Leaflet: information for the patient

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

Valsartán/Hidroclorotiazida Stada 160 mg/12,5 mg film-coated tablets

Valsartán/Hidroclorotiazida Stada 320 mg/12,5 mg film-coated tablets

Valsartán/Hidroclorotiazida Stada 160 mg/25 mg film-coated tablets

Valsartán/Hidroclorotiazida Stada 320 mg/25 mg film-coated tablets

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 give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Valsartán/Hidroclorotiazida Stada

3. How to take Valsartán/Hidroclorotiazida Stada

4. Possible side effects

5. Storage of Valsartán/Hidroclorotiazida Stada

6. Contents of the pack and additional information

Valsartán/Hidroclorotiazida Stada 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 take Valsartán/Hidroclorotiazida Stada

• 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 are more than 3 months pregnant.(In any case, it is better to avoid taking this medication also at the beginning of your pregnancy – see Pregnancy section)
• if you have severe liver diseaseorsmall bile duct destruction in the liver (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 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 aliskiren

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

Warnings and precautions

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

• if you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium or other medications that increase blood potassium levels, such as heparin. Your doctor may consider regularly controlling 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 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 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 have these symptoms when taking valsartán/hidroclorotiazida, stop taking it 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 (a known autoimmune disease)
• if you have diabetes, gout, high levels of cholesterol or triglycerides 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 effusion) or increased eye pressure, which can occur during a period of time ranging from several hours to several weeks 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.
• it may cause increased skin sensitivity to the sun
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The use of hidroclorotiazida, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking valsartán/hidroclorotiazida.
• if you are taking any of the following medications used to treat high blood pressure:

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

-aliskiren

• 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, see your doctor immediately.

If any of these situations apply to you, consult your doctor.

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 Stada”.

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.

Children and adolescents

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

If you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant, inform your doctor. 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. Valsartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy, as it may cause severe damage to your baby (see Pregnancy section).

Concomitant use of Valsartán/Hidroclorotiazida Stada 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 your 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 types of psychiatric diseases
• medications or substances that may increase blood potassium levels. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin
• medications that may decrease blood potassium levels, such as diuretics (urine-producing medications), corticosteroids, laxatives, carbenoxolone, amphotericin, 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
• medications that may induce “torsades de pointes” (irregular heartbeats), such as antiarrhythmics (heart problem medications) and some antipsychotics
• medications that may decrease blood sodium levels, such as antidepressants, antipsychotics, antiepileptics
• medications used to treat gout, such as allopurinol, probenecid, sulfinpirazona
• vitamin D therapy and calcium supplements
• medications used to treat diabetes (oral antidiabetic medications such as metformin or insulin)
• other medications to reduce blood pressure, including metildopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren
• medications that increase blood pressure, such as noradrenaline or adrenaline
• digoxin or other digitalis glycosides (heart problem medications)
• medications that may increase blood sugar levels, such as diazoxide or beta-blockers
• cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide
• pain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors and aspirin in doses above 3 g
• muscle relaxants, such as tubocurarine
• anticholinergic medications (medications used to treat a wide range of conditions such as gastrointestinal cramps, urinary tract spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia)
• amantadine (a medication used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses)
• colestiramine and colestipol (medications used primarily to treat high levels of lipids in the blood)
• ciclosporina, a medication used to prevent organ rejection after transplant
• alcohol, sleep medications, and anesthetics (medications with sedative or pain-relieving effects used, for example, in surgery)
• iodinated contrast media (used for diagnostic imaging tests)

Your doctor may need to modify your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Valsartán/Hidroclorotiazida Stada” and “Warnings and precautions”).

Concomitant use of Valsartán/Hidroclorotiazida Stada with food and beverages

You can take valsartán/hidroclorotiazida with or without food.

Avoid taking 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

If you are pregnant, breastfeeding, or suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

•You must inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become 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. Valsartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy, as it may cause severe damage to your baby when administered from that point on.

•Inform your doctor if you plan to start or are breastfeeding, as 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 machinery, or engaging in 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 may cause, in rare cases, dizziness and affect concentration.

Use in athletes

This medication contains hidroclorotiazida, which may produce a positive result in doping control tests.

Valsartán/Hidroclorotiazida Stada contains lactose and sodium

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

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

• The usual dose of valsartán/hidroclorotiazida is one tablet a day.
• Do not change the dose or interrupt the treatment without consulting your doctor.
• This medication should be taken at the same time every day, usually in the morning.
• You can take valsartán/hidroclorotiazida with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartán/Hidroclorotiazida Stada than you should

If you notice a strong dizziness and/or fainting, lie down and contact your doctor immediately.

If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.

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

If you forget to take Valsartán/Hidroclorotiazida Stada

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

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

If you interrupt the treatment with Valsartán/Hidroclorotiazida Stada

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 throat
• Difficulty swallowing
• Hives and difficulty breathing
• Severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)
• Decreased vision or eye pain due to high blood pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma)
• Fever, sore throat, increased frequency of infections (agranulocytosis)
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion)

These side 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 side effects include:

Uncommon (may affect up to 1 in 100 people):

• Cough
• Low blood pressure
• Dizziness
• Dehydration (with symptoms of thirst, dry mouth and tongue, reduced urine frequency, dark-colored urine, dry skin)
• Muscle pain
• Fatigue
• Tickling or numbness
• Blurred vision
• Ringing in the ears (e.g., tinnitus or buzzing)

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

• Dizziness
• Diarrhea
• Joint pain

Unknown frequency (cannot be estimated from available data):

