Amlodipine/atorvastatin Krka 5 mg/10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Amlodipine/Atorvastatin Krka 5 mg/10 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Amlodipine/atorvastatin is used to prevent cardiovascular events (for example, angina, heart attack) in patients with high blood pressure who also have risk factors for cardiovascular disease, such as smoking, overweight, high cholesterol levels in the blood, family history of heart disease, or diabetes. The presence of these risk factors in combination with high blood pressure increases the risk of cardiovascular events.

Amlodipine/atorvastatin is a product containing two active substances, amlodipine (a calcium antagonist) and atorvastatin (a statin), and is used when your doctor considers it appropriate to take both medicines. Amlodipine is used in the treatment of high blood pressure (hypertension), and atorvastatin reduces cholesterol levels.

High blood pressure (hypertension) is a condition in which blood pressure is persistently and abnormally elevated, and is one of the risk factors for cardiovascular events (angina, heart attack, stroke).

Cholesterol is a substance naturally present in the body and necessary for normal growth. However, if there is too much cholesterol in the blood, it can deposit on the walls of blood vessels, increasing the risk of blood clots and cardiovascular events. This is one of the most common causes of heart disease.

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

Do not take Amlodipine/Atorvastatin Krka

• if you are allergic to amlodipine or atorvastatin, or to any other calcium channel blocker, or to any of the other ingredients of this medicine (listed in section 6)
• if you currently have a liver disease (if you have previously had a liver disease, see the section “Warnings and precautions” below)
• if you have had unexplained abnormal results in liver function blood tests
• if you are pregnant, trying to become pregnant, or breastfeeding
• if you are taking any of the following medicines: ketoconazole, itraconazole (medicines used to treat fungal infections), telithromycin (an antibiotic)
• if you have very low blood pressure (hypotension)
• if you have narrowing of the heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply enough blood to the body)
• if you suffer from heart failure following myocardial infarction
• if you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C

Warnings and precautions

Talk to your doctor or pharmacist before taking Amlodipine/Atorvastatin Krka

• if you have severe respiratory failure
• if you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection), taken orally or by injection. The combination of fusidic acid and Amlodipine/Atorvastatin Krka may cause serious muscle problems (rhabdomyolysis)
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have repeated or unexplained muscle pain, or personal or family history of inherited muscle disorders
• if you have previously experienced muscle problems during treatment with other cholesterol-lowering (lipid-lowering) medicines (e.g. medicines with "statins" or "fibrates")
• if you regularly drink large amounts of alcohol
• if you have previously had a liver disease
• if you are over 70 years old
• if you have had a previous stroke with bleeding in the brain, or have small fluid-filled sacs in the brain due to previous strokes
• if you have or have had myasthenia (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

In any of these cases, your doctor may need to perform a blood test before and possibly during treatment with Amlodipine/Atorvastatin Krka to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, e.g. rhabdomyolysis, increases when taken together with certain medicines (see section 2 “Other medicines and Amlodipine/Atorvastatin Krka”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

While taking this medicine, your doctor will monitor you for diabetes or risk of developing diabetes. This risk increases if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.

Children and adolescents

Amlodipine/Atorvastatin Krka is not recommended for use in children and adolescents.

Other medicines and Amlodipine/Atorvastatin Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may interact with Amlodipine/Atorvastatin Krka. This interaction may mean that one or both medicines become less effective. It may also increase the risk or severity of adverse effects, including the serious muscle damage known as rhabdomyolysis and myopathy (described in Section 4):

