Leaflet: information for the user

Olmesartan/Amlodipino Normon 40 mg/5 mg film-coated tablets EFG

olmesartan medoxomilo / amlodipino

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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must 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 / Amlodipino Normon and what it is used for

2. What you need to know before starting to take Olmesartan / Amlodipino Normon

3. How to take Olmesartan / Amlodipino Normon

4. Possible side effects

5. Storage of Olmesartan / Amlodipino Normon

6. Contents of the pack and additional information

Olmesartan/Amlodipino Normon contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besylate). The two substances help control high blood pressure.

• Olmesartan belongs to a group of medicines called “angiotensin II receptor antagonists”, which decrease blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines called “calcium channel blockers”. Amlodipine prevents calcium from entering the blood vessel wall, preventing blood vessel constriction, which also decreases blood pressure.

The action of both substances contributes to preventing blood vessel constriction, so that they relax and blood pressure decreases.

Olmesartan /Amlodipino Normonis used to treat high blood pressure in patients whose blood pressure is not adequately controlled with olmesartan or amlodipine alone.

Do not take Olmesartan /Amlodipino Normon

• If you are allergic to olmesartan, or to amlodipino, or to a group of special calcium channel blockers called dihidropiridinas, or to any of the othercomponents of this medication (including in the section 6).

Inform your doctor before taking Olmesartan /Amlodipino Normon if you think you may be allergic.

• If you are more than 3 months pregnant. It is best to avoid Olmesartan /Amlodipino Normon at the beginning of pregnancy (see section “Pregnancy and breastfeeding”).
• If you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskirén.
• If you have severe liver problems, if your bile secretion is altered, or if your bile release is blocked (for example, by gallstones), or if you have jaundice (yellow skin and eyes).
• If you have very low blood pressure.
• If you have inadequate blood flow to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heart rate (shock, including cardiogenic shock). Cardiogenic shock means shock due to severe heart problems.
• If your heart's blood flow is blocked (for example, due to aortic stenosis).
• If you have poor heart function (producing difficulty breathing, or peripheral edema) after a heart attack (acute myocardial infarction).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Olmesartan /Amlodipino Normon.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartan/Amlodipino Normon. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartan/Amlodipino 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.
• Aliskirén.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in your blood (for example, potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartan /Amlodipino Normon”.

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

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Intense vomiting, diarrhea, treatment with high doses of medications that increase urine elimination (diuretics), or if you are taking a low-sodium diet.
• Elevated potassium levels in your blood.
• Problems with the adrenal glands (glands that produce hormones located above the kidneys).

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 blood pressure treatment.

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 closely monitor your blood pressure.

Inform your doctor if you are pregnant or think you may be pregnant. Olmesartan /Amlodipino 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 section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years)

Olmesartan /Amlodipino Normon is not recommended for children and adolescents under 18 years.

Use of Olmesartan /Amlodipino Normon with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications:

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

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

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

• Potassium supplements, salt substitutes containing potassium, medications that increase urine elimination(diuretics), orheparin(to thin the blood and prevent blood clots). The use of these medications at the same time as Olmesartan /Amlodipino Normon may elevate potassium levels in your blood.
• Thelithium(medication used to treat mood changes and some types of depression) used at the same time as Olmesartan /Amlodipino Normon may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in your blood.
• Thenonsteroidal anti-inflammatory drugs(NSAIDs, medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) used at the same time as Olmesartan /Amlodipino Normon may increase the risk of kidney failure. The effect of Olmesartan /Amlodipino Normon may be reduced by NSAIDs.
• Colesevelam hydrochloride,a medication that lowers cholesterol levels in your blood, as it may reduce the effect of Olmesartan /Amlodipino Normon. Your doctor may advise you to take Olmesartan /Amlodipino Normon at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of Olmesartan Amlodipino Normon.
• Medications used to treat HIV/AIDS(e.g. ritonavir, indinavir, nelfinavir)or fungal infections(e.g. ketoconazole, itraconazole).
• Diltiazem, verapamil (medications used to treat heart rhythm and high blood pressure problems).
• Rifampicin, erythromycin, clarithromycin (antibiotics).
• St. John's Wort(Hypericum perforatum), herbal remedy.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, a medication used to lower cholesterol and triglyceride levels in your blood.
• Tacrolimus, cyclosporine,used to control the body's immune response, makingit possible for your body to accept the transplanted organ.

