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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartan/Hydrochlorothiazide Normon 20 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, 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Olmesartan/Hydrochlorothiazide Normon is 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. How to store Olmesartan/Hydrochlorothiazide Normon
6. Contents of the pack and other information

1. What Olmesartán/Hidroclorotiazida Normon is and what it is used for

Olmesartán/Hidroclorotiazida Normon contains two active substances, 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 lowers blood pressure by relaxing blood vessels.
• Hidroclorotiazida belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the removal of excess fluid, increasing urine production by the kidneys.

Olmesartán/Hidroclorotiazida Normon will only be prescribed if treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The combined administration of both active substances in Olmesartán/Hidroclorotiazida Normon contributes to a greater reduction in blood pressure than when each substance is given alone.

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

High blood pressure can be controlled with medicines such as Olmesartán/Hidroclorotiazida Normon tablets. Your doctor may also have advised you to make certain 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 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 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 ingredients of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulphonamides).
• If you are more than 3 months pregnant. (Olmesartan/Hydrochlorothiazide Normon should also be avoided at the beginning of pregnancy – see Pregnancy section).
• If you have severe kidney problems.
• If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
• 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 severe liver problems, yellowing of the skin or eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).

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

Warnings and precautions

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

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

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 eye pressure, which may occur within hours to a week after taking Olmesartan/Hydrochlorothiazide Normon. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulphonamides, you may have a higher risk of developing this condition.

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

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

Your doctor may monitor 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 doctor if you have any of the following health conditions:

• 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 (with dizziness) or diarrhoea that is severe or lasts for several days.
• Treatment with high doses of medicines that increase urine elimination (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (e.g., primary hyperaldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• If you have had skin cancer or 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 non-melanoma skin and lip cancer. Protect your skin from sun exposure and UV rays while taking Olmesartan/Hydrochlorothiazide Normon.
• If you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Olmesartan/Hydrochlorothiazide Normon, contact your doctor immediately.

Contact your doctor if you experience severe, persistent diarrhoea causing 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 carry out some blood tests if you have any of these conditions.

Olmesartan/Hydrochlorothiazide Normon may cause increased levels of fats and uric acid (which causes gout – painful joint swelling) in the blood. Your doctor may want to carry out blood tests from time to time to monitor these possible changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor may want to carry out blood tests periodically to monitor this possible change. Some signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, slow, tired, drowsy, restless, nausea, vomiting, reduced 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 lead to a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are scheduled for parathyroid function tests, you must stop taking Olmesartan/Hydrochlorothiazide Normon before the tests are performed.

Athletes are advised that this medicine contains a component that may result in a positive analytical finding in doping controls.

Inform your doctor if you are pregnant or think you might be pregnant. Use of Olmesartan/Hydrochlorothiazide Normon is not recommended at the beginning of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage (see Pregnancy section).

Children and adolescents

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

Use of Olmesartan/Hydrochlorothiazide Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Other blood pressure-lowering medicines (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 angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also 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 together with Olmesartan/Hydrochlorothiazide Normon. These include:
  • Potassium supplements (as well as potassium-containing salt substitutes).
  • Medicines that increase urine elimination (diuretics).
  • Heparin (to thin the blood).
  • Laxatives.
  • Steroids.
  • Adrenocorticotropic hormone (ACTH).
  • Carbenoxolone (a medicine used to treat mouth and stomach ulcers).
  • Sodium penicillin G (an antibiotic also known as sodium benzylpenicillin).
  • Some painkillers such as aspirin or salicylates.
• Lithium (a medicine used to treat mood disorders and certain types of depression) may have increased toxicity when used together with Olmesartan/Hydrochlorothiazide Normon. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used together with Olmesartan/Hydrochlorothiazide Normon, may increase the risk of kidney failure and reduce the effect of Olmesartan/Hydrochlorothiazide Normon.
• Sleeping pills, sedatives, and antidepressants, used together with Olmesartan/Hydrochlorothiazide Normon, may cause a sudden drop in blood pressure upon standing.
• Certain medicines such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medicines used in cancer treatment, such as cyclophosphamide or methotrexate.
• 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.
• Cholestyramine and colestipol, medicines used to lower blood fat levels.
• Anticholinergic medicines, such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, 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 injectable erythromycin, which may alter heart rhythm.
• Oral antidiabetic 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, respectively, since Olmesartan/Hydrochlorothiazide Normon may enhance the blood sugar-raising effect of these medicines.
• Methyldopa, a medicine used to treat high blood pressure.
• Medicines such as noradrenaline, used to increase blood pressure and reduce heart rate.
• Difemanyl, used to treat slow heartbeat or reduce sweating.
• Medicines such as probenecid, sulfinpyrazone, and allopurinol, used in the treatment of 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 excess stomach acid, such as aluminium and magnesium hydroxide, as they may slightly reduce the effect of Olmesartan/Hydrochlorothiazide Normon.
• Cisapride, used to increase movement of food through the stomach and intestine.
• Halofantrine, used for malaria.

Taking Olmesartan/Hydrochlorothiazide Normon with food and drink

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

Be cautious when drinking alcohol while taking Olmesartan/Hydrochlorothiazide Normon, as some people may feel weak or dizzy. If this happens, avoid alcohol, including wine, beer, or alcoholic soft drinks.

