OLMESARTAN/AMLODIPINE KRKA 20 mg/5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan/Amlodipine Krka 20 mg/5 mg Film-Coated Tablets

Olmesartan/Amlodipine Krka 40 mg/5 mg Film-Coated Tablets

Olmesartan/Amlodipine Krka 40 mg/10 mg Film-Coated Tablets

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

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

Olmesartan/Amlodipine Krka 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”. Angiotensin II is a substance produced in your body that makes your blood vessels narrow, thus increasing your blood pressure. Olmesartan medoxomil blocks the effect of angiotensin II, allowing your blood vessels to relax and your blood pressure to decrease.
• Amlodipine belongs to a group of medicines called “calcium channel blockers”. Amlodipine prevents calcium from entering the wall of blood vessels, preventing the blood vessels from narrowing, which also reduces blood pressure.

The action of both substances contributes to preventing the narrowing of blood vessels, allowing them to relax and reducing blood pressure.

Olmesartan/Amlodipine Krka is 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.

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

Do not take Olmesartan/Amlodipine Krka

• if you are allergic to olmesartan or amlodipine or 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/Amlodipine Krka at the start of pregnancy – see section “Pregnancy and breast-feeding”).
• if you have yellowing of the 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 heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to your body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartan/Amlodipine 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 elderly and your dose needs to be increased
• 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)
• If you are taking any of the following medicines used to treat high blood pressure:
• • 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 Krka”.

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 have severe, persistent diarrhea that causes significant weight loss. Your doctor will assess 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 impaired blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You should inform your doctor if you are pregnant or think you might be. Olmesartan/Amlodipine Krka is not recommended during the first trimester of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Children and adolescents

Olmesartan/Amlodipine Krka is not recommended for children and adolescents under 18 years of age.

Elderly 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 drop too much.

Black patients

As with other similar medicines, the blood pressure-lowering effect of Olmesartan/Amlodipine Krka is somewhat less in black patients.

Other medicines and Olmesartan/Amlodipine Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including:

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

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

• Potassium supplements, salt substitutes that contain 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/Amlodipine Krka 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/Amlodipine Krka may increase lithium toxicity. If you need to take lithium, your doctor will measure 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 at the same time as Olmesartan/Amlodipine Krka may increase the risk of kidney failure. The effect of Olmesartan/Amlodipine Krka may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of Olmesartan/Amlodipine Krka. Your doctor may advise you to take Olmesartan/Amlodipine Krka at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion and heartburn), as they may slightly reduce the effect of Olmesartan/Amlodipine 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 body temperature abnormalities).
• Tacrolimus, sirolimus, temsirolimus, and everolimus (a medicine used to alter the functioning of your immune system).
• Simvastatin (a medicine used to lower cholesterol levels).
• Cyclosporin (an immunosuppressant).

Taking Olmesartan/Amlodipine Krka with food and drinks

Olmesartan/Amlodipine Krka can be taken with or without food.

People taking Olmesartan/Amlodipine Krka should 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 can cause an unpredictable increase in the blood pressure-lowering effect of Olmesartan/Amlodipine Krka.

Pregnancy and breast-feeding

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.

Pregnancy

You should inform your doctor if you are pregnant or think you might be. Your doctor will advise you to stop taking Olmesartan/Amlodipine Krka 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 Krka. Olmesartan/Amlodipine Krka is not recommended during the first trimester of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Breast-feeding

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

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

Driving and using machines

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

Olmesartan/Amlodipine Krka contains lactose and sodium

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

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

3. How to take Olmesartan/Amlodipine Krka

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose of Olmesartan/Amlodipine 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/Amlodipine Krka with grapefruit juice.

It is important that you continue to take Olmesartan/Amlodipine Krka until your doctor tells you to stop.

If you take more Olmesartan/Amlodipine Krka than you should

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

If you take more tablets than you should, you may experience a drop in blood pressure, which can lead to dizziness, drowsiness, or weakness. You may feel faint or lose consciousness. Your skin may feel cold and clammy, and you may experience shock.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which 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 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 forgotten dose.

