Package Leaflet: Information for the User

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

Olmesartan medoxomil/Amlodipine

Read this leaflet carefully before you start to take 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 similar symptoms to 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 / amlodipino cinfa contains two substances called olmesartan medoxomilo and amlodipine (as amlodipine besilate). The two substances help to control high blood pressure.

• Olmesartan medoxomilo belongs to a group of medicines called “angiotensin II receptor antagonists”, which reduce blood pressure by relaxing blood vessels.
• 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, thereby also reducing blood pressure.

The action of both substances contributes to preventing blood vessels from narrowing, so they relax and blood pressure decreases.

This medicine is used to treat high blood pressure in patients whose blood pressure is not adequately controlledwith olmesartan medoxomilo or amlodipine alone.

Do not take olmesartan /amlodipino cinfa

• If you are allergic to olmesartan medoxomilo, amlodipino, a group of calcium channel blockers called dihidropiridinas, or any of the other components of this medication (listed in section 6).
• If you think you may be allergic, inform your doctor before taking this medication.
• If you are more than 3 months pregnant. It is best to avoid olmesartan medoxomilo/amlodipino at the beginning of pregnancy (see section “Pregnancy and breastfeeding”).
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.
• If you have severe liver problems, if your bile secretion is altered, or if your bile release is blocked (for example, by gallstones), or if you have jaundice (yellow skin and eyes).
• If you have very low blood pressure.
• If you have inadequate blood flow to tissues, with symptoms such as low blood pressure, weak pulse, rapid heart rate (shock, including cardiogenic shock). Cardiogenic shock means shock due to severe heart problems.
• If your heart's blood flow is blocked (for example, due to aortic stenosis).
• If you have poor heart function (producing difficulty breathing, or peripheral edema) after a heart attack (acute myocardial infarction).

Warnings and precautions

Consult your doctor or pharmacist before starting to take olmesartan /amlodipino cinfa.

Tell your doctorif you are taking any of the following medications used to treat high blood pressure (hypertension):

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

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

See also the information under the heading “Do not take olmesartan /amlodipino cinfa”.

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

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Intense vomiting, diarrhea, treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-sodium diet.
• Elevated potassium levels in the blood.
• Problems with the adrenal glands (glands that produce hormones located above the kidneys).

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

Contact your doctor if you experience severe, persistent diarrhea, and significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your treatment for high blood pressure.

As with any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with alterations in blood flow to the heart or brain can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

You should inform your doctor if you are pregnant or think you may be pregnant. Olmesartan medoxomilo/amlodipino 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 used during the third trimester (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years)

This medication is not recommended for children and adolescents under 18 years.

Taking olmesartan /amlodipino cinfa with other medications

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

• Other blood pressure-lowering medications,as they may increase the effect of olmesartan medoxomilo/amlodipino.

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

If you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take olmesartan /amlodipino cinfa” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medications that increase urine production (diuretics), orheparin(to thin the blood and prevent blood clots). The use of these medications at the same time as olmesartan medoxomilo/amlodipino may elevate potassium levels in the blood.
• Thelithium(medication used to treat mood changes and some types of depression) used at the same time as this medication may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• Thenonsteroidal anti-inflammatory drugs (NSAIDs)(medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) used at the same time as olmesartan medoxomilo/amlodipino may increase the risk of kidney failure. The effect of this medication may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect ofthis medication. Your doctor may advise you to takeOlmesartan medoxomilo/Amlodipino at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect ofthis medication.
• Medications used to treat HIV/AIDS(e.g. ritonavir, indinavir, nelfinavir)or fungal infections(e.g. ketoconazole, itraconazole).
• Diltiazem, verapamil (medications used to treat heart rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin(antibiotics),(medications used to treat tuberculosis or other infections).
• St. John's Wort(Hypericum perforatum),herbal remedy.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, a medication used to lower cholesterol and triglyceride levels in the blood.
• Tacrolimus, cyclosporine,used to control the body's immune response, making it possible for the body to accept the transplanted organ.

Taking olmesartan /amlodipino cinfa with food and drinks

Olmesartan medoxomilo/amlodipino can be taken with or without food. Take the tablets with a little 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 takingolmesartan medoxomilo/amlodipino should not consume grapefruit, or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in the blood levels of the active ingredient amlodipino, which may cause an unpredictable increase in the blood pressure-lowering effect ofthis medication.

Older patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure each time you increase the dose, to ensure that it does not drop too low.

Black patients

As with other similar medications, the blood pressure-lowering effect ofolmesartan medoxomilo/amlodipino is somewhat less in black patients.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, or if you think you may be pregnant.

Your doctor will advise you to stop takingolmesartan medoxomilo/amlodipino as soon as you become pregnant, and will recommend an alternative medication.

Olmesartan medoxomilo/amlodipino 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 used during the third trimester (see section “Pregnancy and breastfeeding”).

If you become pregnant while takingolmesartan medoxomilo/amlodipino, inform and visit your doctor immediately.

Breastfeeding

You should inform your doctor if you are breastfeeding or plan to start breastfeeding.

It has been shown that amlodipino passes into breast milk in small amounts. This medication is not recommended for mothers who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or premature.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before usingthis medication.

Driving and operating machinery

During treatment for high blood pressure, you may experience drowsiness, feel sick, or experience dizziness, or headaches. If this occurs, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

olmesartan /amlodipino cinfa contains sodium.

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

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

• The recommended dose of olmesartan medoxomilo/amlodipino is one tablet per day.
• The tablets can be taken with or without food. Take the tablets with a little liquid (such as a glass of water). Do not chew the tablet. Do not take this medication with grapefruit juice.
• The groove is only for breaking the tablet if it is difficult to swallow it whole.
• If possible, take your daily dose at the same time each day, for example at breakfast time.

