Patient Information Leaflet

Olmesartán/Amlodipino Alter20 mg/5 mg Film-Coated Tablets

Olmesartán/Amlodipino Alter40 mg/5 mg Film-Coated Tablets

Olmesartán/Amlodipino Alter40 mg/10 mg Film-Coated Tablets

olmesartán medoxomilo/amlodipino

Read this leaflet carefully before you start to take 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, 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.

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

• Olmesartan medoxomil 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, which prevents blood vessels from narrowing, thereby also decreasing blood pressure.

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

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

Do not take Olmesartán/Amlodipino Alter

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

Inform your doctor if you think you may be allergic before taking olmesartan medoxomilo/amlodipino.

• If you are more than 3 months pregnant. It is best to avoid olmesartan medoxomilo/amlodipino 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 takeOlmesartán/Amlodipino 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) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskirén.

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 takeOlmesartán/Amlodipino 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 heart valves or heart muscle.
• Intense 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 your blood.
• Problems with the adrenal glands (glands that produce hormones located above the kidneys).

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

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

As with any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with altered blood flow to the heart or brain can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

You should inform your doctor if you are pregnant or think you may be pregnant. Olmesartan medoxomilo/amlodipino 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 medoxomilo/amlodipino is not recommended for children and adolescents under 18 years.

Taking Olmesartán/Amlodipino Alter 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 this medication. 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 takeOlmesartán/Amlodipino Alter” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medications that increase urine production(diuretics), orheparin(to thin the blood and prevent blood clots). The use of these medications at the same time as olmesartan medoxomilo/amlodipino may elevate potassium levels in your blood.
• Lithium(a medication used to treat mood changes and some types of depression) used at the same time as this medication 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 medoxomilo/amlodipino may increase the risk of kidney failure. The effect of olmesartan medoxomilo/amlodipino may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in your blood, as it may reduce the effect of olmesartan medoxomilo/amlodipino. Your doctor may advise you to take olmesartan medoxomilo/amlodipino at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of olmesartan medoxomilo/amlodipino.
• Medications used to treat HIV/AIDS(for example, ritonavir, indinavir, nelfinavir)or to treat fungal infections(for example, ketoconazole, itraconazole).
• Diltiazem, verapamil(medications used to treat heart rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin(antibiotics), (medications used to treat tuberculosis or other infections).
• 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,ciclosporin, used to control the body's immune response, making it 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 Olmesartán/Amlodipino Alter with food and drinks

Olmesartan medoxomilo/amlodipino 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 medoxomilo/amlodipino 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 medoxomilo/amlodipino.

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

As with other similar medications, the blood pressure-lowering effect of olmesartan medoxomilo/amlodipino is somewhat less in black patients.

Pregnancy and breastfeeding

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

Pregnancy

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

Your doctor will advise you to stop taking olmesartan medoxomilo/amlodipino as soon as you become pregnant, and will recommend an alternative medication. Olmesartan medoxomilo/amlodipino 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.

If you become pregnant while taking olmesartan medoxomilo/amlodipino, inform and visit your doctor immediately.

Breastfeeding

You should inform your doctor if you are breastfeeding or plan to start breastfeeding. It has been shown that amlodipino (one of the components of this medication) passes into breast milk in small amounts. Olmesartan medoxomilo/amlodipino is not recommended for mothers who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machines

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended dose is one tablet per day.
• Tablets can be taken with or without food. Take the tablets with a small amount of liquid (such as a glass of water). Do not chew the tablet. Do not take olmesartán medoxomilo/amlodipino with grapefruit juice.
• Try to take your daily dose at the same time each day, for example, at breakfast time.

If you take more Olmesartán/Amlodipino Alter than you should

If you take more tablets than you should, you are likely to 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 Olmesartán/Amlodipino Alter

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 doses.

If you interrupt treatment with Olmesartán/Amlodipino Alter

It is essential to continue taking this medication, 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 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:

During treatment with olmesartan medoxomil/amlodipine, allergic reactions may occur, which can affect the entire body, with inflammation of the face, mouth, and/or larynx (vocal cords), along with pruritus and skin eruption.If this happens, stop taking olmesartan medoxomil/amlodipine and consult your doctor immediately.

