ALBIS PLUS 40 MG/10 MG/25 MG FILM-COATED TABLETS

2. What you need to know before you take Albis Plus

Do not take Albis Plus

• If you are allergic to olmesartan medoxomil, amlodipine or a special group of calcium channel blockers (dihydropyridines), hydrochlorothiazide or substances similar to hydrochlorothiazide (sulfonamides), 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/amlodipine/hydrochlorothiazide.
• If you have severe kidney problems.
• If you have diabetes or kidney impairment and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you have low potassium or sodium levels in your blood, high calcium or uric acid levels (with symptoms of gout or kidney stones) in your blood that do not improve with treatment.
• If you are more than 3 months pregnant. (It is also recommended to avoid olmesartan/amlodipine/hydrochlorothiazide at the start of pregnancy - see section “Pregnancy and breast-feeding”).
• If you have severe liver problems, bile secretion problems, or obstruction of bile drainage from the gallbladder (e.g., due to gallstones), or if you have jaundice (yellowing of the skin and eyes).
• If you have insufficient blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, which means shock due to severe heart problems).
• If you have very low blood pressure.
• If the blood flow to your heart is slow or blocked. This can happen if the blood vessels or heart valves that capture blood from the heart become narrowed (aortic stenosis).
• If you have poor heart function after suffering a heart attack (acute myocardial infarction). Poor heart function can make you feel short of breath or have swelling in your feet and ankles.

Do not take olmesartan/amlodipine/hydrochlorothiazide if any of these apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Albis Plus:

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

• The recommended dose is one tablet per day.
• 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 the tablets with grapefruit juice.
• If possible, take your daily dose at the same time every day, for example at breakfast time.

If you take more Albis Plus than you should

If you take more tablets than you should, you will probably suffer from a drop in blood pressure, accompanied by symptoms such as dizziness, and fast or slow heartbeat.

If you take more tablets than you should or if a child accidentally ingests some tablets, contact your doctor or go to the nearest emergency center immediately and bring the medication package 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 Toxicology Information Service, phone 91 562 04 20.

If you forget to take Albis Plus

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

If you interrupt treatment with Albis Plus

It is important to continue taking this medication unless your doctor tells you to interrupt treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them. If they occur, they are usually mild and do not require interrupting treatment.

The following adverse effects may be serious:

During treatment with olmesartan/amlodipine/hydrochlorothiazide, allergic reactions with inflammation of the face, mouth, and/or larynx (vocal cords), along with itching and skin rash, may occur. If this happens to you, stop taking this medication and consult your doctor immediately.

Olmesartan/amlodipine/hydrochlorothiazide may cause a pronounced drop in blood pressure in susceptible patients. This can cause fainting or severe dizziness. If this happens to you, stop taking this medication, consult your doctor immediately, and remain lying down in a horizontal position.

Olmesartan/amlodipine/hydrochlorothiazide is a combination of three active substances. The following information describes the adverse effects reported so far with the olmesartan/amlodipine/hydrochlorothiazide combination (in addition to those already mentioned) and the adverse effects known for each of the active substances separately, or when two of the substances are taken together.

Unknown frequency: If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started treatment with Albis Plus a long time ago, contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for blood pressure.

To give you an idea of the number of patients who may have adverse effects, they have been classified as frequent, uncommon, rare, and very rare.

These are other adverse effects known so far with olmesartan/amlodipine/hydrochlorothiazide:

If these effects occur, they are often mild and do not require interrupting treatment.

Frequent(may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat and nose, urinary tract infection, dizziness, headache, perception of heartbeats, low blood pressure, nausea, diarrhea, constipation, cramps, joint swelling, urge to urinate, weakness, ankle swelling, fatigue, abnormal laboratory test values.

Uncommon(may affect up to 1 in 100 people)

Dizziness when standing up, vertigo, fast heartbeat, feeling of fainting, flushing and feeling of heat in the face, cough, dry mouth, muscle weakness, inability to have or maintain an erection.

These are the adverse effects known for each of the active substances separately or when two of the substances are taken together:

They may be adverse effects due to olmesartan/amlodipine/hydrochlorothiazide, even if they have not been observed so far with olmesartan/amlodipine/hydrochlorothiazide.

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

Edema (fluid retention).

Frequent(may affect up to 1 in 10 people)

Bronchitis, stomach and intestine infection, vomiting, increased blood sugar, sugar in urine, confusion, drowsiness, visual disturbances (including double vision and blurred vision), nasal congestion, sore throat, difficulty breathing, cough, abdominal pain, heartburn, stomach discomfort, flatulence, joint or bone pain, back pain, bone pain, blood in urine, flu-like symptoms, chest pain, pain.

