Prospect: Patient Information

Teva-ratiopharm Valsartan/Hydrochlorothiazide 160 mg/25 mg Film-Coated Tablets

valsartan/hydrochlorothiazide

Read this prospect carefully before starting to take this medicine, as 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 you must not give it to other people,

even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are

not listed in this prospect. 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 adverse effects

5.- Storage of Valsartan/Hydrochlorothiazide Teva-ratiopharm

6.- Contents of the package and additional information

Valsartán/Hidroclorotiazida Teva-ratiopharm 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 Teva-ratiopharm 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 Teva-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 are more than 3 months pregnant (it is better to avoid the use of Valsartán/Hidroclorotiazida Teva-ratiopharm during the first months of pregnancy, see section 2. Pregnancy and Breastfeeding)
• If you have a severe liver disease, destruction of small bile ducts 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 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 mellitus or kidney insufficiency and are being treated with a medication that lowers blood pressure containing aliskirén.

If any of these situations affect 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 taking potassium-sparing medications, potassium supplements, salt substitutes containing potassium or other medications that increase potassium levels in the blood, such as heparin. Your doctor may consider it necessary to regularly control potassium levels.
• If you have low levels of potassium in the 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 suffer from 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 suffer from renal artery stenosis.
• If you have recently undergone a kidney transplant.
• If you suffer from 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 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 when 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 (LES, a known autoimmune disease).
• If you have diabetes, gout, high levels of cholesterol or triglycerides in the blood.
• If you have previously had 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 vision loss or eye pain. This could be a symptom of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or an increase in pressure in your eyes and may occur from a few hours to weeks after taking Valsartán/Hidroclorotiazida. If not treated, 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 (hypertension)
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example, 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 Teva-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 regularly check your renal function, blood pressure and electrolyte levels (such as potassium) in the blood.

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

Valsartán/Hidroclorotiazida Teva-ratiopharm may cause increased sensitivity to the sun.

Inform your doctor if you are pregnant (or if you suspect you may be pregnant). Valsartán/Hidroclorotiazida Teva-ratiopharm is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from that moment on (see section “Pregnancy and Breastfeeding”).

Children and adolescents

Valsartán/Hidroclorotiazida Teva-ratiopharm is not recommended for use in children and adolescents (under 18 years old).

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/Hidroclorotiazida Teva-ratiopharm may be altered if taken with certain medications. It may be necessary to change the dose, take other precautions or, in some cases, discontinue treatment with one of the medications. This is especially applicable to the following medications:

• lithium, a medication used to treat certain types of mental disorders

psychiatric

• medications or substances that may increase potassium levels in the blood. These

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

• medications that may reduce potassium levels in the blood, such as diuretics, corticosteroids, laxatives, ACTH (a hormone), carbenoxolone, anfotericin, penicillin G, 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.

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

• medications that may reduce sodium levels in your blood, such as antidepressants, antipsychotics, antiepileptics.

• medications for treating gout, such as allopurinol, probenecid, sulfinpirazona.
• vitamin D therapy and calcium supplements.
• medications for treating diabetes (oral antidiabetic medications such as metformin or

insulins)

• other medications for lowering blood pressure, including methyldopa, angiotensin-converting enzyme inhibitors (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 norepinephrine or epinephrine
• digoxin or other digitalis glycosides (medications for treating cardiac problems).
• 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 >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 anesthetics), such as atropine or biperidina.

• amantadine (a medication used to treat Parkinson's disease and also used 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 for organ transplants, 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/Hidroclorotiazida Teva-ratiopharm 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

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

Pregnancy

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

Your doctor will usually recommend that you stop taking Valsartán/Hidroclorotiazida Teva-ratiopharm before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Valsartán/Hidroclorotiazida Teva-ratiopharm. Valsartán/Hidroclorotiazida Teva-ratiopharm is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from that moment on.

