Amolisa Hct

Leaflet attached to the packaging: information for the user

Amolisa HCT, 20 mg + 5 mg + 12.5 mg, film-coated tablets

Amolisa HCT, 40 mg + 5 mg + 12.5 mg, film-coated tablets

Amolisa HCT, 40 mg + 10 mg + 12.5 mg, film-coated tablets

Amolisa HCT, 40 mg + 5 mg + 25 mg, film-coated tablets

Amolisa HCT, 40 mg + 10 mg + 25 mg, film-coated tablets

Olmesartan medoxomil + Amlodipine + Hydrochlorothiazide

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Amolisa HCT and what is it used for
• 2. Important information before taking Amolisa HCT
• 3. How to take Amolisa HCT
• 4. Possible side effects
• 5. How to store Amolisa HCT
• 6. Contents of the pack and other information

1. What is Amolisa HCT and what is it used for

Amolisa HCT contains three active substances called olmesartan medoxomil, amlodipine (as amlodipine besylate), and hydrochlorothiazide. All three substances help to lower high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists, which lower blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines called calcium channel blockers. It also lowers blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. Hydrochlorothiazide lowers blood pressure by helping the body get rid of excess fluid.

The action of these substances results in a decrease in blood pressure. Amolisa HCT is used to treat high blood pressure:

• in adult patients whose blood pressure is not adequately controlled by the combination of olmesartan medoxomil and amlodipine given as a two-component product, or
• in patients who are already taking a combination of olmesartan medoxomil and hydrochlorothiazide and amlodipine as separate tablets or a combination of olmesartan medoxomil and amlodipine and hydrochlorothiazide as separate tablets.

2. Important information before taking Amolisa HCT

When not to take Amolisa HCT

• if the patient is allergic to olmesartan medoxomil, amlodipine or calcium channel blockers (dihydropyridine derivatives), hydrochlorothiazide or substances similar to hydrochlorothiazide (sulfonamides) or any of the other ingredients of this medicine (listed in section 6). If an allergy is suspected, the patient should consult a doctor before taking Amolisa HCT.
• in cases of severe kidney problems.
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.
• if the patient has low potassium, low sodium, high calcium, or high uric acid levels in the blood (with symptoms of gout or kidney stones) that cannot be treated.
• after the third month of pregnancy (the patient should also avoid taking Amolisa HCT in early pregnancy - see "Pregnancy and breastfeeding").
• in cases of severe liver problems, if bile flow is impaired or bile flow from the gallbladder is blocked (e.g., by gallstones) or if jaundice (yellowing of the skin and eyes) occurs.
• in cases of insufficient blood flow to the tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, i.e., shock caused by severe heart problems).
• in cases of very low blood pressure.
• in cases of narrowing or blockage of the blood flow from the heart. This can be due to narrowing of the blood vessels or heart valves (aortic stenosis).
• in cases of weakened heart function after a heart attack (acute myocardial infarction). Weakened heart function can cause shortness of breath or swelling of the feet and ankles.

Amolisa HCT should not be taken if any of the above situations apply to the patient.

Warnings and precautions

Before starting Amolisa HCT, the patient should discuss it with their doctor or pharmacist.

If the patient has previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient experiences severe shortness of breath or difficulty breathing after taking Amolisa HCT, they should seek medical help immediately.
The patient should tell their doctorif they are taking any of the following medicines used to treat high blood pressure:

• angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes,
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also the "When not to take Amolisa HCT" section.
The patient should tell their doctorif they have any of the following conditions:

• Kidney problems or a history of kidney transplant
• Liver disease
• Heart failure or heart valve problems or heart muscle problems
• Severe vomiting, diarrhea, treatment with high doses of diuretics, or a low-salt diet
• High potassium levels in the blood
• Adrenal gland problems (glands that produce hormones, located above the kidneys)
• Diabetes
• Lupus (an autoimmune disease)
• Allergy or asthma
• Skin reactions, such as sunburn or rash caused by sunlight or sunlamps
• If the patient has a history of malignant skin tumors or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of malignant skin tumors and lip cancer (non-melanoma skin cancer). During Amolisa HCT treatment, the patient should protect their skin from sunlight and UV radiation.

The patient should contact their doctorif they experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. The doctor will assess the symptoms and decide how to continue blood pressure treatment.
• Blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure in the eye - they can occur within a few hours to a few weeks after taking Amolisa HCT. If left untreated, they can cause permanent vision loss .

