Olmesartan, amlodipine and hydrochlorothiazide EG: detailed information

Patient Information Leaflet: Information for the User

Olmesartan, amlodipine and hydrochlorothiazide EG 20 mg/5 mg/12.5 mg film-coated tablets
Olmesartan, amlodipine and hydrochlorothiazide EG 40 mg/5 mg/12.5 mg film-coated tablets
Olmesartan, amlodipine and hydrochlorothiazide EG 40 mg/10 mg/12.5 mg film-coated tablets
Olmesartan, amlodipine and hydrochlorothiazide EG 40 mg/5 mg/25 mg film-coated tablets
Olmesartan, amlodipine and hydrochlorothiazide EG 40 mg/10 mg/25 mg film-coated tablets
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4. Contents of this leaflet
1. What Olmesartan, amlodipine and hydrochlorothiazide EG is and what it is used for
2. What you need to know before taking Olmesartan, amlodipine and hydrochlorothiazide EG
3. How to take Olmesartan, amlodipine and hydrochlorothiazide EG
4. Possible side effects
5. How to store Olmesartan, amlodipine and hydrochlorothiazide EG
6. Contents of the pack and other information

1. What Olmesartan, amlodipine and hydrochlorothiazide EG is and what it is used for

Olmesartan, amlodipine and hydrochlorothiazide EG contains three active substances: olmesartan medoxomil, amlodipine (as amlodipine besilate) and hydrochlorothiazide. All three help control high blood pressure.

Olmesartan medoxomil belongs to a group of medicines called "angiotensin II receptor antagonists". These lower blood pressure by relaxing blood vessels.
Amlodipine belongs to a group of substances called "calcium channel blockers". Amlodipine also lowers blood pressure by relaxing blood vessels.
Hydrochlorothiazide belongs to a group of substances called "thiazide diuretics" (medicines that increase urine production). It lowers blood pressure by helping the body eliminate excess water, by increasing urine output through the kidneys.

The combined action of these substances helps reduce blood pressure.
Olmesartan, amlodipine and hydrochlorothiazide EG is used to treat high blood pressure:

in adult patients whose blood pressure is not adequately controlled with a fixed-dose combination of olmesartan medoxomil and amlodipine,
in adult patients already taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide plus amlodipine as a separate tablet, or a fixed-dose combination of olmesartan medoxomil and amlodipine plus hydrochlorothiazide as a separate tablet.

2. What you should know before taking Olmesartan, amlodipine and hydrochlorothiazide EG

DO NOT take Olmesartan, amlodipine and hydrochlorothiazide EG if

you are allergic to olmesartan medoxomil, amlodipine or to a specific group of calcium antagonists (the dihydropyridines), hydrochlorothiazide or substances similar to hydrochlorothiazide (called sulfonamides), or to any of the excipients of this medicine (listed in section 6). If you think you may be allergic, speak with your doctor before taking Olmesartan, amlodipine and hydrochlorothiazide EG.
you have severe kidney problems.
you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
you have low levels of potassium or sodium, or high levels of calcium or uric acid (with symptoms of gout or kidney stones) in your blood that do not improve with treatment.
you are more than 3 months pregnant. (It is also advisable to avoid Olmesartan, amlodipine and hydrochlorothiazide EG during the first months of pregnancy – see section “Pregnancy and breastfeeding”).
you have severe liver problems, if bile secretion is impaired or bile flow is obstructed (for example, due to gallstones), or if you have jaundice (yellowing of the skin and eyes).
you suffer from reduced blood flow to tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, meaning shock due to severe heart problems).
you have very low blood pressure.
blood flow from your heart is slow or blocked. This occurs when blood vessels or valves carrying blood out of the heart narrow (aortic stenosis).
you have reduced cardiac output due to a heart attack (acute myocardial infarction). Reduced cardiac output manifests as shortness of breath or swelling of the feet and ankles.

