User Information: Package Insert

Olmesartán/Amlodipino/Hidroclorotiazida STADA 20 mg/5 mg/12,5 mg Film-Coated Tablets

Olmesartán/Amlodipino/Hidroclorotiazida STADA 40 mg/5 mg/12,5 mg Film-Coated Tablets

Olmesartán/Amlodipino/Hidroclorotiazida STADA 40 mg/10 mg/12,5 mg Film-Coated Tablets

Olmesartán/Amlodipino/Hidroclorotiazida STADA 40 mg/5 mg/25 mg Film-Coated Tablets

Olmesartán/Amlodipino/Hidroclorotiazida STADA 40 mg/10 mg/25 mg Film-Coated Tablets

Olmesartán medoxomilo/Amlodipino/Hidroclorotiazida

Read this package insert carefully before starting to take this medication, as it contains important information for you.

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others 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 not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Olmesartán/Amlodipino/Hidroclorotiazida Stadacontains three active substances called olmesartán medoxomilo, amlodipino (as amlodipino besilato) and hidroclorotiazida. The three substances help control high blood pressure.

• Olmesartán medoxomilobelongs to a group of medicines called “angiotensin II receptor antagonists”, which decrease blood pressure by relaxing blood vessels.
• Amlodipinobelongs to a group of medicines called “calcium channel blockers”. Amlodipino also decreases blood pressure by relaxing blood vessels.
• Hidroclorotiazidabelongs to a group of medicines called thiazide diuretics. It decreases blood pressure by contributing to the elimination of excess fluids, increasing urine production by the kidneys.

The action of these substances contributes to lowering blood pressure.

Olmesartán/amlodipino/hidroclorotiazidais 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 patients already taking a fixed-dose combination of olmesartán medoxomilo and hidroclorotiazida, along with tablets containing only amlodipino, or a fixed-dose combination of olmesartán medoxomilo and amlodipino, along with tablets containing only hidroclorotiazida.

Do not take Olmesartán/Amlodipino/Hidroclorotiazida Stada

• if you are allergic to olmesartán medoxomilo, amlodipino, or a group of calcium channel blockers (dihidropiridinas), hidroclorotiazida, or substances similar to hidroclorotiazida (sulfonamidas), or any of the other components of this medication (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 kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.
• 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, that do not improve with treatment.
• if you are more than 3 months pregnant. (It is also best to avoid olmesartán/amlodipino/hidroclorotiazida at the beginning of pregnancy - see section “Pregnancy and breastfeeding”).
• if you have severe liver problems, bile secretion problems, or obstruction of bile duct drainage from the gallbladder (e.g., due to gallstones), or have jaundice (yellow skin and eyes).
• if you have inadequate blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heart rate, 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 occur if the blood vessels or heart valves that capture blood from the heart become narrowed (aortic stenosis).
• if you have low cardiac output after a heart attack (acute myocardial infarction). Low cardiac output can make you feel short of breath or have swelling in your feet and ankles.

Do not take olmesartán/amlodipino/hidroclorotiazida if any of these cases occur.

Warnings and precautions

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

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

• a converting enzyme inhibitor (IECA) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskirén.

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels in your blood (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartán/Amlodipino/Hidroclorotiazida 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 heart valves or heart muscle
• intense vomiting, diarrhea, treatment with high doses of medications that increase urine elimination (diuretics), or if you are on a low-sodium diet
• high levels of potassium in your blood
• problems with the adrenal glands (glands that produce hormones 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 tanning bed
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly 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 olmesartán/amlodipino/hidroclorotiazida.

Contact your doctorif you experience any of the following symptoms:

• severe, persistent diarrhea that causes significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your treatment for high blood pressure.
• decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased eye pressure, which can occur from a few hours to several weeks after takingolmesartán/amlodipino/hidroclorotiazida. This can lead to permanent vision loss if not treated.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience shortness of breath or severe difficulty breathing after taking olmesartán/amlodipino/hidroclorotiazida, go to your doctor 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.

