Valsartan/hydrochlorothiazide Teva-Ratiopharm 160 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Valsartan/Hydrochlorothiazide Teva-ratiopharm 160 mg/25 mg film-coated tablets EFG

valsartan/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people,

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

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

adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

3.- How to take Valsartan/Hydrochlorothiazide Teva-ratiopharm

4.- Possible side effects

5.- How to store Valsartan/Hydrochlorothiazide Teva-ratiopharm

6.- Contents of the pack and other information

1. What Valsartán/Hidroclorotiazida Teva-ratiopharm is and what it is used for

Valsartán/Hidroclorotiazida Teva-ratiopharm film-coated tablets contain two active substances known as valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists” which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, resulting in increased 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 medicines known as thiazide diuretics. Hydrochlorothiazide increases diuresis, which also lowers blood pressure.

Valsartán/Hidroclorotiazida Teva-ratiopharm is used to treat high blood pressure that is not adequately controlled with either component used alone.

Hypertension increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. What you need to know before taking Valsartán/Hidroclorotiazida Teva-ratiopharm

Do not take Valsartán/Hidroclorotiazida Teva-ratiopharm

• If you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant (it is also advisable to avoid the use of Valsartán/Hidroclorotiazida Teva-ratiopharm during the first months of pregnancy; see section 2. Pregnancy and Breastfeeding)
• If you have severe liver disease, destruction of the small bile ducts in the liver (primary biliary cirrhosis), or bile accumulation in the liver (cholestasis)
• If you have severe kidney disease
• If you are unable to produce urine (anuria)
• If you are undergoing dialysis
• If you have abnormally low levels of potassium or sodium in your blood, or if your blood calcium levels remain high despite treatment
• If you have gout
• If you have diabetes mellitus or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren

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

Talk to your doctor or pharmacist before taking Valsartán/Hidroclorotiazida

• If you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium, or other medicines that increase blood potassium levels, such as heparin. Your doctor may consider regular monitoring of your potassium levels.

• If you have low blood potassium levels.

• 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 kidney function.

• If you have narrowing of the artery supplying the kidney (renal artery stenosis).

• If you have recently undergone a kidney transplant.

• If you have hyperaldosteronism, a condition 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 previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), tell your doctor. If these symptoms occur while you are taking Valsartán/Hidroclorotiazida, stop taking it 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 (SLE, a known autoimmune disease).

• If you have diabetes, gout, high cholesterol, or high triglyceride levels in the blood.

• If you have previously had an allergic reaction to another medicine of this class used to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.

• If you experience vision changes or eye pain. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from hours to weeks after taking Valsartán/Hidroclorotiazida. If untreated, this may lead to vision loss. If you have previously been allergic to penicillin or sulphonamides, you may be at higher risk of developing this condition.

• If you are taking any of the following medicines used to treat hypertension (high blood pressure):

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

• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Valsartán/Hidroclorotiazida Teva-ratiopharm.

• If you have experienced breathing or lung problems (including lung inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop severe shortness of breath or difficulty breathing after taking this medicine, seek immediate medical attention.

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

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

Valsartán/Hidroclorotiazida Teva-ratiopharm may increase skin sensitivity to sunlight.

Inform your doctor if you are pregnant (or suspect you might be). Valsartán/Hidroclorotiazida Teva-ratiopharm is not recommended during early pregnancy, and must not be used after the third month of pregnancy, as it may cause serious harm to your baby when taken from that point onward (see section “Pregnancy and Breastfeeding”).

Children and adolescents

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

Taking Valsartán/Hidroclorotiazida with other medicines

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

The effect of treatment with Valsartán/Hidroclorotiazida Teva-ratiopharm may be altered when taken together with certain medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases, discontinue treatment with one of the medicines. This is especially important for the following medicines:

• lithium, a medicine used to treat certain psychiatric disorders
• medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin
• medicines that may reduce blood potassium levels, such as diuretics, corticosteroids, laxatives, ACTH (a hormone), carbenoxolone, amphotericin, penicillin G, salicylic acid and its derivatives
• certain antibiotics (rifamycin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartán/Hidroclorotiazida
• medicines that may cause “torsades de pointes” (an irregular heart rhythm), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics
• medicines that may reduce sodium levels in your blood, such as antidepressants, antipsychotics, and antiepileptics
• medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic vitamin D and calcium supplements
• medicines used to treat diabetes (oral antidiabetics such as metformin or insulin)
• other medicines used to lower blood pressure, including methyldopa, angiotensin-converting enzyme inhibitors (ACE inhibitors) (such as enalapril, lisinopril, etc.) or aliskiren (see also information under the headings “Do not take Valsartán/Hidroclorotiazida” and “Warnings and precautions”)
• medicines that increase blood pressure, such as noradrenaline or adrenaline
• digoxin or other digitalis glycosides (medicines used to treat heart problems)
• medicines that may increase blood sugar levels, such as diazoxide or beta-blockers
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide
• pain medicines such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) and acetylsalicylic acid >3 g
• muscle relaxants, such as tubocurarine
• anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, dizziness, muscle spasms, Parkinson’s disease, and as anesthetic aids), such as atropine or biperiden
• amantadine (a medicine used to treat Parkinson’s disease and also used to treat or prevent certain viral infections)
• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels)
• cyclosporine, a medicine used in organ transplantation to prevent organ rejection
• alcohol, sleeping medicines, and anesthetics (medicines used to induce sleep or relieve pain, e.g., during surgery)
• iodinated contrast media (agents used in imaging procedures)

Valsartán/Hidroclorotiazida Teva-ratiopharm with food, drinks, and alcohol

You may take Valsartán/Hidroclorotiazida with or without food.

Avoid alcohol until you have discussed it with 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, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

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

Your doctor will usually advise you to stop taking Valsartán/Hidroclorotiazida Teva-ratiopharm before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Valsartán/Hidroclorotiazida Teva-ratiopharm is not recommended during early pregnancy, and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when taken from that point.

Breastfeeding

• Inform your doctor if you are breastfeeding or plan to breastfeed.

The use of Valsartán/Hidroclorotiazida Teva-ratiopharm is not recommended during breastfeeding. Your doctor will choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Before driving, operating tools, handling machinery, or engaging in other activities requiring concentration, make sure you are aware of how Valsartán/Hidroclorotiazida Teva-ratiopharm affects you. Like many other medicines used to treat high blood pressure, Valsartán/Hidroclorotiazida Teva-ratiopharm may rarely cause dizziness and affect your ability to concentrate.

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

Use in athletes:

This medicine contains hydrochlorothiazide, which may lead to a positive result in doping tests.

3. How to take Valsartan/Hydrochlorothiazide Teva-ratiopharm

Follow exactly your doctor's instructions on how to take this medicine. This will help you achieve the best results and reduce the risk of side effects. If in doubt, consult your doctor or pharmacist again.

People with high blood pressure often do not notice any signs of the condition. Many feel perfectly normal. Therefore, it is very important to keep your doctor's appointments, 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 Valsartan/Hydrochlorothiazide Teva-ratiopharm is one tablet per day.
• Do not change the dose or stop treatment without consulting your doctor.
• This medicine should be taken at the same time every day, usually in the morning.
• You may take Valsartan/Hydrochlorothiazide Teva-ratiopharm with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan/Hydrochlorothiazide 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 may also contact the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartan/Hydrochlorothiazide Teva-ratiopharm

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 forgotten doses.

If you stop taking Valsartan/Hydrochlorothiazide Teva-ratiopharm

If you stop treatment with Valsartan/Hydrochlorothiazide Teva-ratiopharm, your high blood pressure may worsen. Do not stop taking the medicine unless your doctor tells you to.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Some adverse effects may be serious and require immediate medical attention:

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

• swelling of the face, tongue or throat

• difficulty swallowing

• hives and difficulty breathing.

• reduced 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)

The frequency of these adverse effects is "not known" (frequency cannot be estimated from the available data).

• serious skin disease causing rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (toxic skin necrolysis)
• fever, sore throat, increased frequency of infections (agranulocytosis)
• acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion)

These adverse effects are very rare (may affect up to 1 in 10,000 people).