If you think you are in any of the conditions described above, do not take Olmesartan, amlodipine and hydrochlorothiazide EG.
Warnings and precautions
Talk to your doctor or pharmacist before taking Olmesartan, amlodipine and hydrochlorothiazide EG.
Consult your doctor if you are taking any of the following medicines used to treat high blood pressure:

an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.
See also the information provided in the section “DO NOT take Olmesartan, amlodipine and hydrochlorothiazide EG if”.
Inform your doctor if you have any of the following health conditions:

kidney problems or a kidney transplant;
liver disease;
heart failure or heart valve or heart muscle problems;
severe vomiting, diarrhea, treatment with high doses of diuretics ("water tablets"), or if you are on a low-salt diet;
elevated potassium levels in the blood;
adrenal gland problems (hormone-producing glands located above the kidneys);
diabetes;
systemic lupus erythematosus (an autoimmune disease);
allergies or asthma;
skin reactions such as sunburn or rash after exposure to sunlight or sunlamps;
if you have had skin cancer or develop a suspicious skin lesion during treatment. Treatment with hydrochlorothiazide, particularly if long-term and at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV radiation during treatment with Olmesartan, amlodipine and hydrochlorothiazide EG.
Inform your doctor if any of the following symptoms occur:
severe and prolonged diarrhea with significant weight loss. Your doctor will evaluate your symptoms and decide whether to continue this antihypertensive treatment.
changes in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur within hours to weeks after starting Olmesartan, amlodipine and hydrochlorothiazide EG. If untreated, this condition may lead to permanent vision loss.

As with any medicine that lowers blood pressure, excessive reduction in blood pressure in patients with circulatory disorders of the heart or brain may lead to a heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.
Olmesartan, amlodipine and hydrochlorothiazide EG may increase levels of fats and uric acid (which causes gout – painful joint swelling) in the blood. Your doctor may wish to perform periodic blood tests to monitor these conditions.
Levels of certain substances called electrolytes in the blood may change. Your doctor may wish to perform periodic blood tests to monitor these conditions. Signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), feeling weak, lethargic, tired, drowsy or unrested, nausea, vomiting, reduced need to urinate, rapid heartbeat. Inform your doctor if these symptoms occur.
If you are scheduled for tests assessing parathyroid function, stop taking Olmesartan, amlodipine and hydrochlorothiazide EG before the tests are performed.
You must inform your doctor if you suspect (or are planning) a pregnancy. Olmesartan, amlodipine and hydrochlorothiazide EG is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section "Pregnancy and breastfeeding").
Children and adolescents (under 18 years of age)
Olmesartan, amlodipine and hydrochlorothiazide EG is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Olmesartan, amlodipine and hydrochlorothiazide EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

Other medicines that lower blood pressure, as they may enhance the effect of Olmesartan, amlodipine and hydrochlorothiazide EG. Your doctor may need to adjust the dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also sections “DO NOT take Olmesartan, amlodipine and hydrochlorothiazide EG” and “Warnings and precautions”).
Lithium (a medicine used to treat mood swings and certain types of depression) used together with Olmesartan, amlodipine and hydrochlorothiazide EG may increase lithium toxicity. If you are to take lithium, your doctor will monitor your lithium blood levels.
Diltiazem, verapamil, used to treat heart rhythm disorders and high blood pressure.
Rifampicin, erythromycin, clarithromycin, tetracyclines or sparfloxacin, antibiotics used for tuberculosis and other infections.
St. John’s wort (Hypericum perforatum) – herbal preparation used for treating depression.
Cisapride, used to speed up food transit through the stomach and intestines.
Diphenylamine, used to treat slow heartbeat or reduce sweating.
Halofantrine, used for malaria.
Vincamine i.v., used to improve circulation in the nervous system.
Amantadine, for the treatment of Parkinson’s disease.
Potassium supplements, potassium-containing salt substitutes, "water tablets" (diuretics), heparin (to thin the blood and prevent thrombosis), ACE inhibitors (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), sodium penicillin G (also known as sodium benzylpenicillin, an antibiotic), certain painkillers such as acetylsalicylic acid or salicylates. Taking these medicines together with Olmesartan, amlodipine and hydrochlorothiazide EG may alter potassium levels in the blood.
Non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis, used together with Olmesartan, amlodipine and hydrochlorothiazide EG may increase the risk of kidney failure. The effect of Olmesartan, amlodipine and hydrochlorothiazide EG may be reduced by NSAIDs. When high doses of salicylates are taken, central nervous system toxic effects may be increased.
Sleeping pills, sedatives and antidepressants, used together with Olmesartan, amlodipine and hydrochlorothiazide EG may cause a sudden drop in blood pressure upon standing.
Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of Olmesartan, amlodipine and hydrochlorothiazide EG. Your doctor may advise you to take Olmesartan, amlodipine and hydrochlorothiazide EG at least 4 hours before colesevelam hydrochloride.
Some antacids (used to treat indigestion or heartburn) may slightly reduce the effect of Olmesartan, amlodipine and hydrochlorothiazide EG.
Some muscle relaxants, such as baclofen and tubocurarine.
Anticholinergic drugs, such as atropine and biperiden.
Calcium supplements.
Dantrolene (infusion for severe disturbances in body temperature).
Simvastatin, a substance used to reduce cholesterol and fat (triglyceride) levels in the blood.
Medicines used to control your body’s immune response (such as tacrolimus, cyclosporine) that allow your body to accept transplanted organs.

