Amolisa Hct

Leaflet accompanying 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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 them, 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 packaging 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 lower high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists, which lower blood pressure by reducing the tension of blood vessels.
• Amlodipine belongs to a group of medicines called calcium antagonists. It also lowers blood pressure by reducing the tension of blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. Hydrochlorothiazide lowers blood pressure by removing excess fluids from the body through increased urine production.

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 taken as a two-component product, or
• in patients who are taking a combination product containing olmesartan medoxomil and hydrochlorothiazide and amlodipine as a separate medicine or a combination product containing olmesartan medoxomil and amlodipine and hydrochlorothiazide as a separate medicine.

2. Important information before taking Amolisa HCT

When not to take Amolisa HCT

• if the patient is allergic to olmesartan medoxomil, amlodipine, or calcium antagonists (dihydropyridine derivatives), hydrochlorothiazide, or other sulfonamide-derived substances, or any of the other ingredients of this medicine (listed in section 6). If there is a suspicion of an allergy, consult a doctor before taking Amolisa HCT.
• in case of severe kidney function disorders.
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.
• if there is low potassium, low sodium, high calcium, or high uric acid levels in the blood (with symptoms of gout or kidney stones) that do not respond to treatment.
• after the 3rd month of pregnancy (it is also recommended to avoid taking Amolisa HCT in early pregnancy - see "Pregnancy and breastfeeding").
• in case of severe liver function disorders, if bile secretion 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 case of insufficient blood supply to tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, i.e., shock caused by severe heart disorders).
• in case of very low blood pressure.
• in case of narrowing or blockage of the blood flow from the heart. This may be due to narrowing of blood vessels or heart valves (aortic stenosis).
• in case of weakened heart function after a heart attack (acute myocardial infarction). Weakened heart function may cause shortness of breath or swelling of the feet and ankles.

Do not take Amolisa HCT if any of the above situations apply to the patient.

Warnings and precautions

Before starting Amolisa HCT, discuss it with a doctor or pharmacist.

If the patient has had breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide in the past. If severe shortness of breath or difficulty breathing occurs after taking Amolisa HCT, seek medical attention immediately.
Tell your doctorif you 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 you have kidney function disorders related to diabetes,
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also "When not to take Amolisa HCT".
Tell your doctorif you have any of the following conditions:

• Kidney function disorders or post-kidney transplant
• Liver disease
• Heart failure or heart valve disorders or heart muscle disorders
• Severe vomiting, diarrhea, treatment with high doses of diuretics, or a low-salt diet
• High potassium levels in the blood
• Adrenal gland disorders (hormone-producing glands located above the kidneys)
• Diabetes
• Lupus erythematosus (an autoimmune disease)
• Allergy or asthma
• Skin reactions, such as sunburn or rash caused by sunlight or sunlamps
• If you have had a malignant skin tumor in the past 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 tumors (non-melanoma skin cancer). During Amolisa HCT treatment, protect your skin from sunlight and UV radiation.

Consult your doctorif you experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your 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 inside 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 blood pressure lowering in patients with circulatory disorders in the heart or brain may lead to a heart attack or stroke. Therefore, your 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). Your doctor will likely recommend periodic blood tests to measure these levels.
Taking Amolisa HCT may affect the electrolyte balance in the patient's body. Your doctor will likely recommend periodic blood tests to measure electrolyte levels. Symptoms of electrolyte disorders include thirst, dry mouth, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), weakness, apathy, fatigue, drowsiness or restlessness, nausea, vomiting, decreased urine production, rapid heartbeat. If such symptoms occur, inform your doctor.
Stop taking Amolisa HCT before performing parathyroid function tests.
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, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Amolisa HCT on your own.

Children and adolescents (under 18 years old)

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

Elderly patients

In patients over 65 years old, the doctor will monitor blood pressure during each dose increase to ensure that there is no excessive blood pressure lowering.

