OLMESARTAN/AMLODIPINE PENSA 40 mg/10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan/Amlodipine Pensa 40 mg/10 mg film-coated tablets EFG

olmesartan medoxomil / amlodipine

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Olmesartan / Amlodipine Pensa and what is it used for
2. What you need to know before taking Olmesartan / Amlodipine Pensa
3. How to take Olmesartan / Amlodipine Pensa
4. Possible side effects
5. Storage of Olmesartan / Amlodipine Pensa
6. Package contents and additional information

1. What is Olmesartan/ Amlodipine Pensa and what is it used for

Olmesartan/Amlodipine Pensa contains two active substances called olmesartan medoxomil and amlodipine (as amlodipine besylate). Both substances help control high blood pressure.

• Olmesartan belongs to a group of medications called "angiotensin II receptor antagonists", which lower blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medications called "calcium channel blockers". Amlodipine prevents calcium from entering the blood vessel wall, which prevents the blood vessels from narrowing, thereby also lowering blood pressure.

The action of both substances contributes to preventing the narrowing of blood vessels, so they relax and blood pressure decreases.

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

2. What you need to know before taking Olmesartan / Amlodipine Pensa

Do not take Olmesartan /Amlodipino Pensa

• If you are allergic to olmesartan medoxomil, or amlodipine, or a special group of calcium channel blockers called dihydropyridines, or any of the other components of this medication (listed in section 6).

If you think you may be allergic, inform your doctor before taking Olmesartan medoxomil/Amlodipine Pensa.

• If you are pregnant for more than 3 months. It is best to avoid Olmesartan medoxomil/Amlodipine Pensa at the start of pregnancy (see section "Pregnancy and lactation").
• If you have diabetes or kidney problems and are being treated with a blood pressure medication that contains aliskiren.
• If you have severe liver problems, if bile secretion is altered, or its release from the gallbladder is blocked (e.g., by gallstones), or if you have jaundice (yellowish skin and eyes).
• If you have very low blood pressure.
• If you have insufficient blood supply to the 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 the blood flow to your heart is blocked (e.g., due to narrowing of the aorta (aortic stenosis)).
• If you have low cardiac output (causing difficulty breathing or peripheral swelling) after a heart attack (acute myocardial infarction).

Warnings and precautions

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

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) (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 medoxomil/Amlodipine Pensa".

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.
• Severe vomiting, diarrhea, treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands (hormone-producing glands located above the kidneys).

Contact your doctor if you experience severe, persistent diarrhea 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 experience abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartan /Amlodipino Pensa. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartan /Amlodipino Pensa on your own.

As with any other medication that lowers blood pressure, excessive blood pressure reduction in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You must inform your doctor if you are pregnant or think you may be pregnant. Olmesartan medoxomil/Amlodipine Pensa is not recommended at the start of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken at this stage (see section "Pregnancy and lactation").

Children and adolescents (under 18 years)

Olmesartan medoxomil/Amlodipine Pensa is not recommended for children and adolescents under 18 years.

Use of Olmesartan /Amlodipino Pensa with other medications

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

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

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 the information under the headings "Do not take Olmesartan medoxomil/Amlodipine Pensa" and "Warnings and precautions").

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

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

Taking Olmesartan Amlodipine Pensa with food and drinks

Olmesartan /Amlodipine Pensa 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 /Amlodipine Pensa should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active ingredient amlodipine in the blood, which can cause an unpredictable increase in the blood pressure-lowering effect of Olmesartan /Amlodipine Pensa.

Elderly patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure whenever your dose is increased, to ensure that it does not decrease too much.

Black patients

As with other similar medications, the blood pressure-lowering effect of Olmesartan /Amlodipine Pensa is slightly less in black patients.

Pregnancy and lactation

Pregnancy

You must inform your doctor if you are pregnant or think you may be pregnant.

Your doctor will advise you to stop taking Olmesartan /Amlodipine Pensa before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of Olmesartan /Amlodipine Pensa. Olmesartan /Amlodipine Pensa is not recommended at the start of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken from the third month of pregnancy onwards.

If you become pregnant while taking Olmesartan /Amlodipine Pensa, inform your doctor immediately.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan /Amlodipine Pensa is not recommended in breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, inform your doctor before taking Olmesartan /Amlodipine Pensa.

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

Driving and using machines

During treatment for high blood pressure, you may feel drowsy, feel sick, or dizzy, or have a headache. If this happens, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

3. How to take/use Olmesartan / Amlodipine Pensa

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• The recommended dose of Olmesartan /Amlodipine Pensa is one tablet per day.
• The 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 /Amlodipine Pensa with grapefruit juice.
• If possible, take your daily dose at the same time each day, for example, at breakfast time.