Olmesartan medoxomil/amlodipine may 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 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, skin itching, 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 treatment for high blood pressure.

Other possible side 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.

Rare (may 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; upper abdominal pain; skin rash; cramps; arm and leg pain; 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, potassium levels in the blood, increased creatinine levels in the blood, increased uric acid levels, increased values of liver function tests (gamma-glutamyl transferase levels).

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

Medication hypersensitivity; fainting; flushing and sensation of heat in the face; red itchy rash (urticaria); facial inflammation.

Side 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; 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 levels in the blood, and increased values of liver and muscle function tests.

Rare (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 prolong bleeding time; rapid allergic reactions, which can affect the entire 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); itching; skin rash; allergic skin rash; urticaria; facial swelling; muscle pain; discomfort.

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

Facial, mouth, and/or laryngeal (vocal cords) inflammation; acute renal failure and renal insufficiency; lethargy; intestinal angioedema: swelling in the intestine that presents 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; drowsiness; flushing and sensation of heat in the face, visual disturbances (including double vision and blurred vision), perception of the heartbeat, diarrhea, constipation, indigestion, cramps, weakness, difficulty breathing.

Rare (may affect up to 1 in 100 people)

Difficulty sleeping; sleep disorders; mood changes, including anxiety; depression; irritability; tremor; taste disturbances; fainting; tinnitus; worsening of angina (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 rash (urticaria); joint or muscle pain; urinary 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 cell called platelets, which could lead to the appearance of bruises and prolong bleeding time; increased glucose levels 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 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 cords) inflammation, along with itching and rash, severe skin reactions, including intense skin eruption, urticaria, skin redness, severe itching, blisters, peeling, and skin inflammation, membrane mucosal inflammation (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 dragging the feet.

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 leaflet. 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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicinesshould not bethrown down the drain or in the trash. Dispose of the packaging and themedicinesyou no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines you no longer need. By doing so, you will help protect the environment.

Composition of Olmesartán/Amlodipino Alter

• The active principles are olmesartán medoxomilo and amlodipino (as besilato).

Olmesartán/Amlodipino Alter20 mg/5 mg: Each tablet contains 20 mg of olmesartán medoxomilo and 5 mg of amlodipino (as besilato).

Olmesartán/Amlodipino Alter40 mg/5 mg: Each tablet contains 40 mg of olmesartán medoxomilo and 5 mg of amlodipino (as besilato).

Olmesartán/Amlodipino Alter40 mg/10 mg: Each tablet contains 40 mg of olmesartán medoxomilo and 10 mg of amlodipino (as besilato).

• The other components are:

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

Tablet coating:

Olmesartán/Amlodipino Alter20 mg/5 mg: Opadry Y-1-7000 (contains hypromelosa, titanium dioxide (E171), and macrogol 400).

Olmesartán/Amlodipino Alter40 mg/5 mg: Opadry Y-1-7000 (contains hypromelosa, titanium dioxide (E171), and macrogol 400) and yellow iron oxide (E172).

Olmesartán/Amlodipino Alter40 mg/10 mg: Opadry Y-1-7000 (contains hypromelosa, titanium dioxide (E171), and macrogol 400) and red iron oxide (E172).

Appearance of the product and contents of the package

Olmesartán/Amlodipino Alter20 mg/5 mg: Film-coated tablets, white, cylindrical, 7 mm in diameter, with the inscription “O2A” engraved on one face and scored on the other face. The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Olmesartán/Amlodipino Alter40 mg/5 mg: Film-coated tablets, cream-colored, cylindrical, 9 mm in diameter, with the inscription “OA5” engraved on one face and scored on the other face. The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Olmesartán/Amlodipino Alter40 mg/10 mg: Film-coated tablets, brown-red, cylindrical, 9 mm in diameter, with the inscription “OA1” engraved on one face and scored on the other face. The score is only for breaking 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

Responsible for Manufacturing

Laboratorios Cinfa, S.A.

Ctra. Olaz-Chipi 10

Polígono Industrial Areta

31620 Huarte, Navarra

Spain

Last review date of this leaflet: February 2025.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/.