Leaflet: information for the user

Olmesartán/Amlodipino/Hidroclorotiazida Teva 20 mg/5 mg/12,5 mg

film-coated tablets EFG

Olmesartán/Amlodipino/Hidroclorotiazida Teva 40 mg/5 mg/12,5 mg

film-coated tablets EFG

Olmesartán/Amlodipino/Hidroclorotiazida Teva 40 mg/10 mg/12,5 mg

film-coated tablets EFG

Olmesartán/Amlodipino/Hidroclorotiazida Teva 40 mg/5 mg/25 mg

film-coated tablets EFG

Olmesartán/Amlodipino/Hidroclorotiazida Teva 40 mg/10 mg/25 mg

film-coated tablets EFG

olmesartán medoxomilo/amlodipino/hidroclorotiazida

Read this leaflet carefully before you start taking this medicine because

it contains important information for you.

• Keep this leaflet, as 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, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isOlmesartán/Amlodipino/Hidroclorotiazida Tevaand what is it used for

2. What you need to know before you start takingOlmesartán/Amlodipino/Hidroclorotiazida

Teva

3. How to takeOlmesartán/Amlodipino/Hidroclorotiazida Teva

4. Possible side effects

5. Storage ofOlmesartán/Amlodipino/Hidroclorotiazida Teva

6. Contents of the pack and additional information

This medication contains three active substances called olmesartán medoxomilo, amlodipino (as amlodipino besilato) and hidroclorotiazida. The three substances help control high blood pressure.

• Olmesartán medoxomilo belongs to a group of medications called “angiotensin II receptor antagonists”, which decrease blood pressure by relaxing blood vessels.
• Amlodipino belongs to a group of medications called “calcium channel blockers”. Amlodipino also decreases blood pressure by relaxing blood vessels.
• Hidroclorotiazida belongs to a group of medications 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 decreasing 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 combination, or
• in patients already taking a fixed combination of olmesartán medoxomilo and hidroclorotiazida, along with tablets containing only amlodipino, or a fixed combination of olmesartán medoxomilo and amlodipino, along with tablets containing only hidroclorotiazida.

Do not take Olmesartán/Amlodipino/Hidroclorotiazida Teva

• 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 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 valves that remove 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 Teva.

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

• An angiotensin-converting enzyme inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskirén.

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

See also the information under the heading “Do not take Olmesartán/Amlodipino/Hidroclorotiazida Teva”.

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.
• Severe vomiting, diarrhea, treatment with high doses of medications that increase urine production (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 a skin lesion appears unexpectedly 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 this medication.
• If you have experienced respiratory or pulmonary problems (including inflammation or fluid in the lungs) after ingesting hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking this medication, seek medical attention immediately.

Contact your doctorif you experience any of the following symptoms:

• Severe diarrhea, persistent, and causing significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.
• Decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur from a few hours to several weeks after taking olmesartán/amlodipino/hidroclorotiazida. This can lead to permanent vision loss if not treated.

Like any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with heart or brain circulation problems 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 the blood. Your doctor will likely want to perform blood tests from time to time to monitor these possible changes.

Changes in blood levels of certain chemicals called electrolytes may occur. 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.Discuss with your doctor if you notice any of these symptoms.

If you are undergoing parathyroid function tests, you should stop taking this medication before the tests are performed.

Inform your doctor if you are pregnant (or think you may be). Olmesartán/amlodipino/hidroclorotiazida is not recommended for use at the beginning of pregnancy, and it should not be taken 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.

Use in athletes

Inform athletes that this medication contains a component that may result in a positive analytical result for doping control.

Children and adolescents (under 18 years)

