AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE KRKA 10 mg/160 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Amlodipine/Valsartan/Hydrochlorothiazide Krka 5 mg/160 mg/12.5 mg film-coated tablets EFG

Amlodipine/Valsartan/Hydrochlorothiazide Krka 5 mg/160 mg/25 mg film-coated tablets EFG

Amlodipine/Valsartan/Hydrochlorothiazide Krka 10 mg/160 mg/12.5 mg film-coated tablets EFG

Amlodipine/Valsartan/Hydrochlorothiazide Krka 10 mg/160 mg/25 mg film-coated tablets EFG

Amlodipine/Valsartan/Hydrochlorothiazide Krka 10 mg/320 mg/25 mg film-coated tablets EFG

amlodipine/valsartan/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Amlodipine/Valsartan/Hydrochlorothiazide Krka is and what it is used for
2. What you need to know before you take Amlodipine/Valsartan/Hydrochlorothiazide Krka
3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Krka
4. Possible side effects
5. Storage of Amlodipine/Valsartan/Hydrochlorothiazide Krka
6. Pack contents and further information

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

Amlodipine/Valsartan/Hydrochlorothiazide Krka film-coated tablets contain three active substances called amlodipine, valsartan, and hydrochlorothiazide. All these substances help to control high blood pressure.

• Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine prevents calcium from entering the blood vessel wall, which prevents the blood vessels from narrowing.
• Valsartan belongs to a group of substances called “angiotensin II receptor antagonists”. Angiotensin II is produced by the body and makes the blood vessels narrow, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II.
• Hydrochlorothiazide belongs to a group of substances known as “thiazide diuretics”. Hydrochlorothiazide increases urine production, which also lowers blood pressure.

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

Amlodipine/Valsartan/Hydrochlorothiazide Krka is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan, and hydrochlorothiazide and who can benefit from taking a single tablet that contains the three substances.

2. What you need to know before you take Amlodipine/Valsartan/Hydrochlorothiazide Krka

Do not take Amlodipine/Valsartan/Hydrochlorothiazide Krka

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking Amlodipine/Valsartan/Hydrochlorothiazide Krka also at the beginning of your pregnancy - see section Pregnancy).
• 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 (included in section 6). If you think you may be allergic, do not take Amlodipine/Valsartan/Hydrochlorothiazide Krka and inform your doctor.

• if you have liver disease, destruction of the small bile ducts within 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 blood potassium or sodium levels.
• if your blood calcium levels are too high despite treatment to reduce blood calcium levels.

• if you have gout (uric acid crystals in the joints).
• if you have severe low blood pressure (hypotension).
• if you have 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 failure and are being treated with a blood pressure-lowering medication that contains aliskiren.

Do not take Amlodipine/Valsartan/Hydrochlorothiazide Krka and inform your doctor if any of the above applies to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amlodipine/Valsartan/Hydrochlorothiazide Krka

• if you have low blood potassium or magnesium levels (with or without symptoms such as muscle weakness, muscle spasms, irregular heartbeat).
• if you have low blood sodium levels (with or without symptoms such as fatigue, confusion, muscle contractions, convulsions).
• if you have high blood calcium levels (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 had a kidney transplant, or have been informed that you have narrowing of the arteries of the kidney.
• if you have liver problems.
• if you have or have had heart failure or coronary artery disease, in particular if you have been prescribed the maximum dose of Amlodipine/Valsartan/Hydrochlorothiazide Krka (10 mg/320 mg/25 mg).
• if you have had a heart attack. Follow your doctor's instructions to carefully start the dosage. Your doctor may also check your kidney function.
• if your doctor has informed you that you have narrowing of the heart valves (so-called “aortic or mitral stenosis”) or that the thickness of your heart muscle has increased abnormally (so-called “hypertrophic cardiomyopathy”).
• if you suffer from aldosteronism. A disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of Amlodipine/Valsartan/Hydrochlorothiazide Krka is not recommended.
• if you suffer from systemic lupus erythematosus (also known as “lupus” or “SLE”).
• if you have diabetes (high blood sugar levels).
• if you have high cholesterol or triglyceride levels in the blood.
• if you experience skin reactions such as rash after sun exposure.
• if you have had an allergic reaction to other blood pressure medications or diuretics (a type of medication also known as “water pills”), 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 Amlodipine/Valsartan/Hydrochlorothiazide Krka and contact your doctor immediately. You should never take Amlodipine/Valsartan/Hydrochlorothiazide Krka again.
• if you experience dizziness and/or fainting during treatment with Amlodipine/Valsartan/Hydrochlorothiazide Krka, inform your doctor as soon as possible.
• if you experience decreased vision or eye pain. These can be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and can occur within hours to weeks of administration of Amlodipine/Valsartan/Hydrochlorothiazide Krka. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it.

