Olmesartan/amlodipine Cinfa 40 mg/10 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

olmesartan/amlodipine cinfa 40 mg/10 mg film-coated tablets EFG

Olmesartan medoxomil/amlodipine

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What olmesartan/amlodipine cinfa is and what it is used for

olmesartan/amlodipine cinfa 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 called “angiotensin II receptor antagonists”, which lower 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, 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.

This medicine is used to treat high blood pressure in patients whose blood pressure is not adequately controlled with olmesartan medoxomil or amlodipine alone.

2. What you need to know before starting olmesartan/amlodipine cinfa

Do not take olmesartan/amlodipine cinfa

• If you are allergic to olmesartan medoxomil, amlodipine, or to a special group of calcium channel blockers called dihydropyridines, or to any of the other components of this medicine (listed in section 6).
• If you think you may be allergic, inform your doctor before taking this medicine.
• If you are more than 3 months pregnant. It is best to avoid olmesartan medoxomil/amlodipine at the beginning of 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 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, rapid heartbeat (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) after a heart attack (acute myocardial infarction).

Warnings and precautions

Talk to your doctor or pharmacist before starting olmesartan/amlodipine cinfa.

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.

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/amlodipine cinfa”.

Tell your doctor if 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.
• 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).

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 develop severe, persistent diarrhea that causes 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, an excessive drop 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 might be pregnant. Use of olmesartan medoxomil/amlodipine is not recommended during 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 at this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years of age)

This medicine is not recommended for children and adolescents under 18 years of age.

Taking olmesartan/amlodipine cinfa with other medicines

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

• Other blood pressure-lowering medicines, as they may increase the effect of olmesartan medoxomil/amlodipine.

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 the information under the headings “Do not take olmesartan/amlodipine cinfa” and “Warnings and precautions”).

• Potassium supplements, potassium-containing salt substitutes, medicines that increase urine output (diuretics), or heparin (used to thin the blood and prevent blood clots). Using these medicines together with olmesartan medoxomil/amlodipine may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression) taken together with this medicine 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 medoxomil/amlodipine may increase the risk of kidney failure. The effect of this medicine may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of this medicine. Your doctor may advise you to take olmesartan medoxomil/amlodipine at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion and acidity), as they may slightly reduce the effect of this medicine.
• Medicines used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir) or for treating fungal infections (e.g., ketoconazole, itraconazole).
• Diltiazem, verapamil (medicines used for heart rhythm problems 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 by infusion for serious body temperature abnormalities).
• Simvastatin, a medicine used to lower cholesterol and fat (triglyceride) levels in the blood.
• Tacrolimus, cyclosporine, used to control the body’s immune response, making it possible for your body to accept a transplanted organ.

Taking olmesartan/amlodipine cinfa with food and drinks

Olmesartan medoxomil/amlodipine 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 olmesartan medoxomil/amlodipine 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 this medicine.

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 medoxomil/amlodipine is somewhat reduced 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 olmesartan medoxomil/amlodipine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of olmesartan medoxomil/amlodipine. Use of this medicine is not recommended during early pregnancy, and it should 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.

If you become pregnant while being treated with olmesartan medoxomil/amlodipine, inform and see your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. It has been shown that amlodipine passes into breast milk in small amounts. This medicine 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 might be pregnant, or plan 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 use machines until symptoms have resolved. Consult your doctor.

olmesartan/amlodipine cinfa contains sodium.

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

3. How to take olmesartan/amlodipine cinfa

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

• The recommended dose of olmesartan medoxomilo/amlodipine is one tablet daily.
• The tablets can be taken with or without food. Take the tablets with some liquid (such as a glass of water). Do not chew the tablet. Do not take this medicine with grapefruit juice.
• The score line is intended only to facilitate breaking the tablet if you have difficulty swallowing it whole.
• If possible, take your daily dose at the same time each day, for example at breakfast time.

If you take more olmesartan/amlodipine cinfa 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.

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take olmesartan/amlodipine cinfa

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 olmesartan/amlodipine cinfa

It is important to continue taking olmesartan medoxomilo/amlodipine 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 will experience 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 medoxomilo/amlodipino, allergic reactions may occur, which can affect the entire body, with swelling of the face, mouth and/or larynx (vocal cords), together with itching and skin rash. Serious skin reactions including severe skin rash, hives, redness of the skin all over the body, intense itching, blistering, peeling and inflammation of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions. If this happens to you, stop taking olmesartan medoxomil/amlodipine immediately and consult your doctor without delay.

This medicine 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 medoxomil/amlodipine, 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 itchy skin, even if you started treatment with olmesartan medoxomil/amlodipine 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 medoxomil/amlodipine:

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; diarrhea; 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 or decrease in blood potassium levels, increase in blood creatinine levels, increase in uric acid levels, increase in liver function test values (gamma-glutamyl transferase levels).

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

Hypersensitivity to the medicine; flushing and sensation of warmth in the face; red, itchy rash (urticaria); facial swelling.

Adverse effects reported with olmesartan medoxomil or amlodipine used alone, but not with olmesartan medoxomil/amlodipine, 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; diarrhea; 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 increased 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, possibly leading to fainting (anaphylactic reactions); angina (chest pain or discomfort, known as angina pectoris); itching; skin rash; allergic skin rash; hives; 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 diarrhea.

Amlodipine

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

Edema (fluid retention).

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

Abdominal pain; nausea; swelling of ankles; drowsiness; flushing and sensation of warmth in the face; visual disturbances (including double vision and blurred vision); awareness of heartbeat; diarrhea; 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 skin lesions due to minor bleeding (purpura); skin discoloration; excessive sweating; skin rash; itching; red, itchy rash (urticaria); joint or muscle pain; urinary problems; need to urinate at night; increased need to urinate; breast enlargement in men; chest pain; pain; malaise; 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 bruising and prolonged bleeding time; increased blood glucose; increased muscle tone or 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, hives, redness of the entire body, severe itching, blistering, peeling and inflammation of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe.

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

Tremors, rigid posture, mask-like facial expression, 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 System for Pharmacovigilance of 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 cinfa

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of olmesartan/amlodipine cinfa

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

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

• The other components are:

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

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

Appearance of the product and contents of the pack

olmesartan/amlodipine cinfa 40 mg/10 mg are film-coated tablets, reddish-brown in colour, cylindrical in shape, scored on one side and marked with "OA1" on the other side.

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

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

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 Medical Devices (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82618/P_82618.html

QR code a: https://cima.aemps.es/cima/dochtml/p/82618/P_82618.html