Prospect: Information for the User

Valsartán/Hidroclorotiazida Aurovitas 80 mg/12,5 mg Film-Coated Tablets

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Valsartán/Hidroclorotiazida Aurovitas and for what it is used

2.What you need to know before starting to take Valsartán/Hidroclorotiazida Aurovitas

3.How to take Valsartán/Hidroclorotiazida Aurovitas

4.Possible adverse effects

5.Storage of Valsartán/Hidroclorotiazida Aurovitas

6.Contents of the package and additional information

Valsartán/Hidroclorotiazida Aurovitas film-coated tablets contain two active ingredients known as valsartán and hidroclorotiazida. These components help control high blood pressure (hypertension).

•Valsartánbelongs to a class of medications known as “angiotensin II receptor antagonists” that help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to constrict, resulting in increased blood pressure. Valsartán acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

•Hidroclorotiazidabelongs to a class of medications known as thiazide diuretics. Hidroclorotiazida increases diuresis, which also decreases blood pressure.

Valsartán/hidroclorotiazida is used to treat high blood pressure that is not adequately controlled with the use of a single component.

Hypertension increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may cause a stroke, heart failure, or renal insufficiency. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

Do not take Valsartán/Hidroclorotiazida Aurovitas

•If you are allergic to valsartan, hidroclorotiazida, sulfonamide derivatives (chemical substances related to hidroclorotiazida) or any of the other components of this medication (listed in section 6).

•If you aremore than 3 months pregnant(it is also recommended to avoid the use of valsartan/hidroclorotiazida at the beginning of your pregnancy – see Pregnancy section).

•If you have asevere liver disease, bile duct destruction in the liver (biliary cirrhosis) that leads to the accumulation of bile in the liver (cholestasis).

•If you have asevere kidney disease.

•If you are unable to produce urine (anuria).

•If you are undergoing dialysis.

•If you have low levels of potassium or sodium in your blood, or if your blood calcium levels are higher than normal despite treatment.

•If you have gout.

•Ifyou have diabetes or kidney insufficiency and are being treated with a blood pressure medication that contains aliskireno.

If any of these situations apply to you, inform your doctor and do not take valsartan/hidroclorotiazida.

Warnings and precautions

Consult your doctor

•If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking valsartan/hidroclorotiazida.

•If you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium or other medications that increase potassium levels in the blood, such as heparin. Your doctor may consider regular monitoring of potassium levels.

•If you have low potassium levels in your blood.

•If you experience severe diarrhea or vomiting.

•If you are taking high doses of diuretics.

•If you have severe heart disease.

•If you have heart failure or have had a heart attack. Follow your doctor's instructions carefully to start treatment. Your doctor may also monitor your kidney function.

•If you have renal artery stenosis.

•If you have recently undergone a kidney transplant.

•If you have primary aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of valsartan/hidroclorotiazida is not recommended.

•If you have kidney or liver disease.

•If you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACE inhibitors), inform your doctor. If you experience these symptoms when taking valsartan/hidroclorotiazida, stop taking valsartan/hidroclorotiazida immediately and never take it again. See also the section 4 “Possible side effects”.

•If you have fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (LES, a known autoimmune disease).

•If you have diabetes, gout, high cholesterol or triglyceride levels in the blood.

•If you have previously had allergic reactions with the use of another medication of this class to lower blood pressure (angiotensin II receptor antagonists), or if you have any type of allergy or asthma.

•If you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur during a period of time ranging from several hours to weeks after taking valsartan/hidroclorotiazida. If left untreated, this may lead to permanent vision loss. You may have a higher risk of developing it if you have had an allergy to penicillin or sulfonamides previously.

•If you are taking any of the following medications used to treat high blood pressure:

-An ACE inhibitor (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

-Aliskireno.

•If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking valsartan/hidroclorotiazida, seek medical attention immediately.

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

See also the information under the heading “Do not take Valsartán/Hidroclorotiazida Aurovitas”.

Valsartan/hidroclorotiazida may cause increased sensitivity to the sun.

It is not recommended to use valsartan/hidroclorotiazida in children and adolescents (under 18 years old).

If you suspect you are pregnant (or may be), you must inform your doctor. Valsartan/hidroclorotiazida is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant because it may cause serious harm to your baby if used during this period (see Pregnancy section).

