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

Introduction

Package Leaflet: Information for the Patient

Olmesartan/Amlodipine Aurovitas 40 mg/5 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 Aurovitas and what is it used for
2. What you need to know before taking Olmesartan/Amlodipine Aurovitas
3. How to take Olmesartan/Amlodipine Aurovitas
4. Possible side effects
5. Storage of Olmesartan/Amlodipine Aurovitas
6. Package Contents and Additional Information

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

Olmesartan medoxomil/amlodipine contains two 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 decrease 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 narrowing of blood vessels, thereby also decreasing blood pressure.

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

Olmesartan medoxomil/amlodipine 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 Aurovitas

Do not take Olmesartan/Amlodipine Aurovitas

• 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 Breastfeeding").
• 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 medoxomil/amlodipine.

Tell your doctorif you are taking any of the following medications used to treat high blood pressure (hypertension):

• a converting enzyme inhibitor (e.g., enalapril, lisinopril, ramipril), especially 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 Aurovitas".

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 diuretics, or if you are on a low-salt diet.
• High potassium levels 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.

As with any other medication that lowers blood pressure, excessive blood pressure reduction 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 Breastfeeding").

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

Children and Adolescents (under 18 years)

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

Other Medications and Olmesartan/Amlodipine Aurovitas

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 medoxomil/amlodipine.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking a converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings "Do not take Olmesartan/Amlodipine Aurovitas" and "Warnings and Precautions").

• Potassium supplements, salt substitutes containing potassium, 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 olmesartan medoxomil/amlodipine 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 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, sirolimus, temsirolimus, everolimus, and 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 Aurovitas 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 can 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 less in black patients.

Pregnancy and Breastfeeding

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. Olmesartan medoxomil/amlodipine is not recommended at the start of pregnancy, and it should not be taken when 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 and consult your doctor immediately.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It has been shown that amlodipine 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.

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 experience drowsiness, feel sick, or dizzy, or have a headache. If this occurs, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

Olmesartan/Amlodipine Aurovitas contains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Olmesartan/Amlodipine Aurovitas contains Sodium

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

3. How to Take Olmesartan/Amlodipine Aurovitas

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

• The recommended dose of olmesartan medoxomil/amlodipine 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 Aurovitas 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 medication package or this package leaflet with you.

In case of overdose or accidental ingestion, call the Toxicology Information Service. Telephone 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take Olmesartan/Amlodipine Aurovitas

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 Aurovitas

It is important to continue taking olmesartan medoxomil/amlodipine, 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.

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 may be serious, although they affect only a small group of people:

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/amlodipineand consult your doctor immediately.

Olmesartan medoxomil/amlodipine 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 medoxomil/amlodipine, consult your doctor immediately, and remain lying down in a horizontal position.

Frequency not known (cannot be estimated from available data)

If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started treatment with olmesartan medoxomil/amlodipine a long time ago, contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high 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
• Numbness or tingling of the hands or feet
• Vertigo
• Noticing heartbeats
• Rapid heartbeats
• Low blood pressure with symptoms such as dizziness, lightheadedness
• 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
• Urinary urgency
• Sexual inactivity
• Impotence
• 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
• Redness and feeling of heat in the face
• Red itchy patches (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
• Pain in the joints or 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 levels in the blood, and increased liver and muscle function test values

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

• Reduced number of a type of blood cell called platelets, which can cause easy bruising or prolonged bleeding
• 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 with skin rash
• 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 renal 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
• Drowsiness
• Redness and feeling of heat in the face
• Visual disturbances (including double vision and blurred vision)
• Noticing heartbeats
• Diarrhea
• Constipation
• Indigestion
• Cramps
• Weakness
• Breathing difficulties

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 patches on the skin due to small hemorrhages (purpura)
• Skin discoloration
• Excessive sweating
• Skin rash
• Itching
• Urticaria, joint or muscle pain
• Urination problems
• Need to urinate at night
• Increased need to urinate
• Enlargement of the breasts in men
• Chest pain
• Pain, 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):

• Reduced number of white blood cells, which can increase the risk of infections
• Reduced number of a type of blood cell called platelets, which can cause bruising and prolonged bleeding
• Increased blood glucose levels
• Increased muscle tension or increased resistance to passive movement (hypertonia)
• Numbness or tingling of the hands or feet
• Heart attack
• Inflammation of blood vessels
• Inflammation of the liver or pancreas
• Inflammation of the stomach wall
• Gingival hypertrophy
• 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

Frequency not known (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 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 Medicines Agency's website: 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/Amlodipine Aurovitas

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

Do not use this medicine after the expiration date stated on the carton, blister, or label after "EXP". The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Olmesartan/Amlodipine Aurovitas40 mg/5 mg film-coated tablets EFG

• The active ingredients are olmesartan medoxomil and amlodipine. Each film-coated tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).
• The other ingredients are:

Core of the tablet:microcrystalline cellulose (101 and 102), pregelatinized corn starch, sodium croscarmellose, anhydrous colloidal silica, lactose, magnesium stearate.

Coating of the tablet:partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), talc, macrogol 4000, yellow iron oxide (E172), red iron oxide (E172).

Appearance and Package Contents

Film-coated tablet.

Cream-colored, round, biconvex film-coated tablets with the inscription "K" on one side and "28" on the other side.

Olmesartan/Amlodipine Aurovitas 40 mg/5 mg film-coated tablets EFG are available in blisters.

Package Sizes:

14, 28, 30, 56, 90, and 98 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Olmesartan/Amlodipine AB 40 mg/5 mg film-coated tablets/comprimés pelliculés/Filmtabletten

Germany: Olmesartan/Amlodipin PUREN 40 mg/5 mg film-coated tablets

Netherlands: Olmesartan medoxomil/Amlodipine Aurobindo 40 mg/5 mg film-coated tablets

Portugal: Amlodipine + Olmesartan medoxomil Generis

Spain: Olmesartán/Amlodipino Aurovitas 40 mg/5 mg film-coated tablets EFG

Date of the Last Revision of this Leaflet:May 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/).