Package Leaflet: Information for the User

Amlodipino/Valsartán/Hidroclorotiazida Teva 5 mg/160 mg/12,5 mg Film-Coated Tablets EFG

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. Do 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.

This medicine contains three substances called amlodipino, valsartán and hidroclorotiazida. All these substances help control high blood pressure.

• Amlodipino belongs to a group of substances called«calcium channel blockers». Amlodipino prevents calcium from entering the blood vessel wall, which prevents blood vessel narrowing.
• Valsartán belongs to a group of substances called«angiotensin II receptor antagonists». Angiotensin II is produced by the body and causes blood vessels to narrow, thereby raising blood pressure. Valsartán acts by blocking the effect of angiotensin II.
• Hidroclorotiazida belongs to a group of substances known as«thiazide diuretics». Hidroclorotiazida increases urine production, which also lowers blood pressure.

As a result of the three mechanisms, blood vessels relax and blood pressure decreases.

This medicine is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipino, valsartán and hidroclorotiazida and who may benefit from taking a tablet that contains the three substances.

Do not take Amlodipino/Valsartán/Hidroclorotiazida Teva

• if you are more than 3 months pregnant.(In any case, it is recommended to avoid taking this medication also at the beginning of your pregnancy - see Pregnancy section).
• if you are allergic toamlodipinoor to any other calcium channel blocker, valsartán, hidroclorotiazida, sulfonamide-derived medications(medications used to treat chest or urinary infections),or to any of the other components ofthis medication (listed in section6).

If you think you may be allergic, do not take this medication and inform your doctor.

• if you have liver disease, bile duct destruction inside the liver (biliary cirrhosis) that leads to bile accumulation in the liver (cholestasis).
• if you have severe kidney problems or if you are undergoing dialysis.
• if you are unable to urinate (anuria).
• if your blood potassium or sodium levels are too low despite treatment to increase potassium or sodium levels in the blood.
• if your blood calcium levels are too high despite treatment to reduce calcium levels in the blood.

• if you have gout (crystals of uric acid in the joints).
• if you have severe low blood pressure (hypotension).
• if you have aortic stenosis (narrowing of the aortic valve) or cardiogenic shock (a situation in which your heart cannot supply enough blood to your body).
• if you have heart failure after a heart attack.

• if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskireno.

Do not take Amlodipino/Valsartán/Hidroclorotiazida Teva and inform your doctorif you are affected by any of the above cases.

Warnings and precautions

• Consult your doctor or pharmacist before starting to take this medicationif you have low levels of potassium or magnesium in the blood(with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
• if you have low sodium levels in the blood (with or without symptoms such as fatigue, confusion,muscle contractions, convulsions).
• if you have high calcium levels in the blood(with or without symptoms such as nausea, vomiting, constipation, abdominal pain, frequent urination,thirst, muscle contractions, and muscle weakness).
• if you have kidney problems, have undergone a kidney transplant, or if you have been informed that you suffer from kidney artery narrowing.
• if you have liver problems.
• if you have or have had heart failure or coronary disease, particularly if you have been prescribed the maximum dose of Amlodipino/Valsartán/Hidroclorotiazida (10mg/320mg/25mg).
• if you have had a heart attack. Follow your doctor's instructions to start treatment carefully. Your doctor may also check your renal function.
• if your doctor has informed you that you suffer from aortic or mitral valve narrowing (also known as“aortic or mitral stenosis”) or that your heart muscle has abnormally increased in thickness (also known as“hypertrophic obstructive cardiomyopathy”).
• if you suffer from aldosteronism. A disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of this medication is not recommended.
• if you suffer from systemic lupus erythematosus (also known as“lupus”or“LES”).
• if you have diabetes (high blood sugar levels).
• if you have high levels of cholesterol or triglycerides in the blood.
• if you experience skin reactions such as sun exposure rash.
• if you have had an allergic reaction to other medications for high blood pressure or diuretics, especially if you suffer from asthma and allergies.
• if you have been ill (with vomiting or diarrhea).
• if you have experienced swelling, particularly in the face and throat, while taking other medications (including ACE inhibitors). If you have these symptoms,stop taking this medication and contact your doctor immediately.Never take this medication again.
• if you experience dizziness and/or fainting during treatment with this medication, inform your doctor as soon as possible.
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the eye's vascular layer (choroidal effusion) or increased intraocular pressure and may appearin a matter of hours to weeks after administration of this medication. If left untreated, this can cause permanent vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing it.
• if you are taking any of the following medications used to treat high blood pressure:
• • an ACE inhibitor (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskireno.
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its 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.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (such as potassium) in the blood at regular intervals.