If you stop taking Olmesartan/Amlodipine Krka

Your doctor will tell you how long to take your medicine. Your condition may return if you stop using your medicine before your doctor advises. 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 interrupting treatment.

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

• Sudden wheezing, chest pain, shortness of breath or difficulty breathing
• Swelling of eyelids, face or lips
• Swelling of the tongue and throat that causes great difficulty breathing
• Severe skin reactions including intense skin rashes, hives, redness of the skin all over the body, intense itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heartbeat
• 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 may lower blood pressure too much in susceptible individuals or as a result of an allergic reaction. This could cause dizziness or severe fainting. If this happens, stop taking Olmesartan/Amlodipino Krka, contact your doctor immediately and lie down.

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

Possible Adverse Effects of OLMESARTAN:

Frequent Adverse Effects(may affect up to 1 in 10 people):

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

Infrequent Adverse Effects(may affect up to 1 in 100 people):

• Rapid allergic reactions that can affect the whole body and can cause respiratory problems, as well as a rapid drop in blood pressure that can even lead to fainting (anaphylactic reactions),
• Vertigo,
• Vomiting,
• Weakness, discomfort,
• Muscle pain,
• Skin rash, allergic skin rashes, itching, exanthema (skin rash), skin bumps (papules),
• Angina (pain or discomfort in the chest).

In blood tests, a reduction in the number of a type of blood cell, known as platelets (thrombocytopenia), has been observed.

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

• Lack of energy,
• Intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting and diarrhea,
• Muscle cramps,
• Kidney function impairment, kidney failure.

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

Possible Adverse Effects of AMLODIPINO:

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

Very Frequent Adverse Effects(may affect up to 1 in 10 people):

• Edema (fluid retention).

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

Frequent Adverse 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),
• Changes in bowel habits, diarrhea, constipation, indigestion,
• Fatigue, weakness,
• Visual disturbances, double vision,
• Muscle cramps,
• Swelling of ankles.

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

Infrequent Adverse Effects(may affect up to 1 in 100 people):

• Mood changes, anxiety, depression, insomnia,
• Tremors, taste disturbances, fainting,
• Feeling of numbness or tingling in the limbs, loss of pain sensation,
• Ringing in the ears,
• Low blood pressure,
• Sneezing/nasal secretion caused by inflammation of the nasal lining (rhinitis),
• Cough,
• Dry mouth, vomiting (being sick),
• Hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration,
• Urination changes, increased need to urinate at night, increased number of times urinating,
• Impotence, discomfort or enlargement of the breasts in men
• Pain, discomfort,
• Joint or muscle pain, back pain,
• Weight gain or loss.

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

• Confusion.

Very Rare Adverse Effects(may affect up to 1 in 10,000 people):

• Decrease in the number of white blood cells, decrease in platelets in the blood, which can result in unusual bruising or easy bleeding (damage to red blood cells),
• Excess sugar in the blood (hyperglycemia),
• A nerve disorder that can cause weakness, numbness or tingling,
• Gingivitis,
• Abdominal swelling (gastritis),
• Liver function changes, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzyme that can affect some medical tests,
• Increased muscle tension,
• Inflammation of blood vessels, often with skin rash,
• Sensitivity to light.

Adverse Effects of Unknown Frequency(cannot be estimated from the available data):

• Tremor, rigid posture, mask-like face, slow movements and unsteady gait, stumbling.

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 not mentioned in this leaflet. 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. Storage of Olmesartan/Amlodipino Krka

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

Do not use this medicine after the expiry date that appears on the packaging after "EXP". The expiry date is the last day of the month indicated.

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

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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 besylate).

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

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

• The other ingredients (excipients) are siliconized microcrystalline cellulose (cellulose, microcrystalline, colloidal anhydrous silica), pregelatinized corn 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 Package Contents

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 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

You can request more information about this medicine by contacting 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:March 2025

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/).