Amlodipine/valsartan/hydrochlorothiazide Krka 10 mg/320 mg/25 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

Please read all of this leaflet carefully before you start taking this medicine, as 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 pass it on to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Amlodipine/Valsartan/Hydrochlorothiazide Krka is and what it is used for
2. What you need to know before taking Amlodipine/Valsartan/Hydrochlorothiazide Krka
3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Krka
4. Possible side effects
5. How to store Amlodipine/Valsartan/Hydrochlorothiazide Krka
6. Contents of the pack and other information

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

Amlodipine/Valsartan/Hydrochlorothiazide Krka tablets contain three substances called amlodipine, valsartan, and hydrochlorothiazide. All of these substances help control high blood pressure.

• Amlodipine belongs to a group of substances known as "calcium channel blockers". Amlodipine prevents calcium from entering the blood vessel wall, thereby preventing blood vessels from narrowing.
• Valsartan belongs to a group of substances known as "angiotensin II receptor antagonists". Angiotensin II is produced by the body and causes blood vessels to 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 these three mechanisms, blood vessels relax and blood pressure is reduced.

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 separately, and who may benefit from taking a single tablet containing the three substances.

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

Do not take Amlodipine/Valsartan/Hydrochlorothiazide Krka

• if you are more than 3 months pregnant. (In any case, Amlodipine/Valsartan/Hydrochlorothiazide Krka is recommended to be avoided also during early pregnancy – see Pregnancy section).

• if you are allergic to amlodipine or any other calcium channel blocker, valsartan, hydrochlorothiazide, sulphonamide-derived medicines (medicines used to treat chest or urinary tract infections), or to any of the other ingredients of this medicine (listed 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 (primary biliary cirrhosis) leading to bile accumulation in the liver (cholestasis).

• if you have severe kidney problems or 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 narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart cannot supply enough blood to the body).

• if you have heart failure following a heart attack.

• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Consult your doctor or pharmacist before taking Amlodipine/Valsartan/Hydrochlorothiazide Krka

• if you have low levels of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle cramps, irregular heartbeat).

• if you have low levels of sodium in your blood (with or without symptoms such as fatigue, confusion, muscle twitching, seizures).

• if you have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle spasms, and muscle weakness).

• if you have kidney problems, have had a kidney transplant, or have been told you have narrowing of the arteries to the kidneys.

• if you have liver problems.

• if you have or have had heart failure or coronary artery disease, especially 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 carefully when starting treatment. Your doctor may also monitor your kidney function.

• if your doctor has informed you that you have narrowing of the heart valves (called “aortic or mitral stenosis”) or abnormal thickening of your heart muscle (called “obstructive hypertrophic cardiomyopathy”).

• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of Amlodipine/Valsartan/Hydrochlorothiazide Krka is not recommended.

• if you have systemic lupus erythematosus (also known as “lupus” or “SLE”).

• if you have diabetes (high blood sugar).

• if you have high cholesterol or triglyceride levels in your blood.

• if you experience skin reactions such as rash after sun exposure.

• if you have had an allergic reaction to other high blood pressure medicines or diuretics (a type of medicine also known as “water pills”), especially if you have 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 medicines (including angiotensin-converting enzyme inhibitors). If you have these symptoms, stop taking Amlodipine/Valsartan/Hydrochlorothiazide Krka and contact your doctor immediately. You must 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 vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours to weeks after taking Amlodipine/Valsartan/Hydrochlorothiazide Krka. If left untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulphonamides, you may have an increased risk of developing this condition.

• if you are taking any of the following medicines for high blood pressure:

• • an angiotensin-converting enzyme inhibitor (ACEI) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.

• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from sun and UV exposure while taking Amlodipine/Valsartan/Hydrochlorothiazide Krka.

• If you have had breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking Amlodipine/Valsartan/Hydrochlorothiazide Krka, see your doctor immediately.

Your doctor may monitor 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”.

Inform your doctor if any of the above conditions apply to you.

