Amolisa hct

Poland
Brand name Amolisa hct
Form tablets, film-coated
Active substance / Dosage
Prescription type Prescription only
ATC code
Registration number 100432877
Amolisa hct tablets, film-coated

Package leaflet: 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
Olmesartanum medoxomilum + Amlodipinum + Hydrochlorothiazidum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

  1. What Amolisa HCT is and what it is used for
  2. What you need to know 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 Amolisa HCT is and what it is used for

Amolisa HCT contains three active substances: olmesartan medoxomil, amlodipine (as 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 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 (water pills). Hydrochlorothiazide lowers blood pressure by removing excess fluid from the body through increased urine production.

The combined effect of these substances results in reduced blood pressure.
Amolisa HCT is used to treat high blood pressure:

  • in adult patients whose blood pressure is not adequately controlled with a combination of olmesartan medoxomil and amlodipine taken as a two-component product, or
  • in patients who are taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide along with amlodipine as a separate medicine, or a fixed-dose combination of olmesartan medoxomil and amlodipine along with hydrochlorothiazide as a separate medicine.

2. Important information before using Amolisa HCT

When not to use Amolisa HCT

  • if the patient is allergic to olmesartan medoxomil, amlodipine or a calcium antagonist (dihydropyridine derivatives), hydrochlorothiazide or substances similar to hydrochlorothiazide (sulfonamides), or any of the other ingredients of this medicine (listed in section 6). If allergy is suspected, 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 are not responding to treatment.
  • after the 3rd month of pregnancy (the use of Amolisa HCT should also be avoided in early pregnancy - see section "Pregnancy and breastfeeding").
  • in case of severe liver disorders, if bile excretion is impaired or bile flow from the gallbladder is blocked (e.g. by gallstones), or if jaundice (yellowing of the skin and eyes) is present.
  • in case of inadequate 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 outflow tract from the heart. This may result from 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 breathlessness or swelling of the feet and ankles.

Do not use Amolisa HCT if any of the above situations apply to the patient.
Warnings and precautions
Before starting Amolisa HCT, discuss this with your doctor or pharmacist.
If the patient previously experienced breathing problems or lung disorders (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If severe breathlessness or breathing difficulties occur after taking Amolisa HCT, seek immediate medical help.
Tell your doctor if the patient is 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 disorders related to diabetes,
  • aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium).
See also section "When not to use Amolisa HCT".
Tell your doctor if any of the following conditions are present:

  • Kidney disorders or status post kidney transplant
  • Liver diseases
  • Heart failure or disorders of heart valves or heart muscle
  • Severe vomiting, diarrhoea, treatment with high doses of diuretics (water tablets) or a low-salt diet
  • Increased potassium levels in the blood
  • Adrenal gland disorders (glands producing hormones, located above the kidneys)
  • Diabetes
  • Systemic lupus erythematosus (an autoimmune disease)
  • Allergy or bronchial asthma
  • Skin reactions such as sunburn or rash after exposure to sunlight or artificial UV light (solarium)
  • If the patient previously had skin cancer or develops an unexpected skin change during treatment. Treatment with hydrochlorothiazide, especially in high doses over a long period, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). While taking Amolisa HCT, protect the skin from sunlight and UV radiation.

Contact your doctor if the patient experiences any of the following symptoms:

  • Severe, persistent diarrhoea causing significant weight loss. The doctor may assess the symptoms and decide how to continue antihypertensive treatment.
  • Vision impairment or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure – they may occur from several hours to several weeks after taking Amolisa HCT. If untreated, they may lead to permanent vision loss.

