Leaflet: information for the user

Olmesartan/Amlodipino Krka 20 mg/5 mg film-coated tablets

Olmesartan/Amlodipino Krka 40 mg/5 mg film-coated tablets

Olmesartan/Amlodipino Krka 40 mg/10 mg film-coated tablets

olmesartan medoxomil/amlodipine

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 give it to others even if they have the same symptoms as you, as it may harm them.

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

Olmesartan/AmlodipinoKrkacontains two substances called olmesartan medoxomil and amlodipine (as amlodipine besylate). The two substances help control high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor antagonists.” Angiotensin II is a substance produced in your body that causes your blood vessels to constrict, increasing your blood pressure. Olmesartan medoxomil blocks the effect of angiotensin II so that your blood vessels relax and your blood pressure decreases.
• Amlodipine belongs to a group of medicines called “calcium channel blockers.” Amlodipine prevents calcium from entering the blood vessel wall, preventing blood vessel constriction, which also decreases blood pressure.

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

Olmesartan/AmlodipinoKrkais used to treat high blood pressure (hypertension) in patients who are already being treated with olmesartan medoxomil and amlodipine at these doses, instead of taking two separate medicines.

Do not take Olmesartan/Amlodipino Krka

• if you are allergic to olmesartan, or to amlodipino or to any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (It is better to avoid Olmesartan/Amlodipino Krka at the beginning of pregnancy – see section “Pregnancy and breastfeeding”).
• if you have yellow skin and eyes (jaundice) or problems with the drainage of bile from the gallbladder (biliary obstruction, for example, gallstones).
• if you have very low blood pressure (hypotension).
• if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which your heart is unable to supply enough blood to the body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskireno.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartan/Amlodipino Krka.

Tell your doctorif you have any of the following health problems:

• Kidney problems
• Liver disease
• Recent heart attack
• Severe increase in blood pressure (hypertensive crisis)
• You are of advanced age and your dose must be increased
• Heart failure or problems with heart valves or heart muscle
• Intense vomiting, diarrhea, treatment with high doses of medicines that increase urine elimination (diuretics), or if you are on a low-salt diet
• Elevated potassium levels in the blood
• Problems with the adrenal glands (glands that produce hormones located above the kidneys)
• If you are taking any of the following medicines used to treat high blood pressure:
• • a converting enzyme inhibitor (ACE inhibitor) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskireno.

Your doctor may check your kidney function, blood pressure, and electrolyte levels in the blood (such as potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartan/Amlodipino Krka”.

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

Contact your doctor if you have 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 medicine that lowers blood pressure, an excessive decrease in blood pressure in patients with altered blood flow in the heart or brain can cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You must inform your doctor if you are pregnantor think you may be. Olmesartan/Amlodipino Krka 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

Olmesartan/Amlodipino Krka is not recommended for children and adolescents under 18 years.

Older patients

If you are over 65 years old, your doctor will regularly check your blood pressure whenever 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/Amlodipino Krka is somewhat less in black patients.

Other medicines and Olmesartan/Amlodipino Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medicines:

• Other blood pressure-lowering medicines, as they may increase the effect of Olmesartan/Amlodipino Krka. Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskireno (see also the information under the headings “Do not take Olmesartan/Amlodipino Krka” and “Warnings and precautions”).

• Supplements of potassium, salt substitutes containing potassium, diuretics, or heparin (to thin the blood and prevent blood clots). The use of these medicines at the same time as Olmesartan/Amlodipino Krka may increase potassium levels in the blood.
• Lithium (medicine used to treat mood changes and some types of depression) used at the same time as Olmesartan/Amlodipino Krka may increase its toxicity. If you need to take lithium, your doctor will measure lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) used at the same time as Olmesartan/Amlodipino Krka may increase the risk of kidney failure. The effect of Olmesartan/Amlodipino Krka may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of Olmesartan/Amlodipino Krka. Your doctor may advise you to take Olmesartan/Amlodipino Krka at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion and heartburn), as they may slightly reduce the effect of Olmesartan/Amlodipino Krka.
• Ketoconazole, itraconazole (for the treatment of fungal infections).
• Ritonavir, indinavir, nelfinavir (medicines used for HIV/AIDS).
• Rifampicin, erythromycin, clarithromycin (medicines used for bacterial infections).
• Hypericum perforatum(St. John's Wort).
• Diltiazem, verapamil (medicines used for heart problems).
• Dantrolene (in infusion for severe abnormalities of body temperature).
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medicine used to alter the functioning of your immune system).
• Simvastatin (medicine used to lower cholesterol levels).
• Ciclosporin (immunosuppressant).