Breastfeeding

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

Valsartán/Hidroclorotiazida Teva-ratiopharm is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machines

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

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

Use in athletes:

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

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 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

morning.

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

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 make up 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 doubts about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious and require immediate medical attention:

• You should visit your doctor immediately if you notice symptoms of angioedema, such as:

• Swelling in the face, tongue, or throat
• Difficulty swallowing
• Hives 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 from the available data)

• Severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic skin necrosis)
• 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 (they 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 (they can 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
• Noises (e.g. ringing or buzzing) in the ears

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

• Dizziness
• Diarrhea
• Joint pain

Unknown frequency (cannot be estimated from the available data)

• Difficulty breathing
• Severe reduction in urine output
• Low sodium levels in the blood (which can cause fatigue, confusion, muscle cramps, 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)

High bilirubin levels in the blood (which, in severe cases, can cause the skin and eyes to turn yellow)

• High levels of urea nitrogen and creatinine in the blood (which can indicate abnormal kidney function)

• High levels of uric acid in the blood (which, in severe cases, can trigger a gout attack)

• Syncope (fainting)

The following side effects have been observed in medicines containing valsartan or hydrochlorothiazide separately:

Valsartan

Rare (they can affect up to 1 in 100 people)

- Dizziness

- Abdominal pain

Very rare (they 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 (cannot be estimated from the available data)

• Blisters on the skin (sign of bullous dermatitis)
• Rash on the skin 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 on the skin, red-purple spots, fever (signs of vasculitis)
• Rash, itching, hives, difficulty breathing or choking, dizziness (hypersensitivity reactions)

• Low platelet count (sometimes with bleeding or frequent bruising)
• High potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)

• 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
• Low hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, can cause anemia)

• Renal insufficiency
• Low sodium levels in the blood (which can cause fatigue, confusion, muscle cramps, and/or in severe cases, seizures)

Hydrochlorothiazide

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

- Low potassium levels in the blood

- Increased levels of lipids in the blood

Common (they 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 (they 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 changes that may occur with yellow skin or eyes

• Irregular heartbeat
• Headache
• Sleep disturbances
• Depression
• Low platelet count (sometimes with bleeding or frequent bruising)
• Dizziness
• Sensation of tingling or numbness
• Visual disturbances

Very rare (they 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, hives, difficulty breathing or choking, dizziness (hypersensitivity reactions)

• Rash, facial, associated with pain, muscle disorders, fever (lupus erythematosus)
• Severe 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 (leukopenia)
• Confusion, fatigue, pulmonary contractions, and spasms, rapid breathing (hypochloremic alkalosis)

• Lack or low levels of different blood cells

Unknown frequency (cannot be estimated from the 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 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 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.

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

Composition of Valsartán/Hidroclorotiazida Teva-ratiopharm

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

of valsartán and 25 mg of hidroclorotiazida.

?The other components are: anhydrous colloidal silica, sodium carboxymethyl starch from potato,

crospovidone, microcrystalline cellulose, cornstarch and magnesium stearate.

The coating contains: hypromellose, macrogol 8000, talc, titanium dioxide (E171),

red iron oxide (E172),black iron oxide (E172), yellow iron oxide (E172).

Appearance of Valsartán/Hidroclorotiazida Teva-ratiopharm and contents of the package

Coated tablets, round, brown, engraved with “93” on one face and with “7430” on the other face of the tablet.

The product is available in package sizes of 1, 14, 15, 28, 30, 50, 56, 60, 84, 90, 98 and 100 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

TEVA PHARMA S.L.U.

C/ Anabel Segura, 11

Edificio Albatros B, 1st floor

28108 Alcobendas (MADRID)

Responsible for manufacturing

Pharmachemie B.V.

Swensweg 5, Postbus 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 Operations Poland Sp. z o.o.,

Mogilska 80 Str.

31-546 Kraków

Poland

Last review date of this leaflet:March 2025

Detailed and updated information on this medication 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 medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71149/P_71149.html

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