Olmesartan Normon 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartán Normon 10 mg

film-coated tablets EFG

Olmesartán medoxomilo

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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 the adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Olmesartán Normon is and what it is used for
2. What you need to know before taking Olmesartán Normon
3. How to take Olmesartán Normon
4. Possible side effects
5. How to store Olmesartán Normon
6. Contents of the pack and other information

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

Olmesartán Normon belongs to a group of medicines known as angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.

This medicine is used to treat high blood pressure (also known as hypertension) in adults, and in children and adolescents aged 6 to less than 18 years. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain, and eyes. In some cases, this may lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms. It is important to control your blood pressure to prevent organ damage.

High blood pressure can be managed with medications such as Olmesartán 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 intake, and decreasing salt in your diet). Your doctor may also recommend regular physical exercise, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before taking Olmesartán Normon

Do not take Olmesartán Normon

• If you are allergic to olmesartan medoxomil or to any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant. (It is also advisable to avoid Olmesartán Normon tablets at the beginning of pregnancy – see Pregnancy section).
• If you have yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example due to gallstones).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before starting to take Olmesartán Normon.

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 levels of electrolytes (such as potassium) at regular intervals.

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

Tell your doctor if you have any of the following health problems:

• Kidney problems.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhoea, treatment with high doses of medicines that increase urine output (diuretics), or if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands.

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

Consult your doctor if you develop abdominal pain, nausea, vomiting, or diarrhoea after taking Olmesartán Normon. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartán Normon on your own.

As with any other medicine that lowers blood pressure, an excessive drop in 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.

You should inform your doctor if you are pregnant or think you might be pregnant. The use of Olmesartán Normon is not recommended at the beginning of 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 period (see Pregnancy section).

Children and adolescents

Olmesartán Normon has been studied in children and adolescents. For further information, consult your doctor. Olmesartán Normon is not recommended in children aged 1 year to less than 6 years, and must not be used in children under 1 year of age, as there is no experience with its use in this age group.

Other medicines and Olmesartán Normon

Inform 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, as they may enhance the effect of Olmesartán 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 the information under the headings “Do not take Olmesartán Normon” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, diuretics (medicines that increase urine output), or heparin (a blood thinner). Taking these medicines together with Olmesartán Normon may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression), as it may increase lithium toxicity when taken together with Olmesartán 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), as their use together with Olmesartán Normon may increase the risk of kidney failure and reduce the effectiveness of Olmesartán Normon.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of olmesartan. Your doctor may advise you to take Olmesartán Normon at least 4 hours before colesevelam hydrochloride.
• Certain antacids (medicines for indigestion), as they may slightly reduce the effect of Olmesartán Normon.

Elderly patients

If you are over 65 years old and your doctor decides to increase the dose of olmesartan medoxomil to 40 mg daily, your doctor will regularly monitor your blood pressure to ensure it does not drop too low.

Patients of black race:

As with other similar medicines, the blood pressure-lowering effect of Olmesartán Normon is somewhat reduced in patients of black race.

Taking Olmesartán Normon with food and drink

Olmesartán Normon can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you to stop taking Olmesartán Normon before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Olmesartán Normon. The use of Olmesartán Normon is not recommended at the beginning of 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. Olmesartán Normon is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

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

Driving and using machines

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

Olmesartán Normon contains lactose:

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

3. How to take Olmesartán Normon

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

The recommended initial dose is 1 tablet of Olmesartán Normon 10 mg once daily. If blood pressure is not adequately controlled, your doctor may increase the dose to 20 mg or 40 mg per day or prescribe additional treatment.

In patients with mild to moderate renal impairment, the maximum dose is 20 mg once daily.

The tablets can be taken with or without food. Take the tablets with a sufficient amount of liquid (for example, a glass of water). If possible, take your dose at the same time each day, for example with breakfast.

Children and adolescents aged 6 to less than 18 years:

The recommended initial dose is 10 mg once daily. If the patient's blood pressure is not adequately controlled, the doctor may decide to adjust the dose up to 20 or 40 mg once daily. In children weighing less than 35 kg, the dose will not exceed 20 mg once daily.

If you take more Olmesartán Normon than you should

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

You may also consult your pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Olmesartán Normon

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

If you stop taking Olmesartán 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. If they do occur, they are often mild and do not require discontinuation of treatment.

The following adverse effects may be serious, although they affect only a few people:

In rare cases (may affect up to 1 in 1,000 people), the following systemic allergic reactions have been reported: swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking Olmesartán Normon and consult your doctor immediately.

Rarely (but slightly more frequently in elderly patients), Olmesartán Normon may cause a marked drop in blood pressure in susceptible individuals, or as a result of an allergic reaction. This may lead to fainting or severe dizziness. If this happens, stop taking Olmesartán Normon, consult your doctor immediately, and remain lying down in a horizontal position.

Frequency not known: 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 proceed with your blood pressure treatment.

The following are other known adverse effects reported so far with Olmesartán Normon:

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

Dizziness, headache, nausea, indigestion, diarrhoea, stomach pain, gastroenteritis, fatigue, sore throat, nasal congestion and discharge, bronchitis, influenza-like symptoms, cough, pain, chest pain, back pain, bone pain, joint pain, urinary tract infection, swelling of ankles, feet, legs, hands or arms, blood in urine.

Some changes in certain blood test results have also been observed: increase in fat levels (hypertriglyceridaemia), increase in uric acid levels (hyperuricaemia), increase in blood urea, elevations in liver and muscle function tests.

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 decrease in blood pressure that may even lead to fainting (anaphylactic reactions), facial swelling, vertigo, vomiting, weakness, feeling of malaise, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives), angina pectoris (chest pain or discomfort).

In blood tests, a decrease in the number of a type of blood cells called platelets (thrombocytopenia) has been observed.

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

Lack of energy, muscle cramps, worsening of kidney function, kidney failure, intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Some changes in certain blood test results have been observed. These include increased levels of potassium in the blood (hyperkalaemia) and increased levels of components related to kidney function.

Other adverse effects in children and adolescents:

Adverse effects observed in children are similar to those reported in adults. However, dizziness and headache have been observed more frequently in children, and nosebleeds are a frequent adverse effect observed only in children.

Reporting of adverse effects

If you experience any type 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 Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan Normon

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

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.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Olmesartán Normon

The active substance is olmesartan medoxomil.

Each film-coated tablet contains 10 mg of olmesartan medoxomil.

The other components are: microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate, titanium dioxide (E 171), talc, macrogol 600 and hydroxypropylmethylcellulose (see section 2, “Olmesartán Normon contains lactose”).

Appearance of the product and contents of the pack

Olmesartán Normon 10 mg film-coated tablets are white, round, biconvex tablets.

Olmesartán Normon 10 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: April 2026.

Other sources of information

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