Leaflet: information for the user

Amlodipine/Valsartan/Hydrochlorothiazide STADA 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, 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

1.What is Amlodipine/Valsartan/Hydrochlorothiazide Stada and what is it used for

2.What you need to know before you start taking Amlodipine/Valsartan/Hydrochlorothiazide Stada

3.How to take Amlodipine/Valsartan/Hydrochlorothiazide Stada

4.Possible side effects

5.Storage of Amlodipine/Valsartan/Hydrochlorothiazide Stada

6.Contents of the pack and additional information

Amlodipino/Valsartán/Hidroclorotiazida Stada tablets contain 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 increasing 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 decreases 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 that contains the three substances.

Do not takeAmlodipino/Valsartán/HidroclorotiazidaStada

• 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 antagonist, valsartán, hidroclorotiazida, sulfonamide-derived medications (medications used to treat chest or urinary tract infections), or to any of the other components of this medication (listed 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 (crystals of uric acid in the joints).
• if you have severe low blood pressure (hypotension).
• if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a situation 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 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 Amlodipino/Valsartán/Hidroclorotiazida Stada:

• 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, convulsions).
• 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 if you have been informed that you suffer from narrowing of the kidney arteries.
• 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 (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 your doctor has informed you that you suffer from narrowing of the heart valves (known as "aortic or mitral stenosis") or that the thickness of your heart muscle has increased abnormally (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 amlodipino/valsartán/hidroclorotiazida is not recommended.
• if you suffer from 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 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 amlodipino/valsartán/hidroclorotiazida and contact your doctor immediately. You should never take amlodipino/valsartán/hidroclorotiazida 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 vascular layer of the eye (choroidal hemorrhage) or increased intraocular pressure and may appear within hours to weeks of administering amlodipino/valsartán/hidroclorotiazida. If not treated, this can cause permanent vision loss. You may be at greater risk of developing this if you have had an allergy to penicillin or sulfonamides.
• 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 severe shortness of breath or difficulty breathing after taking amlodipino/valsartán/hidroclorotiazida, see your doctor immediately.

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 Amlodipino/Valsartán/Hidroclorotiazida Stada".

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.

Inform your doctorif 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 aged 6 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 function should be monitored periodically in elderly patients, particularly those taking the maximum dose of amlodipino/valsartán/hidroclorotiazida (10 mg/320 mg/25 mg).

Other medications and Amlodipino/Valsartán/Hidroclorotiazida Stada

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 modify 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 the amount of potassium 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 Stada" and "Warnings and precautions").

Use with caution with:

• alcohol, sleeping pills, and anesthetics;
• 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);
• iodinated contrast media (agents used in imaging studies);
• 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 and some antipsychotics;
• medications that may reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics;
• medications that may reduce the amount of potassium in the blood, 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 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 nitrates, or other substances called "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 perfusion for severe temperature abnormalities);
• vitamin D and calcium salts.

Taking Amlodipino/Valsartán/Hidroclorotiazida Stada 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 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

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 serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctorifyou are planning to start or are currently breastfeeding. Amlodipino has been shown to pass into breast milk in small amounts. Amlodipino/valsartán/hidroclorotiazida is not recommended for use during this period. Your doctor may decide to administer a treatment that is more suitable 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, you may feel dizzy, drowsy, nauseous, or experience headaches while taking amlodipino/valsartán/hidroclorotiazida. If you experience these symptoms, do not drive or operate tools or machinery.

Use in athletes

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

Amlodipino/Valsartán/Hidroclorotiazida Stada contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this 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..

Dosage

• The recommended dose of amlodipine/valsartan/hydrochlorothiazide isone tabletper day.

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

Do not exceed the prescribed dose.

Administration Form

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

If you take more Amlodipino/Valsartán/Hidroclorotiazida Stadathan 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 difficulty breathing that may develop up to 24-48 hours after ingestion.

