Prospecto : information for the user

Valsartán/Hidroclorotiazida SUN 80 mg/12,5 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as 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 should not be given to others, even if they have the same symptoms, 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 SUN and for what it is usedand

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

3. How to take Valsartán/Hidroclorotiazida SUN

4. Possible adverse effects

5. Storage of Valsartán/Hidroclorotiazida SUN

6. Contents of the package and additional information

Valsartán/Hidroclorotiazida SUN 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 an increase in 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 kidney failure. 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 SUN:

??if you are allergic to valsartán, hidroclorotiazida, sulfonamides derivatives

(chemically related substances to hidroclorotiazida) or to any of the other

components of Valsartán/Hidroclorotiazida SUN (listed in section 6).

??if you are more than 3 months pregnant.

(In any case, it is better to avoid taking Valsartán/Hidroclorotiazida SUN, also at the beginning of your pregnancy – see Pregnancy section).

??if you have a severe liver disease,severesmall bile duct destruction in the liver (biliary cirrhosis) that leads to bile accumulation in the liver (cholestasis).

??if you have a severe kidney disease.

??if you cannot urinate (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.

??if you have diabetes or kidney insufficiency, and you are being treated with a medication to reduce blood pressure that contains aliskirén.

If any of these situations apply to you, inform your doctor and do not take Valsartán/Hidroclorotiazida SUN.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Valsartán / Hidroclorotiazida tablets:

• 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 Valsartán/Hidroclorotiazida SUN, seek medical attention immediately.
• 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 regularly monitoring your potassium levels.

??if you have low levels of potassium in your blood.

??if you experience severe diarrhea or vomiting.

??if you are taking high doses of a diuretic.

??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 a narrowing of the renal artery.

??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, valsartán/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 Valsartán / Hidroclorotiazida tablets, stop taking Valsartán/Hidroclorotiazida tablets immediately and never take it again. See also section 4 “Possible side effects”.

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

??if you have diabetes, gout, high levels of cholesterol or lipids in your blood.

??if you have previously had an allergic reaction with the use of another medication of this class to reduce 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 hemorrhage) or an increase in eye pressure, which can occur during a period of time ranging from several hours to a week after taking Valsartán/Hidroclorotiazida. If left untreated, this can lead to permanent vision loss. You may be at higher risk of developing it if you have had an allergy to penicillin or sulfonamides in the past.

??if you are taking any of the following medications used to treat high blood pressure:

or“ACE inhibitors” such as enalapril, lisinopril, etc.

oraliskirén

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

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

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

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

Valsartán/Hidroclorotiazida may cause increased sensitivity to the sun.

Inform your doctor if you think you may be pregnant or plan to become pregnant. Valsartán/Hidroclorotiazida is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to your baby (see Pregnancy section).

Children and adolescents

Valsartán/Hidroclorotiazida is not recommended for use in children and adolescents (under 18 years old).

Tests

The use of Valsartán/Hidroclorotiazida may result in a positive test for doping.

Taking Valsartán/Hidroclorotiazida with other medications

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

The effect of valsartán/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 one of the medications. This is particularly applicable to the following medications:

??lithium, a medication used to treat certain psychiatric disorders

??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, carbenoxolona, amfotericina, or penicillin G

??some antibiotics (of the rifampicin group), a medication used to protect against rejection in a transplant (ciclosporina), or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Valsartán / Hidroclorotiazida tablets

??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 to treat gout, such as alopurinol, probenecid, sulfinpirazona

?vitamin D therapy and calcium supplements

?medications to treat diabetes (insulin or oral antidiabetic medications such as metformin)

??other medications to reduce blood pressure,including metildopa, ACE inhibitors (such as enalapril, lisinopril, etc.,) or aliskirén (see also the information under the headings “Do not take Valsartán/Hidroclorotiazida SUN” and “Warnings and precautions”??medications that increase blood pressure, such as noradrenaline or adrenaline

?digoxina or other digitalis glycosides (medications used to treat heart problems)

?medications that may increase blood sugar levels, such as diazoxida 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 tubocurarina

??anticholinergic medications,(medications used to treat a wide variety of disorders such as gastrointestinal cramps, urinary tract spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia)

??amantadina (medication used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses)

??colestiramina and colestipol (medications used mainly to treat high levels of lipids in the blood)

??ciclosporina, a medication used to prevent organ rejection in transplant patients

??alcohol, sleep medications, and anesthetics (medications with sedative or pain-relieving effects used, for example, in surgery)

?contrast agents containing iodine (used for diagnostic imaging tests)

Taking valsartán/hidroclorotiazida with food, drinks, and alcohol

You can take valsartán/hidroclorotiazida with or without food. Avoid drinking alcohol until you have consulted your doctor. Alcohol may further lower your blood pressure and/or increase the risk of dizziness and weakness.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication

Pregnancy:

??You must inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant.Your doctor will usually advise you to stop taking valsartán/hidroclorotiazida before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead of valsartán/hidroclorotiazida.

Valsartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to your baby when administered from that point on.