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

Taking Olmesartán/Amlodipino/Hidroclorotiazida Teva with other medications

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.
• An angiotensin-converting enzyme inhibitor (ACEI) or aliskirén (see also the information under the headings “Do not take Olmesartán/Amlodipino/Hidroclorotiazida Teva” and “Warnings and precautions”).
• Lithium (a medication used to treat mood changes and certain 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 the blood.
• Diltiazem, verapamil, used for heart rhythm and high blood pressure problems.
• Rifampicin, erythromycin, clarithromycin, tetracyclines, or ciprofloxacin, antibiotics used for tuberculosis and other infections.
• St. John's Wort (Hypericum perforatum), a plant-based remedy for depression treatment.
• Cisaprida, used to increase stomach and intestinal movement.
• Difemanilo, used to treat slow heart rhythm 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 production (diuretics), heparin (to thin the blood and prevent blood clots), angiotensin-converting enzyme inhibitors (ACEIs) (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolona (medication for mouth and stomach ulcers), penicillin G sodium (antibiotic also called benzylpenicillin sodium), certain analgesics such as aspirin or salicylates. Using these medications at the same time as olmesartán/amlodipino/hidroclorotiazida may alter potassium levels in the blood.
• Nonsteroidal 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 problems. The effect of olmesartán/amlodipino/hidroclorotiazida may be reduced by NSAIDs. High doses of salicylates may increase the toxic effect on the central nervous system.
• Sedatives, sleep-inducing medications, and antidepressants, used with olmesartán/amlodipino/hidroclorotiazida may cause a sudden drop in blood pressure when standing up.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the 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 hydrochloride.
• Certain antacids (remedies for indigestion and heartburn), as they may slightly reduce the effect of olmesartán/amlodipino/hidroclorotiazida.
• Certain muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medications, such as atropine and biperiden.
• Calcium supplements.
• Dantrolene (in infusion for severe body temperature anomalies).
• Simvastatina, used to lower cholesterol and triglyceride levels in the blood.
• Medications used to control the body's immune response (e.g., tacrolimus, sirolimus, temsirolimus, everolimus, and ciclosporina), which allows 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 thioridazina, chlorpromazina, levomepromazina, trifluoperazina, ciamemazina, sulpirida, amisulprida, pimozida, sultoprida, tiaprida, droperidol, or haloperidol.
• Treating low blood sugar (e.g., diazóxido) or high 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 erythromycin injections.
• Treating HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir).
• Treating fungal infections (e.g., ketoconazol, itraconazol, amphotericin).
• Treating heart problems, such as quinidina, hidroquinidina, disopiramida, amiodarona, sotalol, bepridilo, or digital.
• Treating cancer, such as amifostina, ciclofosfamida, or metotrexato.
• Increasing blood pressure and decreasing heart rate, such as noradrenalina.
• Treating gout, such as probenecid, sulfinpirazona, and alopurinol.
• Lowering cholesterol and triglyceride levels in the blood, such as colestiramina and colestipol.
• Lowering blood sugar levels, such as metformina or insulina.

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

Taking Olmesartán/Amlodipino/Hidroclorotiazida Teva with food and drinks

This medication 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 blood levels of the active ingredient amlodipino, which may cause an unpredictable increase in the hypotensive effect of olmesartán/amlodipino/hidroclorotiazida.

Be careful when drinking alcohol while taking this medication, 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 you increase the dose, 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 recommend another medication in place of olmesartán/amlodipino/hidroclorotiazida. Olmesartán/amlodipino/hidroclorotiazida is not recommended for use during pregnancy, and it should not be taken 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 plan to start breastfeeding. It has been shown that amlodipino and hidroclorotiazida pass into breast milk in small amounts. Olmesartán/amlodipino/hidroclorotiazida is not recommended for use in breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed.

If you are pregnant, 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 this medication for high blood pressure. If this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

This medication contains:

Sodium

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

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 indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day.

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 tablets with grapefruit juice.

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

If you take more Olmesartán/Amlodipino/Hidroclorotiazida 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 a rapid or slow heart rate.

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

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 with you the packaging of the medication or this leaflet.

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

If you forgot to take Olmesartán/Amlodipino/Hidroclorotiazida Teva

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

If you interrupt treatment with Olmesartán/Amlodipino/Hidroclorotiazida Teva

It is essential 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.

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

The following two side effects can 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, stop taking this medication 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 this medication, consult your doctor immediately, and remain lying down in a horizontal position.

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

• Infrequent: If you experience yellowing of the white of the eyes, dark urine, itching on the skin, 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 continue your blood pressure medication.

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, they have been classified as frequent, infrequent, rare, and very rare.

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

If these side effects occur, they are often mild and do 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,
• Perception of heartbeats,
• Low blood pressure,
• Nausea,
• Diarrhea,
• Constipation,
• Cramps,
• Swelling of the joints,
• Sensation of urgency to urinate,
• Weakness,
• Swelling of the 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 the muscles,
• Inability to have or maintain an erection.

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 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 intestinal infection,
• Vomiting, increase in 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,
• Discomfort in the stomach,
• Flatulence,
• Pain in the 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 the sense 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 heartbeats, 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,
• Urticaria (hives) with itching,
• Increased sweating,
• Pruritus,
• Skin rash,
• Reactions to light, such as sunburn or skin eruption,
• Muscle pain,
• Difficulty urinating,
• Sensation of needing to urinate at night,
• Enlargement of the breasts in men,
• Decreased libido,
• Swelling of the face,
• Sensation of discomfort,
• Weight gain or loss,
• Fatigue.

