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

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartan/Hydrochlorothiazide Normon 160mg/12.5mg

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 and other information:

1. What is Valsartan/Hydrochlorothiazide Normon and what is it used for
2. What you need to know before you take Valsartan/Hydrochlorothiazide Normon
3. How to take Valsartan/Hydrochlorothiazide Normon
4. Possible side effects
   1. Storage of Valsartan/Hydrochlorothiazide Normon

1. Contents of the pack and further information

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

Valsartan/Hydrochlorothiazide Normon contains 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 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 the blood vessels in the brain, heart, and kidneys, and may cause a 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 disorders.

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

Do not takeValsartan/Hydrochlorothiazide Normon

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

• if you are pregnant more than 3months(in any case, it is best to avoid taking this medicine also at the beginning of your 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 a buildup of bile in the liver (cholestasis),
• if you have severe kidney disease,
• if you are unable to urinate (anuria),
• if you are undergoing dialysis,
• if you have low potassium or sodium levels 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 failure 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 Valsartan/Hydrochlorothiazide Normon.

Warnings and precautions

Consult your doctor

• if you are using potassium-sparing medicines, potassium supplements, salt substitutes that contain potassium, or other medicines that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly check 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 when starting treatment. Your doctor may also monitor your kidney function.
• if you have 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 medicines (including ACE inhibitors), inform your doctor. If you have these symptoms when taking valsartan/hydrochlorothiazide, stop treatment immediately and never take it again (see section 4 Possible side effects),
• if you have fever, rash, and joint pain, which can 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 increased pressure in the eye and can occur within a time frame of 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 had an allergy to penicillin or sulfonamides,
• if you are taking any of the following medicines used to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril), particularly if you have diabetes-related kidney problems.
  • Aliskiren.
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking hydrochlorothiazide.
• 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, seek medical attention immediately.
• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Valsartan/Hydrochlorothiazide Normon. Your doctor will decide whether to continue treatment. Do not stop taking Valsartan/Hydrochlorothiazide Normon 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 the information under the heading “Do not take Valsartan/Hydrochlorothiazide Normon”.

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, think you may be pregnant, or are planning to become pregnant, inform your doctor. Valsartan/hydrochlorothiazide is not recommended during the first trimester of pregnancy and should not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby (see section Pregnancy and breastfeeding).

Doping tests

This medicine, as it contains hydrochlorothiazide, may produce a positive analytical result in doping tests.

Use of Valsartan/Hydrochlorothiazide Normon with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

The effect of treatment with valsartan/hydrochlorothiazide may be altered if taken with certain medicines. Your doctor may need to modify your dose and/or take other precautions or, in some cases, discontinue treatment with one of the medicines. This is especially applicable to the following medicines:

• lithium, a medicine used to treat certain psychiatric disorders,
• medicines or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin,
• medicines that can decrease the amount of potassium in the blood, such as diuretics (medicines to urinate), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G,
• certain antibiotics (of the rifampicin group), a medicine used to protect against rejection in a transplant (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of valsartan/hydrochlorothiazide,
• medicines that can induce “torsades de pointes” (irregular heartbeats), such as anti-arrhythmics (medicines used to treat heart problems) and certain antipsychotics,
• medicines that can reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics,
• medicines to treat gout, such as allopurinol, probenecid, sulfinpyrazone,
• therapeutic vitamin D and calcium supplements,
• medicines to treat diabetes (oral antidiabetics such as metformin or insulin),
• other medicines to lower blood pressure, including methyldopa, ACE inhibitors (such as lisinopril, enalapril, etc.) or aliskiren (see the information under the headings “Do not take Valsartan/Hydrochlorothiazide Normon” and “Warnings and precautions”),
• medicines that increase blood pressure, such as noradrenaline or adrenaline,
• digoxin or other digitalis glycosides (medicines used to treat heart problems),
• medicines that can increase blood sugar levels, such as diazoxide or beta-blockers,
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide,
• medicines for pain, such as non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid in doses greater than 3 g,
• muscle relaxants, such as tubocurarine,
• anticholinergic medicines (medicines used to treat a wide range of disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia),
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases),
• cholestyramine and colestipol (medicines primarily used to treat high lipid levels in the blood),
• cyclosporin, a medicine used to prevent organ rejection after transplantation,
• alcohol, sleeping medicines, and anesthetics (medicines with a sedative effect or for pain used, for example, in the case of surgery),
• iodinated contrast media (used for diagnostic imaging tests).

TakingValsartan/Hydrochlorothiazide Normonwith food, drinks, and alcohol

Avoid taking alcohol until you have consulted your doctor. Alcohol can further lower your blood pressure and/or increase the risk of dizziness and weakness.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

• You must inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.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 recommend that you take another medicine to lower your blood pressure instead. Valsartan/hydrochlorothiazide is not recommended during the first trimester of pregnancy and should not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby.

• Tell your doctor if you are about to start or are breastfeeding, as valsartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may decide to administer a treatment that is more suitable if you wish to breastfeed, especially 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, in rare cases, cause dizziness and affect your ability to concentrate.

Valsartan/Hydrochlorothiazide Normoncontains lactose, sorbitol (E-420), and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains 18.5 mg of sorbitol (E-420) in each tablet.

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

3. How to take Valsartan/Hydrochlorothiazide Normon

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 unsure, consult 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 tablets 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 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 takemore Valsartan/Hydrochlorothiazide Normonthan you should

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

If you forget to takeValsartan/Hydrochlorothiazide Normon

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 takingValsartan/Hydrochlorothiazide Normon

If you stop your treatment with valsartan/hydrochlorothiazide, your hypertension 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 fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• Fever, sore throat, increased frequency of infections (agranulocytosis).

These adverse 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 adverse effects include:

Uncommon(may affect up to 1 in 100 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 less than 1 in 1,000 people):

• dizziness,
• diarrhea,
• joint pain,

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

• difficulty breathing,
• 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 less than 1 in 1,000 people):

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

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

• skin blisters (sign of bullous dermatitis),

• skin rash with or without itching along with any 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,
• elevated liver function values,
• decrease in hemoglobin and hematocrit levels (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.

Uncommon(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 blood sugar levels,
• sugar in the urine,
• worsening of diabetic metabolic state,
• constipation, diarrhea, stomach or intestinal discomfort, liver changes (which 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, numbness,
• vision changes.

Rare(may affect less than 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),
• 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 twitches, and spasms, rapid breathing (hypochloremic alkalosis).
• acute breathing difficulties (signs include severe breathing difficulties, fever, weakness, and confusion).

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

• 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),
• skin and lip cancer (non-melanoma skin cancer).

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 (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 Normon

• Keep out of the reach and sight of children.
• Do not use this medicine after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.
• Do not store above 30°C. Store in the original packaging to protect from moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

• Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofValsartan/Hydrochlorothiazide Normon

• The active ingredients are valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients are:

Core: microcrystalline cellulose (E-460i), anhydrous colloidal silica (E-551), sorbitol (E-420), magnesium carbonate (E-504), pregelatinized starch (from corn), povidone, sodium fumarate, and sodium lauryl sulfate, crospovidone.

Coating: lactose monohydrate, hypromellose (E-464), macrogol 4000, titanium dioxide (E-171), brown iron oxide (E-172), and red iron oxide (E-172).

Appearance of the Product and Package Contents

Film-coated tablets.

Valsartan/Hydrochlorothiazide Normon 160 mg/12.5 mg: cylindrical, biconvex, coated, and reddish in color.

The tablets are presented in packages of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

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

Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Prospectus:February 2025

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