Leaflet: information for the user

Valsartan/Hydrochlorothiazide Normon 320 mg/12.5 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 workload of 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 affect 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 potassium levels in the blood, such as heparin. Your doctor may consider it necessary to regularly control potassium levels,
• if you have low levels of potassium in the blood,
• if you experience severe diarrhea or vomiting,
• if you are taking high doses of a diuretic,
• if you have a 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 a narrowing of the renal 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, 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 have these symptoms when taking Valsartán/Hidroclorotiazida, stop taking it immediately and never take it again (see 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 the 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 and may occur during a period of time ranging from several hours to a week after taking Valsartán/Hidroclorotiazida. If not treated, this can lead to permanent vision loss. You may have a 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:
  • a converting enzyme inhibitor (ACE inhibitor) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
  • aliskirén.

• if you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The treatment with hidroclorotiazida, particularly its 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 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, seek medical attention 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 renal function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

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

Valsartán/Hidroclorotiazida may cause increased 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. In general, your doctor will 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 damage to your baby (see Pregnancy and breastfeeding section).

Drug test

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 valsartán/hidroclorotiazida treatment 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 especially applicable to the following medications:

• lithium, a medication used to treat certain types of psychiatric diseases,
• medications or substances that may increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin,
• medications that may decrease potassium levels in the blood, such as diuretics (urine medications), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G,
• some antibiotics (of 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 Valsartán/Hidroclorotiazida,
• medications that may induce "torsades de pointes" (irregular heartbeats), such as antiarrhythmics (medications used to treat heart problems) and some antipsychotics,
• medications that may reduce 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 (oral antidiabetic medications such as metformin or insulin),
• other medications used 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 norepinephrine or epinephrine,
• digoxin or other digitalis glycosides (medications used to treat heart problems),
• medications that may 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 transplant,
• alcohol, sleep medications, and anesthetics (medications with sedative or pain-relieving effects used, for example, in surgery),
• contrast agents containing iodine (used for diagnostic imaging tests).

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

Avoid taking alcohol until you have consulted with 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.In general, your doctor will 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 damage to your baby when administered from that point on.
• Inform your doctor if you are planning to initiate or are in the breastfeeding periodas 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 in newborns or premature babies.

Driving and operating machines

Before driving a vehicle, using tools, or operating machines, or performing 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 him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) 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 signs 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 call the Toxicology 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 dose.

If You Stop Taking Valsartán/Hidroclorotiazida Normon

If you stop taking valsartán/hidroclorotiazida, your 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 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 production,
• 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),
• high bilirubin levels in the blood (which, in severe cases, may cause yellowing of the skin and eyes),
• high levels of urea nitrogen and creatinine in the blood (which may indicate abnormal kidney function),
• high 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):

• feeling of spinning,
• 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):

• blistering of the skin (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 symptoms similar to the flu,
• skin rash, red-purple spots, 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,
• elevation of liver function values,
• decrease in hemoglobin levels and reduction in the percentage of red blood cells 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 nausea and vomiting,
  • dizziness, dizziness when standing up,
  • difficulty achieving or maintaining an erection.

Rare (may 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,
• glucose in the urine,
• emergence 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 disturbance.

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

• 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 (leukopenia),
• confusion, fatigue, muscle spasms, 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, bruising, 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 medicationafter 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 medicationif you observe that the packaging is damaged or shows signs of deterioration.

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 pointat 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 12.5 mg of hidroclorotiazida.

• The other components are: microcrystalline cellulose (E460i), lactose monohydrate, croscarmellose sodium, povidone K29-K32, talc (E553b), magnesium stearate (E470b), anhydrous colloidal silica (E551), polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, soy lecithin (E322), iron oxide red (E172), and iron oxide yellow (E172).

Appearance of the product and content of the packaging

Valsartán/Hidroclorotiazida Normon 320 mg/12.5 mg is presented in the form of film-coated tablets, of pink 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

ACTAVIS LIMITED

BLB16 Bulebel Industrial Estate(Zejtun) – ZTN08 – Malta

BALKANPHARMA DUPNITSA AD

3, Samokovsko Shosse Str. (Dupnitsa)– 2600 –Bulgaria

Last review date of this prospectus:February 2025

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