OLMESARTAN/AMLODIPINE/HYDROCHLOROTHIAZIDE TEVA 40 mg/5 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan/Amlodipine/Hydrochlorothiazide Teva 20 mg/5 mg/12.5 mg

film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Teva 40 mg/5 mg/12.5 mg

film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Teva 40 mg/10 mg/12.5 mg

film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Teva 40 mg/5 mg/25 mg

film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Teva 40 mg/10 mg/25 mg

film-coated tablets EFG

olmesartan medoxomil/amlodipine/hydrochlorothiazide

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 further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Olmesartan/Amlodipine/Hydrochlorothiazide Teva and what is it used for
2. What you need to know before you take Olmesartan/Amlodipine/Hydrochlorothiazide Teva

Teva

1. How to take Olmesartan/Amlodipine/Hydrochlorothiazide Teva
2. Possible side effects
3. Storage of Olmesartan/Amlodipine/Hydrochlorothiazide Teva
4. Contents of the pack and other information

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

This medicine contains three active substances called olmesartan medoxomil, amlodipine (as amlodipine besylate) and hydrochlorothiazide. The three substances help to control high blood pressure.

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

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, or
• 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 you take Olmesartan/Amlodipine/Hydrochlorothiazide Teva

Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Teva

• 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 ingredients 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 problems and are being treated with a blood pressure medicine that contains 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 recommended to avoid olmesartan/amlodipine/hydrochlorothiazide at the start of pregnancy - see section “Pregnancy and breast-feeding”).
• if you have severe liver problems, liver secretion problems, or bile drainage obstruction from the gallbladder (e.g., due to gallstones), or 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 pump blood out of 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 apply to you.

Warnings and precautions

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

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 check 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 Teva”.

Tell your doctor if 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 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, 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 this medicine.
• if you have experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking this medicine, seek medical attention immediately.

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 can occur from a few hours to a few weeks after taking olmesartan/amlodipine/hydrochlorothiazide. This can lead to permanent vision impairment if not treated.

As with any other medicine that lowers blood pressure, excessive lowering of blood pressure in patients with altered blood flow in the heart or brain may cause a heart attack or stroke. That's why 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. Talk to your doctor if you notice any of these symptoms.

If you are going to have parathyroid function tests, you should stop taking this medicine before these tests are performed.

You must inform your doctor if you are pregnant (or think you might be). Olmesartan/amlodipine/hydrochlorothiazide is not recommended during pregnancy, and 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 breast-feeding”).

Use in athletes

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

Children and adolescents (under 18 years)

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

Taking Olmesartan/Amlodipine/Hydrochlorothiazide Teva with other medicines

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.
• 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 Teva” and “Warnings and precautions”).
• Lithium (a medicine used to treat mood changes and some types of depression) as its toxicity may increase when used with olmesartan/amlodipine/hydrochlorothiazide. If you have to take lithium, your doctor will measure 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 the treatment of depression.
• Cisapride, used to increase food movement in the stomach and intestines.
• 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, 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 the treatment of mouth and stomach ulcers), sodium penicillin G (an antibiotic also called sodium benzylpenicillin), and some pain relievers such as acetylsalicylic acid (“aspirin”) 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 high doses of salicylates are used, the toxic effect on the central nervous system may increase.
• 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.
• Some muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and biperiden.
• Calcium supplements.
• Dantrolene (in infusion for severe body temperature abnormalities).
• Simvastatin, used to lower cholesterol and fat (triglycerides) levels in the blood.
• Medicines used to control the body's immune response (e.g., tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporin), which allows your body to accept a transplanted organ.

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

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 Teva with food and drinks

This medicine 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 this medicine, as some people may feel faint or dizzy. If this happens to you, do not drink any alcohol.

Elderly patients

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

Pregnancy and breast-feeding

Pregnancy

You must inform your doctor if you are pregnant or think you might be. Your doctor will advise you to stop taking olmesartan/amlodipine/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of olmesartan/amlodipine/hydrochlorothiazide. This medicine is not recommended during pregnancy, and must not be taken when you are more than 3 months pregnant, 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.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. Olmesartan/amlodipine/hydrochlorothiazide is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment if you wish to breast-feed.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 gone away. Consult your doctor.

This medicine contains:

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

Lactose

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

3. How to take/use Olmesartan/Amlodipine/Hydrochlorothiazide Teva

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

The recommended dose is one tablet per day.

The tablets can be taken with or without food. Swallow the tablet 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 every day, for example at breakfast time.

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

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

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Olmesartan/Amlodipine/Hydrochlorothiazide Teva

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

If you stop treatment with Olmesartan/Amlodipine/Hydrochlorothiazide Teva

It is important to continue taking this medication, 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.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them. If they occur, they are often mild and do not require treatment to be interrupted.

The following two adverse effects can be serious, although they only affect 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, can occur. If this happens to you, stop taking this medication and consult your doctor immediately.

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

• In very rare cases, acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion) can occur. If this happens, stop taking this medication and contact your doctor immediately.

