OLMESARTAN/AMLODIPINE ALTER 40 mg/5 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Olmesartan/Amlodipine Alter20 mg/5 mg film-coated tablets EFG

Olmesartan/Amlodipine Alter40 mg/5 mg film-coated tablets EFG

Olmesartan/Amlodipine Alter40 mg/10 mg film-coated tablets EFG

olmesartan medoxomil/amlodipine

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

• Keep this patient information, 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 patient information. See section 4.

Contents of the Patient Information

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

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

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

• Olmesartan medoxomil 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, thus 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 Alter 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 Alter

Do not take Olmesartan/Amlodipine Alter

• 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.

• If you are pregnant for more than 3 months. It is recommended to avoid olmesartan medoxomil/amlodipine 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 (yellowing of the 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 take Olmesartan/Amlodipine Alter.

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/Amlodipine Alter".

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

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with the 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).

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartan/Amlodipine Alter. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartan/Amlodipine Alter on your own.

Contact your doctor if you experience severe, persistent, and weight-loss-causing diarrhea. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

As with any other medication that lowers blood pressure, an excessive decrease in blood pressure in patients with altered 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 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 is not recommended for children and adolescents under 18 years.

Taking Olmesartan/Amlodipine Alter with other medications

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

• Other blood pressure-lowering medications, as they may increase the effect of this medication. 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 Olmesartan/Amlodipine Alter" 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 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 this medication may increase its toxicity. If you need to take lithium, your doctor will monitor your lithium levels in the 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 may increase the risk of kidney problems. The effect of olmesartan medoxomil/amlodipine 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. Your doctor may advise you to take olmesartan medoxomil/amlodipine at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of olmesartan medoxomil/amlodipine.
• Medications used for HIV/AIDS(e.g., ritonavir, indinavir, nelfinavir) or for the treatment of fungal infections(e.g., ketoconazole, itraconazole).
• Diltiazem, verapamil(medications used for heart rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin(antibiotics, medications used for tuberculosis or other infections).
• 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 might take any other medication.

Taking Olmesartan/Amlodipine Alter with food and drinks

Olmesartan medoxomil/amlodipine 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 medoxomil/amlodipine 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 may cause an unpredictable increase in the blood pressure-lowering effect of olmesartan medoxomil/amlodipine.

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 medoxomil/amlodipine is somewhat smaller in black patients.

Pregnancy and lactation

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.

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 medoxomil/amlodipine before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of olmesartan medoxomil/amlodipine. It is not recommended to use this medication 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 medoxomil/amlodipine, inform your doctor immediately.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It has been shown that amlodipine (one of the components of this medication) passes into breast milk in small amounts. Olmesartan medoxomil/amlodipine 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.

Driving and using machines

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

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which is essentially "sodium-free".

3. How to take Olmesartan/Amlodipine Alter

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 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 medoxomil/amlodipine 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/Amlodipine Alter 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.

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 bring the medication packaging or this patient information with you.

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

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

If you forget to take Olmesartan/Amlodipine Alter

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/Amlodipine Alter

It is important to continue taking this medication, unless your doctor tells you to stop.

If you have any other questions about 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 discontinuation of treatment.

The following adverse effects can be serious:

During treatment with olmesartan medoxomil/amlodipine, 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 to you, stop taking olmesartan medoxomil/amlodipine and consult your doctor immediately.

Olmesartan medoxomil/amlodipine can cause a pronounced 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 medoxomil/amlodipine, 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/Amlodipino Alter 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 medoxomil/amlodipine:

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 blood test results have also been observed: increased and decreased potassium levels in the blood, increased creatinine levels in the blood, increased uric acid levels, and increased liver function test values (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.

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

Olmesartan medoxomil

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 blood test results, such as increased levels of a type of fat (hypertriglyceridemia); increased uric acid and urea levels in the blood, and increased liver and muscle function test values.

Uncommon (may 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 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; malaise.

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 insufficiency; lethargy; intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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 sleepiness; flushing and feeling of heat in the face, visual disturbances (including double vision and blurred vision), perception of 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, breast enlargement 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)

Decrease in the number of white blood cells, which can increase the risk of infections; decrease in the number of a type of blood cell called platelets, which can cause 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; blood vessel inflammation; liver or pancreas inflammation; stomach wall inflammation; 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 body skin, severe itching, blisters, peeling, and skin inflammation, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe.

Unknown frequency (cannot be estimated from available data)

Tremors, rigid posture, mask-like face, slow movements, and unsteady gait.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. 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. Storage of Olmesartán/Amlodipino Alter

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Olmesartán/Amlodipino Alter

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

Olmesartán/Amlodipino Alter 20 mg/5 mg: Each film-coated tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).

Olmesartán/Amlodipino Alter 40 mg/5 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).

Olmesartán/Amlodipino Alter 40 mg/10 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besylate).

• The other ingredients are:

Core of the tablet: Pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

Coating of the tablet:

Olmesartán/Amlodipino Alter 20 mg/5 mg: Opadry Y-1-7000 (contains hypromellose, titanium dioxide (E171), and macrogol 400).

Olmesartán/Amlodipino Alter 40 mg/5 mg: Opadry Y-1-7000 (contains hypromellose, titanium dioxide (E171), and macrogol 400) and yellow iron oxide (E172).

Olmesartán/Amlodipino Alter 40 mg/10 mg: Opadry Y-1-7000 (contains hypromellose, titanium dioxide (E171), and macrogol 400) and red iron oxide (E172).

Appearance of the product and package contents

Olmesartán/Amlodipino Alter 20 mg/5 mg: Film-coated tablets, white, cylindrical, 7 mm with the inscription "O2A" engraved on one side and scored on the other side. The score line is only for fracturing and facilitating swallowing, but not for dividing into equal doses.

Olmesartán/Amlodipino Alter 40 mg/5 mg: Film-coated tablets, cream-colored, cylindrical, 9 mm with the inscription "OA5" engraved on one side and scored on the other side. The score line is only for fracturing and facilitating swallowing, but not for dividing into equal doses.

Olmesartán/Amlodipino Alter 40 mg/10 mg: Film-coated tablets, brown-red, cylindrical, 9 mm with the inscription "OA1" engraved on one side and scored on the other side. The score line is only for fracturing and facilitating swallowing, but not for dividing into equal doses.

The tablets are available in packages of 28 film-coated tablets.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Laboratorios Cinfa, S.A.

Ctra. Olaz-Chipi 10

Polígono Industrial Areta

31620 Huarte, Navarra

Spain

Date of the last revision of this leaflet: February 2025.

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