AMLODIPINE/ATORVASTATIN KRKA 5 mg/10 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

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

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

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

Amlodipine/atorvastatin is used to prevent cardiovascular events (such as angina pectoris, heart attack) in patients with high blood pressure and who also have risk factors for cardiovascular disease, such as smoking, being overweight, high cholesterol levels 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.

Amlodipine/atorvastatin is a product that contains 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 to treat high blood pressure (hypertension) and atorvastatin reduces cholesterol levels.

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

Cholesterol is a substance that is naturally found in the body and is 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 forming and suffering cardiovascular events. This is one of the most common causes of heart disease.

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

Do not take Amlodipine/Atorvastatin Krka

• if you are allergic to amlodipine or atorvastatin or any other calcium channel blocker or to any of the other ingredients of this medicine (listed in section 6)
• if you currently have a disease that affects the liver (if in the past you had a disease that affected the liver, see below in the "Warnings and precautions" section)
• if you have had unexplained abnormal results in blood tests for liver function
• 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 valve (aortic stenosis) or cardiogenic shock (a situation where the heart is unable to provide enough blood to the body)
• if you have heart failure after a heart attack
• if you use the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C

Warnings and precautions

Consult your doctor or pharmacist before taking Amlodipine/Atorvastatin Krka

• if you have severe respiratory failure
• if you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections), orally or by injection. The combination of fusidic acid and Amlodipine/Atorvastatin Krka can 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, personal or family history of muscle problems
• if you have had muscle problems in the past while taking other cholesterol-lowering medicines (e.g., statins or fibrates)
• if you regularly drink large amounts of alcohol
• if you have had liver disease in the past
• 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 that causes generalized muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).

In any of these cases, your doctor will need to perform a blood test before and possibly during treatment with Amlodipine/Atorvastatin 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 with certain medicines (see section 2 "Other medicines and Amlodipine/Atorvastatin Krka").

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medicines may be necessary to diagnose and treat this problem.

While taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fat in the 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 take any other medicines. There are some medicines that can interact with Amlodipine/Atorvastatin Krka. This interaction can mean that one or both medicines are less effective. It can also increase the risk or severity of side effects, including the important 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 medicines for treating fungal infections, e.g., ketoconazole, itraconazole
• Medicines for controlling your lipid levels: fibrates (e.g., gemfibrozil) or colestipol
• Medicines for controlling your heart rate, 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., 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 in 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 that are known to interact with Amlodipine/Atorvastatin Krka include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a pain reliever), colchicine (used for gout), and antacids (products for indigestion that contain aluminum or magnesium)
• Amifostine (used in cancer treatment)
• Sildenafil (for erectile dysfunction)
• Dantrolene and baclofen (muscle relaxants)
• Corticosteroids
• Cyclosporine (an immunosuppressant)
• Medicines without a prescription that contain St. John's Wort (Hypericum perforatum)
• If you have to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine. Your doctor will tell you when you can restart treatment with Amlodipine/Atorvastatin Krka. The use of Amlodipine/Atorvastatin Krka with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

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

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

Taking Amlodipine/Atorvastatin Krka with food, drinks, and alcohol

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

Grapefruit juice

Do not drink more than one or two glasses of grapefruit juice per day because large amounts of grapefruit juice can alter the effects of Amlodipine/Atorvastatin Krka.

Alcohol

Avoid drinking too much alcohol while taking Amlodipine/Atorvastatin Krka. See the details in the "Warnings and precautions" section.

Pregnancy and breastfeeding

Do not take Amlodipine/Atorvastatin Krka if you are pregnant, breastfeeding, or trying to become pregnant. When taking Amlodipine/Atorvastatin Krka or any other medicine, women of childbearing age must take adequate 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; this is essentially "sodium-free".

3. How to take Amlodipine/Atorvastatin Krka

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

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

Amlodipine/atorvastatin should be swallowed whole, with a little water. The 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 fat restriction in the diet, quitting smoking, and regular exercise.

If you think the effect of the amlodipine/atorvastatin tablets is too strong or too weak, tell 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 915620420, indicating the medicine and the amount taken. Bring the remaining tablets, the package, and the complete box so that hospital staff can easily identify the medicine you have taken.

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/Atorvastatin 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 forgotten doses.

If you stop taking Amlodipine/Atorvastatin Krka

Do not stop taking amlodipine/atorvastatin unless your doctor tells you to.

If you have any further questions on the use of this medicine or want to stop treatment, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• swelling of the face, tongue, and airways that can cause great difficulty in breathing,
• if you have unexplained muscle weakness, muscle pain on palpation, muscle pain or rupture, or a change in urine color to reddish-brown, and at the same time, you feel unwell or have a fever. (Very rarely, this combination of effects can become a potentially life-threatening disease 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 sensation of heartbeat), difficulty breathing,
• inflammation of the nasal passages, sore throat, nosebleeds,
• feeling of discomfort, abdominal pain, indigestion, changes in bowel habits (including diarrhea, constipation, and flatulence),
• pain in muscles and joints, muscle cramps and spasms, back pain, pain in the limbs, muscle fatigue,
• increase in blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels), increase in creatine kinase in the blood, blood test results showing 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 (inflammation of the liver),
• runny nose, loss of appetite, decrease in blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels), weight gain or loss,
• difficulty sleeping, with nightmares, mood changes (including anxiety), depression, tremors, nervous system disorders (decreased sensitivity) of the 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 color changes, decreased skin sensitivity to touch or pain, numbness or tingling in the fingers and toes, skin rash, hives or itching,
• urinary disorders (including excessive urination at night and increased frequency of urination), impotence, abnormal breast development in men,
• feeling of discomfort, pancreatitis (inflammation of the pancreas that causes 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, very intense muscle pain or cramps, muscle rupture that can very rarely lead to rhabdomyolysis (destruction of muscle cells), and abnormal muscle degradation. Abnormal muscle degradation does not always disappear, even after stopping this medication, and can be potentially life-threatening and cause kidney problems,
• decrease in platelet count in the blood,
• liver disorders (yellowing of the skin and whites of the eyes),

• severe allergic skin reactions, skin redness, blistering rash, skin peeling that can spread rapidly to the rest of the body and may start with symptoms such as those of the flu, accompanied by high fever (toxic epidermal necrolysis) inflammation of the deep layers of the skin - including inflammation of the lips, eyelids, and tongue,
• tendon inflammation, tendon injury,
• confusion.

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

• allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse,
• reduction of white blood cell levels in the blood,
• increased muscle tension or stiffness,
• heart attack, inflammation of small blood vessels, stomach pain (gastritis),
• gum growth, gum bleeding
• hearing loss, liver failure,
• photosensitivity (skin sensitivity to light),

Adverse 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, tremors, and/or movement disorders

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

Reporting of Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that are not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Amlodipine/Atorvastatin Krka

• The active ingredients are amlodipine and atorvastatin. Each tablet contains 5 mg of amlodipine (as amlodipine besylate) and 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
• The other ingredients are:

Core of the tablet

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

Coating

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

Appearance of the Product and Packaging Contents

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

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

You can request more information about this medicine from 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 Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:June 2023

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