Package Leaflet: Information for the Patient

Olmesartán/Amlodipino Aurovitas 40 mg/5 mg Film-Coated Tablets

olmesartán medoxomilo/amlodipino

Read this leaflet carefully before you start taking 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Olmesartán/Amlodipino Aurovitas

3. How to take Olmesartán/Amlodipino Aurovitas

4. Possible side effects

5. Storage of Olmesartán/Amlodipino Aurovitas

6. Contents of the pack and additional information

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

• Olmesartán medoxomilo belongs to a group of medications called “angiotensin II receptor antagonists”, which decrease blood pressure by relaxing blood vessels.
• Amlodipino belongs to a group of medications called “calcium channel blockers”. Amlodipino prevents calcium from entering the blood vessel wall, preventing blood vessel constriction, which also decreases blood pressure.

The action of both substances contributes to preventing blood vessel constriction, allowing blood vessels to relax and blood pressure to decrease.

Olmesartán medoxomilo/amlodipinois used to treat high blood pressure in patients whose blood pressure is not adequately controlled with olmesartán medoxomilo or amlodipino alone.

Do not take Olmesartán/Amlodipino Aurovitas

• If you are allergic to olmesartan medoxomil, or to amlodipine, or to a special group of calcium channel blockers called dihydropyridines, or to any of the othercomponents of this medication (listed in section 6).

Inform your doctor if you think you may be allergic before taking olmesartan medoxomil/amlodipine.

• If you are more than 3 months pregnant. It is best to avoid olmesartan medoxomil/amlodipine 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 aliskiren.
• 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 the blood flow to your heart 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 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 (ACE inhibitor) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
• Aliskiren.

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 take Olmesartán/Amlodipino 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.
• Vomiting intensively, 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 the blood.
• Problems with the adrenal glands (glands that produce hormones located above the kidneys).

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

As with any other medication that lowers blood pressure, an excessive decrease in blood pressure in patients with heart or brain blood flow abnormalities can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

Inform your doctor if you are pregnant or think you may be pregnant. Olmesartan medoxomil/amlodipine 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 medoxomil/amlodipine is not recommended for children and adolescents under 18 years.

Other medications and Olmesartán/Amlodipino Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to 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 an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Olmesartán/Amlodipino Aurovitas” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, diuretics, orheparin(to thin the blood and prevent blood clots). The use of these medications with olmesartan medoxomil/amlodipinemay elevate potassium levels in the blood.
• Thelithium(medication used to treat mood changes and some types of depression) used at the same time as olmesartan medoxomil/amlodipinemay increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in the 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 medoxomil/amlodipinemay increase the risk of kidney failure. 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,as they may slightly reduce the effect of olmesartan medoxomil/amlodipine.
• Medications used to treat HIV/AIDS(e.g. ritonavir, indinavir, nelfinavir)or fungal infections(e.g. 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 the blood.
• Tacrolimus,sirolimus, temsirolimus, everolimusand ciclosporin,used to control the body's immune response, makingit possible for the 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 Aurovitas with food and drinks

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

People taking olmesartan medoxomil/amlodipineshould 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 amlodipine, which may cause an unpredictable increase in the blood pressure-lowering effect of olmesartan medoxomil/amlodipine.

Older patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure each time you increase the dose, to ensure that it does not decrease too much.

Black patients

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you may be pregnant.

Your doctor will advise you to stop taking olmesartan medoxomil/amlodipinebefore 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 for use at the beginning of pregnancy, and it should not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used during this period.

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

Breastfeeding

Inform your doctor if you are breastfeeding or plan to startbreastfeeding. Amlodipine has been shown to pass into breast milk in small amounts.It is not recommended to take olmesartan medoxomil/amlodipinein mothers who are breastfeeding, 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, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

During blood pressure treatment, you may experience drowsiness, feel sick or dizzy, or have a headache. If this occurs, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

Olmesartán/Amlodipino Aurovitas contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them beforetakingthismedication.

Olmesartán/Amlodipino Aurovitas contains sodium

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

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

• The recommended dose of olmesartán medoxomilo/amlodipino is one tablet per day.
• 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 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 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 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.

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

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

If you forget to take Olmesartán/Amlodipino Aurovitas

If you forget to take a dose, take the usual dose the next day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Olmesartán/Amlodipino Aurovitas

It is essential to continue taking olmesartán medoxomilo/amlodipino, 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 medications, this medication 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 can be serious, although they may affect only a small group of people:

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/amlodipineand 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 (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 some 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 olmesartanmedoxomil/amlodipine:

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

• Dizziness
• Headache
• Swelling of the ankles, feet, legs, hands, or arms
• Fatigue.