• Some antibiotics, e.g. rifampicin, fusidic acid, or "macrolide antibiotics", e.g. erythromycin, clarithromycin, telithromycin, or some antifungal medicines, e.g. ketoconazole, itraconazole
• Medicines to control your lipid levels: fibrates (e.g. gemfibrozil) or colestipol
• Medicines to control your heart rhythm, e.g. amiodarone, diltiazem, and verapamil
• Anticonvulsants, e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone
• Medicines used to modify the function of your immune system, e.g. cyclosporine, tacrolimus, sirolimus, temsirolimus, and everolimus
• Medicines such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc., nelfinavir, used in the treatment of HIV infection
• Some medicines used for the treatment of hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus
• Medicines used in the treatment of depression, e.g. nefazodone and imipramine
• Medicines used in the treatment of mental disorders, e.g. neuroleptics
• Medicines for treating heart failure, e.g. beta-blockers
• Medicines for treating high blood pressure, e.g. angiotensin II receptor antagonists, ACE inhibitors, verapamil, and diuretics
• Alpha-blockers used in the treatment of high blood pressure and prostate problems
• Other medicines known to interact with Amlodipine/Atorvastatin Krka include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a painkiller), colchicine (used for treating gout), and antacids (indigestion remedies containing aluminium or magnesium)
• Amifostine (used in cancer treatment)
• Sildenafil (for erectile dysfunction)
• Dantrolene and baclofen (muscle relaxants)
• Steroids
• Cyclosporine (an immunosuppressant)
• Over-the-counter medicines containing St. John’s wort (Hypericum perforatum)
• If you need to take oral fusidic acid to treat a bacterial infection, you will have to stop taking this medicine. Your doctor will advise you when you can restart treatment with Amlodipine/Atorvastatin Krka. Using Amlodipine/Atorvastatin Krka with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria)

Amlodipine/Atorvastatin Krka may lower your blood pressure even more if you are already taking other medicines for high blood pressure.

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Taking Amlodipine/Atorvastatin Krka with food, drinks and alcohol

Amlodipine/Atorvastatin Krka can be taken at any time of day, with or without food.

Grapefruit juice

Do not drink more than one or two glasses of grapefruit juice per day, as large quantities of grapefruit juice may alter the effects of Amlodipine/Atorvastatin Krka.

Alcohol

Avoid drinking large amounts of alcohol while taking Amlodipine/Atorvastatin Krka. See details in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding

Do not take Amlodipine/Atorvastatin Krka if you are pregnant, breastfeeding, or trying to become pregnant. Women of childbearing potential who are taking Amlodipine/Atorvastatin Krka or any other medicine should use appropriate contraceptive measures. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Do not drive or operate machinery if you feel dizzy after taking this medicine.

Amlodipine/Atorvastatin Krka contains sodium

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

3. How to take Amlodipine/Atorvastatin Krka

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Adults

The usual starting dose of amlodipine/atorvastatin for adults is one 5 mg/10 mg tablet daily. If necessary, your doctor may increase the dose to one daily tablet of amlodipine/atorvastatin 10 mg/10 mg.

Amlodipine/atorvastatin tablets should be swallowed whole with a little water. The tablets may be taken orally at any time of day, with or without food. However, try to take your tablet at the same time every day.

Follow your doctor's dietary recommendations, especially regarding dietary fat restriction, smoking cessation, and regular exercise.

If you feel that the effect of amlodipine/atorvastatin tablets is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

This medicine is not recommended for children and adolescents.

If you take more Amlodipine/Atorvastatin Krka than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount ingested. Bring any remaining tablets, the outer carton, and the full pack so that hospital staff can easily identify the medicine you have taken.

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/Atorvastatin Krka

If you forget to take a dose, take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

If you stop taking Amlodipine/Atorvastatin Krka

Do not stop taking amlodipine/atorvastatin unless instructed by your doctor.

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

4. Possible adverse effects

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

If any of the following occur, stop taking Amlodipine/Atorvastatin Krka and inform your doctor immediately:

• swelling of the face, tongue, or airways, which may cause severe breathing difficulties,
• unexplained muscle weakness, muscle pain upon palpation, muscle pain or tearing, or change in urine color to red-brown, together with feeling unwell or having a fever. (Very rarely, this combination of effects may lead to a serious, potentially fatal condition called rhabdomyolysis),
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Very common adverse effects, which may affect more than 1 in 10 people, include:

• swelling of arms, hands, legs, joints, or feet.

Common adverse effects, which may affect up to 1 in 10 people, include:

• allergic reaction,
• headache (especially at the beginning of treatment), dizziness, feeling of fatigue, somnolence,
• irregular heartbeat, flushing,
• palpitations (abnormal awareness of heartbeat), difficulty breathing,
• nasal inflammation, sore throat, nosebleeds,
• feeling unwell, abdominal pain, indigestion, changes in bowel habits (including diarrhea, constipation, and flatulence),
• muscle and joint pain, muscle cramps and spasms, back pain, limb pain, muscle fatigue,
• increased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully), increased creatine kinase in blood, blood test results indicating that your liver function may become abnormal,
• vision problems (including double vision), blurred vision.

