Olmesartan/amlodipine/hydrochlorothiazide Stada 40 mg/5 mg/12.5 mg film-coated tablets EFG: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olmesartan/Amlodipine/Hydrochlorothiazide STADA 20 mg/5 mg/12.5 mg film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide STADA 40 mg/5 mg/12.5 mg film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide STADA 40 mg/10 mg/12.5 mg film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide STADA 40 mg/5 mg/25 mg film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide STADA 40 mg/10 mg/25 mg film-coated tablets EFG

Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide

Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any 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 you, as it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet

What Olmesartan/Amlodipine/Hydrochlorothiazide STADA is and what it is used for
What you need to know before taking Olmesartan/Amlodipine/Hydrochlorothiazide STADA
How to take Olmesartan/Amlodipine/Hydrochlorothiazide STADA
Possible side effects
How to store Olmesartan/Amlodipine/Hydrochlorothiazide STADA
Contents of the pack and other information

1. What Olmesartán/Amlodipino/Hidroclorotiazida Stada is and what it is used for

Olmesartán/Amlodipino/Hidroclorotiazida Stada contains three active substances: olmesartán medoxomilo, amlodipino (as amlodipino besilato), and hidroclorotiazida. These three substances help control high blood pressure.

Olmesartán medoxomilo belongs to a group of medicines called “angiotensin II receptor antagonists,” which lower blood pressure by relaxing blood vessels.
Amlodipino belongs to a group of medicines called “calcium channel blockers.” Amlodipino also lowers blood pressure by relaxing blood vessels.
Hidroclorotiazida belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

The combined action of these substances helps reduce your blood pressure.

Olmesartán/amlodipino/hidroclorotiazida is used to treat high blood pressure:

in adult patients whose blood pressure is not adequately controlled with the combination of olmesartán medoxomilo and amlodipino taken as a fixed-dose combination
in adult patients who are already taking a fixed-dose combination of olmesartán medoxomilo and hidroclorotiazida together with tablets containing only amlodipino, or a fixed-dose combination of olmesartán medoxomilo and amlodipino together with tablets containing only hidroclorotiazida.

2. What you need to know before taking Olmesartán/Amlodipino/Hidroclorotiazida Stada

DO NOT take Olmesartán/Amlodipino/Hidroclorotiazida Stada

if you are allergic to olmesartán medoxomil, amlodipine, or a specific group of calcium channel blockers (dihydropyridines), hydrochlorothiazide, or substances similar to hydrochlorothiazide (sulfonamides), or to any of the other components of this medicine (listed in section 6). If you think you may be allergic, inform your doctor before taking olmesartán/amlodipino/hidroclorotiazida.
if you have severe kidney problems.
if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
if you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood, which do not improve with treatment.
if you are more than 3 months pregnant. (It is also advisable to avoid olmesartán/amlodipino/hidroclorotiazida early in pregnancy – see section “Pregnancy and breastfeeding”).
if you have severe liver problems, biliary secretion disorders, or obstruction of bile drainage from the gallbladder (e.g., due to gallstones), or have jaundice (yellowing of the skin and eyes).
if you have inadequate blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, meaning shock due to serious heart problems).
if you have very low blood pressure.
if blood flow from your heart is slow or blocked. This may occur if the blood vessels or valves bringing blood from the heart are narrowed (aortic stenosis).
if you have low cardiac output after a heart attack (acute myocardial infarction). Low cardiac output may make you feel short of breath or have swelling in your feet and ankles.

Do not take olmesartán/amlodipino/hidroclorotiazida if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting Olmesartán/Amlodipino/Hidroclorotiazida Stada.

Tell your doctor if you are taking any of the following medicines used to treat high blood pressure (hypertension):

an angiotensin-converting enzyme inhibitor (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 blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “DO NOT take Olmesartán/Amlodipino/Hidroclorotiazida Stada”.

