Olmesartan/amlodipine Aurovitas 40 mg/10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Olmesartan/Amlodipine Aurovitas 40 mg/10 mg film-coated tablets EFG

olmesartan medoxomil/amlodipine

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Olmesartan/Amlodipine Aurovitas is and what it is 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. How to store Olmesartan/Amlodipine Aurovitas
6. Contents of the pack and other information

1. What Olmesartán/Amlodipino Aurovitas is and what it is used for

Olmesartán medoxomilo/amlodipino contains two substances called olmesartán medoxomilo and amlodipino (as amlodipino besilato). Both substances help control high blood pressure.

• Olmesartán medoxomilo belongs to a group of medicines known as “angiotensin II receptor antagonists”, which lower blood pressure by relaxing blood vessels.
• Amlodipino belongs to a group of medicines known as “calcium channel blockers”. Amlodipino prevents calcium from entering the blood vessel wall, thereby preventing blood vessels from narrowing, which also reduces blood pressure.

The combined action of both substances helps prevent the narrowing of blood vessels, allowing them to relax and thereby reducing blood pressure.

Olmesartán medoxomilo/amlodipino is used to treat high blood pressure in patients whose blood pressure is not adequately controlled with olmesartán medoxomilo or amlodipino 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, amlodipine, or to a special group of calcium channel blockers known as 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 best to avoid olmesartan medoxomil/amlodipine in early pregnancy (see section “Pregnancy and breastfeeding”).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have severe liver problems, if bile secretion is impaired, or its release from the gallbladder is blocked (e.g., due to gallstones), or if you have jaundice (yellowing of the skin and eyes).
• If you have very low blood pressure.
• If you have inadequate blood supply to tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat (shock, including cardiogenic shock). Cardiogenic shock means shock due to serious heart problems.
• If blood flow to your heart is blocked (e.g., due to narrowing of the aorta (aortic stenosis)).
• If you have low cardiac output (causing shortness of breath or peripheral swelling) following a heart attack (acute myocardial infarction).

Warnings and precautions

Talk to your doctor or pharmacist before starting olmesartan medoxomil/amlodipine.

Tell your doctor if 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), 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 Aurovitas”.

Tell your doctor if you have any of the following health conditions:

• 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 medicines that increase urine output (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 experience severe, persistent diarrhea causing significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

As with any other medicine that lowers blood pressure, an excessive drop in blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

Inform your doctor if you are pregnant or think you might be pregnant. The use of olmesartan medoxomil/amlodipine is not recommended during early 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 during this period (see section “Pregnancy and breastfeeding”).

Consult your doctor if you develop 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 of age)

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

Other medicines and Olmesartan/Amlodipine Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the following medicines:

• Other blood pressure-lowering medicines, 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 an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Olmesartan/Amlodipine Aurovitas” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medicines that increase urine output (diuretics), or heparin (used to thin the blood and prevent blood clots). Taking these medicines together with olmesartan medoxomil/amlodipine may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression) taken together with olmesartan medoxomil/amlodipine may increase its toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) taken together with olmesartan medoxomil/amlodipine may increase the risk of kidney failure. The effect of olmesartan medoxomil/amlodipine may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, 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 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 (administered intravenously for severe body temperature abnormalities).
• Simvastatin, a medicine used to lower cholesterol and fat (triglyceride) levels in the blood.
• Tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine, used to suppress the body’s immune response, making it possible for your body to accept a transplanted organ.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Taking Olmesartan/Amlodipine Aurovitas with food and drink

Olmesartan medoxomil/amlodipine can be taken with or without food. Take the tablets with some liquid (such as a glass of water). If possible, take the daily dose at the same time each day, for example, with breakfast.

People taking olmesartan medoxomil/amlodipine should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of olmesartan medoxomil/amlodipine.

Elderly patients

If you are over 65 years of age, your doctor will regularly monitor your blood pressure each time your dose is increased, to ensure it does not drop too low.

Black patients

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

Pregnancy and breastfeeding

Pregnancy

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 becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of olmesartan medoxomil/amlodipine is not recommended during early pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

If you become pregnant while taking olmesartan medoxomil/amlodipine, inform and see your doctor immediately.

Breastfeeding

Inform 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 for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

During treatment for high blood pressure, you may feel drowsy, unwell, dizzy, or have a headache. If this happens, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Olmesartan/Amlodipine Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him 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 Olmesartán/Amlodipino Aurovitas

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended dose of olmesartan medoxomil/amlodipine is one tablet daily.
• The tablets can be taken with or without food. Take the tablets with some 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 Olmesartán/Amlodipino Aurovitas 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 fast or slow heartbeat.

If you take more tablets than prescribed or if a child accidentally ingests any tablets, contact your doctor immediately or go to the nearest emergency department and bring the medicine packaging or this leaflet with you.

In case of overdose or accidental ingestion, call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Excess fluid may accumulate in the lungs (pulmonary edema), causing breathing difficulties that may develop 24–48 hours after ingestion.

If you forget to take Olmesartán/Amlodipino 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 Olmesartán/Amlodipino Aurovitas

It is important to continue taking olmesartan medoxomil/amlodipine unless your doctor tells you to stop treatment.

