VALSARTAN HYDROCHLOROTHIAZIDE ALTER 160 mg/12.5 mg FILM-COATED TABLETS

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. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Valsartan/Hydrochlorothiazide Alter and what is it used for

Valsartan/Hydrochlorothiazide Alter film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartanbelongs to a class of medicines 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 narrow, leading to an increase in blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazidebelongs to a class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also decreases blood pressure.

Valsartan/Hydrochlorothiazide Alter is used to treat high blood pressure that is not adequately controlled with the use of a single component.

High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead to a 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 disorders.

2. What you need to know before you take Valsartan/Hydrochlorothiazide Alter

Do not takeValsartan/Hydrochlorothiazide Alter

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

• if you are pregnant more than 3 months(in any case, it is better to avoid taking this medicine also at the beginning of your pregnancy – see section “Pregnancy and breast-feeding”).
• if you have severe liver disease, destruction of the small bile ducts in the liver (biliary cirrhosis) leading to a buildup of bile 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 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 kidney impairment and are being treated with a medicine to reduce blood pressure that contains aliskiren.

If any of these situations apply to you, tell your doctor and do not take this medicine.

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. Treatment with hydrochlorothiazide, in particular its long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Valsartan/Hydrochlorothiazide Alter.
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Valsartan/Hydrochlorothiazide Alter, see your doctor immediately.
• if you are using potassium-sparing medications, potassium supplements, salt substitutes that contain potassium, or other medications that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly monitor your potassium levels.
• if you have low levels of potassium 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 a narrowing of the kidney artery.
• if you have recently undergone a kidney transplant.
• if you have hyperaldosteronism, a disease 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 swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACE inhibitors), inform your doctor. If you have these symptoms when taking valsartan/hydrochlorothiazide, stop treatment with valsartan/hydrochlorothiazide immediately and never take it again. See also section 4 “Possible side effects”.
• if you have fever, rash, and joint pain, which may be signs of systemic lupus erythematosus (a known autoimmune disease).
• if you have diabetes, gout, high cholesterol or triglyceride levels in your blood.
• if you have previously had an allergic reaction with the use of another medicine in this class to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.
• if you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and may occur during a period of time ranging from 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 it if you have previously been allergic to penicillin or sulfonamides.
• if you are taking any of the following medications used to treat high blood pressure (high blood pressure):
• • an angiotensin-converting enzyme inhibitor (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 on your own.

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

See also the information under the heading “Do not take Valsartan/Hydrochlorothiazide Alter”.

Valsartan/hydrochlorothiazide may cause increased sensitivity of the skin to the sun.

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

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• You must tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.Your doctor will normally advise you to stop taking valsartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine to lower your blood pressure instead. It is not recommended to use valsartan/hydrochlorothiazide at the start of pregnancy (first 3 months) and in no case should it be administered from the third month of pregnancy onwards as it may cause serious harm to your baby when administered from this time on.

• Tell your doctor if you are about to start or are already breast-feedingas it is not recommended to administer valsartan/hydrochlorothiazide to women during this period. Your doctor may decide to administer a treatment that is more suitable if you want to breast-feed, especially to newborns or premature babies.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or performing other activities that require concentration, make sure you know how you react to the effects of valsartan/hydrochlorothiazide. Like many other medicines used to treat high blood pressure, valsartan/hydrochlorothiazide can cause dizziness and affect your ability to concentrate.

Use in athletes

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

3. How to take Valsartan/Hydrochlorothiazide Alter

Always take this medicine exactly as your doctor has told you. This will help you to get the best results and reduce the risk of side effects. If you are not sure, ask your doctor or pharmacist.

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 Valsartan/Hydrochlorothiazide Alter tablets to 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 every day, usually in the morning.
• You can take valsartan/hydrochlorothiazide with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan/Hydrochlorothiazide Alter than you should

If you notice a strong 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Valsartan/Hydrochlorothiazide 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 Valsartan/Hydrochlorothiazide Alter

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

If you have any further questions on 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 all people suffer from them.

Some adverse 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 pharynx
• 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 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 (the frequency cannot be estimated from the 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 urination frequency, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• noises (e.g., ringing or buzzing) in the ears

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

• dizziness
• diarrhea
• joint pain

Unknown frequency (the frequency cannot be estimated from the available data)

• breathing difficulties
• severe decrease in diuresis
• low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle fasciculation, and/or convulsions)
• low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• low white blood cell count (with symptoms such as fever, skin infections, sore throat, or mouth ulcers due to infections, weakness)
• increased bilirubin levels in the blood (which, in severe cases, can cause yellowing of the skin and eyes)
• increased urea and creatinine levels in the blood (which may indicate abnormal kidney function)
• increased uric acid levels in the blood (which, in severe cases, can 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)

• feeling of rotation
• abdominal pain

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

• intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown frequency (the frequency cannot be estimated from the available data)

• skin blisters (sign of bullous dermatitis)
• skin rash with or without itching along with some of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, 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 spasms, 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
• elevation of liver function values
• decrease in hemoglobin levels and reduction of red blood cell percentage in the blood (which, in severe cases, can cause anemia)
• renal failure
• low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle fasciculation, and/or convulsions).

Hydrochlorothiazide

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

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

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
• skin rash with itching and other types of rash
• decreased appetite
• mild vomiting and nausea
• dizziness, dizziness when standing up
• 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 sun sensitivity)
• high calcium levels in the blood
• high sugar levels in the blood
• sugar in the urine
• worsening of diabetic metabolic state
• constipation, diarrhea, stomach or intestinal discomfort, liver disorders that may appear along 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)

• blood vessel inflammation with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• rash on the face, joint pain, muscle disorders, fever (lupus erythematosus)
• severe pain in the upper abdomen (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (breathing difficulties 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 spasms, rapid breathing (hypochloremic alkalosis)
• acute breathing difficulties (signs include severe breathing difficulties, fever, weakness, and confusion)

Unknown frequency (the frequency cannot be estimated from the available data)

• skin and lip cancer (non-melanoma skin cancer)
• decreased 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)
• weakness, bruising, and frequent infections (aplastic anemia)
• significant decrease in urine production (possible signs of kidney disorder or kidney failure)
• skin 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 Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Valsartan/Hydrochlorothiazide Alter

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

Appearance of the Product and Package Contents

Round, biconvex, uncoated tablets, and dark pink in color.

The tablets are presented in blister packs of 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 Last Revision of this Prospectus: February 2025.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.gob.aemps.es/.