Package Leaflet: Information for the Patient

Amlodipino/Atorvastatina Krka 5 mg/10 mg Film-Coated Tablets

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to yours, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Amlodipino/atorvastatina is used to prevent cardiovascular events (for example, angina pectoris, myocardial infarction) in patients with high blood pressure and who also have risk factors for cardiovascular disease, such as smoking, overweight, high levels of cholesterol in the blood, family history of heart disease or diabetes. The presence of these risk factors associated with high blood pressure makes patients more likely to suffer cardiovascular events.

Amlodipino/atorvastatina is a product that contains two active principles, amlodipino (calcium antagonist) and atorvastatina (statin) and is used when your doctor considers it appropriate to take both medications. Amlodipino is used in the treatment of high blood pressure (hypertension) and atorvastatina reduces cholesterol levels.

High blood pressure (hypertension) is a disease in which the blood pressure is permanently elevated in an abnormal manner and is one of the risk factors for suffering cardiovascular events (angina pectoris, myocardial infarction, cerebrovascular accident).

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

Do not take Amlodipino/Atorvastatina Krka

• if you are allergic to amlodipine or atorvastatin or to any other calcium channel blocker or to any of the other components of this medicine (listed in section 6)
• if you currently have a liver disease (if in the past you had a liver disease, see the section “Warnings and precautions” below)
• if you have had unjustified 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 or mycoses), telithromycin (an antibiotic)
• if you have low blood pressure (hypotension)
• if you have aortic stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition where the heart is unable to provide enough blood to the body)
• if you suffer from heart failure after a myocardial infarction
• if you use the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C

Warnings and precautions

Consult your doctor or pharmacist before taking Amlodipino/Atorvastatina Krka

• if you have severe respiratory failure
• if you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections), by mouth or by injection. The combination of fusidic acid and Amlodipino/Atorvastatina Krka may cause severe muscle problems (rhabdomyolysis)
• if you have kidney problems
• if you have hypothyroidism (low thyroid function)
• if you have repeated or unjustified muscle pain, personal or family history of hereditary muscle problems
• if you have had muscle problems during treatment with other medicines to reduce cholesterol (lipids) (e.g. medicines with “statins” or “fibrates”)
• if you regularly drink large amounts of alcohol
• if in the past you 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 embolisms in the brain due to previous strokes
• if you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4)

In any of these cases, your doctor will need to perform a blood test before and possibly during treatment with Amlodipino/Atorvastatina Krka, to calculate the risk of muscle side effects. It is known that the risk of muscle side effects, e.g. rhabdomyolysis, increases when taken at the same time as certain medicines (see section 2 “Other medicines and Amlodipino/Atorvastatina Krka”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be necessary to diagnose and treat this problem.

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

Children and adolescents

Amlodipino/Atorvastatina Krka is not recommended for use in children and adolescents.

Other medicines and Amlodipino/Atorvastatina Krka

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. There are some medicines that may interact with Amlodipino/Atorvastatina Krka. This interaction may involve that one or both medicines are less effective. It may also increase the risk or severity of side effects, including the important muscle deterioration 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 medicines to treat fungal infections, e.g. ketoconazole, itraconazole
• Medicines to control your lipid levels: fibrates (e.g. gemfibrozil) or cholestyramine
• 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 functioning of your immune system, e.g. ciclosporin, tacrolimus, sirolimus, temsirolimus and everolimus
• Medicines, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc., nelfinavir, used in the treatment of HIV infection
• Some medicines used to treat hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Letermovir, a medicine that helps to prevent diseases caused by cytomegalovirus
• Medicines used to treat depression, e.g. nefazodone and imipramine
• Medicines used in the treatment of mental disorders, e.g. neuroleptics
• Medicines to treat heart failure, e.g. beta blockers
• Medicines to treat 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 that are known to interact with Amlodipino/Atorvastatina Krka include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (anticonvulsant for epilepsy), cimetidine (used for heartburn and stomach ulcers), phenazone (a painkiller), colchicine (used for gout) and antacids (products for indigestion containing aluminium or magnesium)
• Amifostine (used to treat cancer)
• Sildenafil (for erectile dysfunction)
• Dantrolene and baclofen (muscle relaxants
• Stroids
• Ciclosporin (an immunosuppressant)
• Over-the-counter medicines containing St. John's Wort (Hypericum perforatum)
• If you have to take fusidic acid orally to treat a bacterial infection, you will have to stop taking this medicine. Your doctor will tell you when you can restart the treatment with Amlodipino/Atorvastatina Krka. The use of Amlodipino/Atorvastatina Krka with fusidic acid may cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Amlodipino/Atorvastatina Krka may reduce your blood pressure even more if you are already taking other medicines to treat high blood pressure.

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

Taking Amlodipino/Atorvastatina Krka with food, drinks and alcohol

Amlodipino/Atorvastatina Krka can be taken at any time of the day, with or without food.

Orange juice

Do not drink more than one or two glasses of orange juice per day because in large quantities orange juice may alter the effects of Amlodipino/Atorvastatina Krka.

Alcohol

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

Pregnancy and breastfeeding

Do not take Amlodipino/Atorvastatina Krka if you are pregnant, breastfeeding or trying to become pregnant.When taking Amlodipino/Atorvastatina Krka or any other medicine, women of childbearing age should take the necessary contraceptive measures. Consult your doctor or pharmacist before usinganymedicine.

