OLMESARTAN/HYDROCHLOROTHIAZIDE NORMON 20 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan/Hydrochlorothiazide Normon 20 mg/12.5 mg film-coated tablets EFG

Olmesartan Medoxomil/Hydrochlorothiazide

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Olmesartan/Hydrochlorothiazide Normon and what is it used for
2. What you need to know before taking Olmesartan/Hydrochlorothiazide Normon
3. How to take Olmesartan/Hydrochlorothiazide Normon
4. Possible side effects
5. Storage of Olmesartan/Hydrochlorothiazide Normon
6. Package Contents and Additional Information

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

Olmesartan/Hydrochlorothiazide Normon contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used to treat high blood pressure (hypertension):

• Olmesartan medoxomil belongs to a group of medications called angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medications called thiazide diuretics. It lowers blood pressure by helping to remove excess fluids, increasing urine production by the kidneys.

Olmesartan/Hydrochlorothiazide Normon will only be given if treatment with olmesartan medoxomil alone has not adequately controlled your blood pressure. The combined administration of both active substances in Olmesartan/Hydrochlorothiazide Normon helps to reduce blood pressure more than if each substance were administered alone.

You may already be taking medications to treat high blood pressure, but your doctor may believe it is necessary for you to take Olmesartan/Hydrochlorothiazide Normon to lower it further.

High blood pressure can be controlled with medications like Olmesartan/Hydrochlorothiazide Normon tablets. Your doctor has probably also recommended that you make some lifestyle changes to help lower your blood pressure (such as losing weight, quitting smoking, reducing alcohol consumption, and reducing salt intake in your diet). Your doctor may also have recommended that you exercise regularly, such as walking or swimming. It is essential to follow your doctor's advice.

2. What you need to know before taking Olmesartan/Hydrochlorothiazide Normon

Do not take Olmesartan/Hydrochlorothiazide Normon

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other components of this medication (listed in section 6) or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are pregnant for more than 3 months. (It is also best to avoid Olmesartan/Hydrochlorothiazide Normon at the start of pregnancy - see section Pregnancy).
• If you have severe kidney problems.
• If you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.
• If you have low potassium or sodium levels in your blood, high calcium or uric acid levels in your blood (with symptoms of gout or kidney stones), which do not improve with treatment.
• If you have severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).

If you think you have any of these conditions, or are unsure, do not take the tablets. Talk to your doctor and follow their advice.

Warnings and Precautions

Consult your doctor before starting to take Olmesartan/Hydrochlorothiazide Normon.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartan/Hydrochlorothiazide Normon. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartan/Hydrochlorothiazide Normon on your own.

If you experience a decrease in vision 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 can occur within a few hours to a week after taking Olmesartan/Hydrochlorothiazide Normon. This can lead to permanent vision loss if left untreated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it.

Before taking the tablets, tell your doctorif you are taking any of the following medications used to treat high blood pressure (hypertension):

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

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

See also the information under the heading "Do not take Olmesartan/Hydrochlorothiazide Normon".

Before taking the tablets, tell your doctorif you have any of the following health problems:

• Mild to moderate kidney problems, or if you have recently had a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Vomiting (while feeling nauseous) or diarrhea, which is severe or prolonged for several days.
• Treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (such as primary hyperaldosteronism).
• Diabetes.
• Systemic lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• If you have had skin cancer or if you 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 skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Olmesartan/Hydrochlorothiazide Normon.
• 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 severe shortness of breath or difficulty breathing after taking Olmesartan/Hydrochlorothiazide Normon, seek medical attention immediately.

Contact your doctor if you experience severe, persistent diarrhea that causes significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Your doctor may want to see you more often and perform some tests if you have any of these problems.

Olmesartan/Hydrochlorothiazide Normon may cause an increase in blood fat and uric acid levels (which can cause gout - painful swelling of the joints) in the blood. Your doctor will likely want to perform a blood test from time to time to monitor these possible changes.

