Package Leaflet: Information for the Patient

Valsartan/Hydrochlorothiazide Sandoz 80 mg/12.5 mg Film-Coated Tablets

Valsartan/Hydrochlorothiazide Sandoz 160 mg/12.5 mg Film-Coated Tablets

Valsartan/Hydrochlorothiazide Sandoz 160 mg/25 mg Film-Coated Tablets

Valsartan/Hydrochlorothiazide Sandoz 320 mg/12.5 mg Film-Coated Tablets

Valsartan/Hydrochlorothiazide Sandoz 320 mg/25 mg Film-Coated Tablets

Valsartan/Hydrochlorothiazide

Read this leaflet carefully before you start taking this medicine because 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 others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

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

3.How to take Valsartan/Hydrochlorothiazide Sandoz

4.Possible side effects

5Storage of Valsartan/Hydrochlorothiazide Sandoz

6.Contents of the pack and additional information

Valsartán/Hidroclorotiazida Sandoz 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 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 takeValsartán/Hidroclorotiazida Sandoz

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

• if you aremore than 3 months pregnant(it is better to avoid taking Valsartán/Hidroclorotiazida Sandoz, also at the beginning of your pregnancy – see Pregnancy section),
• if you have a severe liver disease,liver cirrhosisthat leads to the accumulation of bile in the liver (cholestasis),
• if you have a severe kidney disease,
• if you are unable to produce urine (anuria),
• if you are being treated with a kidney artificial,
• if you have lower than normal 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 are being treated with a medication to reduce blood pressure that contains aliskirén.

If any of these situations affect you, do not take this medication and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsartán/Hidroclorotiazida Sandoz

• if you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium or other medications that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to control your potassium levels regularly,
• 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 a severe heart disease,
• if you have heart failure or have experienced a heart attack. Follow your doctor's instructions for the initial dose carefully. Your doctor may also check your kidney function,
• if you have a 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, valsartán/hidroclorotiazida is not recommended,
• if you have kidney or liver disease,
• if you have ever experienced swelling mainly of the tongue and face while taking other medications (including ACE inhibitors). If you have these symptoms, stop taking valsartán/hidroclorotiazida and contact your doctor immediately. Do not take valsartán/hidroclorotiazida 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 (LES, a known autoimmune disease),
• if you have diabetes, gout, high levels of cholesterol or triglycerides in your blood,
• if you have previously experienced 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 a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in your eye and may occur from the first hours to weeks after taking valsartán/hidroclorotiazida. This can lead to vision loss if not treated. If you have previously had an allergy to sulfonamides or penicillin, you may have a higher risk of developing it,
• it may cause increased sensitivity of the skin to the sun,
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, especially its 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 Valsartán/Hidroclorotiazida Sandoz,
• 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, go to your doctor immediately,
• if you are taking any of the following medications used to treat high blood pressure:
• • an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  • Aliskirén.

If you find yourself in any of these cases, consult your doctor.

Your doctor may check 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 Sandoz”.

Consult your doctor if you think you are (or may be) pregnant.

Generally, your doctor will 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 at any time during the third month of pregnancy, as it may cause serious damage to your baby (see Pregnancy section).

Inform your doctor if you are going to start or are in the lactation period.

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

Driving and operating machines

Before driving a vehicle, using tools or operating machines, or performing other activities that require concentration, make sure you know your reactions to the effects of valsartán/hidroclorotiazida. Like many other medications used to treat high blood pressure, Valsartán/Hidroclorotiazida Sandoz may cause, in rare cases, dizziness and affect your ability to concentrate.

Always take this medication exactly as your doctor tells you to. This will help you get the best results and reduce the risk of side effects. Consult your doctor or pharmacist if you have any doubts.

People with high blood pressure often do not notice any symptoms 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 treatment, your doctor may suggest increasing or decreasing the dose.

