OLMESARTAN/AMLODIPINE/HYDROCHLOROTHIAZIDE STADA 40 mg/10 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you, 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Olmesartan/Amlodipine/Hydrochlorothiazide Stada and what is it used for
2. What you need to know before you start taking Olmesartan/Amlodipine/Hydrochlorothiazide Stada
3. How to take Olmesartan/Amlodipine/Hydrochlorothiazide Stada
4. Possible side effects
5. Storage of Olmesartan/Amlodipine/Hydrochlorothiazide Stada

1. Package contents and further information

1. What is Olmesartan/Amlodipine/Hydrochlorothiazide Stada and what is it used for

Olmesartan/Amlodipine/Hydrochlorothiazide Stada contains three active substances called olmesartan medoxomil, amlodipine (as amlodipine besylate) and hydrochlorothiazide. The three substances help to control high blood pressure.

• Olmesartan medoxomilbelongs to a group of medicines called “angiotensin II receptor antagonists”, which lower blood pressure by relaxing blood vessels.
• Amlodipinebelongs to a group of medicines called “calcium channel blockers”. Amlodipine also lowers blood pressure by relaxing blood vessels.
• Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping to remove excess fluid, increasing urine production by the kidneys.

The action of these substances contributes to lowering your blood pressure.

Olmesartan/amlodipine/hydrochlorothiazide is used to treat high blood pressure:

• in adult patients whose blood pressure is not adequately controlled with the combination of olmesartan medoxomil and amlodipine, taken as a fixed-dose combination
• in patients who are already taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide, along with tablets containing only amlodipine, or a fixed-dose combination of olmesartan medoxomil and amlodipine, along with tablets containing only hydrochlorothiazide.

2. What you need to know before taking Olmesartan/Amlodipine/Hydrochlorothiazide Stada

DO NOT take Olmesartan/Amlodipine/Hydrochlorothiazide Stada

• if you are allergic to olmesartan medoxomil, amlodipine, or a special 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 olmesartan/amlodipine/hydrochlorothiazide.
• if you have severe kidney problems.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• if you have low levels of potassium or sodium in your blood, high levels of calcium or uric acid (with symptoms of gout or kidney stones) in your blood, which do not improve with treatment.
• if you are pregnant for more than 3 months. (It is also best to avoid olmesartan/amlodipine/hydrochlorothiazide at the start of pregnancy - see section "Pregnancy and breastfeeding").
• if you have severe liver problems, bile secretion problems, or obstruction of bile drainage from the gallbladder (e.g., due to gallstones), or if you have jaundice (yellowing of the skin and eyes).
• if you have insufficient blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, which means shock due to severe heart problems).
• if you have very low blood pressure.
• if the blood flow to your heart is slow or blocked. This can happen if the blood vessels or valves that capture blood from the heart become narrowed (aortic stenosis).
• if you have poor heart performance after suffering a heart attack (acute myocardial infarction). Poor heart performance can make you feel short of breath or have swelling in your feet and ankles.

Do not take olmesartan/amlodipine/hydrochlorothiazide if any of these cases apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartan/Amlodipine/Hydrochlorothiazide Stada.

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

• a converter 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 Olmesartan/Amlodipine/Hydrochlorothiazide Stada".

Tell your doctorif you have any of the following health problems:

• kidney problems or a kidney transplant
• liver disease
• heart failure or problems with the 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 being in the sun or in a solarium
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking olmesartan/amlodipine/hydrochlorothiazide

Contact your doctorif you experience any of the following symptoms:

• severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment
• decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur from a few hours to a few weeks after taking olmesartan/amlodipine/hydrochlorothiazide. This can lead to permanent vision impairment if left untreated.
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking olmesartan/amlodipine/hydrochlorothiazide, seek medical attention immediately.

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

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

Olmesartan/amlodipine/hydrochlorothiazide may cause an increase in lipid and uric acid levels in the blood. Your doctor will likely want to perform a blood test from time to time to monitor these possible changes.

A change in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely want to perform a blood test from time to time to monitor this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, slowness, fatigue, drowsiness or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

If you are going to have parathyroid function tests, you should stop taking olmesartan/amlodipine/hydrochlorothiazide before these tests are performed.

Athletes are informed that this medicine contains a component that may result in a positive doping test.

You should inform your doctor if you are pregnant (or think you might be). Olmesartan/amlodipine/hydrochlorothiazide is not recommended during pregnancy, and it should not be taken if you are pregnant for more than 3 months, 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)

Olmesartan/amlodipine/hydrochlorothiazide is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Olmesartan/Amlodipine/Hydrochlorothiazide Stada

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

• other blood pressure-lowering medicines, as they may increase the effect of olmesartan/amlodipine/hydrochlorothiazide.

