Valsartan/hydrochlorothiazide Alter 160 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

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

• Keep this leaflet as 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 may 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 this leaflet

1. What Valsartan/Hydrochlorothiazide Alter is and what it is used for
2. What you need to know before taking Valsartan/Hydrochlorothiazide Alter
3. How to take Valsartan/Hydrochlorothiazide Alter
4. Possible side effects
5. How to store Valsartan/Hydrochlorothiazide Alter
6. Contents of the pack and other information

1. What Valsartán/Hidroclorotiazida Alter is and what it is used for

Valsartán/Hidroclorotiazida Alter 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, leading to 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 urine production, which also lowers blood pressure.

Valsartán/Hidroclorotiazida Alter is used to treat high blood pressure that is not adequately controlled with a single component alone.

Hypertension increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure 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 Alter

Do not take Valsartán/Hidroclorotiazida Alter

• if you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide), or any of the other ingredients of this medicine (listed in section 6).

• if you are more than 3 months pregnant (in any case, it is better to avoid taking this medicine also during the early stages of pregnancy – see section “Pregnancy and breastfeeding”).

• if you have severe liver disease, destruction of the small bile ducts in the liver (biliary cirrhosis) leading to 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 are higher than normal despite treatment.

• if you have gout.

• if you have diabetes or renal insufficiency 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 this medicine.

Warnings and precautions

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

• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Valsartán/Hidroclorotiazida Alter.
• if you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Valsartán/Hidroclorotiazida Alter, seek medical attention immediately.
• if you are using potassium-sparing medications, potassium supplements, potassium-containing salt substitutes, or other medicines that increase blood potassium levels, such as heparin. Your doctor may consider it necessary to monitor your potassium levels regularly.
• 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 monitor your kidney function.
• if you have 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, valsartan/hydrochlorothiazide 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 other medicines (including ACE inhibitors), inform your doctor. If you experience these symptoms while taking valsartan/hydrochlorothiazide, stop 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, or high cholesterol or triglyceride levels in your 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 loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within several hours to one week after taking valsartan/hydrochlorothiazide. If untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulphonamides.
• if you are taking any of the following medicines used to treat high blood pressure:
  • an angiotensin-converting enzyme inhibitor (ACEI) (e.g., 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 Valsartán/Hidroclorotiazida Alter. Your doctor will decide whether to continue treatment. Do not stop taking Valsartán/Hidroclorotiazida Alter as monotherapy.

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 Alter”.

Valsartán/hydrochlorothiazide may cause increased skin sensitivity to sunlight.

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

If you are pregnant, suspect you might be pregnant, or plan to become pregnant, you must inform your doctor. The use of valsartán/hydrochlorothiazide is not recommended during the first trimester of pregnancy (first 3 months) and must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby (see section “Pregnancy and breastfeeding”).

Taking Valsartán/Hidroclorotiazida Alter with other medicines

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

The effect of treatment with valsartán/hydrochlorothiazide may be altered if 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 particularly relevant for the following medicines:

• lithium, a medicine used to treat certain psychiatric conditions
• 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 decrease blood potassium levels, such as diuretics (medicines to increase urine production), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G
• certain antibiotics (rifampicin group), a drug used to prevent transplant rejection (cyclosporine), or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may enhance the effect of valsartán/hydrochlorothiazide
• medicines that may induce "torsades de pointes" (irregular heartbeats), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics
• medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic vitamin D and calcium supplements
• medicines for diabetes (insulin or oral antidiabetics such as metformin)
• other blood pressure-lowering medicines, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also information under the headings “Do not take Valsartán/Hidroclorotiazida Alter” and “Warnings and precautions”)
• medicines that may 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 at doses exceeding 3 g
• muscle relaxants, such as tubocurarine
• anticholinergic medicines (medicines used to treat a wide range of disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, travel sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia)
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases)
• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels)
• cyclosporine, a medicine used to prevent rejection of transplanted organs
• alcohol, sleeping medicines, and anesthetics (medicines with sedative or pain-relieving effects used, for example, during surgery)
• iodinated contrast agents (used in diagnostic imaging procedures).

Taking Valsartán/Hidroclorotiazida 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 likelihood of dizziness and weakness.

