Prospect: Information for the user

Olmesartán/Amlodipino Kern Pharma 40 mg/5 mg film-coated tablets EFG

Olmesartán medoxomilo/Amlodipino

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to take Olmesartán/Amlodipino Kern Pharma

3. How to take Olmesartán/Amlodipino Kern Pharma

4. Possible adverse effects

5. Storage of Olmesartán/Amlodipino Kern Pharma

6. Contents of the package and additional information

Olmesartán/AmlodipinoKern Pharmacontains two substances called olmesartan medoxomil and amlodipine (as amlodipine besylate). The two substances help to control high blood pressure.

• Olmesartan belongs to a group of medicines called “angiotensin II receptor antagonists”, which decrease 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 blood vessel constriction, thereby also decreasing blood pressure.

The action of both substances contributes to preventing blood vessel constriction, so that they relax and blood pressure decreases.

Olmesartán/Amlodipino Kern Pharmais used to treat high blood pressure in patients whose blood pressure is not adequately controlled with olmesartan or amlodipine alone.

Do not take Olmesartán/AmlodipinoKern Pharma

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

Inform your doctor before taking Olmesartán/AmlodipinoKern Pharmaif you think you may be allergic.

• If you are more than 3 months pregnant. It is best to avoid Olmesartán/AmlodipinoKern Pharmaat 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 use Olmesartán/AmlodipinoKern Pharma.

Tell your doctorif you are taking any of the following medications used to treat high blood pressure (hypertension):

• An angiotensin-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/AmlodipinoKern 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 heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-sodium diet.
• High levels of potassium in your blood.
• Problems with the adrenal glands (glands that produce hormones located above the kidneys).

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartán/AmlodipinoKern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartán/AmlodipinoKern Pharmain monotherapy.

Like any other medication that lowers blood pressure, excessive lowering of 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. Olmesartán/AmlodipinoKern Pharmais not recommended 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)

Olmesartán/AmlodipinoKern Pharmais not recommended for children and adolescents under 18 years.

Use of Olmesartán/AmlodipinoKern Pharmawith other medications

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 Olmesartán/AmlodipinoKern Pharma.

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/AmlodipinoKern Pharma” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medications that increase urine production(diuretics), orheparin(to thin the blood and prevent blood clots). The use of these medications with Olmesartán/AmlodipinoKern Pharmamay increase potassium levels in your blood.

• Lithium(a medication used to treat mood changes and some types of depression) used at the same time as Olmesartán/AmlodipinoKern Pharmamay increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in your blood.

• Nonsteroidal anti-inflammatory drugs (NSAIDs)(medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) used at the same time as Olmesartán/AmlodipinoKern Pharmamay increase the risk of kidney failure. The effect of Olmesartán/AmlodipinoKern Pharmamay be reduced by NSAIDs.

• Colesevelam hydrochloride,a medication that lowers cholesterol levels in the blood, as it may reduce the effect of Olmesartán/AmlodipinoKern Pharma. Your doctor may advise you to take Olmesartán/AmlodipinoKern Pharmaat least 4 hours before colesevelam hydrochloride.

• Certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of Olmesartán/AmlodipinoKern Pharma.
• 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 and high blood pressure problems).
• Rifampicin, erythromycin, clarithromycin (antibiotics).
• 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, cyclosporine,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/AmlodipinoKern Pharmawith food and drinks

Olmesartán/AmlodipinoKern Pharmacan 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 Olmesartán/AmlodipinoKern Pharmashould 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 Olmesartán/AmlodipinoKern Pharma.

Older patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure whenever you increase your dose, to ensure that it does not drop too low.

Black patients

Like other similar medications, the blood pressure-lowering effect of Olmesartán/AmlodipinoKern Pharmais somewhat lower 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 Olmesartán/AmlodipinoKern Pharmabefore becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of Olmesartán/AmlodipinoKern Pharma. Olmesartán/AmlodipinoKern Pharmais not recommended 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.

If you become pregnant while taking Olmesartán/AmlodipinoKern Pharma, inform and visit your doctor immediately.

Breastfeeding

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

Inform your doctor if you are breastfeeding or plan to startbreastfeeding. Olmesartán/AmlodipinoKern Pharmais not recommended for 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, consult your doctor or pharmacist before using this medication.

