OLMESARTAN/AMLODIPINE KERN PHARMA 40 mg/10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Olmesartan/Amlodipine Kern Pharma contains two active substances called olmesartan medoxomil and amlodipine (as amlodipine besylate). Both substances help to control high blood pressure.

• Olmesartan 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 Kern Pharma is used to treat high blood pressure in patients whose blood pressure is not adequately controlled with olmesartan or amlodipine alone.

2. What you need to know before you take Olmesartan/Amlodipine Kern Pharma

Do not take Olmesartan/Amlodipine Kern Pharma

• If you are allergic to olmesartan, 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/Amlodipine Kern Pharma.

• If you are more than 3 months pregnant. It is better to avoid Olmesartan/Amlodipine Kern Pharma 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 poor heart function (causing difficulty breathing or swelling) after a heart attack (acute myocardial infarction).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Olmesartan/Amlodipine Kern Pharma.

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 Kern Pharma”.

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 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.

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

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/Amlodipine Kern Pharma is not recommended during the first trimester 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 during this period (see section “Pregnancy and breast-feeding”).

Children and adolescents (under 18 years)

Olmesartan/Amlodipine Kern Pharma is not recommended for children and adolescents under 18 years.

Using Olmesartan/Amlodipine Kern Pharma with other medicines

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/Amlodipine Kern Pharma.

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 Kern Pharma” 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). Using these medicines at the same time as Olmesartan/Amlodipine Kern Pharma may increase potassium levels in the blood.

• Lithium(a medicine used to treat mood changes and some types of depression) used at the same time as Olmesartan/Amlodipine Kern Pharma 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) used at the same time as Olmesartan/Amlodipine Kern Pharma may increase the risk of kidney problems. The effect of Olmesartan/Amlodipine Kern Pharma may be reduced by NSAIDs.

• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of Olmesartan/Amlodipine Kern Pharma. Your doctor may advise you to take Olmesartan/Amlodipine Kern Pharma at least 4 hours before colesevelam hydrochloride.

• Certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of Olmesartan/Amlodipine Kern Pharma.
• 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).
• St. John's Wort(Hypericum perforatum), a herbal remedy.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, a medicine used to lower blood cholesterol and fat (triglyceride) levels.
• Tacrolimus, 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 Kern Pharma with food and drinks

Olmesartan/Amlodipine Kern Pharma 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/Amlodipine Kern Pharma must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can cause 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/Amlodipine Kern Pharma.

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 drop too much.

Black patients

As with other similar medicines, the blood pressure-lowering effect of Olmesartan/Amlodipine Kern Pharma 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.

Your doctor will advise you to stop taking Olmesartan/Amlodipine Kern Pharma before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Olmesartan/Amlodipine Kern Pharma. Olmesartan/Amlodipine Kern Pharma is not recommended during the first trimester 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 during this period.

If you become pregnant while taking Olmesartan/Amlodipine Kern Pharma, inform your doctor immediately.

Breast-feeding

Amlodipine has been shown to pass into breast milk in small amounts.

Tell your doctor if you are breast-feeding or about to start breast-feeding. Olmesartan/Amlodipine Kern Pharma 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.

3. How to take Olmesartan/Amlodipine Kern Pharma

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are not sure, ask your doctor or pharmacist again.

• The recommended dose of Olmesartan/Amlodipine Kern Pharma 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/Amlodipine Kern Pharma 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 Kern Pharma 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 swallows some tablets, contact your doctor or go to the nearest emergency department immediately 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 Kern Pharma

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 Kern Pharma

It is important to continue taking Olmesartan/Amlodipine Kern Pharma 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 interruption of treatment.

The following adverse effects may be serious, although they affect only a small group of people:

During treatment with Olmesartan/Amlodipino Kern Pharma, 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. If this happens to you, stop taking Olmesartan/Amlodipino Kern Pharma and consult your doctor immediately.

Olmesartan/Amlodipino Kern Pharma 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/Amlodipino Kern Pharma, consult your doctor immediately, and remain lying down in a horizontal position.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started treatment with Olmesartan/Amlodipino Kern Pharma a long time ago, contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with blood pressure treatment.

Other possible adverse effects with Olmesartan/Amlodipino Kern Pharma:

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.

Some changes in the results of certain blood tests have also 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; flushing and feeling of heat in the face; red hives with itching (urticaria); facial inflammation.

Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Adverse effects reported with the use of olmesartan medoxomil or amlodipine alone, but not with Olmesartan/Amlodipino Kern Pharma, or with a higher frequency:

Olmesartan

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.

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; feeling of sleepiness; flushing 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; breast enlargement 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 glucose in the blood; increased muscle tension or greater resistance to passive movement (hypertonia); tingling or numbness of the hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach wall; 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 body skin, severe itching, blisters, peeling, and skin inflammation, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions, sometimes very severe.

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 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. Conservation of Olmesartan/Amlodipino Kern Pharma

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 and on the blister pack (after "CAD"). The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that 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 that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Olmesartan/Amlodipino Kern Pharma

The active ingredients are:

Olmesartan/Amlodipino Kern Pharma 40 mg/10 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as amlodipine besylate).

The other components (excipients) are: pregelatinized cornstarch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, Opadry II white 85F18422 (contains: poly(vinyl alcohol), titanium dioxide (E-171), macrogol 4000, and talc), and red iron oxide (E-172).

Appearance of the product and package contents

Olmesartan/Amlodipino Kern Pharma 40 mg/10 mg is presented in the form of film-coated tablets, reddish in color, round, biconvex, and with the inscription 410 on one face.

Olmesartan/Amlodipino Kern Pharma film-coated tablets are presented in a package of 28 tablets.

Marketing authorization holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last revision of this prospectus: February 2025.

Other sources of information

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.