If you take more olmesartan / amlodipino cinfa than you should

If you take more tablets than you should, you will probably experience a drop in blood pressure, accompanied by symptoms such as dizziness, and a rapid or slow heart rate.

If you take more tablets than you should or a child accidentally ingests some tablets, contact your doctor immediately or go to the nearest emergency center and bring the medication packaging or this leaflet with you.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after ingestion.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take olmesartan / amlodipino cinfa

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

If you interrupt treatment with olmesartan / amlodipino cinfa

It is essential to continue taking olmesartan medoxomilo/amlodipino, unless your doctor tells you to stop treatment.

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.

The following side effects can be serious, although they may only affect a small group of people:

During treatment with olmesartan medoxomil/amlodipine, allergic reactions can occur, which can affect the entire body, with inflammation of the face, mouth, and/or larynx (vocal cords), along with itching and skin rash. Severe skin reactions that include intense skin rash, hives, body-wide redness, intense itching, blisters, peeling, and skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.If this happens, stop taking olmesartan medoxomil/amlodipine and consult your doctor immediately..

This medicine can cause a pronounced drop in blood pressure in susceptible patients, or as a result of an allergic reaction. This can cause severe dizziness or fainting.If this happens, stop taking olmesartan medoxomil/amlodipine, consult your doctor immediately, and remain lying down in a horizontal position.

Unknown frequency: If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with olmesartan medoxomil/amlodipine some time ago,contact your doctor immediately, who will evaluate your symptoms and decide how to continue treatment for high blood pressure.

Other possible side effects with olmesartan medoxomil/amlodipine:

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

Dizziness; headache; swelling of the ankles, feet, legs, hands, or arms; fatigue.

Rare (can affect up to 1 in 100 people):

Dizziness when standing up; lack of energy; tingling or numbness in the hands or feet; vertigo; feeling the heartbeat; rapid heartbeat; low blood pressure with symptoms such as dizziness, fainting; difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth; upper abdominal pain; skin rash; cramps; arm and leg pain; back pain; sensation of urgency to urinate; sexual inactivity; inability to achieve or maintain an erection; weakness.

Also, some changes in the results of certain blood tests have been observed: Increase, as well as decrease, of potassium levels in the blood, increase of creatinine levels in the blood, increase of uric acid levels, increase in liver function test values (gamma-glutamyl transferase levels).

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

Medication hypersensitivity; fainting; redness and feeling of heat in the face; red, itchy hives (urticaria); facial inflammation.

Side effects reported with the use of olmesartan medoxomil or amlodipine alone, but not with olmesartan medoxomil/amlodipine, or with a higher frequency:

Olmesartan medoxomil

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

Common cold; sore throat; congestion and nasal discharge; cough; abdominal pain; viral gastroenteritis; diarrhea; indigestion; nausea; joint and bone pain; back pain; blood in the 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 levels in the blood, and increased liver and muscle function test values.

Rare (can affect up to 1 in 100 people):

Reduction in the number of a type of blood cell, called platelets, which can cause easy bruising or prolong bleeding time; rapid allergic reactions that can affect the entire body and cause respiratory problems, as well as rapid drop in blood pressure, which can even cause fainting (anaphylactic reactions); angina (chest pain or discomfort known as angina pectoris); itching; skin rash; allergic skin rash; urticaria rash; facial swelling; muscle pain; discomfort.

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

Facial, mouth, and/or laryngeal inflammation (vocal cords); acute kidney failure and renal insufficiency; lethargy.

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

Amlodipine

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

Edema (fluid retention).

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

Abdominal pain; nausea; swelling of the ankles; drowsiness; redness and feeling of heat in the face, visual disturbances (including double vision and blurred vision), feeling the heartbeat, diarrhea, constipation, indigestion, cramps, weakness, difficulty breathing.

Rare (can affect up to 1 in 100 people):

Difficulty sleeping; sleep disorders; mood changes including anxiety; depression; irritability; tremor; taste disturbances; fainting; tinnitus; worsening of angina pectoris (chest pain or discomfort); irregular heartbeat; nasal congestion or discharge; hair loss; purple spots or patches on the skin due to small hemorrhages (purpura); skin discoloration; excessive sweating; skin rash; itching; red, itchy hives (urticaria); joint or muscle pain; urinary problems; need to urinate at night; increased need to urinate, increased breast size in men, chest pain; pain; feeling of discomfort; weight gain or loss.

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

Confusion.

Very rare (can 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 cell called platelets, which could lead to the appearance of bruises and prolong bleeding time; increased blood glucose levels; increased muscle tension or greater 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 thickening; elevated liver enzymes; yellow skin and eyes; increased skin sensitivity to light; allergic reactions, itching, rash, facial, mouth, and/or laryngeal inflammation (vocal cords), along with itching and rash, severe skin reactions, including intense skin rash, urticaria, body-wide redness, intense itching, blisters, peeling, and skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) sometimes very severe.

Unknown frequency(cannot be estimated from available data):

Tremors, rigid posture, mask-like face, slow movements, and unsteady gait dragging the feet.

Reporting of side effects

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of olmesartan/amlodipine cinfa

• The active principles are olmesartan medoxomil and amlodipine (as besilate).

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

• The other components are:

Tablet core:pregelatinized cornstarch, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Tablet coating:Opadry Y-1-7000 (hypromellose, titanium dioxide, macrogol), yellow iron oxide (E-172).

Appearance of the product and content of the packaging

olmesartan/amlodipine cinfa 40 mg/5 mg are film-coated tablets, cream-colored, cylindrical, scored on one face and with the inscription “OA5” on the other face.

This medicine is available in packaging of 28 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:February 2025

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

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/82617/P_82617.html

QR code to:https://cima.aemps.es/cima/dochtml/p/82617/P_82617.html