Additionally, inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines for:

Treating certain mental disorders such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol.
Treating hypoglycemia (such as diazoxide) or hypertension (beta-blockers, methyldopa), since Olmesartan, amlodipine and hydrochlorothiazide EG may affect the action of these medicines.
Treating heart rhythm disorders such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or injectable erythromycin.
Treating HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir).
Treating fungal infections (e.g., ketoconazole, itraconazole, amphotericin).
Treating heart conditions such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil or digitalis.
Treating tumors such as amifostine, cyclophosphamide or methotrexate.
Increasing blood pressure and slowing heart rate such as noradrenaline.
Treating gout such as probenecid, sulfinpyrazone and allopurinol.
Reducing plasma fat levels such as cholestyramine and colestipol.
Reducing plasma glucose levels such as metformin or insulin.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Olmesartan, amlodipine and hydrochlorothiazide EG with food and drinks
Olmesartan, amlodipine and hydrochlorothiazide EG can be taken regardless of meals.
People taking Olmesartan, amlodipine and hydrochlorothiazide EG must not consume grapefruit or grapefruit juice, as grapefruit and its juice may increase blood levels of the active substance amlodipine, which could unpredictably enhance the hypotensive effect of Olmesartan, amlodipine and hydrochlorothiazide EG.
During treatment with Olmesartan, amlodipine and hydrochlorothiazide EG, avoid drinking alcohol, as you may feel confused or dizzy. If this happens, do not drink alcohol.
Elderly
If you are over 65 years old, your doctor will regularly monitor your blood pressure with each dose increase to prevent it from dropping too much.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you suspect (or are planning) a pregnancy. Your doctor will usually advise you to stop treatment with Olmesartan, amlodipine and hydrochlorothiazide EG before becoming pregnant or as soon as pregnancy is confirmed, and will prescribe another medicine instead. Use of Olmesartan, amlodipine and hydrochlorothiazide EG is not recommended during pregnancy and must not be taken if you are more than three months pregnant, as it may seriously harm your unborn child if taken after the third month of pregnancy.
If you become pregnant while being treated with Olmesartan, amlodipine and hydrochlorothiazide EG, contact your doctor immediately.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. Olmesartan, amlodipine and hydrochlorothiazide EG is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
You may experience drowsiness, discomfort, dizziness or headache during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor.
Olmesartan, amlodipine and hydrochlorothiazide EG contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.
Doping
For athletes: using this medicine without medical need constitutes doping and may result in a positive anti-doping test.

3. How to take Olmesartan, amlodipine and hydrochlorothiazide EG

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dosage
The recommended dose of Olmesartan, amlodipine and hydrochlorothiazide EG is one tablet daily.
Method of administration
The tablet can be taken independently of food. Swallow the tablet with some liquid (such as a glass of water). Do not chew the tablet. Do not take it with grapefruit juice.
If possible, take your daily dose at the same time each day, for example with breakfast.
The break line on the tablet is not intended for dividing the tablet.
The break line on the tablet is not intended for dividing the tablet.
If you take more Olmesartan, amlodipine and hydrochlorothiazide EG than you should
If you take more tablets than prescribed, you may experience a drop in blood pressure with symptoms such as dizziness, or a faster or slower heartbeat.
If you take more tablets than you should, or if a child accidentally swallows any, go immediately to a doctor or the nearest emergency room, taking the medicine pack or this leaflet with you.
If you forget to take Olmesartan, amlodipine and hydrochlorothiazide EG
If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for the forgotten dose.
If you stop taking Olmesartan, amlodipine and hydrochlorothiazide EG
It is important to continue taking Olmesartan, amlodipine and hydrochlorothiazide EG unless your doctor tells you to stop.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If they do occur, they are mostly mild and do not require stopping treatment.
Although they do not occur in all people, the following two side effects can be serious:
During treatment with Olmesartan, amlodipine and hydrochlorothiazide EG, allergic reactions may occur with swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash. If this happens, stop taking Olmesartan, amlodipine and hydrochlorothiazide EG and contact your doctor immediately.
Olmesartan, amlodipine and hydrochlorothiazide EG may cause excessive lowering of blood pressure in sensitive individuals. This could lead to severe dizziness or fainting. If this happens, stop taking Olmesartan, amlodipine and hydrochlorothiazide EG, contact your doctor immediately, and remain lying down.
Olmesartan, amlodipine and hydrochlorothiazide EG is a combination of three active substances. The information below first lists other side effects reported so far with the combination Olmesartan, amlodipine and hydrochlorothiazide EG (in addition to those already mentioned above), and secondly, those side effects known for each of the three substances when taken separately or when two substances are administered together.
To give you an idea of how many patients may experience side effects, they are listed according to how frequently they have been reported.
These are the other side effects with Olmesartan, amlodipine and hydrochlorothiazide EG so far known:
If they occur, they are mostly mild and do not require stopping treatment.
Common (may affect up to 1 in 10 people)