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 the information under the headings "DO NOT take Olmesartan/Amlodipine/Hydrochlorothiazide Stada" and "Warnings and precautions")

• lithium(a medicine used to treat mood changes and some types of depression) may increase its toxicity if used with olmesartan/amlodipine/hydrochlorothiazide. If you need to take lithium, your doctor will monitor your lithium blood levels
• diltiazem, verapamil, used for heart rhythm problems and high blood pressure
• rifampicin, erythromycin, clarithromycin, tetracyclinesor sparfloxacin, antibiotics used for tuberculosis and other infections
• St. John's Wort(Hypericum perforatum), a herbal remedy for depression
• cisapride, used to increase food movement in the stomach and intestine
• difemanil, used to treat slow heart rate or to decrease sweating
• halofantrine, used for malaria
• vincamine IV, used to improve blood circulation in the nervous system
• amantadine, used for Parkinson's disease
• potassium supplements, salt substitutes that contain potassium, diuretics(which increase urine production), heparin(to thin the blood and prevent blood clots), ACE inhibitors(to lower blood pressure), laxatives, corticosteroids, adrenocorticotropic hormone (ACTH), carbenoxolone(a medicine for treating mouth and stomach ulcers), sodium penicillin G(an antibiotic also known as sodium benzylpenicillin), certain pain relieverssuch as acetylsalicylic acid or salicylates. The use of these medicines at the same time as olmesartan/amlodipine/hydrochlorothiazide may alter potassium levels in the blood
• non-steroidal anti-inflammatory medicines (NSAIDs)(medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as olmesartan/amlodipine/hydrochlorothiazide, may increase the risk of kidney failure. The effect of olmesartan/amlodipine/hydrochlorothiazide may be reduced by NSAIDs. If you use high doses of salicylates, it may increase the toxic effect on the central nervous system
• sleep-inducing medicines, sedatives, and antidepressants, used with olmesartan/amlodipine/hydrochlorothiazide, may cause a sudden drop in blood pressure when standing up
• colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of olmesartan/amlodipine/hydrochlorothiazide. Your doctor may advise you to take olmesartan/amlodipine/hydrochlorothiazide at least 4 hours before colesevelam hydrochloride
• certain antacids(remedies for indigestion and acidity), as they may slightly reduce the effect of olmesartan/amlodipine/hydrochlorothiazide
• certain muscle relaxants, such as baclofen and tubocurarine
• anticholinergic medicines, such as atropine and biperiden
• calcium supplements
• dantrolene(in infusion for severe body temperature anomalies)
• 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 make it possible for your body to accept a transplanted organ

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

Tell 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, sultoprida, tiaprida, droperidol, or haloperidol
• treating low blood sugar levels(e.g., diazoxide) or high blood pressure(e.g., beta-blockers, methyldopa), as olmesartan/amlodipine/hydrochlorothiazide 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 reducing heart rate, such as noradrenaline.
• treating gout, such as probenecid, sulfinpyrazone, and allopurinol
• lowering blood fat levels, such as colestyramine and colestipol
• lowering blood sugar levels, such as metformin or insulin

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

Taking Olmesartan/Amlodipine/Hydrochlorothiazide Stada with food, drinks, and alcohol

Olmesartan/amlodipine/hydrochlorothiazide can be taken with or without food.

People taking olmesartan/amlodipine/hydrochlorothiazide should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active ingredient amlodipine in the blood, which can cause an unpredictable increase in the blood pressure-lowering effect of olmesartan/amlodipine/hydrochlorothiazide.

Be careful when drinking alcohol while taking olmesartan/amlodipine/hydrochlorothiazide, as some people may feel faint or dizzy. If this happens, do not drink any alcohol.

Elderly patients

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

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant or think you might be. Your doctor will advise you to stop taking olmesartan/amlodipine/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medicine. Olmesartan/amlodipine/hydrochlorothiazide is not recommended during pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken at this stage.

If you become pregnant while taking olmesartan/amlodipine/hydrochlorothiazide, inform and consult your doctor immediately.

Breastfeeding

Tell 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. Olmesartan/amlodipine/hydrochlorothiazide is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed.

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

Driving and using machines

You may feel drowsy, sick, or dizzy, or have a headache while being treated for high blood pressure. If this happens, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

Olmesartan/Amlodipine/Hydrochlorothiazide Stada contains lactose

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

3. How to take Olmesartan/Amlodipine/Hydrochlorothiazide Stada

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dose

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

Method of administration

The tablets can be taken with or without food. Take the tablets with a little 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 break the tablet.

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

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

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

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine package and 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 the treatment.

If you have any other 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 all people suffer from them. If they occur, they are often mild and do not require treatment interruption.

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

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

Olmesartan/amlodipine/hydrochlorothiazide may cause a pronounced decrease in blood pressure, in susceptible patients. This can cause 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.

Unknown frequency: If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with olmesartan/amlodipine/hydrochlorothiazide a long time ago, contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for blood pressure.

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

Acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

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

To give you an idea of the number of patients who may have adverse effects, they have been classified according to the frequency in which they have been reported.

These are other known adverse effects of olmesartan/amlodipine/hydrochlorothiazide:

If these effects occur, they are often mild and do not require treatment interruption.

