OLMESARTAN/AMLODIPINE ALTER 20 mg/5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

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 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Olmesartan/Amlodipine Alter is and what it is used for
2. What you need to know before you take Olmesartan/Amlodipine Alter
3. How to take Olmesartan/Amlodipine Alter
4. Possible side effects
5. Storage of Olmesartan/Amlodipine Alter
6. Contents of the pack and other information

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

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

• Olmesartan medoxomil belongs to a group of medicines called “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, which prevents the blood vessels from narrowing, and thus lowers 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 you take 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 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.

• If you are more than 3 months pregnant. It is better to avoid olmesartan medoxomil/amlodipine at the start of pregnancy (see section “Pregnancy and breast-feeding”).
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine 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 heart output (causing difficulty breathing or 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 medicines used to treat high blood pressure (hypertension):

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may check 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 medicines 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 have severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

As with any other medicine 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 must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage (see section “Pregnancy and breast-feeding”).

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 medicines

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

• Other blood pressure-lowering medicines, as they may increase the effect of this medicine. Your doctor may need to change 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, medicines that increase urine production(diuretics), or heparin(to thin the blood and prevent blood clots). Taking these medicines at the same time as olmesartan medoxomil/amlodipine may increase potassium levels in the blood.
• Lithium(a medicine used to treat mood changes and some types of depression) taken at the same time as this medicine may increase its toxicity. If you have to take lithium, your doctor will measure lithium levels in your blood.
• Non-steroidal anti-inflammatory medicines(NSAIDs, medicines 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 medicine 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.
• Medicines used for HIV/AIDS(e.g., ritonavir, indinavir, nelfinavir) or for the treatment of fungal infections(e.g., ketoconazole, itraconazole).
• Diltiazem, verapamil(medicines used for heart rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin(antibiotics), (medicines 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 medicine used to lower cholesterol and fat (triglyceride) levels in the blood.
• Tacrolimus, cyclosporin, 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 medicines.

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 check your blood pressure each time your dose is increased, to make sure it does not decrease too much.

Black patients

As with other similar medicines, the blood pressure-lowering effect of olmesartan medoxomil/amlodipine is somewhat smaller in black patients.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of olmesartan medoxomil/amlodipine. It is not recommended to take this medicine at the start of pregnancy, and it must not be taken when you are more than 3 months pregnant, 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.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. It has been shown that amlodipine (one of the ingredients of this medicine) passes into breast milk in small amounts. Olmesartan medoxomil/amlodipine is not recommended for breast-feeding mothers, and your doctor may choose another treatment if you wish to breast-feed, 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 dizzy, or have a headache. If this happens, do not drive or use machines until the symptoms have gone away. Consult your doctor.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., it is essentially “sodium-free”.

3. How to take Olmesartan/Amlodipine Alter

Follow exactly the administration instructions of this medicine given 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 take the medicine pack or this leaflet with you.

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 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 medicine, unless your doctor tells you to stop.

If you have any further questions on 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 all people suffer from them. If they occur, they are often mild and do not require interrupting 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 the treatment for blood pressure.

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.

Also, some changes in the results of certain blood tests have been observed: increase, as well as decrease of potassium levels in the blood, increase of creatinine levels in the blood, increase of uric acid levels, increase in liver function test values (gamma glutamyl transferase levels).

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

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

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; pain in the joints and bones; 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 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 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; 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; feeling of sleepiness; redness 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 or red 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; urinary 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)

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 greater 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; 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 the available data)

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

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 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 Olmesartan/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 that appears on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE collection point at 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/Amlodipino Alter

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

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

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

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

• The other ingredients are:

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

Tablet coating:

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

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

Olmesartan/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

Olmesartan/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.

Olmesartan/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.

Olmesartan/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/.