Olmesartan/amlodipine Alter 20 mg/5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olmesartán/Amlodipino Alter 20 mg/5 mg film-coated tablets EFG

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

Olmesartán/Amlodipino Alter 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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Olmesartán/Amlodipino Alter contains two substances called olmesartán medoxomilo and amlodipino (as amlodipino besilato). These two substances help control high blood pressure.

• Olmesartán medoxomilo 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 Alter is used to treat high blood pressure in patients whose blood pressure is not adequately controlled with olmesartán medoxomilo or amlodipino alone.

2. What you need to know before taking Olmesartan/Amlodipine Alter

Do not take Olmesartan/Amlodipine Alter

• If you are allergic to olmesartan medoxomil, amlodipine, or to a specific 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 olmesartan medoxomil/amlodipine.

• If you are more than 3 months pregnant. It is best to avoid olmesartan medoxomil/amlodipine 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 its release from the gallbladder is blocked (e.g., due to gallstones), or if you have jaundice (yellowing of the skin and eyes).
• If your blood pressure is very low.
• 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 taking Olmesartan/Amlodipine Alter.

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

• 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/Amlodipine Alter”.

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).

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartan/Amlodipine Alter. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartan/Amlodipine Alter used as monotherapy.

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.

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. The use of olmesartan medoxomil/amlodipine is not recommended in early pregnancy, and it must not be taken after 3 months of pregnancy, 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)

Olmesartan medoxomil/amlodipine is not recommended for children and adolescents under 18 years of age.

Taking Olmesartan/Amlodipine Alter 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 enhance the effect of this medicine. 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 the information under the headings “Do not take Olmesartan/Amlodipine Alter” 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). 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 olmesartan medoxomil/amlodipine may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of olmesartan medoxomil/amlodipine. 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 olmesartan medoxomil/amlodipine.
• 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 intravenously for severe disturbances in body temperature).
• Simvastatin, a medicine used to lower cholesterol and fat (triglyceride) levels in the blood.
• Tacrolimus, cyclosporine, medicines used to control the body’s immune response, allowing acceptance of a transplanted organ.

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

Taking Olmesartan/Amlodipine Alter with food and drink

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, with breakfast.

People taking olmesartan medoxomil/amlodipine must 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 medoxomil/amlodipine.

Elderly patients

If you are over 65 years of age, your doctor will regularly monitor your blood pressure each time your dose is increased, to ensure it does not drop too low.

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

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

You must 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. The use of this medicine is not recommended in early pregnancy, and it 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.

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 (one of the components of this medicine) passes into breast milk in small amounts. Olmesartan medoxomil/amlodipine is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

During treatment for high blood pressure, you may feel drowsy, unwell, dizzy, or have headaches. If this occurs, 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, i.e., essentially “sodium-free”.

3. How to take Olmesartán/Amlodipino Alter

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

• The recommended dose 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 olmesartan medoxomil/amlodipine 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 Alter 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 ingests any tablets, contact your doctor immediately or go to the nearest emergency department, and take the medicine's 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 the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Olmesartán/Amlodipino Alter

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 Alter

It is important to continue taking this medicine 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:

During treatment with olmesartan medoxomilo/amlodipino, 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 medoxomilo/amlodipino and consult your doctor immediately.

Olmesartan medoxomilo/amlodipino 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 medoxomilo/amlodipino, 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/Amlodipino Alter 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 medoxomilo/amlodipino:

Common (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, and increases 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; red, itchy rash (urticaria); facial swelling.

Adverse effects reported with olmesartan medoxomilo or amlodipino used alone, but not with olmesartan medoxomilo/amlodipino, or with a higher frequency:

Olmesartan medoxomilo

Common (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 (hypertriglyceridaemia); increased uric acid and urea in blood, and increases 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 (chest pain or discomfort, 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 causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Amlodipino

Very common (may affect more than 1 in 10 people)

Oedema (fluid retention).

Common (may affect up to 1 in 10 people)

Abdominal pain; nausea; swollen 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 small haemorrhages (purpura); skin discolouration; excessive sweating; skin rash; itching; red, itchy rash (urticaria); joint or muscle pain; problems 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 bruising 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, severe skin reactions, including severe skin rash, urticaria, redness of the skin, 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 facial expression, slow movements and unbalanced gait with shuffling steps.

Reporting of adverse effects

If you experience any kind of adverse effect, consult 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 Medicinal Products: 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 Alter

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

This medicine does not require any special storage conditions.

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

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

6. Contents of the pack and other information

Composition of Olmesartan/Amlodipine Alter

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

Olmesartan/Amlodipine Alter 20 mg/5 mg: Each tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besilate).

Olmesartan/Amlodipine Alter 40 mg/5 mg: Each tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as besilate).

Olmesartan/Amlodipine Alter 40 mg/10 mg: 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, and magnesium stearate.

Tablet coating:

Olmesartan/Amlodipine Alter 20 mg/5 mg: Opadry Y-1-7000 (contains hypromellose, titanium dioxide (E171), and polyethylene glycol 400).

Olmesartan/Amlodipine Alter 40 mg/5 mg: Opadry Y-1-7000 (contains hypromellose, titanium dioxide (E171), and polyethylene glycol 400) and yellow iron oxide (E172).

Olmesartan/Amlodipine Alter 40 mg/10 mg: Opadry Y-1-7000 (contains hypromellose, titanium dioxide (E171), and polyethylene glycol 400) and red iron oxide (E172).

Appearance of the product and contents of the pack

Olmesartan/Amlodipine Alter 20 mg/5 mg: Film-coated tablets, white in colour, cylindrical, 7 mm in size, with the imprint “O2A” on one side and a breakline on the other side. The breakline is intended only to facilitate breaking and swallowing, but not for dividing the tablet into equal doses.

Olmesartan/Amlodipine Alter 40 mg/5 mg: Film-coated tablets, cream-coloured, cylindrical, 9 mm in size, with the imprint “OA5” on one side and a breakline on the other side. The breakline is intended only to facilitate breaking and swallowing, but not for dividing the tablet into equal doses.

Olmesartan/Amlodipine Alter 40 mg/10 mg: Film-coated tablets, reddish-brown in colour, cylindrical, 9 mm in size, with the imprint “OA1” on one side and a breakline on the other side. The breakline is intended only to facilitate breaking and swallowing, but not for dividing the tablet into equal doses.

The tablets are available in packs of 28 film-coated tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Laboratorios Cinfa, S.A.

Ctra. Olaz-Chipi 10

Polígono Industrial Areta

31620 Huarte, Navarra

Spain

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) https://www.aemps.gob.es/.