upper respiratory tract infections
inflammation of the throat and nose
urinary tract infections
dizziness
headache
awareness of heartbeat
low blood pressure
nausea
diarrhoea
constipation
cramps
joint swelling
urgency to urinate
weakness
ankle swelling
fatigue
abnormal laboratory test results

Uncommon (may affect up to 1 in 100 people)

dizziness upon standing
vertigo
rapid heartbeat
feeling of weakness
flushing and sensation of warmth in the face
cough
dry mouth
muscle weakness
inability to achieve or maintain an erection

These are the side effects known for each of the components taken alone or for two components taken together:
They may be side effects of Olmesartan, amlodipine and hydrochlorothiazide EG even if they have not been observed so far.
Very common (may affect more than 1 in 10 people)

oedema (fluid retention)

Common (may affect up to 1 in 10 people)

bronchitis
gastric and intestinal infection
vomiting
increased blood sugar levels
sugar in urine
confusion
drowsiness
visual disturbances (including double vision and blurred vision)
stuffy or runny nose
sore throat
breathing difficulties
cough
abdominal pain
heartburn
gastric discomfort
flatulence
joint or bone pain
back pain
musculoskeletal pain
blood in urine
flu-like symptoms
chest pain
pain

Uncommon (may affect up to 1 in 100 people)

reduction in the number of a type of blood cells called platelets, which may lead to easier bruising or prolonged bleeding time
anaphylactic reactions
abnormally reduced appetite (anorexia)
difficulty falling asleep
irritability
mood changes, including anxiety
feeling low or depressed
chills
sleep disorders
altered sense of taste
loss of consciousness
reduced tactile sensitivity
tingling sensation
worsening of near vision
ringing in the ears (tinnitus)
angina (chest pain or discomfort, known as angina pectoris)
irregular heartbeat
rash
hair loss
allergic skin inflammation
skin redness
red spots or dots on the skin due to small haemorrhages (purpura)
skin discoloration
red, itchy swellings (urticaria)
excessive sweating
itching
skin rash
skin reactions to light such as sunburn or rash
muscle pain
urination problems
nocturnal urgency to urinate
breast enlargement in men
reduced sexual desire
facial swelling
feeling unwell
weight gain or loss
exhaustion

Rare (may affect up to 1 in 1,000 people)

enlargement and pain of the salivary glands
reduction in the number of white blood cells in the blood, possibly increasing the risk of infections
low red blood cell count (anaemia)
bone marrow damage
restlessness
lack of interest (apathy)
epileptic seizures (convulsions)
seeing yellow objects
dry eyes
blood clots (thrombosis, embolism)
fluid accumulation in the lungs
pneumonia
inflammation of blood vessels and small skin blood vessels
pancreatitis
yellowing of the skin and eyes
acute inflammation of the gallbladder
symptoms of lupus erythematosus such as rash, joint pain, and cold fingers and hands
severe skin reactions including intense rash, urticaria, redness of the skin over the entire body surface, severe itching, blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes life-threatening
impaired movement
acute kidney failure
non-infectious inflammation of the kidney
reduced kidney function
fever

Very rare (may affect up to 1 in 10,000 people)

increased muscle tone
numbness of hands or feet
heart attack
inflammation of the stomach
gum thickening
intestinal obstruction
liver inflammation