Tell your doctor if you have any of the following health conditions:

kidney problems or a kidney transplant
liver disease
heart failure or problems with heart valves or heart muscle
severe vomiting, diarrhea, treatment with high doses of medicines that increase urine elimination (diuretics), or if you are on a low-salt diet
high levels of potassium in the blood
problems with the adrenal glands (hormone-producing glands located above the kidneys)
diabetes
lupus erythematosus (an autoimmune disease)
allergy or asthma
skin reactions such as sunburn or rash after sun exposure or use of sunbeds
if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking olmesartán/amlodipino/hidroclorotiazida.

Contact your doctor if you experience any of the following symptoms:

severe, persistent diarrhea causing significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment
vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from hours to weeks after taking olmesartán/amlodipino/hidroclorotiazida. This may lead to permanent vision impairment if not treated.
if you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking olmesartán/amlodipino/hidroclorotiazida, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking olmesartán/amlodipino/hidroclorotiazida. Your doctor will decide whether to continue treatment. Do not stop taking olmesartán/amlodipino/hidroclorotiazida on your own.

As with any other medicine that lowers blood pressure, excessive reduction in blood pressure in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

Olmesartán/amlodipino/hidroclorotiazida may increase blood levels of lipids and uric acid (which causes gout – painful joint swelling). Your doctor may want to perform periodic blood tests to monitor these potential changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor may want to perform periodic blood tests to monitor this possible change. Some signs of electrolyte imbalances are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, slow, tired, sleepy, restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

If you are scheduled for parathyroid function tests, you must stop taking olmesartán/amlodipino/hidroclorotiazida before the tests are performed.

Athletes should be aware that this medicine contains a component that may lead to a positive analytical finding in doping controls.

Inform your doctor if you are pregnant (or think you might be). Use of olmesartán/amlodipino/hidroclorotiazida is not recommended early in pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years of age)

The use of olmesartán/amlodipino/hidroclorotiazida is not recommended in children and adolescents under 18 years of age.

Other medicines and Olmesartán/Amlodipino/Hidroclorotiazida Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the following medicines:

other blood pressure-lowering medicines, as they may enhance the effect of olmesartán/amlodipino/hidroclorotiazida.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “DO NOT take Olmesartán/Amlodipino/Hidroclorotiazida Stada” and “Warnings and precautions”)

lithium (a medicine used to treat mood disorders and certain types of depression) – its toxicity may increase when used together with olmesartán/amlodipino/hidroclorotiazida. If you need to take lithium, your doctor will monitor lithium levels in your blood
diltiazem, verapamil, used for heart rhythm problems and high blood pressure
rifampicin, erythromycin, clarithromycin, tetracyclines, or sparfloxacin, antibiotics used for tuberculosis and other infections
St. John’s wort (Hypericum perforatum), a herbal remedy for depression
cisapride, used to increase gastrointestinal motility
difemethiazine, used to treat slow heart rate or reduce sweating
halofantrine, used for malaria
vincamine IV, used to improve blood circulation in the nervous system
amantadine, used for Parkinson’s disease
potassium supplements, potassium-containing salt substitutes, diuretics (medicines that increase urine elimination), heparin (to thin the blood and prevent blood clots), angiotensin-converting enzyme inhibitors (ACE inhibitors) (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine for mouth and stomach ulcers), sodium penicillin G (an antibiotic also known as sodium benzylpenicillin), some painkillers such as acetylsalicylic acid or salicylates. Using these medicines together with olmesartán/amlodipino/hidroclorotiazida may alter blood potassium levels
non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used together with olmesartán/amlodipino/hidroclorotiazida may increase the risk of kidney failure. The effect of olmesartán/amlodipino/hidroclorotiazida may be reduced by NSAIDs. High doses of salicylates may increase central nervous system toxicity
sleep-inducing medicines, sedatives, and antidepressants, used together with olmesartán/amlodipino/hidroclorotiazida may cause a sudden drop in blood pressure upon standing
colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of olmesartán/amlodipino/hidroclorotiazida. Your doctor may advise you to take olmesartán/amlodipino/hidroclorotiazida at least 4 hours before colesevelam hydrochloride
certain antacids (remedies for indigestion and heartburn), as they may slightly reduce the effect of olmesartán/amlodipino/hidroclorotiazida
some muscle relaxants, such as baclofen and tubocurarine
anticholinergic medicines, such as atropine and biperiden
calcium supplements
dantrolene (administered intravenously for severe body temperature abnormalities)
simvastatin, used to lower cholesterol and fat (triglyceride) levels in the blood
medicines used to control the body’s immune response (e.g., tacrolimus, cyclosporine), which help the body accept a transplanted organ

