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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Olmesartan medoxomil/Hydrochlorothiazide

Read the entire 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, because 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 the 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 adverse 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 body get rid 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 has likely also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and decreasing salt intake). 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 (sulfonamides).
• If you are more than 3 months pregnant. (It is also advisable to avoid Olmesartan/Hydrochlorothiazide Normon in early pregnancy – see Pregnancy section).
• If you have 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 your blood, high levels of calcium or uric acid in your blood (with symptoms of gout or kidney stones) that do not improve with treatment.
• If you have moderate or 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 a decrease in vision 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 sulfonamides, 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 inhibitor (ACE inhibitor) (e.g., 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:

• 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 output (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, particularly 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, seek medical attention immediately.

Contact your doctor if you experience severe, persistent diarrhoea leading to significant weight loss. Your doctor will assess your symptoms and decide how to continue your blood pressure treatment.

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

Olmesartan/Hydrochlorothiazide Normon may increase blood levels of fats and uric acid (which causes gout – painful joint swelling). Your doctor may want to perform blood tests periodically to monitor these potential changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor may want to perform 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, sluggish, 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 heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

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

Athletes should be aware 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 may be pregnant. Use of Olmesartan/Hydrochlorothiazide Normon is not recommended in early pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if taken during 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 using, have recently used, or might need to use 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 inhibitor (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 blood when used together with Olmesartan/Hydrochlorothiazide Normon. These include:
  • Potassium supplements (as well as salt substitutes containing potassium).
  • Medicines that increase urine output (diuretics).
  • Heparin (a blood thinner).
  • 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 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 muscle relaxants such as baclofen and tubocurarine.
• Amifostine and other cancer treatments such as cyclophosphamide or methotrexate.
• Cholestyramine and colestipol, medicines used to lower blood fat levels.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, which 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, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Certain heart medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis.
• 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.
• 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.
• Some antacids used to treat excess stomach acid, such as aluminium and magnesium hydroxide, which may slightly reduce the effect of Olmesartan/Hydrochlorothiazide Normon.
• Cisapride, used to increase movement of food through 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 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 beverages.

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 think you may be pregnant. Your doctor will 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 it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

Inform 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 an alternative 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 medicine.

Use in athletes

Athletes should be aware 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 Olmesartán/Hidroclorotiazida Normon

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

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

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 will experience 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 whole body, with swelling of the face, mouth and/or larynx, together 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 may cause blood pressure to drop too low. 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 you do not need 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 and strong heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle cramps and muscle pain, joint pain, arms and legs, back pain, erectile problems in men, blood in urine.

Uncommonly, some 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 will tell you if you need to take any action.

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

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

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

Increase in blood urea nitrogen, decrease in haemoglobin and haematocrit values. Your doctor will monitor you with a blood test and will tell you if you need to take any action.

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

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, diarrhoea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, flu-like symptoms, pain.

Frequently, some 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 values.

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

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

Uncommonly, some 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.

Rarely, some 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 and uric acid levels.

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

Feeling confused, abdominal pain, stomach discomfort, feeling bloated, diarrhoea, nausea, vomiting, constipation, glucose in urine.

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

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

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 minor bleeding (purpura), skin swelling (hives).

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

Inflammation and pain of the salivary glands, decrease in white blood cells, decrease in platelets in blood, anaemia, 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, gallbladder infection, symptoms of systemic lupus erythematosus (such as skin rash, joint pain, and coldness in hands and fingers), skin allergic reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which sometimes causes movement disorders).

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 (hypochloraemic 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 type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 sight and reach of children.

No special storage conditions are required.

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

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

6. Contents of the pack and other information

Composition of Olmesartán/Hidroclorotiazida Normon

The active substances 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: 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 product and pack contents

Olmesartán/Hidroclorotiazida Normon 40 mg/12.5 mg is presented as film-coated tablets, reddish-yellow in colour, elliptical, biconvex and printed.

Olmesartán/Hidroclorotiazida Normon 40 mg/12.5 mg film-coated tablets are supplied in a pack containing 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.