Frequency not known (frequency cannot be estimated from the available data)

decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
tremors, rigid posture, expressionless face, slow movements and shuffling, unbalanced gait
skin and lip tumours (non-melanoma skin cancer)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olmesartan, amlodipine and hydrochlorothiazide EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister,
following the word “EXP.” The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Olmesartan, amlodipine and hydrochlorothiazide EG contains
Olmesartan, amlodipine and hydrochlorothiazide EG 20 mg/5 mg/12.5 mg film-coated tablets
The active substances are olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide. Each film-coated tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine (as besilate) and 12.5 mg of hydrochlorothiazide.
The other components are:
Tablet core
Monohydrate lactose, microcrystalline cellulose (E 460), crospovidone (E 1202), anhydrous colloidal silica (E 551), magnesium stearate.
Film coating
Hypromellose, monohydrate lactose, macrogol (E 1521), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Olmesartan, amlodipine and hydrochlorothiazide EG 40 mg/5 mg/12.5 mg film-coated tablets
The active substances are olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as besilate) and 12.5 mg of hydrochlorothiazide.
The other components are:
Tablet core
Monohydrate lactose, microcrystalline cellulose (E 460), crospovidone (E 1202), anhydrous colloidal silica (E 551), magnesium stearate.
Film coating
Hypromellose, monohydrate lactose, macrogol (E 1521), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

Olmesartan, amlodipine and hydrochlorothiazide EG 40 mg/10 mg/12.5 mg film-coated tablets
The active substances are olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as besilate) and 12.5 mg of hydrochlorothiazide.
The other components are:
Tablet core
Monohydrate lactose, microcrystalline cellulose (E 460), crospovidone (E 1202), anhydrous colloidal silica (E 551), magnesium stearate.
Film coating
Hypromellose, monohydrate lactose, macrogol (E 1521), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Olmesartan, amlodipine and hydrochlorothiazide EG 40 mg/5 mg/25 mg film-coated tablets
The active substances are olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as besilate) and 25 mg of hydrochlorothiazide.
The other components are:
Tablet core
Monohydrate lactose, microcrystalline cellulose (E 460), crospovidone (E 1202), anhydrous colloidal silica (E 551), magnesium stearate.
Film coating
Hypromellose, monohydrate lactose, macrogol (E 1521), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

Olmesartan, amlodipine and hydrochlorothiazide EG 40 mg/10 mg/25 mg film-coated tablets
The active substances are olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as besilate) and 25 mg of hydrochlorothiazide.
The other components are:
Tablet core
Monohydrate lactose, microcrystalline cellulose (E 460), crospovidone (E 1202), anhydrous colloidal silica (E 551), magnesium stearate.
Film coating
Hypromellose, monohydrate lactose, macrogol (E 1521), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Description of the appearance of Olmesartan, amlodipine and hydrochlorothiazide EG and the contents of the pack
Olmesartan, amlodipine and hydrochlorothiazide EG 20 mg/5 mg/12.5 mg is presented as film-coated tablets with a diameter of 8.1 ± 0.2 mm, orange-white in colour, round and biconvex in shape.
Olmesartan, amlodipine and hydrochlorothiazide EG 40 mg/5 mg/12.5 mg is presented as film-coated tablets with a diameter of 11.1 ± 0.2 mm, light yellow in colour, round and biconvex in shape.
Olmesartan, amlodipine and hydrochlorothiazide EG 40 mg/10 mg/12.5 mg is presented as film-coated tablets with a diameter of 11.1 ± 0.2 mm, reddish-grey in colour, round and biconvex in shape.
Olmesartan, amlodipine and hydrochlorothiazide EG 40 mg/5 mg/25 mg is presented as film-coated tablets, light yellow in colour, oval-shaped, biconvex with a score line on one side and a length of 16.4 ± 0.2 mm.
Olmesartan, amlodipine and hydrochlorothiazide EG 40 mg/10 mg/25 mg is presented as film-coated tablets, reddish-grey in colour, oval-shaped, biconvex with a score line on one side and a length of 16.4 ± 0.2 mm.

