Olmesartan/amlodipine Kern Pharma 40 mg/5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Olmesartan/Amlodipine Kern Pharma 40 mg/5 mg film-coated tablets EFG

Olmesartan medoxomil/Amlodipine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult 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 Kern Pharma is and what it is used for
2. What you need to know before taking Olmesartan/Amlodipine Kern Pharma
3. How to take Olmesartan/Amlodipine Kern Pharma
4. Possible side effects
5. How to store Olmesartan/Amlodipine Kern Pharma
6. Contents of the pack and other information

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

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

• Olmesartán 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 called “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 reducing blood pressure.

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

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

Do not take Olmesartán/Amlodipino Kern Pharma

• If you are allergic to olmesartan, or to amlodipine, or to a specific 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 Olmesartán/Amlodipino Kern Pharma.

• If you are more than 3 months pregnant. It is best to avoid Olmesartán/Amlodipino Kern Pharma 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 from 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 Olmesartán/Amlodipino Kern Pharma.

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), especially 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 Olmesartán/Amlodipino Kern Pharma”.

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.

Consult your doctor if you develop abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartán/Amlodipino Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartán/Amlodipino Kern Pharma when used as monotherapy.

As with any other medicine that lowers blood pressure, excessive reduction 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. Use of Olmesartán/Amlodipino Kern Pharma 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 taken at this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years of age)

Olmesartán/Amlodipino Kern Pharma is not recommended for children and adolescents under 18 years of age.

Taking Olmesartán/Amlodipino Kern Pharam with other medicines

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 enhance the effect of Olmesartán/Amlodipino Kern Pharma.

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Olmesartán/Amlodipino Kern Pharma” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, diuretics (medicines that increase urine output), or heparin (used to thin the blood and prevent blood clots). Taking these medicines together with Olmesartán/Amlodipino Kern Pharma may increase potassium levels in the blood.

• Lithium (a medicine used to treat mood disorders and certain types of depression) taken together with Olmesartán/Amlodipino Kern Pharma 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 Olmesartán/Amlodipino Kern Pharma may increase the risk of kidney failure. The effect of Olmesartán/Amlodipino Kern Pharma may be reduced by NSAIDs.

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

• Certain antacids (remedies for indigestion and acidity), as they may slightly reduce the effect of Olmesartán/Amlodipino Kern Pharma.

• Medicines used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir) or for treating fungal infections (e.g., ketoconazole, itraconazole).

• Diltiazem, verapamil (medicines used for heart rhythm disorders and high blood pressure).

• Rifampicin, erythromycin, clarithromycin (antibiotics).

• St. John’s wort (Hypericum perforatum), a herbal remedy.

• Dantrolene (by infusion for severe disturbances in body temperature).

• Simvastatin, a medicine used to lower cholesterol and fat (triglyceride) levels in the blood.

• Tacrolimus, cyclosporine, used to control the body's immune response, allowing acceptance of a transplanted organ.

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

Taking Olmesartán/Amlodipino Kern Pharma with food and drinks

Olmesartán/Amlodipino Kern Pharma 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.

Patients taking Olmesartán/Amlodipino Kern Pharma 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 Olmesartán/Amlodipino Kern Pharma.

Elderly patients

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

Black patients

As with other similar medicines, the blood pressure-lowering effect of Olmesartán/Amlodipino Kern Pharma 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 Olmesartán/Amlodipino Kern Pharma before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Olmesartán/Amlodipino Kern Pharma. Use of Olmesartán/Amlodipino Kern Pharma is not recommended during early pregnancy, and 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 onwards.

If you become pregnant while taking Olmesartán/Amlodipino Kern Pharma, inform and consult your doctor immediately.

Breastfeeding

It has been shown that amlodipine passes into breast milk in small amounts.

Inform your doctor if you are breastfeeding or planning to breastfeed. Olmesartán/Amlodipino Kern Pharma is not recommended for breastfeeding mothers, and your doctor may choose another 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 headaches. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor.

3. How to take Olmesartán/Amlodipino Kern Pharma

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

• The recommended dose of Olmesartán/Amlodipino Kern Pharma 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 Olmesartán/Amlodipino Kern Pharma with grapefruit juice.
• If possible, take your daily dose at the same time each day, for example, with breakfast.

If you take more Olmesartán/Amlodipino Kern Pharma than you should

If you take more tablets than you should, you may 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 some tablets, contact your doctor immediately or go to the nearest emergency center, and bring the medicine packaging or this leaflet with you.

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Olmesartán/Amlodipino Kern Pharma

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

If you stop taking Olmesartán/Amlodipino Kern Pharma

It is important to continue taking Olmesartán/Amlodipino Kern Pharma 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/Amlodipine Kern Pharma, allergic reactions may occur, which can affect the whole 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/Amlodipine Kern Pharma and consult your doctor immediately.

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

Other possible adverse effects with Olmesartan/Amlodipine 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 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; arm and leg pain; back pain; feeling 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:

Increase or decrease in blood potassium levels, increase in blood creatinine levels, increase in uric acid levels, elevation in liver function test values (gamma-glutamyl transferase levels).

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

Hypersensitivity to the medicine; flushing and sensation of warmth in the face; itchy red rash (urticaria); facial swelling.

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

Adverse effects reported with olmesartan medoxomil or amlodipine used alone, but not with Olmesartan/Amlodipine Kern Pharma, or reported with a higher frequency:

Olmesartan

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 and bone pain; back pain; blood in 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 whole body and may cause breathing difficulties as well as a rapid drop in blood pressure, possibly leading 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 renal failure and kidney failure; lethargy.

Intestinal angioedema: swelling in the intestine presenting 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 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 rash (urticaria); joint or muscle pain; urinary problems; need to urinate at night; increased need to urinate; breast enlargement in men; chest pain; pain; malaise; 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 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 enlargement; 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, blistering, peeling and skin inflammation, inflammation of 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 Kern Pharma

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

Do not use this medicine after the expiry date stated on the packaging and blister (after "EXP"). The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Amlodipine Kern Pharma

The active substances are:

Olmesartan/Amlodipine Kern Pharma 40 mg/5 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate).

The other components (excipients) are: pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, Opadry II White 85F18422 (containing: 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 container

Olmesartan/Amlodipine Kern Pharma 40 mg/5 mg is presented as light yellow, round, biconvex, film-coated tablets with the imprint "405" on one side.

Olmesartan/Amlodipine Kern Pharma film-coated tablets are available in packs containing 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 most recent review of this leaflet: February 2025.

Other sources of information

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