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

• Dizziness when standing up
• Lack of energy
• Tickling or numbness of the hands or feet
• Dizziness
• Noticing heartbeats
• Fast heartbeats
• Low blood pressure with symptoms such as dizziness, fainting
• Difficulty breathing
• Cough
• Nausea
• Vomiting
• Indigestion
• Diarrhea
• Constipation
• Dry mouth
• Abdominal pain
• Skin rash
• Cramps
• Pain in the arms and legs
• Back pain
• Urgency to urinate
• Sexual dysfunction
• 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 levels of potassium in the blood, increased levels of creatinine in the blood, increased levels of uric acid, and increased values of liver function tests (gamma-glutamyl transferase levels).

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

• Medication hypersensitivity
• Fainting
• Redness and sensation of heat in the face
• Red, itchy patches (urticaria)
• Face 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
• Gastroenteritis caused by a virus, diarrhea
• Indigestion
• Nausea
• Pain in the joints or bones
• Back pain
• Blood in the urine
• Urinary tract infection
• Chest pain
• Symptoms similar to the flu
• Pain
• Changes in the results of blood tests, such as increased levels of a type of fat (hypertriglyceridemia); increased uric acid and urea in the blood, and increased values of liver and muscle function tests.

Infrequent (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
• Quick 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, known as angina pectoris)
• Itching
• Skin rash
• Allergic skin rash
• Urticaria, red, itchy patches
• Swelling of the face
• Muscle pain
• Discomfort.

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

• Inflammation of the face, mouth, and/or larynx (vocal cords)
• Acute renal failure and renal insufficiency
• Lethargy.

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 the ankles
• Sensation of sleepiness
• Redness and sensation of heat in the face
• Visual disturbances (including double vision and blurred vision)
• Noticing heartbeats
• Diarrhea
• Constipation
• Indigestion
• Cramps
• Weakness
• Difficulty breathing.

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

• Difficulty sleeping
• Sleep disorders
• Changes in mood, including anxiety
• Depression
• Irritability
• Tremors
• Changes in taste
• Fainting
• Tinnitus (ringing in the ears)
• Worsening of angina pectoris (chest pain or discomfort)
• Irregular heartbeat
• Nasal secretion or congestion
• Loss of hair
• Purple spots or patches on the skin due to small hemorrhages (purpura)
• Decoloration of the skin
• Excessive sweating
• Skin rash
• Itching
• Urticaria, red, itchy patches, pain in the joints or muscles
• Difficulty urinating
• Urinary urgency at night
• Increased urinary frequency
• 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):

• 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 cause bruising and prolong bleeding time
• Increased blood glucose
• Increased muscle tension or increased resistance to passive movement (hypertonia)
• Tickling or numbness of the hands or feet
• Heart attack
• Vascular inflammation
• Inflammation of the liver or pancreas
• Inflammation of the stomach wall
• Encysted gingivitis
• Elevated liver enzymes
• Yellow skin and eyes
• Increased sensitivity of the skin to light
• Severe 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 skin, severe itching, blisters, peeling, and inflammation of the skin, inflammation of the mucous membranes (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 with dragging of 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 prospectus. 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 medication.

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

Do not use this medication after the expiration date that appears on the box, blister pack, or label after “CAD”. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

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

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

-The other components are:

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

Tablet coating:partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), talc, macrogol 4000, yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the package

Film-coated tablet.

Film-coated tablets of cream color, round, biconvex, with the inscription “K” on one face and “28” on the other face.

Olmesartan/Amlodipine Aurovitas 40 mg/5 mg film-coated tablets 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 responsible

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer responsible

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 medicinal product is authorized in the Member States of the European Economic Area with the following names:

Bélgica:Olmesartan/Amlodipine AB 40 mg/5 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Alemania:Olmesartan/AmlodipinPUREN 40 mg/5 mg Filmtabletten

Países Bajos:Olmesartan medoxomil/Amlodipine Aurobindo 40 mg/5 mg, filmomhulde tabletten

Portugal:Amlodipina + Olmesartan medoxomilo Generis

España:Olmesartán/Amlodipino Aurovitas 40 mg/5 mg comprimidos recubiertos con película EFG

Last review date of this leaflet:July 2022

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