Taking Olmesartan/Amlodipino Krka with food and drinks

Olmesartan/Amlodipino Krkacan be taken with or without food.

People taking Olmesartan/Amlodipino Krka should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in blood levels of the active ingredient amlodipino, which may cause an unpredictable increase in the blood pressure-lowering effect of Olmesartan/Amlodipino Krka.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you are pregnant, or if you think you may be. Your doctor will advise you to stop taking Olmesartan/Amlodipino Krka before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Olmesartan/Amlodipino Krka. Olmesartan/Amlodipino Krka 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.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan/Amlodipino Krka is 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.

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

Driving and operating machines

Olmesartan/Amlodipino Krka may affect your ability to drive or operate machines. If the tablets make you feel sick, dizzy, or tired, or give you a headache, do not drive or operate machines and contact your doctor immediately.

Olmesartan/Amlodipino Krka contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

This medicine contains less than 1 mmolof sodium (23 mg) per tablet; that is, it is essentially “sodium-free”.

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

The recommended dose of Olmesartan/Amlodipino Krka is one tablet per day.

Take the tablets with a little liquid (such as a glass of water) with or without food. If possible, take your daily dose at the same time each day. Do not take Olmesartan/Amlodipino Krka with grapefruit juice.

It is essential that you continue taking Olmesartan/Amlodipino Krka until your doctor tells you otherwise.

If you take more Olmesartan/Amlodipino Krka than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or go to the nearest emergency center.

If you take more tablets than you should, you will likely experience a drop in blood pressure, which can be severe. You may feel dizzy, disoriented, depressed, or weak. If the drop in blood pressure is severe enough, you may experience shock. Your skin may feel cold and clammy, and you may lose consciousness.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty breathing, which can develop within 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 Olmesartan/Amlodipino Krka

If you forget to take a dose, do not worry. Take it as soon as you remember and continue as before. If you forget to take your tablet one day, take the normal dose the next day. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Olmesartan/Amlodipino Krka

Your doctor will tell you how long you should take your medication. Your condition may return if you stop using your medication before being advised to do so. 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.

Although not many people may experience them, the following side effects can be serious. Consult your doctor immediatelyif you experience any of the following side effects after taking this medicine.

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat that causes severe difficulty breathing
• Severe skin reactions including intense skin rashes, urticaria, skin redness all over the body, intense itching, blisters, peeling, and skin swelling, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heart rhythm
• Inflamed pancreas that can cause severe abdominal and back pain accompanied by a feeling of discomfort

Rarely (but slightly more frequent in older people) Olmesartan/Amlodipino Krka can lower blood pressure too much in susceptible individuals or as a result of an allergic reaction. This could cause severe dizziness or fainting. If this occurs, stop taking Olmesartan/Amlodipino Krka, immediately contact your doctor, and lie down.

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

Possible side effects of OLMESARTAN:

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

• Dizziness, headache,
• Nausea, indigestion, diarrhea, stomach pain, gastroenteritis,
• Fatigue,
• Sore throat, secretion or nasal congestion, bronchitis, flu-like symptoms, cough,
• Pain, chest pain, back pain, bone, or joint pain,
• Urinary tract infection,
• Swelling of ankles, feet, legs, hands, or arms,
• Blood in urine.

Some changes in blood tests have also been observed, including the following:

• Increased levels of fat (hypertriglyceridemia),
• Increased levels of uric acid (hyperuricemia),
• Increased blood urea,
• Increases in liver and muscle function tests.

Rare side effects(may affect up to 1 in 100 people):

• Quick allergic reactions that can affect the whole body and cause respiratory problems, as well as a rapid drop in blood pressure that can even lead to fainting (anaphylactic reactions),
• Dizziness,
• Vomiting,
• Weakness, discomfort,
• Muscle pain,
• Rash on the skin, allergic skin eruptions, itching, exanthema (skin eruption), skin bumps (papules),
• Angina (chest pain or discomfort).

Reduced blood platelet count (thrombocytopenia) has been observed in blood tests.

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

• Lack of energy,
• Intestinal angioedema: swelling in the intestine that is accompanied by symptoms such as abdominal pain, nausea, vomiting, and diarrhea,
• Muscle cramps,
• Renal function deterioration, renal insufficiency.

