Prospecto: Information for the User

Valsartan/HydrochlorothiazideTeva-ratiopharm160 mg/12.5 mg Film-Coated Tablets

Read this prospectus carefully before starting to take this medicine because

it contains important information for you.

???????Keep this prospectus, as you may need to read it again.

???????If you have any questions, consult your doctor or pharmacist.

???????This medicine has been prescribed for you only and should not be given to other people,

even if they havethe 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 prospectus. See section 4.

1. What is Valsartan/Hydrochlorothiazide Teva-ratiopharm and for what it is used

2. What you need to know before starting to take Valsartan/Hydrochlorothiazide Teva-ratiopharm

3. How to take Valsartan/Hydrochlorothiazide Teva-ratiopharm

4. Possible side effects

5. Storage of Valsartan/Hydrochlorothiazide Teva-ratiopharm

6. Contents of the pack and additional information

Valsartán/HidroclorotiazidaTeva-ratiopharmfilm-coated tablets contain two active ingredients known as valsartán and hidroclorotiazida.

These components help to control high blood pressure (hypertension).

???????Valsartánbelongs to a class of medications known as “angiotensin II receptor antagonists” that help to control high blood pressure.

Angiotensin II is a substance in the body that causes blood vessels to constrict, resulting in an increase in 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 urine production, which also decreases blood pressure.

Valsartán/HidroclorotiazidaTeva-ratiopharmis used to treat high blood pressure that is not adequately controlled with the use of a single component.

High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys and can 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 conditions.

Do not take Valsartán/HidroclorotiazidaTeva-ratiopharm

• If you are allergic to valsartan, hidroclorotiazida, sulfonamide derivatives (substances

chemically related to hidroclorotiazida) or to any of the other

components of this medication (listed in section 6).

• If you aremore than 3 months pregnant. (In any case, it is better to avoid taking this

medication also at the beginning of your pregnancy, see section “Pregnancy and Breastfeeding”.

• If you have a severe liver disease,small bile duct destruction in the liver (biliary cirrhosis) leading to bile accumulation 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 low levels of potassium or sodium in your blood, or if your blood calcium levels are higher than normal despite treatment.

Caution is also advised in patients with a history of kidney disease or liver disease.

• If you have gout.
• If you have diabetes mellitus or kidney insufficiency and are being treated with a medication

that lowers blood pressure containing aliskirén.

If any of these situations apply to you, inform your doctor and do not take Valsartán/Hidroclorotiazida.

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.

Warnings and precautions

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

• 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 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 severe heart disease.
• If you have heart failure or have had a heart attack. Follow your doctor's instructions carefully when starting treatment. Your doctor may also check 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/HidroclorotiazidaTeva-ratiopharmis not recommended.
• If you have kidney or liver disease.
• If you have ever experienced swelling of the tongue and face, caused by an allergic reaction called angioedema when taking another medication (including ACE inhibitors), tell your doctor. If these symptoms occur while you are taking Valsartán/Hidroclorotiazida, stop taking Valsartán/Hidroclorotiazida immediately and do not take it again. See 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 experienced an allergic reaction with the use of another medication of this class to lower blood pressure (angiotensin II receptor antagonists), or if

you suffer from any type of allergy or asthma.

• If you experience a decrease in vision or eye pain. This could be a symptom of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in your eyes and can occur from a few hours to weeks after taking Valsartán/Hidroclorotiazida. If left untreated, it can lead to vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at a higher risk of developing this.

• 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.

• If you have had skin cancer or if a skin lesion appears unexpectedly 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 sun exposure and UV rays while taking Valsartán/HidroclorotiazidaTeva-ratiopharm.
• If you have experienced respiratory or pulmonary problems (including inflammation or fluid in the lungs) after ingesting hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking this medication, seek medical attention immediately.

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

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

Valsartán/HidroclorotiazidaTeva-ratiopharmmay cause increased sensitivity to the sun.

If you are pregnant, if you suspect you may be, or ifyou plan to becomepregnant, you must inform your doctor. Valsartán/HidroclorotiazidaTeva-ratiopharmis not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy because it may cause serious harm to your baby (see section “Pregnancy and Breastfeeding”).

Children and adolescents

Valsartán/HidroclorotiazidaTeva-ratiopharmis not recommended for use in children and adolescents (under 18 years).