• if you are taking any of the following medications used to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor (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. Treatment with hydrochlorothiazide, in particular 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 and UV exposure while taking Amlodipine/Valsartan/Hydrochlorothiazide Krka.
• If you have had respiratory or lung 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 Amlodipine/Valsartan/Hydrochlorothiazide Krka, seek medical attention immediately.

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

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

See also the information under the heading “Do not take Amlodipine/Valsartan/Hydrochlorothiazide Krka”.

Tell your doctor if any of the above applies to you.

Children and adolescents

Amlodipine/Valsartan/Hydrochlorothiazide Krka is not recommended for use in children and adolescents under 18 years of age.

Elderly patients (65 years and older)

Amlodipine/Valsartan/Hydrochlorothiazide Krka can be used in patients 65 years and older at the same dose as used in other adults and in the same way as they have previously taken the three substances called amlodipine, valsartan, and hydrochlorothiazide. The blood pressure of elderly patients should be monitored periodically, especially those taking the maximum dose of Amlodipine/Valsartan/Hydrochlorothiazide Krka (10 mg/320 mg/25 mg).

Other medicines and Amlodipine/Valsartan/Hydrochlorothiazide Krka

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Your doctor may need to change your dose and/or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially important if you are using any of the following medicines:

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 that contain potassium, potassium-sparing medications, and heparin;
• an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Amlodipine/Valsartan/Hydrochlorothiazide Krka” and “Warnings and precautions”.

Should be used 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 viral diseases);
• anticholinergic medications (medications used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia);
• anticonvulsant and mood-stabilizing medications used to treat epilepsy and bipolar disorder (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, or other resins (substances used primarily to treat high lipid levels in the blood);
• simvastatin (a medication used to control high cholesterol levels);
• cyclosporine (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 procedures);
• medications for treating diabetes (oral medications such as metformin or insulins);
• medications for treating gout, such as allopurinol;
• medications that may increase blood sugar levels (beta-blockers, diazoxide);
• medications that may induce “torsade de pointes” (irregular heartbeat), such as antiarrhythmics (medications used to treat heart problems) and some antipsychotics;
• medications that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics;
• medications that may reduce blood potassium levels, such as diuretics (water pills), corticosteroids, laxatives, amphotericin, or penicillin G;
• medications used to increase blood pressure, such as adrenaline or noradrenaline;
• medications used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
• medications used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medications used to treat esophageal inflammation and ulcers (carbenoxolone);
• medications used to relieve pain or inflammation, especially nonsteroidal anti-inflammatory medications (NSAIDs), including selective cyclooxygenase-2 (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 body temperature abnormalities);
• vitamin D and calcium salts.

Taking Amlodipine/Valsartan/Hydrochlorothiazide Krka with food, drinks, and alcohol

Patients who have been prescribed Amlodipine/Valsartan/Hydrochlorothiazide Krka should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure-lowering effects of Amlodipine/Valsartan/Hydrochlorothiazide Krka. Consult your doctor before drinking alcohol. Alcohol can significantly lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking Amlodipine/Valsartan/Hydrochlorothiazide Krka before you become pregnant or as soon as you find out you are pregnant, and recommend that you take another blood pressure medication instead. Amlodipine/Valsartan/Hydrochlorothiazide Krka is not recommended during the first trimester of pregnancy and should not be used after the third month of pregnancy as it may cause serious harm to your baby when administered after this time.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. It has been shown that amlodipine passes into breast milk in small amounts. Amlodipine/Valsartan/Hydrochlorothiazide Krka is not recommended for use in breastfeeding women. Your doctor may decide to prescribe a treatment that is more suitable if you wish to breastfeed, especially newborns or premature babies.

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

This medication may make you feel dizzy, sleepy, nauseous, or have a headache. If you experience these symptoms, do not drive or use tools or machines.

Amlodipine/Valsartan/Hydrochlorothiazide Krka contains sodium

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

3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Krka

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

The normal dose of Amlodipine/Valsartan/Hydrochlorothiazide Krka is one tablet per day.

• Swallow the tablet whole with a glass of water.
• You can take Amlodipine/Valsartan/Hydrochlorothiazide Krka with or without food. Do not take Amlodipine/Valsartan/Hydrochlorothiazide Krka 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 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 Toxicology 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 can develop up to 24-48 hours after ingestion.

If you forget to take Amlodipine/Valsartan/Hydrochlorothiazide 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 not take a double dose (two tablets at the same time) to make up for forgotten doses.