• Frequency not known: 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 a long time ago, contact your doctor immediately, who will evaluate your symptoms and decide how to continue with your blood pressure medication.

Olmesartan/amlodipine/hydrochlorothiazide is a combination of three active substances. The following information 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 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 as frequent, infrequent, rare, and very rare.

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

If these effects occur, they are often mild and do not require treatment to be interrupted.

Frequent(may affect up to 1 in 10 people):

• upper respiratory tract infection,
• sore throat and nose,
• urinary tract infection,
• dizziness, headache,
• perception of heartbeats,
• low blood pressure,
• nausea,
• diarrhea,
• constipation,
• cramps,
• swelling of the joints,
• urge to urinate,
• weakness,
• swelling of the ankles,
• fatigue,
• abnormal laboratory test values.

Infrequent(may affect up to 1 in 100 people):

• dizziness when standing up,
• vertigo,
• fast 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 so far with olmesartan/amlodipine/hydrochlorothiazide.

Very frequent(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,
• 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.

Infrequent(may affect up to 1 in 100 people):

• reduction in the number of a type of blood cells called platelets, which can increase the risk of bleeding,
• anaphylactic reactions,
• abnormal decrease in appetite (anorexia),
• sleep problems, irritability,
• mood changes including anxiety,
• feeling of depression,
• chills, sleep disorders,
• alteration of taste,
• loss of consciousness,
• decreased 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,
• redness of the skin,
• purple 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 need to urinate at night,
• increase in breast size in men,
• decreased sexual desire,
• swelling of the face,
• feeling of discomfort,
• weight gain or loss,
• 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 can 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,
• 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, 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 inflammation of the kidney,
• decrease in kidney function,
• fever.

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

• high muscle tension,
• numbness of hands or feet,
• acute difficulty breathing (signs include severe difficulty breathing, fever, weakness, and confusion),
• heart attack,
• stomach inflammation,
• gum thickening,
• intestinal obstruction,
• liver inflammation.

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

• decreased vision or eye pain (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 Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Olmesartan/Amlodipine/Hydrochlorothiazide Teva

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and blister after EXP or CAD. The expiration date is the last day of the month indicated.

Store in the original package to protect it from light. This medication does not require special storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Olmesartan/Amlodipine/Hydrochlorothiazide Teva

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

The active ingredients are 20 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

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

The active ingredients are 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

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

The active ingredients are 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

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

The active ingredients are 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 25 mg of hydrochlorothiazide.

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

The active ingredients are 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besylate), and 25 mg of hydrochlorothiazide.

The other components are:

Core of the tablet:Microcrystalline cellulose, lactose monohydrate, povidone (K-30), crospovidone, sodium starch glycolate (type A), hydrated silica, magnesium stearate

Coating:

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

Opadry white II 85F18378 coating: partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b)

Olmesartan/Amlodipine/Hydrochlorothiazide Teva 40 mg/5 mg/12.5 mg and 40 mg/5 mg/25 mg film-coated tablets EFG

Opadry yellow II 85F22055 coating: partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), yellow iron oxide (E172).

Olmesartan/Amlodipine/Hydrochlorothiazide Teva 40 mg/10 mg/12.5 and 40 mg/10 mg/25 mg film-coated tablets EFG

Opadry pink II 85F94526 coating: partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), red iron oxide (E172).

Appearance of the product and package contents

Olmesartan/Amlodipine/Hydrochlorothiazide Teva 20 mg/5 mg/12.5 mg film-coated tablets EFG: White, round tablets with beveled edges, with the inscription “OA” on one side and “05” on the other side.

Olmesartan/Amlodipine/Hydrochlorothiazide Teva 40 mg/5 mg/12.5 mg film-coated tablets EFG: Yellow, round tablets with beveled edges, with the inscription “OA” on one side and “06” on the other side.

Olmesartan/Amlodipine/Hydrochlorothiazide Teva 40 mg/10 mg/12.5 mg film-coated tablets EFG: Pink, round tablets with beveled edges, with the inscription “OA” on one side and “03” on the other side.

Olmesartan/Amlodipine/Hydrochlorothiazide Teva 40 mg/5 mg/25 mg film-coated tablets EFG: Yellow, elongated tablets with beveled edges, with the inscription “OA” on one side and “04” on the other side.

Olmesartan/Amlodipine/Hydrochlorothiazide Teva 40 mg/10 mg/25 mg film-coated tablets EFG: Pink, elongated tablets with beveled edges, with the inscription “OA” on one side and “02” on the other side.

Olmesartan/Amlodipine/Hydrochlorothiazide Teva is available in blisters of 14, 28, 56, and 98 film-coated tablets or unit-dose blisters of 28 x 1 and 98 x 1 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer

Teva Operations Poland Sp. z.o.o.

Ul. Mogilska 80,

31-546 Krakow,

Poland

Balkanpharma Dupnitsa AD

3, Samokovsko Shosse Str.

2600 Dupnitsa

Bulgaria

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108, Madrid (Spain)

Date of the last revision of this leaflet:June 2022

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

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85742/P_85742.html

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