Leaflet: information for the user

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

Olmesartan medoxomil/Hydrochlorothiazide

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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.

1. What is Olmesartan/Hydrochlorothiazide Normon and what it is 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. Contents of the pack and additional information

Olmesartán/Hidroclorotiazida Normon contains two active principles, olmesartán medoxomilo and hidroclorotiazida, which are used in the treatment of high blood pressure (hypertension):

• Olmesartán medoxomilo belongs to a group of medicines called angiotensin II receptor antagonists. It reduces blood pressure by relaxing blood vessels.
• Hidroclorotiazida belongs to a group of medicines called thiazide diuretics. It reduces blood pressure by contributing to the elimination of excess fluids, increasing urine production by the kidneys.

Olmesartán/Hidroclorotiazida Normon will only be given if treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The concurrent administration of both active substances in Olmesartán/Hidroclorotiazida Normon contributes to reducing blood pressure more than if each substance were administered alone.

You may already be taking medicines to treat high blood pressure, but your doctor may believe it necessary for you to take Olmesartán/Hidroclorotiazida Normon to lower it further.

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

Do not take Olmesartán/Hidroclorotiazida Normon

• If you are allergic to olmesartán medoxomilo or to hidroclorotiazida, or to any of the other components of this medication (listed in section 6) or to substances similar to hidroclorotiazida (sulfonamides).
• If you are more than 3 months pregnant. (It is also best to avoid Olmesartán/Hidroclorotiazida Normon at the beginning of pregnancy - see Pregnancy section).
• If you have kidney problems.
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.
• If you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid in the blood (with symptoms of gout or kidney stones), that do not improve with treatment.
• If you have moderate or severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, by gallstones).

If you think you have any of these cases, 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 Olmesartán/Hidroclorotiazida Normon

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartán/Hidroclorotiazida Normon. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartán/Hidroclorotiazida Normon in monotherapy.

If you experience a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and may occur within a few hours to a week after taking Olmesartán/Hidroclorotiazida 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 medications used to treat high blood pressure (hypertension):

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

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

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

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

• Renal transplant.
• Liver diseases.
• Heart failure or problems with heart valves or heart muscle.
• Nausea (feeling dizzy) or diarrhea, which is severe or lasts for several days.
• Treatment with high doses of medications that increase urine elimination (diuretics), or if you are on a low-sodium diet.
• Problems with the adrenal glands (for example, primary hyperaldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• If you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The treatment with hidroclorotiazida, 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 exposure and UV rays while taking Olmesartán/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 Olmesartán/Hidroclorotiazida Normon, seek medical attention immediately.

Contact your doctor if you experience severe, persistent diarrhea, and significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your treatment for high blood pressure.

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

Olmesartán/Hidroclorotiazida Normon may cause an increase in blood levels of fats and uric acid (which causes gout – painful swelling of the joints). Your doctor will probably want to perform blood tests from time to time to monitor these possible changes.

There may be a change in blood levels of certain chemical substances called electrolytes. Your doctor will probably want to perform blood tests 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 weak, slow, tired, drowsy, or restless, nausea, vomiting, decreased need to urinate, rapid heart rate.Tell your doctor if you notice any of these symptoms.

Like any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with heart or brain blood flow problems can cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are to undergo parathyroid function tests, you should stop taking Olmesartán/Hidroclorotiazida Normon before the tests are performed.

It is reported to athletes that this medication contains a component that may establish a positive analytical result for doping control.

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

Children and adolescents

Olmesartán/Hidroclorotiazida Normon is not recommended for children and adolescents under 18 years old.