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

If you forgot to take Amlodipino/Valsartán/Hidroclorotiazida Stada

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 make up for the missed doses.

If you interrupt the treatment with Amlodipino/Valsartán/Hidroclorotiazida Stada

Stoppingyour treatment withamlodipine/valsartan/hydrochlorothiazide may cause your disease to worsen. Do not stop taking the medicationunless 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 are fine. It is very important that you take this medication exactly as your doctor has indicated 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 doubts 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 severe and require immediate medical attention.

Consult your doctor immediately if, after taking this medicine, 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)

Less frequent (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):

• sudden hissing sounds while breathing (sudden sibilance), 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, skin peeling, skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• heart attack
• pancreatitis that may cause severe abdominal pain and back pain accompanied by a feeling of great 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 people):

• low potassium levels in the blood
• increased blood lipids

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

• drowsiness
• palpitations(feeling the heartbeat)
• angina
• swelling of the ankles (edema)
• abdominal pain
• postprandial gastritis
• 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
• pruritus and other types of rash
• inability to achieve or maintain an erection

Less frequent (may affect up to 1 in 100 people):

• rapid heart rate
• sensation that everything is spinning
• vision disorder
• gastritis
• chest pain
• increased urea, creatinine, and uric acid in the blood
• high calcium, lipid, or sodium levels 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
• trembling
• changes in mood
• anxiety
• depression
• drowsiness
• altered sense of taste
• syncope
• loss of pain sensation
• visual disturbances
• visual deterioration
• tinnitus in the ears
• runny nose and nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• alteration of bowel habits
• indigestion
• hair loss
• itching of the skin
• skin discoloration
• urination disorder
• increased need to urinate at night
• increased frequency of urination
• discomfort or enlargement of the breasts 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 hematoma under the skin)
• glucose 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
• purpuric skin lesions
• kidney disorders
• confusion

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

• decreased white blood cell count
• low platelet count in the blood that may cause unusual bruises or easy bleeding (damage to red blood cells)
• gingivitis
• abdominal swelling (gastritis)
• hepatitis
• yellow skin discoloration (jaundice)
• increased liver enzymes that may affect some medical tests
• muscle tension
• inflammation of blood vessels often with skin eruptions
• light sensitivity
• movement disorders combining stiffness, trembling, and/or movement disorders
• fever, shortness of breath, or sore throat, increased frequency of infections (low or very low white blood cell count)
• skin pale, fatigue, shortness of breath, dark-colored 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 upper abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, sibilance, 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 not known (the frequency cannot be estimated from available data):

• abnormal results of kidney function tests in the 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
• 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)
• bullous dermatitis (sign of a disease called dermatitis bullosa)
• skin cancer and lip cancer (non-melanoma skin cancer)

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through the Spanish System for 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.

Store below 30°C.

Store in the original packaging to protect it from moisture.

Medicines should not be thrown into the drains or trash.Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need.This will help protect the environment.

Composition of Amlodipino/Valsartán/Hidroclorotiazida Stada

The active principles are amlodipine, 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: microcrystalline cellulose (E460); povidone K30 (E1201); anhydrous colloidal silica (E551); sodium carboxymethylcellulose (type A) (E468) (derived from potato starch); magnesium stearate (E470b); crospovidone (E1202); pregelatinized cornstarch; hypromellose 2910 (E464); macrogol 6000 (E1521), and titanium dioxide (E171).

Appearance of the product and contents of the package

The film-coated tablets of Amlodipino/Valsartán/Hidroclorotiazida Stada 5 mg/160 mg/12.5 mg are biconvex, oval, white in color, approximately 15.6 mm in length, and approximately 6.2 mm in width.

Amlodipino/Valsartán/Hidroclorotiazida Stada is available in packages containing blisters of 28, 30, 60, 90, 98, 100, 105, or 120 film-coated tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2 – 18,

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2,

1190 Wien

Austria

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: February 2025

The detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/