Some changes in blood test results have also been observed. These include increased levels of potassium (hyperkalemia) and increased levels of compounds related to renal function.

Possible side effects of AMLODIPINO:

The following very frequent side effect has been described. If this causes you problems or lasts more than a week, you should contact your doctor.

Very frequent side effects(may affect up to 1 in 10 people):

• Edema (fluid retention).

The following frequent side effects have been reported. If any of these cause you problems or last more than a week, you should contact your doctor.

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

• Headache, dizziness, drowsiness (especially at the start of treatment),
• Palpitations (awareness of your heartbeat), flushing,
• Abdominal pain, discomfort (nausea),
• Alteration of bowel habits, diarrhea, constipation, indigestion,
• Fatigue, weakness,
• Visual disturbances, double vision,
• Muscle cramps,
• Swelling of ankles.

Other side effects that have been reported include the following list. If any of these symptoms worsen or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Rare side effects(may affect up to 1 in 100 people):

• Mood changes, anxiety, depression, insomnia,
• Tremors, taste disturbances, fainting,
• Numbness or tingling in limbs, loss of pain sensation,
• Ringing in the ears,
• Low blood pressure,
• Nasal congestion/secreting caused by inflammation of the nasal mucosa (rhinitis),
• Cough,
• Dry mouth, vomiting (being sick),
• Hair loss, increased sweating, skin itching, red patches on the skin, skin discoloration,
• Urination changes, increased need to urinate at night, increased frequency of urination,
• Inability to get an erection, discomfort or breast enlargement in men
• Pain, discomfort,
• Joint or muscle pain, back pain,
• Weight gain or loss.

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

• Confusion.

Very rare side effects(may affect up to 1 in 10,000 people):

• Decreased white blood cell count, decreased platelet count in blood, which can result in unusual bruising or bleeding (damage to red blood cells),
• High blood sugar (hyperglycemia),
• A nerve disorder that can cause weakness, numbness, or tingling,
• Gingivitis (inflammation of the gums),
• Abdominal swelling (gastritis),
• Liver function alteration, hepatitis (inflammation of the liver), yellow skin (jaundice), increased liver enzyme that can affect some medical tests,
• Muscle tension increase,
• Inflammation of blood vessels, often with skin rash,
• Sensitivity to light.

Side effects of unknown frequency(cannot be estimated from available data):

• Tremor, stiff posture, mask-like face, slow movements, and dragging feet, unsteadily.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for 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 after “CAD”. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture.

This medication does not require any special storage temperature.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Olmesartan/Amlodipino Krka

• The active ingredients are olmesartan medoxomil and amlodipine.
• Each film-coated tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besilate).

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

Each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besilate).

• The other components (excipients) are siliconized microcrystalline cellulose (cellulose, microcrystalline, anhydrous colloidal silica), pregelatinized maize starch, lactose monohydrate, sodium croscarmellose and magnesium stearate (E470b) in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172) - only for 40 mg/5 mg film-coated tablets and 40 mg/10 mg film-coated tablets - and red iron oxide (E172) - only for 40 mg/10 mg film-coated tablets. See section 2 “Olmesartan/Amlodipino Krka contains lactose and sodium”.

Appearance of the product and contents of the package

20 mg /5 mg film-coated tablets: film-coated tablet, white or almost white, round, biconvex and with beveled edges. Tablet dimensions: diameter: 7 mm, thickness: 2.5 - 4.2 mm.

40 mg /5 mg film-coated tablets: film-coated tablet, pale yellowish-brown, round, biconvex, with beveled edges and marked with a 5 on one face of the tablet. Tablet dimensions: diameter: 9 mm, thickness: 3.6 - 5.3 mm.

40 mg /10 mg film-coated tablets: film-coated tablet, reddish-brown, round, biconvex with beveled edges and scored on one face of the tablet. Tablet dimensions: diameter: 9 mm, thickness: 3.6 - 5.3 mm.

The tablet can be divided into equal doses.

Olmesartan/Amlodipino Krka is available in blister packs of 14, 28, 30, 56, 60, 84, 90, 98 film-coated tablets, and in single-dose blister packs of 14x1, 28x1, 30x1, 56x1, 60x1, 84x1, 90x1, 98x1 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain.

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

Last review date of this leaflet:March 2025

Further 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/).