Lactation:

??Inform your doctor if you plan to start or are breastfeeding

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

Driving and operating machinery

Before driving a vehicle, using tools, or operating machines, or engaging in other activities that require concentration, make sure you know how you react to the effects of Valsartán/hidroclorotiazida. Like many other medications used to treat high blood pressure, Valsartán/hidroclorotiazida may cause, in rare cases, dizziness and affect concentration.

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 side effects. If in 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 tell you 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 usual dose of valsartán/hidroclorotiazida is one tablet per day.
• Do not change the dose or interrupt 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 SUN than you should

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.

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

If you forget to take Valsartán/Hidroclorotiazida SUN

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 make up for the missed doses.

If you interrupt treatment with Valsartán/Hidroclorotiazida SUN

If you stop taking valsartán/hidroclorotiazida, 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 medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious 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 pharynx

??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 blood 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 taking Valsartán/Hidrochlorothiazide SUN and contact your doctor immediately (see also section 2 "Warnings and precautions").

Other possible side effects include:

Uncommon (may affect up to 1 in 100 people)

??low blood pressure

??dizziness

??dehydration (with symptoms of thirst, dry mouth and tongue, reduced urine output, dark urine, dry skin)

??muscle pain

??fatigue

??tingling or numbness

??blurred vision

??ringing in the ears

Rare (may affect up to 1 in 10,000 people)??dizziness

??diarrhea

??joint pain

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

Unknown frequency (frequency cannot be estimated from available data)

??difficulty breathing

??severe reduction in urine output

??low sodium levels in the blood (which can cause fatigue, confusion, muscle fasciculations, and/or seizures in severe cases)

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

??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, in severe cases, can cause the skin and eyes to turn yellow)

??increased urea and creatinine levels in the blood (which may indicate abnormal kidney function)

??increased uric acid levels in the blood (which, in severe cases, can trigger a gout attack)

??syncope (fainting)

The following side effects have been observed with valsartan or hydrochlorothiazide alone:

Valsartan

Uncommon (may affect up to 1 in 100 people)??vertigo

??abdominal pain

Rare (may affect up to 1 in 10,000 people)

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

Unknown frequency (frequency cannot be estimated from available data)

• skin blisters (sign of dermatitis bullosa)

??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 symptoms similar to the flu.

??skin rash, red-purple spots, fever, itching (signs of vascular inflammation)

??low platelet count (sometimes with bleeding or bruising more frequently than usual)

??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

??elevated liver function values

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

??renal insufficiency

??low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle fasciculations, and/or seizures)

Hidrochlorotiazida

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

??reduced appetite

??light 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 alterations that may appear with yellow skin and eyes

??irregular heartbeat

??headache

??sleep disturbances

??depression

??low platelet count (sometimes with bleeding or bruising under the skin)

??dizziness

??tingling or numbness

??visual disturbances

Rare (may affect up to 1 in 10,000 people)?inflammation of the blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)

?eruptive, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)

?skin rash, joint pain, muscle disorders, fever (lupus erythematosus)

?severe stomach pain (pancreatitis)

?difficulty breathing with fever, cough, wheezing, shortness of breath (difficulty breathing that includes pneumonitis and pulmonary edema)

?fever, sore throat, increased frequency of infections (agranulocytosis)

?paleness, fatigue, shortness of breath, dark urine (hemolytic anemia)

?confusion, fatigue, muscle cramps and spasms, rapid breathing (hypochloremic alkalosis)

?Acute respiratory distress (the signs include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency (frequency cannot be estimated from available data)?weakness, bruising, and frequent infections (aplastic anemia)

?significant reduction in urine production (possible signs of renal impairment or renal failure)

?skin rash, redness of the skin, 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 Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

This medication does not require special conditions for conservation in terms of temperature.Store in the original packaging to protect from humidity.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and the

medications that you do not need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and the medications that you do not need. By doing so, you will help protect the environment.

Composition of Valsartan/Hydrochlorothiazide SUN 80 mg/12.5 mg

Valsartan/Hydrochlorothiazide SUN contains two active principles: Valsartan and hydrochlorothiazide.

Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.

The other components are the following excipients:

Tablet core:microcrystalline cellulose, crospovidone, anhydrous colloidal silica, talc, magnesium stearate, and pregelatinized cornstarch.

Tablet coating:hydroxypropyl cellulose,hypromellose, and titanium dioxide (E171).

Appearance of the product and contents of the package

The film-coated tablets of Valsartan Hidroclorotiazida SUN 80 mg/12.5 mg are white or almost white, oval-shaped, 12.5 x 6.0 mm, engraved with “VH 1” on one side and smooth on the other side.

They may contain 10, 14, 20, 28, 30, 56, 90, 98, 100, or 280 film-coated tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Responsible for manufacturing

TERAPIA S.A.

124 Fabricii Street.,

400632 Cluj Napoca

Romania

Or

Sun Pharmaceutical Industries Europe BV,

Polarisavenue 87,

2132 JH Hoofddorp,

Netherlands

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 – Barcelona. Spain

Tel.: +34 93 342 7890

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

Germany:Valsartan COMP BASICS 80mg/12.5mg Filmtabletten

Spain:Valsartán Hidroclorotiazida SUN 80 mg/12.5 mg film-coated tablets

Italy:Valsartan e Idroclorotiazide SUN 80 mg/12.5 mg film-coated tablets

Last review date of this leaflet: January 2025

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