If you experience any of these symptoms, stop taking Valsartan/Hydrochlorothiazide and 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 frequency of

urination, dark-colored urine, dry skin)

• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• noises (e.g. ringing or buzzing) in the ears

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

• dizziness
• diarrhea
• joint pain

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

• difficulty breathing
• severe decrease in urine output
• low sodium levels in the blood (which may trigger fatigue, confusion, muscle twitching

and/or, in severe cases, seizures)

• low potassium levels in the blood (sometimes with muscle weakness, muscle cramps,

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 blood (which, in severe cases, may cause yellowing of the

skin and eyes)

• increased blood urea nitrogen and creatinine levels (which may indicate abnormal

kidney function)

• increased blood uric acid levels (which, in severe cases, may trigger a gout attack)

• syncope (fainting)

The following adverse effects have been observed with medicines containing valsartan or hydrochlorothiazide separately:

Valsartan

Uncommon (may affect up to 1 in 100 people)

• sensation of spinning
• abdominal pain

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

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

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

• blisters on the skin (sign of bullous dermatitis)
• skin rash with or without itching, together with one or more of the following signs or symptoms:

fever, joint pain, muscle pain, swollen lymph nodes

and/or flu-like symptoms

• skin rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)

• low platelet count (sometimes with more frequent bleeding or bruising than usual)

• high potassium levels in blood (sometimes with muscle cramps, 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

• elevated liver function test values

• decreased hemoglobin levels and reduced percentage of red blood cells in the

blood (which, in severe cases, may lead to anemia)

• renal failure
• low sodium levels in the blood (which may trigger fatigue, confusion, muscle twitching

and/or, in severe cases, seizures)

Hydrochlorothiazide

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

• low potassium levels in blood
• increased blood lipid levels

Common (may affect up to 1 in 10 people)

• low sodium levels in blood
• low magnesium levels in blood
• high uric acid levels in blood
• itchy rash and other types of skin rash
• loss of appetite
• mild vomiting and nausea
• dizziness, dizziness upon standing
• inability to achieve or maintain erection

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

• swelling and blisters on the skin (due to increased sensitivity to sunlight)
• high calcium levels in blood
• high blood sugar levels
• sugar in urine
• worsening of metabolic diabetes
• constipation, diarrhea, stomach or intestinal discomfort, liver disorders which

may occur along with yellowing of the skin or eyes

• irregular heartbeat
• headache
• sleep disturbances
• sadness (depression)
• low platelet count (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness sensation
• vision disturbances

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

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)

• rash, itching, hives, difficulty breathing or choking, dizziness (hypersensitivity reactions)

• facial rash associated with pain, muscle disorders, fever (lupus erythematosus)

• severe pain in the upper abdomen (pancreatitis)

• difficulty breathing, with fever, cough, difficulty swallowing, dyspnea (breathing difficulty including pneumonia and pulmonary edema)

• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia)

• fever, sore throat or ulcers due to infections (leucopenia)

• confusion, fatigue, pulmonary contractions and spasms, rapid breathing (hypochloremic alkalosis)

• absence or low levels of various blood cells

Not known (cannot be estimated from the available data)

• weakness, bruising and frequent infections (aplastic anemia)

• severe reduction in urine output (possible sign of kidney disorders or kidney failure)

  • rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)

• muscle spasm

• 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 they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartán/Hidroclorotiazida Teva-ratiopharm

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Do not use Valsartán/Hidroclorotiazida Teva-ratiopharm if you notice that the packaging is damaged or shows signs of deterioration.

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your usual pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán/Hidroclorotiazida Teva-ratiopharm

• The active substances are valsartan and hydrochlorothiazide. Each tablet contains 160 mg
of valsartan and 25 mg of hydrochlorothiazide.

• The other components are: anhydrous colloidal silica, sodium potato starch glycolate,
crospovidone, microcrystalline cellulose, corn starch 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 pack

Film-coated tablets, round, brown, engraved with "93" on one side and "7430" on the other side of the tablet.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder

TEVA PHARMA S.L.U.
C/ Anabel Segura, 11
Edificio Albatros B, 1st floor
28108 Alcobendas (MADRID)
Spain

Manufacturer

Pharmachemie B.V.
Swensweg 5, Postbus 552
2003 RN Haarlem
The 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

Date of the most recent revision of this leaflet: March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71149/P_71149.html

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