Use of Olmesartán/Hidroclorotiazida Normon with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

• Other blood pressure-lowering medications (anti-hypertensives), as they may increase the effect of Olmesartán/Hidroclorotiazida Normon. Your doctor may need to adjust your dose and/or take other precautions: If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskirén (see also the information under the headings “Do not take Olmesartán/Hidroclorotiazida Normon” and “Warnings and precautions”).
• Medications that may alter blood potassium levels if taken at the same time as Olmesartán/Hidroclorotiazida Normon. These include:
• • Potassium supplements (as well as salt substitutes that contain potassium).
  • Diuretics.
  • Heparin (to thin the blood).
  • Laxatives.
  • Glucocorticoids.
  • Adrenocorticotropic hormone (ACTH).
  • Carbenoxolone (medication for the treatment of mouth and stomach ulcers).
  • Penicillin G sodium (antibiotic also called benzylpenicillin sodium).
  • Some analgesics such as aspirin or salicylates.
• Lithium (medication used to treat mood changes and some types of depression) if taken at the same time as Olmesartán/Hidroclorotiazida Normon may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as Olmesartán/Hidroclorotiazida Normon may increase the risk of kidney insufficiency and decrease the effect of Olmesartán/Hidroclorotiazida Normon.
• Sedatives, sleep inducers, and antidepressants, used with Olmesartán/Hidroclorotiazida Normon may cause a sudden drop in blood pressure when standing up.
• Some medications such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medications used to treat cancer, such as cyclophosphamide or methotrexate.
• Colestiramine and colestipol, medications to reduce blood fat levels.
• Colesevelam hydrochloride, a medication that reduces blood cholesterol levels, as it may decrease the effect of Olmesartán/Hidroclorotiazida Normon. Your doctor may advise you to take Olmesartán/Hidroclorotiazida Normon at least 4 hours before colesevelam hydrochloride.
• Anticholinergic medications, such as atropine and biperiden.
• Medications such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Some medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digital, used to treat heart problems.
• Medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injectables, which may change heart rhythm.
• Oral diabetes medications, such as metformin, or insulin, used to reduce blood sugar levels.
• Beta-blockers and diazoxide, medications used to treat high blood pressure or low blood sugar, respectively, as Olmesartán/Hidroclorotiazida Normon may intensify the effect of increasing blood sugar that these medications produce.
• Metildopa, a medication used to treat high blood pressure.
• Medications such as noradrenaline, used to increase blood pressure and decrease heart rate.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Medications such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medication.
• Ciclosporin, a medication used to prevent organ transplant rejection.
• Antibiotics in the tetracycline group, or enoxacin.
• Amphotericin, a medication used to treat fungal infections.
• Some antacids, used to treat excess stomach acid, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of Olmesartán/Hidroclorotiazida Normon.
• Cisapride, used to increase stomach and intestinal movement.
• Halofantrine, used to treat malaria.

Taking Olmesartán/Hidroclorotiazida Normon with food and drinks

Olmesartán/Hidroclorotiazida Normon can be taken with or without food.

Be careful when drinking alcohol while taking Olmesartán/Hidroclorotiazida Normon, as some people may feel weak or dizzy. If this happens, do not drink any alcohol, including wine, beer, or alcoholic beverages.

Black patients

Like other similar medications, the blood pressure-lowering effect of Olmesartán/Hidroclorotiazida Normon is somewhat less in black patients.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant or think you may be pregnant. Your doctor will advise you to stop taking Olmesartán/Hidroclorotiazida Normon before becoming pregnant or as soon as you know you are pregnant, and will recommend another medication in place of Olmesartán/Hidroclorotiazida Normon. Olmesartán/Hidroclorotiazida Normon is not recommended for use during pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period (see Pregnancy section).

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Olmesartán/Hidroclorotiazida Normon is not recommended for use in breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed.

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

Use in athletes

It is reported to athletes that this medication contains a component (hidroclorotiazida) that may establish a positive analytical result for doping control.

Driving and operating machines

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

Olmesartán/Hidroclorotiazida Normon contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet of Olmesartán/Hidroclorotiazida Normon 40 mg/12.5 mg per day. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmesartán/Hidroclorotiazida Normon 40 mg/25 mg per day.

Take the tablets with water. If possible, take your dose at the same time every day , for example, at breakfast time. It is essential to continue taking Olmesartán/Hidroclorotiazida Normon until your doctor tells you to stop.

If you take more Olmesartán/Hidroclorotiazida 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 immediately or go to the nearest hospital emergency center and bring the medication packaging with you.