As with other blood pressure-lowering medicines, excessive lowering of blood pressure in patients with circulatory disorders of 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 increase blood lipid and uric acid levels (causing gout – painful joint swelling). The doctor will likely recommend periodic blood tests to monitor these levels.
Treatment with Amolisa HCT may affect the patient's electrolyte balance. The doctor will likely recommend periodic blood tests to monitor electrolyte levels. Symptoms of electrolyte imbalance include: thirst, dryness of the oral mucosa, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), weakness, apathy, fatigue, drowsiness or restlessness, nausea, vomiting, reduced urine output, rapid heartbeat. If such symptoms occur, inform your doctor.
Discontinue Amolisa HCT before undergoing parathyroid function tests.
Inform your doctor if pregnancy is suspected (or planned). Use of Amolisa HCT is not recommended in early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding").
If the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Amolisa HCT, discuss this with the doctor. The doctor will decide on further treatment. Do not independently decide to stop taking Amolisa HCT.
Children and adolescents (under 18 years of age)
Amolisa HCT is not recommended for use in children and adolescents under 18 years of age.
Elderly patients
In patients over 65 years of age, the doctor will monitor blood pressure at each dose increase to ensure that blood pressure does not drop too much.
Amolisa HCT and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, and any medicines you plan to take:

  • Other blood pressure-lowering medicines, which may enhance the effect of Amolisa HCT. The doctor may recommend dose adjustment and/or additional precautions: if the patient is taking ACE inhibitors or aliskiren (see also sections "When not to use Amolisa HCT" and "Warnings and precautions").
  • Lithium (a medicine used to treat mood disorders and certain types of depression) – concomitant use with Amolisa HCT may increase lithium toxicity. If lithium treatment is necessary, the doctor will recommend monitoring lithium blood levels.
  • 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 stimulating gastrointestinal motility.
  • Difemanil, a medicine used in slow heart rate and reducing sweating.
  • Halofantrine, a medicine used to treat malaria.
  • Intravenous vincamine, a medicine used to improve cerebral circulation.
  • Amantadine, a medicine used in Parkinson's disease.
  • Potassium supplements, potassium-containing salt substitutes, diuretics (water tablets), heparin (thins blood and prevents clot formation), ACE inhibitors (lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (used to treat oral and gastric ulcers), sodium G penicillin (sodium salt of benzylpenicillin, an antibiotic), certain painkillers such as acetylsalicylic acid or salicylates. Concomitant use of these medicines with Amolisa HCT may cause changes in blood potassium levels.
  • Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling and other inflammatory symptoms, including joint inflammation), taken together with Amolisa HCT, may increase the risk of kidney failure. NSAIDs may reduce the effectiveness of Amolisa HCT. When high doses of salicylates are used, toxic effects on the central nervous system may be intensified.
  • Sedatives, tranquilizers and antidepressants taken together with Amolisa HCT may cause sudden drop in blood pressure upon standing.
  • Colesevelam hydrochloride (a medicine that lowers blood cholesterol levels) – possible reduction in effectiveness of Amolisa HCT. The doctor may recommend taking Amolisa HCT at least 4 hours before colesevelam hydrochloride.
  • Some medicines that neutralize stomach acid (medicines used for indigestion or heartburn), as the effect of Amolisa HCT may be slightly reduced.
  • Some muscle relaxants, such as baclofen and tubocurarine.
  • Anticholinergic medicines, such as atropine and biperiden.
  • Calcium supplements.
  • Dantrolene (administered by infusion in severe body temperature disorders).
  • Simvastatin, used to reduce cholesterol and fat (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.

Also, tell your doctor or pharmacist if you are currently or recently taking, or plan to take, any of the following medicines:

  • Medicines used in certain psychiatric disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol.
  • Medicines used in low blood sugar (e.g. diazoxide) or blood pressure-lowering medicines (e.g. beta-blockers, methyldopa), as Amolisa HCT may affect their action.
  • Medicines used to treat heart rhythm disorders, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or intravenous erythromycin.
  • Medicines used in HIV/AIDS infection (e.g. ritonavir, indinavir, nelfinavir).
  • Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole, amphotericin).
  • Medicines used in heart disorders, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil or digitalis.
  • Anticancer medicines, such as amifostine, cyclophosphamide, methotrexate.
  • Medicines increasing blood pressure and heart contractility, such as noradrenaline.
  • Medicines used in gout, such as probenecid, sulfinpyrazone and allopurinol.
  • Medicines reducing blood lipid levels, such as cholestyramine and colestipol.
  • Medicines reducing blood sugar levels, such as metformin or insulin.

