Prospect: information for the user

Valsartán/Hidroclorotiazida Stadafarma 160 mg/25 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine,because 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 do not appear in this prospect. See section 4.

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

2. What you need to knowbeforestarting totake Valsartán/Hidroclorotiazida Stadafarma

3. How to take Valsartán/Hidroclorotiazida Stadafarma

4. Possible adverse effects

5. Storage of Valsartán/Hidroclorotiazida Stadafarma

6.Contents of the package and additional information

Valsartán/Hidroclorotiazida Stadafarma 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 Stadafarma

• if you are allergic (hypersensitive) to valsartán, hidroclorotiazida, sulfonamide derivatives (substances chemically 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 (it is also better to avoid the use of valsartán/hidroclorotiazida at the beginning of pregnancy – see Pregnancy section).
• if you have a severe liver disease, destruction of small bile ducts in the liver (biliary cirrhosis) leading to a buildup of bile in the liver (cholestasis).
• if you have a 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 blood pressure-lowering medication containing aliskirén.

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 Stadafarma

• if you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium or other medications that increase the amount of potassium in the blood, such as heparin. Your doctor may consider it necessary to regularly monitor 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 a 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 renal function.
• if you have a narrowing of the renal artery.
• if you have recently undergone a kidney transplant.
• if you have primary aldosteronism, 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 experience 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 lipids in your blood.
• if you have previously experienced an allergic reaction with the use of another medication of this class to lower 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 this if you have previously been allergic to penicillin or sulfonamides.
• if you are taking any of the following medications used to treat high blood pressure:

- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

- aliskirén

• 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 cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking valsartán/hidroclorotiazida.
• 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, seek medical attention immediately.

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

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.

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

Valsartán/hidroclorotiazida may cause increased sensitivity to the sun.

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

You should inform your doctor if you suspect you are pregnant (or may be). Valsartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Use in athletes

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

Taking Valsartán/Hidroclorotiazida Stadafarma 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 and/or take other precautions or, in some cases, discontinue treatment with 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 the amount of potassium in the blood, such as potassium supplements, salt substitutes containing potassium, potassium-sparing medications, heparin
• medications that may decrease the amount of potassium in the blood, such as diuretics (urine-producing medications), corticosteroids, laxatives, carbenoxolona, amfotericin, 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 antiarrhythmic medications (heart problem medications) and some antipsychotics.
• medications that may reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics

• medications used to treat gout, such as allopurinol, probenecid, sulfinpirazona
• therapeutic vitamin D and calcium supplements
• medications used to treat diabetes (oral antidiabetic medications such as metformin or insulin)
• other medications to lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskirén, (see also the information under the headings “Do not take Valsartán/Hidroclorotiazida Stadafarma” and “Warnings and precautions”
• medications that increase blood pressure, such as noradrenaline or adrenaline
• digoxin or other digitalis glycosides (medications used to treat heart problems)
• medications used to 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 tubocurarina
• anticholinergic medications, (medications used to treat a wide range of disorders such as gastrointestinal cramps, urinary tract spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia)
• amantadina (a medication used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses)
• colestiramina and colestipol (medications used to treat high levels of lipids in the blood)
• ciclosporina, a medication used to prevent organ rejection after transplantation
• 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)

Taking Valsartán/Hidroclorotiazida Stadafarma with food, drinks, and alcohol

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

• You should inform your doctor if you suspect you are pregnant (or may be)

Generally, your doctor will advise you to stop taking valsartán/hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of valsartán/hidroclorotiazida. Valsartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

• Inform your doctor if you are breastfeeding or planning to start

Valsartán/hidroclorotiazida is not recommended for use in breastfeeding mothers, and your doctor may choose another treatment for you if you wish to start breastfeeding, especially if your baby is newborn or premature.

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 how valsartán/hidroclorotiazida affects you. Like many other medications used to treat high blood pressure, valsartán/hidroclorotiazida may cause, in rare cases, dizziness and affect concentration.