Children and adolescents

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

Elderly people (65 years and older)

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

Other medicines and Amlodipine/Valsartan/Hydrochlorothiazide Krka

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. 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 medicines. This is especially important if you are taking any of the following medicines:

Do not take together with:

• lithium (a medicine used to treat certain types of depression);
• medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• an ACE inhibitor or aliskiren (see also 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 (medicines for patients undergoing surgery or other procedures);
• amantadine (treatment for Parkinson’s disease, also used to treat or prevent certain viral illnesses);
• anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anesthesia);
• anticonvulsant and mood-stabilizing medicines used to treat epilepsy and bipolar disorder (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, or other resins (substances mainly used to treat high blood lipid levels);
• simvastatin (a medicine used to control high cholesterol);
• cyclosporine (a medicine used in transplant patients to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis);
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (medicines used to treat heart problems);
• verapamil, diltiazem (heart medicines);
• iodinated contrast agents (substances used in imaging scans);
• medicines for diabetes (oral medicines such as metformin or insulin);
• medicines for gout, such as allopurinol;
• medicines that may increase blood sugar levels (beta-blockers, diazoxide);
• medicines that may cause “torsade de pointes” (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics;
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics;
• medicines that may reduce blood potassium levels, such as diuretics (“water pills”), corticosteroids, laxatives, amphotericin, or penicillin G;
• medicines to increase blood pressure, such as adrenaline or noradrenaline;
• medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
• medicines used for inflammation and ulceration of the esophagus (carbenoxolone);
• medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
• muscle relaxants (medicines used to relax muscles during surgery);
• nitroglycerin and other nitrates, or other substances called “vasodilators”;
• other medicines used to treat high blood pressure, including methyldopa;
• rifampicin (used, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John’s wort;
• dantrolene (administered by infusion for serious body temperature abnormalities);
• tacrolimus (used to control the body’s immune response to allow acceptance of a transplanted organ);
• vitamin D and calcium salts.

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

People prescribed Amlodipine/Valsartan/Hydrochlorothiazide Krka should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effect of Amlodipine/Valsartan/Hydrochlorothiazide Krka. Consult your doctor before drinking alcohol. Alcohol may greatly lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking Amlodipine/Valsartan/Hydrochlorothiazide Krka before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Use of Amlodipine/Valsartan/Hydrochlorothiazide Krka is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are or plan to breastfeed. Amlodipine has been shown to pass into breast milk in small amounts. Administration of Amlodipine/Valsartan/Hydrochlorothiazide Krka to women during breastfeeding is not recommended. Your doctor may decide to prescribe a treatment more suitable for breastfeeding, especially if the infant is a newborn or premature.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

This medicine may make you feel dizzy, drowsy, nauseous, or cause headache. If you experience these symptoms, do not drive or operate tools or machinery.

Amlodipine/Valsartan/Hydrochlorothiazide Krka contains sodium

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

3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Krka

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. This will help you achieve the best results and reduce the risk of adverse effects.

The usual dose of Amlodipine/Valsartan/Hydrochlorothiazide Krka is one tablet daily.

• It is best to take the tablet at the same time each day. The best time is in the morning.
• Swallow the tablet whole with a glass of water.
• You may 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 recommend 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 immediately to the nearest hospital, or call the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Amlodipine/Valsartan/Hydrochlorothiazide Krka

If you forget to take a dose of this medicine, take it as soon as you remember, and then take the next dose at your usual time. If it is almost time for your next dose, take only the next tablet at the usual time. Do not take a double dose (two tablets at once) to make up for forgotten doses.

If you stop taking Amlodipine/Valsartan/Hydrochlorothiazide Krka

Stopping your treatment with Amlodipine/Valsartan/Hydrochlorothiazide Krka may cause your condition to worsen. Do not stop taking the medicine unless your doctor tells you to.

Keep taking this medicine, even if you feel well

People with high blood pressure often do not notice any symptoms of their condition. Many feel well. It is very important that you take this medicine exactly as your doctor has instructed to achieve the best results and reduce the risk of adverse effects. Continue attending your doctor's appointments even if you feel well.

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

4. Possible adverse effects

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

As with any combination containing three active substances, adverse effects associated with each individual component cannot be excluded. The adverse effects observed with Amlodipine/Valsartan/Hydrochlorothiazide Krka or with one of its three active ingredients (amlodipine, valsartan, and hydrochlorothiazide) are listed below and may occur when using Amlodipine/Valsartan/Hydrochlorothiazide Krka.

Some adverse effects may be serious and require immediate medical attention.

Contact your doctor immediately if, after taking this medicine, you experience any of the following serious adverse effects:

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

• dizziness
• low blood pressure (feeling faint, 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 causing severe breathing difficulty
• severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blistering, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• heart attack
• inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a strong feeling of malaise
• weakness, bruising, fever and frequent infections
• stiffness

Other adverse effects may include:

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

• low potassium levels in blood
• increased blood lipids

Common (may affect up to 1 in 10 patients)