Pregnancy and breastfeeding

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

• You must inform your doctor if you are pregnant, suspect you might be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking valsartan/hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Valsartan/hydrochlorothiazide is not recommended during early pregnancy and must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

• Inform your doctor if you are planning to start or are currently breastfeeding, as valsartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, operating machinery, or engaging in other activities requiring concentration, ensure you are aware of how valsartan/hydrochlorothiazide affects you. Like many other medicines used to treat high blood pressure, valsartan/hydrochlorothiazide may rarely cause dizziness and affect your ability to concentrate.

Use in athletes

This medicine contains hydrochlorothiazide, which may result in a positive doping test.

3. How to take Valsartán/Hidroclorotiazida Alter

Always take this medicine exactly as your doctor has told you. 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 experience any symptoms; many feel completely normal. For this reason, it is very important to attend your doctor's appointments regularly, even if you feel well.

Your doctor will tell you exactly how many tablets of valsartan/hydrochlorothiazide 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 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 each day, usually in the morning.
• You may take valsartan/hydrochlorothiazide 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine 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 your next dose, skip the missed dose.

Do not take a double dose to make up for forgotten doses.

If you stop taking Valsartán/Hidroclorotiazida Alter

If you stop treatment with valsartan/hydrochlorothiazide, your high blood pressure may worsen. Do not stop taking the medicine unless instructed by your doctor.

If you have any further 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 pharynx

• difficulty swallowing

• urticaria and difficulty breathing.

• Serious skin disease causing skin rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)

• Decreased vision or eye pain due to high pressure (possible signs of acute angle-closure glaucoma)

• Fever, sore throat, increased frequency of infections (agranulocytosis).

These adverse effects are very rare (may 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 adverse effects include:

Uncommon (may affect up to 1 in 10 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 (frequency cannot be estimated from available data)

• difficulty breathing
• severe decrease in urine output
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations and/or seizures)
• low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, irregular heartbeat)
• 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, may cause yellowing of the skin and eyes)
• increased blood urea nitrogen and creatinine levels (which may indicate abnormal kidney function)
• increased uric acid levels in the blood (which, in severe cases, may trigger an attack of gout)
• 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 presenting symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Frequency not known (frequency cannot be estimated from 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 inflammation of blood vessels)
• low platelet count (sometimes with increased bleeding or bruising)
• high potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
• allergic reactions (with symptoms such as skin rash, itching, urticaria, 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, in severe cases, may cause fatigue, confusion, muscle fasciculations and/or seizures).

Hydrochlorothiazide

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

• low potassium levels in the blood
• increased blood lipid levels

Common (may affect up to 1 in 10 people)

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• itchy rash and other types of skin rash
• decreased appetite
• mild vomiting and nausea
• dizziness, dizziness upon standing
• inability to achieve or maintain an 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 the blood
• high blood sugar levels
• sugar in the urine
• worsening of diabetic metabolic state
• constipation, diarrhea, stomach or intestinal discomfort, liver disorders which may occur together with yellowing of the skin and eyes
• irregular heartbeat
• headache
• sleep disturbances
• sadness (depression)
• low platelet count (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• vision disturbances

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

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• rash, itching, urticaria, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• severe pain in the upper abdomen (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (breathing difficulty including pneumonitis and pulmonary edema)
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fever, sore throat or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, muscle twitching and cramps, rapid breathing (hypochloremic alkalosis)
• acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion)

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

• skin and lip cancer (non-melanoma skin cancer)
• decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• weakness, bruising and frequent infections (aplastic anemia)
• marked decrease in urine production (possible signs of kidney dysfunction or kidney failure)
• skin rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle cramps
• fever (pyrexia)
• weakness (asthenia)

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 Valsartan/Hydrochlorothiazide Alter

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

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

Do not store above 30°C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartan/Hydrochlorothiazide Alter

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

Appearance of the product and contents of the pack

Round, biconvex, film-coated tablets without a break line, pink in colour.

The tablets are supplied in blister packs containing 28 tablets.

Marketing Authorization Holder

Laboratorios Alter S.A.
C/Mateo Inurria 30
28036 Madrid
Spain

Manufacturer

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

Date of the most recent revision of this package leaflet: February 2025.

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