Uncommon adverse effects, which may affect up to 1 in 100 people, include:

• hepatitis (liver inflammation),
• runny nose, loss of appetite, decreased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully), weight gain or weight loss,
• difficulty sleeping, nightmares, mood changes (including anxiety), depression, tremor, sensory nerve disturbances (reduced sensitivity) in arms and legs, memory loss,
• ringing or buzzing in the ears,
• weakness, increased sweating, low blood pressure,
• dry mouth, taste disturbances, vomiting, belching,
• hair loss, bruising or small spots on the skin, skin discoloration, reduced skin sensitivity to touch or pain, numbness or tingling in fingers and toes, skin rash, hives, or itching,
• urinary disorders (including excessive urination at night and increased urinary frequency), impotence, abnormal breast development in men,
• feeling unwell, pancreatitis (inflammation of the pancreas causing stomach pain), pain, neck pain, chest pain,
• positive urine tests for white blood cells,
• abnormal heart rhythm,
• cough.

Rare adverse effects, which may affect up to 1 in 1,000 people, include:

• unexpected bleeding or bruising,
• severe muscle inflammation, intense muscle pain or cramps, muscle tearing, which very rarely may lead to rhabdomyolysis (destruction of muscle cells), and abnormal muscle breakdown. Abnormal muscle breakdown does not always resolve even after stopping this medicine and may be potentially fatal and lead to kidney problems,
• decreased platelet count in blood,
• liver disorders (yellowing of the skin and whites of the eyes),
• severe allergic skin reactions, skin redness, blistering rash, skin peeling that may rapidly spread to the rest of the body, which may begin with flu-like symptoms accompanied by high fever (toxic epidermal necrolysis), swelling of the deeper layers of the skin – including swelling of the lips, eyelids, and tongue,
• inflammation or swelling of skeletal muscle, blistering rash, sudden and severe skin swelling in one area,
• tendon inflammation, tendon injury,
• confusion,
• skin rash or mouth ulcers (drug-induced lichenoid reaction).

Very rare adverse effects, which may affect up to 1 in 10,000 people, include:

• allergic reaction – symptoms may include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse,
• reduced white blood cell count,
• increased muscle tone or stiffness,
• heart attack, inflammation of small blood vessels, stomach pain (gastritis),
• gum overgrowth, bleeding gums,
• hearing loss, liver failure,
• photosensitivity (skin sensitivity to light).

Adverse effects with unknown frequency: frequency cannot be estimated from available data:

• persistent muscle weakness,
• sexual difficulties,
• respiratory problems such as persistent cough and/or difficulty breathing or fever,
• movement disorders combining stiffness, tremor, and/or movement disturbances,
• diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• myasthenia gravis (a condition causing generalized muscle weakness, which in some cases affects muscles used for breathing),
• ocular myasthenia (a condition causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs, double vision, drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, 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 Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine/Atorvastatin Krka

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

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

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Amlodipine/Atorvastatin Krka

• The active substances are amlodipine and atorvastatin. Each tablet contains 5 mg of amlodipine (as amlodipine besilate) and 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
• Other components are:

Tablet core

polysorbate 80, calcium carbonate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, pregelatinized starch (from maize), magnesium stearate and colloidal anhydrous silica. See section 2 “Amlodipine/Atorvastatin Krka contains sodium”.

Film coating

hypromellose (6 cp), titanium dioxide (E171), talc and propylene glycol (E1520)

Appearance of the product and contents of the pack

Amlodipine/Atorvastatin Krka 5 mg/10 mg film-coated tablets are white, round, biconvex, film-coated tablets with bevelled edges. Tablet dimensions: approximately 6 mm.

The tablets are available in boxes of 10, 14, 20, 28, 30, 50, 56, 60, 90 and 100 tablets in blisters.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

For more information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

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

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

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