ASTUCOR 10 mg/10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Astucor 10 mg/10 mg Film-Coated Tablets

amlodipine besylate/atorvastatin calcium trihydrate

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

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

Contents of the Package Leaflet:

1. What Astucor is and what it is used for
2. What you need to know before taking Astucor
3. How to take Astucor
4. Possible side effects
5. Storage of Astucor

1. Package Contents and Additional Information

1. What Astucor is and what it is used for

Astucor 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, 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.

Astucor is a product that contains two active substances, amlodipine (calcium antagonist) and atorvastatin (statin), and is used when your doctor considers it appropriate to take both medications. 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 cardiovascular events (angina pectoris, heart attack, stroke).

Cholesterol is a substance that occurs naturally 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 and cardiovascular events. This is one of the most common causes of heart disease.

2. What you need to know before taking Astucor

Do not take Astucor

• if you are allergic (hypersensitive) to amlodipine or atorvastatin or to any other calcium channel blocker or to any of the other components of this medication (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 the "Warnings and Precautions" section below)
• 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 medications: ketoconazole, itraconazole (medications used to treat fungal infections or mycosis), telithromycin (an antibiotic)
• if you have low blood pressure (hypotension)
• if you have narrowing of the cardiac valve of the aorta (aortic stenosis) or cardiogenic shock (a situation where the heart is unable to provide enough blood to the body)
• if you suffer from heart failure after a heart attack
• if you use the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take Astucor

• if you have severe respiratory failure
• if you are taking or have taken in the last 7 days a medication that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Astucor 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 hereditary muscle disorders
• if you have had muscle problems in the past while taking other cholesterol-lowering medications (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 (see section 4).

In any of these cases, your doctor will indicate whether you should have blood tests before and possibly during treatment with Astucor to calculate the risk of muscle side effects. It is known that the risk of muscle side effects, such as rhabdomyolysis, increases when taken with certain medications (see "Other Medications and Astucor" section).

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

While taking this medication, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure.

Other Medications and Astucor

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. There are some medications that can interact with Astucor. This interaction can mean that one or both medications 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, such as rifampicin, fusidic acid, or "macrolide antibiotics", such as erythromycin, clarithromycin, telithromycin, or medications to treat fungal infections, such as ketoconazole, itraconazole
• Medications to control lipid levels: fibrates (e.g., gemfibrozil) or colestipol
• Medications to control heart rhythm, such as amiodarone, diltiazem, and verapamil
• Anticonvulsants, such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone
• Medications used to modify the functioning of the immune system, such as cyclosporine, tacrolimus, sirolimus, temsirolimus, and everolimus
• Medications used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc., nelfinavir
• Some medications used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Letermovir, a medication that helps prevent diseases caused by cytomegalovirus
• Medications used to treat depression, such as nefazodone and imipramine
• Medications used to treat mental disorders, such as neuroleptics
• Medications used to treat heart failure, such as beta blockers
• Medications used to treat high blood pressure, such as angiotensin II antagonists, ACE inhibitors, verapamil, and diuretics
• Alpha blockers used to treat high blood pressure and prostate problems.
• Other medications that are known to interact with Astucor include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used to treat heartburn and peptic ulcer), phenazone (a pain reliever), colchicine (used to treat gout), and antacids (products for indigestion that contain aluminum or magnesium).
• Amifostine (used to treat cancer)
• Sildenafil (for erectile dysfunction)
• Dantrolene and baclofen (muscle relaxants)
• Corticosteroids
• Over-the-counter medications that contain St. John's Wort (Hypericum perforatum).
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medication. Your doctor will indicate when you can restart treatment with Astucor. The use of Astucor with fusidic acid can cause muscle weakness, sensitization, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Astucor may reduce your blood pressure even more if you are already taking other medications to treat high blood pressure.

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

Taking Astucor with Food, Drinks, and Alcohol

Astucor 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 amounts of grapefruit juice can alter the effects of Astucor.

Alcohol

Avoid drinking too much alcohol while taking Astucor. See the details in the "Warnings and Precautions" section.

Pregnancy, Breastfeeding, and Fertility

Do not take Astucor if you are pregnant, breastfeeding, or trying to become pregnant. When taking Astucor or any other medication, women of childbearing age should take adequate contraceptive measures. Consult your doctor or pharmacist before using this medication.

Amlodipine has been shown to pass into breast milk in small amounts.

Driving and Using Machines

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

Astucor Contains Sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

3. How to Take Astucor

Follow the instructions for administration of this medication contained in this package leaflet or as indicated by your doctor. If you have any doubts, ask your doctor or pharmacist.

Adults

The usual initial dose of Astucor 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.