• The recommended dose of Valsartán/Hidroclorotiazida Sandoz is one tablet per day.
• Do not change the dose or stop 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 Sandoz than you should

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

If you accidentally take too many tablets, contact your doctor, pharmacist, or hospital. You can also contact the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Valsartán/Hidroclorotiazida Sandoz

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 the missed dose.

If you interrupt treatment with Valsartán/Hidroclorotiazida Sandoz

If you stop taking Valsartán/Hidroclorotiazida Sandoz, 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 using 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.

You should contact your doctor immediately if you experience acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion), this is a very rare adverse reaction (it can affect up to 1 in 10,000 people).

If you experience any of these symptoms, stop taking Valsartán/Hidroclorotiazida Sandoz and consult your doctor immediately (see also section 2 “Warnings and precautions”).

Other possible side effects:

Frequent, affecting 1 to 10 per 1,000 patients

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

Rare, affecting less than 1 in 10,000 patients

• dizziness,
• diarrhea,
• joint pain.

Frequency not known, based on available data

• difficulty breathing,
• significant decrease in urine output,
• low sodium levels in the blood (which can lead to fatigue, confusion, muscle spasms, 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),
• high bilirubin levels in the blood (which, in severe cases, can cause the skin and eyes to turn yellow),
• high levels of urea nitrogen and creatinine in the blood (which can indicate abnormal kidney function),
• high levels of uric acid in the blood (which, in severe cases, can trigger a gout attack),
• syncope (fainting).

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

Valsartan

Frequent, affecting 1 to 10 per 1,000 patients

• vertigo,
• abdominal pain.

Rare, affecting less than 1 in 10,000 patients

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

Frequency not known, based on available data

• skin blisters (symptom 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 symptoms similar to the flu,
• skin rash, red-purple spots, fever, itching (symptoms of vasculitis),
• 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,
• increased liver function values,
• low 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 can lead to fatigue, confusion, muscle spasms, and/or seizures in severe cases).

Hydrochlorothiazide

Very common, affecting more than 1 in 10 patients

• low potassium levels in the blood,
• increased levels of lipids in the blood.

Common, affecting more than 1 in 100 patients

• low sodium levels in the blood,
• low magnesium levels in the blood,
• high levels of uric acid in the blood,
• skin rash with itching and other types of rash,
• loss of appetite,
• mild vomiting and nausea,
• dizziness, vertigo when standing up,
• difficulty achieving or maintaining an erection.

Rare, affecting 1 in 10,000 patients

• swelling and blisters in the skin (due to increased sensitivity to the sun),
• high levels of calcium in the blood,
• high levels of sugar in the blood,
• sugar in the urine,
• emergence of diabetic metabolic state,
• constipation, diarrhea, stomach or intestinal discomfort, liver alterations that can occur with yellow discoloration of the 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, affecting less than 1 in 10,000 patients

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis),
• rash, itching, skin redness, difficulty breathing or swallowing, dizziness (hypersensitivity reactions),
• severe skin disease that produces rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis),
• skin rash, joint pain, muscle disorders, fever (lupus erythematosus),
• severe stomach pain (pancreatitis),
• difficulty breathing, with fever, cough, wheezing, shortness of breath (respiratory distress including pneumonitis and pulmonary edema),
• fever, sore throat, more frequent infections (agranulocytosis),
• paleness, fatigue, shortness of breath, dark urine (hemolytic anemia),
• fever, sore throat, or mouth ulcers due to infections (leucopenia),
• confusion, fatigue, muscle cramps, and spasms, rapid breathing (hypochloremic alkalosis).

Frequency not known, based on available data

• weakness, bruises, and frequent infections (aplastic anemia),
• severely reduced urine production (possible signs of kidney disorder or renal failure),
• decreased vision or eye pain due to high pressure (possible symptom of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or angle-closure glaucoma),
• rash, skin redness, blisters on the lips, eyes, or mouth, fever (possible symptom 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 theSistema Español de Farmacovigilancia de medicamentos de Uso Humano: http://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. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect it from moisture.