A change in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely want to perform a blood test from time to time to monitor this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, slowness, fatigue, drowsiness or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

As with any other medication that lowers blood pressure, excessive blood pressure reduction in patients with altered blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are going to have parathyroid function tests, you should stop taking Olmesartan/Hydrochlorothiazide Normon before these tests are performed.

Athletes are informed that this medication contains a component that may result in a positive doping test.

You must inform your doctor if you are pregnant or think you may be pregnant. It is not recommended to use Olmesartan/Hydrochlorothiazide Normon during pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken at this stage (see section Pregnancy).

Children and Adolescents

Olmesartan/Hydrochlorothiazide Normon is not recommended for children and adolescents under 18 years of age.

Using Olmesartan/Hydrochlorothiazide Normon with Other Medications

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

In particular, inform your doctor or pharmacist about any of the following medications:

• Other blood pressure-lowering medications (antihypertensives), as they may increase the effect of Olmesartan/Hydrochlorothiazide Normon. Your doctor may need to adjust your dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Olmesartan/Hydrochlorothiazide Normon" and "Warnings and Precautions").
• Medications that may alter potassium levels in the blood if used at the same time as Olmesartan/Hydrochlorothiazide Normon. These include:
• • Potassium supplements (as well as salt substitutes that contain potassium).
  • Medications that increase urine production (diuretics).
  • Heparin (to thin the blood).
  • Laxatives.
  • Steroids.
  • Adrenocorticotropic hormone (ACTH).
  • Carbenoxolone (medication for treating mouth and stomach ulcers).
  • Sodium penicillin G (antibiotic also called benzylpenicillin sodium).
  • Certain pain relievers such as aspirin or salicylates.
• Lithium (medication used to treat mood changes and some types of depression) may increase its toxicity if used at the same time as Olmesartan/Hydrochlorothiazide Normon. If you need to take lithium, your doctor will monitor your lithium levels in the blood.
• Non-steroidal anti-inflammatory medications (NSAIDs) (medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) may increase the risk of kidney failure and decrease the effect of Olmesartan/Hydrochlorothiazide Normon if used at the same time.
• Sedatives, sleep-inducing medications, and antidepressants used with Olmesartan/Hydrochlorothiazide Normon may cause a sudden drop in blood pressure when standing.
• Certain medications such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medications used for cancer treatment, such as cyclophosphamide or methotrexate.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may decrease the effect of Olmesartan/Hydrochlorothiazide Normon. Your doctor may advise you to take Olmesartan/Hydrochlorothiazide Normon at least 4 hours before colesevelam hydrochloride.
• Colestyramine and colestipol, medications used to lower fat levels in the blood.
• Anticholinergic medications, such as atropine and biperiden.
• Medications such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultoprida, tiaprida, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Certain medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart problems.
• Medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injections, which can change heart rhythm.
• Oral antidiabetic medications, such as metformin, or insulin, used to lower blood sugar levels.
• Beta-blockers and diazoxide, medications used to treat high blood pressure or low blood sugar levels, respectively, as Olmesartan/Hydrochlorothiazide Normon may increase the effect of increasing blood sugar levels that these medications produce.
• Methyldopa, a medication used to treat high blood pressure.
• Medications such as norepinephrine, used to increase blood pressure and decrease heart rate.
• Difemanil, used to treat slow heartbeat or reduce sweating.
• Medications such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medication.
• Cyclosporine, a medication used to prevent organ transplant rejection.
• Antibiotics such as tetracyclines or esparfloxacin.
• Amphotericin, a medication used to treat fungal infections.
• Certain antacids, used to treat stomach acid excess, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of Olmesartan/Hydrochlorothiazide Normon.
• Cisapride, used to increase food movement in the stomach and intestine.
• Halofantrine, used to treat malaria.

Taking Olmesartan/Hydrochlorothiazide Normon with Food and Drinks

Olmesartan/Hydrochlorothiazide Normon can be taken with or without food.

Be careful when drinking alcohol while taking Olmesartan/Hydrochlorothiazide Normon, as some people may feel weak or dizzy. If this happens to you, do not drink any alcohol, including wine, beer, or drinks with alcohol.