If you take more Olmesartan /Amlodipino Pensa 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 rapid or slow heart rate.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion.

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

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

If you forget to take Olmesartan /Amlodipino Pensa

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

If you stop taking Olmesartan /Amlodipino Pensa

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

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. If they occur, they are often mild and do not require interruption of treatment.

The following adverse effects may be serious, although they affect only a small group of people:

During treatment with Olmesartan medoxomil/Amlodipine Pensa, allergic reactions may 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 to you, stop taking Olmesartan/Amlodipine Pensa and consult your doctor immediately.

Olmesartan medoxomil/Amlodipine Pensa may cause a marked decrease in blood pressure, in susceptible patients, or as a result of an allergic reaction. This can cause fainting or severe dizziness. If this happens to you, stop taking Olmesartan/Amlodipine Pensa, consult your doctor immediately, and remain lying down in a horizontal position.

Unknown frequency: If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started treatment with Olmesartan/Amlodipine Pensa a long time ago, contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with blood pressure treatment.

Other possible adverse effects with Olmesartan/Amlodipine Pensa:

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

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

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

Dizziness when standing up; lack of energy; tingling or numbness of the hands or feet; vertigo; noticing heartbeats; rapid heartbeat; low blood pressure with symptoms such as dizziness, dizziness; difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth; pain in the upper abdomen; skin rash; cramps; pain in the arms and legs; back pain; feeling of urgency to urinate; sexual inactivity; inability to have or maintain an erection; weakness.

Some changes in the results of certain blood tests have also 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 (may affect up to 1 in 1,000 people):

Hypersensitivity to the medicine; fainting; flushing and feeling of heat in the face; red hives with itching (urticaria); facial inflammation.

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

Adverse effects reported with the use of olmesartan medoxomil or amlodipine alone, but not with Olmesartan/Amlodipine Pensa, or with a higher frequency:

Olmesartan

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

Bronchitis; sore throat; nasal congestion and 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.

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

Reduction in the number of a type of blood cells called platelets, which can cause easy bruising or prolonged bleeding time; rapid allergic reactions, which can affect the whole body and cause respiratory problems, as well as a 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 (may affect up to 1 in 1,000 people):

Inflammation of the face, mouth, and/or larynx (vocal cords); acute kidney failure and kidney failure; lethargy.

Amlodipine

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

Edema (fluid retention).

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

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

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

Difficulty sleeping; sleep disorders; mood changes including anxiety; depression; irritability; tremors; taste disturbances; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (chest pain or discomfort); irregular heartbeat; nasal secretion or congestion; hair loss; purple spots or spots on the skin due to small hemorrhages (purpura); skin discoloration; excessive sweating; skin rash; itching; red hives with itching (urticaria); joint or muscle pain; urination problems; need to urinate at night; increased need to urinate, increased breast size in men, chest pain; pain; feeling of discomfort; weight gain or loss.

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

Confusion.

Very rare (may 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 cells called platelets, which could lead to bruising and prolonged bleeding time; increased blood glucose; increased muscle tension or increased resistance to passive movement (hypertonia); tingling or numbness of the hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach wall; gum thickening; elevated liver enzymes; yellowing of the skin and eyes; increased sensitivity of the skin to light; allergic reactions, itching, rash, inflammation of the face, mouth, and/or larynx (vocal cords), along with itching and rash, severe skin reactions, including intense skin rash, urticaria, redness of the skin of the body, severe itching, blisters, peeling, and skin inflammation, inflammation of the mucous membranes, sometimes very severe.

Unknown frequency (cannot be estimated from available data):

Toxic epidermal necrolysis

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Olmesartan/Amlodipine Pensa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging (after "CAD.:"). The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Olmesartan/Amlodipine Pensa

The active ingredients are olmesartan medoxomil and amlodipine (as besylate).

Each tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besylate).

The other components are:

Tablet core: Pregelatinized cornstarch, sodium croscarmellose, microcrystalline cellulose, and magnesium stearate.

Tablet coating: Opadry Y-1-7000 and Red Iron Oxide (E172).

Appearance of the product and package contents

Film-coated tablet, brown-red, cylindrical, scored on one side and with the inscription "OA1" on the other side.

The score serves only to facilitate fractionation and swallowing but not to divide into equal doses.

Olmesartan/Amlodipine Pensa is presented in packages containing 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Laboratorios Cinfa, S.A.

Ctra. Olaz-Chipi, 10, Pol. Ind. Areta, Huarte, 31620 Navarra

Spain

Date of the last revision of this prospectus:February 2025

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