Uncommon(may affect up to 1 in 100 people)

Decrease in the number of a type of blood cells called platelets, which can cause easy bruising or prolonged bleeding, anaphylactic reactions, abnormal decrease in appetite (anorexia), sleep problems, irritability, mood changes including anxiety, feeling of depression, chills, sleep disorders, alteration of taste, loss of consciousness, decreased sense of touch, tingling sensation, worsening of myopia, ringing in the ears (tinnitus), angina (pain or unpleasant sensation in the chest, known as angina pectoris), irregular heartbeats, rash, hair loss, allergic skin inflammation, skin redness, purple spots or patches on the skin due to small hemorrhages (purpura), skin discoloration, red itchy patches (urticaria), increased sweating, itching, skin rash, skin reactions to light, such as sunburn or skin rash, muscle pain, urination problems, feeling of needing to urinate at night, breast enlargement in men, decreased sexual desire, facial swelling, feeling of discomfort, weight gain or loss, exhaustion.

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

Inflammation and pain of the salivary glands, decrease in the number of white blood cells in the blood, which could increase the risk of infections, decrease in the number of red blood cells (anemia), bone marrow damage, restlessness, feeling of loss of interest (apathy), seizures (convulsions), yellowish perception of objects when looking at them, dry eyes, blood clots (thrombosis, embolism), fluid accumulation in the lungs, pneumonia, inflammation of blood vessels and small blood vessels in the skin, pancreatitis, yellowing of the skin and eyes, acute inflammation of the gallbladder, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, severe skin reactions including intense skin rash, urticaria, skin redness of the body, severe itching, blisters, peeling, and skin inflammation, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe, movement impairment, acute kidney failure, non-infectious inflammation of the kidney, decreased kidney function, fever, intestinal angioedema (swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea).

Very rare(may affect up to 1 in 10,000 people)

High muscle tension, numbness of hands or feet, heart attack, stomach inflammation, gum thickening, intestinal obstruction, liver inflammation, acute breathing difficulty (signs include severe breathing difficulty, fever, weakness, and confusion).

Adverse effects of unknown frequency(cannot be estimated from available data)

Decreased vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma). Tremors, rigid posture, mask-like face, slow movements, and unsteady gait. Skin and lip cancer (non-melanoma skin cancer).

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Albis Plus

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the package and blister after "CAD". The expiration date is the last day of the month indicated.

No special storage conditions are required for Albis Plus 20 mg/5 mg/12.5 mg, Albis Plus 40 mg/10 mg/12.5 mg, and Albis Plus 40 mg/10 mg/25 mg.

Do not store at a temperature above 30°C for Albis Plus 40 mg/5 mg/12.5 mg and Albis Plus 40 mg/5 mg/25 mg.

Medications should not be thrown away through the sewers or in the trash. Deposit the packages and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Albis Plus

• The active ingredients are olmesartan medoxomil, amlodipine (as amlodipine besylate), and hydrochlorothiazide.

Albis Plus 20 mg/5 mg/12.5 mg: Each film-coated tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

Albis Plus 40 mg/5 mg/12.5 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

Albis Plus 40 mg/10 mg/12.5 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

Albis Plus 40 mg/5 mg/25 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 25 mg of hydrochlorothiazide.

Albis Plus 40 mg/10 mg/25 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besylate), and 25 mg of hydrochlorothiazide.

• Other components are:

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

Tablet coating: Polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172) (40 mg/5 mg/12.5 mg and 40 mg/5 mg/25 mg tablets), and red iron oxide (E172) (40 mg/10 mg/12.5 mg and 40 mg/10 mg/25 mg tablets).

Appearance of the product and package contents

Albis Plus 20 mg/5 mg/12.5 mg: Film-coated tablets, white, round, biconvex, with the inscription "t5" on one face.

Albis Plus 40 mg/5 mg/12.5 mg: Film-coated tablets, light yellow, round, biconvex, with the inscription "t4" on one face.

Albis Plus 40 mg/10 mg/12.5 mg: Film-coated tablets, pink, round, biconvex, with the inscription "t3" on one face.

Albis Plus 40 mg/5 mg/25 mg: Film-coated tablets, light yellow, oblong, biconvex, with the inscription "t2" on one face and scored on the other face. The score line is only for breaking and facilitating swallowing but not for dividing into equal doses.

Albis Plus 40 mg/10 mg/25 mg: Film-coated tablets, pink, oblong, biconvex, with the inscription "t1" on one face and scored on the other. The score line is only for breaking and facilitating swallowing but not for dividing into equal doses.

Albis Plus is presented in blister 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.

Olaz-Chipi 10, Polígono Industrial Areta

31620 Huarte, Navarra

Spain

Date of the last revision of this leaflet:February 2025

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