Amlodipine/valsartan Krka 10 mg/160 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Amlodipine/Valsartan Krka tablets contain two substances called amlodipine and valsartan. Both 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.

This means that both substances help prevent the narrowing of blood vessels. As a result, blood vessels relax and blood pressure decreases.

Amlodipine/Valsartan Krka is used to treat high blood pressure in adults whose blood pressure is not adequately controlled by amlodipine or valsartan alone.

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

Do not take Amlodipine/Valsartan Krka:

• if you are allergic to amlodipine or to any other calcium channel blocker. This may include itching, skin redness, or difficulty breathing.
• if you are allergic to valsartan or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, inform your doctor before taking Amlodipine/Valsartan Krka.
• if you have severe liver problems or biliary disorders such as biliary cirrhosis or cholestasis.
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy; see Pregnancy section.)
• if you have severely 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 high blood sugar levels and have type 2 diabetes (also called non-insulin-dependent diabetes mellitus) or have impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor before starting Amlodipine/Valsartan Krka:

• if you have been ill (with vomiting or diarrhoea).
• if you have liver or kidney problems.
• if you have had a kidney transplant or if you have been told you have narrowing of the arteries to your kidneys.
• if you have a disease affecting the adrenal glands called "primary hyperaldosteronism".
• if you have had heart failure or a heart attack. Follow your doctor's instructions carefully when starting treatment. Your doctor may also check your kidney function.
• if your doctor has told you that you have narrowing of the heart valves (called "aortic or mitral stenosis") or that the thickness of your heart muscle has increased abnormally (called "obstructive hypertrophic cardiomyopathy").
• if you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you get these symptoms, stop taking Amlodipine/Valsartan Krka and contact your doctor immediately. You must never take Amlodipine/Valsartan Krka again.
• if you are taking any of the following medicines 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.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.

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

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

Tell your doctor before taking Amlodipine/Valsartan Krka if any of the above conditions apply to you.

Children and adolescents

The use of Amlodipine/Valsartan Krka is not recommended in children and adolescents (under 18 years of age).

Taking Amlodipine/Valsartan Krka with other medicines

Tell 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 for the following medicines:

• an ACE inhibitor or aliskiren (see also information under the headings “Do not take Amlodipine/Valsartan Krka” and “Warnings and precautions”);
• diuretics (a type of medicine that increases urine production);
• lithium (a medicine used to treat certain types of depression);
• potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other substances that may increase potassium levels;
• certain types of pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors). Your doctor may also monitor your kidney function;
• anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John’s wort;
• nitroglycerin and other nitrates, or other substances called "vasodilators";
• medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
• antibiotics (medicines used to treat bacterial infections) such as rifampicin, erythromycin, clarithromycin, telithromycin;
• verapamil, diltiazem (heart medicines);
• simvastatin (a medicine used to control high cholesterol levels);
• dantrolene (intravenous infusion for severe abnormalities in body temperature);
• medicines used to prevent transplant rejection (cyclosporine, tacrolimus).

Taking Amlodipine/Valsartan Krka with food and drink

People taking Amlodipine/Valsartan Krka must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can increase blood levels of the active substance amlodipine, which may cause an unpredictable increase in the blood pressure-lowering effects of Amlodipine/Valsartan Krka.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking Amlodipine/Valsartan Krka before becoming pregnant or as soon as you become pregnant, and will recommend an alternative antihypertensive medicine. Amlodipine/Valsartan Krka is not recommended during early pregnancy (first 3 months) and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from this stage.

Breastfeeding

It has been shown that amlodipine passes into breast milk in small amounts. Inform your doctor if you are breastfeeding or plan to breastfeed, as Amlodipine/Valsartan Krka is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable for you if you wish to breastfeed, especially if your baby is a newborn or premature.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine may make you feel dizzy, which could affect your ability to concentrate. Therefore, if you are unsure how this medicine affects you, do not drive, operate machinery, or perform any activities requiring concentration.

Amlodipine/Valsartan Krka contains sodium

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

3. How to take Amlodipine/Valsartan Krka

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

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

• It is preferable to take the medicine at the same time each day.
• Swallow the tablets with a glass of water.
• You may take Amlodipine/Valsartan Krka with or without food. Do not take Amlodipine/Valsartan 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.

Amlodipine/Valsartan Krka and elderly patients (65 years of age or older)

Your doctor should exercise caution when increasing your dose.

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

If you take more Amlodipine/Valsartan Krka than you should

If you have taken too many Amlodipine/Valsartan Krka tablets, or if someone else has taken your tablets, contact a doctor immediately.

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 Krka

If you forget to take your medicine, take it as soon as you remember. Then take your next dose at the usual time. However, if it is almost time for your next dose, do not take the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Amlodipine/Valsartan Krka

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

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

4. Possible adverse effects

Like all medicines, Amlodipine/Valsartán Krka may produce adverse effects, although not everyone experiences them.

