Leaflet: information for the user

Olmesartan Normon 40 mg

film-coated tablets EFG

Olmesartan medoxomil

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 pass it on 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 Normon and what it is used for

2. What you need to know before taking Olmesartan Normon

3. How to take Olmesartan Normon

4. Possible side effects

5. Storage of Olmesartan Normon

6. Contents of the pack and additional information

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

Olmesartán Normon is used in the treatment of high blood pressure (also known as hypertension). High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain, and eyes. In some cases, this can lead to a heart attack, heart failure, or kidney failure, stroke, or blindness. Normally, high blood pressure does not present symptoms. It is essential to control blood pressure to prevent damage.

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

Do not take Olmesartán Normon

• If you are allergic to olmesartan medoxomilo or any of the other components of this medication (listed in section 6).
• If you are more than 3 months pregnant. (It is also best to avoid taking Olmesartán Normon tablets at the beginning of pregnancy - see Pregnancy section).
• If you have yellow 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 medication to lower blood pressure that contains aliskiren.

Warnings and precautions

Consult your doctor before starting to take Olmesartán Normon.

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

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.
• Aliskiren

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

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

Tell your doctorif you have any of the following health problems:

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

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.

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

Inform your doctor if you are pregnant or think you may be pregnant. Olmesartán 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 used from the third month of pregnancy (see Pregnancy section).

Children and adolescents

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

Taking Olmesartán Normon with other medications

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

• Other blood pressure-lowering medications, as they may increase the effect of Olmesartán Normon.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Olmesartán Normon” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medications that increase urine production (diuretics), or heparin (to thin the blood). The use of these medications at the same time as Olmesartán Normon may elevate potassium levels in the blood.
• Lithium (a medication used to treat mood changes and some types of depression), as used at the same time as Olmesartán Normon may increase its toxicity. If you need to take lithium, your doctor will measure lithium levels in the blood.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (medications to relieve pain, swelling, and other symptoms of inflammation, including arthritis), as used at the same time as Olmesartán Normon may increase the risk of kidney failure and reduce the effect of Olmesartán Normon.
• Colesevelam hydrochloride, a medication 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 (remedies for indigestion), as they may slightly reduce the effect of Olmesartán Normon.

Older patients

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

Black patients:

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

Taking Olmesartán Normon with food and drinks

Olmesartán Normon can be taken with or without food.

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 Olmesartán Normon before becoming pregnant or as soon as you know you are pregnant, and will recommend another medication in place of Olmesartán Normon. Olmesartán 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 used from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Olmesartán Normon is not recommended for use in breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Olmesartán 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. If in doubt, consult your doctor or pharmacist again.

The recommended initial dose is 1 Olmesartán Normon 10 mg tablet per day. 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 insufficiency, the maximum dose is 20 mg per day.

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

If you take more Olmesartán Normon than you should

In case you take a higher dose than necessary or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency center immediately and bring the medication packaging with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Olmesartán Normon

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

If you interrupt treatment with Olmesartán Normon

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

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

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

The following side effects may be serious:

Unknown frequency: if you experience yellowish discoloration 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 very rare cases (they may affect up to 1 in 1,000 people) the following allergic reactions that can affect the whole body have been reported: facial, mouth, and/or laryngeal inflammation, along with itching and skin rash.If this happens, stop taking Olmesartan Normon and consult your doctor immediately.

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

These are other side effects known so far with Olmesartan Normon:

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

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

Some changes have also been observed in the results of certain blood tests: increased levels of fat (hypertriglyceridemia), increased levels of uric acid (hyperuricemia), increased urea in the blood, increased values in liver and muscle function tests.

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

Quick allergic reactions that can affect the whole body and may cause breathing problems, as well as a rapid decrease in blood pressure that can even lead to fainting (anaphylactic reactions), vertigo, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives), chest pain (angina).

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

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

Lack of energy, muscle cramps, worsening of kidney function, kidney failure,

Some changes have been observed in the results of certain blood tests. These include increased levels of potassium in the blood (hyperkalemia) and increased levels of components related to kidney function. Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Reporting 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 Pharmacovigilance of Medicines for Human Use: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.

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.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of 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 unused packaging and medications. By doing so, you will help protect the environment.

Composition of Olmesartán Normon

The active ingredient is olmesartan medoxomil.

Each film-coated tablet contains 40 mg of olmesartan medoxomil.

The other components are: microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, low-substitution 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 packaging

Olmesartán Normon 40 mg film-coated tablets are white, elongated and biconvex tablets.

Olmesartán Normon 40 mg film-coated tablets are presented in a pack of 28 tablets.

Holder of the marketing authorization and manufacturer responsible

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 medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.