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

If you forget to take Olmesartán/Hidroclorotiazida Normon

If you forget to take a daily dose, take the usual dose the next day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Olmesartán/Hidroclorotiazida Normon

It is essential to continue taking Olmesartán/Hidroclorotiazida Normon, unless your doctor tells you to stop.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

However, the following side effects can be serious:

• Unknown frequency: if you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with Olmesartan Normon some time ago,contact your doctor immediatelywho will evaluate 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, stop taking Olmesartan/Hidrochlorothiazide Normon and consult your doctor immediately.
• In sensitive individuals or as a result of an allergic reaction, Olmesartan/Hidrochlorothiazide Normon can cause blood pressure to drop too low. Infrequently, dizziness or fainting can occur.If this happens, stop taking Olmesartan/Hidrochlorothiazide Normon, consult your doctor immediately, and remain lying down in a horizontal position.

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

These are other side effects known so far with the combination Olmesartan/Hidrochlorothiazide:

If these effects occur, they are often mild anddo not need to interrupt treatment.

Frequent side effects (can affect up to 1 in 10 people):

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

Rare side effects (can affect up to 1 in 100 people):

Fast and intense heart rate (palpitations), hives, eczema, dizziness, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, and muscle pain, joint pain, arm and leg pain, back pain, erectile dysfunction in men, blood in urine.

Also, 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 levels of potassium in the blood, increased levels of calcium in the blood, increased blood sugar, increased values of liver function tests. Your doctor will monitor you through a blood test and tell you if you need to take any action.

Rare side effects (can affect up to 1 in 1,000 people):

Unpleasant sensation, alterations in consciousness, skin swelling (hives), acute renal insufficiency.

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

Increased urea nitrogen in the blood, decreased values of hemoglobin and hematocrit. Your doctor will monitor you through 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 side effects reported with the use of olmesartan medoxomil or

hidrochlorothiazide alone, but not with the combinationOlmesartan/Hidrochlorothiazideor in a higher frequency:

Olmesartan medoxomil:

Frequent side effects (can affect up to 1 in 10 people):

Bronchitis, cough, congestion, and nasal 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, including:

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

Rare side effects (can affect up to 1 in 100 people):

Fast and intense allergic reactions that can affect the whole body and can cause breathing problems, as well as a rapid decrease in blood pressure that can even cause fainting (anaphylactic reactions), inflammation of the face, angina (chest pain or discomfort), unpleasant sensation, skin rash, itching, hives, skin swelling (hives).

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

Reduction in the number of a type of blood cell, called platelets (thrombocytopenia).

Rare side effects (can affect up to 1 in 1,000 people):

Renal function deterioration, lack of energy.

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

Increased potassium in the blood

Hidrochlorothiazide:

Very frequent side effects (can affect more than 1 in 10 people):

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

Frequent side effects (can affect up to 1 in 10 people):

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

Rare side effects (can affect up to 1 in 100 people):

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

Rare side effects (can affect up to 1 in 1,000 people):

Salivary gland inflammation and pain, 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, 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, biliary tract infection, symptoms of lupus erythematosus (such as skin rash, joint pain, and cold hands and fingers), skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which sometimes causes movement alteration).

Very rare side effects (can 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 (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Side 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 hemorrhage) or acute angle-closure glaucoma].

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 Vigilance of Medicinal Products for Human Use: https://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.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging and in the blister (after “CAD”). The expiration date is the last day of the month indicated.

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 point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Olmesartán/Hidroclorotiazida Normon

The active principles are:

Olmesartán/Hidroclorotiazida Normon 40 mg/12,5 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

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

* See previous section “Olmesartán/Hidroclorotiazida Normon contains lactose”

Appearance of the product and contents of the packaging

Olmesartán/Hidroclorotiazida Normon 40 mg/12,5 mg is presented in the form of film-coated tablets, yellow-brown in color, elliptical, biconvex, and printed.

Olmesartán/Hidroclorotiazida Normon 40 mg/12,5 mg film-coated tablets are presented in a package of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:February 2025

Other sources of information

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