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

Inform your doctorif you are affected by any of the cases mentioned.

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

Children and adolescents

This medication is not recommended for use in children or adolescents under 18years.

Older adults (65years and older)

This medication may be used in people 65years and older at the same dose as used in other adults and in the same way as they have already taken the three substances called amlodipino, valsartán, and hidroclorotiazida. Renal pressure should be monitored regularly in elderly patients, particularly those taking the maximum dose of Amlodipino/Valsartán/Hidroclorotiazida (10mg/320mg/25mg).

Use of Amlodipino/Valsartán/Hidroclorotiazida Teva with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. Your doctor may need to adjust your dose and/or take other precautions. In some cases, you may need to stop taking one of the medications. This is especially important if you are taking any of the medications listed below:

Do not take with:

• lithium (a medication used to treat certain types of depression);
• medications or substances that may increase blood potassium levels. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin;
• an ACE inhibitor or aliskireno (see also the information under the headings“Do not take Amlodipino/Valsartán/Hidroclorotiazida Teva” and “Warnings and precautions”.

Use with caution with:

• alcohol, sleeping pills, and anesthetics (medications for patients undergoing surgery and other procedures);
• amantadine (treatment for Parkinson's disease, also used to treator prevent certain diseases caused by viruses);
• anticholinergic medications (medications used to treat various disorders such as gastrointestinal upset, urinary tract spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia);
• anticonvulsants and mood stabilizers used to treat epilepsy and bipolar disorder (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• colestiramine, colestipol, or other resins (substances primarily used to treat high blood lipid levels);
• simvastatin (a medication used to control high cholesterol levels);
• ciclosporina (a medication used in transplants to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis);
• cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide;
• digoxinor other digitalis glycosides (medications used to treat heart problems);
• verapamil, diltiazem (heart medications);
• iodinated contrast media(agents used in imaging tests);
• medications used to treat diabetes (oral medications such as metformin or insulin);
• medications used to treat gout, such as allopurinol;
• medications that may increase blood sugar levels (beta-blockers, diazoxide);
• medications that may induce“torsades de pointes”(irregular heart rhythm), such as antiarrhythmics (medications used to treat heart problems) and certain antipsychotics;
• medications that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics;
• medications that may reduce blood potassium levels, such as diuretics, corticosteroids, laxatives, amphotericin B, or penicillin G;
• medications used to increase blood pressure, such as adrenaline or noradrenaline;
• medications used to treat HIV/AIDS (e.g. ritonavir,indinavir, nelfinavir);
• medications used to treat fungal infections (e.g. ketoconazole, itraconazole);
• medications used to treat esophageal inflammation and ulceration (carbenoxolone);
• medications used to relieve pain or inflammation, especially nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors;
• muscle relaxants(medications used to relax muscles during surgery);
• nitroglycerin and other vasodilators;
• other medications used to treat high blood pressure, including methyldopa;
• rifampicin (used, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John's Wort;
• dantrolene (in infusion for severe body temperature anomalies);
• vitamin D and calcium salts.

Taking Amlodipino/Valsartán/Hidroclorotiazida Teva with food, drinks, and alcohol

People who have been prescribed this medication should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may lead to an increase in the blood levels of the active ingredient amlodipino, which may cause unpredictable reductions in blood pressure.Consult your doctor before drinking alcohol. Alcohol may significantly lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctorbefore using this medication.Your doctor will usually advise you to stop taking this medication before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. This medication is not recommended for use at the beginning of pregnancy and should not be administered after the thirdmonth of pregnancy as it may cause severe damage to your baby when administered from that point onwards.