Like any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with heart or brain blood flow abnormalities can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

Olmesartán/amlodipino/hidroclorotiazida may cause an increase in lipid and uric acid levels in your blood. Your doctor will likely want to perform blood tests from time to time to monitor these possible changes.

You may experience changes in the levels of certain substances in your blood called electrolytes. Your doctor will likely want to perform blood tests 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 weak, slow, tired, drowsy, or restless, nausea, vomiting, decreased need to urinate, rapid heart rate.Tell your doctor if you notice any of these symptoms.

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

It is reported to athletes that this medication contains a component that can result in a positive analytical control test for doping as positive.

Inform your doctor if you are pregnant (or think you may be). Do not use olmesartán/amlodipino/hidroclorotiazida at the beginning of pregnancy, and do not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years)

Olmesartán/amlodipino/hidroclorotiazida is not recommended for use in children and adolescents under 18 years.

Other medications and Olmesartán/Amlodipino/Hidroclorotiazida Stada

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

• other blood pressure-lowering medications, as they may increase 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 (IECA) oraliskirén(see also the information under the headings “Do not take Olmesartán/Amlodipino/Hidroclorotiazida Stada” and “Warnings and precautions”)

• thelithium(medication used to treat mood changes and some types of depression) if used at the same time as olmesartán/amlodipino/hidroclorotiazida may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in your blood
• diltiazem,verapamilo,used for heart rhythm and high blood pressure problems
• rifampicina,eritromicina, claritromicina, tetraciclinas o esparfloxacino,antibioticsused for tuberculosis and other infections
• St. John's Wort(Hypericum perforatum), herbal remedy for depression treatment
• cisaprida, used to increase stomach and intestinal movement
• difemanilo, used for slow heart rate or to reduce sweating
• halofantrina, used for malaria
• vincamina IV, used to improve blood circulation in the nervous system
• amantadina,used for Parkinson's disease
• potassium supplements, salt substitutes containing potassium, medications that increase urine elimination(diuretics),heparina(to thin the blood and prevent blood clots),IECA(to lower blood pressure),laxatives,steroids,adrenocorticotropic hormone(ACTH),carbenoxolona(medication for mouth and stomach ulcers),penicilina G sódica(antibiotic also called bencilpenicilina sódica),some analgesicssuch as ácido acetil salicílico or salicilatos. The use of these medications at the same time as olmesartán/amlodipino/hidroclorotiazida may alter potassium levels in your blood
• thenonsteroidal anti-inflammatory drugs(NSAIDs, medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as olmesartán/amlodipino/hidroclorotiazida may increase the risk of kidney failure. The effect of olmesartán/amlodipino/hidroclorotiazida may be reduced by NSAIDs. If high doses of salicylates are used, it may increase the toxic effect on the central nervous system
• sleep-inducing medications, sedatives, and antidepressants, used with olmesartán/amlodipino/hidroclorotiazida may cause a sudden drop in blood pressure when standing up
• colesevelam hidrocloruro, a medication that lowers cholesterol levels in your blood, 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 hidrocloruro
• some antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of olmesartán/amlodipino/hidroclorotiazida
• some muscle relaxants, such as baclofeno and tubocurarina
• anticholinergic medications, such as atropina and biperideno
• calcium supplements
• dantroleno(in infusion for severe body temperature abnormalities)
• simvastatina, used to lower cholesterol and triglyceride levels in your blood
• medications used to control the body's immune response(e.g., tacrolimus,ciclosporina), which makes it possible for your body to accept the transplanted organ