Use in athletes

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

Taking Valsartán/Hidroclorotiazida with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The effect of treatment with Valsartán/HidroclorotiazidaTeva-ratiopharmmay be altered if taken with certain medications. You may need to change the dose, 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 disorders,

psychiatric disorders,

• medications or substances that may increase the amount of potassium in your blood. These

include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, heparin,

• medications that may reduce the amount of potassium in your blood, such as diuretics,

corticosteroids, laxatives, ACTH (a hormone), carbenoxolona, anfotericina, penicillin G, and salicylic acid and derivatives.

• some antibiotics (rifampicin group), a medication used to protect against transplant rejection (ciclosporina) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Valsartán/Hidroclorotiazida,

Valsartán/Hidroclorotiazida,

• medications that may induce “torsades de pointes” (irregular heart rhythm), such as antiarrhythmics, (medications used to treat heart problems) and

some antipsychotics,

• medications that may reduce the amount of sodium in your blood, such as antidepressants, antipsychotics, and antiepileptics,

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

insulins),

• other medications used 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” 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 that may increase blood sugar levels, such as diazoxide or beta blockers,

• medications used to treat cancer, such as methotrexate or cyclophosphamide,

cyclophosphamide,

• pain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including

selective COX-2 inhibitors and aspirin (>3g),

• muscle relaxants, such as tubocurarine,
• anticholinergic medications (medications used to treat a variety of disorders such as

gastrointestinal cramps, urinary tract spasms, asthma, dizziness, muscle spasms, Parkinson's disease, and anesthetic assistants), such as atropine or biperidina.

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

viruses),

• colestiramine and colestipol (medications used primarily to treat high levels of lipids in the blood),
• ciclosporina, a medication used for organ transplantation, to prevent organ rejection.
• alcohol, sleep medications, and anesthetics (medications used, for example, during surgery),
• contrast agents with iodine (agents used for imaging tests).

Valsartán/HidroclorotiazidaTeva-ratiopharmwith food, drinks, and alcohol

You can take Valsartán/HidroclorotiazidaTeva-ratiopharmwith or without food.

Avoid drinking 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 before using this medication.

Pregnancy

• You must inform your doctor if you are pregnant, if you suspect you may be, or if you plan to become

pregnant.

Generally, your doctor will advise you to stop takingValsartán/HidroclorotiazidaTeva-ratiopharmbefore becoming pregnant or as soon as you become

pregnant, and recommend taking another antihypertensive medication instead. Valsartán/HidroclorotiazidaTeva-ratiopharmis not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to your baby when administered from that point on.

Breastfeeding

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

Not recommended to administer Valsartán/HidroclorotiazidaTeva-ratiopharmto women during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in 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/HidroclorotiazidaTeva-ratiopharm. Like many other medications used to treat high blood pressure, Valsartán/HidroclorotiazidaTeva-ratiopharmmay cause, in rare cases, dizziness and affect concentration.

Valsartán/HidroclorotiazidaTeva-ratiopharmcontains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. This will help you achieve the best results and reduce the risk of adverse effects. 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 tell you exactly how many tablets of Valsartán/Hidroclorotiazida Teva-ratiopharm 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 Teva-ratiopharm 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 mornings.

You can take Valsartán/Hidroclorotiazida Teva-ratiopharm with or without food.

Swallow the tablet with a glass of water.

If you take more Valsartán/Hidroclorotiazida Teva-ratiopharm than you should

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

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

If you forget to take Valsartán/Hidroclorotiazida Teva-ratiopharm

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

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

If you interrupt treatment with Valsartán/Hidroclorotiazida Teva-ratiopharm

If you stop taking Valsartán/Hidroclorotiazida Teva-ratiopharm, 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.

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
• Urticaria and difficulty breathing

• 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)

The frequency of these side effects is “unknown” (the frequency cannot be estimated based on available data)

• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion)
• Severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)
• Fever, sore throat, increased frequency of infections (agranulocytosis)

These side effects are very rare (can affect up to 1 in 10,000 people)

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

Other side effects include:

Rare(can affect up to 1 in 100 people)

?Cough

?Low blood pressure

?Dehydration (with symptoms of thirst, dry mouth and tongue, reduced urine frequency, dark urine, dry skin)

?Muscle pain

?Fatigue

?Tickling or numbness

?Blurred vision

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

Very rare(can affect up to 1 in 10,000 people)

?Dizziness

?Diarhea

?Joint pain

Unknown frequency(the frequency cannot be estimated from available data)

?Difficulty breathing

?Severe reduction in diuresis

?Low sodium levels in the blood (which can lead to fatigue, confusion, muscle pain, and/or in severe cases, seizures)

