Olmesartan/amlodipine/hydrochlorothiazide Alter 20 mg/5 mg/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olmesartán/Amlodipino/Hidroclorotiazida Alter 20 mg/5 mg/12.5 mg film-coated tablets EFG

Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg/5 mg/12.5 mg film-coated tablets EFG

Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg/5 mg/25 mg film-coated tablets EFG

Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg/10 mg/12.5 mg film-coated tablets EFG

Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg/10 mg/25 mg film-coated tablets EFG

Olmesartán medoxomilo / Amlodipino / Hidroclorotiazida

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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Olmesartán/Amlodipino/Hidroclorotiazida Alter contains three active substances: olmesartán medoxomilo, amlodipino (as amlodipino besilato), and hidroclorotiazida. These three substances help control high blood pressure.

• Olmesartán medoxomilo belongs to a group of medicines called “angiotensin II receptor antagonists,” which lower blood pressure by relaxing blood vessels.
• Amlodipino belongs to a group of medicines called “calcium channel blockers.” Amlodipino also lowers blood pressure by relaxing blood vessels.
• Hidroclorotiazida belongs to a group of medicines known as thiazide diuretics. It reduces blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

The combined action of these substances helps reduce your blood pressure. Olmesartán/hidroclorotiazida/amlodipino is used to treat high blood pressure:

• in adult patients whose blood pressure is not adequately controlled with the combination of olmesartán medoxomilo and amlodipino taken as a fixed-dose combination, or
• in patients who are already taking a fixed-dose combination of olmesartán medoxomilo and hidroclorotiazida together with tablets containing only amlodipino, or a fixed-dose combination of olmesartán medoxomilo and amlodipino together with tablets containing only hidroclorotiazida.

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

Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Alter

• If you are allergic to olmesartan medoxomil, amlodipine, or a specific group of calcium channel blockers (dihydropyridines), hydrochlorothiazide, substances similar to hydrochlorothiazide (sulfonamides), 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/amlodipine/hydrochlorothiazide.
• If you have severe kidney problems.
• If you have diabetes or renal failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood, which do not improve with treatment.
• If you are more than 3 months pregnant. (It is also advisable to avoid olmesartan/amlodipine/hydrochlorothiazide at the beginning of pregnancy – see section “Pregnancy and breastfeeding”).
• If you have severe liver problems, biliary secretion disorders, or obstruction of bile drainage from the gallbladder (e.g., due to gallstones), or have jaundice (yellowing of the skin and eyes).
• If you have inadequate blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, meaning shock due to serious heart problems).
• If you have very low blood pressure.
• If blood flow from your heart is slow or blocked. This may occur if the blood vessels or valves collecting blood from the heart are narrowed (aortic stenosis).
• If you have low cardiac output after a heart attack (acute myocardial infarction). Low cardiac output may make you feel short of breath or have swelling in your feet and ankles.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Olmesartan/Amlodipine/Hydrochlorothiazide Alter:

• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking this medicine.
• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnea or severe difficulty breathing after taking Olmesartan/Amlodipine/Hydrochlorothiazide Alter, seek medical attention immediately.

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

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/Hydrochlorothiazide 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 diuretics (medicines that increase urine elimination), 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).
• Diabetes.
• Systemic lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• Skin reactions such as sunburn or rash after sun exposure or use of tanning beds.

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

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

As with any other medicine that lowers blood pressure, excessive reduction 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 increase blood levels of lipids and uric acid (which causes gout – painful joint swelling). Your doctor may periodically perform blood tests to monitor these potential changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor may periodically perform blood tests to monitor this possible effect. Some signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, drowsy, or restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

If you are scheduled for parathyroid function tests, you should stop taking olmesartan/amlodipine/hydrochlorothiazide before the tests are performed.

Athletes should be aware that this medicine contains a component that may lead to a positive result in doping control tests.

Inform your doctor if you are pregnant (or think you might be). Use of olmesartan/amlodipine/hydrochlorothiazide is not recommended at the beginning of pregnancy, and it 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)

The use of olmesartan/amlodipine/hydrochlorothiazide is not recommended in children and adolescents under 18 years of age.

