Package Insert: Information for the User

Astucor 10 mg/10 mg Film-Coated Tablets

amlodipine besylate/atorvastatin calcium trihydrate

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Astucor is used to prevent cardiovascular events (such as chest pain, heart attack) in patients with high blood pressure and who also have risk factors for cardiovascular disease, such as smoking, being overweight, high levels of cholesterol in the blood, a 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 ingredients, amlodipine (calcium antagonist) and atorvastatin (statin) and is used when your doctor considers it appropriate to take both medications. Amlodipine is used in the treatment of high blood pressure (hypertension) and atorvastatin 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 (chest pain, heart attack, stroke).

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 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 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 mycosis), 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 are using 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 medicine containing fusidic acid (used to treat bacterial infections), by mouth or by injection. The combination of fusidic acid and Astucor may cause severe muscle problems (rhabdomyolysis).
• if you have kidney problems
• if you have a thyroid gland with low activity (hypothyroidism)
• if you have repeated or unjustified muscle pains, personal or family history of hereditary muscle problems
• if you have had muscle problems during treatment with other medicines to reduce cholesterol (lipids) (for example, 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 embolisms of fluid 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 myasthenic eye (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 tell you if blood tests should be done 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, for example rhabdomyolysis, increases when taken with certain medicines (see section “Other medicines and Astucor”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed 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 sugars and fats in your blood, overweight and high blood pressure.

Other medicines and Astucor

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 Astucor. This interaction may mean 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, for example rifampicin, fusidic acid or “macrolide” antibiotics, for example erythromycin, clarithromycin, telithromycin, or medicines to treat fungal infections, for example, ketoconazole, itraconazole
• Medicines to control your lipid levels: fibrates (for example gemfibrozil) or cholestyramine
• Medicines to control your heart rhythm, for example amiodarone, diltiazem and verapamil
• Anticonvulsants, for example carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone
• Medicines used to modify the functioning of your immune system, for example ciclosporin, tacrolimus, sirolimus, temsirolimus and everolimus
• Medicines used in the treatment of HIV infection, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc, nelfinavir
• Some medicines used to treat hepatitis C, such as 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, for example nefazodone and imipramine
• Medicines used in the treatment of mental disorders, for example neuroleptics
• Medicines to treat heart failure, for example beta blockers
• Medicines to treat high blood pressure, for example, angiotensin II 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 Astucor include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used for treating gout) and antacids (products for indigestion that contain aluminium or magnesium).
• Amifostine (used for cancer treatment)
• Sildenafil (for erectile dysfunction)
• Dantrolene and baclofen (muscle relaxants)
• Steroids
• Over-the-counter medicines that contain St. John's Wort (Hypericum perforatum).
• If you have to take fusidic acid orally to treat a bacterial infection, you will need to stop taking Astucor. Your doctor will tell you when you can start taking Astucor again. Taking Astucor with fusidic acid may cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Astucor may lower 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 Astucor with food, drinks and alcohol

Astucor 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 large amounts of orange juice may alter the effects of Astucor.

Alcohol

Avoid drinking large amounts of alcohol while taking Astucor. See the details in the section “Warnings and precautions”.

Pregnancy, breastfeeding and fertility

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

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

Driving and operating machinery

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

Astucor contains sodium

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

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor. In case of doubt, 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 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 every day at the same time.

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

If you estimate that the effect of Astucor 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 Astucor than you should

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

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

Take the remaining tablets, the container, 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 compensate for missed doses.

If you interrupt treatment with Astucor

Do not stop taking Astucor unless your doctor tells you to. If you have any other doubts about the use of this medication or want to interrupt 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 Astucor and inform your doctor immediately:

• Swelling of the face, tongue, and airways that may cause severe difficulty breathing
• If you experience unexplained muscle weakness, muscle pain on palpation, muscle pain or rupture, or a change in urine color to brown-red and at the same time you feel unwell or have a fever. (This combination of side effects is very rarely 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 heartbeats), difficulty breathing
• Swelling of nasal passages, sore throat, nasal bleeding
• Feeling of discomfort, abdominal pain, indigestion, change in bowel habits (including diarrhea, constipation, and flatulence)
• Muscle and joint pain, muscle cramps, spasms, back pain, limb pain

• Increased blood sugar levels (if you have diabetes, continue to closely monitor your blood sugar levels), increased creatine kinase in the blood, abnormal liver function test results
• Visual disturbances (including double vision), blurred vision

Rare (may affect up to 1 in 100 people)

• Jaundice (inflammation of the liver)
• Runny nose

• Loss of appetite, decreased blood sugar levels (if you have diabetes, continue to closely monitor your blood sugar levels), weight gain or loss
• Difficulty sleeping, having nightmares, mood changes (including anxiety), depression, tremors, numbness or tingling in the arms and legs, memory loss
• Tinnitus or buzzing in the ears
• Weakness, increased sweating, low blood pressure
• Dry mouth, altered taste, vomiting, belching
• Hair loss, bruises or small spots on the skin, skin discoloration, 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 urination frequency)
• Impotence, abnormal breast development in men
• Feeling of discomfort, muscle fatigue, pancreatitis (inflammation of the pancreas that causes abdominal pain), pain, neck pain, chest pain
• Positive urine tests for white blood cells
• Abnormal heart rhythm
• Cough

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

• Unexpected bleeding or bruising
• Severe muscle inflammation, intense muscle pain or cramps, muscle rupture that rarely can lead to rhabdomyolysis (destruction of muscle cells) and abnormal muscle rupture. Abnormal muscle rupture may not always resolve 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 white of the eyes)
• Severe allergic dermatological reactions, skin redness, rash with blisters, 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)
• Deep skin layer inflammation - including inflammation of the lips, eyelids, and tongue
• Swelling or inflammation of the skeletal muscle, rash with blisters, sudden and severe skin inflammation in a specific area
• Tendon inflammation, tendon injury
• Confusion

Unknown frequency: cannot be estimated from available data

• Constant muscle weakness

• Sexual dysfunction
• Respiratory problems including persistent cough and/or difficulty breathing or fever
• Movement disorders including rigidity, tremors, and/or movement disorders
• Diabetes. It 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 medication.
• 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 your arms or legs that worsens after periods of activity, double vision, eyelid drooping, 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 does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not use Astucor after the expiration date that appears on the blister and box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medicines should not be disposed of through drains or trash.Deposit the packaging and unused medicines at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

Composition of Astucor

The active principles are amlodipine and atorvastatina. The Astucor 10mg/10mg tablets contain 10 mg of amlodipine as amlodipine besilate and 10 mg of atorvastatina as atorvastatina calcium trihydrate.

The other components are: calcium carbonate (E-170), sodium croscarmellose, microcrystalline cellulose (E-460i), pregelatinized cornstarch (cornstarch), polisorbate 80, hypromellose (E-463), anhydrous colloidal 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), aluminium lake of indigo carmine (E-132), macrogol 3000 and talc (E-553b)].

Appearance of the product and content of the container

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

The Astucor tablets are available in boxes with blisters containing 28 or 200 tablets.

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almirall, S.A.

General Mitre, nº 151

08022 – Barcelona

Spain

Responsible for manufacturing

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

Last review date of this leaflet: March 2023

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