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 low blood sugar (e.g., diazoxide) or high blood pressure (e.g., beta-blockers, methyldopa), since olmesartán/amlodipino/hidroclorotiazida may affect the mechanism of action of these medicines
treating heart rhythm problems, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injections
treating HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir)
treating fungal infections (e.g., ketoconazole, itraconazole, amphotericin)
treating heart problems, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis
treating cancer, such as amifostine, cyclophosphamide, or methotrexate
increasing blood pressure and decreasing heart rate, such as noradrenaline
treating gout, such as probenecid, sulfinpyrazone, and allopurinol
lowering blood fat levels, such as cholestyramine and colestipol
lowering blood sugar levels, such as metformin or insulin

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Taking Olmesartán/Amlodipino/Hidroclorotiazida Stada with food, drinks, and alcohol

Olmesartán/amlodipino/hidroclorotiazida can be taken with or without food.

People taking olmesartán/amlodipino/hidroclorotiazida should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effect of olmesartán/amlodipino/hidroclorotiazida.

Be cautious when drinking alcohol while taking olmesartán/amlodipino/hidroclorotiazida, as some people may feel faint or dizzy. If this happens, do not consume alcohol.

Elderly patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure each time your dose is increased, to ensure that your blood pressure does not drop too much.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you might be. Your doctor will advise you to stop taking olmesartán/amlodipino/hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of olmesartán/amlodipino/hidroclorotiazida is not recommended during pregnancy, and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

If you become pregnant while being treated with olmesartán/amlodipino/hidroclorotiazida, inform and see your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. Olmesartán/amlodipino/hidroclorotiazida is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You may feel drowsy, unwell, dizzy, or have a headache while being treated for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Olmesartán/Amlodipino/Hidroclorotiazida Stada contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Olmesartan/Amlodipine/Hydrochlorothiazide Stada

Follow exactly the instructions given by your doctor or pharmacist for administering this medicine. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose of olmesartan/amlodipine/hydrochlorothiazide is one tablet daily.

Method of administration

The tablets can be taken with or without food. Take the tablets with some liquid (such as a glass of water). Do not chew the tablet. Do not take the tablets with grapefruit juice.

If possible, take your daily dose at the same time each day, for example at breakfast time.

Tablets of 40 mg/5 mg/25 mg and 40 mg/10 mg/25 mg: The score line should not be used to divide the tablet.

If you take more Olmesartan/Amlodipine/Hydrochlorothiazide Stada than you should

If you take more tablets than you should, you are likely to experience a drop in blood pressure, accompanied by symptoms such as dizziness, and fast or slow heartbeat.

If you take more tablets than prescribed or if a child accidentally ingests any tablets, contact your doctor immediately or go to the nearest emergency department, and bring the medicine package or this leaflet with you.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 24–48 hours after ingestion.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested. It is recommended to bring the medicine container and package leaflet to the healthcare professional.

If you forget to take Olmesartan/Amlodipine/Hydrochlorothiazide Stada

If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Olmesartan/Amlodipine/Hydrochlorothiazide Stada

It is important to continue taking olmesartan/amlodipine/hydrochlorothiazide unless your doctor tells you to stop.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. If they do occur, they are often mild and do not require discontinuation of treatment.