Taking Olmesartan/Amlodipine/Hydrochlorothiazide Alter with other medicines

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

• Other blood pressure-lowering medicines, as they may enhance 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 information under the headings “Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Alter” and “Warnings and precautions”).
• Lithium, a medicine used to treat mood disorders and certain types of depression, may have increased toxicity when taken with olmesartan/amlodipine/hydrochlorothiazide. If you must take lithium, your doctor will monitor 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 gastrointestinal motility.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Halofantrine, used for malaria.
• Vincamine IV, used to improve blood circulation in the nervous system.
• Amantadine, used for Parkinson’s disease.
• Potassium supplements, potassium-containing salt substitutes, diuretics (medicines that increase urine elimination), heparin (to thin blood and prevent 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 known as sodium benzylpenicillin), some painkillers such as acetylsalicylic acid (“aspirin”) or salicylates. Taking these medicines together with olmesartan/amlodipine/hydrochlorothiazide may alter blood potassium levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other inflammatory symptoms, including arthritis), when taken with olmesartan/amlodipine/hydrochlorothiazide, may increase the risk of renal failure. The effect of olmesartan/amlodipine/hydrochlorothiazide may be reduced by NSAIDs. High doses of salicylates may increase central nervous system toxicity.
• Sleep-inducing medicines, sedatives, and antidepressants, when used with olmesartan/amlodipine/hydrochlorothiazide, may cause a sudden drop in blood pressure upon standing.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, 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), which may slightly reduce the effect of olmesartan/amlodipine/hydrochlorothiazide.
• Some muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and biperiden.
• Calcium supplements.
• Dantrolene (by 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 help the body accept a transplanted organ.

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

• Treating certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• Treating low blood sugar (e.g., diazoxide) or high blood pressure (e.g., beta-blockers, methyldopa), since olmesartan/amlodipine/hydrochlorothiazide may affect the mechanism of action of these medicines.
• Treating heart rhythm disorders, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injections.
• Treating HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir).
• Treating fungal infections (e.g., ketoconazole, itraconazole, amphotericin).
• Treating heart problems, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis.
• Treating cancer, such as amifostine, cyclophosphamide, or methotrexate.
• Increasing blood pressure and decreasing heart rate, such as noradrenaline.
• Treating gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Lowering blood fat levels, such as cholestyramine and colestipol.
• Lowering blood sugar levels, such as metformin or insulin.

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

Taking Olmesartan/Amlodipine/Hydrochlorothiazide Alter 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 may increase blood levels of the active ingredient amlodipine, potentially causing an unpredictable increase in the blood pressure-lowering effect of olmesartan/amlodipine/hydrochlorothiazide.

Be cautious when drinking alcohol while taking olmesartan/amlodipine/hydrochlorothiazide, as some people may feel faint or dizzy. If this happens, avoid alcohol.

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 that your blood pressure does not drop too much.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you might be. Your doctor will advise you to stop taking olmesartan/amlodipine/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of olmesartan/amlodipine/hydrochlorothiazide is not recommended during pregnancy, and must not be taken after the third month 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/amlodipine/hydrochlorothiazide, inform and see your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. 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 an alternative treatment if you wish to breastfeed.

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.

Driving and using machines

You may feel drowsy, unwell, dizzy, or have a headache while being treated for high blood pressure. 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; hence, it is essentially “sodium-free”.

3. How to take Olmesartán/Amlodipino/Hidroclorotiazida Alter

Follow exactly the administration instructions for this medicine as indicated 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 the tablets 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/Hidroclorotiazida 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 center, and bring the medicine container 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.

If you forget to take Olmesartán/Amlodipino/Hidroclorotiazida 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/Hidroclorotiazida 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 can be serious:

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

Olmesartan/amlodipine/hydrochlorothiazide may cause a marked drop in blood pressure in susceptible patients. This may lead to fainting or severe dizziness. If this happens to you, stop taking this medicine, 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 first describes adverse effects reported so far with the combination olmesartan/amlodipine/hydrochlorothiazide (in addition to those already mentioned), and secondly, the known adverse effects of each of the individual active substances, or when two of the substances are taken together.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or itching of the skin, even if you started treatment with Olmesartán/Amlodipino/Hidroclorotiazida Alter some time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

To give you an idea of how many patients may experience adverse effects, they have been classified as common, uncommon, rare, and very rare.

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

If these effects occur, they are often mild and it is not necessary to discontinue treatment.

Common (may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat and nose, urinary tract infection, dizziness, headache, awareness of heartbeat, low blood pressure, nausea, diarrhea, constipation, cramps, joint swelling, urgency to urinate, weakness, ankle swelling, fatigue, abnormal laboratory test results.