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

A small number of patients have experienced these serious adverse effects (may affect up to 1 in 1,000 patients). If you notice any of the following, inform your doctor immediately:

Allergic reaction with symptoms such as rash, itching, swelling of the face, lips or tongue, difficulty breathing, low blood pressure (feeling faint, dizziness).

Other possible adverse effects of Amlodipine/Valsartán Krka:

Common (may affect up to 1 in 10 patients): Flu; nasal congestion, sore throat and discomfort when swallowing; headache; swelling in the arms, hands, legs, ankles or feet; fatigue; asthenia (weakness); flushing and warmth of the face and/or neck.

Uncommon (may affect up to 1 in 100 patients): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness in the hands or feet; vertigo, rapid heartbeat including palpitations; dizziness upon standing; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; joint pain.

Rare (may affect up to 1 in 1,000 patients): Feeling of anxiety; ringing in the ears (tinnitus); fainting; increased amount of urine or urgent need to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, lightheadedness; excessive sweating; rash all over the body, itching, muscle spasms. Tell your doctor if any of the mentioned effects affect you severely.

Adverse effects reported with amlodipine or valsartan alone, not observed with Amlodipine/Valsartán Krka or observed with higher frequency than with Amlodipine/Valsartán Krka:

Amlodipine

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

• 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 difficulty breathing.
• Severe skin reactions including severe rash, hives, redness of the skin all over the body, intense itching, blistering, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, irregular heartbeat.
• Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a marked feeling of malaise.

The following adverse effects have been reported. If any of these cause problems or last longer than one week, consult your doctor.

Common (may affect up to 1 in 10 patients): Dizziness, drowsiness; palpitations (awareness of heartbeat); hot flushes, swelling of the ankles (oedema); abdominal pain, feeling unwell (nausea).

Uncommon (may affect up to 1 in 100 patients): Mood changes, anxiety, depression, drowsiness, tremor, taste disturbances, fainting, loss of pain sensation; visual disturbances, impaired vision, ringing in the ears; low blood pressure; sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (feeling unwell); hair loss, increased sweating, skin itching, skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; inability to achieve an erection, discomfort or enlargement of the breasts in men, pain, malaise, muscle pain, muscle cramps; weight gain or weight loss.

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

Very rare (may affect up to 1 in 10,000 patients): Decrease in white blood cells, decrease in blood platelets which may cause easy bleeding or unusual bruising (damage to red blood cells); high blood sugar (hyperglycaemia); gum inflammation, abdominal swelling (gastritis); abnormal liver function, 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, photosensitivity; disorders combining stiffness, tremor and/or movement disorders.

Frequency not known (cannot be estimated from available data): tremor, rigid posture, mask-like facial expression, slow movements and shuffling gait with imbalance.

Valsartan

Very rare (may affect up to 1 in 10,000 patients): Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency not known (frequency cannot be estimated from available data): Decrease in red blood cells, fever, sore throat or mouth ulcers due to infection; spontaneous skin bleeding or bruising; increased potassium levels in blood; abnormal liver function tests; reduced kidney function and severely reduced kidney function; swelling, mainly of the face and throat; muscle pain; skin rash, purplish red spots; fever; itching; allergic reaction, blistering skin disease (sign of a condition called bullous dermatitis).

If you experience any of the cases mentioned, consult your doctor immediately.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine/Valsartan Krka

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

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

6. Contents of the pack and other information

Composition of Amlodipine/Valsartan Krka

• The active substances are Amlodipine and Valsartan 10 mg / 160 mg film-coated tablets:

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

• The other components are microcrystalline cellulose, magnesium stearate, sodium croscarmellose, povidone K25, sodium lauryl sulfate, mannitol and anhydrous colloidal silica in the tablet core; and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, talc, yellow iron oxide (E172) in the coating.

See section 2: “Amlodipine/Valsartan Krka contains sodium”

Nature of the medicinal product and content of the pack

Amlodipine/Valsartan Krka 10 mg/160 mg film-coated tablets (tablets): this medicine is presented as pale yellow-brown, oval, biconvex film-coated tablets (tablet diameter: 13x8 mm, thickness: 3.8 mm-5.4 mm).

Tablets 5 mg/160 mg and 10 mg/160 mg: Blister (OPA/Alu/PVC-Alu foil laminates): 28, 30, 56, 90, 98 and 100 tablets in a box.

Only some 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-Str. 5, 27472 Cuxhaven, Germany

Krka-farma d.o.o., V. Holjevca 20/E, 10 450 Jastrebarsko, Croatia

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, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the EEA Member States under the following names:

Date of the last revision of this leaflet: June 2025

Detailed and up-to-date 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/)