The following adverse effects may be serious, although they affect only a small group of people:

During treatment with olmesartan/amlodipine/hydrochlorothiazide, allergic reactions may occur, with swelling of the face, mouth and/or larynx (vocal cords), along with itching and skin rash. If this happens to you, stop taking olmesartan/amlodipine/hydrochlorothiazide and consult your doctor immediately.

Olmesartan/amlodipine/hydrochlorothiazide may cause a marked drop in blood pressure in susceptible patients. This may lead to fainting or severe dizziness. If this happens to you, stop taking olmesartan/amlodipine/hydrochlorothiazide, consult your doctor immediately, and remain lying down in a horizontal position.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching—even if you started treatment with olmesartan/amlodipine/hydrochlorothiazide some time ago—contact your doctor immediately, who will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

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

Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion).

Olmesartan/amlodipine/hydrochlorothiazide is a combination of three active substances. The information below first describes the adverse effects reported so far with the combination olmesartan/amlodipine/hydrochlorothiazide (in addition to those already mentioned), and secondly, the known adverse effects of each of the individual active substances, or when two of the substances are taken together.

To give you an idea of how many patients may experience adverse effects, these have been classified according to how frequently they have been reported.

These are other adverse effects currently known with olmesartan/amlodipine/hydrochlorothiazide:

If these effects occur, they are often mild and you do not need to stop treatment.

Frequent (may affect up to 1 in 10 people)

upper respiratory tract infection
sore throat and nasal pain
urinary tract infection
dizziness
headache
awareness of heartbeat
low blood pressure
nausea
diarrhea
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 faint
facial flushing and sensation of warmth
cough
dry mouth
muscle weakness
inability to achieve or maintain an erection

These are the known adverse effects for each of the active substances individually or when two of the substances are taken together:

These may be adverse effects due to olmesartan/amlodipine/hydrochlorothiazide, even if they have not been observed so far.

Very common (may affect more than 1 in 10 people)

edema (fluid retention)

Frequent (may affect up to 1 in 10 people)

bronchitis
stomach and intestinal infection
vomiting
increased blood sugar
sugar in urine
confusion
drowsiness
visual disturbances (including double vision and blurred vision)
nasal discharge or congestion
sore throat
difficulty breathing
cough
abdominal pain
heartburn
stomach discomfort
flatulence
joint or bone pain
back pain
bone 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 easy bruising or prolonged bleeding time
anaphylactic reactions
abnormally low appetite (anorexia)
difficulty sleeping
irritability
mood changes including anxiety
feeling of depression
chills
sleep disorders
altered sense of taste
loss of consciousness
reduced sense of touch
tingling sensation
worsening of myopia
ringing in the ears (tinnitus)
angina (chest pain or discomfort, known as angina pectoris)
irregular heartbeat
rash
hair loss
allergic skin inflammation
skin redness
purple spots or patches on the skin due to minor bleeding (purpura)
skin discoloration
itchy red welts (urticaria)
increased sweating
pruritus
skin rash
skin reactions to light, such as sunburn or skin eruption
muscle pain
problems urinating
feeling of needing to urinate at night
enlargement of the breasts in men
decreased sexual desire
facial swelling
feeling unwell
weight gain or weight loss
exhaustion

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

inflammation and pain of the salivary glands
decreased number of white blood cells in the blood, which could increase the risk of infections
decreased number of red blood cells (anemia)
bone marrow damage
restlessness
feeling of loss of interest (apathy)
seizures
yellowish perception of objects when looking at them
dry eyes
blood clots (thrombosis, embolism)
fluid accumulation in the lungs
pneumonia
inflammation of blood vessels and small blood vessels in the skin
inflammation of the pancreas
yellowing of the skin and eyes
acute inflammation of the gallbladder
symptoms of systemic lupus erythematosus such as skin rash, joint pain, and coldness in hands and fingers
severe skin reactions including severe skin rash, urticaria, body-wide skin redness, severe itching, blisters, peeling and inflammation of the skin, and inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe
impaired movement
acute kidney failure
non-infectious inflammation of the kidney
decreased kidney function
fever
intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

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

Adverse effects with unknown frequency (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan/Amlodipine/Hydrochlorothiazide Stada

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 after "EXP:". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE Point located at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Amlodipine/Hydrochlorothiazide Stada

20 mg/5 mg/12.5 mg:

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.