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,
• 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 the 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 inflammation of the skin, inflammation of the 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.

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

• High muscle tension,
• Numbness of hands or feet,
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion),
• Heart attack,
• Inflammation of the stomach,
• Swelling of the gums,
• Intestinal obstruction,
• Inflammation of the liver.

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

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

Keep this medication out of the 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 packaging to protect it from light. This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Olmesartán/Amlodipino/Hidroclorotiazida Teva

Olmesartán/Amlodipino/Hidroclorotiazida Teva 20 mg/5 mg/12,5 mg film-coated tablets EFG

The active ingredients are 20 mg of olmesartán medoxomilo, 5 mg of amlodipino (as amlodipino besilato) and 12,5 mg of hidroclorotiazida.

Olmesartán/Amlodipino/Hidroclorotiazida Teva 40 mg/5 mg/12,5 mg film-coated tablets EFG

The active ingredients are 40 mg of olmesartán medoxomilo, 5 mg of amlodipino (as amlodipino besilato) and 12,5 mg of hidroclorotiazida.

Olmesartán/Amlodipino/Hidroclorotiazida Teva 40 mg/10 mg/12,5 mg film-coated tablets EFG

The active ingredients are 40 mg of olmesartán medoxomilo, 10 mg of amlodipino (as amlodipino besilato) and 12,5 mg of hidroclorotiazida.

Olmesartán/Amlodipino/Hidroclorotiazida Teva 40 mg/5 mg/25 mg film-coated tablets EFG

The active ingredients are 40 mg of olmesartán medoxomilo, 5 mg of amlodipino (as amlodipino besilato) and 25 mg of hidroclorotiazida.

Olmesartán/Amlodipino/Hidroclorotiazida Teva 40 mg/10 mg/25 mg film-coated tablets EFG

The active ingredients are 40 mg of olmesartán medoxomilo, 10 mg of amlodipino (as amlodipino besilato) and 25 mg of hidroclorotiazida.

The other components are:

Tablet core:Microcrystalline cellulose, lactose monohydrate, povidone (K-30), crospovidone, sodium starch glycolate (type A), hydrated colloidal silica, magnesium stearate

Coating:

Olmesartán/Amlodipino/Hidroclorotiazida Teva 20 mg/5 mg/12,5 mg film-coated tablets EFG:

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

Olmesartán/Amlodipino/Hidroclorotiazida Teva 40 mg/5 mg/12,5 mg and 40 mg/5 mg/25 mg film-coated tablets EFG

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

Olmesartán/Amlodipino/Hidroclorotiazida Teva 40 mg/10 mg/12,5 and 40 mg/10 mg/25 mg film-coated tablets EFGfilm-coated tablets EFG

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

Appearance of the product and packaging content

Olmesartán/Amlodipino/Hidroclorotiazida Teva 20 mg/5 mg/12,5 mg film-coated tablets EFG: White, round, beveled-edge tablets with the inscription “OA” on one face and “05” on the other face.

Olmesartán/Amlodipino/Hidroclorotiazida Teva 40 mg/5 mg/12,5 mg film-coated tablets EFG: Yellow, round, beveled-edge tablets with the inscription “OA” on one face and “06” on the other face.

Olmesartán/Amlodipino/Hidroclorotiazida Teva 40 mg/10 mg/12,5 mg film-coated tablets EFG: Pink, round, beveled-edge tablets with the inscription “OA” on one face and “03” on the other face.

Olmesartán/Amlodipino/Hidroclorotiazida Teva 40 mg/5 mg/25 mg film-coated tablets EFG: Yellow, elongated, beveled-edge tablets with the inscription “OA” on one face and “04” on the other face.

Olmesartán/Amlodipino/Hidroclorotiazida Teva 40 mg/10 mg/25 mg film-coated tablets EFG: Pink, elongated, beveled-edge tablets with the inscription “OA” on one face and “02” on the other face.

Olmesartán/Amlodipino/Hidroclorotiazida Teva is available in blisters of 14, 28, 56 and 98 film-coated tablets or perforated unit-dose blisters of 28 x 1 and 98 x 1 film-coated tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

Netherlands

Responsible 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

For further information about this medicinal product, please contact 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)

Last review date of this leaflet:June 2022

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

You can access detailed and updated information about this medicinal product 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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