Astucor should be swallowed whole, with a little water. The tablets can 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 fat restriction in the diet, quitting smoking, and regular exercise.

If you think the effect of the Astucor tablets is too strong or too weak, tell your doctor or pharmacist.

Use in Children and Adolescents

This medication is not recommended for children and adolescents.

If You Take More Astucor Than You Should

If you accidentally take too many Astucor tablets (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicology Information Service at 91 562 04 20 (indicating the medication and the amount taken).

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion.

Bring any remaining tablets, the package, and the complete box so that hospital staff can easily identify the medication you have taken.

If You Forget to Take Astucor

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 Interrupt Treatment with Astucor

Do not stop taking Astucor unless your doctor tells you to. If you have any other questions about the use of this medication or want to interrupt 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 Astucor 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 be a potentially life-threatening condition called rhabdomyolysis)
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Very Common (may affect more than 1 in 10 people)

• Swelling of arms, hands, legs, joints, or feet

Common (may affect up to 1 in 10 people)

• Allergic reaction
• Headache (especially at the beginning of treatment), dizziness, feeling of fatigue, drowsiness
• Irregular heartbeat, flushing
• Palpitations (abnormal sensation of heartbeat), difficulty breathing
• Nasal passage inflammation, sore throat, nosebleeds
• Feeling of discomfort, abdominal pain, indigestion, change in bowel habits (including diarrhea, constipation, and flatulence)
• Pain in muscles and joints, muscle cramps and spasms, back pain, pain in the limbs.

• Increased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels), increased creatine kinase in the blood, blood test results that show your liver function may become abnormal.
• Vision problems (including double vision), blurred vision

Uncommon (may affect up to 1 in 100 people)

• Hepatitis (inflammation of the liver)
• Rhinitis

• 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, having nightmares, mood changes (including anxiety), depression, tremors, nerve sensitivity 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 discoloration, decreased skin sensitivity to touch or pain, numbness or tingling in the fingers and toes, skin rash, urticaria or itching
• Urinary disorders (including excessive urination at night and increased frequency of urination)
• Impotence, abnormal development of the breasts in men
• Feeling of discomfort, muscle fatigue, 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 (may affect up to 1 in 1,000 people)

• Unexpected bleeding or bruising
• Severe muscle inflammation, very intense muscle pain or cramps, muscle rupture that can rarely lead to rhabdomyolysis (destruction of muscle cells) and abnormal muscle rupture. Abnormal muscle rupture may not always disappear, even after stopping Astucor, and can be life-threatening and cause kidney problems
• Decreased 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 flu-like symptoms accompanied by high fever (toxic epidermal necrolysis)
• Inflammation of the deep layers of the skin - including inflammation of the lips, eyelids, and tongue
• Inflammation or swelling of the skeletal muscle, blistering rash, sudden and severe inflammation of the skin in an area
• Tendon inflammation, tendon injury
• Confusion

Very Rare (may affect up to 1 in 10,000 people)

• 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
• Decrease in white blood cell count
• 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)

Frequency Not Known: cannot be estimated from the available data

• Constant muscle weakness

• Sexual dysfunction
• Respiratory problems including persistent cough and/or difficulty breathing or fever
• Disorders of the combination of stiffness, tremors, and/or movement disorders
• Diabetes. It 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 medicine.
• Severe myasthenia (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 your 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Astucor

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

Do not use Astucor after the expiration date that appears on the blister pack and carton after CAD. The expiration 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. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Astucor Composition

The active ingredients are amlodipine and atorvastatin. The Astucor 10mg/10mg tablets contain 10 mg of amlodipine as amlodipine besylate and 10 mg of atorvastatin as atorvastatin calcium trihydrate.

The other ingredients are: calcium carbonate (E-170), sodium croscarmellose, microcrystalline cellulose (E-460i), pregelatinized corn starch (corn starch), polysorbate 80, hypromellose (E-463), colloidal anhydrous silica (E-551), and magnesium stearate (E-470b).

The coating of the Astucor 10 mg/10 mg tablets contains: Opadry II Blue 85F10919 [polyvinyl alcohol, titanium dioxide (E-171), aluminum lake of indigo carmine (E-132), macrogol 3000, and talc (E-553b)].

Product Appearance and Package Contents

The Astucor 10 mg/10 mg tablets are blue, oval-shaped, and marked with CDT 101.

Astucor tablets are available in cartons with blister packs containing 28 or 200 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almirall, S.A.

General Mitre, nº 151

08022 – Barcelona

Spain

Manufacturer

Klocke Pharma-Service GmbH

Strassburger Strasse 77

Appenweier 77767

Germany

or

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 – Freiburg Im Breisgau

Germany

or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

Date of the Last Revision of this Prospectus: March 2023

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