Leaflet: information for the user

Amlodipine/Valsartan/Hydrochlorothiazide pensa 5 mg/160 mg/12.5 mg

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 vessels from 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.

Amlodipino/valsartán/hidroclorotiazida 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 containing the three substances.

Do not take Amlodipino/Valsartán/Hidroclorotiazida pensa

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking amlodipino/valsartán/hidroclorotiazida also at the beginning of your pregnancy - see Pregnancy section).
• if you are allergic to amlodipino or to any other calcium channel blocker, valsartán, hidroclorotiazida, sulfonamide-derived medications (medications used to treat chest or urinary tract infections), or to any of the other components of this medication (included in section 6).

If you think you may be allergic, do not take amlodipino/valsartán/hidroclorotiazida and inform your doctor.

• if you have liver disease, destruction of the small bile ducts inside the liver (biliary cirrhosis) that leads to the accumulation of bile 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 (uric acid crystals 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 condition in which your heart cannot supply enough blood to the 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 reduce blood pressure that contains aliskiren.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take amlodipino/valsartán/hidroclorotiazida

• if 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 levels of sodium in the blood (with or without symptoms such as fatigue, confusion, muscle contractions, seizures).
• if you have high levels of calcium in the blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle contractions, and muscle weakness).
• if you have kidney problems, have undergone a kidney transplant, or have been informed that you have a narrowing of the kidney arteries.
• if you have liver problems.
• if you have or have had heart failure or coronary artery disease, particularly if you have been prescribed the maximum dose of amlodipino/valsartán/hidroclorotiazida (10 mg/320 mg/25 mg).
• 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 you have aortic or mitral valve stenosis (a condition in which the heart valves are narrowed) or if you have an abnormal thickening of your heart muscle (hypertrophic obstructive cardiomyopathy).
• if you have a condition called aldosteronism. A disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of amlodipino/valsartán/hidroclorotiazida is not recommended.
• if you have a disease called 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 sunburn.
• if you have had an allergic reaction to other medications for high blood pressure or diuretics, especially if you have asthma and allergies.
• if you have been sick (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 amlodipino/valsartán/hidroclorotiazida and contact your doctor immediately. You should never take this medication again.
• if you experience dizziness and/or fainting during treatment with amlodipino/valsartán/hidroclorotiazida, 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 hemorrhage) or increased intraocular pressure and may appear within hours to a week of administering amlodipino/valsartán/hidroclorotiazida. If left untreated, this can cause permanent vision loss.
• if you are taking any of the following medications used to treat high blood pressure:
• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.
• 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 amlodipino/valsartán/hidroclorotiazida.
• 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 X, see your doctor immediately.
• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Amlodipino/Valsartán/Hidroclorotiazida Pensa. Your doctor will decide whether to continue treatment. Do not stop taking Amlodipino/Valsartán/Hidroclorotiazida Pensa on your own.

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

See also the information under the heading "Do not take Amlodipino/Valsartán/Hidroclorotiazida Pensa".

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

Children and adolescents

Amlodipino/valsartán/hidroclorotiazida is not recommended for use in children or adolescents under 18 years old.

Older adults (65 years and older)

Amlodipino/valsartán/hidroclorotiazida may be used in people 65 years 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 (10 mg/320 mg/25 mg).

Use of Amlodipino/Valsartán/Hidroclorotiazida pensa 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 potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin;
• an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Amlodipino/Valsartán/Hidroclorotiazida Pensa" 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 treat or 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 used mainly to treat high levels of lipids in the blood);
• 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;
• digoxin or other digitalis glycosides (medications used to treat heart problems);
• verapamil, diltiazem (heart medications);
• contrast agents containing iodine (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 sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics;
• medications that may reduce potassium levels in the blood, such as diuretics (medications for urination), 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 inflammation and ulceration of the esophagus (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, e.g., to treat tuberculosis), erythromycin, clarithromycin (antibiotics)
• St. John's Wort;
• dantrolene (in infusion for severe body temperature abnormalities);
• vitamin D and calcium salts.

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

People who have been prescribed amlodipino/valsartán/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 lead to 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

You must inform your doctorif you are pregnant,if you suspect you may be pregnant or if you plan to become pregnant. Your doctor will usually advise you to stop taking amlodipino/valsartán/hidroclorotiazida before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Amlodipino/valsartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy as it may cause severe damage to your baby when administered from that point onwards.

Lactation

You must inform your doctorifyou are planning to initiate or are in the lactation period. It has been shown that amlodipino passes into breast milk in small amounts. Amlodipino/valsartán/hidroclorotiazida 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 machines.

Warning about doping

This medication contains hidroclorotiazida, which may produce a positive result in doping control tests.

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 amlodipine/valsartan/hydrochlorothiazide isone tabletper day.

• It is better 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 amlodipine/valsartan/hydrochlorothiazide with or without food. Do not take amlodipine/valsartan/hydrochlorothiazide with grapefruit or grapefruit juice.

Depending on your response to treatment, your doctor may suggest a higher or lower dose.

Do not exceed the prescribed dose.

If you take more Amlodipine/Valsartan/Hydrochlorothiazide than you should

If you have accidentally taken too many tablets of amlodipine/valsartan/hydrochlorothiazide, consult your doctor immediately. You may need medical attention.

