Olmesartan/amlodipine PensA 20 mg/5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olmesartán/Amlodipino Pensa 20 mg/5 mg film-coated tablets EFG

Olmesartan medoxomil/Amlodipine

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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 other people, even if they have the same symptoms as you, because it may harm them.

­ - If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Olmesartán/Amlodipino Pensa is and what it is used for

2. What you need to know before taking Olmesartán/Amlodipino Pensa

3. How to take Olmesartán/Amlodipino Pensa

4. Possible side effects

5. How to store Olmesartán/Amlodipino Pensa

6. Contents of the pack and other information

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

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

• Olmesartan medoxomil belongs to a group of medicines known as "angiotensin II receptor antagonists," which lower 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, thereby preventing blood vessels from narrowing, which also reduces blood pressure.

The combined action of both substances helps prevent the narrowing of blood vessels, allowing them to relax and thereby lowering blood pressure.

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

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

Do not take Olmesartan/Amlodipine Pensa

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

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

• If you are more than 3 months pregnant. It is best to avoid Olmesartan medoxomil/Amlodipine Pensa in early pregnancy (see section “Pregnancy and breastfeeding”).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have severe liver problems, if bile secretion is impaired, or its release from the gallbladder is blocked (e.g., due to gallstones), or if you have jaundice (yellowing of the skin and eyes).
• If you have very low blood pressure.
• If you have inadequate blood supply to tissues, with symptoms such as low blood pressure, weak pulse, or rapid heart rate (shock, including cardiogenic shock). Cardiogenic shock means shock due to serious heart problems.
• If blood flow to your heart is blocked (e.g., due to narrowing of the aorta (aortic stenosis)).
• If you have low cardiac output (causing shortness of breath or peripheral swelling) following a heart attack (acute myocardial infarction).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Olmesartan/Amlodipine Pensa.

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 (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 doctor if you have any of the following health conditions:

• 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 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 (hormone-producing glands located above the kidneys).

Contact your doctor if you develop 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/Amlodipine Pensa. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartan/Amlodipine Pensa on your own.

As with any other medicine that lowers blood pressure, excessive reduction 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 must inform your doctor if you are pregnant or think you might be pregnant. The use of Olmesartan medoxomil/Amlodipine Pensa is not recommended during early pregnancy, and it must 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 of age)

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

Using Olmesartan/Amlodipine Pensa with other medicines

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

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

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 Olmesartan medoxomil/Amlodipine Pensa” and “Warnings and precautions”).

• Potassium supplements, potassium-containing salt substitutes, medicines that increase urine output (diuretics), or heparin (used to thin the blood and prevent blood clots). Using these medicines together with Olmesartan medoxomil/Amlodipine Pensa may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression) when used together with Olmesartan medoxomil/Amlodipine Pensa may increase its toxicity. 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 medoxomil/Amlodipine Pensa may increase the risk of kidney failure. The effect of Olmesartan medoxomil/Amlodipine Pensa may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, 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 acid reflux), as they may slightly reduce the effect of Olmesartan medoxomil/Amlodipine Pensa.
• Medicines used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir) or for fungal infections (e.g., ketoconazole, itraconazole).
• Diltiazem, verapamil (medicines used for heart rhythm disorders and high blood pressure).
• Rifampicin, erythromycin, clarithromycin (antibiotics).
• St. John’s wort (Hypericum perforatum), a herbal remedy.
• Dantrolene (administered intravenously for severe body temperature abnormalities).
• Simvastatin, a medicine used to lower cholesterol and fat (triglyceride) levels in the blood.
• Tacrolimus, cyclosporine, used to suppress the body’s immune response, making it possible for your body to accept a transplanted organ.

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

Taking Olmesartan/Amlodipine Pensa with food and drink

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

People taking Olmesartan/Amlodipine Pensa must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could lead to 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 each time your dose is increased, to ensure it does not drop too low.

Black patients

As with other similar medicines, the blood pressure-lowering effect of Olmesartan/Amlodipine Pensa is somewhat lower in black patients.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant or think you might 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 recommend an alternative medicine instead of Olmesartan/Amlodipine Pensa. The use of Olmesartan/Amlodipine Pensa is not recommended during early 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 onward.

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

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan/Amlodipine Pensa 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 was born prematurely.

It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or planning to breastfeed, you must 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 medicine.

Driving and using machines

During treatment for high blood pressure, you may feel drowsy, unwell, dizzy, or have a headache. If this happens, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

3. How to take Olmesartan / Amlodipine Pensa

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

• The recommended dose of Olmesartan / Amlodipine Pensa is one tablet daily.
• The tablets can be taken with or without food. Take the tablets with some 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 with breakfast.

