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

Package leaflet: Information for the user

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 give it to others even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What this leaflet contains

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

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

Olmesartan/Amlodipine Krka contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besilate). Both substances help control high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines known as “angiotensin II receptor antagonists”. Angiotensin II is a substance produced in your body that causes your blood vessels to narrow, thereby increasing your blood pressure. Olmesartan medoxomil blocks the effect of angiotensin II, allowing 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 blood vessel wall, which prevents blood vessels from narrowing, thus also lowering blood pressure.

The combined action of both substances helps prevent 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 taking Olmesartan/Amlodipino Krka

Do not take Olmesartan/Amlodipino Krka

• if you are allergic to olmesartan, amlodipine, or any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (It is best to avoid Olmesartan/Amlodipino Krka at the beginning of pregnancy – see section “Pregnancy and breastfeeding”).
• if you have yellowing of the skin or eyes (jaundice) or problems with bile drainage from the gallbladder (biliary obstruction, e.g., 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 following a heart attack.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Olmesartan/Amlodipino Krka.

Tell your doctor if you have any of the following health conditions:

• Kidney problems
• Liver disease
• Recent heart attack
• Severe increase in blood pressure (hypertensive crisis)
• You are elderly and your dose is being increased
• 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)
• If you are taking any of the following medicines for high blood pressure:
  • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly 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 Olmesartan/Amlodipino Krka”.

Contact 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 develop severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

Like 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.

You must inform your doctor if you are pregnant or think you may be pregnant. Use of Olmesartan/Amlodipino Krka is not recommended at the beginning 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 stage (see section “Pregnancy and breastfeeding”).

Children and adolescents

Olmesartan/Amlodipino 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 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 Olmesartan/Amlodipino Krka is somewhat reduced in black patients.

Other medicines and Olmesartan/Amlodipino Krka

Tell 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 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 angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Olmesartan/Amlodipino Krka” 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 Olmesartan/Amlodipino Krka may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression) taken together with Olmesartan/Amlodipino Krka 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 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 (used to treat 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 (administered by infusion for serious body temperature abnormalities).
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to alter the function of your immune system).
• Simvastatin (a medicine used to lower cholesterol levels).
• Cyclosporine (an immunosuppressant).

Taking Olmesartan/Amlodipino Krka with food and drink

Olmesartan/Amlodipino Krka can 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 increase blood levels of the active ingredient amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effect of Olmesartan/Amlodipino Krka.

Pregnancy and breastfeeding

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.

Pregnancy

Inform your doctor if you are pregnant or think you may be pregnant. 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 recommend an alternative medicine instead of Olmesartan/Amlodipino Krka. Use of Olmesartan/Amlodipino Krka is not recommended at the beginning of pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan/Amlodipino Krka is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

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

Driving and using machines

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

Olmesartan/Amlodipino Krka contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Olmesartan/Amlodipino Krka

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

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

Take the tablets with some 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 important 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 department.

If you take more tablets than you should, you are likely to experience a drop in blood pressure, which may become dangerously low. You may feel dizzy, lightheaded, fatigued, or weak. If the drop in blood pressure is severe enough, shock may occur. Your skin may feel cold and clammy, and you may lose consciousness.

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

If you forget to take a dose, do not worry. Take it as soon as you remember and then 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 stop taking Olmesartan/Amlodipino Krka

Your doctor will advise you on how long you should take this medicine. Your condition may return if you stop taking the medicine before being advised to do so.

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.

Although not common, the following effects may be serious. Consult your doctor immediately if you experience any of the following adverse 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 causing severe difficulty breathing
• Severe skin reactions including intense skin rash, hives, redness of the skin all over the body, severe itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, irregular heartbeat
• Inflamed pancreas which may cause severe abdominal and back pain accompanied by a general feeling of illness

Rarely (but slightly more frequently in elderly patients), Olmesartan/Amlodipine Krka may cause excessive lowering of blood pressure in susceptible individuals or as a result of an allergic reaction. This could lead to severe dizziness or fainting. If this occurs, stop taking Olmesartan/Amlodipine Krka, contact your doctor immediately, and lie down.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or itching of the skin, even if treatment with Olmesartan/Amlodipine Krka was started some time ago, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Possible adverse effects of OLMESARTAN:

Common adverse effects (may affect up to 1 in 10 people):

• Dizziness, headache
• Nausea, indigestion, diarrhea, stomach pain, gastroenteritis
• Fatigue
• Sore throat, nasal discharge or congestion, bronchitis, flu-like symptoms, cough
• Pain, chest, 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:

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

Uncommon adverse effects (may affect up to 1 in 100 people):

• Rapid allergic reactions that may affect the whole body and may cause breathing problems as well as a rapid drop in blood pressure that could even lead to fainting (anaphylactic reactions)
• Dizziness
• Vomiting
• Weakness, malaise
• Muscle pain
• Skin rash, allergic skin eruptions, itching, exanthema (skin rash), skin lumps (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 associated with symptoms such as abdominal pain, nausea, vomiting and diarrhea
• Muscle cramps
• Worsening of kidney function, kidney failure

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

Possible adverse effects of AMLODIPINE:

The following very common adverse effect has been reported. If this causes you problems or lasts longer than one week, you should contact your doctor.

Very common adverse effects (may affect up to 1 in 10 people):

• Edema (fluid retention)

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

Common adverse effects (may affect up to 1 in 10 people):

• Headache, dizziness, drowsiness (especially at the beginning 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 listed in this leaflet, inform your doctor or pharmacist.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting
• Sensation of numbness or tingling in the limbs, loss of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/nasal discharge due to inflammation of the nasal lining (rhinitis)
• Cough
• Dry mouth, vomiting (feeling sick)
• Hair loss, increased sweating, skin itching, red spots on the skin, skin discoloration
• Urination disturbances, increased need to urinate at night, increased frequency of urination
• Inability to achieve an erection, discomfort or enlargement of the breasts in men
• Pain, discomfort
• Joint or muscle pain, back pain
• Weight gain or weight 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 white blood cell count, decrease in platelets in blood, which may result in unusual bruising or easy bleeding (damage to red blood cells)
• High blood sugar (hyperglycemia)
• A nerve disorder that may cause weakness, tingling or numbness
• Gum inflammation
• Abdominal swelling (gastritis)
• Impaired liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzyme that may affect certain medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rash
• Light sensitivity

Adverse effects with unknown frequency (cannot be estimated from available data):

• Tremor, rigid posture, mask-like face, slow movements, and walking with feet dragging unsteadily

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 Medicines: 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 Krka

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to 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 conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Amlodipine Krka

• The active substances 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 (microcrystalline cellulose, anhydrous colloidal 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/Amlodipine Krka contains lactose and sodium”.

Nature of the product and contents of the pack

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

40 mg/5 mg film-coated tablets: pale brownish-yellow, round, biconvex film-coated tablet with bevelled edges, marked with a "5" on one side. Tablet dimensions: diameter: 9 mm, thickness: 3.6 – 5.3 mm.

40 mg/10 mg film-coated tablets: reddish-brown, round, biconvex film-coated tablet with bevelled edges and a score line on one side. Tablet dimensions: diameter: 9 mm, thickness: 3.6 – 5.3 mm.

The tablet can be divided into equal doses.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

For more information about this medicine, 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 medicine is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: March 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).