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.

If you forget to take Amlodipine/Valsartan/Hydrochlorothiazide

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, only take the next tablet at the usual time. Do not take a double dose (two tablets at once) to compensate for the missed doses.

If you interrupt treatment with Amlodipine/Valsartan/Hydrochlorothiazide

Stopping your treatment with amlodipine/valsartan/hydrochlorothiazide may cause your condition to worsen. Do not stop taking the medication unless your doctor tells you to.

Always take this medication, 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

As with any combination that contains three active principles, it cannot be ruled out that side effects associated with each individual component may occur. The side effects observed with amlodipino/valsartán/hidroclorotiazida or one of its three active principles (amlodipino, valsartán, and hidroclorotiazida) appear below and may occur with the use of amlodipino/valsartán/hidroclorotiazida

Some side effects may be serious and require immediate medical attention. Consult your doctor immediately if, after taking this medicine, you experience any of the following serious side effects:

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

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

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

• reduced urine production (reduced kidney function)

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

• spontaneous bleeding
• irregular heartbeat
• liver disorder

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

• sudden wheezing, 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, skin redness all over the body, severe itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (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
• acute respiratory difficulty (signs include severe breathing difficulty, fever, weakness, and confusion)

Other side effects may include:

Very frequent (may affect more than 1 in 10 patients)

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

Frequent (may affect up to 1 in 10 patients)

• drowsiness
• palpitations (feeling the heartbeat)
• angina
• swelling of the ankles (edema)
• abdominal pain
• postprandial discomfort
• fatigue
• headache
• frequency of urination
• high uric acid levels in the blood
• low magnesium levels in the blood
• low sodium levels in the blood
• dizziness, dizziness when standing up
• decreased appetite
• nausea and vomiting
• pruritic rash and other types of rash
• inability to achieve or maintain an erection

Infrequent (may affect up to 1 in 100 patients)

• rapid heartbeat
• sensation of everything spinning
• vision disorder
• gastric discomfort
• chest pain
• increased levels of urea nitrogen, 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
• tingling or numbness
• neuropathy
• sudden and transient loss of consciousness
• low blood pressure when standing up
• cough
• shortness of breath
• throat irritation
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• skin redness
• shaking
• mood changes
• anxiety
• depression
• drowsiness
• altered sense of taste
• syncope
• loss of pain sensation
• visual disturbances
• visual deterioration
• tinnitus in the ears
• runny nose/secretion caused by inflammation of the nasal mucosa (rhinitis)
• alteration of bowel habits
• indigestion
• hair loss
• itching of the skin
• skin discoloration
• urinary disorder
• 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 patients)

• low platelet count in the blood (sometimes with bleeding or hematoma under the skin)
• glucose in the urine
• high blood sugar levels
• 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
• purpuric spots on the skin
• kidney disorders
• confusion

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

• decreased white blood cell count
• decreased platelet count in the blood that may cause unusual bruises or easy bleeding (damage to red blood cells)
• gingivitis
• abdominal distension (gastritis)
• hepatitis
• yellow skin discoloration (jaundice)
• increased liver enzymes that may affect some medical tests
• increased muscle tension
• inflammation of blood vessels often with skin eruptions
• light sensitivity
• disorders combining stiffness, tremor, 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-colored urine (hemolytic anemia, abnormal decrease in red blood cells due to rupture in blood vessels or other parts of the body)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe upper abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonitis)
• facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, red-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 unknown (the frequency cannot be estimated from available data)

• alteration of kidney function test results in blood, increased 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
• increased 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 dysfunction or renal insufficiency)
• severe skin disease that causes rash, red skin, blisters on the lips, eyes, or mouth, skin peeling, fever (erythema multiforme)
• muscle spasm
• fever (pyrexia)
• bullous dermatitis (sign of a disease called dermatitis bullosa)
• 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 leaflet. 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 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 conditions for conservation.

Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

Medications should not be thrown down the drains or in the trash. Deposit the packaging and medications that you do not need in the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need.This way, you will help protect the environment.

Composition ofAmlodipino/Valsartán/Hidroclorotiazida pensa

The active principles of this medication are amlodipine (as amlodipine besilate), valsartan, and hydrochlorothiazide.

Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.

The other components are:

Core of the tablet:silicified microcrystalline cellulose, crospovidone, and magnesium stearate.

Coating:Opadry white (II 85F18422) (polyvinyl alcohol, polyethylene glycol/macrogol, titanium dioxide (E171), and talc).

Appearance of the product and content of the container

The Amlodipino/Valsartán/Hidroclorotiazida pensa 5 mg/160 mg/12.5 mg tablets are biconvex, oblong, scored, and white film-coated tablets.

The score is only for breaking and facilitating swallowing, but not for dividing into equal doses

Amlodipino/Valsartán/Hidroclorotiazida pensa isavailable in containers that contain 28 film-coated tablets in perforated dose blister packs.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

LABORATORIOS CINFA, S.A.

C/Olaz Chipi, 10 – Industrial Park Areta

31620 Huarte-Pamplona (Navarra)

Spain

Last review date of this leaflet: December 2024

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/