Package Insert: Information for the Patient

Valsartan/Hydrochlorothiazide Alter 160 mg/12.5 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Valsartán/Hidroclorotiazida Alter 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 Alter 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 renal insufficiency. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

Do not takeValsartan/Hydrochlorothiazide Alter

• If you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide), or any of the other components of this medication (listed in section 6).

• If you are more 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, destruction of small bile ducts in the liver (biliary cirrhosis) that leads to a buildup of bile in the liver (cholestasis).
• If you have a severe kidney disease.
• If you are unable to produce urine (anuria).
• If you are undergoing dialysis.
• If you have low levels of potassium or sodium in your blood, or if your calcium levels in your blood are higher than normal despite treatment.
• If you have gout.
• If you have diabetes or kidney insufficiency and are being treated with a medication to reduce blood pressure that contains aliskiren.

If any of these situations affect you, inform your doctor and do not take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsartan/Hydrochlorothiazide Alter:

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly 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 Valsartan/Hydrochlorothiazide Alter.
• 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 severe shortness of breath or difficulty breathing after taking Valsartan/Hydrochlorothiazide Alter, seek medical attention immediately.
• If you are using 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 regular monitoring of 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 renal function.
• If you have renal artery stenosis.
• If you have recently undergone a kidney transplant.
• If you have primary aldosteronism, a condition 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 angioedema, a type of allergic reaction characterized by swelling of the tongue and face, when taking other medications (including ACE inhibitors), inform your doctor. If you experience these symptoms when taking valsartan/hydrochlorothiazide, discontinue treatment immediately and never take it again. See also section 4 “Possible side effects”.
• If you have fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (a known autoimmune disease).
• If you have diabetes, gout, high levels of cholesterol or triglycerides in your blood.
• If you have previously experienced an allergic reaction with the use of another medication in this class to lower blood pressure (angiotensin II receptor antagonists), or if you have any type of allergy or asthma.
• If you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased eye pressure, which can occur within several hours to a week after taking valsartan/hydrochlorothiazide. If left untreated, this can lead to permanent vision loss. You may be at higher risk of developing this if you have had an allergy to penicillin or sulfonamides in the past.
• 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
  • Aliskiren

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Valsartan/Hydrochlorothiazide Alter.Your doctor will decide whether to continue treatment. Do not stop taking Valsartan/Hydrochlorothiazide Alter in monotherapy.

Your doctor may 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 Valsartan/Hydrochlorothiazide Alter”.

Valsartan/hydrochlorothiazide may increase your skin's sensitivity to the sun.

This medication is not recommended for use in children and adolescents (under 18 years old).

If you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant, inform your doctor. Valsartan/hydrochlorothiazide is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy, as it may cause serious harm to your baby (see section “Pregnancy and breastfeeding”).

Taking Valsartan/Hydrochlorothiazide Alter with other medications

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

The effect of treatment with valsartan/hydrochlorothiazide may be altered if taken with certain medications. You may need to change the dose, take additional 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 psychiatric disorders
• Medications or substances that can increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin
• Medications that can decrease potassium levels in the blood, such as diuretics (medications to urinate), corticosteroids, laxatives, carboxolona, amfotericin, or penicillin G
• Some antibiotics (in the rifampicin group), a medication used to protect against rejection in a transplant (ciclosporina), or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of valsartan/hydrochlorothiazide
• Medications that can induce “torsades de pointes” (irregular heartbeats), such as antiarrhythmics (medications used to treat heart problems) and some antipsychotics
• Medications that can decrease sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics
• Medications used to treat gout, such as allopurinol, probenecid, sulfinpirazona
• Vitamin D therapy and calcium supplements
• Medications used to treat diabetes (insulin or oral antidiabetic medications such as metformin)
• Other medications to lower blood pressure, including metildopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also the information under the headings “Do not take Valsartan/Hydrochlorothiazide Alter” and “Warnings and precautions”)
• 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
• Pain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors and aspirin in doses above 3 g
• Muscle relaxants, such as tubocurarine
• Anticholinergic medications (medications used to treat a wide range of disorders, such as gastrointestinal cramps, urinary tract spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia)
• Amantadine (a medication used to treat Parkinson's disease and also 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 to prevent organ rejection after transplantation
• Alcohol, sleep medications, and anesthetics (medications with sedative or pain-relieving effects used, for example, in surgery)
• Iodinated contrast media (used for diagnostic imaging tests).

Taking Valsartan/Hydrochlorothiazide Alter with food, drinks, and alcohol

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 or pharmacist before using this medication.

• You must inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant.Generally, your doctor will advise you to stop taking valsartan/hydrochlorothiazide before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Valsartan/hydrochlorothiazide is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that point on.

