OLMESARTAN/AMLODIPINE AUROVITAS 40 mg/10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Olmesartan/Amlodipine Aurovitas 40 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 and other information

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

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

Olmesartan medoxomil/amlodipine 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, thereby 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 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 you take 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 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 medicine that contains aliskiren.
• If you have severe liver problems, if bile secretion is altered, or its release by 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 serious 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 performance (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 medicines used to treat high blood pressure (hypertension):

• a medicine called 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 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 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).

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, excessive lowering of blood pressure in patients with altered blood flow in 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 might be pregnant. Olmesartan medoxomil/amlodipine is not recommended at the start of pregnancy, and 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”).

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 medicines and Olmesartan/Amlodipine Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• Other blood pressure-lowering medicines, as they may increase the effect of olmesartan medoxomil/amlodipine.

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 Aurovitas” 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 olmesartan medoxomil/amlodipine 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 to treat HIV/AIDS(e.g. ritonavir, indinavir, nelfinavir) or to treat fungal infections(e.g. ketoconazole, itraconazole).
• Diltiazem, verapamil(medicines used to treat heart rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin(antibiotics), medicines used to treat 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, sirolimus, temsirolimus, everolimus, and 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 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 must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can cause an unpredictable increase in the blood levels of the active ingredient amlodipine, 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 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

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 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. Olmesartan medoxomil/amlodipine is not recommended at the start of pregnancy, and 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 passes into breast milk in small amounts. Olmesartan medoxomil/amlodipine is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment if you wish to breast-feed, especially if your baby is newborn or premature.

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.

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.

Olmesartan/Amlodipine Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Olmesartan/Amlodipine Aurovitas contains sodium

This medicine 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 exactly the instructions of your doctor or pharmacist for taking this medicine. If you are not sure, 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 a fast or slow heart rate.

If you take more tablets than you should, or a child accidentally swallows some tablets, contact your doctor or go to the nearest emergency department immediately and take the medicine pack or this leaflet with you.

In case of overdose or accidental ingestion, call the Toxicology Information Service. Telephone 91 562 04 20, stating the medicine and the amount taken.

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 normal 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.

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 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 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.

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 heartbeat
• Low blood pressure with symptoms such as dizziness, fainting
• 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 discharge
• 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):

• Decreased 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 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
• 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 congestion or discharge
• Hair loss
• Purple spots or patches on the skin due to small hemorrhages (purpura)
• Discoloration of the skin
• 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):

• Decreased number of white blood cells, which can increase the risk of infections
• Decreased 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 lining
• 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 severe 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 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/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. Deposit the packaging and unused medicines in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Olmesartan/Amlodipine Aurovitas40 mg/10 mg film-coated tablets EFG

• The active ingredients are olmesartan medoxomil and amlodipine. 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: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.

Appearance and Package Contents

Film-coated tablet.

White to off-white, round, biconvex film-coated tablets with "M" engraved on one side and "29" on the other side.

Olmesartan/Amlodipine Aurovitas 40 mg/10 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/10 mg film-coated tablets/comprimés pelliculés/Filmtabletten

Germany: Olmesartan/Amlodipin PUREN 40 mg/10 mg film-coated tablets

Netherlands: Olmesartan medoxomil/Amlodipine Aurobindo 40 mg/10 mg film-coated tablets

Portugal: Amlodipine + Olmesartan medoxomil Generis

Spain: Olmesartán/Amlodipino Aurovitas 40 mg/10 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/).