Other medications and Valsartán/Hidroclorotiazida AurovitasValsartán/Hidroclorotiazida Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

The effect of valsartan/hidroclorotiazida treatment may be altered if taken with certain medications. You may need to change the dose, take other precautions or, in some cases, discontinue treatment with one of the medications. This is especially applicable to the following medications:

•Lithium, a medication used to treat certain types of mental illnesses.

•Medications or substances that may increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin.

•Medications that may decrease potassium levels in the blood, such as diuretics (medications to urinate), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G.

•Some antibiotics (in the group of rifampicin), a medication used to protect against rejection after a transplant (ciclosporina) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of valsartan/hidroclorotiazida.

•Medications that may induce “torsades de pointes” (irregular heartbeats), such as antiarrhythmics (medications used to treat heart problems) and some antipsychotics.

•Medications that may reduce sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics.

•Medications used to treat gout, such as allopurinol, probenecid, sulfinpirazona.

•Vitamin D therapy and calcium supplements.

•Medications used to treat diabetes (oral antidiabetic medications such as metformin, or insulin).

•Other medications to lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskireno (see also the information under the headings “Do not take Valsartán/Hidroclorotiazida Aurovitas” and “Warnings and precautions”).

•Medications that increase blood pressure, such as norepinephrine or epinephrine.

•Digoxin or other digitalis glycosides (medications used to treat heart problems).

•Medications that may increase blood sugar levels, such as diazoxide or beta-blockers.

•Cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide.

•Medications for pain, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors and aspirin in doses above 3 g.

•Muscle relaxants, such as tubocurarine.

•Anticholinergic medications (medications used to treat a wide range of disorders such as gastrointestinal cramps, urinary tract spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia).

•Amantadine (a medication used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses).

•Cholestyramine and colestipol (medications used mainly to treat high lipid levels in the blood).

•Ciclosporina, a medication used to prevent organ rejection after transplantation.

•Alcohol, sleep aids, and anesthetics (medications with sedative or pain-relieving effects used, for example, in surgery).

•Iodinated contrast media (used for diagnostic imaging tests).

Taking Valsartán/Hidroclorotiazida Aurovitas with food, drinks, and alcohol

Avoid taking alcohol until you have consulted with your doctor. Alcohol may further lower your blood pressure and/or increase the risk of dizziness and weakness.

Pregnancy and lactation

•You must inform your doctor if you suspect you are pregnant (or may be)

Generally, your doctor will advise you to stop taking valsartan/hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant, and recommend taking another medication instead of valsartan/hidroclorotiazida. Valsartan/hidroclorotiazida is not recommended at the beginning of pregnancy and should not be administered after the third month of pregnancy as it may cause serious harm to your baby if used during this period.

•Inform your doctor if you are planning to start or are breastfeeding

It is not recommended to administer valsartan/hidroclorotiazida to women during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in newborns or premature babies.

Driving and operating machinery

Before driving a vehicle, using tools or operating machinery, or engaging in other activities that require concentration, make sure you know your reactions to the effects ofvalsartan/hidroclorotiazida. Like many other medications used to treat high blood pressure,valsartan/hidroclorotiazidamay cause, in rare cases, dizziness and affect concentration.

Valsartán/Hidroclorotiazida Aurovitas contains lactose

This medication contains lactose. If your doctor has indicated that you have a intolerance to certain sugars, consult with them before taking this medication.

Valsartán/Hidroclorotiazida Aurovitas contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per dose; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. This will help you achieve the best results and reduce the risk of adverse effects. In case of doubt, consult your doctor or pharmacist again.

People with high blood pressure often do not notice any signs of the disease; many feel normal. This makes it very important to attend your appointments with your doctor, even if you feel well.

Your doctor will indicate exactly how many tablets of valsartán/hidroclorotiazida you should take. Depending on how you respond to the treatment, your doctor may suggest increasing or decreasing the dose.

• The recommended dose of valsartán/hidroclorotiazida is one tablet per day.

• Do not change the dose or interrupt the treatment without consulting your doctor.

• This medication should be taken at the same time every day, usually in the morning.

• You can take valsartán/hidroclorotiazida with or without food.

• Swallow the tablet with a glass of water.

If you take more Valsartán/Hidroclorotiazida Aurovitas than you should

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Valsartán/Hidroclorotiazida Aurovitas

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Valsartán/Hidroclorotiazida Aurovitas

If you stop taking the medication, your high blood pressure may worsen. Do not stop taking the medication unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medicationcan cause side effects, although not everyone will experience them.

Some side effects can be severe and require immediate medical attention:

•You should visit your doctor immediately if you notice symptoms of angioedema, such as:

-swelling in the face, tongue, or throat.