?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 can indicate abnormal kidney function)

?Increased uric acid levels in the blood (which, in severe cases, can trigger a gout attack)

?Syncope (fainting)

Side effects observed with valsartan or hydrochlorothiazide alone, but not with Valsartán/Hidroclorotiazida Teva-ratiopharm:

Valsartan

Rare(can affect up to 1 in 100 people)

?Sensation of rotation

?Abdominal pain

Very rare (can affect up to 1 in 10,000 people)

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

Unknown frequency (the frequency cannot be estimated from available data)

?Blisters on the skin (sign of bullous dermatitis)

?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

?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 rash, itching, urticaria, difficulty breathing or swallowing, dizziness)

?Swelling mainly of the face and throat; rash; itching

?Elevation of liver function values

?Decreased 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 pain, and/or in severe cases, seizures)

Hydrochlorothiazide

Very common(can affect more than 1 in 10 people)

?Low potassium levels in the blood

?Increased lipids in the blood

Common(can 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(can 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 metabolic diabetes.

?Constipation, diarrhea, stomach or intestinal discomfort, liver alterations that may occur with yellow skin or eyes

?Irregular heartbeat

?Headache

?Sleep disturbances

?Depression (sadness)

?Low platelet count (sometimes with bleeding or bruising under the skin)

?Dizziness

?Tickling or numbness

?Visual disturbances

Very rare(can affect up to 1 in 10,000 people)

?Inflammation of blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)

?Rash, itching, urticaria, difficulty breathing or swallowing, dizziness (allergic reactions)

?Rash, facial pain, muscle disorders, fever (lupus erythematosus), severe upper stomach pain (pancreatitis)

?Difficulty breathing, with fever, cough, difficulty swallowing, dyspnea (respiratory difficulty including pneumonia and pulmonary edema)

?Pale skin, fatigue, dyspnea, dark urine (hemolytic anemia)

?Fever, sore throat, or mouth ulcers due to infections (leucopenia)

?Confusion, fatigue, pulmonary contractions, and spasms, rapid breathing (hypochloremic alkalosis)

?Lack or low levels of different blood cells

Unknown frequency(the frequency cannot be estimated from available data)

?Weakness, bruises, and frequent infections (aplastic anemia)

?Severe reduction in urine output (possible sign of renal disorders 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 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 prospectus. 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 and blister after CAD. The expiration date is the last day of the month indicated.

?Do not store at a temperature above 30°C.

?Do not use Valsartán/Hidroclorotiazida Teva-ratiopharm 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. Dispose of the packaging and medications that you no longer need at the SIGRE collection point of your usual pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Valsartán/Hidroclorotiazida Teva-ratiopharm

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

of valsartán and 12.5 mg of hidroclorotiazida.

?The other components are: Anhydrous colloidal silica, sodium starch glycolate (type A),

Crospovidona, Microcrystalline cellulose, Cornstarch, Magnesium stearate

?The coating of the tablet contains: Hypromellose, Macrogol, Talc, Titanium dioxide (E171), Iron oxide red (E172), Iron oxide yellow (E172)

Appearance of the product and contents of the package

?The coated tablets of Valsartán/HidroclorotiazidaTeva-ratiopharm160 mg/12.5 mg are

round, convex, red, 9.5 mm in diameter, with the inscription “VH” on one side.

?The tablets are presented in blister packs with 14, 28, 30, 56, 60, 84, 98 and 100

tablets.

Hospital pack: 56, 98 and 280 coated tablets.

You may only find some package sizes commercially available.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid (Spain)

Responsible for manufacturing

TEVA UK Ltd

Brampton Road, Hampden Park,

Eastbourne, East Sussex, BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5, P.O. Box 552, 2003 RN Haarlem

Netherlands

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

TEVA Czech Industries s.r.o.

Ostravská 29, c.p. 305, 747 70 Opava –Komárov

Czech Republic

TEVA Pharma, S.L. U.

C/C nº 4, Industrial Estate Malpica, 50016 Zaragoza,

Spain

Teva Pharmaceutical Works Private Limited Company

Táncsics Mihály út 82

Gödöllö H-2100

Hungary

Teva Operations Poland Sp. z o.o.,

Mogilska 80 Str.

31-546 Kraków

Poland

Last review date of this leaflet: March 2025

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

You can access detailed and updated information on this medicine by scanning with your smartphone the QR code included in the packaging. You can also access this information on the following internet address: https://cima.aemps.es/cima/dochtml/p/73989/P_73989.html

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