Uncommon (may affect up to 1 in 100 people)

Dizziness upon standing, vertigo, rapid heartbeat, feeling faint, flushing and sensation of warmth in the face, cough, dry mouth, muscle weakness, inability to achieve or maintain an erection.

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

These 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).

Common (may affect up to 1 in 10 people)

Bronchitis, stomach and intestinal infection, vomiting, increased blood sugar, sugar in urine, confusion, drowsiness, visual disturbances (including double vision and blurred vision), nasal discharge or 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)

Reduction in the number of a type of blood cells called platelets, which may lead to easy bruising or prolonged bleeding time, anaphylactic reactions, abnormal decrease in appetite (anorexia), sleep disturbances, irritability, mood changes including anxiety, feeling depressed, chills, sleep disorders, altered sense of taste, loss of consciousness, reduced sense of touch, tingling sensation, worsening of myopia, ringing in the ears (tinnitus), angina (chest pain or discomfort, known as angina pectoris), irregular heartbeat, rash, hair loss, allergic skin inflammation, skin redness, purple spots or patches on the skin due to small hemorrhages (purpura), skin discoloration, itchy red welts (urticaria), increased sweating, pruritus, skin rash, skin reactions to light such as sunburn or skin rash, muscle pain, difficulty urinating, feeling of need to urinate at night, breast enlargement in men, decreased sex drive, facial swelling, feeling unwell, weight gain or loss, exhaustion.

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

Inflammation and pain of the salivary glands, decreased number of white blood cells in the blood, which could increase the risk of infections, decreased number of red blood cells (anemia), bone marrow damage, restlessness, feeling of loss of interest (apathy), attacks (seizures), 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, inflammation of the pancreas, yellowing of the skin and eyes, acute inflammation of the gallbladder, symptoms of lupus erythematosus such as skin rash, joint pains, and coldness in hands and fingers, severe skin reactions including intense skin rash, urticaria, redness of the skin of the body, severe itching, blisters, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe, deterioration of movement, acute kidney failure, non-infectious inflammation of the kidney, reduced kidney function, fever, intestinal angioedema (swelling in the intestine causing 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, inflammation of the stomach, gum enlargement, intestinal obstruction, liver inflammation, acute breathing difficulty (signs include severe shortness of breath, 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 unbalanced gait with shuffling steps.

Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Olmesartan/Amlodipine/Hydrochlorothiazide Alter

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

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

No special storage conditions are required for Olmesartan/Amlodipine/Hydrochlorothiazide Alter 20 mg/5 mg/12.5 mg, Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg/10 mg/12.5 mg, and Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg/10 mg/25 mg.

Do not store at temperatures above 30°C for Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg/5 mg/12.5 mg and Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg/5 mg/25 mg.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Amlodipine/Hydrochlorothiazide Alter

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

Olmesartan/Amlodipine/Hydrochlorothiazide Alter 20 mg /5 mg/12.5 mg: Each film-coated tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besilate) and 12.5 mg of hydrochlorothiazide.

Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg /5 mg/12.5 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besilate) and 12.5 mg of hydrochlorothiazide.

Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg /10 mg/12.5 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besilate) and 12.5 mg of hydrochlorothiazide.

Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg /5 mg/25 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besilate) and 25 mg of hydrochlorothiazide.

Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg /10 mg/25 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besilate) and 25 mg of hydrochlorothiazide.

• The other components are:

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

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

Appearance of the product and contents of the pack

Olmesartan/Amlodipine/Hydrochlorothiazide Alter 20 mg /5 mg/12.5 mg: White, round, biconvex, film-coated tablets with the inscription “t5” on one side.

Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg /5 mg/12.5 mg: Light yellow, round, biconvex, film-coated tablets with the inscription “t4” on one side.

Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg /10 mg/12.5 mg: Pink, round, biconvex, film-coated tablets with the inscription “t3” on one side.

Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg /5 mg/25 mg: Light yellow, oblong, biconvex, film-coated tablets with the inscription “t2” on one side and a score line on the other. The score line is intended only to facilitate breaking for ease of swallowing and is not intended to divide the tablet into equal doses.

Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg /10 mg/25 mg: Pink, oblong, biconvex, film-coated tablets with the inscription “t1” on one side and a score line on the other. The score line is intended only to facilitate breaking for ease of swallowing and is not intended to divide the tablet into equal doses.

Olmesartan/Amlodipine/Hydrochlorothiazide Alter is available in blister packs in containers 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 most recent revision of this summary: February 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/