Driving and operating machinery

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

Amlodipino/Atorvastatina Krka contains sodium

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

Followexactlytheadministrationinstructionsforthismedicationasprescribedbyyourdoctor.Incaseofdoubt,consultyourdoctororpharmacistagain.

Adults

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

Amlodipino/atorvastatina tablets should be swallowed whole with a little water. Tablets can be taken orally at any time of the 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, quitting smoking, and regular exercise.

If you think the effect of amlodipino/atorvastatina tablets is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

This medication is not recommended for children and adolescents.

If you take more Amlodipino/Atorvastatina Krka than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested. Bring the remaining tablets, the packaging, and the complete box so that hospital staff can easily identify the medication taken.

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

If you forgot to take Amlodipino/Atorvastatina Krka

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

If you interrupt treatment with Amlodipino/Atorvastatina Krka

Do not stop taking amlodipino/atorvastatina unless your doctor tells you to.

If you have any other questions about using this medication or want to discontinue treatment, ask your doctor or pharmacist.

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

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

• swelling of the face, tongue, and areas of the body that may cause great difficulty breathing,
• if you have, unexplained muscle weakness, muscle pain on palpation, pain or rupture in the muscles or a change in the color of the urine to brown-red and at the same time you feel unwell or have a fever. (Very rarely, this combination of side effects can be a potentially fatal serious disease called rhabdomyolysis),
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Very common side effects, which can affect more than 1 in 10 people, include:

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

Common side effects, which can affect up to 1 in 10 people, include:

• allergic reaction,

• headache (especially at the beginning of treatment), dizziness, feeling of fatigue, drowsiness,
• irregular heartbeat, flushing,

• palpitations (abnormal sensation of the heartbeat),difficulty breathing,
• inflammation of the nasal passages, sore throat, nasal bleeding,
• sensation of discomfort, abdominal pain, indigestion, change in bowel habits (including diarrhea, constipation, and flatulence),
• muscle and joint pain, cramps, and spasms, back pain, pain in the limbs, muscle fatigue,
• increase in blood sugar levels (if you have diabetes, continue to monitor your blood sugar levels carefully), increase in creatine kinase in the blood, abnormal liver function test results,

abnormal heart rhythm,

-cough.

Rare side effects, which can affect up to 1 in 100 people, include:

• hepatitis (inflammation of the liver),
• runny nose, loss of appetite, decrease in blood sugar levels (if you have diabetes, continue to monitor your blood sugar levels carefully), weight gain or loss,
• difficulty sleeping, with nightmares, changes in mood (including anxiety), depression, tremor, sensory nerve damage (decreased sensitivity) of the arms and legs, memory loss,
• ringing or buzzing in the ears,
• weakness, increased sweating, low blood pressure,
• dry mouth, taste alterations, vomiting, belching,
• hair loss, bruises or small spots on the skin, skin color change, decreased skin sensitivity to touch or pain, numbness or tingling in the fingers of the hands and feet, skin rash, urticaria or itching,
• urinary disorders (including nocturia and increased frequency of urination), impotence, abnormal breast development in men,
• sensation of discomfort, pancreatitis (inflammation of the pancreas that causes abdominal pain), pain, neck pain, chest pain,
• positive urine tests for white blood cells in the blood,

abnormal heart rhythm,

-cough.

Very rare side effects, which can affect up to 1 in 10,000 people, include:

• allergic reaction - symptoms may include sudden hissing sounds while breathing and chest pain or oppression, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse,
• reduction of white blood cells in the blood,
• increase in muscle tension,
• heart attack, inflammation of small blood vessels, stomach pain (gastritis),
• gum growth, gum bleeding
• hearing loss, liver insufficiency,
• photosensitivity (sensitivity of the skin to light),

Side effects of unknown frequency: the frequency cannot be estimated from the available data:

• constant muscle weakness,
• sexual difficulties
• respiratory problems such as persistent cough and/or difficulty breathing or fever
• disorders that combine stiffness, tremor, and/or movement disorders

• diabetes. This is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medicine,
• myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing),
• myasthenia ocular (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from moisture.

Medications should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at 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. By doing so, you will help protect the environment.

Composition of Amlodipino/Atorvastatina Krka

• The active ingredients are amlodipino and atorvastatina. Each tablet contains 5 mg of amlodipino (as besilato de amlodipino) and 10 mg of atorvastatina (as atorvastatina cálcica trihidratada).
• The other components are:

Tablet core

polisorbato 80, calcium carbonate, croscarmelosa de sodio, hidroxipropilcelulosa, celulosa microcristalina, pregelatinized cornstarch, magnesium stearate and anhydrous colloidal silica. See section 2 “Amlodipino/Atorvastatina Krka contains sodium”.

Coating

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

Appearance of the product and contents of the package

The film-coated tablets of Amlodipino/Atorvastatina Krka 5 mg/10 mg are white, round, biconvex tablets, coated with a film, with beveled edges.Dimensions of the tablet: approximately 6 mm.

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

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

For more 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 medicinal productis authorized in the Member States of the European Economic Area with the following names:

Last revision date of this leaflet:June 2023

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