Like other blood pressure-lowering medicines, excessive lowering of blood pressure in patients with circulatory problems in the heart or brain may lead to heart attack or stroke. Therefore, the doctor will recommend careful monitoring of blood pressure in such patients.
Amolisa HCT may cause increased lipid and uric acid levels in the blood (a cause of gout - painful joint swelling). The doctor will likely recommend periodic blood tests to measure these levels.
Taking Amolisa HCT may affect the patient's electrolyte balance. The doctor will likely recommend periodic blood tests to measure electrolyte levels. Symptoms of electrolyte disturbances include thirst, dry mouth, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), weakness, apathy, fatigue, drowsiness or restlessness, nausea, vomiting, decreased urine output, rapid heartbeat. If such symptoms occur, the patient should inform their doctor.
Amolisa HCT should be discontinued before parathyroid function tests are performed.
The patient should inform their doctor if they suspect (or plan) pregnancy. Amolisa HCT is not recommended during pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").
If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Amolisa HCT, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Amolisa HCT on their own.

Children and adolescents (under 18 years)

Amolisa HCT is not recommended for children and adolescents under 18 years of age.

Elderly patients

In patients over 65 years of age, the doctor will monitor blood pressure during each dose increase to ensure that it does not decrease too much.

Amolisa HCT and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take:

• Other blood pressure-lowering medicinesmay enhance the effect of Amolisa HCT. The doctor may recommend a dose change and/or take other precautions: if the patient is taking ACE inhibitors or aliskiren (see also "When not to take Amolisa HCT" and "Warnings and precautions").
• Lithium(a medicine used to treat mood disorders and some types of depression) - concurrent use with Amolisa HCT may increase lithium toxicity. If lithium is necessary, the doctor will recommend monitoring lithium levels in the blood.
• Diltiazem, verapamil, medicines used to treat heart rhythm disorders and high blood pressure.
• Rifampicin, erythromycin, clarithromycin, tetracycline, or sparfloxacin, antibiotics used to treat tuberculosis and other infections.
• St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression.
• Cisapride, a medicine that stimulates gastrointestinal motility.
• Difemanil, a medicine used in cases of slow heart rate and reduced sweating.
• Halofantrine, a medicine used to treat malaria.
• Winkamine administered intravenously, a medicine used to improve cerebral circulation.
• Amantadine, a medicine used to treat Parkinson's disease.
• Potassium supplements, salt substitutes containing potassium, diuretics(diuretics), heparin(thins blood and prevents clot formation), ACE inhibitors (blood pressure-lowering medicines), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), penicillin sodium G (sodium salt of benzylpenicillin, an antibiotic), and certain painkillers, such as acetylsalicylic acid or salicylates. Taking these medicines with Amolisa HCT may cause changes in potassium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs)(medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), taken concurrently with Amolisa HCT, may increase the risk of kidney failure. NSAIDs may weaken the effect of Amolisa HCT. In cases of high doses of salicylates, toxic effects on the central nervous system may be enhanced.
• Sedatives, tranquilizers, and antidepressantstaken concurrently with Amolisa HCT may cause sudden drops in blood pressure when standing up.
• Cholestyramine hydrochloride(a medicine that lowers cholesterol levels in the blood) - possible weakening of Amolisa HCT's effect. The doctor may recommend taking Amolisa HCT at least 4 hours before taking cholestyramine hydrochloride.
• Certain antacids (medicines used to treat heartburn or indigestion), as Amolisa HCT's effect may be slightly reduced.
• Certain muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and bipiperidine.
• Calcium supplements.
• Dantrolene(administered by infusion in cases of severe body temperature disorders).
• Simvastatin, used to lower cholesterol and triglyceride levels in the blood.
• Medicines used to control the body's immune response(such as tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine), which allow the body to accept a transplanted organ.

The patient should also tell their doctor or pharmacist about any other medicines they are currently taking or have recently taken, as well as any medicines they plan to take:

• Medicines used to treat certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyanemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• Medicines used to treat low blood sugar(e.g., diazoxide) or blood pressure-lowering medicines(e.g., beta-blockers, methyldopa), as Amolisa HCT may affect the action of these medicines.
• Medicines used to treat heart rhythm disorders, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin administered by injection.
• Medicines used to treat HIV/AIDS infections(e.g., ritonavir, indinavir, nelfinavir).
• Medicines used to treat fungal infections(e.g., ketoconazole, itraconazole, amphotericin).
• Medicines used to treat heart problems, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis.
• Anticancer medicines, such as amifostine, cyclophosphamide, methotrexate.
• Medicines that increase blood pressure and heart rate, such as norepinephrine.
• Medicines used to treat gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Medicines that lower lipid levels in the blood, such as cholestyramine and colestipol.
• Medicines that lower blood sugar levels, such as metformin or insulin.

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Taking Amolisa HCT with food and drink

Amolisa HCT can be taken with or without food.
Patients taking Amolisa HCT should not consume grapefruit juice or grapefruits, as they may cause an increase in the level of the active substance amlodipine in the blood, which may result in unpredictable enhancement of Amolisa HCT's blood pressure-lowering effect.
The patient should be cautious when drinking alcohol while taking Amolisa HCT, as it may cause dizziness or fainting in some individuals. If such symptoms occur, the patient should not consume alcohol.