Valsartán/Hidroclorotiazida Stadafarma contains sorbitol

80 mg/12.5 mg: This medication contains 9.25 mg of sorbitol per tablet.

160 mg/25 mg: This medication contains 18.5 mg of sorbitol per tablet.

Valsartán/Hidroclorotiazida Stadafarma contains sodium

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

Valsartán/Hidroclorotiazida Stadafarma contains lactose

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

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 adverse effects. If you are unsure, consult your doctor or pharmacist again.

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 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 Stadafarma than you should

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.

In case of overdose or accidental ingestion, 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 Stadafarma

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 dose.

If you interrupt treatment with Valsartán/Hidroclorotiazida Stadafarma

If you stop taking the medication, 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, valsartan/hydrochlorothiazide can cause side effects, although not everyone will experience them.

Some side effects may 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 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)

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:

Rare (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
• tingling or numbness
• blurred vision
• ringing in the ears (e.g. tinnitus or buzzing)

Very rare (may affect fewer than 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 (cannot be estimated from available data):

• difficulty breathing
• severe decrease in urine production
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or seizures)

• 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 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, may trigger a gout attack)
• syncope (fainting)

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

Valsartan

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

• feeling of spinning
• abdominal pain

Unknown frequency (cannot be estimated from available data):

• blistering skin (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 patches, 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)
• 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 red blood cell percentage 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 fasciculations, and/or seizures)

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
• loss of appetite
• mild vomiting and nausea
• dizziness, dizziness when standing up
• difficulty achieving or maintaining an erection

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

• skin swelling and blisters (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

Very rare (may affect fewer than 1 in 10,000 people):

• inflammation of blood vessels with symptoms such as skin rash, red-purple patches, fever (vasculitis)
• skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• skin 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, and spasms, rapid breathing (hypochloremic alkalosis)
• acute respiratory distress (the signs include severe difficulty breathing, fever, weakness, and confusion)

Unknown frequency (cannot be estimated from available data):

• weakness, bruising, and frequent infections (aplastic anemia)
• significant decrease in urine production (possible signs of renal impairment or renal 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 cancer and lip cancer (non-melanoma skin cancer)

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Do not useValsartán/Hidroclorotiazida Stadafarmaafter the expiration date that appears on the packaging and in the blister pack, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Store in the original packaging to protect it from moisture.

Do not useValsartán/Hidroclorotiazida Stadafarmaif 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 medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Valsartan/Hydrochlorothiazide Stadafarma

The active principles are valsartan and hydrochlorothiazide.

One tablet of Valsartan/Hydrochlorothiazide Stadafarma 160 mg/25 mg film-coated tablets contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.

The other components are:

Core tablet:microcrystalline cellulose, anhydrous colloidal silica, sorbitol (E-420), magnesium carbonate, pregelatinized cornstarch, povidone K-30, stearate fumarate and sodium, lauryl sulfate of sodium, crospovidone type A.

Film coating:monohydrate lactose, hypromellose, macrogol 4000, titanium dioxide (E 171), yellow iron oxide (E 172), brown iron oxide (E 172).

Appearance of the product and content of the container

Film-coated tablets.

Valsartan/Hydrochlorothiazide Stadafarma 160 mg/25 mg film-coated tablets: are brownish cylindrical and biconvex tablets.

The tablets are presented in containers of 14, 28, 30, 56, 98 and 280 tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern(Barcelona)

Spain

[email protected]

Responsible for manufacturing

CINFA Laboratories, S.A.

Olaz-Chipi, 10 - Areta Industrial Estate

31620 Huarte (Pamplona)

Spain

or

ZENTIVA k.s.

U. Kabelovny 130. 10237, Prague 10

Republic of Czech

or

Liconsa Laboratories, S.A.

Avda. Miralcampo, Nº 7, Miralcampo Industrial Estate

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet: February 2025

Detailed and updated information on this medication is available on the website of theSpanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/