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

Taking Olmesartan /Amlodipino Normon with food and drinks

Olmesartan /Amlodipino Normon can be taken with or without food. Take the tablets with a little liquid (such as a glass of water). If possible, take your daily dose at the same time each day, for example, at breakfast time.

People taking Olmesartan /Amlodipino Normon should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in the blood levels of the active ingredient amlodipino, which may cause an unpredictable increase in the blood pressure-lowering effect of Olmesartan /Amlodipino Normon.

Older patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure each time you increase your dose, to ensure that it does not drop too low.

Black patients

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

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 /Amlodipino Normon before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of Olmesartan /Amlodipino Normon. Olmesartan /Amlodipino 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 during the third month of pregnancy.

If you become pregnant while taking Olmesartan /Amlodipino Normon, inform and visit your doctor immediately.

Breastfeeding

Amlodipino has been shown to pass into breast milk in small amounts.

Inform your doctor if you are breastfeeding or about to startbreastfeeding. It is not recommended to take Olmesartan /Amlodipino Normon in mothers who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature.

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

Driving and operating machines

During blood pressure treatment, you may experience drowsiness, feel sick, or dizzy, or have headaches. If this occurs, do not drive or operate machines until the symptoms have disappeared. Consult your doctor.

Olmesartan/Amlodipino Normon contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.

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

The recommended dose of Olmesartan /Amlodipino Normon is one tablet per day.

Tablets can be taken with or without food. Take the tablets with a little liquid (such as a glass of water). Do not chew the tablet. Do not take Olmesartan /Amlodipino Normon with grapefruit juice.

Try to take your daily dose at the same time each day, for example at breakfast time.

If you take more Olmesartan /Amlodipino Normon than you should

If you take more tablets than you should, you will probably experience a drop in blood pressure, accompanied by symptoms such as dizziness, and a rapid or slow heart rate.

If you take more tablets than you should or a child accidentally ingests some tablets, contact your doctor immediately or go to the nearest emergency center and bring the medication packaging or this leaflet with you.

Excess fluid may accumulate in the lungs (pulmonary edema) causing breathing difficulties that may develop up to 24-48 hours after ingestion.

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

If you forget to take Olmesartan /Amlodipino Normon

If you forget to take a dose, take the usual dose the next day.Do nottake a double dose to make up for the missed doses.

If you interrupt treatment with Olmesartan /Amlodipino Normon

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

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. If they occur, they are often mild and do not require interrupting treatment.

The following side effects can 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.

During treatment with Olmesartan / Amlodipino Normon, allergic reactions can occur, which can affect the whole body, with inflammation of the face, mouth, and/or larynx (vocal cords), along with itching and skin rash.If this happens, stop taking Olmesartan / Amlodipino Normon and consult your doctor immediately.

Olmesartan / Amlodipino Normon can cause a pronounced drop in blood pressure in susceptible patients, or as a result of an allergic reaction. This can cause severe dizziness or fainting.If this happens, stop taking Olmesartan / Amlodipino Normon, consult your doctor immediately, and remain lying down in a horizontal position.

Other possible side effects with Olmesartan / Amlodipino Normon:

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

Dizziness; headache; swelling of the ankles, feet, legs, hands, or arms; fatigue.

Infrequent (can affect up to 1 in 100 people):

Dizziness when standing up; lack of energy; tingling or numbness of the hands or feet; vertigo; feeling the heartbeat; rapid heartbeat; low blood pressure with symptoms such as dizziness, fainting; difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth; abdominal pain; skin rash; muscle cramps; back pain; sensation of urgency to urinate; sexual inactivity; inability to achieve or maintain an erection; weakness.

Also, some changes in the results of certain blood tests have been observed:

Increased, as well as decreased levels of potassium in the blood, increased levels of creatinine in the blood, increased levels of uric acid, increased values of liver function tests (gamma-glutamyl transferase levels).

