tablets of AuroValsart HCT you should take. Your doctor may decide to increase or decrease the dose, depending on your response to treatment.

• The recommended dose of AuroValsart 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.
• AuroValsart HCT may be taken with or without food.
• Swallow the tablet with a glass of water.

If you take more AuroValsart HCT than you should
If you experience severe dizziness and/or fainting, lie down immediately and contact your doctor without delay.
If you accidentally take too many tablets, contact your doctor, pharmacist, or hospital immediately.

If you forget to take AuroValsart 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 one.

Stopping AuroValsart HCT
Stopping treatment with AuroValsart HCT may cause your high blood pressure to worsen. Do not stop taking the medicine unless your doctor tells you to.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and require immediate medical attention.
You should contact a doctor if symptoms of angioedema occur, such as:

• swelling of the face, tongue or throat,
• difficulty swallowing,
• hives and breathing difficulties,
• severe skin disorders causing rash, redness of the skin, formation of blisters on the lips, eyes or mucous membranes of the mouth, skin peeling, fever (toxic epidermal necrolysis),
• sudden worsening of distance vision (acute myopia), worsening of vision or eye pain due to increased intraocular pressure (possible symptoms of fluid accumulation in

the avascular membrane surrounding the eye - excessive accumulation of fluid between the choroid and sclera - or acute angle-closure glaucoma),

• fever, sore throat, frequent infections (agranulocytosis).

The above adverse reactions are very rare or their frequency is unknown.
If any of these symptoms occur, treatment with AuroValsart HCT must be stopped immediately and medical advice sought (see also section 2 "Warnings and precautions").
Other adverse reactions include:
Not common (may affect up to 1 in 100 people):

• 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 colour, dry skin)
• muscle pain
• feeling of fatigue
• tingling or numbness
• blurred vision
• noises (e.g. ringing, buzzing) in the ears

Very rare (may affect 1 in 10,000 people):

• dizziness
• diarrhoea
• joint pain

Frequency unknown (frequency cannot be estimated from available data):

• difficulty breathing,
• 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 sometimes be associated with muscle weakness, muscle cramps, cardiac arrhythmias),
• low white blood cell count (with symptoms such as fever, skin infections, sore throat or oral 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 levels and increased creatinine levels in the blood (which may indicate impaired kidney function),
• increased uric acid levels in the blood (which may, in rare cases, trigger gout),
• fainting.

The following adverse reactions have been reported after using medicines containing
valsartan or hydrochlorothiazide alone:
Valsartan:
Not common (may affect up to 1 in 100 people):

• sensation of spinning
• abdominal pain

Very rare (may affect 1 in 10,000 people):

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

Frequency unknown (frequency cannot be estimated from available data):

• blisters on the skin (symptoms of bullous dermatitis)
• skin rash with or without itching, occurring with one or more 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, cardiac arrhythmias)
• 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 proportion of red blood cells in the blood (both factors may cause anaemia in severe cases)
• renal 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
• itchy rash and other types of skin rash
• decreased appetite
• mild nausea and vomiting
• dizziness, fainting upon standing
• inability to achieve or maintain 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 glucose levels
• presence of glucose in the urine
• worsening of metabolic disturbances in diabetes
• constipation, diarrhoea, discomfort in the stomach or intestines, liver disorders which may occur together with yellowing of the skin and eyes
• palpitations
• headache
• sleep disturbances
• low mood (depression)
• low platelet count (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numb游戏副本

5. How to store AuroValsart HCT

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry". The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What AuroValsart HCT contains
The active substances 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 the active substances.
AuroValsart HCT, 160 mg + 12.5 mg
Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide as the active substances.
AuroValsart HCT, 160 mg + 25 mg
Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide as the active substances.
AuroValsart HCT, 320 mg + 12.5 mg
Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide as the active substances.

The 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, iron oxide yellow (E 172), iron oxide red (E 172).
AuroValsart HCT, 160 mg + 25 mg
Hypromellose (6 cP), titanium dioxide (E 171), talc, macrogol 4000, iron oxide yellow (E 172), iron oxide black (E 172), iron oxide red (E 172).
AuroValsart HCT, 320 mg + 12.5 mg
Hypromellose (6 cP), titanium dioxide (E 171), talc, macrogol 4000, iron oxide red (E 172), iron oxide black (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, bevelled-edge, biconvex film-coated tablets, embossed with the code “I” on one side and “61” on the other.
AuroValsart HCT, 160 mg + 12.5 mg
Dark red, oval, bevelled-edge, biconvex film-coated tablets, embossed with the code “I” on one side and “62” on the other.
AuroValsart HCT, 160 mg + 25 mg
Brown-orange, oval, bevelled-edge, biconvex film-coated tablets, embossed with the code “I” on one side and “63” on the other.
AuroValsart HCT, 320 mg + 12.5 mg
Pink, oval, bevelled-edge, biconvex film-coated tablets, embossed with the code “I” on one side and “64” on the other.

AuroValsart HCT is available in blister packs.
Pack sizes:
Blister packs: 14, 28, 56, 98 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
Poland

Manufacturer/Importer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorised for use in 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