If you stop treatment with Amlodipine/Valsartan/Hydrochlorothiazide Krka

Stopping your treatment with Amlodipine/Valsartan/Hydrochlorothiazide Krka 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

Hypertensive people 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 indicated to achieve 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

As with any combination that contains three active ingredients, the side effects associated with each individual component cannot be excluded. The side effects observed with Amlodipine/Valsartan/Hydrochlorothiazide Krka or one of its three active ingredients (amlodipine, valsartan, and hydrochlorothiazide) are listed below and may occur with the use of Amlodipine/Valsartan/Hydrochlorothiazide Krka.

Some side effects can be serious and require immediate medical attention.

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

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

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

Uncommon(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 wheezing, chest pain, shortness of breath or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat that causes great difficulty breathing
• severe skin reactions that include intense rash, hives, redness of the skin 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 a great feeling of discomfort
• weakness, bruising, fever, and frequent infections
• stiffness

Other side effects may include:

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

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

Frequent (may affect up to 1 in 10 patients)

• drowsiness
• palpitations (feeling the heartbeat)
• hot flashes
• swelling of the ankles (edema)
• abdominal pain
• stomach discomfort after eating
• fatigue
• headache
• frequent 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
• itchy rash and other types of rash
• inability to achieve or maintain an erection

Uncommon (may affect up to 1 in 100 patients)

• rapid heartbeat
• feeling that everything is spinning
• vision disorder
• stomach discomfort
• chest pain
• increased 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
• cramps/weakness/pain in the muscles
• pain in the limbs
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness when standing up or after exercising
• lack of energy
• sleep disturbances
• tingling or numbness
• neuropathy
• sudden 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
• redness of the skin
• tremor
• mood changes
• anxiety
• depression
• drowsiness
• taste disturbances
• fainting
• loss of pain sensation
• visual disturbances
• visual impairment
• ringing in the ears
• sneezing/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
• 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 bruising under the skin)
• sugar in the urine
• high blood sugar levels
• worsening of diabetic metabolic condition
• abdominal discomfort
• constipation
• liver disorders that may present with yellowing of the skin and eyes, or darkening of the urine (hemolytic anemia)
• increased sensitivity of the skin to the sun
• purplish spots on the skin
• kidney disorders
• confusion

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

• decrease in the number of white blood cells in the blood
• decrease in blood platelets that can cause unusual bruising or easy bleeding (damage to red blood cells)
• inflammation of the gums
• abdominal swelling (gastritis)
• inflammation of the liver (hepatitis)
• yellowing of the skin (jaundice)
• increase in liver enzymes that can affect some medical tests
• increase in muscle tension
• inflammation of blood vessels often with skin rashes
• sensitivity to light
• 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 urine (hemolytic anemia, abnormal decrease in red blood cells both in blood vessels and in 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 spots, fever (vasculitis)
• severe skin disease that causes rash, red skin, blisters on the lips, eyes, or mouth, peeling of the skin, fever (toxic epidermal necrolysis)
• acute respiratory difficulty (signs include severe respiratory difficulty, fever, weakness, and confusion)
• intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• alteration of kidney function test results in blood, increased potassium in the blood, low red blood cell count
• abnormal red blood cell count
• low levels of a certain type of white blood cell and platelets in the blood
• increased creatinine in the blood
• abnormal liver function test
• significant decrease in urine production
• inflammation of blood vessels
• weakness, bruising, and frequent infections (aplastic anemia)
• decreased vision or eye pain due to high eye pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• shortness of breath
• severe decrease in urine production (possible signs of kidney disorder or kidney failure)
• severe skin disease that causes rash, red skin, blisters on the lips, eyes, or mouth, peeling of the skin, fever (erythema multiforme)
• muscle spasm
• fever (pyrexia)
• blistering skin disease (sign of a disease called bullous dermatitis)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Amlodipine/Valsartan/Hydrochlorothiazide Krka

Keep this medication out of 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 storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Contents and Additional Information

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 besylate), 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 besylate), 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 besylate), 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 besylate), 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 besylate), 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 tablet core and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, red iron oxide (E172) - in the coating of 10 mg/160 mg/12.5 mg and 10 mg/320 mg/25 mg film-coated tablets, and yellow iron oxide (E172) - in the coating of 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.

Product Appearance and Packaging Contents

5 mg/160 mg/12.5 mg:

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

10 mg/160 mg/25 mg:

Film-coated tablets, brownish yellow, oval, biconvex with the engraving "K4" on one side 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 packs 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 calendar blisters.

Not all pack sizes may be marketed.

Marketing Authorisation 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

You can request more information about this medicinal product by contacting the local representative of the marketing authorisation holder:

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

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

Date of last revision of this leaflet:April 2025

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