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

• treating certain mental disorders, such as tioridazina, clorpromazina, levomepromazina, trifluoperazina, ciamemazina, sulpirida, amisulprida, pimozida, sultoprida, tiaprida, droperidol, or haloperidol
• treating low blood sugar(e.g., diazóxido) orhigh blood pressure(e.g., beta-blockers, metildopa), as olmesartán/amlodipino/hidroclorotiazida may affect the mechanism of action of these medications
• treating heart rhythm problems,such as mizolastina, pentamidina, terfenadina, dofetilida, ibutilida, or intravenous eritromicina
• treating HIV/AIDS(e.g., ritonavir, indinavir, nelfinavir)
• treating fungal infections(e.g., ketoconazol, itraconazol, anfotericina)
• treating heart problems, such as quinidina, hidroquinidina, disopiramida, amiodarona, sotalol, bepridilo, or digital
• treating cancer, such as amifostina, ciclofosfamida, or metotrexato
• increasing blood pressureanddecreasing heart rate,such as noradrenalina.
• treating gout, such as probenecid, sulfinpirazona, and alopurinol
• lowering cholesterol levels in your blood, such as colestiramina and colestipol
• lowering blood sugar levels, such as metformina or insulin

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

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 cause an increase in the levels of the active ingredient amlodipino in your blood, which may cause an unpredictable increase in the effect of lowering blood pressure of olmesartán/amlodipino/hidroclorotiazida.

Be careful when drinking alcohol while taking olmesartán/amlodipino/hidroclorotiazida, as some people may feel dizzy, nauseous, or experience headaches. If this happens, do not drink any alcohol.

Older 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 low.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, or if you think you may 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 advise you to take another medication. Do not use olmesartán/amlodipino/hidroclorotiazida during pregnancy, and do not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy.

If you become pregnant while taking olmesartán/amlodipino/hidroclorotiazida, inform and visit your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to start breastfeeding. It has been shown that amlodipino and hidroclorotiazida pass into breast milk in small amounts. Do not use olmesartán/amlodipino/hidroclorotiazida in mothers who are breastfeeding, and your doctor may choose another treatment if you want 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 medication.

Driving and operating machinery

You may feel drowsy, nauseous, or experience headaches while taking medication for high blood pressure. If this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

Olmesartán/Amlodipino/Hidroclorotiazida Stada contains lactose

This medication contains lactose.If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Dose

The recommended dose of olmesartán/amlodipino/hidroclorotiazida is one tablet per day.

Administration Form

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.

Try to take your daily dose at the same time every day, for example at breakfast time.

40 mg/5 mg/25 mg and 40 mg/10 mg/25 mg tablets: The groove should not be used to break the tablet.

If you take more Olmesartán/Amlodipino/Hidroclorotiazida Stada than you should

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

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

Excess fluid may accumulate in the lungs (pulmonary edema) causing breathing difficulties that may develop up to 24-48 hours after ingestion.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Olmesartán/Amlodipino/Hidroclorotiazida Stada

If you forget to take a dose, take the usual dose the next day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Olmesartán/Amlodipino/Hidroclorotiazida Stada

It is essential to continue taking olmesartán/amlodipino/hidroclorotiazida, unless your doctor tells you to stop treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If they occur, they are often mild and do not require interrupting treatment.

The following side effects can be serious, although they may 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, stop taking olmesartan/amlodipine/hydrochlorothiazide and consult your doctor immediately.

Olmesartan/amlodipine/hydrochlorothiazide can cause a pronounced drop in blood pressure in susceptible patients. This can cause severe dizziness or fainting.If this happens, 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, itching of the skin, even if you started treatment with olmesartan/amlodipine/hydrochlorothiazide some time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high blood pressure.

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

Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Olmesartan/amlodipine/hydrochlorothiazide is a combination of three active substances. The following information, first, describes the side effects reported so far with the combination olmesartan/amlodipine/hydrochlorothiazide (in addition to those already mentioned) and, second, the known side 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 experience side effects, these have been classified according to the frequency with which they have been reported.

These are other side effects known so far with olmesartan/amlodipine/hydrochlorothiazide:

If these side effects occur, they are often mild anddo not require interrupting treatment.