Tell your doctor or pharmacist about all medicines currently or recently taken, and 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 increase blood levels of the active substance – amlodipine, which could unpredictably intensify the blood pressure-lowering effect of Amolisa HCT.
Exercise caution when drinking alcohol while taking Amolisa HCT, as some people may experience fainting or dizziness. If such symptoms occur, do not consume alcohol.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if pregnancy is suspected (or planned). The doctor will usually recommend discontinuing Amolisa HCT before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Use of Amolisa HCT is not recommended during pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.
If pregnancy occurs 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. Use of Amolisa HCT during breastfeeding is not recommended. The doctor may recommend an alternative medicine.
If you are pregnant or breastfeeding, suspect you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
During treatment for high blood pressure, drowsiness, nausea, dizziness or headache may occur. In such cases, do not drive or operate machinery until symptoms subside. Consult your doctor for advice.
Amolisa HCT contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Amolisa HCT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Amolisa HCT

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.

  • The recommended dose of Amolisa HCT is one tablet per day.
  • The tablet may be taken with or without food. Swallow the tablet with a drink (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 each day, for example during breakfast.

Taking more Amolisa HCT than recommended
If you take more tablets than recommended, excessive lowering of blood pressure may occur,
with symptoms such as dizziness, increased or decreased heart rate.
If you take more than the recommended dose, or if a child accidentally swallows any amount of the
medicine, seek immediate medical advice from a doctor or the nearest hospital emergency department,
taking the medicine pack or this leaflet with you.
Breathlessness caused by excess fluid accumulating in the lungs (pulmonary oedema) may occur
up to 24–48 hours after taking the medicine.
Missed dose of Amolisa HCT
If you miss a dose, take your usual dose the next day. Do not take a double dose to make up for a
missed dose.
Stopping Amolisa HCT
It is important to continue taking Amolisa HCT until your doctor advises you to stop.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions are often mild and do not require discontinuation of the medicine.
The following adverse reactions may be severe, although they do not occur frequently:

  • Allergic reactions with swelling of the face, mouth and/or throat, accompanied by itching and rash, may occur during treatment with Amolisa HCT. In such a case, Amolisa HCT must be discontinued and medical advice must be sought immediately.
  • In susceptible individuals, severe dizziness or fainting due to excessive lowering of blood pressure may occur during treatment with Amolisa HCT. In such a case, Amolisa HCT must be discontinued, medical advice must be sought immediately, and the patient must remain in a lying position.
  • Frequency unknown (frequency cannot be estimated from available data): If yellowing of the whites of the eyes, dark urine or skin itching occurs, even if treatment with Amolisa HCT was initiated significantly earlier, medical advice must be sought immediately, so that the physician can assess the symptoms and decide how to continue treatment for hypertension.

