ALBIS PLUS 20 mg/5 mg/12.5 mg FILM-COATED TABLETS

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Albis Plus. Your doctor will decide whether to continue treatment. Do not stop taking Albis Plus on your own.

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

• a medicine called an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may need to 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 Plus”.

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

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with your heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medicines that increase urine production (diuretics), or if you are on a low-salt diet.
• High potassium levels in your blood.
• Problems with your adrenal glands (hormone-producing glands located above your kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• Skin reactions such as sunburn or rash after being in the sun or using a sunbed.

Contact your doctor if you experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.
• Decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and may occur from a few hours to a few weeks after taking olmesartan/amlodipine/hydrochlorothiazide. This can lead to permanent vision impairment if left untreated.

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 cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

Olmesartan/amlodipine/hydrochlorothiazide may cause an increase in lipid and uric acid levels in your blood. Your doctor will likely want to perform a blood test from time to time to monitor these potential changes.

A change in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely want to perform a blood test from time to time to monitor this potential change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, slowness, tiredness, drowsiness or restlessness, nausea, vomiting, decreased need to urinate, rapid heart rate. Tell your doctor if you notice any of these symptoms.

If you are going to have parathyroid function tests, you should stop taking olmesartan/amlodipine/hydrochlorothiazide before these tests are performed.

Athletes are informed that this medicine contains a component that may result in a positive doping test.

You must inform your doctor if you are pregnant (or think you might be). Olmesartan/amlodipine/hydrochlorothiazide is not recommended during 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 at this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years)

Olmesartan/amlodipine/hydrochlorothiazide is not recommended for use in children and adolescents under 18 years.

Taking Albis Plus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

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

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 Albis Plus” and “Warnings and precautions”).
• Lithium(a medicine used to treat mood changes and some types of depression) may have its toxicity increased if taken with olmesartan/amlodipine/hydrochlorothiazide. If you need to take lithium, your doctor will monitor your lithium blood levels.
• Diltiazem, verapamil, used for heart rhythm problems and high blood pressure.
• Rifampicin, erythromycin, clarithromycin, tetracyclines, or sparfloxacin, antibiotics used for tuberculosis and other infections.
• St. John's Wort(Hypericum perforatum), a herbal remedy for depression.
• Cisapride, used to increase food movement in the stomach and intestines.
• Difemanil, used to treat slow heart rate or to decrease sweating.
• Halofantrine, used for malaria.
• Vincamine IV, used to improve blood circulation in the nervous system.
• Amantadine, used for Parkinson's disease.
• Potassium supplements, salt substitutes that contain potassium, medicines that increase urine production(diuretics), heparin(to thin blood and prevent blood clots), angiotensin-converting enzyme inhibitors (ACE inhibitors) (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine for mouth and stomach ulcers), sodium penicillin G (an antibiotic also called sodium benzylpenicillin), and some pain relievers like acetylsalicylic acid (“aspirin”) or salicylates. Taking these medicines with olmesartan/amlodipine/hydrochlorothiazide may alter potassium levels in your blood.
• Non-steroidal anti-inflammatory medicines(NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as olmesartan/amlodipine/hydrochlorothiazide, may increase the risk of kidney failure. The effect of olmesartan/amlodipine/hydrochlorothiazide may be reduced by NSAIDs. If you use high doses of salicylates, the toxic effect on the central nervous system may increase.
• Sedatives, hypnotics, and antidepressants, used with olmesartan/amlodipine/hydrochlorothiazide, may cause a sudden drop in blood pressure when standing up.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of olmesartan/amlodipine/hydrochlorothiazide. Your doctor may advise you to take olmesartan/amlodipine/hydrochlorothiazide at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of olmesartan/amlodipine/hydrochlorothiazide.
• Certain muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and biperiden.
• Calcium supplements.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, used to lower cholesterol and fat (triglyceride) levels in the blood.
• Medicines used to control the body's immune response(e.g., tacrolimus, cyclosporine), which allow your body to accept a transplanted organ.

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

Taking Albis Plus with food and drinks

Olmesartan/amlodipine/hydrochlorothiazide can be taken with or without food.

People taking olmesartan/amlodipine/hydrochlorothiazide should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active ingredient amlodipine in the blood, which may cause an unpredictable increase in the blood pressure-lowering effect of olmesartan/amlodipine/hydrochlorothiazide.

Be careful when drinking alcohol while taking olmesartan/amlodipine/hydrochlorothiazide, as some people may feel faint or dizzy. If this happens to you, do not drink any alcohol.

Elderly patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure whenever your dose is increased, to ensure that your blood pressure does not drop too much.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant or think you might be. Your doctor will advise you to stop taking olmesartan/amlodipine/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of olmesartan/amlodipine/hydrochlorothiazide. Olmesartan/amlodipine/hydrochlorothiazide is not recommended during 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 at this stage.

If you become pregnant while taking olmesartan/amlodipine/hydrochlorothiazide, inform and consult your doctor immediately.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. Olmesartan/amlodipine/hydrochlorothiazide is not recommended for breastfeeding mothers, and your doctor may choose a different treatment if you wish to breastfeed.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You may feel drowsy, sick, or dizzy while being treated for high blood pressure. If this happens, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How 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 rapid 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, which 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 the missed 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 cause adverse effects, although not all people suffer from them. If they occur, they are often mild and do not require interrupting treatment.

The following adverse effects can 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, infrequent, rare, and very rare.

These are other known adverse effects of 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.

Infrequent(may affect up to 1 in 100 people)

Dizziness when standing up, vertigo, rapid 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 known adverse effects 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 frequent(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.

Infrequent(may affect up to 1 in 100 people)

Reduction 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 disorders, 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, increased breast size 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 kidney inflammation, decreased kidney function, fever, intestinal angioedema (swelling in the intestine with 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 Medication Surveillance System for Human Use: 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 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 down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This 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 side.

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

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

Albis Plus 40 mg/5 mg/25 mg: Film-coated tablets, light yellow, oblong, biconvex, with the inscription "t2" on one side and scored on the other side. 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 side 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/