• Difficulty breathing
• Severe reduction in urine production
• Low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle twitching, and/or convulsions)
• Low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• Low white blood cell count in the blood (with symptoms such as fever, skin infections, sore throat, or mouth ulcers due to infections, weakness)
• Increased bilirubin levels in the blood (which, in severe cases, may cause yellowing of the skin and eyes)
• 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, may trigger a gout attack)
• Syncope (fainting)

The following side effects have been observed with valsartan or hydrochlorothiazide-containing medicines separately

Valsartan

Uncommon (may affect up to 1 in 100 people):

• Vertigo
• Abdominal pain

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

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

Unknown frequency (cannot be estimated from available data):

• Blisters on the skin (sign of dermatitis bullosa)
• Rash with or without itching, along with one or more of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or flu-like symptoms
• Rash, red-purple spots, fever, itching (signs 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)
• Low sodium levels in the blood (sometimes with nausea, fatigue, confusion, general discomfort, convulsions)
• Allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• Swelling mainly of the face and throat; rash; itching
• Increased liver function values
• Decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may cause anemia)
• Renal insufficiency
• Low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle twitching, and/or convulsions)

Hydrochlorothiazide

Very common (may affect more than 1 in 10 people):

• Low potassium levels in the blood
• Increased lipid levels 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
• Rash with itching and other types of rash
• Loss of appetite
• Mild vomiting and 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 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 (sadness)
• 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 blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)
• Rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• Rash, joint pain, muscle pain, fever (lupus erythematosus)
• Severe stomach pain (pancreatitis)
• Difficulty breathing with fever, cough, wheezing, shortness of breath (difficulty breathing that includes pneumonitis and pulmonary edema)
• Pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)
• Fever, sore throat, or mouth ulcers due to infections (leukopenia)
• Confusion, fatigue, muscle cramps, spasms, rapid breathing (hypochloremic alkalosis)

Unknown frequency (cannot be estimated from available data):

• Weakness, bruises, and frequent infections (aplastic anemia)
• Significant reduction in urine production (possible signs of renal impairment or renal failure)
• 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 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 Pharmacovigilance 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. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

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

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Valsartan/Hydrochlorothiazide Stada

The active principles are:

• valsartan
• hydrochlorothiazide

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

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

320 mg/12.5 mg:Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.

160 mg/25 mg:Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.

320 mg/25 mg:Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.

The other components of the core are:

• Lactose monohydrate
• Powdered cellulose
• Hypromellose
• Sodium croscarmellose
• Anhydrous colloidal silica
• Magnesium stearate

The other components of the coating are:

80 mg/12.5 mg:

• Hypromellose
• Macrogol 8000
• Talc
• Titanium dioxide (E171)
• Iron oxide red (E172)

160 mg/12.5 mg:

• Hypromellose
• Macrogol 8000
• Talc
• Iron oxide red (E172)
• Iron oxide yellow (E172)
• Iron oxide black (E172)

320 mg/12.5 mg and 160 mg/25 mg:

• Hypromellose
• Macrogol 8000
• Talc
• Titanium dioxide (E171)
• Iron oxide red (E172)
• Iron oxide yellow (E172)
• Iron oxide black (E172)

320 mg/25 mg:

• Hypromellose
• Macrogol 8000
• Talc
• Titanium dioxide (E171)
• Iron oxide yellow (E172)

Appearance of the product and contents of the package

Valsartan/Hydrochlorothiazide Stada 80 mg/12.5 mg film-coated tabletsare oblong, biconvex, and pink.

Valsartan/Hydrochlorothiazide Stada 160 mg/12.5 mg film-coated tabletsare oblong, biconvex, and brown.

Valsartan/Hydrochlorothiazide Stada 320 mg/12.5 mg film-coated tabletsare oblong, biconvex, and pink.

Valsartan/Hydrochlorothiazide Stada 160 mg/25 mg film-coated tabletsare oblong, biconvex, and orange.

Valsartan/Hydrochlorothiazide Stada 320 mg/25 mg film-coated tabletsare oblong, biconvex, and yellow.

Valsartan/Hydrochlorothiazide Stada 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg: are presented in Al/PVC/PVDC blister packs with 10, 14, 28, 30, 50, 56, 90, 98, and 100 tablets.

Valsartan/Hydrochlorothiazide Stada 320 mg/12.5 mg, 320 mg/25 mg: are presented in Al/PVC/PVDC blister packs with 7, 10, 28, 30, 56, 90, 98, 126, 154, and 182 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

Eurogenerics N.V.

Heizel Esplanade Heysel b 22

B-1020 Brussels

Belgium

or

LAMP S. Prospero S.p.A.

Via della Pace, 25/A

I-41030 San Prospero (Modena)

Italy

or

STADA Arzneimittel AG

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

A-1190 Vienna

Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

AustriaValsartan HCT STADA Filmtabletten

BelgiumCo-Valsartan EG filmomhulde tabletten

BulgariaValsavil Comp ????????? ????????

DenmarkValsartore Comp

FinlandValsartore Comp tabletti, kalvopäällysteisen

GermanyValsartan/HCT STADA Filmtabletten

IrelandValtan Comp film-coated tablets

ItalyValsartan e Idroclorotiazide EG compresse rivestite con film

LuxembourgCo-Valsartan EG comprimés pelliculés

PortugalValsartan + Hidroclorotiazida Ciclum comprimidos revestidos

SpainValsartán/Hidroclorotiazida STADA comprimidos recubiertos con película EFG

SwedenValsartore Comp filmdragerade tabletter

NetherlandsValsartan/HCT CF, filmomhulde tabletten

Last revision date of this leaflet:February 2025

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