Package Leaflet: Information for the Patient

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

Amlodipino/Valsartán/Hidroclorotiazida Krka 5 mg/160 mg/25 mg Film-Coated Tablets

Amlodipino/Valsartán/Hidroclorotiazida Krka 10 mg/160 mg/12,5 mg Film-Coated Tablets

Amlodipino/Valsartán/Hidroclorotiazida Krka 10 mg/160 mg/25 mg Film-Coated Tablets

Amlodipino/Valsartán/Hidroclorotiazida Krka 10 mg/320 mg/25 mg Film-Coated Tablets

amlodipino/valsartán/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. 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.

1.What isAmlodipino/Valsartán/Hidroclorotiazida Krkaand what it is used for

2.What you need to know before starting to takeAmlodipino/Valsartán/Hidroclorotiazida Krka

3.How to takeAmlodipino/Valsartán/Hidroclorotiazida Krka

4.Possible side effects

5.Storage ofAmlodipino/Valsartán/Hidroclorotiazida Krka

6.Contents of the pack and additional information

Amlodipino/Valsartán/Hidroclorotiazida Krka 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 lowers blood pressure.

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

Amlodipino/Valsartán/Hidroclorotiazida Krka 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 Krka

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking Amlodipino/Valsartán/Hidroclorotiazida Krka also at the beginning of your pregnancy - see Pregnancy section).
• if you are allergic to amlodipine or any other calcium channel blocker, valsartan, hydrochlorothiazide, sulfonamide-derived medications (medications used to treat chest or urinary tract infections), or 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 Krka 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 Krka 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 Krka

• 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, 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 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 Krka (10 mg/320 mg/25 mg).
• if you have had a heart attack. Follow your doctor's instructions to start taking the medication carefully. Your doctor may also check your renal function.
• if your doctor has informed you that you have a narrowing of the heart valves (which is called "aortic or mitral stenosis") or that the thickness of your heart muscle has increased abnormally (which is called "hypertrophic obstructive cardiomyopathy").
• if you have aldosteronism. A disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of Amlodipino/Valsartán/Hidroclorotiazida Krka 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 after exposure to the sun.
• if you have had an allergic reaction to other medications for high blood pressure or diuretics (a type of medication also known as "urine medications"), 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 Krka and contact your doctor immediately. Never take Amlodipino/Valsartán/Hidroclorotiazida Krka again.
• if you experience dizziness and/or fainting during treatment with Amlodipino/Valsartán/Hidroclorotiazida Krka, 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 effusion) or an increase in intraocular pressure and may appear within hours to weeks of administration of Amlodipino/Valsartán/Hidroclorotiazida Krka. If not treated, this can cause permanent loss of vision. If you have previously had an allergy to penicillin or sulfonamide, you may have 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.
  • aliskiren.

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, 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 Krka.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Amlodipino/Valsartán/Hidroclorotiazida Krka, go to your doctor immediately.

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

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

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

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

Children and adolescents

Amlodipino/Valsartán/Hidroclorotiazida Krka is not recommended for use in children or adolescents under 18 years old.

Older adults (65 years and older)

Amlodipino/Valsartán/Hidroclorotiazida Krka can 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 amlodipine, valsartan, and hydrochlorothiazide. Renal function should be monitored periodically in elderly patients, particularly those taking the maximum dose of Amlodipino/Valsartán/Hidroclorotiazida Krka (10 mg/320 mg/25 mg).

Other medications and Amlodipino/Valsartán/Hidroclorotiazida Krka

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 the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin;
• an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Amlodipino/Valsartán/Hidroclorotiazida Krka" 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 levels of cholesterol);
• 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 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, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John's Wort;
• dantrolene (in infusion for severe abnormalities of body temperature);
• vitamin D and calcium salts.

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

People who have been prescribed Amlodipino/Valsartán/Hidroclorotiazida Krka 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 amlodipine, which may cause unpredictable reductions in the blood pressure-lowering effects of Amlodipino/Valsartán/Hidroclorotiazida Krka. 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

Inform your doctor if 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 Krka before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Amlodipino/Valsartán/Hidroclorotiazida Krka 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 doctor if you are or plan to start breastfeeding.Amlodipine has been shown to pass into breast milk in small amounts.Amlodipino/Valsartán/Hidroclorotiazida Krka 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

This medication may make you feel dizzy, drowsy, nauseous, or experience headaches. If you experience these symptoms, do not drive or use tools or machines.

Amlodipino/Valsartán/Hidroclorotiazida Krka contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per coated tablet; it is essentially "sodium-free".

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

The normal dose of Amlodipino/Valsartán/Hidroclorotiazida Krka isone tablet per 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 Amlodipino/Valsartán/Hidroclorotiazida Krka with or without food. Do not take Amlodipino/Valsartán/Hidroclorotiazida Krka 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 Krka than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or go to the nearest hospital immediately, or call the Toxicological Information Service. Phone: 91 562 04 20 indicating the medication and the amount ingested.

