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 them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 to 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

• in case of severe kidney problems.
• after the 3rd month of pregnancy (you should also avoid taking Amolisa HCT in early pregnancy - see "Pregnancy and breastfeeding").
• in case of severe liver problems, 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 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 case of very low blood pressure.
• in case 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 case 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.

You should not take Amolisa HCT if any of the above situations apply to you.

Warnings and precautions

Before starting Amolisa HCT, you should discuss it with your doctor or pharmacist.

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:

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

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:

• Kidney problems or a history of kidney transplantation
• Liver disease
• Heart failure or problems with heart valves or heart muscle
• 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
• Systemic lupus erythematosus (an autoimmune disease)
• Allergy or asthma
• Skin reactions, such as sunburn or rash caused by sunlight or sunlamps
• If you have had skin cancer in the past or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially at high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). While taking Amolisa HCT, you should protect your skin from sunlight and UV radiation.

You should contact your doctorif you experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your doctor may 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 lowering of blood pressure in patients with circulatory problems 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 increase lipid and uric acid levels in the blood (a cause of gout - a painful swelling of the joints). 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 output, 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 become pregnant while taking Amolisa HCT, you should immediately consult your doctor. 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.

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, your doctor will monitor blood pressure during each dose increase to ensure that it does not drop too much.

Amolisa HCT and other medicines

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:

• 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 sections "When not to take Amolisa HCT" and "Warnings and precautions").
• Lithium(a medicine used to treat mood disorders and some types of depression) - concomitant use with Amolisa HCT may increase lithium toxicity. If lithium is necessary, your doctor will recommend monitoring lithium levels in your 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 (blood pressure-lowering medicines), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat oral 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 your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs)(medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), taken concomitantly 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 antidepressant medicinestaken concomitantly with Amolisa HCT may cause a sudden drop in blood pressure when standing up.
• Cholestyramine hydrochloride(a medicine that lowers cholesterol levels in the blood) - possible weakening of the effect of Amolisa HCT. 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 the effect of Amolisa HCT 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.

You should also tell your doctor or pharmacist about any medicines you are currently taking or have recently taken, as well as any medicines you plan to take:

• Medicines used to treat certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, 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 disorders, 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 noradrenaline.
• 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.

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.

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 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 individuals. If such symptoms occur, you should not consume alcohol.

Pregnancy and breastfeeding

Pregnancy

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.

Breastfeeding

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 child, you should 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, 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".

3. How to take Amolisa HCT

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should 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. The tablet should be swallowed with a liquid (e.g., a glass of water). The tablets should not be chewed. You should not take Amolisa HCT with grapefruit juice.
• If possible, you 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 you take more tablets than recommended, you may experience excessive lowering of blood pressure with symptoms such as dizziness, rapid or slow heartbeat. If you take a higher dose than recommended or if a child accidentally swallows any amount of the medicine, you should immediately consult your 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.

Missing a dose of Amolisa HCT

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.

Stopping Amolisa HCT treatment

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.

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 the medicine.

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, you should stop taking Amolisa HCT and immediately contact your doctor.
• In susceptible individuals, severe dizziness or fainting due to excessive lowering of blood pressure may occur when taking Amolisa HCT. In such cases, you should stop taking Amolisa HCT, immediately contact your doctor, and remain in a lying position.
• Frequency not known (frequency cannot be estimated from the available data) If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started taking Amolisa HCT much earlier, you should immediately contact your 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 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 concomitantly.

Other possible side effects of Amolisa HCT:

If you experience the following side effects, they are usually mild and do not require discontinuation of treatment.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; muscle spasms; joint swelling; increased urine production; feeling of weakness; swelling around the ankles; 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.

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

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 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 occur in less than 1 in 100 people) Swelling and pain of the salivary glands; decreased white blood cell count, which may increase the risk of infections; low red blood cell count (anemia); bone marrow damage; restlessness; lack of interest (apathy); seizures; yellow vision; dry eye; blood clots (thrombosis, embolism); inflammation of blood vessels and small blood vessels in the skin; pancreatitis; yellowing of the skin and eyes; acute inflammation of the gallbladder; symptoms of systemic lupus erythematosus, 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 of the skin, sometimes life-threatening; movement disorders; acute kidney failure; non-infectious kidney inflammation; kidney dysfunction; fever. Edema of the intestinal wall: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea. Rare(may occur in less than 1 in 1,000 people) High muscle tone; numbness of hands or feet; heart attack; stomach inflammation; thickening of the gums; 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, stiffness, mask-like face, slow movements, and shuffling gait when walking. Malignant tumors of the skin and lips (non-melanoma skin cancer).

Reporting side effects

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 of the 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

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 the month stated. 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.

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, croscarmellose sodium, 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: about 8 mm] Light orange, round, biconvex film-coated tablets with the symbol "S1" embossed on one side and smooth on the other. 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. 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. 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. 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. 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

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: 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