Amolisa HCT is a combination of three active substances. The information below refers to adverse reactions reported so far during treatment with the fixed combination Amolisa HCT (in addition to those mentioned above), as well as adverse reactions observed with individual substances or with two substances used simultaneously.
Other possible adverse reactions of Amolisa HCT:
If the following adverse symptoms occur, they are often mild and do not require discontinuation of treatment.
Common (may affect fewer than 1 in 10 people)
Upper respiratory tract infection; sore throat, nasal symptoms; urinary tract infection; central dizziness; headache; palpitations; low blood pressure; nausea; diarrhoea; constipation; cramps; joint swelling; increased urination; feeling of weakness; swelling around the ankles; feeling of fatigue; abnormal laboratory test results.
Uncommon (may affect fewer than 1 in 100 people)
Dizziness upon standing; labyrinthine dizziness; increased heart rate; fainting; flushing and feeling of warmth in the face; cough; dryness of the oral mucosa; muscle weakness; inability to achieve or maintain erection.
Other adverse reactions observed during treatment with individual substances or two substances used simultaneously:
The following adverse reactions may occur during treatment with Amolisa HCT, even if they have not been observed so far:
Very common (may affect at least 1 in 10 people)
Oedema (fluid retention in the body).
Common (may affect fewer than 1 in 10 people)
Bronchitis; stomach and intestinal infection; vomiting; increased blood glucose levels; presence of glucose in urine; confusion; drowsiness; visual disturbances (including double and blurred vision); nasal discharge or nasal congestion; sore throat; breathing difficulties; cough; abdominal pain; heartburn; discomfort in the stomach; bloating; bone or joint pain; back pain; musculoskeletal pain; presence of blood in urine; influenza-like symptoms; chest pain; pain.
Uncommon (may affect fewer than 1 in 100 people)
Decreased platelet count, which may lead to easy bruising or prolonged bleeding time; anaphylactic reactions; marked loss of appetite (anorexia); sleep disorders; irritability; mood changes, including anxiety; low mood or depression; chills; sleep disturbances; taste disturbances; loss of consciousness; reduced sense of touch; tingling sensation; worsening of myopia; ringing in the ears (tinnitus); angina pectoris (chest pain or discomfort known as angina attack); heart rhythm disturbances; rash; hair loss; allergic dermatitis; skin redness; purple skin spots due to small haemorrhages (purpura); skin discoloration; red, itchy lumps (urticaria); increased sweating; itching; skin eruptions; photosensitivity reactions such as sunburn or rash; muscle pain; difficulty in passing urine; need to pass urine at night; breast enlargement in men; decreased libido; facial swelling; malaise; weight gain or weight loss; exhaustion.
Rare (may affect fewer than 1 in 1,000 people)
Swelling and pain in the salivary glands; decreased number of white blood cells, which may increase susceptibility to infections; low number of red blood cells (anaemia); bone marrow damage; motor restlessness; feeling of lack of interest (apathy); seizures; yellow vision; dry eyes; blood clots (thrombosis, embolism); inflammation of blood vessels and small blood vessels of the skin; pancreatitis; yellowing of the skin and eyes; acute cholecystitis; symptoms of systemic lupus erythematosus such as rash, joint pain, coldness of hands and fingers; severe skin reactions, including severe skin rash, urticaria, redness of the entire body, intense itching, blistering, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes life-threatening; movement disorders; acute kidney failure; non-infectious kidney inflammation; impaired kidney function, fever.
Angioedema of the intestine: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
Very rare (may affect fewer than 1 in 10,000 people)
Increased muscle tone; numbness of hands or feet; myocardial infarction; inflammation of the gastric mucosa; gingival hyperplasia; intestinal obstruction; hepatitis.
Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion).
Frequency unknown (cannot be estimated from available data)
Sudden worsening of distance vision (acute myopia), visual impairment or eye pain due to increased intraocular pressure (possible symptoms of fluid accumulation in the vascular membrane surrounding the eye – excessive fluid accumulation between choroid and sclera – or acute angle-closure glaucoma). Worsening of vision or eye pain (possible symptoms of acute angle-closure glauzone).
Tremor, postural rigidity, facial masking, slowed movements, shuffling gait and unsteady walking.
Malignant skin and lip tumours (non-melanoma skin cancers).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse reactions allows additional information on the safety of the medicine to be collected.
Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store Amolisa HCT

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

Other ingredients are:
Tablet core: microcrystalline cellulose (PH-101 and PH-102), pregelatinized maize 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 film-coated tablets with strengths: 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 film-coated tablets with strength: 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]
Reddish-grey, 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]
Reddish-grey, 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 Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
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 medicinal product is authorised in the European Economic Area countries 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/10 mg/25 mg
Film tablets
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