If you have any further questions about 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 everyone will experience them. If they do 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 number of people:

During treatment with olmesartan medoxomilo/amlodipino, allergic reactions may occur, which can affect the entire body, with swelling of the face, mouth and/or larynx (vocal cords), together with itching and skin rash. If this happens to you, stop taking olmesartan medoxomilo/amlodipino and consult your doctor immediately.

Olmesartan medoxomilo/amlodipino may cause a marked drop in blood pressure in susceptible patients, or as a result of an allergic reaction. This may lead to fainting or severe dizziness. If this happens to you, stop taking olmesartan medoxomilo/amlodipino, 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, skin itching, even if you started treatment with olmesartan medoxomilo/amlodipino some time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

Other possible adverse effects with olmesartan medoxomilo/amlodipino:

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 upon standing
• Lack of energy
• Tingling or numbness in the hands or feet
• Vertigo
• Awareness of heartbeat
• Rapid heartbeat
• Low blood pressure with symptoms such as dizziness, lightheadedness
• Difficulty breathing
• Cough
• Nausea
• Vomiting
• Indigestion
• Diarrhea
• Constipation
• Dry mouth
• Upper abdominal pain
• Skin rash
• Cramps
• Pain in arms and legs
• Back pain
• Feeling of urgency to urinate
• Loss of sexual drive
• Inability to achieve or maintain an erection
• Weakness.

Some changes in the results of certain blood tests have also been observed: increase as well as decrease in blood potassium levels, increase in blood creatinine levels, increase in uric acid levels, and elevation in 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 sensation of warmth in the face
• Itchy red welts (urticaria)
• Facial swelling.

Adverse effects reported with olmesartan medoxomilo or amlodipino used alone, but not with olmesartan medoxomilo/amlodipino, or reported with higher frequency:

Olmesartan medoxomilo:

Frequent (may affect up to 1 in 10 people):

• Bronchitis
• Sore throat
• Nasal congestion and discharge
• Cough, abdominal pain
• Viral gastroenteritis, diarrhea
• Indigestion
• Nausea
• Joint or 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 in blood, and increases in 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 may lead to easy bruising or prolonged bleeding time
• Rapid allergic reactions, which may affect the entire body and may cause breathing difficulties, as well as a rapid drop in blood pressure, which may even lead to fainting (anaphylactic reactions)
• Angina (chest pain or discomfort, known as angina pectoris)
• Itching
• Skin rash
• Allergic skin rash
• Urticarial rash
• Facial swelling
• Muscle pain
• Malaise.

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

• Swelling of the face, mouth and/or larynx (vocal cords)
• Acute kidney injury and renal failure
• Lethargy
• Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Amlodipino

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 ankles
• Drowsiness
• Flushing and sensation of warmth in the face
• Visual disturbances (including double vision and blurred vision)
• Awareness of heartbeat
• 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
• Tremor
• Taste disturbances
• Fainting
• Ringing in the ears (tinnitus)
• Worsening of angina pectoris (chest pain or discomfort)
• Irregular heartbeat
• Nasal discharge or congestion
• Hair loss
• Purple spots or skin lesions due to minor bleeding (purpura)
• Skin discoloration
• Excessive sweating
• Skin rash
• Itching
• Itchy red welts (urticaria), joint or muscle pain
• Urination problems
• Need to urinate at night
• Increased need to urinate
• Breast enlargement 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):

• 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 known as platelets, which could lead to bruising and prolonged bleeding time
• Increased blood glucose
• Increased muscle tone or increased resistance to passive movement (hypertonia)
• Tingling or numbness in the hands or feet
• Heart attack
• Inflammation of blood vessels
• Inflammation of the liver or pancreas
• Inflammation of the stomach lining
• Gum overgrowth
• Elevated liver enzymes
• Yellowing of the skin and eyes
• Increased skin sensitivity to light
• Allergic reactions, itching, rash, swelling of the face, mouth and/or larynx (vocal cords), together with itching and rash, severe skin reactions, including severe skin rash, urticaria, redness of the skin, severe itching, blisters, peeling and inflammation of the skin, inflammation of 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 unbalanced gait with shuffling steps.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the carton, blister, or label after "EXP". The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Amlodipine Aurovitas 40 mg/10 mg film-coated tablets EFG

• The active substances are olmesartan medoxomil and amlodipine. Each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besylate).
• The other components are:

Tablet core: microcrystalline cellulose (101 and 102), pregelatinized corn starch, sodium croscarmellose, anhydrous colloidal silica, lactose, magnesium stearate.

Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), talc, macrogol 4000.

Appearance of the product and contents of the pack

Film-coated tablet.

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

Olmesartan/Amlodipine Aurovitas 40 mg/10 mg film-coated tablets EFG are available in blisters.

Pack sizes:

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

Only some pack 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

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorised in the Member States of the European Economic Area (EEA) under the following names:

Belgium: Olmesartan/Amlodipine AB 40 mg/10 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Germany: Olmesartan/AmlodipinPUREN 40 mg/10 mg Filmtabletten

Netherlands: Olmesartan medoxomil/Amlodipine Aurobindo 40 mg/10 mg, filmomhulde tabletten

Portugal: Amlodipina + Olmesartan medoxomilo Generis

Spain: Olmesartán/Amlodipino Aurovitas 40 mg/10 mg comprimidos recubiertos con película EFG

Date of the most recent revision of this leaflet: May 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).