VALSARTAN/HYDROCHLOROTHIAZIDE STADA 320 mg/12.5 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the patient

Valsartan/Hydrochlorothiazide Stada 80 mg/12.5 mg film-coated tablets EFG

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

Valsartan/Hydrochlorothiazide Stada 320 mg/12.5 mg film-coated tablets EFG

Valsartan/Hydrochlorothiazide Stada 160 mg/25 mg film-coated tablets EFG

Valsartan/Hydrochlorothiazide Stada 320 mg/25 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Valsartan/Hydrochlorothiazide Stada and what is it used for
2. What you need to know before taking Valsartan/Hydrochlorothiazide Stada
3. How to take Valsartan/Hydrochlorothiazide Stada
4. Possible side effects
5. Storage of Valsartan/Hydrochlorothiazide Stada
6. Package contents and additional information

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

Valsartan/Hydrochlorothiazide Stada film-coated tablets contain two active ingredients known as valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartan belongs 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 narrow, increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazide belongs to a class of medications known as thiazide diuretics. Hydrochlorothiazide increases diuresis, which also decreases blood pressure.

Valsartan/hydrochlorothiazide is used to treat high blood pressure that is not adequately controlled with the use of a single component.

Hypertension increases the load on the heart and arteries. If left untreated, it can damage the blood vessels of the brain, heart, and kidneys and can lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal values reduces the risk of developing these disorders.

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

DO NOT take Valsartan/Hydrochlorothiazide Stada

• if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related to hydrochlorothiazide), or any of the other components of this medication (listed in section 6)
• if you are pregnant for more than 3 months.(In any case, it is best to avoid taking this medication also at the beginning of your pregnancy – see section Pregnancy)
• if you have severe liver disease, destruction of the small bile ducts in the liver (biliary cirrhosis) that leads to an accumulation of bile 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 low potassium or sodium levels 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 failure and are being treated with a medication to lower 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 Valsartan/Hydrochlorothiazide Stada.

• if you are using potassium-sparing medications, potassium supplements, salt substitutes that contain potassium, or other medications that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly monitor your potassium levels.
• if you have low potassium levels 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 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 medications (including ACE inhibitors), inform your doctor. If you have these symptoms when taking valsartan/hydrochlorothiazide, stop treatment immediately and never take it again. See also section 4 "Possible side effects".
• if you have fever, rash, and joint pain, which can be signs of systemic lupus erythematosus (a known autoimmune disease).
• if you have diabetes, gout, high cholesterol or triglyceride levels in your blood.
• if you have previously had an allergic reaction with the use of another medication 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 an increase in eye pressure and can occur during a period of time that ranges from several hours to several weeks after taking valsartan/hydrochlorothiazide. If left untreated, this can lead to permanent vision loss. You may be more likely to develop it if you have previously had an allergy to penicillin or sulfonamides.
• 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. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking valsartan/hydrochlorothiazide.
• if you are taking any of the following medications used to treat high blood pressure (high blood pressure):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have diabetes-related kidney problems
• aliskiren
  • if you have had respiratory or pulmonary 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, seek medical attention immediately.

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

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

See also the information under the heading "Do not take Valsartan/Hydrochlorothiazide Stada".

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

Children and adolescents

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

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. Valsartan/hydrochlorothiazide is not recommended during the first trimester of pregnancy (first 3 months) and should not be taken after the third month of pregnancy as it may cause serious harm to your baby (see section Pregnancy).

Taking Valsartan/Hydrochlorothiazide Stada with other medications

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

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

• lithium, a medication used to treat certain psychiatric disorders
• medications or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin
• medications that can decrease the amount of potassium in the blood, such as diuretics (medications to urinate), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G
• certain antibiotics (from the rifampicin group), a medication used to protect against transplant rejection (cyclosporine), or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of valsartan/hydrochlorothiazide
• medications that can induce "torsades de pointes" (irregular heartbeats), such as anti-arrhythmics (medications used to treat heart problems) and some antipsychotics
• medications that can reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics
• medications to treat gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic vitamin D and calcium supplements
• medications to treat diabetes (oral antidiabetics such as metformin or insulin)
• other medications to lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren
• medications that increase blood pressure, such as norepinephrine or epinephrine
• digoxin or other digitalis glycosides (medications used to treat heart problems)
• medications that can increase blood sugar levels, such as diazoxide or beta-blockers
• cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide
• medications for pain, such as non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid in doses greater than 3 g
• muscle relaxants, such as tubocurarine
• anticholinergic medications (medications used to treat a wide range of disorders, such as gastrointestinal cramps, bladder 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 viral diseases)
• cholestyramine and colestipol (medications primarily used to treat high lipid levels in the blood)
• cyclosporine, a medication used to prevent organ transplant rejection
• alcohol, sleeping medications, and anesthetics (medications with a sedative effect or for pain used, for example, in surgery)
• iodinated contrast media (used in diagnostic imaging tests)

It may be necessary for your doctor 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 Valsartan/Hydrochlorothiazide Stada" and "Warnings and precautions").

