Albis 20 mg/5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Albis 20 mg/5 mg film-coated tablets EFG

Albis 40 mg/5 mg film-coated tablets EFG

Albis 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should 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, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Albis is and what it is used for

Albis 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”, which lower blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines known as “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 thereby reducing blood pressure.

Albis 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 taking Albis

Do not take Albis

• If you are allergic to olmesartan medoxomilo, or to 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 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, impaired bile secretion, or blocked bile release from the gallbladder (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 heart rate (shock, including cardiogenic shock). Cardiogenic shock means shock due to serious heart problems.
• If blood flow from 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

Consult your doctor or pharmacist before starting to take Albis.

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 Albis”.

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 Albis. Your doctor will decide whether to continue treatment. Do not stop taking Albis as monotherapy.

Contact your doctor if you develop severe, persistent diarrhea causing 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.

Inform your doctor if you are pregnant or think you might be pregnant. Use of olmesartan medoxomil/amlodipine is not recommended in early 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 (under 18 years of age)

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

Taking Albis 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 information under the headings “Do not take Albis” 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 acid reflux), 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 disorders and high blood pressure).
• Rifampicin, erythromycin, clarithromycin (antibiotics) 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, ciclosporin, used to suppress the body’s immune response, making organ transplantation possible.

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

Taking Albis 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, with breakfast.

People taking olmesartan medoxomil/amlodipine must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can increase blood levels of the active ingredient amlodipine, which may 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 whenever 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

Inform your doctor if you are pregnant or think you may 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 in early 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.

If you become pregnant while taking 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 an alternative 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, thus essentially “sodium-free”.

3. How to take Albis

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

• The recommended dose is one tablet per day.
• 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 Albis 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 package 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 Albis

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

If you stop taking Albis

It is important to continue taking this medicine unless your doctor tells you to stop.

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 produce 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:

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 skin itching, even if you started treatment with Albis some time ago, contact your doctor immediately, who will assess your symptoms and decide how to continue your blood pressure treatment.

Other possible adverse effects with olmesartan medoxomilo/amlodipino:

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: increased as well as decreased blood potassium levels, increased blood creatinine levels, increased blood uric acid levels, and increased values in liver function tests (levels of gamma-glutamyl transferase).

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

Hypersensitivity to the medicine; fainting; redness and feeling 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 reported with higher frequency:

Olmesartan medoxomilo

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 values in liver and muscle function tests.

Uncommon (may affect up to 1 in 100 people)

Reduction in the number of a type of blood cells called platelets, which may cause easy bruising or prolonged bleeding time; rapid allergic reactions affecting the whole body, which may cause breathing difficulties and a rapid drop in blood pressure, possibly leading 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 diarrhea.

Amlodipino

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; redness and feeling 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 spots due to small hemorrhages (purpura); skin discoloration; excessive sweating; skin rash; itching; red, itchy rash (urticaria); joint or muscle pain; problems with urination; need to urinate at night; increased need to urinate; breast enlargement in men; chest pain; pain; malaise; weight gain or weight 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 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 sensitivity of the skin 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 face, slow movements and unbalanced gait with shuffling steps.

Reporting of adverse effects

If you experience any 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 Albis

Keep this medicine out of 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 refers to the last day of the month indicated.

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

6. Contents of the container and additional information

Composition of Albis

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

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

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

Albis 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 corn starch, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

Tablet coating:

Albis 20 mg/5 mg: Opadry Y-1-7000 (contains hypromellose, titanium dioxide (E171), and macrogol 400).

Albis 40 mg/5 mg: Opadry Y-1-7000 (contains hypromellose, titanium dioxide (E171), and macrogol 400) and yellow iron oxide (E172).

Albis 40 mg/10 mg: Opadry Y-1-7000 (contains hypromellose, titanium dioxide (E171), and macrogol 400) and red iron oxide (E172).

Appearance of the product and contents of the container

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

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

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

The tablets are available in packs containing 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 review 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 (AEMPS) https://www.aemps.gob.es/.