Olmesartan, amlodipine and hydrochlorothiazide EG is available in packs of 14x1, 28x1, 30x1, 56x1, 98x1, 100x1 in OPA-AL-PVC/AL blisters, divisible for single dose.
Olmesartan, amlodipine and hydrochlorothiazide EG is available in packs of 14x1, 28x1, 30x1, 56x1, 98x1, 100x1 in OPA-AL-PVC/AL blisters, divisible for single dose.
Olmesartan, amlodipine and hydrochlorothiazide EG is available in packs of 14x1, 28x1, 30x1, 56x1, 98x1, 100x1 in OPA-AL-PVC/AL blisters, divisible for single dose.
Olmesartan, amlodipine and hydrochlorothiazide EG is available in packs of 14x1, 28x1, 30x1, 56x1, 98x1, 100x1 in OPA-AL-PVC/Al blisters, divisible for single dose.
Olmesartan, amlodipine and hydrochlorothiazide EG is available in packs of 14x1, 28x1, 30x1, 56x1, 98x1, 100x1 in OPA-AL-PVC/AL blisters, divisible for single dose.

Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milan, Italy

Manufacturers
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
Clonmel Healthcare Limited, 3 Waterford Road, Clonmel, Co. Tipperary, E91 D768, Ireland

This medicinal product is authorized in the European Economic Area countries under the following names:
Netherlands:
Olmesartan medoxomil/Amlodipine/HCT STADA 20/5/12.5 mg film-coated tablets
Olmesartan medoxomil/Amlodipine/HCT STADA 40/5/12.5 mg film-coated tablets
Olmesartan medoxomil/Amlodipine/HCT STADA 40/10/12.5 mg film-coated tablets
Olmesartan medoxomil/Amlodipine/HCT STADA 40/5/25 mg film-coated tablets
Olmesartan medoxomil/Amlodipine/HCT STADA 40/10/25 mg film-coated tablets

Belgium:
Olmesartan/Amlodipine/HCT EG 20/5/12.5 mg film-coated tablets
Olmesartan/Amlodipine/HCT EG 40/5/12.5 mg film-coated tablets
Olmesartan/Amlodipine/HCT EG 40/10/12.5 mg film-coated tablets
Olmesartan/Amlodipine/HCT EG 40/5/25 mg film-coated tablets
Olmesartan/Amlodipine/HCT EG 40/10/25 mg film-coated tablets

Luxembourg:
Olmesartan/Amlodipine/HCT EG 20/5/12.5 mg film-coated tablets
Olmesartan/Amlodipine/HCT EG 40/5/12.5 mg film-coated tablets
Olmesartan/Amlodipine/HCT EG 40/10/12.5 mg film-coated tablets
Olmesartan/Amlodipine/HCT EG 40/5/25 mg film-coated tablets
Olmesartan/Amlodipine/HCT EG 40/10/25 mg film-coated tablets

Germany:
Olmesartan/Amlodipin/HCT AL 20 mg/5 mg/12.5 mg Filmtabletten
Olmesartan/Amlodipin/HCT AL 40 mg/5 mg/12.5 mg Filmtabletten
Olmesartan/Amlodipin/HCT AL 40 mg/10 mg/12.5 mg Filmtabletten
Olmesartan/Amlodipin/HCT AL 40 mg/5 mg/25 mg Filmtabletten
Olmesartan/Amlodipin/HCT AL 40 mg/10 mg/25 mg Filmtabletten

Spain:
Olmesartan/Amlodipino/hidroclorotiazida STADA 20 mg/5 mg/12.5 mg comprimidos recubiertos con película EFG
Olmesartan/Amlodipino/hidroclorotiazida STADA 40 mg/5 mg/12.5 mg comprimidos recubiertos con película EFG
Olmesartan/Amlodipino/hidroclorotiazida STADA 40 mg/10 mg/12.5 mg comprimidos recubiertos con película EFG
Olmesartan/Amlodipino/hidroclorotiazida STADA 40 mg/5 mg/25 mg comprimidos recubiertos con película EFG
Olmesartan/Amlodipino/hidroclorotiazida STADA 40 mg/10 mg/25 mg comprimidos recubiertos con película EFG

Ireland:
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 20 mg/5 mg/12.5 mg film-coated tablets
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 40 mg/5 mg/12.5 mg film-coated tablets
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 40 mg/5 mg/25 mg film-coated tablets
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 40 mg/10 mg/12.5 mg film-coated tablets
Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 40 mg/10 mg/25 mg film-coated tablets

Portugal:
Amlodipina + Olmesartan medoxomilo + Hidroclorotiazida Ciclum

Croatia:
OMELIA

Italy:
Olmesartan, amlodipine and hydrochlorothiazide EG