Pregnancy and breastfeeding

Pregnancy

The patient should inform their doctor if they suspect (or plan) pregnancy. The doctor will usually recommend stopping Amolisa HCT before planned pregnancy or immediately after confirming pregnancy and recommend taking a different medicine instead of Amolisa HCT. Amolisa HCT is not recommended during pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus.
If the patient becomes pregnant while taking Amolisa HCT, they should immediately consult their doctor.

Breastfeeding

The patient should inform their doctor if they are breastfeeding or plan to breastfeed. It has been shown that small amounts of amlodipine and hydrochlorothiazide pass into human milk. Amolisa HCT is not recommended during breastfeeding. The doctor may recommend a different medicine.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

During treatment for high blood pressure, dizziness, nausea, dizziness, or headache may occur. In such cases, the patient should not drive vehicles or operate machines until the symptoms have resolved. The patient should consult their doctor for advice.
Amolisa HCT contains lactose
If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.
Amolisa HCT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

3. How to take Amolisa HCT

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

• The recommended dose of Amolisa HCT is one tablet per day.
• The tablet can be taken with or without food. The tablet should be swallowed with a liquid (e.g., a glass of water). The tablets should not be chewed. Amolisa HCT should not be taken with grapefruit juice.
• If possible, the patient should take the daily dose at the same time every day, e.g., during breakfast.

Taking a higher dose of Amolisa HCT than recommended

If the patient takes more tablets than recommended, they may experience excessive lowering of blood pressure with symptoms such as dizziness, rapid or slow heartbeat.
If the patient takes a higher dose than recommended or accidentally swallows any amount of the medicine, they should immediately consult their doctor or the emergency department of the nearest hospital, taking the medicine packaging or this leaflet with them.
Even 24-48 hours after taking the medicine, shortness of breath caused by excessive fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Amolisa HCT

If the patient misses a dose, they should take their usual dose the next day. They should not take a double dose to make up for the missed dose.

Stopping Amolisa HCT treatment

It is important to continue taking Amolisa HCT until the doctor recommends stopping it.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Amolisa HCT can cause side effects, although not everybody gets them.
Side effects are often mild and do not require treatment to be stopped.

The following side effects may be serious, although they are rare:

• During treatment with Amolisa HCT, allergic reactions with swelling of the face, mouth, and/or throat, with accompanying itching and rash may occur. In such cases, Amolisa HCT should be discontinued, and the patient should immediately consult their doctor.
• In susceptible individuals, severe dizziness or fainting due to excessive lowering of blood pressure may occur when taking Amolisa HCT. In such cases, Amolisa HCT should be discontinued, the patient should immediately consult their doctor, and remain in a lying position.
• Frequency not known (cannot be estimated from the available data) If yellowing of the whites of the eyes, dark urine, itching, or liver problems occur, even if Amolisa HCT was started much earlier, the patient should immediately consult their doctor, who will assess the symptoms and decide how to continue treating high blood pressure.

Amolisa HCT is a combination of three active substances. The following information refers to side effects that have been reported so far during treatment with Amolisa HCT (in addition to those listed above) and those side effects that have been observed with individual substances or two substances taken together:

Other possible side effects of Amolisa HCT:

If the patient experiences the following side effects, they are usually mild and do not require treatment to be stopped.
Common(may affect up to 1 in 10 people)
Upper respiratory tract infection; sore throat; nasal congestion; urinary tract infection; dizziness; headache; palpitations; low blood pressure; nausea; diarrhea; constipation; muscle spasms; joint swelling; increased urine output; feeling of weakness; ankle swelling; feeling of tiredness; abnormal laboratory test results.
Uncommon(may affect up to 1 in 100 people)
Orthostatic dizziness; vertigo; rapid heartbeat; fainting; flushing; cough; dry mouth; muscle weakness; impotence.

Other side effects observed with individual substances or two substances taken together:

The following side effects may occur during treatment with Amolisa HCT, even if they have not been observed so far:
Very common(may affect more than 1 in 10 people)
Edema (fluid retention in the body).
Common(may affect up to 1 in 10 people)
Bronchitis; gastrointestinal infection; vomiting; increased blood sugar levels; presence of sugar in the urine; confusion; drowsiness; visual disturbances (including double vision and blurred vision); nasal congestion; sore throat; difficulty breathing; cough; abdominal pain; heartburn; discomfort in the stomach; bloating; back pain; muscle or joint pain; blood in the urine; flu-like symptoms; chest pain; pain.
Uncommon(may affect up to 1 in 100 people)
Decreased white blood cell count, which may increase the risk of infection; decreased platelet count, which may cause easy bruising or prolonged bleeding; anemia; bone marrow damage; restlessness; apathy; seizures; yellow vision; dry eye; blood clots (thrombosis, embolism); inflammation of blood vessels and small blood vessels in the skin; pancreatitis; jaundice; acute gallbladder inflammation; symptoms of lupus, such as rash, joint pain, and finger or toe numbness; severe skin reactions, including intense skin rash, hives, redness of the skin, severe itching, blistering, and peeling, sometimes life-threatening; movement disorders; acute kidney failure; non-infectious kidney inflammation; kidney impairment; fever.
Rare(may affect up to 1 in 1,000 people)
Swollen and painful salivary glands; decreased white blood cell count, which may increase the risk of infection; anemia; bone marrow damage; restlessness; apathy; seizures; visual disturbances; ringing in the ears (tinnitus); angina pectoris (chest pain or discomfort, known as angina attack); heart rhythm disorders; skin rash; hair loss; allergic skin inflammation; skin redness; purple spots on the skin due to small bleeding (purpura); skin discoloration; red, itchy bumps (hives); increased sweating; itching; skin rash; skin reactions to sunlight, such as sunburn or rash; muscle pain; difficulty urinating; need to urinate at night; breast enlargement in men; decreased libido; facial swelling; malaise; weight gain or loss; exhaustion.
Very rare(may affect up to 1 in 10,000 people)
Muscle stiffness; numbness or tingling of the hands or feet; heart attack; stomach inflammation; intestinal obstruction; liver inflammation.
Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).
Frequency not known(cannot be estimated from the available data)
Sudden worsening of distant vision (acute angle-closure glaucoma), blurred vision, or eye pain due to increased pressure in the eye (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma). Worsening of vision or eye pain (possible symptoms of acute angle-closure glaucoma).
Tremors, stiff posture, mask-like face, slow movements, and shuffling gait.
Malignant skin tumors and lip cancer (non-melanoma skin cancer).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Amolisa HCT

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Amolisa HCT contains

The active substances of Amolisa HCT are olmesartan medoxomil, amlodipine, and hydrochlorothiazide.
Each film-coated tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.
Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.
Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.
Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 25 mg of hydrochlorothiazide.
Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besylate), and 25 mg of hydrochlorothiazide.

Other ingredients are:

Tablet core: microcrystalline cellulose (PH-101 and PH-102), corn starch, colloidal anhydrous silica, sodium croscarmellose, lactose, magnesium stearate
Tablet coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172), red iron oxide (E 172) (only in tablets coated in doses: 20 mg + 5 mg + 12.5 mg, 40 mg + 10 mg + 12.5 mg, 40 mg + 10 mg + 25 mg), black iron oxide (E 172) (only in tablets coated in a dose of 20 mg + 5 mg + 12.5 mg)

What Amolisa HCT looks like and contents of the pack

Film-coated tablet.
Amolisa HCT, 20 mg + 5 mg + 12.5 mg, film-coated tablets: [Size: about 8 mm]
Light orange, round, biconvex film-coated tablets with the symbol "S1" embossed on one side and smooth on the other side.
Amolisa HCT, 40 mg + 5 mg + 12.5 mg, film-coated tablets: [Size: about 10.5 mm]
Light yellow, round, biconvex film-coated tablets with the symbol "S2" embossed on one side and smooth on the other side.
Amolisa HCT, 40 mg + 10 mg + 12.5 mg, film-coated tablets: [Size: about 10.5 mm]
Gray-red, round, biconvex film-coated tablets with the symbol "S3" embossed on one side and smooth on the other side.
Amolisa HCT, 40 mg + 5 mg + 25 mg, film-coated tablets: [Size: about 15 x 7 mm]
Light yellow, oval, biconvex film-coated tablets with the symbol "S4" embossed on one side and smooth on the other side.
Amolisa HCT, 40 mg + 10 mg + 25 mg, film-coated tablets: [Size: about 15 x 7 mm]
Gray-red, oval, biconvex film-coated tablets with the symbol "S5" embossed on one side and smooth on the other side.
Pack sizes: 14, 28, 30, 56, 60, 98, and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebuggia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany:

OlmeAmlodipinHCT PUREN 20 mg/5 mg/12.5 mg - 40 mg/5 mg/12.5 mg - 40 mg/10 mg/12.5 mg - 40 mg/5 mg/25 mg - 40 mg/10mg/25 mg Filmtabletten

Poland:

Amolisa HCT

Portugal:

Amlodipine + Olmesartan medoxomil + Hydrochlorothiazide Generis

Spain:

Olmesartán/Amlodipino/Hidroclorotiazida Aurovitas 20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, 40 mg/5 mg/25 mg and 40 mg/10 mg/25 mg comprimidos recubiertos con película EFG

Date of last revision of the leaflet: 01/2025