Leaflet: information for the user

Valsartan/Hydrochlorothiazide Normon 320 mg/25 mg film-coated tablets EFG

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Valsartán/Hidroclorotiazida Normon contains two active principles 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 is used to treat high blood pressure that is not adequately controlled with the use of a single component.

Hypertension increases the load on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys and may cause a cerebral infarction, 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 take Valsartán/Hidroclorotiazida Normon

If any of these situations apply to you, inform your doctor and do not take valsartán/hidroclorotiazida.

Warnings and precautions

Consult your doctor:

• if you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium or other medications that increase blood potassium levels, such as heparin. Your doctor may need to regularly monitor your 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 kidney function,
• if you have a narrowing of the renal artery;
• 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 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 experience these symptoms when taking Valsartán/Hidroclorotiazida, stop taking it immediately and never take it again (see section 4 Adverse reactions),
• 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 cholesterol or triglyceride levels in your blood,
• if you have previously experienced an allergic reaction with the use of another medication of this class to reduce 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 effusion) or increased eye pressure, which can occur within a few hours to a week after taking Valsartán/Hidroclorotiazida. 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:

• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
• aliskirén.

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The use of hidroclorotiazida, particularly long-term high-dose use, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking hidroclorotiazida.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking Valsartán/Hidroclorotiazida, see your doctor immediately.
• if you experience abdominal pain, nausea, vomiting or diarrhea after taking Valsartán/Hidroclorotiazida Normon. Your doctor will decide whether to continue treatment. Do not stop taking Valsartán/Hidroclorotiazida Normon in monotherapy.

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

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

Valsartán/Hidroclorotiazida may cause increased skin sensitivity to the sun.

Valsartán/Hidroclorotiazida is not recommended for 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. Your doctor will usually advise you to stop taking Valsartán/Hidroclorotiazida before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Valsartán/Hidroclorotiazida is not recommended for use at the beginning of pregnancy (first 3 months), and in any case, it should not be administered from the third month of pregnancy as it may cause serious harm to your baby (see Pregnancy and breastfeeding section).

Drug testing

This medication, containing hidroclorotiazida, may produce a positive analytical result in drug tests.

Other medications and Valsartán/Hidroclorotiazida Normon

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The effect of treatment with valsartán/hidroclorotiazida may be altered if taken with certain medications. Your doctor may need to modify your dose and/or take other 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 diseases,
  • medications or substances that may increase blood potassium levels. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin,
  • medications that may decrease blood potassium levels, such asdiuretics (urine-producing medications),corticosteroids, laxatives,carbenoxolona, amfotericina or penicilina G,
  • some antibiotics (of the rifampicina 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 Valsartán/Hidroclorotiazida,
  • medications that may induce “torsades de pointes” (irregular heartbeats), such as antiarrhythmic medications (used to treat heart problems) and some antipsychotics,
  • medications that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics,
  • medications used to treat gout, such as alopurinol, probenecid, sulfinpirizona,
  • vitamin D therapy and calcium supplements,
  • medications used to treat diabetes (oral antidiabetic medications such as metformin or insulin),
• other medications to reduce blood pressure, including metildopa, ACE inhibitors (such as lisinopril, enalapril, etc.)or aliskirén (see the information under the headings “Do not take Valsartán/Hidroclorotiazida Normon”and“Warnings and precautions”),
• • medications that increase blood pressure, such as noradrenaline or adrenaline,
• digoxin or other digitalis glycosides (medications used to treat heart problems),
• • medications that may increase blood sugar levels, such as diazóxida or beta-blockers,
  • medications used to treat cancer, such as methotrexate or cyclophosphamide,
  • medications for pain, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors and aspirin in doses above 3 g,
  • muscle relaxants, such as tubocurarina,
  • anticholinergic medications(medications used to treat a wide range of conditions such as gastrointestinal cramps, urinary tract spasms, asthma, travel sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia),
  • amantadina (a medication used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses),
  • colestiramina and colestipol (medications used primarily to treat high lipid levels in the blood),
  • ciclosporina a medication used to prevent organ rejection after transplant,
• 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 Valsartán/Hidroclorotiazida Normon 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

Consult your doctor or pharmacist before using any medication.

