VALSARTAN/HYDROCHLOROTHIAZIDE SUN 160 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

1. What is Valsartan/Hydrochlorothiazide SUN and what is it used for

Valsartan/Hydrochlorothiazide SUN film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. These substances help to control high blood pressure (hypertension).

Valsartanbelongs to a class of medicines known as “angiotensin II receptor antagonists” that help to control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, leading to an increase in blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, the blood vessels relax and blood pressure decreases.

Hydrochlorothiazidebelongs 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 the use of a single component.

High blood pressure increases the strain on the heart and arteries. If left uncontrolled, it can damage blood vessels in the brain, heart, and kidneys, and may lead 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 disorders.

2. What you need to know before you take Valsartan/Hydrochlorothiazide SUN Do not take Valsartan/Hydrochlorothiazide SUN:

Do not take Valsartan/Hydrochlorothiazide SUN:

if you are allergic to valsartan, hydrochlorothiazide, sulfonamides (chemically related substances to hydrochlorothiazide) or to any of the other ingredients of Valsartan/Hydrochlorothiazide SUN (listed in section 6).

if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking Valsartan/Hydrochlorothiazide SUN, also at the start of your pregnancy – see section Pregnancy).

if you have severe liver disease, destruction of the small bile ducts in the liver (biliary cirrhosis) leading to a buildup of bile in the liver (cholestasis).

if you have severe kidney disease.

if you are unable to 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 problems and are being treated with a medicine to reduce blood pressure that contains aliskiren.

If any of these conditions apply to you, inform your doctor and do not take Valsartan/Hydrochlorothiazide SUN.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Valsartan/Hydrochlorothiazide SUN:

• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Valsartan/Hydrochlorothiazide SUN, seek medical attention immediately.
• if you are using potassium-sparing medicines, potassium supplements, salt substitutes that contain potassium, or other medicines that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly check 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 when starting treatment. Your doctor may also monitor your kidney function.

if you have narrowing of the kidney artery.

if you have recently undergone a kidney transplant.

if you have hyperaldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, valsartan/hydrochlorothiazide 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 medicines (including ACE inhibitors), inform your doctor. If you have these symptoms when taking Valsartan/Hydrochlorothiazide SUN, stop taking it immediately and never take it again. See also section 4 “Possible side effects”.

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

if you have diabetes, gout, high cholesterol or lipid levels in your blood.

if you have previously had an allergic reaction with the use of another medicine in this class to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.

if you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a time frame of several hours to a week after taking Valsartan/Hydrochlorothiazide SUN. If left untreated, this can lead to permanent vision loss. You may be at higher risk of developing it if you have previously been allergic to penicillin or sulfonamides.

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

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

or aliskiren

• if you have had skin cancer or if you 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 skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Valsartan/Hydrochlorothiazide SUN.

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

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

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

Valsartan/Hydrochlorothiazide SUN may cause increased sensitivity of the skin to the sun.

Inform your doctor if you think you might be pregnant or are planning to become pregnant. The use of valsartan/hydrochlorothiazide is not recommended at the start of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to your baby (see section Pregnancy).

Children and adolescents

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

Tests

The use of Valsartan/Hydrochlorothiazide SUN may result in a positive doping test.

Taking Valsartan/Hydrochlorothiazide SUN with other medicines

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

The effect of treatment with valsartan/hydrochlorothiazide may be altered if taken with certain medicines. It may be necessary to change the dose, take other precautions, or, in some cases, stop treatment with one of the medicines. This is especially applicable to the following medicines:

lithium, a medicine used to treat some types of psychiatric disorders

medicines or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin

medicines that can decrease the amount of potassium in the blood, such as diuretics (medicines to urinate), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G

some antibiotics (of the rifampicin group), a medicine used to protect against rejection in a transplant (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Valsartan/Hydrochlorothiazide SUN

medicines that can induce “torsades de pointes” (irregular heartbeats), such as anti-arrhythmics (medicines used to treat heart problems) and some antipsychotics

medicines that can reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics

medicines for treating gout, such as allopurinol, probenecid, sulfinpyrazone

vitamin D therapy and calcium supplements

medicines for treating diabetes (insulin or oral antidiabetics such as metformin)

other medicines for lowering blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also the information under the headings “Do not take Valsartan/Hydrochlorothiazide SUN” and “Warnings and precautions”)

medicines that increase blood pressure, such as noradrenaline or adrenaline

digoxin or other digitalis glycosides (medicines used to treat heart problems)

medicines that can increase blood sugar levels, such as diazoxide or beta-blockers

cytotoxic medicines (used to treat cancer) such as methotrexate or cyclophosphamide

medicines for pain such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid in doses above 3 g

muscle relaxants, such as tubocurarine

anticholinergic medicines (used to treat a wide range of disorders such as gastrointestinal cramps, bladder spasms, asthma, travel sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia)

amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases)

colestipol and cholestyramine (medicines used primarily to treat high lipid levels in the blood)

cyclosporin, a medicine used to prevent organ rejection after transplantation

alcohol, sleeping pills, and anesthetics (medicines with a sedative or pain-relieving effect used, for example, in case of surgery)

iodinated contrast media (used for diagnostic imaging examinations)

Taking valsartan/hydrochlorothiazide with food, drinks, and alcohol

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine

Pregnancy:

You must inform your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant.Your doctor will normally advise you to stop taking valsartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will recommend that you take another medicine to lower your blood pressure instead of valsartan/hydrochlorothiazide.

