Valsartan/hydrochlorothiazide Alter 320 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Valsartan/Hydrochlorothiazide Alter 320mg/12.5mg film-coated tablets EFG

Read the entire 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.

Leaflet contents

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 adverse effects
5. How to store Valsartan/Hydrochlorothiazide Alter

Pack contents 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 either 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 also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these complications.

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 to any of the other components 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 early pregnancy – see section “Pregnancy and breastfeeding”)
• if you have severe liver disease, destruction of the small bile ducts in the liver (primary 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 the blood, or if your blood calcium levels remain high despite treatment
• if you have gout
• if you have diabetes 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 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 taking potassium-sparing agents, potassium supplements, salt substitutes containing potassium, or other medicines that increase blood potassium levels, such as heparin. Your doctor may consider regular monitoring of potassium levels necessary.
• 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 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 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 loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within several hours to one week after taking valsartan/hydrochlorothiazide. If left untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergic reaction to penicillin or sulphonamides.
• 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

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 without medical advice.

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

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

Valsartan/hydrochlorothiazide may increase skin sensitivity to sunlight.

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

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, inform your doctor. The use of valsartan/hydrochlorothiazide is not recommended during early pregnancy (first 3 months) and must not be used from the third month of pregnancy onward, as it may cause severe 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 medicines.

The effect of treatment with valsartan/hydrochlorothiazide 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 particularly important 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 agents, and heparin
• medicines that may decrease blood potassium levels, such as diuretics (medicines that 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 increase the effect of valsartan/hydrochlorothiazide
• medicines that may cause “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 used to treat 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 above 3 g
• muscle relaxants, such as tubocurarine
• anticholinergic medicines (used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion 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 infections)
• 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 media (used in diagnostic imaging procedures)

Taking Valsartán/Hidroclorotiazida Alter with food, drinks, and alcohol

Avoid consuming 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 may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking valsartan/hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive treatment. Valsartan/hydrochlorothiazide is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause severe harm to your baby when used from that time.
• Inform your doctor if you plan to start or are currently breastfeeding, as valsartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may choose a more suitable treatment if you wish to breastfeed, especially if the infant is a newborn or premature.

Driving and using machines

Before driving, operating tools, handling 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 concentration ability.

Use in athletes

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

3. How to take Valsartán/Hidroclorotiazida Alter

Always take this medicine exactly as your doctor has instructed you. Doing so 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 noticeable symptoms and may feel perfectly normal. For this reason, it is very important to keep your scheduled appointments with your doctor, even if you feel well.

Your doctor will tell you exactly how many valsartan/hydrochlorothiazide tablets you should take. Depending on how you respond to treatment, your doctor may decide to adjust your dose upward or downward.

• 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 immediately and contact your doctor right away.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Valsartán/Hidroclorotiazida Alter

If you miss 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 a missed dose.

If you stop taking Valsartán/Hidroclorotiazida Alter

If you discontinue treatment with valsartan/hydrochlorothiazide, your hypertension may worsen. Do not stop taking the medicine unless your doctor tells you to do so.

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 everybody gets 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

• hives and difficulty breathing

• Serious skin disease causing rash, redness of the skin, blisters on lips, eyes or mouth, skin peeling, fever (toxic skin 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 frequency not known (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-coloured urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• noises (e.g. ringing or buzzing) in the ears

Very rare (may affect less than 1 in 10,000 people)

• dizziness
• diarrhoea
• 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 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 presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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 blood vessel inflammation)
• low platelet count (sometimes with bleeding or bruising more frequently than usual)
• high potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
• 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 cause 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, diarrhoea, stomach or intestinal discomfort, liver disorders which may occur 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, hives, 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-coloured urine (haemolytic anaemia)
• fever, sore throat or mouth ulcers due to infections (leucopenia)
• confusion, fatigue, muscle twitching and cramps, rapid breathing (hypochloraemic alkalosis)
• acute respiratory difficulty (signs include severe breathing difficulty, 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 anaemia)
• marked decrease in urine production (possible signs of kidney impairment or kidney failure)
• skin rash, redness of the skin, blisters on 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 is the last day of the month indicated.

Do not store above 30°C. Store 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 collection point at your pharmacy. If you are unsure, 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 Valsartan/Hydrochlorothiazide Alter

• The active substances are valsartan and hydrochlorothiazide. Each tablet contains 320 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, red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the medicinal product and contents of the pack

Oblong, film-coated tablets without a break line, yellowish-brown in colour.

The tablets are presented 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 leaflet: February 2025

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