Valsartan/hydrochlorothiazide Aurovitas 160 mg/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Valsartan/Hydrochlorothiazide Aurovitas 160 mg/12.5 mg film-coated tablets EFG

Please read all of this leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

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

• Valsartan belongs to a class of medicines 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 narrow, resulting in increased blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazide belongs to a class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also lowers blood pressure.

Valsartan/hydrochlorothiazide is used to treat high blood pressure that is not adequately controlled with a single component.

Hypertension increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. What you need to know before taking Valsartan/Hydrochlorothiazide Aurovitas

Do not take Valsartan/Hydrochlorothiazide Aurovitas

• if you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant (it is also best to avoid using valsartan/hydrochlorothiazide at the beginning of your pregnancy – see Pregnancy section).
• if you have severe liver disease, destruction of the small bile ducts in the liver (primary biliary cirrhosis) leading to bile accumulation in the liver (cholestasis).
• if you have severe kidney disease.
• if you are unable to produce urine (anuria).
• if you are undergoing dialysis.
• if you have abnormally low levels of potassium or sodium in your blood, or if your blood calcium levels remain high despite treatment.
• if you have gout.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Consult your doctor

• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking valsartan/hydrochlorothiazide.
• if you are taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, or other medicines that increase blood potassium levels, such as heparin. Your doctor may consider regular monitoring of potassium levels necessary.
• if you have low blood potassium levels.
• if you experience severe diarrhoea 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 when starting treatment. Your doctor may also monitor your kidney function.
• if you have narrowing of the renal artery (the artery supplying the kidney).
• if you have recently undergone a kidney transplant.
• if you have hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, the use of valsartan/hydrochlorothiazide is not recommended.
• if you have kidney or liver disease.
• if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including angiotensin-converting enzyme inhibitors), inform your doctor. If you develop these symptoms while taking valsartan/hydrochlorothiazide, stop taking it immediately and never take it again. See also section 4 “Possible side effects”.
• if you develop fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (SLE, a known autoimmune disease).
• if you have diabetes, gout, or high cholesterol or triglyceride levels in your blood.
• if you have previously had allergic reactions to another medicine of this class used to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.
• if you experience loss of vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from several hours to weeks after taking valsartan/hydrochlorothiazide. If untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulphonamides.
• if you are taking any of the following medicines used to treat hypertension (high blood pressure):
  • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.
• if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking valsartan/hydrochlorothiazide, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Valsartan/Hydrochlorothiazide Aurovitas”.

Valsartan/hydrochlorothiazide may increase the skin’s sensitivity to sunlight.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking valsartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking valsartan/hydrochlorothiazide on your own.

The use of valsartan/hydrochlorothiazide is not recommended in children and adolescents (under 18 years of age).

If you suspect you are pregnant (or might be), you must inform your doctor. The use of valsartan/hydrochlorothiazide is not recommended at the beginning of pregnancy, and it must 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 medicines and Valsartan/Hydrochlorothiazide Aurovitas

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

The effect of treatment with valsartan/hydrochlorothiazide may be altered when taken together with certain medicines. It may be necessary to adjust the dose, take additional precautions, or, in some cases, discontinue treatment with one of the medicines. This particularly applies to the following medicines:

• lithium, a medicine used to treat certain psychiatric conditions.
• medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
• medicines that may decrease blood potassium levels, such as diuretics (medicines to increase urine production), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G.
• certain antibiotics (rifampicin group), a drug used to prevent transplant rejection (cyclosporine), or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of valsartan/hydrochlorothiazide.
• medicines that may induce “torsades de pointes” (irregular heartbeats), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics.
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics.
• medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone.
• therapeutic vitamin D and calcium supplements.
• medicines used to treat diabetes (oral antidiabetics such as metformin, or insulin).
• other blood pressure-lowering medicines, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also information under the headings “Do not take Valsartan/Hydrochlorothiazide Aurovitas” and “Warnings and precautions”).
• medicines that may increase blood pressure, such as noradrenaline or adrenaline.
• digoxin or other digitalis glycosides (medicines used to treat heart problems).
• medicines that may increase blood sugar levels, such as diazoxide or beta-blockers.
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide.
• pain medicines, such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) and acetylsalicylic acid at doses above 3 g.
• muscle relaxants, such as tubocurarine.
• anticholinergic medicines (used to treat a wide range of disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anaesthesia).
• amantadine (a medicine used to treat Parkinson’s disease and also to treat or prevent certain viral infections).
• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels).
• cyclosporine, a medicine used to prevent rejection of transplanted organs.
• alcohol, sleeping medicines, and anaesthetics (medicines with sedative or pain-relieving effects, used, for example, during surgery).
• iodinated contrast media (used in diagnostic imaging procedures).

Taking Valsartan/Hydrochlorothiazide Aurovitas with food, drinks, and alcohol

Avoid alcohol until you have discussed it with your doctor. Alcohol may further lower your blood pressure and/or increase the likelihood of dizziness and weakness.

Pregnancy and breastfeeding

• Inform your doctor if you suspect you are pregnant (or might be)

Generally, your doctor will advise you to stop taking valsartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Valsartan/hydrochlorothiazide is not recommended at the beginning of pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from this stage.