• You must inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant.Your doctor will usually advise you to stop taking Valsartán/Hidroclorotiazida Normon before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Valsartán/Hidroclorotiazida is not recommended for use at the beginning of pregnancy (first 3 months), and in any case, it should not be administered from the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

• Inform your doctor if you are planning to start or are breastfeedingas valsartán/hidroclorotiazida 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 machines

Before driving a vehicle, using tools or operating machines, or engaging in other activities that require concentration, make sure you know your reactions to the effects of valsartán/hidroclorotiazida. Like many other medications used to treat high blood pressure, valsartán/hidroclorotiazida may cause, in rare cases, dizziness and affect concentration.

Valsartán/Hidroclorotiazida Normon contains lactose and sodium

This medication contains lactose.If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially “sodium-free”.

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 the 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 Normon 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 can also contact the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Valsartán/Hidroclorotiazida Normon

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 doses.

If you interrupt treatment with Valsartán/Hidroclorotiazida Normon

If you stop taking the medication, 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 fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma),
• Fever, sore throat, increased frequency of infections (agranulocytosis).

These side effects are very rare or of unknown frequency.

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

Other side effects include:

Rare (may 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-colored urine, dry skin),
• muscle pain,
• fatigue,
• tingling or numbness,
• blurred vision,
• ringing in the ears (e.g. tinnitus or buzzing).

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

• dizziness,
• diarrhea,
• joint pain,

Unknown 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 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, may cause yellowing of the skin and eyes),
• 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, may trigger a gout attack),
• syncope (fainting),

The following side effects have been observed with valsartan or hydrochlorothiazide-containing medications separately:

Valsartan:

Rare (may affect up to 1 in 100 people):

• vertigo,
• abdominal pain.

Very rare (may 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 (cannot be estimated from available data):

• skin blisters (sign of dermatitis bullosa),

• skin 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 flu-like symptoms,
• skin rash, red-purple patches, fever, itching (signs 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 skin rash, itching, hives, difficulty breathing or swallowing, dizziness),
• swelling mainly of the face and throat; skin rash; itching,
• increased liver function values,
• low hemoglobin levels and reduced red blood cell percentage in the blood (which, in severe cases, may cause anemia),
• renal insufficiency,
• 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 levels of 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 in 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, and stomach or intestinal discomfort, liver alterations that may appear with yellow skin and eyes,
• irregular heartbeat,
• headache,
• sleep disturbances,
• depression,
• low platelet count (sometimes with bleeding or bruising under the skin),
• dizziness,
• tingling or numbness,
• vision disturbances.

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

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

• skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions),
• skin rash, joint pain, muscle pain, fever (lupus erythematosus),
• severe stomach pain,
• 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 (leucopenia),
• confusion, fatigue, muscle cramps, and rapid breathing (hypochloremic alkalosis).
• acute respiratory distress (the signs include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency (cannot be estimated from available data):

• weakness, bruises, and frequent infections (aplastic anemia),
• significant decrease in urine production (possible signs of renal impairment or renal 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),
• skin cancer and lip cancer (non-melanoma skin cancer).

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 Medicinal Products for Human Use(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 store at a temperature above 30 °C.
• 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 use this medication if you observe that the packaging is damaged or shows signs of deterioration.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Valsartán/Hidroclorotiazida Normon

• The active principles are valsartán and hidroclorotiazida. Each tablet contains 320 mg of valsartán and 25 mg of hidroclorotiazida.

• The other components are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K29-K32, talc, magnesium stearate, anhydrous colloidal silica, polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, soy lecithin (E322), iron oxide red (E172), and iron oxide yellow (E172).

Appearance of the product and contents of the packaging

Valsartán/Hidroclorotiazida Normon 320 mg/25 mg is presented in the form of film-coated tablets, yellow in color, oval, biconvex, with the inscription “V” on one face and “H” on the other.

It is available in a blister pack containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6–28760 Tres Cantos–Madrid (Spain)

Responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Last review date of this leaflet:February 2025

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