OLMESARTAN/HYDROCHLOROTHIAZIDE NORMON 40 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan/Hydrochlorothiazide Normon 40 mg/12.5 mg film-coated tablets EFG

Olmesartan Medoxomil/Hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of the pack

1. What is Olmesartan/Hydrochlorothiazide Normon and what is it used for
2. What you need to know before you take Olmesartan/Hydrochlorothiazide Normon
3. How to take Olmesartan/Hydrochlorothiazide Normon
4. Possible side effects
5. Storage of Olmesartan/Hydrochlorothiazide Normon
6. Contents of the pack and other 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 in the treatment of high blood pressure (hypertension):

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

Olmesartan/Hydrochlorothiazide Normon will only be given if treatment with olmesartan medoxomil alone has not controlled your blood pressure sufficiently. The combination of the two active substances in Olmesartan/Hydrochlorothiazide Normon has been shown to be more effective at lowering blood pressure than either substance alone.

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

High blood pressure can be controlled with medicines such as Olmesartan/Hydrochlorothiazide Normon tablets. Your doctor may also have recommended that you make some changes to your lifestyle, such as losing weight, stopping smoking, reducing the amount of alcohol you drink, and reducing the amount of salt in your diet. Your doctor may also have recommended that you exercise regularly, such as walking or swimming. It is important to follow your doctor's advice.

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

Do not take Olmesartan/Hydrochlorothiazide Normon

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6) or to medicines similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant. (It is also better to avoid Olmesartan/Hydrochlorothiazide Normon at the start of pregnancy - see section Pregnancy).
• If you have kidney problems.
• If you have diabetes or kidney impairment and are treated with a blood pressure medicine containing aliskiren.
• If you have low potassium or sodium levels, 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 moderate or severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with the drainage of bile from the gallbladder (bile duct obstruction, e.g., due to gallstones).

If you think any of these apply to you, or if you are not sure, do not take the tablets. Talk to your doctor and follow their advice.

Warnings and precautions

Talk to your doctor before you start taking Olmesartan/Hydrochlorothiazide Normon

Talk to your doctor if you have stomach pain, nausea, vomiting, or diarrhea after taking Olmesartan/Hydrochlorothiazide Normon. Your doctor will decide whether you should 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 pressure in the eye, and can occur within hours to a week after taking Olmesartan/Hydrochlorothiazide Normon. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may have a higher risk of developing it.

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

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

Your doctor may want to check your kidney function, blood pressure, and blood electrolyte levels (e.g., 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:

• Kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Vomiting (while feeling nauseous) or diarrhea, which is severe or prolonged for several days.
• Treatment with high doses of medicines that increase urine production (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (e.g., 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 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 suffer from severe, persistent diarrhea that causes significant weight loss. Your doctor will assess 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). Your doctor will probably want to perform a blood test from time to time to check for these possible changes.

A change in blood levels of certain chemicals called electrolytes may occur. Your doctor will probably want to perform a blood test from time to time to check for 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, tiredness, sleepiness or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

As with any other medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired 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 medicine contains a component that may result in a positive doping test.

You should inform your doctor if you are pregnant or think you might be pregnant. It is not recommended to take Olmesartan/Hydrochlorothiazide Normon during pregnancy, and you should not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of 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 medicines

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

In particular, tell your doctor or pharmacist about any of the following medicines:

• Other medicines used to treat high blood pressure (anti-hypertensives), as they may increase the effect of Olmesartan/Hydrochlorothiazide Normon. Your doctor may need to change 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”).
• Medicines that may alter potassium levels in the blood when used with Olmesartan/Hydrochlorothiazide Normon. These include:
• • Potassium supplements (as well as salt substitutes that contain potassium).
  • Medicines that increase urine production (diuretics).
  • Heparin (to thin the blood).
  • Laxatives.
  • Corticosteroids.
  • Adrenocorticotropic hormone (ACTH).
  • Carbenoxolone (a medicine used to treat mouth and stomach ulcers).
  • Sodium penicillin G (an antibiotic also known as benzylpenicillin sodium).
  • Certain pain relievers such as aspirin or salicylates.
• Lithium (a medicine used to treat mood changes and some types of depression) may have its toxicity increased if taken with Olmesartan/Hydrochlorothiazide Normon. If you have to take lithium, your doctor will measure lithium levels in your blood.
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as Olmesartan/Hydrochlorothiazide Normon, may increase the risk of kidney failure and reduce the effect of Olmesartan/Hydrochlorothiazide Normon.
• Sedatives, hypnotics, and antidepressants, used with Olmesartan/Hydrochlorothiazide Normon, may cause a sudden drop in blood pressure when standing up.
• Certain muscle relaxants such as baclofen and tubocurarine.
• Amifostine and other medicines used to treat cancer, such as cyclophosphamide or methotrexate.
• Cholestyramine and colestipol, medicines used to lower blood fat levels.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of Olmesartan/Hydrochlorothiazide Normon. Your doctor may advise you to take Olmesartan/Hydrochlorothiazide Normon at least 4 hours before colesevelam hydrochloride.
• Anticholinergic medicines, such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart problems.
• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injections, which can change the heart rhythm.
• Oral anti-diabetic medicines, such as metformin, or insulin, used to lower blood sugar levels.
• Beta-blockers and diazoxide, medicines 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 caused by these medicines.
• Methyldopa, a medicine used to treat high blood pressure.
• Medicines such as noradrenaline, used to increase blood pressure and decrease heart rate.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Medicines such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medicine.
• Cyclosporine, a medicine used to prevent organ transplant rejection.
• Antibiotics of the tetracycline group or sparfloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Certain antacids, used to treat stomach acid excess, such as aluminum and magnesium hydroxide, as they may slightly reduce the effect of Olmesartan/Hydrochlorothiazide Normon.
• Cisapride, used to increase food movement in the stomach and intestines.
• Halofantrine, used to treat malaria.