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

If you forget to take Amlodipino/Valsartán/Hidroclorotiazida Krka

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 nottake a double dose (two tablets at once) to compensate for the missed doses.

If you interrupt treatment with Amlodipino/Valsartán/Hidroclorotiazida Krka

Stopping your treatment with Amlodipino/Valsartán/Hidroclorotiazida Krka 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.

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 Krka or one of its three active principles (amlodipino, valsartán, and hidroclorotiazida) appear below and may occur with the use of Amlodipino/Valsartán/Hidroclorotiazida Krka.

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):

• decreased 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 onset of 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, severe itching, blistering, peeling, and skin 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 severe discomfort
• weakness, bruises, fever, and frequent infections
• stiffness

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)
• headaches
• swelling of the ankles (edema)
• abdominal pain
• discomfort after eating
• fatigue
• headaches
• frequent urination
• high levels of uric acid in the blood
• low levels of magnesium in the blood
• low levels of sodium in the blood
• dizziness, dizziness when standing up
• decreased appetite
• nausea and vomiting
• skin rash with itching and other types of rash
• difficulty achieving or maintaining an erection

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

• rapid heartbeat
• sensation of spinning
• vision disorder
• stomach discomfort
• chest pain
• increased levels of nitrogen, creatinine, and uric acid in the blood
• high levels of calcium, lipids, or sodium in the blood
• low levels of potassium 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 limbs
• difficulty standing or walking 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 on 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
• feeling of 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
• emergence 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 patches 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 swelling (gastritis)
• liver inflammation (hepatitis)
• yellow discoloration of the skin (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, shaking, 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 and other parts of the body)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe pain in the upper abdomen (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 patches, fever (vasculitis)
• severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)
• acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion)
• intestinal angioedema: swelling in the intestine that is accompanied by 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, 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
• important 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)
• bullous dermatitis (sign of a disease called dermatitis bullosa)
• cancer of the skin and lips (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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: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.

Medicines should not be thrown down the drains or in the trash. Dispose of 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 Amlodipine/Valsartan/Hydrochlorothiazide Krka

• The active ingredients of Amlodipine/Valsartan/Hydrochlorothiazide Krka are amlodipine, valsartan, and hydrochlorothiazide.

5 mg/160 mg/12.5 mg:

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

5 mg/160 mg/25 mg:

Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.

10 mg/160 mg/12.5 mg:

Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.

10 mg/160 mg/25 mg:

Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.

10 mg/320 mg/25 mg:

Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besilate), 320 mg of valsartan, and 25 mg of hydrochlorothiazide.

• The other components (excipients) are: microcrystalline cellulose, povidone K25, sodium croscarmellose, sodium lauryl sulfate, mannitol, anhydrous colloidal silica; magnesium stearate (E470b) in the core of the tablet and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, iron oxide red (E172) - in the coating of the 10 mg/160 mg/12.5 mg and 10 mg/320 mg/25 mg film-coated tablets and iron oxide yellow (E172) - in the coating of the 5 mg/160 mg/25 mg and 10 mg/160 mg/25 mg film-coated tablets. See section 2 “Amlodipine/Valsartan/Hydrochlorothiazide Krka” contains sodium.

Appearance of the product and contents of the package

5 mg/160 mg/12.5 mg:

Film-coated tablets, white or almost white, oval, biconvex with the engraving “K1” on one face and smooth on the other. The dimensions are approximately 13x8 mm.

5 mg/160 mg/25 mg:

Film-coated tablets, pale yellow, oval, biconvex with the engraving “K3” on one face and smooth on the other. The dimensions are approximately 13x8 mm.

10 mg/160 mg/12.5 mg:

Film-coated tablets, pink, oval, biconvex with the engraving “K2” on one face and smooth on the other. The dimensions are approximately 13x8 mm.

10 mg/160 mg/25 mg:

Film-coated tablets, yellow-brown, oval, biconvex with the engraving “K4” on one face and smooth on the other. The dimensions are approximately 13x8 mm.

10 mg/320 mg/25 mg:

Film-coated tablets, reddish-brown, oval, and biconvex. The dimensions are approximately 18x9 mm.

Amlodipine/Valsartan/Hydrochlorothiazide Krka is available in packages of:

• 7, 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, and 100 x 1 film-coated tablets in blisters.
• 7, 14, 28, 56, 84, 98, 7 x 1, 14 x 1, 28 x 1, 56 x 1, 84 x 1, and 98 x 1 film-coated tablets in blisters, in calendarized blisters.

Not all package sizes may be marketed.

Marketing Authorization Holder

KRKA d.d. Novo mesto, Šmarješka cesta 6 8501 Novo mesto, Slovenia

Manufacturer

KRKA d.d. Novo mesto, Šmarješka cesta 6 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann Straße 5, 27472 Cuxhaven, Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Last revision date of this leaflet:April 2025

For detailed information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/