Driving and operating machines

During high blood pressure treatment, you may experience drowsiness, nausea, dizziness, or headaches. If this occurs, do not drive or operate machines until the symptoms have disappeared. Consult your doctor.

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/Amlodipino Kern Pharma 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/Amlodipino 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 Olmesartán/Amlodipino Kern Pharma than you should

If you take more tablets than you should, you will likely 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.

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forget to take Olmesartán/Amlodipino Kern Pharma

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 Kern Pharma

It is essential to continue taking Olmesartán/Amlodipino Kern Pharma, 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 medicines, this medicine can 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 Olmesartán/Amlodipino Kern Pharma, allergic reactions can 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 Olmesartán/Amlodipino Kern Pharma and consult your doctor immediately.

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

Unknown frequency: If you experience yellowing of the white of the eyes, dark urine, itching of the skin, even if you started treatment with Olmesartán/Amlodipino Kern Pharma some time ago, contact your doctor immediately, who will evaluate your symptoms and decide how to continue treatment for high blood pressure.

Other possible side effects with Olmesartán/Amlodipino Kern Pharma:

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

Dizziness; headache; swelling of the ankles, feet, legs, hands, or arms; fatigue.

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

Dizziness when standing up; lack of energy; tingling or numbness of the hands or feet; vertigo; feeling the heartbeat; rapid heartbeat; low blood pressure with symptoms such as dizziness, fainting; difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth; upper abdominal pain; skin rash; cramps; arm and leg pain; back pain; sensation of urgency to urinate; sexual inactivity; inability to achieve or maintain an erection; weakness.

Some changes in the results of certain blood tests have also 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, increased values of liver function tests (gamma-glutamyl transferase levels).

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

Medication hypersensitivity; fainting; flushing and sensation of heat in the face; red itchy rash (urticaria); facial inflammation.

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

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

Olmesartan

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

Bronchitis; sore throat; congestion and nasal 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 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 (can 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; rapid 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); itching; skin rash; allergic skin eruption; urticaria; facial swelling; muscle pain; discomfort.

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

Facial, mouth, and/or laryngeal inflammation (vocal cords); acute renal failure and renal insufficiency; lethargy.

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

Amlodipine

Very frequent (can affect more than 1 in 10 people):

Edema (fluid retention).

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

Abdominal pain; nausea; swelling of the ankles; drowsiness; flushing and sensation of heat in the face, visual disturbances (including double vision and blurred vision), feeling the heartbeat, diarrhea, constipation, indigestion, cramps, weakness, difficulty breathing.

Infrequent (can 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 (chest pain or discomfort); irregular heartbeat; nasal secretion or congestion; hair loss; purple spots or patches on the skin due to small hemorrhages (purpura); skin discoloration; excessive sweating; skin rash; itching; red itchy rash (urticaria); joint or muscle pain; urinary problems; nocturia; increased need to urinate; increased size of the breasts in men; chest pain; pain; feeling of discomfort; weight gain or loss.

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

Confusion.

Very rare (can 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 the appearance of bruises and prolong bleeding time; increased glucose in the blood; increased muscle tension or increased resistance to passive movement (hypertonia); tingling or numbness of the hands or feet; heart attack; inflammation of the 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; severe allergic reactions, itching, rash, facial, mouth, and/or laryngeal inflammation (vocal cords), along with itching and rash, severe skin reactions, including intense skin eruption, urticaria, skin redness, severe itching, blisters, peeling, and skin inflammation, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other severe allergic reactions.

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 medicine.

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

Do not use this medication after the expiration date that appears on the packaging and in the blister (after “CAD”). The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Olmesartán/Amlodipino Kern Pharma

The active principles are:

Olmesartán/Amolidipino Kern Pharma 40 mg/5 mg: each film-coated tablet contains 40 mg of olmesartán medoxomilo and 5 mg of amlodipino (as amlodipino besilato).

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 yellow iron oxide (E-172).

Appearance of the product and contents of the packaging

Olmesartán/Amlodipino Kern Pharma 40 mg/5 mg is presented in the form of film-coated tablets, light yellow in color, round, biconvex, and with the inscription 405 on one face.

Olmesartán/Amlodipino Kern Pharma film-coated tablets are presented in a pack of 28 tablets.

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet: February 2025.

Other sources of information

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