Frequent(may affect up to 1 in 10 people)

• upper respiratory tract infection
• throat and nose pain
• urinary tract infection
• dizziness
• headache
• perception of heartbeats
• low blood pressure
• nausea
• diarrhea
• constipation
• cramps
• joint swelling
• urinary urgency
• weakness
• ankle swelling
• fatigue
• abnormal laboratory test values

Uncommon(may affect up to 1 in 100 people)

• dizziness when standing up
• vertigo
• rapid heartbeat
• feeling of fainting
• flushing and feeling of heat in the face
• cough
• dry mouth
• muscle weakness
• inability to have or maintain an erection

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

They may be adverse effects due to olmesartan/amlodipine/hydrochlorothiazide, even if they have not been observed yet.

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 intestine infection
• vomiting
• increased blood sugar
• sugar in urine
• confusion
• drowsiness
• visual disturbances (including double vision and blurred vision)
• nasal secretion or congestion
• throat pain
• breathing difficulties
• 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 can cause easy bruising or prolonged bleeding
• anaphylactic reactions
• abnormal decrease in appetite (anorexia)
• sleeping problems
• irritability
• mood changes including anxiety
• feeling of depression
• chills
• sleep disorders
• alteration of the sense of taste
• loss of consciousness
• decrease in the sense of touch
• tingling sensation
• worsening of myopia
• ringing in the ears (tinnitus)
• angina (pain or unpleasant sensation in the chest, known as angina pectoris)
• irregular heartbeats
• rash
• hair loss
• allergic skin inflammation
• skin redness
• purple-colored spots or patches on the skin due to small hemorrhages (purpura)
• skin discoloration
• red itchy patches (urticaria)
• increased sweating
• itching
• skin rash
• skin reactions to light, such as sunburn or skin rash
• muscle pain
• urination problems
• feeling of needing to urinate at night
• increase in breast size in men
• decrease in sexual desire
• facial swelling
• feeling of discomfort
• weight increase or decrease
• exhaustion

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

• inflammation and pain of the salivary glands
• decrease in the number of white blood cells in the blood, which could increase the risk of infections
• decrease in the number of red blood cells (anemia)
• bone marrow damage
• restlessness
• feeling of loss of interest (apathy)
• seizures (convulsions)
• 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
• pancreatitis
• yellowing of the skin and eyes
• acute inflammation of the gallbladder
• symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers
• severe skin reactions including intense skin rash, urticaria, skin redness of the body, severe itching, blisters, peeling, and skin inflammation, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe
• worsening of movement
• acute kidney failure
• non-infectious kidney inflammation
• decrease in kidney function
• fever
• intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• high muscle tension
• numbness of hands or feet
• heart attack
• stomach inflammation
• gum thickening
• intestinal obstruction
• liver inflammation

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

• decrease in 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 unsteady gait
• skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the packaging and blister after "EXP:". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Olmesartan/Amlodipine/Hydrochlorothiazide Stada

20 mg/5 mg/12.5 mg:

• The active ingredients are olmesartan medoxomil, amlodipine (as besylate), and hydrochlorothiazide. Each film-coated tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine (as besylate), and 12.5 mg of hydrochlorothiazide.

40 mg/5 mg/12.5 mg:

• The active ingredients are olmesartan medoxomil, amlodipine (as besylate), and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as besylate), and 12.5 mg of hydrochlorothiazide.

40 mg/10 mg/12.5 mg:

• The active ingredients are olmesartan medoxomil, amlodipine (as besylate), and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as besylate), and 12.5 mg of hydrochlorothiazide.

40 mg/5 mg/25 mg:

• The active ingredients are olmesartan medoxomil, amlodipine (as besylate), and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as besylate), and 25 mg of hydrochlorothiazide.

40 mg/10 mg/25 mg:

• The active ingredients are olmesartan medoxomil, amlodipine (as besylate), and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as besylate), and 25 mg of hydrochlorothiazide.

• The other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E 460), crospovidone (E 1202), anhydrous colloidal 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 for 20 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, and 40 mg/10 mg/25 mg doses)

Appearance of the product and package contents

20 mg/5 mg/12.5 mg: Film-coated tablets, orange-white in color, round, biconvex, with a diameter of 8.1 ± 0.2 mm.

40 mg/5 mg/12.5 mg: Film-coated tablets, light yellow in color, round, biconvex, with a diameter of 11.1 ± 0.2 mm.

40 mg/10 mg/12.5 mg: Film-coated tablets, pale red in color, round, biconvex, with a diameter of 11.1 ± 0.2 mm.

40 mg/5 mg/25 mg: Film-coated tablets, light yellow in color, oval, biconvex, with a score line on one side and a length of 16.4 ± 0.2 mm.

40 mg/10 mg/25 mg: Film-coated tablets, pale red in color, oval, biconvex, with a score line on one side and a length of 16.4 ± 0.2 mm.

Olmesartan/Amlodipine/Hydrochlorothiazide Stada is available in blister packs of 14x1, 28x1, 30x1, 56x1, 98x1, 100x1 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratory 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

or

Clonmel Healthcare Ltd.

3 Waterford Road

E91 D768 Clonmel, Co. Tipperary

Ireland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:January 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/