Black Patients

As with other similar medications, the blood pressure-lowering effect of Olmesartan/Hydrochlorothiazide Normon is somewhat smaller in black patients.

Pregnancy and Breastfeeding

Pregnancy

You must inform your doctor if you are pregnant (or think you may be pregnant). Your doctor will generally advise you to stop taking Olmesartan/Hydrochlorothiazide Normon before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take a different medication instead of Olmesartan/Hydrochlorothiazide Normon. It is not recommended to use Olmesartan/Hydrochlorothiazide Normon during pregnancy, and it should not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after this point.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. It is not recommended to use Olmesartan/Hydrochlorothiazide Normon during breastfeeding, and your doctor will choose a different treatment for you if you wish to breastfeed.

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Use in Athletes

Athletes are informed that this medication contains a component (hydrochlorothiazide) that may result in a positive doping test.

Driving and Using Machines

You may feel drowsy or dizzy while being treated for high blood pressure. If this happens, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

Olmesartan/Hydrochlorothiazide Normon contains Lactose

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

3. How to Take Olmesartan/Hydrochlorothiazide Normon

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Recommended Dose

The recommended dose is 1 tablet of Olmesartan/Hydrochlorothiazide Normon 20 mg/12.5 mg per day. If your blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmesartan/Hydrochlorothiazide Normon 20 mg/25 mg per day.

Take the tablets with water. If possible, take your dose at the same time each day, for example, at breakfast time. It is essential to continue taking this medication until your doctor tells you to stop.

If you take more Olmesartan/Hydrochlorothiazide Normon than you should

If you take more tablets than you should, or if a child accidentally ingests one or more tablets, contact your doctor or go to the nearest hospital emergency department immediately and bring the medication package with you.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Olmesartan/Hydrochlorothiazide Normon

If you forget to take a daily dose, take the usual dose the next day. Do nottake a double dose to make up for missed doses.

If you stop taking Olmesartan/Hydrochlorothiazide Normon

It is essential to continue taking this medication unless your doctor tells you to stop.

If you have any other questions about using this medication, 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.

However, the following adverse effects may be serious:

• Frequency not known: if you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with Olmesartán Normon a long time ago, contact your doctor immediatelywho will assess your symptoms and decide how to continue with blood pressure treatment.
• In rare cases, allergic reactions can occur that can affect the whole body, with inflammation of the face, mouth, and/or larynx, along with itching and skin rash. If this happens to you, stop taking Olmesartán/Hidroclorotiazida Normon and consult your doctor immediately.
• Olmesartán/Hidroclorotiazida Normon may cause a pronounced drop in blood pressure, in susceptible patients or as a result of an allergic reaction. Infrequently, fainting or dizziness can occur. If this happens to you, stop taking Olmesartán/Hidroclorotiazida Normon, consult your doctor immediately, and remain lying down in a horizontal position.

Olmesartán/Hidroclorotiazida Normon is a combination of two active principles. The following information, first, describes the adverse effects reported so far with the combination Olmesartán/Hidroclorotiazida (in addition to those already mentioned) and, second, the known adverse effects of the two active principles separately.

These are other known adverse effects so far with the combination Olmesartán/Hidroclorotiazida:

If these effects occur, they are often mild and it is not necessary to interrupt treatment.

Common Adverse Effects (may affect up to 1 in 10 people):

Dizziness, weakness, headache, fatigue, chest pain, swelling of ankles, feet, legs, hands, or arms.

Uncommon Adverse Effects (may affect up to 1 in 100 people):

Fast and intense heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, and muscle pain, joint pain, back pain, erection problems in men, blood in urine.

Also, some changes in blood test results have been observed infrequently, including: increased levels of fat in the blood, increased urea or uric acid in the blood, increased creatinine, increased or decreased potassium levels in the blood, increased calcium levels in the blood, increased blood sugar, increased liver function test values. Your doctor will monitor you with a blood test and tell you if you need to take any action.