Amolisa HCT and other medicines

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:

• Other blood pressure-lowering medicinesmay enhance the effect of Amolisa HCT. Your doctor may recommend a dose change and/or take other precautions: if you are 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, your 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 reducing 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 (lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), sodium penicillin G (an antibiotic), and some painkillers, such as acetylsalicylic acid or salicylates. Taking these medicines concurrently 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 blood pressure lowering when standing up.
• Cholestyramine hydrochloride(a medicine that lowers cholesterol levels in the blood) - possible weakening of Amolisa HCT's effect. Your doctor may recommend taking Amolisa HCT at least 4 hours before taking cholestyramine hydrochloride.
• Certain antacids (medicines used to treat indigestion or heartburn), 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 intravenously 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.

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.

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.
Caution is advised when consuming alcohol while taking Amolisa HCT, as it may cause dizziness or fainting in some individuals. If such symptoms occur, do not consume alcohol.

Pregnancy and breastfeeding

Pregnancy

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, consult your doctor immediately.

Breastfeeding

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, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

During treatment for high blood pressure, drowsiness, nausea, dizziness, or headache may occur. In such cases, do not drive or operate machinery until the symptoms have resolved. Consult your doctor for advice.
Amolisa HCT contains lactose
If you have been diagnosed with an intolerance to some sugars, consult 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 is essentially "sodium-free".

3. How to take Amolisa HCT

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

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

Overdose of Amolisa HCT

If you take more tablets than recommended, excessive blood pressure lowering may occur with symptoms such as dizziness, rapid or slow heartbeat.
If you take more than the recommended dose or if a child accidentally swallows any amount of the medicine, 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 excessive fluid accumulation in the lungs (pulmonary edema) may occur.

Missed dose of Amolisa HCT

If you miss a dose, take the usual dose the next day. Do 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 your doctor recommends stopping it.
If you have any further questions about taking this medicine, consult your 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 discontinuation of treatment.

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, accompanied by itching and rash, may occur. In such cases, stop taking Amolisa HCT and contact your doctor immediately.
• In susceptible individuals, severe dizziness or fainting due to excessive blood pressure lowering may occur when taking Amolisa HCT. In such cases, stop taking Amolisa HCT, contact your doctor immediately, and remain in a lying position.
• Frequency not known (cannot be estimated from available data) If yellowing of the whites of the eyes, dark urine, itching, or skin rash occurs, even if Amolisa HCT was started much earlier, contact your doctor immediately, 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 the combination product Amolisa HCT (in addition to those listed above) and those side effects observed with individual substances or when two substances are taken together.

Other possible side effects of Amolisa HCT:

If the following side effects occur, they are usually mild and do not require treatment discontinuation.
Common(may occur in less than 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; cramps; joint swelling; increased urine production; feeling of weakness; ankle swelling; feeling of fatigue; abnormal laboratory test results.
Uncommon(may occur in less than 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; abnormal laboratory test results.

Other side effects observed with individual substances or when two substances are 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 occur in at least 1 in 10 people)
Edema (fluid retention in the body).
Common(may occur in less than 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 occur in less than 1 in 100 people)
Swollen and painful salivary glands; decreased platelet count, which may cause easy bruising or prolonged bleeding; anaphylactic reactions; significant loss of appetite (anorexia); sleep disturbances; irritability; mood changes, including anxiety; decreased well-being or depression; chills; sleep disturbances; taste disturbances; loss of consciousness; decreased sensation; tingling; severe visual disturbances; tinnitus (ringing in the ears); angina pectoris (chest pain or discomfort - 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; exhaustion.
Rare(may occur in less than 1 in 1,000 people)
Swollen and painful salivary glands; decreased white blood cell count, which may increase the risk of infections; low red blood cell count (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 cold hands and feet; severe skin reactions, including intense skin rash, hives, skin redness, severe itching, blistering, and peeling, sometimes life-threatening; movement disorders; acute kidney failure; non-infectious kidney inflammation; kidney function impairment; fever.
Oedema of the intestinal tract: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
Very rare(may occur in less than 1 in 10,000 people)
High muscle tone; 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 vision loss 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). Vision loss 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 tumors (non-melanoma skin cancer).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, 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.

5. How to store Amolisa HCT

Keep this medicine out of the 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 the month.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging 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 silicon dioxide, 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 with 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 with 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: approximately 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: approximately 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: approximately 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: approximately 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: approximately 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.

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: [email protected]

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:

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

Date of last revision of the leaflet: 01/2025