Do not use Valsartán/Hidroclorotiazida Sandoz if you observe that the packaging is damaged or shows signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment..

Composition ofValsartán /Hidroclorotiazida Sandoz

Valsartán/Hidroclorotiazida Sandoz 80 mg/12,5 mg

The active ingredients are valsartán and hidroclorotiazida. Each tablet contains 80 mg of valsartán and 12.5 mg of hidroclorotiazida.

The other components are:

Core

microcrystalline cellulose, crospovidone, magnesium stearate, and anhydrous colloidal silica.

Coating

hypromellose, macrogol 8000, talc, titanium dioxide (E171), iron oxide red (E172), and iron oxide yellow (E172).

Valsartán/Hidroclorotiazida Sandoz 160 mg/12,5 mg

The active ingredients are valsartán and hidroclorotiazida. Each tablet contains 160 mg of valsartán and 12.5 mg of hidroclorotiazida.

The other components are:

Core

microcrystalline cellulose, crospovidone, magnesium stearate, and anhydrous colloidal silica.

Coating

hypromellose, macrogol 8000, talc, titanium dioxide (E171), and iron oxide red (E172).

Valsartán/Hidroclorotiazida Sandoz 160 mg/25 mg

The active ingredients are valsartán and hidroclorotiazida. Each tablet contains 160 mg of valsartán and 25 mg of hidroclorotiazida.

The other components are:

Core

microcrystalline cellulose, crospovidone, magnesium stearate, and anhydrous colloidal silica.Coating

hypromellose, macrogol 4000, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172).

Valsartán/Hidroclorotiazida Sandoz 320 mg/12,5 mg

The active ingredients are valsartán and hidroclorotiazida. Each tablet contains 320 mg of valsartán and 12.5 mg of hidroclorotiazida.

The other components are:

Core

microcrystalline cellulose, crospovidone, magnesium stearate, and anhydrous colloidal silica.Coating

hypromellose, macrogol 4000, talc, titanium dioxide (E171), iron oxide red (E172), and iron oxide black (E172).

Valsartán/Hidroclorotiazida Sandoz 320 mg/25 mg

The active ingredients are valsartán and hidroclorotiazida. Each tablet contains 320 mg of valsartán and 25 mg of hidroclorotiazida.

The other components are:

Core

microcrystalline cellulose, crospovidone, magnesium stearate, and anhydrous colloidal silica.Coating

hypromellose, macrogol 4000, talc, titanium dioxide (E171), and iron oxide yellow (E172).

Appearance of the product and contents of the package

Valsartán/Hidroclorotiazida Sandoz 80 mg/12,5 mg

film-coated tablet, orange-yellow, oval, slightly convex, with the imprint (engraved) “HGH” on one side and “CG” on the other side.

Valsartán/Hidroclorotiazida Sandoz 160 mg/12,5 mg

film-coated tablet, dark red, oval, slightly convex, with the imprint (engraved) “HHH” on one side and “CG” on the other side.

Valsartán/Hidroclorotiazida Sandoz 160 mg/25 mg

film-coated tablet, dark orange, oval, slightly convex, with the imprint (engraved) “HXH” on one side and “NVR” on the other side.

Valsartán/Hidroclorotiazida Sandoz 320 mg/12,5 mg

film-coated tablet, pink, oval, with beveled edges, with the imprint (engraved) “NVR” on one side and “HIL” on the other side.

Valsartán/Hidroclorotiazida Sandoz 320 mg/25 mg

film-coated tablet, yellow, oval, with beveled edges, with the imprint (engraved) “NVR” on one side and “CTI” on the other side.

Package sizes:

They may contain 7, 10, 14, 15, 20, 28, 30, 50, 50x1, 56, 60, 84, 90, 98, 100, or 280 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Salutas Pharma GmbH

Ott-von-Guericke-allee 1,

39179 Barleben,

Germany

or

LEK S.A.

