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

Introduction

Package Leaflet: Information for the User

Olmesartan/Amlodipine TecniGen 20 mg/5 mg film-coated tablets EFG

Olmesartan/Amlodipine TecniGen 40 mg/5 mg film-coated tablets EFG

Olmesartan/Amlodipine TecniGen 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

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

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

Olmesartan/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, and thus also 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 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 TecniGen

Do not take Olmesartan/Amlodipine TecniGen:

• 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 lactation”).
• 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 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 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 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 use olmesartan medoxomil/amlodipine.

Tell your doctorif you are taking any of the following medicines 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 need to 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 TecniGen”.

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. Your doctor will decide whether to continue treatment. Do not stop taking olmesartan/amlodipine on your own.

Contact your doctor if you suffer from severe, persistent, and weight-loss-causing diarrhea. 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 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. 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 lactation”).

Children and adolescents

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

Other medicines and Olmesartan/Amlodipine TecniGen

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 olmesartan medoxomil/amlodipine.

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

If you are taking a converting enzyme inhibitor (e.g., enalapril, lisinopril, ramipril) or aliskiren (see also the information under the headings “Do not take Olmesartan/Amlodipine TecniGen” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing 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 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, 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 might take any other medicine.

Taking Olmesartan/Amlodipine with food and drinks

Olmesartan/Amlodipine can be taken with or without food. Take the tablets with a little liquid (e.g., a glass of water). If possible, take your daily dose at the same time each day, e.g., at breakfast time.

People taking olmesartan medoxomil/amlodipine must 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 ensure that 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 lactation

If you are pregnant or breastfeeding, 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 might be.

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.

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 for breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed, 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 disappeared. Consult your doctor.

Olmesartan/Amlodipine TecniGen contains lactose and sodium

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

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

3. How to take Olmesartan/Amlodipine TecniGen

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of 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 (e.g., 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, e.g., at breakfast time.

If you take more Olmesartan/Amlodipine TecniGen than you should

If you take more tablets than you should, you will probably suffer from low 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 immediately or go to the nearest emergency center 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 TecniGen:

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 TecniGen:

It is important to continue taking olmesartan medoxomil/amlodipine, unless your doctor tells you to stop. If you have any other 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 interruption 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 may occur, which can affect the whole body, with inflammation of the face, mouth, and/or larynx (vocal cords), along with itching and skin rash. Severe skin reactions, including intense skin rash, hives, redness of the skin all over the body, intense itching, blistering, peeling, and skin inflammation, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions. If this happens to you, stop taking olmesartan medoxomil/amlodipine and 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.

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 medoxomil/amlodipine a long time ago, contact your doctor immediatelywho will assess your symptoms and decide how to continue with blood pressure treatment.

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); 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; joint and 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 the blood, and increased liver and muscle function test values.

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

Decrease 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), 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 secretion or congestion; hair loss; purple spots or 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; urination problems; need to urinate at night; increased need to urinate, increased breast size 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):

Decrease in the number of white blood cells, which could increase the risk of infections; decrease 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 increased resistance to passive movement (hypertonia); tingling or numbness of the hands or feet; heart attack; blood vessel inflammation; liver or pancreas inflammation; stomach wall inflammation; 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 skin all over the body, intense itching, blisters, peeling, and skin inflammation, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions.

Unknown frequency (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 prospectus. You can also report it 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. Conservation of Olmesartan/Amlodipine TecniGen

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

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.

No special storage conditions are required.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Olmesartan/Amlodipine TecniGen:

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

Olmesartan/Amlodipine TecniGen 20 mg/5 mg film-coated tablets EFG: each tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besylate).

Olmesartan/Amlodipine TecniGen 40 mg/5 mg film-coated tablets EFG: each tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besylate).

Olmesartan/Amlodipine TecniGen 40 mg/10 mg film-coated tablets EFG:

Each tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as amlodipine besylate).

The other components are:

Tablet core:Povidone, pregelatinized starch (from corn), silicified microcrystalline cellulose (microcrystalline cellulose and anhydrous colloidal silica), lactose monohydrate, magnesium stearate

Tablet coating:Poly(vinyl alcohol), macrogol, talc, titanium dioxide (E 171), yellow iron oxide (E 172), in the 5 mg/40 mg and 10 mg/40 mg doses, red iron oxide (E 172), in the 10 mg/40 mg dose.

Appearance of the product and package contents

Olmesartan/Amlodipine TecniGen 20 mg/5 mg film-coated tablets EFG:

are white, round tablets with beveled edges, 6.10 mm ± 0.20 mm in diameter, with the inscription "OA1" on one face and smooth on the other.

Olmesartan/Amlodipine TecniGen 40 mg/5 mg film-coated tablets EFG:

are cream-colored, round tablets with beveled edges, 8.10 mm ± 0.20 mm in diameter, with the inscription "OA3" on one face and smooth on the other.

Olmesartan/Amlodipine TecniGen 40 mg/10 mg film-coated tablets EFG:

are brown-red, round tablets with beveled edges, 8.10 mm ± 0.20 mm in diameter, with the inscription "OA4" on one face and smooth on the other.

Olmesartan/Amlodipine TecniGen is available in packages of 28 film-coated tablets.

Marketing authorization holder

Tecnimede España, Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) Spain

Manufacturer

Laboratori Fundación DAU

C/ C, 12-14 Pol. Ind. Zona Franca,

Barcelona, 08040, Spain

Or

Atlantic Pharma – Produções Farmacêuticas S.A.

Rua da Tapada Grande, nº 2, Abrunheira,

2710 – 089 Sintra

Portugal

Or

Tecnimede – Sociedade Técnico-Medicinal S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

Date of the last revision of this prospectus: February 2025

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/