-difficulty swallowing.

-hives and difficulty breathing.

•Severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis).

•Acute myopia, decreased vision or eye pain due to high intraocular pressure (possible signs of choroidal effusion or acute angle-closure glaucoma).

•Fever, sore throat, increased frequency of infections (agranulocytosis).

These side effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop takingvalsartan/hydrochlorothiazideand contact your doctor immediately (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 symptoms of thirst, dry mouth and tongue, reduced urination, dark urine, dry skin)

•muscle pain

•fatigue

•tingling or numbness

•blurred vision

•ringing in the ears (e.g., tinnitus or buzzing)

Rare:may affect up to 1 in 10,000 people

•dizziness

•diarrhea

•joint pain

Unknown frequency:cannot be estimated from available data

•difficulty breathing

•severe decrease in urine production

•low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or convulsions)

•low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)

•low white blood cell count in the blood (with symptoms such as fever, skin infections, sore throat, or mouth ulcers due to infections, weakness)

•high bilirubin levels in the blood (which, in severe cases, may cause yellowing of the skin and eyes)

•high urea and creatinine levels in the blood (which may indicate abnormal kidney function)

•high uric acid levels in the blood (which, in severe cases, may trigger a gout attack)

•syncope (fainting)

The following side effects have been observed with medications containing valsartan or hydrochlorothiazide separately:

Valsartan

Uncommon:may affect up to 1 in 100 people

•vertigo

•abdominal pain

Unknown frequency:cannot be estimated from available data

•skin blisters (sign of bullous dermatitis)

•skin rash with or without itching, along with one or more of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or flu-like symptoms

•skin rash, red-purple spots, fever, itching (signs of vasculitis)

•low platelet count in the blood (sometimes with bleeding or unusual bruising)

•high potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)

•allergic reactions (with symptoms such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness)

•swelling, mainly of the face and throat; skin rash; itching

•increased liver function values

•decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may cause anemia)

•renal insufficiency

•low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or convulsions)

Hydrochlorothiazide

Very common:may affect more than 1 in 10 people

•low potassium levels in the blood

•increased lipids 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

•skin rash with itching and other types of rash

•decreased appetite

•mild vomiting and nausea

•dizziness, dizziness when standing up

•difficulty achieving or maintaining an erection

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

•swelling and blisters on the skin (due to increased sensitivity to the sun)

•high calcium levels in the blood

•high blood sugar levels

•sugar in the urine

•worsening of diabetic metabolic state

•constipation, diarrhea, stomach or intestinal discomfort, liver alterationsthat may appear withyellow skin and eyes

•irregular heartbeat

•headache

•sleep disturbances

•depression

•low platelet count (sometimes with bleeding or unusual bruising)

•dizziness

•tingling or numbness

•visual disturbances

Very rare:may affect up to 1 in 10,000 people

•inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)

•skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)

•facial rash, joint pain, muscle disorders, fever (lupus erythematosus)

•severe upper stomach pain(pancreatitis)

•pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia)

•fever, sore throat, or mouth ulcers due to infections (leukopenia)

•confusion, fatigue, muscle cramps, rapid breathing (hypochloremic alkalosis)

•acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion)

Unknown frequency:cannot be estimated from available data

•weakness, bruises, and frequent infections (aplastic anemia)

•severe decrease in urine production (possible sign of renal impairment or renal insufficiency)

•skin rash, redness, blisters on the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme)

•muscle spasms

•fever (pyrexia)

•weakness (asthenia)

•skin cancer and lip cancer (non-melanoma skin cancer)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Valsartán/Hidroclorotiazida Aurovitas

-The active principles are valsartán and hidroclorotiazida.Cada comprimido recubierto con película contains 80 mg of valsartán and 12.5 mg of hidroclorotiazida.

-The other components are:

Core of the tablet:microcrystalline cellulose, lactose monohydrate, crospovidone (type B), anhydrous colloidal silica, hypromellose (5 cps), sodium lauryl sulfate, magnesium stearate, talc.

Coating of the tablet:hypromellose (6 cps), macrogol 8000, talc, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

Appearance of the product and contents of the package

Orange-colored film-coated tablets, oval, bisected, biconvex, with the mark “I” on one face and “61” on the other.

Valsartán/hidroclorotiazida is available in blister packs.

Pack sizes:

Blister pack: 14, 28, 56 and 98 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:February 2022

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).