Lactation

Inform your doctorifyou are planning to start or are breastfeeding.Amlodipino has been shown to pass into breast milk in small amounts. This medication is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in newborns or premature babies.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

As with other medications used to treat high blood pressure, this medication may cause dizziness, drowsiness, nausea, or headaches. If you experience these symptoms, do not drive or operate tools or machinery.

Use in athletes

This medication containshidroclorotiazidawhich may produce a positive result in doping control tests.

Amlodipino/Valsartán/Hidroclorotiazida Teva contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again. This will help you obtain the best results and reduce the risk of adverse effects.

The normal dose of Amlodipino/Valsartán/Hidroclorotiazida isone tabletper day.

• It is best to take the tablet at the same time every day. The best time is in the morning.
• Swallow the tablet whole with a glass of water.

You can take this medication with or without food.Do not take this medication with grapefruit or grapefruit juice.

Your doctor may suggest a higher or lower dose depending on your response to treatment.

Do not exceed the prescribed dose.

If you take more Amlodipino/Valsartán/Hidroclorotiazida Teva than you should

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

If you have accidentally taken too many tablets of this medication, consult your doctor immediately. You may need medical attention.

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.

If you forget to take Amlodipino/Valsartán/Hidroclorotiazida Teva

If you forget to take a dose of this medication, take it as soon as you remember and then take the next dose at the usual time. If it is almost time for the next dose, you should only take the next tablet at the usual time.Do nottake a double dose (two tablets at once) to compensate for the missed doses.

If you interrupt treatment with Amlodipino/Valsartán/Hidroclorotiazida Teva

Stoppingyour treatment withthis medication may cause your condition to worsen. Do not stop taking the medication unless your doctor tells you to.

Take this medication always, even if you feel well

People with hypertension often do not notice any symptoms of their problem. Many feel well. It is very important that you take this medication exactly as your doctor has instructed to obtain the best results and reduce the risk of adverse effects. Keep your appointments with your doctor even if you feel well.

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

This medication, like all others, may cause side effects, although not everyone will experience them.

As with any combination of three active ingredients, it cannot be ruled out that side effects associated with each individual component may occur. The side effects observed with this medication or one of its three active ingredients (amlodipine, valsartan, and hydrochlorothiazide) are listed below and may occur with the use of this medication.

Some side effects may be severe and require immediate medical attention.

Consult your doctor immediately if, after taking this medication, you experience any of the following severe side effects:

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

• dizziness
• low blood pressure (sensation of fainting, dizziness, sudden loss of consciousness)

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

• decreased urine production (reduced kidney function)

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

• spontaneous bleeding
• irregular heartbeat
• liver disorder

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

• acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion)
• sudden wheezing while breathing, chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat that causes severe difficulty breathing
• severe skin reactions that include intense skin rash, blisters, body-wide redness, severe itching, blistering, peeling, skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• heart attack
• pancreatitis that can cause severe abdominal pain and back pain accompanied by severe discomfort
• weakness, bruises, fever, and frequent infections
• stiffness

Other side effects may include:

Very frequent (may affect more than 1 in 10 people):

• low potassium levels in the blood
• high levels of lipids in the blood

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

• dizziness, dizziness when standing up
• decreased appetite
• nausea and vomiting
• skin rash with itching and other types of rash
• inability to achieve or maintain an erection

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

• rapid heartbeat
• sensation of everything spinning around
• vision disorder
• stomach discomfort
• chest pain
• high levels of urea, creatinine, and uric acid in the blood
• high levels of calcium, lipids, or sodium in the blood
• low potassium levels in the blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered sense of taste
• back pain
• swelling of the joints
• muscle cramps/weakness/pain
• pain in the extremities
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness when standing up or after exercise
• lack of energy
• sleep disturbances
• numbness or tingling
• neuropathy
• sudden and transient loss of consciousness
• low blood pressure when standing up
• coughs
• shortness of breath
• irritation of the throat
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• skin redness
• tremors
• mood changes
• anxiety
• depression
• insomnia
• altered sense of taste
• fainting
• loss of pain sensation
• vision disturbances
• visual deterioration
• ringing in the ears
• nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• alteration of bowel habits
• indigestion
• hair loss
• skin itching
• skin discoloration
• urinary disorders
• increased need to urinate at night
• increased frequency of urination
• breast discomfort in men
• pain
• discomfort
• weight loss