Patients of Black race

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking Olmesartan/Hydrochlorothiazide Normon before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Olmesartan/Hydrochlorothiazide Normon is not recommended during pregnancy, and must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby if taken from this point.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Use of Olmesartan/Hydrochlorothiazide Normon is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you wish to breastfeed.

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

Use in athletes

Athletes are advised that this medicine contains a component (hydrochlorothiazide) that may result in a positive analytical finding in doping controls.

Driving and using machines

You may feel drowsy or dizzy while being treated for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Olmesartan/Hydrochlorothiazide Normon contains lactose

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

3. How to take Olmesartan/Hydrochlorothiazide Normon

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Recommended dose: 1 tablet of Olmesartan/Hydrochlorothiazide Normon 20 mg/12.5 mg once daily. If blood pressure is not adequately controlled, your doctor may change your dose to 1 tablet of Olmesartan/Hydrochlorothiazide Normon 20 mg/25 mg once daily.

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

If you take more Olmesartan/Hydrochlorothiazide Normon than you should

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

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

If you forget to take Olmesartan/Hydrochlorothiazide Normon

If you miss a daily dose, take your usual dose the next day. Do not take a double dose to make up for missed doses.

If you stop taking Olmesartan/Hydrochlorothiazide Normon

It is important to continue taking this medicine unless your doctor tells you to stop.

If you have any further questions about 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 everyone experiences them.

However, the following adverse effects may be serious:

• Unknown frequency: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you started treatment with Olmesartán Normon some time ago, contact your doctor immediately, who will assess your symptoms and decide how to continue your blood pressure treatment.
• In rare cases, allergic reactions may occur that can affect the entire body, with swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens, stop taking Olmesartán/Hidroclorotiazida Normon and consult your doctor immediately.
• Olmesartán/Hidroclorotiazida Normon may cause a marked drop in blood pressure in susceptible patients or as a result of an allergic reaction. Fainting or dizziness may occur infrequently. If this happens, 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 substances. 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 each of the two active substances when used separately.

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

If these effects occur, they are often mild and it is not necessary to discontinue 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):

Rapid or strong heartbeat (palpitations), rash, eczema, dizziness, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, muscle pain, joint pain, arms and legs pain, back pain, erectile problems in men, blood in urine.

Infrequent changes in blood test results have also been observed, including: Increase in blood fat levels, increase in blood urea or uric acid, increase in creatinine, increase or decrease in blood potassium levels, increase in blood calcium levels, increase in blood sugar, increase in liver function test values. Your doctor will monitor you with a blood test and advise you whether any action is needed.

Rare adverse effects (may affect up to 1 in 1,000 people):

Feeling unwell, disturbances in consciousness, skin swelling (hives), acute renal failure.

Rare changes in blood test results have also been observed, including:

Increase in blood urea nitrogen, decrease in hemoglobin and hematocrit values. Your doctor will monitor you with a blood test and advise you whether any action is needed.

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

Additional adverse effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone, but not with the combination Olmesartán/Hidroclorotiazida or at a higher frequency:

Olmesartan medoxomil:

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

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

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

Increase in blood fat levels, increase in blood urea or uric acid, increase in liver or muscle function test levels.

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

Rapid allergic reactions affecting the whole body, which may cause breathing difficulties and a rapid drop in blood pressure that may even lead to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives).

Uncommon changes in blood test results have also 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):

Worsening of kidney function, lack of energy.

Rare changes in blood test results have also been observed, including:

Increase in blood potassium levels.

Hydrochlorothiazide:

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

Changes in blood tests including: increase in blood fat levels and uric acid levels.

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

Feeling confused, abdominal pain, stomach discomfort, bloating sensation, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

Changes in blood test results have also been observed, including:

Increase in creatinine, urea, calcium, and blood sugar levels; decrease in blood chloride, potassium, magnesium, and sodium levels. Increase in serum amylase (hyperamylasemia).

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

Decreased or loss of appetite, severe difficulty breathing, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light-sensitive skin reactions, 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 blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, 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, gallbladder infection, symptoms of lupus erythematosus such as skin rash, joint pain, and coldness in hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing movement disturbances).

Very rare adverse effects (may affect up to 1 in 10,000 people):

Electrolyte imbalance which may cause abnormally low levels of chloride in blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus).

Acute breathing difficulty (signs include severe breathing difficulty, fever, weakness, and confusion).

Adverse effects with unknown frequency: Skin and lip cancer (non-melanoma skin cancer).

Reduced vision or eye pain due to increased 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 kind of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan/Hydrochlorothiazide Normon

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container and on the blister pack (after "EXP"). The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and other information

Composition of Olmesartán/Hidroclorotiazida Normon

The active substances are:

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

The other components (excipients) are: monohydrate lactose*, 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 medicinal product and contents of the pack

Olmesartán/Hidroclorotiazida Normon 20 mg/12.5 mg is presented as film-coated tablets, reddish-yellow in colour, round biconvex tablets with imprinting.

Olmesartán/Hidroclorotiazida Normon film-coated tablets are available in a pack of 28 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the most recent revision of this leaflet: February 2025

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.