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

Medication hypersensitivity; fainting; flushing and sensation of heat in the face; red itchy patches (urticaria); facial inflammation. Intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Side effects reported with the use of olmesartan medoxomilo or amlodipino alone, but not with Olmesartan / Amlodipino Normon, or with a higher frequency:

Olmesartan

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

Bronchitis; sore throat; congestion and nasal secretion; cough; abdominal pain; viral gastroenteritis; diarrhea; indigestion; nausea; joint and bone pain; back pain; blood in the urine; urinary tract infection; chest pain; flu-like symptoms; pain. Changes in the results of blood tests, such as increased levels of a type of fat (hypertriglyceridemia); increased uric acid and urea in the blood, and increased values of liver and muscle function tests.

Infrequent (can affect up to 1 in 100 people):

Reduction in the number of a type of blood cell, called platelets, which can cause easy bruising or prolong bleeding time; rapid allergic reactions, which can affect the whole body and cause respiratory problems, as well as rapid drop in blood pressure, which can even cause fainting (anaphylactic reactions);angina (chest pain or discomfort, known as angina pectoris); itching;skin rash; allergic skin rash; urticaria; facial swelling; muscle pain; discomfort.

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

Facial, mouth, and/or laryngeal (vocal cord) inflammation; acute renal failure and renal insufficiency;lethargy.

Amlodipino

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

Edema (fluid retention).

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

Abdominal pain; nausea; swelling of the ankles; feeling sleepy; flushing and sensation of heat in the face, visual disturbances (including double vision and blurred vision), feeling the heartbeat, diarrhea, constipation, indigestion, muscle cramps, weakness, difficulty breathing.

Infrequent (can affect up to 1 in 100 people):

Difficulty sleeping; sleep disorders; mood changes, including anxiety; depression; irritability; tremor; taste disturbances; fainting; ringing in the ears (tinnitus);emergenceofangina(chest pain or discomfort); irregular heartbeat;nasal secretion or congestion; hair loss;purple spots or patches on the skin due to small hemorrhages (purpura);skin discoloration;excessive sweating;skin rash; itching; red itchy patches (urticaria);joint or muscle pain;urinary problems;nighttime urination;increased need to urinate;breast enlargement in men;chest pain;pain; feeling unwell;weight gain or loss.

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

Confusion.

Very rare (can affect up to 1 in 10,000 people):

Reduction in the number of white blood cells, which could increase the risk of infections; reduction in the number of a type of blood cell called platelets, which could cause the appearance of bruises and prolong bleeding time; increased glucose in the blood; increased muscle tension or increased resistance to passive movement (hypertonia);tingling or numbness of the hands or feet; heart attack; inflammation of the blood vessels; inflammation of the liver or pancreas; inflammation of the stomach wall; gum thickening; elevated liver enzymes; yellow skin and eyes; increased skin sensitivity to light; severe allergic reactions, itching, rash, facial, mouth, and/or laryngeal (vocal cord) inflammation, along with itching and rash, severe skin reactions, including intense skin rash, urticaria, skin redness, severe itching, blisters, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other severe allergic reactions.

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines 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.

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.

This medication does not require special conditions for conservation.

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/Amlodipino Normon

The active principles are:

Olmesartán/Amlodipino Normon 40 mg/5 mg: each film-coated tablet contains 40 mg of olmesartán medoxomilo and 5 mg of amlodipino (as amlodipine besilate).

The other components (excipients) are: pregelatinized maize starch, microcrystalline cellulose, croscarmellose, anhydrous colloidal silica, magnesium stearate, opadry II white 85F18422 (contains: poly(vinyl alcohol), titanium dioxide (E-171), macrogol 4000 and talc) and yellow iron oxide (E-172).

Appearance of the product and contents of the packaging

Olmesartán/Amlodipino Normon 40 mg/5 mg is presented in the form of film-coated tablets, light yellow in color, round, biconvex, and with the inscription 405 on one face.

Olmesartán/Amlodipino Normon film-coated tablets are presented in a pack 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 medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.