Frequent(may affect up to 1 in 10 people)

• Upper respiratory tract infection
• Sore throat and runny nose
• Urinary tract infection
• Dizziness
• Headache
• Palpitations
• Low blood pressure
• Nausea
• Diarrhea
• Constipation
• Cramps
• Joint swelling
• Urgency to urinate
• Weakness
• Swelling of ankles
• Tiredness
• Abnormal laboratory test results

Infrequent(may affect up to 1 in 100 people)

• Dizziness when standing up
• Dizziness
• Fast heart rate
• Sensation of fainting
• Redness and warmth of the face
• Cough
• Dry mouth
• Weakness of muscles
• Impotence

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

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

Frequent(may affect up to 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 secretion or congestion
• Sore throat
• Difficulty breathing
• Cough
• Abdominal pain
• Heartburn
• Indigestion
• Flatulence
• Pain in joints or bones
• Back pain
• Bone pain
• Blood in urine
• Symptoms similar to the flu
• Chest pain
• Pain

Infrequent(may affect up to 1 in 100 people)

• Reduction in the number of a type of blood cell called platelets, which can cause easy bruising or prolong bleeding time
• Anaphylactic reactions
• Abnormal decrease in appetite (anorexia)
• Difficulty sleeping
• Irritability
• Changes in mood including anxiety
• Sensation of depression
• Chills
• Sleep disorders
• Alteration of taste
• Loss of consciousness
• Decreased sense of touch
• Sensation of numbness
• Worsening of myopia
• Tinnitus (ringing in the ears)
• Angina (pain or uncomfortable sensation in the chest, known as angina pectoris)
• Irregular heartbeat
• Rash
• Hair loss
• Allergic inflammation of the skin
• Redness of the skin
• Purple patches or spots on the skin due to small hemorrhages (purpura)
• Decoloration of the skin
• Red, itchy patches (urticaria)
• Increased sweating
• Pruritus
• Skin eruption
• Severe skin reactions to light, such as sunburn or skin rash
• Muscle pain
• Difficulty urinating
• Sensation of needing to urinate at night
• Enlargement of breasts in men
• Decreased libido
• Swelling of the face
• Sensation of discomfort
• Weight gain or loss
• Exhaustion

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

• Inflammation and pain of 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
• Sensation of loss of interest (apathy)
• Seizures (convulsions)
• Yellowish perception of objects when looking at them
• Dry eyes
• Clots of blood (thrombosis, embolism)
• Accumulation of fluid 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 lupus erythematosus such as skin rash, joint pain, and cold hands and fingers
• Severe skin reactions including intense skin rash, urticaria, redness of the body skin, severe itching, blisters, peeling, and skin inflammation, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe
• Deterioration of movement
• Acute renal insufficiency
• Non-infectious inflammation of the kidney
• Decreased renal 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
• Inflammation of the stomach
• Thickening of the gums
• Intestinal obstruction
• Inflammation of the liver

Unknown frequency(cannot be estimated from available data)

• Decreased vision or eye pain due to increased pressure (possible signs of accumulation of fluid in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma)
• Tremors, rigid posture, mask-like face, slow movements, and unsteady gait dragging the feet.
• Skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister after“CAD:”.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Olmesartan/Amlodipine/Hydrochlorothiazide Stada

20 mg/5 mg/12.5 mg:

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

• The other components are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose (E 460), crospovidone (E 1202), anhydrous colloidal silica (E 551), magnesium stearate

Coating of the tablet:

hypromellose

lactose monohydrate

macrogol (E 1521)

titania dioxide (E 171)

yellow iron oxide (E 172)

red iron oxide (E 172)

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

Appearance of the product and contents of the package

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

40 mg/5 mg/12.5 mg:Film-coated tablets, yellowish 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, yellowish in color, oval, biconvex, with a groove on one face 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 groove on one face and a length of 16.4 ± 0.2 mm.

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse, 2-18

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd.

3 Waterford Road

E91 D768 Clonmel, Co. Tipperary

Ireland

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet:January 2025

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/