Taking Valsartan/Hydrochlorothiazide Stada with food and drinks

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 possibility of dizziness and weakness.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

• You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking valsartan/hydrochlorothiazide before becoming pregnant or as soon as you become pregnant, and will recommend taking another antihypertensive medication instead. Valsartan/hydrochlorothiazide is not recommended during the first trimester of pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby.

• Inform your doctor if you are about to start or are breastfeeding, as valsartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially newborns or premature babies.

Driving and using machines

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

Use in athletes

This medication contains hydrochlorothiazide, which can produce a positive result in doping tests.

Valsartan/Hydrochlorothiazide Stada contains lactose and sodium

If your doctor has told you that you have an 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".

3. How to take Valsartan/Hydrochlorothiazide Stada

Follow your doctor's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again.

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

Your doctor will indicate exactly how many valsartan/hydrochlorothiazide tablets you should 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 medication 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 Stada than you should

If you notice 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Valsartan/Hydrochlorothiazide Stada

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 missed doses.

If you stop taking Valsartan/Hydrochlorothiazide Stada

If you stop your treatment with valsartan/hydrochlorothiazide, your hypertension 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.

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)
• 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)
• Acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

These adverse effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop taking valsartan/hydrochlorothiazideand contact your doctor immediately (see also section 2 "Warnings and Precautions").

Other 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 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

Frequency not known (cannot be estimated from the available data):

• breathing difficulties
• severe decrease in diuresis
• low sodium levels in the blood (which, in severe cases, can 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 (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)
• fainting (syncope)

The following adverse effects have been observed with medicines containing 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 with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Frequency not known (cannot be estimated from the available data):

• blistering of the skin (sign of bullous dermatitis)
• skin rash with or without itching along with some 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)
• low sodium levels in the blood (sometimes with nausea, fatigue, confusion, general discomfort, convulsions)
• 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 and 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 twitching, 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
• mild nausea and vomiting
• dizziness, dizziness when standing up
• inability to achieve or maintain an erection

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

• swelling and blistering of 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 along 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 the blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• facial rash, 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)
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fever, sore throat, or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, muscle twitching, and spasms, rapid breathing (hypochloremic alkalosis)

Frequency not known (cannot be estimated from the available data):

• weakness, bruising, and frequent infections (aplastic anemia)
• significant decrease in urine production (possible signs of kidney disorder 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 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 leaflet. 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 Stada

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

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

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. 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 Stada

The active ingredients 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 ingredients of the core are:

• Lactose monohydrate
• Microcrystalline cellulose
• Hypromellose
• Sodium croscarmellose
• Colloidal anhydrous silica
• Magnesium stearate

The other ingredients of the coating are:

80 mg/12.5 mg:

• Hypromellose
• Macrogol 8000
• Talc
• Titanium dioxide (E171)
• Red iron oxide (E172)

160 mg/12.5 mg:

• Hypromellose
• Macrogol 8000
• Talc
• Red iron oxide (E172)
• Yellow iron oxide (E172)
• Black iron oxide (E172)

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

• Hypromellose
• Macrogol 8000
• Talc
• Titanium dioxide (E171)
• Red iron oxide (E172)
• Yellow iron oxide (E172)
• Black iron oxide (E172)

320 mg/25 mg:

• Hypromellose
• Macrogol 8000
• Talc
• Titanium dioxide (E171)
• Yellow iron oxide (E172)

Appearance of the Product and Package Contents

Valsartan/Hydrochlorothiazide Stada 80 mg/12.5 mg film-coated tablets EFG are oblong, biconvex, and pink in color.

Valsartan/Hydrochlorothiazide Stada 160 mg/12.5 mg film-coated tablets EFG are oblong, biconvex, and brown in color.

Valsartan/Hydrochlorothiazide Stada 320 mg/12.5 mg film-coated tablets EFG are oblong, biconvex, and pink in color.

Valsartan/Hydrochlorothiazide Stada 160 mg/25 mg film-coated tablets EFG are oblong, biconvex, and orange in color.

Valsartan/Hydrochlorothiazide Stada 320 mg/25 mg film-coated tablets EFG are oblong, biconvex, and yellow in color.

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

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

Not all pack sizes may be marketed.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

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

Austria Valsartan HCT STADA Filmtabletten

Belgium Co-Valsartan EG film-coated tablets

Bulgaria Valsavil Comp ????????? ????????

Denmark Valsartore Comp

Finland Valsartore Comp film-coated tablets

Germany Valsartan/HCT STADA Filmtabletten

Ireland Valtan Comp film-coated tablets

Italy Valsartan and Hydrochlorothiazide EG film-coated tablets

Luxembourg Co-Valsartan EG film-coated tablets

Portugal Valsartan + Hydrochlorothiazide Ciclum film-coated tablets

Spain Valsartan/Hydrochlorothiazide STADA film-coated tablets EFG

Sweden Valsartore Comp film-coated tablets

Netherlands Valsartan/HCT CF, film-coated tablets

Date of the last revision of this leaflet:February 2025

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