Olmesartan/amlodipine Viatris 40 mg/5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olmesartán/Amlodipino Viatris 40 mg/5 mg film-coated tablets EFG

olmesartan medoxomil/amlodipine

Please read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Olmesartán/Amlodipino Viatris 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 lowers 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 Viatris 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 Viatris

Do not take Olmesartán/Amlodipino Viatris

• If you are allergic to olmesartan, or to amlodipine, or to a special 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 Viatris.

• If you are more than 3 months pregnant. It is best to avoid Olmesartán/Amlodipino Viatris 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 if 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, or rapid heart rate (shock, including cardiogenic shock). Cardiogenic shock means shock due to serious heart problems.
• If blood flow to 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 to use Olmesartán/Amlodipino Viatris.

Tell your doctor if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• An angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

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

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 Viatris”.

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 develop severe, persistent diarrhea leading to significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

As with any other medicine that lowers blood pressure, excessive lowering of 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 might be pregnant. Use of Olmesartán/Amlodipino Viatris is not recommended in early 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 of age)

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

Other medicines and Olmesartán/Amlodipino Viatris

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 increase the effect of Olmesartán/Amlodipino Viatris.

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

If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Olmesartán/Amlodipino Viatris” 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 Viatris 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 Viatris 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 Viatris may increase the risk of kidney failure. The effect of Olmesartán/Amlodipino Viatris may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of Olmesartán/Amlodipino Viatris. Your doctor may advise you to take Olmesartán/Amlodipino Viatris at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion and acid reflux), as they may slightly reduce the effect of Olmesartán/Amlodipino Viatris.
• Medicines used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir) or for fungal infections (e.g., ketoconazole, itraconazole).
• Diltiazem, verapamil (medicines used for heart rhythm disorders and high blood pressure).
• Rifampicin, erythromycin, clarithromycin (antibiotics), medicines used for tuberculosis or other infections.
• St. John’s wort (Hypericum perforatum), a herbal remedy.
• Dantrolene (administered intravenously for serious body temperature abnormalities).
• Simvastatin, a medicine used to lower cholesterol and fat (triglyceride) levels in the blood.
• Tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine, used to control the body’s immune response, making it possible for the body to accept 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 Viatris with food and drink

Olmesartán/Amlodipino Viatris 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, at breakfast time.

People taking Olmesartán/Amlodipino Viatris 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 Olmesartán/Amlodipino Viatris.

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 Viatris is somewhat less pronounced 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 Viatris before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Olmesartán/Amlodipino Viatris. Use of Olmesartán/Amlodipino Viatris is not recommended in early pregnancy, and it 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 onward.

If you become pregnant while being treated with Olmesartán/Amlodipino Viatris, inform and see your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. It has been shown that amlodipine passes into breast milk in small amounts. Olmesartán/Amlodipino Viatris 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.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 happens, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; hence, it is essentially “sodium-free”.

3. How to take Olmesartán/Amlodipino Viatris

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

• The recommended dose of Olmesartán/Amlodipino Viatris is one tablet daily.
• The tablets can be taken with or without food. Swallow the tablets with some liquid (such as a glass of water). Do not chew the tablet. Do not take Olmesartán/Amlodipino Viatris 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 Viatris than you should

If you take more tablets than you should, you are likely to experience a drop in blood pressure, accompanied by symptoms such as dizziness, and fast or slow heartbeat.

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

If you take more tablets than prescribed or if a child accidentally ingests any tablets, contact your doctor immediately or go to the nearest emergency department, and bring the medicine package or this leaflet with you.

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

If you forget to take Olmesartán/Amlodipino Viatris

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

If you stop taking Olmesartán/Amlodipino Viatris

It is important to continue taking Olmesartán/Amlodipino Viatris 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 experiences 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 Viatris, 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 Viatris and consult your doctor immediately.

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

Other possible adverse effects with Olmesartan/Amlodipine Viatris:

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; diarrhoea; constipation; dry mouth; pain in the upper abdomen; skin rash; cramps; pain in arms and legs; 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 as well as decrease in blood potassium levels, increase in blood creatinine levels, increase in uric acid levels, elevation in liver function test values (levels of gamma-glutamyl transferase).

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

Hypersensitivity to the medicine; fainting; redness and sensation of warmth in the face; itchy red welts (urticaria); facial swelling.

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

Olmesartan medoxomil

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

Bronchitis; sore throat; nasal congestion and discharge; cough; abdominal pain; viral gastroenteritis; diarrhoea; 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 elevation 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, which may even lead to fainting (anaphylactic reactions); angina (pain or discomfort in the chest, 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 kidney failure and renal failure; lethargy, intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Amlodipine

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

Oedema (fluid retention).

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

Abdominal pain; nausea; swelling of ankles; drowsiness; redness and sensation of warmth in the face, visual disturbances (including double vision and blurred vision), awareness of heartbeat, diarrhoea, 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 spots on the skin due to minor bleeding (purpura); skin discoloration; excessive sweating; skin rash; itching; itchy red welts (urticaria); joint or muscle pain; difficulty urinating; need to urinate during the night; increased need to urinate, breast enlargement in men, chest pain; pain; feeling of discomfort; 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 the appearance of bruises and prolonged bleeding time; increased blood glucose; increased muscle tone or increased 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 wall; 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, serious skin reactions, including severe skin rash, urticaria, redness of the skin of the body, severe itching, blisters, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe.

Frequency not known (cannot be estimated from available data):

Tremors, rigid posture, mask-like face, slow movements and unbalanced gait with shuffling steps.

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 listed in this leaflet. You may 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 Viatris

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 or CAD. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Amlodipine Viatris

The active substances are olmesartan and amlodipine (as amlodipine besilate).

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

The other components are:

Tablet core:

microcrystalline cellulose (E-460i), sodium lauryl sulfate (E-487), citric acid monohydrate (E-330), hydroxypropylcellulose (E-463), sodium croscarmellose (E-466), maltose, mannitol (E-421), low-substituted hydroxypropylcellulose (E-463), magnesium stearate (E-572).

Tablet coating (Opadry II Yellow 85F520148):

partially hydrolysed polyvinyl alcohol (E-1203), titanium dioxide (E-171), macrogol/PEG (E-1521), talc (E-553b), yellow iron oxide (E-172), red iron oxide (E-172).

Appearance of the product and contents of the pack

Olmesartan/Amlodipine Viatris are yellow, round, biconvex, film-coated tablets marked with "M" on one side and "OA2" on the other.

PVC/Alu/OPA-Alu blister pack containing 28 film-coated tablets.

PVC/Alu/OPA-Alu calendar blister pack containing 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Mylan Hungary Kft.

H-2900 Komárom

Mylan útca 1

Hungary

Date of the most recent revision of this leaflet: February 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/