The use of valsartan/hydrochlorothiazide is not recommended at the start of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to your baby when administered after this time.

Breastfeeding:

Inform your doctor if you are about to start or are breastfeeding

Valsartan/hydrochlorothiazide is not recommended for use in women during breastfeeding. Your doctor may decide to give you a treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or engaging in other activities that require concentration, make sure you know how you react to the effects of Valsartan/Hydrochlorothiazide SUN. Like many other medicines used to treat high blood pressure, Valsartan/Hydrochlorothiazide SUN can, in rare cases, cause dizziness and affect your ability to concentrate.

3. How to take Valsartan/Hydrochlorothiazide SUN

Follow the instructions for administration of this medicine exactly as indicated by your doctor. This will help you get the best results and reduce the risk of side effects. If you are unsure, 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 Valsartan/Hydrochlorothiazide SUN tablets to take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

• The usual 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 can take valsartan/hydrochlorothiazide with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan/Hydrochlorothiazide SUN than you should

If you notice a strong 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 medicine and the amount ingested).

If you forget to take Valsartan/Hydrochlorothiazide SUN

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 Valsartan/Hydrochlorothiazide SUN

If you stop your 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some adverse 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)
• Rapid onset of decreased distant vision (acute myopia), decreased vision, or eye pain due to high 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 SUN and contact your doctor immediately (see also section 2 "Warnings and Precautions").

Other possible 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 urination frequency, dark-colored urine, dry skin)

??muscle pain

??fatigue

??tingling or numbness

??blurred vision

??noises (e.g., ringing or buzzing) 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.

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

??breathing difficulties

??severe decrease in diuresis

??low sodium levels in the blood (which can cause fatigue, confusion, muscle fasciculation, and/or convulsions 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 adverse effects have been observed with valsartan or hydrochlorothiazide separately:

Valsartan

Uncommon(may affect up to 1 in 100 people)??feeling of rotation

??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.

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

• blisters on the skin (sign of bullous dermatitis)

??skin rash with or without itching along with any 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 (symptoms of blood vessel 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

??elevation of liver function values

??decrease in hemoglobin levels and reduction of red blood cell percentage in the blood (which, in severe cases, can cause anemia)

??renal failure

??low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle fasciculation, 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

??vomiting and mild nausea

??dizziness, dizziness when standing up

??inability to achieve or maintain an erection

Rare(may affect up to 1 in 1,000 people)? swelling and blisters on the skin (due to increased sun sensitivity)

??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 changes that may appear 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)

? rash on the face, joint pain, muscle disorders, fever (lupus erythematosus)

? severe pain in the upper abdomen (pancreatitis)

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

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

? pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)

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

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

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

? significant decrease in urine production (possible signs of kidney disorder or kidney failure)

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

? muscle spasms

? fever (pyrexia)

? weakness (asthenia)

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Valsartan / Hydrochlorothiazide SUN

Keep this medicine out of sight and reach of children.

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

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

This medicine does not require special storage conditions regarding temperature. Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Valsartan / Hydrochlorothiazide SUN 160 mg/12.5 mg

Valsartan/Hydrochlorothiazide SUN contains two active ingredients: Valsartan and Hydrochlorothiazide.

Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.

The other ingredients are:

Core of the tablet:microcrystalline cellulose, crospovidone, anhydrous colloidal silica, talc, magnesium stearate, and pregelatinized corn starch.

Coating of the tablet:hydroxypropyl cellulose,hypromellose, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and package contents

The film-coated tablets of Valsartan Hydrochlorothiazide SUN 160 mg/12.5 mg are peach-colored, oval, engraved with "VH 2" 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 pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer

TERAPIA S.A.

124 Fabricii Street.,

400632 Cluj Napoca

Romania

O

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 under the following names:

Germany: Valsartan COMP BASICS 160mg/12.5mg Filmtabletten

Spain: Valsartan Hydrochlorothiazide SUN 160 mg/12.5 mg film-coated tablets EFG

Italy: Valsartan and Hydrochlorothiazide SUN 160 mg/12.5 mg film-coated tablets

Date of the last revision of this prospectus: January 2025

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