• drowsiness
• palpitations (awareness of heartbeat)
• hot flushes
• swelling of the ankles (edema)
• abdominal pain
• stomach discomfort after eating
• fatigue
• headache
• frequent urination
• high uric acid levels in blood
• low magnesium levels in blood
• low sodium levels in blood
• dizziness, dizziness upon standing
• 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
• sensation of spinning (vertigo)
• vision disorders
• stomach discomfort
• chest pain
• increased blood urea nitrogen, creatinine, and uric acid
• high levels of calcium, lipids, or sodium in blood
• decreased potassium in blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered sense of taste
• back pain
• joint swelling
• muscle cramps, weakness, or pain
• limb pain
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness upon standing or after exercise
• shortness of breath
• throat irritation
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• skin redness
• tremor
• mood changes
• anxiety
• depression
• drowsiness
• taste disturbances
• fainting
• loss of pain sensation
• visual disturbances
• visual impairment
• ringing in the ears (tinnitus)
• sneezing, nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• changes in bowel habits
• indigestion
• hair loss
• skin itching
• skin discoloration
• urinary disorders
• increased need to urinate at night
• increased frequency of urination
• discomfort or enlargement of breasts in men
• pain
• feeling unwell
• weight loss

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

• low platelet count in blood (sometimes with bleeding or bruising under the skin)
• sugar in urine
• high blood sugar levels
• worsening of diabetic metabolic state
• abdominal discomfort
• constipation
• liver disorders, which may present with yellowing of the skin and eyes or dark-colored urine (hemolytic anemia)
• increased sensitivity of the skin to sunlight
• purplish spots on the skin
• kidney disorders
• confusion

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

• decreased number of white blood cells in blood
• decreased platelets in blood which may cause unusual bruising or easy bleeding (damage to red blood cells)
• gum inflammation
• abdominal swelling (gastritis)
• inflammation of the liver (hepatitis)
• yellowing of the skin (jaundice)
• increased liver enzymes, which may affect certain medical tests
• increased muscle tension
• inflammation of blood vessels, often with skin rashes
• 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 urine (hemolytic anemia, abnormal reduction due to breakdown of red blood cells both in blood vessels and other body parts)
• confusion, fatigue, muscle cramps and spasms, rapid breathing (hypochloremic alkalosis)
• severe pain in the upper stomach (inflammation of the pancreas)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonitis)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)
• severe skin disease causing rash, red skin, blisters on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion)
• intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• alteration in blood test results for kidney function, increased potassium in blood, low red blood cell count
• abnormal red blood cell count
• low levels of certain types of white blood cells and platelets in blood
• increased creatinine in 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 intraocular pressure (possible signs of fluid accumulation in the eye's vascular layer (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 causing rash, red skin, blisters on lips, eyes or mouth, skin peeling, fever (erythema multiforme)
• muscle spasm
• fever (pyrexia)
• blistering skin disease (sign of a condition called bullous dermatitis)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine/Valsartan/Hydrochlorothiazide Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container and blister pack after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine/Valsartan/Hydrochlorothiazide Krka

• The active substances in Amlodipine/Valsartan/Hydrochlorothiazide Krka are amlodipine, valsartan and hydrochlorothiazide.

5 mg/160 mg/12.5 mg:

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

5 mg/160 mg/25 mg:

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

10 mg/160 mg/12.5 mg:

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

10 mg/160 mg/25 mg:

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

10 mg/320 mg/25 mg:

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

• The other components (excipients) are: microcrystalline cellulose, povidone K25, croscarmellose sodium, sodium lauryl sulfate, mannitol, anhydrous colloidal silica; magnesium stearate (E470b) in the tablet core; and in the coating: 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; 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.

Nature of the product and pack contents

5 mg/160 mg/12.5 mg:

Film-coated tablets, white or almost white, oval-shaped, biconvex, with the imprint “K1” on one side and smooth on the other. Dimensions are approximately 13x8 mm.

5 mg/160 mg/25 mg:

Film-coated tablets, pale yellow, oval-shaped, biconvex, with the imprint “K3” on one side and smooth on the other. Dimensions are approximately 13x8 mm.

10 mg/160 mg/12.5 mg:

Film-coated tablets, pink, oval-shaped, biconvex, with the imprint “K2” on one side and smooth on the other. Dimensions are approximately 13x8 mm.

10 mg/160 mg/25 mg:

Film-coated tablets, pale brown, oval-shaped, biconvex, with the imprint “K4” on one side and smooth on the other. Dimensions are approximately 13x8 mm.

10 mg/320 mg/25 mg:

Film-coated tablets, reddish-brown, oval-shaped and biconvex. 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 blister packs.
• 7, 14, 28, 56, 84, 98, 7 x 1, 14 x 1, 28 x 1, 56 x 1, 84 x 1, 98 x 1 film-coated tablets in blister packs, in calendar blister packs.

Not all pack 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 more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

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

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

Date of the most recent review of this leaflet: February 2026

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