Ul. Domaniewska 50 C

02-672 Warszawa

Poland

or

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana,

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2D9220 Lendava

Slovenia

or

Sandoz S.R.L.

Str. Livezeni nr. 7A,

540472 Targu-Mures

Romania

or

LEK, S.A.

Ul Podlipie, 16

Strykow

PL95-010

Poland

or

NOVARTIS FARMA S.P.A.

Via Provinciale Schito 131

Torre Annunziata

80058 Italy

This medicinal product is authorized in themember states of the European Economic Area withthe following names:

Sweden: Valsartan/Hydrochlorothiazide Sandoz

Austria: Valsartan/HCTSandoz 80 mg/12,5 mg – Filmtabletten

Valsartan/HCTSandoz 160 mg/12,5 mg – Filmtabletten

Valsartan/HCTSandoz 160 mg/25 mg – Filmtabletten

Valsartan/HCTSandoz 320 mg/12,5 mg – Filmtabletten

Valsartan/HCTSandoz 320 mg/25 mg – Filmtabletten

Belgium: Co-Valsartan Sandoz 80 mg / 12,5 mg filmomhulde tabletten

Co-Valsartan Sandoz 160 mg / 12,5 mg filmomhulde tabletten

Co-Valsartan Sandoz 160 mg / 25 mg filmomhulde tabletten

Co-Valsartan Sandoz 320 mg / 12,5 mg filmomhulde tabletten

Co-Valsartan Sandoz 320 mg / 25 mg filmomhulde tabletten

Bulgaria: Suvartar H

Cyprus: Valsartan Hydrochlorothiazid Sandoz 80 mg/12,5 mg

Valsartan Hydrochlorothiazid Sandoz 160 mg/12,5 mg

Valsartan Hydrochlorothiazid Sandoz 160 mg/25 mg

Valsartan Hydrochlorothiazid Sandoz 320 mg/12,5 mg

Valsartan Hydrochlorothiazid Sandoz 320 mg/25 mg

Czech Republic: Valsartan/Hydrochlorothiazid Sandoz 80 mg/12,5 mg

Valsartan/Hydrochlorothiazid Sandoz 160 mg/12,5 mg

Valsartan/Hydrochlorothiazid Sandoz 160 mg/25 mg

Valsartan/Hydrochlorothiazid Sandoz 320 mg/12,5 mg

Valsartan/Hydrochlorothiazid Sandoz 320 mg/25 mg

Germany: ValsartanHCTSandoz 80 mg/12,5 mg Filmtabletten

ValsartanHCTSandoz 160 mg/12,5 mg Filmtabletten

ValsartanHCTSandoz 160 mg/25 mg Filmtabletten

ValsartanHCTSandoz 320 mg/12,5 mg Filmtabletten

ValsartanHCTSandoz 320 mg/25 mg Filmtabletten

Denmark: Valsartan Hydrochlorthiazid Sandoz

Estonia: ValsartanHCTSandoz 80 mg/12,5mg

ValsartanHCTSandoz 160 mg/12,5mg

ValsartanHCTSandoz 160 mg/25mg

ValsartanHCTSandoz 320 mg/12,5mg

ValsartanHCTSandoz 320 mg/25mg

Greece: ValsartanHCT/Sandoz

Spain: Valsartan Hidrocloritiazida Sandoz 80/12,5 mg comprimidos recubiertos con película EFG

Valsartan Hidrocloritiazida Sandoz 160/12,5 mg comprimidos recubiertos con película EFG

Valsartan Hidrocloritiazida Sandoz 160/25 mg comprimidos recubiertos con película EFG

Valsartan Hidrocloritiazida Sandoz 320/12,5 mg comprimidos recubiertos con película EFG

Valsartan Hidrocloritiazida Sandoz 320/25 mg comprimidos recubiertos con película EFG

Last revision date of this leaflet: February 2025

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