• Inform your doctor if you plan to start or are currently breastfeeding

Valsartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially if the infant is a newborn or premature.

Driving and using machines

Before driving a vehicle, operating tools, handling machinery, or engaging in other activities requiring concentration, make sure you are aware of how valsartan/hydrochlorothiazide affects you. Like many other medicines used to treat high blood pressure, valsartan/hydrochlorothiazide may rarely cause dizziness and affect your ability to concentrate.

Valsartan/Hydrochlorothiazide Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Valsartan/Hydrochlorothiazide Aurovitas contains sodium

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

3. How to take Valsartán/Hidroclorotiazida Aurovitas

Follow exactly the instructions given by your doctor for taking this medicine. This will help you achieve the best results and reduce the risk of side effects. If in doubt, consult your doctor or pharmacist again.

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

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

• The recommended dose of valsartan/hydrochlorothiazide is one tablet per day.
• Do not change the dose or stop treatment without consulting your doctor.
• This medicine should be taken at the same time every day, usually in the morning.
• You may take valsartan/hydrochlorothiazide 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, seek immediate medical advice from your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 your next dose, skip the missed dose.

Do not take a double dose to make up for forgotten doses.

If you stop taking Valsartán/Hidroclorotiazida Aurovitas

If you stop treatment with valsartan/hydrochlorothiazide, your high blood pressure may worsen. Do not stop taking the medicine unless your doctor tells you to.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• You must see your doctor immediately if you notice symptoms of angioedema, such as:
  • swelling of the face, tongue, or pharynx.
  • difficulty swallowing.
  • hives and difficulty breathing.
• Serious skin disease causing skin rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis).
• Sudden decrease in distance vision (acute myopia), decreased vision or eye pain due to high intraocular pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• Fever, sore throat, increased frequency of infections (agranulocytosis).

These adverse effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop taking valsartan/hydrochlorothiazide and contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other adverse 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 frequency of urination, dark-colored urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• noises (e.g., ringing or buzzing) in the ears

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

• dizziness
• diarrhea
• joint pain

Frequency not known: cannot be estimated from available data

• difficulty breathing
• severe decrease in urine output
• low blood sodium levels (which, in severe cases, may cause fatigue, confusion, muscle fasciculations and/or seizures)
• low blood potassium levels (sometimes with 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 blood bilirubin levels (which, in severe cases, may cause yellowing of the skin and eyes)
• increased blood urea nitrogen and creatinine levels (which may indicate abnormal kidney function)
• increased blood uric acid levels (which, in severe cases, may trigger a gout attack)
• syncope (fainting)

The following adverse effects have been observed with medicines containing valsartan or hydrochlorothiazide separately:

Valsartan

Uncommon: may affect up to 1 in 100 people

• sensation of spinning
• abdominal pain

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

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

Frequency not known: cannot be estimated from available data

• blisters on the skin (sign of bullous dermatitis)
• skin rash with or without itching together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
• skin rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
• low blood platelet count (sometimes with unusual bleeding or bruising)
• high blood potassium levels (sometimes with muscle cramps, irregular heartbeat)
• 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 test values
• decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may cause anemia)
• renal failure
• low blood sodium levels (which, in severe cases, may cause fatigue, confusion, muscle fasciculations and/or seizures)

Hydrochlorothiazide

Very common: may affect more than 1 in 10 people

• low blood potassium levels
• increased blood lipid levels

Common: may affect up to 1 in 10 people

• low blood sodium levels
• low blood magnesium levels
• high blood uric acid levels
• itchy rash and other types of skin rash
• decreased appetite
• mild vomiting and nausea
• dizziness, dizziness upon standing
• inability to achieve or maintain an erection

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

• skin swelling and blisters (due to increased sensitivity to sunlight)
• high blood calcium levels
• high blood sugar levels
• sugar in the urine
• worsening of diabetic metabolic state
• constipation, diarrhea, stomach or intestinal discomfort, liver disturbances that may occur with yellowing of the skin and eyes
• irregular heartbeat
• headache
• sleep disturbances
• sadness (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

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• severe upper abdominal pain (pancreatitis)
• pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)
• fever, sore throat or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, muscle twitches and cramps, rapid breathing (hypochloremic alkalosis)
• acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion)

Frequency not known: cannot be estimated from available data

• weakness, bruising, and frequent infections (aplastic anemia)
• severe decrease in urine production (possible sign of kidney impairment or renal failure)
• rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle cramps
• fever (pyrexia)
• weakness (asthenia)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartan/Hydrochlorothiazide Aurovitas

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartan/Hydrochlorothiazide Aurovitas

• The active substances are valsartan and hydrochlorothiazide. Each film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other components are:

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

Tablet coating: 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 pack

Reddish-brown, oval, bevelled, biconvex, film-coated tablets, marked “I” on one side and “62” on the other.

Valsartan/hydrochlorothiazide is available in blister packs.

Pack sizes:

Blister: 14, 28, 56 and 98 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

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:

Date of the most recent review of this leaflet: September 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).