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

• low platelet count in the blood (sometimes with bleeding or bruising under the skin)
• sugar in the urine
• high blood sugar
• worsening of diabetic metabolic state
• abdominal discomfort
• constipation
• liver disorders that may be accompanied by yellow skin and eyes, or dark-colored urine (hemolytic anemia)
• increased skin sensitivity to the sun
• purplish skin spots
• kidney disorders
• confusion

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

• decreased white blood cell count
• decreased platelet count in the blood that may cause unusual bruising or bleeding (damage to red blood cells)
• inflammation of the gums
• abdominal swelling (gastritis)
• inflammation of the liver (hepatitis)
• yellow skin discoloration (jaundice)
• increased liver enzymes that may affect some medical tests
• muscle tension
• inflammation of blood vessels often with skin rash
• light sensitivity
• movement disorders combining stiffness, tremors, and/or movement disorders
• fever, sore throat, or mouth ulcers, increased frequency of infections (low or very low white blood cell count)
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia, abnormal decrease in red blood cells due to rupture in blood vessels and other parts of the body)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe stomach pain (inflammation of the pancreas)
• facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, purple spots, fever (vasculitis)
• severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)
• intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Frequency not known (the frequency cannot be estimated from available data):

• alteration of kidney function test results in blood, high potassium levels in the blood, low red blood cell count in the blood
• abnormal red blood cell count
• low count of a certain type of white blood cell and platelets in the blood
• high creatinine levels in the blood
• abnormal liver function test
• significant decrease in urine production
• inflammation of blood vessels
• weakness, bruises, and frequent infections (aplastic anemia)
• decreased vision or eye pain due to high intraocular pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma)
• shortness of breath
• severe decrease in urine production (possible signs of renal impairment or renal insufficiency)
• severe skin disease that causes rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (erythema multiforme)
• muscle spasms
• fever (pyrexia)
• blistering skin disease (sign of a disease called bullous dermatitis)
• skin cancer 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://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 packaging and blister (after CAD/EXP). The expiration date is the last day of the month indicated.

Blister: Do not store above 30° C.

Store in the original packaging to protect it from light and moisture.

HDPE Bottle: Store in the original packaging to protect it from moisture.

Do not useAmlodipino/Valsartán/Hidroclorotiazida Tevaif you observe that the packaging is damaged or shows signs of manipulation.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofAmlodipino/Valsartán/Hidroclorotiazida Teva

Amlodipino/Valsartán/Hidroclorotiazida Teva 5mg/160mg/12,5mg coated tablets EFG

The active ingredients of Amlodipino/Valsartán/Hidroclorotiazida Teva are amlodipino (as amlodipino besilato), valsartán and hidroclorotiazida. Each coated tablet contains 5mg of amlodipino (as amlodipino besilato),160mg of valsartán, and 12,5mg of hidroclorotiazida.

The other components are:

Core tablet: microcrystalline cellulose; low-substituted hydroxypropyl cellulose; anhydrous colloidal silica; magnesium stearate; talc

Coating:Poly (vinyl alcohol)(E1203); titanium dioxide (E171); talc (E553b); macrogol 4000 (E1521); Acid methacrylic and ethyl acrylate copolymer (1:1); sodium hydrogen carbonate (E500(ii))

Appearance of the product and contents of the package

The coated tablets of Amlodipino/Valsartán/Hidroclorotiazida Teva 5mg/160mg/12,5mg coated tablets are oval, white, 7,70 mm x 16 mm in size, with the impression “C12” marked on one side.

Amlodipino/Valsartán/Hidroclorotiazida Teva is available in packages containing 14, 28, 30, 56, 90 and 98coated tablets.

Amlodipino/Valsartán/Hidroclorotiazida Teva is available in bottles containing 100 coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

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:February 2025

Other sources of information

The detailed information about this medicinal product is available on the website of theSpanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

You can access detailed and updated information about this medicinal product by scanning with your smartphone the QR code included in the packaging. You can also access this information on the following internet address:https://cima.aemps.es/cima/dochtml/p/85356/P_85356.html

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