Taking Olmesartan/Hydrochlorothiazide Normon with food and drink

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

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

Black patients

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

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you to stop taking Olmesartan/Hydrochlorothiazide Normon before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Olmesartan/Hydrochlorothiazide Normon. It is not recommended to take Olmesartan/Hydrochlorothiazide Normon during pregnancy, and you should not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan/Hydrochlorothiazide Normon is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you want to breastfeed.

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

Use in athletes

Athletes are informed that this medicine 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 medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Olmesartan/Hydrochlorothiazide Normon

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, consult your doctor or pharmacist again.

The recommended doseis one Olmesartan/Hydrochlorothiazide Normon 40 mg/12.5 mg tablet per day. If your blood pressure is not controlled sufficiently, your doctor may change the dose to one Olmesartan/Hydrochlorothiazide Normon 40 mg/25 mg tablet 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 important that you continue to take Olmesartan/Hydrochlorothiazide Normon 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 takes one or more tablets, contact your doctor or go to the nearest hospital emergency department immediately and take the medicine pack with you.

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

If you forget to take Olmesartan/Hydrochlorothiazide Normon

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

If you stop taking Olmesartan/Hydrochlorothiazide Normon

It is important to continue taking Olmesartan/Hydrochlorothiazide Normon unless your doctor tells you to stop.

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.

However, the following adverse effects may be serious:

• Unknown frequency: 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 the treatment for high blood pressure.
• 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.
• In sensitive individuals or as a result of an allergic reaction, Olmesartán/Hidroclorotiazida Normon can cause blood pressure to drop too low. 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, secondly, 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.

Frequent adverse effects (may affect up to 1 in 10 people):

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

Infrequent 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, arm and leg pain, back pain, erection problems in men, blood in urine.

Also, infrequently, some changes in blood tests have been observed, 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, rarely, some changes in blood test results have been observed, 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

hydrochlorothiazide alone, but not with the combinationOlmesartán/Hidroclorotiazidaor at a higher frequency:

Olmesartán medoxomil:

Frequent 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, frequently, some changes in blood test results have been observed, including:

Increased levels of fat in the blood, increased urea or uric acid in the blood, increased liver or muscle function test values.

Infrequent adverse effects (may affect up to 1 in 100 people):

Rapid allergic reactions that can affect the whole body and can 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, infrequently, some changes in blood test results have been observed, 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, rarely, some changes in blood test results have been observed, including:

Increased potassium in the blood

Hydrochlorothiazide:

Very frequent adverse effects (may affect more than 1 in 10 people):

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

Frequent 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 in urine.

Also, some changes in blood test results have been observed, including:

Increased creatinine, urea, calcium, and sugar levels in the blood, decreased chloride, potassium, magnesium, and sodium levels in the blood. Increased serum amylase (hyperamylasemia).

Infrequent adverse effects (may affect up to 1 in 100 people):

Decreased or lost 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 number of white blood cells, decreased number of platelets in the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures (convulsions), yellow vision, 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 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 high 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 does not appear 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.

No special storage conditions are required.

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.

Medicines should not be thrown away through wastewater or household waste. 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 40 mg/12.5 mg: each film-coated tablet contains 40 mg of olmesartán medoxomil and 12.5 mg of hydrochlorothiazide.

The other components (excipients) are: lactose monohydrate*, hydroxypropylcellulose (E463), low-substituted 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 40 mg/12.5 mg is presented in the form of film-coated tablets, yellow-reddish in color, elliptical, biconvex, and serigraphed.

Olmesartán/Hidroclorotiazida Normon 40 mg/12.5 mg 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.