Rare Adverse Effects (may affect up to 1 in 1,000 people):

Feeling of discomfort, altered consciousness, skin swelling (hives), acute kidney failure.

Also, some changes in blood test results have been observed rarely, including: increased blood urea nitrogen, decreased hemoglobin and hematocrit values. Your doctor will monitor you with a blood test and tell you if you need to take any action.

Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Additional Adverse Effects Reported with the Use of Olmesartán Medoxomil or Hidroclorotiazida Alone, but not with the Combination Olmesartán/Hidroclorotiazida or at a Higher Frequency:

Olmesartán Medoxomil:

Common Adverse Effects (may affect up to 1 in 10 people):

Bronchitis, cough, nasal congestion and secretion, sore throat, abdominal pain, indigestion, diarrhea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, flu-like symptoms, pain.

Also, some changes in blood test results have been observed frequently, including: increased levels of fat in the blood, increased urea or uric acid in the blood, increased liver or muscle function test values.

Uncommon Adverse Effects (may affect up to 1 in 100 people):

Rapid allergic reactions that can affect the whole body and cause breathing problems, as well as a rapid drop in blood pressure that can lead to fainting (anaphylactic reactions), facial inflammation, angina (chest pain or discomfort, known as angina pectoris), feeling of discomfort, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives).

Also, some changes in blood test results have been observed infrequently, including: reduction in the number of a type of blood cells called platelets (thrombocytopenia).

Rare Adverse Effects (may affect up to 1 in 1,000 people):

Renal function impairment, lack of energy.

Also, some changes in blood test results have been observed rarely, including: increased potassium in the blood.

Hidroclorotiazida:

Very Common Adverse Effects (may affect more than 1 in 10 people):

Changes in blood tests, including: increased fat in the blood and uric acid levels.

Common Adverse Effects (may affect up to 1 in 10 people):

Feeling of confusion, abdominal pain, stomach discomfort, feeling of swelling, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

Also, some changes in blood test results have been observed, including: increased creatinine, urea, calcium, and blood sugar levels, decreased chloride, potassium, magnesium, and sodium levels in the blood. Increased serum amylase (hyperamylasemia).

Uncommon Adverse Effects (may affect up to 1 in 100 people):

Decreased or loss of appetite, severe breathing difficulties, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions due to light sensitivity, itching, purple spots or patches on the skin due to small hemorrhages (purpura), skin swelling (hives).

Rare Adverse Effects (may affect up to 1 in 1,000 people):

Inflammation and pain of the salivary glands, decreased white blood cell count, decreased platelet count in the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures (convulsions), yellowish perception of objects when looking at them, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, infection in the gallbladder, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, allergic skin reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which can sometimes cause movement disorders).

Very Rare Adverse Effects (may affect up to 1 in 10,000 people):

Electrolyte imbalance that can cause an abnormally low level of chloride in the blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus).

Acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

Adverse Effects of Unknown Frequency: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]

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 Olmesartán/Hidroclorotiazida Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and on the blister pack (after "CAD"). The expiration date is the last day of the month indicated.

Do not store above 30°C.

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. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Olmesartán/Hidroclorotiazida Normon

The active ingredients are:

Olmesartán/Hidroclorotiazida Normon 20 mg/12.5 mg: each film-coated tablet contains 20 mg of olmesartán medoxomil and 12.5 mg of hidroclorotiazida.

The other components (excipients) are: lactose monohydrate*, hydroxypropylcellulose (E463), low-substitution hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, hypromellose, titanium dioxide (E 171), macrogol 6000, talc, red iron oxide (E 172), and yellow iron oxide (E 172).

• See previous section "Olmesartán/Hidroclorotiazida Normon contains lactose"

Appearance of the Product and Package Contents

Olmesartán/Hidroclorotiazida Normon 20 mg/12.5 mg is presented in the form of film-coated tablets, yellow-red in color, round, biconvex, and serigraphed.

Olmesartán/Hidroclorotiazida Normon film-coated tablets are presented in a package of 28 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Prospectus:February 2025

Other Sources of Information

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