• Inform your doctor if you plan to start or are breastfeedingsince valsartan/hydrochlorothiazide is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for 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 how you react to the effects of valsartan/hydrochlorothiazide. Like many other medications used to treat high blood pressure, valsartan/hydrochlorothiazide may cause, in rare cases, dizziness and affect concentration.

Use in athletes

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

Always take this medication exactly as your doctor tells you to. This will help you get the best results and reduce the risk of side effects. If you are unsure, consult your doctor or pharmacist again.

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

Your doctor will tell you exactly how many tablets of valsartán/hidroclorotiazida you should take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

• The recommended dose of valsartán/hidroclorotiazida is one tablet per day.
• Do not change the dose or stop treatment without consulting your doctor.
• This medication should be taken at the same time every day, usually in the morning.
• You can take valsartán/hidroclorotiazida with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartán/Hidroclorotiazida Alter 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 Alter

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 Alter

If you stop taking valsartán/hidroclorotiazida, 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.

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.
• 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 blood pressure (possible signs of acute angle-closure glaucoma)
• Fever, sore throat, increased frequency of infections (agranulocytosis).

These side effects are very rare (can affect up to 1 in 10,000 people) or of unknown frequency (frequency cannot be estimated from available data).

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

Other side effects include:

Rare (can affect up to 1 in 10 people)

• Cough
• Low blood pressure
• Dizziness
• Dehydration (with symptoms of thirst, dry mouth and tongue, reduced urine frequency, dark urine, dry skin)
• Muscle pain
• Fatigue
• Tickling or numbness
• Blurred vision
• Noises (e.g. ringing or buzzing) in the ears

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

• Dizziness
• Diarrhea
• Joint pain

Unknown frequency (frequency cannot be estimated from available data)

• Difficulty breathing
• Severe decrease in urine production
• 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 in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
• Increased bilirubin levels in the blood (which, in severe cases, can cause the skin and eyes to turn yellow)
• Increased levels of urea nitrogen and creatinine in the blood (which may indicate abnormal kidney function)
• Increased 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 with valsartan or hydrochlorothiazide-containing medicines separately:

Valsartan

Rare (can affect up to 1 in 100 people)

• Vertigo
• 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 (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, hives, difficulty breathing or swallowing, dizziness)
• Swelling mainly of the face and throat; rash; itching
• Increased 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, in severe cases, can cause fatigue, confusion, muscle twitching, and/or convulsions).

Hydrochlorothiazide

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

• Low potassium levels in the blood
• Increased levels of 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 diabetic metabolic state
• Constipation, diarrhea, stomach or intestinal discomfort, liver alterations that may appear with jaundice and yellowing of the skin and eyes
• Irregular heartbeat
• Headache
• Sleep disturbances
• Depression
• 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 the blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)
• Rash, itching, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• Rash, joint pain, muscle disorders, fever (lupus erythematosus)
• Severe stomach pain (pancreatitis)
• Difficulty breathing with fever, cough, wheezing, shortness of breath (difficulty breathing that includes pneumonitis and pulmonary edema)
• Pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia)
• Fever, sore throat, or mouth ulcers due to infections (leukopenia)
• Confusion, fatigue, muscle twitching, and spasms, rapid breathing (hypochloremic alkalosis)
• Acute respiratory distress (the signs include severe difficulty breathing, fever, weakness, and confusion)

Unknown frequency (frequency cannot be estimated from available data)

• Skin cancer and lip cancer (non-melanoma skin cancer)
• 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)
• Weakness, bruises, and frequent infections (aplastic anemia)
• Significant decrease in urine production (possible signs of renal impairment 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)

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 Usehttps://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 after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment

Composition of Valsartan/Hidroclorotiazida Alter

• The active principles are valsartan and hidroclorotiazida. Each tablet contains 160 mg of valsartan and 12.5 mg of hidroclorotiazida.
• The other components are: microcrystalline cellulose, polyvinylpyrrolidone, crospovidone, anhydrous colloidal silica, and magnesium stearate.
• The tablet coating contains hypromellose, titanium dioxide (E171), triacetin, iron oxide red (E172), and iron oxide yellow (E172).

Appearance of the product and contents of the packaging

Round, biconvex, unnotched, dark pink tablets.

The tablets are presented in blister packs containing 28 tablets.

Marketing Authorization Holder

Laboratorios Alter S.A.

C/Mateo Inurria 30

28036 Madrid

Spain

Responsible for Manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

or

Pharmex Advanced Laboratories, S.L.

Ctra. A-431, Km. 19

14720 Almodóvar del Río, Córdoba

Spain

Last review date of this leaflet: February 2025.

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