Olmesartan medoxomil + Amlodipine + Hydrochlorothiazide
Amolisa HCT contains three active substances called olmesartan medoxomil, amlodipine (as amlodipine besylate), and hydrochlorothiazide. All three substances help lower high blood pressure.
The action of these substances results in lowering blood pressure. Amolisa HCT is used to treat high blood pressure:
You should not take Amolisa HCT if any of the above situations apply to you.
If, in the past, after taking hydrochlorothiazide, you have had breathing or lung problems (including pneumonia or fluid accumulation in the lungs). If, after taking Amolisa HCT, you experience severe shortness of breath or difficulty breathing, you should seek medical help immediately.
You should tell your doctorif you are taking any of the following medicines used to treat high blood pressure:
Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood.
See also the section "When not to take Amolisa HCT".
You should tell your doctorif you have any of the following conditions:
You should contact your doctorif you experience any of the following symptoms:
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, your doctor will recommend careful monitoring of blood pressure in such patients.
Amolisa HCT may increase lipid and uric acid levels in the blood (a cause of gout - painful joint swelling). Your doctor will likely recommend periodic blood tests to measure these levels.
Taking Amolisa HCT may affect the electrolyte balance in your body. Your doctor will likely recommend periodic blood tests to measure electrolyte levels. Symptoms of electrolyte disturbances include thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), weakness, apathy, fatigue, drowsiness or restlessness, nausea, vomiting, decreased urine production, rapid heartbeat. If you experience such symptoms, you should inform your doctor.
You should stop taking Amolisa HCT before performing parathyroid function tests.
You should inform your doctor if you suspect (or plan) pregnancy. It is not recommended to take Amolisa HCT during pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Amolisa HCT, you should discuss it with your doctor. Your doctor will decide on further treatment. You should not stop taking Amolisa HCT on your own.
Amolisa HCT is not recommended for children and adolescents under 18 years of age.
In patients over 65 years of age, your doctor will monitor your blood pressure when increasing the dose to ensure that it does not drop too much.
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take:
You should also tell your doctor or pharmacist about any other medicines you are currently taking or have recently taken, as well as any medicines you plan to take:
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
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 the blood pressure-lowering effect of Amolisa HCT.
You should be cautious when drinking alcohol while taking Amolisa HCT, as it may cause dizziness or fainting in some people. If such symptoms occur, you should not consume alcohol.
You should inform your doctor if you suspect (or plan) pregnancy. Your 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. It is not recommended to take Amolisa HCT during pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus.
If you become pregnant while taking Amolisa HCT, you should immediately consult your doctor.
You should inform your doctor if you are breastfeeding or plan to breastfeed. It has been shown that small amounts of amlodipine and hydrochlorothiazide pass into human milk. It is not recommended to take Amolisa HCT during breastfeeding. Your doctor may recommend a different medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.
During treatment for high blood pressure, drowsiness, nausea, dizziness, or headache may occur. In such cases, you should not drive vehicles or operate machines until the symptoms have resolved. You should consult your doctor for advice.
Amolisa HCT contains lactose
If you have been diagnosed with intolerance to some sugars, you should contact your 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".
This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
If you take more tablets than recommended, you may experience excessive lowering of blood pressure with symptoms such as dizziness, rapid or slow heart rate.
If you take a higher dose than recommended or if a child accidentally swallows any amount of the medicine, you should immediately go to a doctor or the emergency department of the nearest hospital, taking the medicine packaging or this leaflet with you.
Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.
If you miss a dose, you should take your usual dose the next day. You should not take a double dose to make up for the missed dose.
It is important to continue taking Amolisa HCT until your doctor recommends stopping it.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are often mild and do not require discontinuation of treatment.
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 the combination product Amolisa HCT (in addition to those listed above) and those side effects that have been observed with individual substances or two substances taken together:
If you experience the following side effects, they are usually mild and do not require treatment discontinuation.
Common(may affect up to 1 in 10 people)
Upper respiratory tract infection; sore throat, nose; urinary tract infection; dizziness of central origin; headache; palpitations; low blood pressure; nausea; diarrhea; constipation; muscle spasms; joint swelling; increased urine production; feeling of weakness; swelling around the ankles; feeling of fatigue; abnormal laboratory test results.
Uncommon(may affect up to 1 in 100 people)
Dizziness when standing up; dizziness of labyrinthine origin; rapid heartbeat; fainting; flushing and feeling of warmth on the face; cough; dry mouth; muscle weakness; impotence.
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 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; musculoskeletal pain; blood in urine; flu-like symptoms; chest pain; pain.
Uncommon(may affect up to 1 in 100 people)
Pain and swelling of the salivary glands; decreased white blood cell count, which can increase the risk of infection; anemia (low red blood cell count); 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)
Pain and swelling of the salivary glands; decreased platelet count, which can cause easy bruising or prolonged bleeding; allergic reactions; severe loss of appetite (anorexia); sleep disturbances; irritability; mood changes, including anxiety; depression; chills; sleep disturbances; taste disturbances; loss of consciousness; numbness; tingling; tinnitus (ringing in the ears); angina pectoris (chest pain or discomfort, known as angina attack); arrhythmias; rash; hair loss; allergic skin inflammation; skin redness; purple spots on the skin due to small blood vessel bleeding (purpura); skin discoloration; red, itchy bumps (hives); increased sweating; itching; skin rashes; skin reactions to light, 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; fatigue.
Very rare(may affect up to 1 in 10,000 people)
Muscle stiffness; numbness or tingling of hands or feet; heart attack; stomach inflammation; gum hypertrophy; intestinal obstruction; liver inflammation.
Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).
Frequency not known(cannot be estimated from 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, stiffness, mask-like face, slow movements, and shuffling gait.
Malignant skin tumors and lip tumors (non-melanoma skin cancer).
If you experience any side effects, including those not listed in this leaflet, you should tell your 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, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.
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 in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
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.
Tablet core: microcrystalline cellulose (PH-101 and PH-102), cornstarch, 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)
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]
Red-brown, 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]
Red-brown, 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.
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl
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
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:
Amlodipina + Olmesartan medoxomilo + Hidroclorotiazida 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
Need help understanding this medicine or your symptoms? Online doctors can answer your questions and offer guidance.