40 mg/5 mg/12.5 mg:

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.

40 mg/10 mg/12.5 mg:

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.

40 mg/5 mg/25 mg:

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.

40 mg/10 mg/25 mg:

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.
Other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E 460), crospovidone (E 1202), colloidal anhydrous silica (E 551), magnesium stearate

Tablet coating:

hypromellose

lactose monohydrate

macrogol (E 1521)

titanium dioxide (E 171)

yellow iron oxide (E 172)

red iron oxide (E 172)

black iron oxide (E 172) (only in the 20 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg and 40 mg/10 mg/25 mg strengths)

Appearance of the product and contents of the pack

20 mg/5 mg/12.5 mg: Orange-white film-coated tablets, round, biconvex, with a diameter of 8.1 ± 0.2 mm.

40 mg/5 mg/12.5 mg: Light yellow film-coated tablets, round, biconvex, with a diameter of 11.1 ± 0.2 mm.

40 mg/10 mg/12.5 mg: Pale red film-coated tablets, round, biconvex, with a diameter of 11.1 ± 0.2 mm.

40 mg/5 mg/25 mg: Light yellow film-coated tablets, oval, biconvex, with a groove on one side and a length of 16.4 ± 0.2 mm.

40 mg/10 mg/25 mg: Pale red film-coated tablets, oval, biconvex, with a groove on one side and a length of 16.4 ± 0.2 mm.

Olmesartan/Amlodipine/Hydrochlorothiazide Stada is available in unit-dose cut blister packs (oPA-Alu-PVC/Alu) containing 14x1, 28x1, 30x1, 56x1, 98x1, 100x1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse, 2-18

61118 Bad Vilbel

Germany

Clonmel Healthcare Ltd.

3 Waterford Road

E91 D768 Clonmel, Co. Tipperary

Ireland

This medicinal product is authorized in the European Economic Area member states under the following names:

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/Amlodipine/HCT AL 20 mg/5 mg/12.5 mg film-coated tablets Olmesartan/Amlodipine/HCT AL 40 mg/5 mg/12.5 mg film-coated tablets Olmesartan/Amlodipine/HCT AL 40 mg/10 mg/12.5 mg film-coated tablets Olmesartan/Amlodipine/HCT AL 40 mg/5 mg/25 mg film-coated tablets Olmesartan/Amlodipine/HCT AL 40 mg/10 mg/25 mg film-coated tablets
Spain	Olmesartan/Amlodipine/Hydrochlorothiazide STADA 20 mg/5 mg/12.5 mg film-coated tablets EFG Olmesartan/Amlodipine/Hydrochlorothiazide STADA 40 mg/5 mg/12.5 mg film-coated tablets EFG Olmesartan/Amlodipine/Hydrochlorothiazide STADA 40 mg/10 mg/12.5 mg film-coated tablets EFG Olmesartan/Amlodipine/Hydrochlorothiazide STADA 40 mg/5 mg/25 mg film-coated tablets EFG Olmesartan/Amlodipine/Hydrochlorothiazide STADA 40 mg/10 mg/25 mg film-coated tablets 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/10 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/25 mg film-coated tablets
Croatia	OMELIA
Italy	Olmesartan/Amlodipine/Hydrochlorothiazide EG

Date of the last revision of this leaflet: January 2025

Detailed and up-to-date information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/