If you take more Olmesartan / Amlodipine Pensa than you should

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

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

If you take more tablets than prescribed or if a child accidentally ingests any tablets, contact your doctor immediately or go to the nearest emergency department and bring the medicine packaging or this leaflet with you.

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

If you forget to take Olmesartan / Amlodipine Pensa

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 Olmesartan / Amlodipine Pensa

It is important to continue taking Olmesartan / Amlodipine Pensa 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 experiences 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 small number of people:

During treatment with Olmesartan medoxomilo/Amlodipino Pensa, allergic reactions may occur, which can affect the whole body, with swelling of the face, mouth and/or larynx (vocal cords), together with itching and skin rash. If this happens to you, stop taking Olmesartan/Amlodipino Pensa and consult your doctor immediately.

Olmesartan medoxomilo/Amlodipino Pensa may cause a marked drop in blood pressure in susceptible patients, or as a result of an allergic reaction. This may lead to fainting or severe dizziness. If this happens to you, stop taking Olmesartan/Amlodipino Pensa, 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 Olmesartan/Amlodipino Pensa some time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

Other possible adverse effects with Olmesartan/Amlodipino 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 upon standing; lack of energy; tingling or numbness in the hands or feet; vertigo; awareness of heartbeat; rapid heartbeat; low blood pressure with symptoms such as dizziness, lightheadedness; difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth; upper abdominal pain; skin rash; cramps; pain in arms and legs; back pain; urgency to urinate; sexual inactivity; inability to achieve or maintain an erection; weakness.

Some changes in blood test results have also been observed:

Increase or decrease in blood potassium levels, increase in blood creatinine levels, increase in uric acid levels, elevation in liver function test values (gamma-glutamyl transferase levels).

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

Hypersensitivity to the medicine; fainting; facial flushing and sensation of warmth; itchy red welts (urticaria); facial swelling.

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

Adverse effects reported with olmesartan medoxomil or amlodipine used alone, but not with Olmesartan/Amlodipino Pensa, or reported with higher frequency:

Olmesartan

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

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

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

Reduction in the number of a type of blood cells called platelets, which may cause easy bruising or prolonged bleeding time; rapid allergic reactions affecting the whole body, which may cause breathing difficulties and a rapid drop in blood pressure, possibly leading to fainting (anaphylactic reactions); angina (chest pain or discomfort, known as angina pectoris); itching; skin rash; allergic skin rash; urticarial rash; facial swelling; muscle pain; malaise.

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

Swelling of the face, mouth and/or larynx (vocal cords); acute kidney failure and renal insufficiency; 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; ankle swelling; drowsiness; facial flushing and sensation of warmth; visual disturbances (including double vision and blurred vision); awareness of heartbeat; 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; tremor; taste disturbances; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (chest pain or discomfort); irregular heartbeat; nasal discharge or congestion; hair loss; purple spots or skin lesions due to minor bleeding (purpura); skin discoloration; excessive sweating; skin rash; itching; itchy red welts (urticaria); joint or muscle pain; urinary problems; need to urinate at night; increased frequency of urination; breast enlargement in men; chest pain; pain; malaise; 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 white blood cell count, which could increase the risk of infections; reduction in the number of a type of blood cells known as platelets, which could lead to bruising and prolonged bleeding time; increased blood glucose; increased muscle tone or resistance to passive movement (hypertonia); tingling or numbness in the hands or feet; heart attack; inflammation of blood vessels; liver or pancreas inflammation; inflammation of the stomach lining; gum overgrowth; elevated liver enzymes; yellowing of the skin and eyes; increased skin sensitivity to light; allergic reactions, itching, rash, swelling of the face, mouth and/or larynx (vocal cords), together with itching and rash, severe skin reactions including severe skin rash, urticaria, redness of the skin, severe itching, blisters, peeling and skin inflammation, inflammation of mucous membranes, sometimes very severe.

Frequency not known (cannot be estimated from available data):

Toxic epidermal necrolysis.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects 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. Olmesartán/Amlodipino Pensa Storage

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

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartán/Amlodipino Pensa

The active substances are olmesartan medoxomil and amlodipine (as besilate).

Each tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besilate).

The other components are:

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

Tablet coating: Opadry Y-1-7000.

Appearance of the product and contents of the pack

Film-coated tablet, white, cylindrical, scored on one side and marked with the inscription “O2A” on the other side.

The score is intended only to facilitate breaking the tablet and swallowing, but not to divide it into equal doses.

Olmesartán/Amlodipino Pensa is available in packs 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 most recent review of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.