Astucor 10 mg/10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Astucor 10 mg/10 mg film-coated tablets

amlodipine besilate/atorvastatin calcium trihydrate

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, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. See section 4.

Leaflet contents:

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. How to store Astucor
6. Contents of the pack and other information

1. What Astucor is and what it is used for

Astucor is used to prevent cardiovascular events (for example, angina, heart attack) in patients with high blood pressure who also have additional 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.

Astucor 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 lowers 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 may deposit in 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 ingredients of this medicine (listed in section 6)
• if you currently have a liver disease (if you have previously had a liver disease, see below section “Warnings and precautions”)
• 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 low blood pressure (hypotension)
• if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where 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, pharmacist, or nurse before taking Astucor

• 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 Astucor 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 pains, or personal or family history of inherited muscle disorders
• if you previously had muscle problems during treatment with other cholesterol-lowering (lipid-lowering) medicines (e.g. medicines containing “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 previously had a stroke with bleeding in the brain, or have small fluid-filled pockets in the brain due to prior strokes
• if you have or have had myasthenia (a disease characterized by 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 advise blood tests before and possibly during treatment with Astucor to assess the risk of muscle-related adverse effects. The risk of experiencing muscle-related adverse effects, such as rhabdomyolysis, is known to increase when taken concomitantly with certain medicines (see section “Other medicines and Astucor”).

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 the blood, are overweight, and have high blood pressure.

Other medicines and Astucor

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. Some medicines may interact with Astucor. 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, for example rifampicin, fusidic acid, or “macrolide antibiotics” such as erythromycin, clarithromycin, telithromycin, or medicines to treat fungal infections, for example ketoconazole, itraconazol
• Medicines to control your lipid levels: fibrates (e.g. gemfibrozil) or colestipol
• 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 function of your immune system, for example cyclosporine, 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 for the treatment of hepatitis C, such as telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Letermovir, a medicine that helps 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 to treat high blood pressure and prostate problems
• Other medicines known to interact with Astucor include ezetimibe (cholesterol-lowering), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium)
• Amifostine (used in cancer treatment)
• Sildenafil (for erectile dysfunction)
• Dantrolene and baclofen (muscle relaxants)
• Steroids
• 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 must stop taking this medicine. Your doctor will advise you when you can restart treatment with Astucor. Using Astucor with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia)

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 recently used any other medicines, including those obtained 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 quantities may alter the effects of Astucor.

Alcohol

Avoid drinking large amounts of alcohol while taking Astucor. See 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. Women of childbearing potential must use adequate contraceptive measures when taking Astucor or any other medicine. Consult your doctor or pharmacist before using this medicine.

It has been shown that amlodipine passes into breast milk in small amounts.

Driving and using machines

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”.

3. How to take Astucor

Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Adults

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

Astucor 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 each day.

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

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

Use in children and adolescents

This medicine is not recommended for use in 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 immediately or call the Toxicology Information Service at 91 562 04 20 (indicating the medicine and the amount ingested).

Excess fluid may accumulate in the lungs (pulmonary edema), causing breathing difficulties, which may develop within 24–48 hours after ingestion.

Bring any remaining tablets, the carton, and the complete packaging so that hospital staff can easily identify the medicine you have taken.

If you forget to take Astucor

If you miss a dose, take the next scheduled dose at the correct time.

Do not take a double dose to make up for missed doses.

If you stop taking Astucor

Do not stop taking Astucor unless instructed by your doctor. If you have any further questions about using this medicine or wish to discontinue treatment, consult 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 Astucor and contact your doctor immediately:

• Swelling of the face, tongue, or airways, which may cause severe breathing difficulty
• If you experience unexplained muscle weakness, muscle tenderness, muscle pain or muscle breakdown, or a change in urine color to red-brown, especially if you also feel unwell or have a fever. (Very rarely, this combination of effects may lead to a serious, 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 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
• Increased blood sugar levels (if you have diabetes, continue to monitor your blood sugar levels carefully), increased blood creatine kinase, blood test results indicating possible abnormal liver function
• Vision problems (including double vision), blurred vision

Uncommon (may affect up to 1 in 100 people)

• Hepatitis (inflammation of the liver)
• Runny nose
• Loss of appetite, decreased blood sugar levels (if you have diabetes, 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 sensation) in arms and legs, memory loss
• Ringing or buzzing in the ears
• Weakness, increased sweating, low blood pressure
• Dry mouth, taste disturbances, vomiting, burping
• 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 frequency of urination)
• Impotence, abnormal breast development in men
• Feeling unwell, muscle fatigue, 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 (may affect up to 1 in 1,000 people)

• Unexpected bleeding or bruising
• Severe muscle inflammation, intense muscle pain or cramps, muscle breakdown, which rarely may lead to rhabdomyolysis (destruction of muscle cells) and abnormal muscle rupture. Abnormal muscle rupture may not resolve even after stopping Astucor and can be life-threatening and cause kidney problems
• Decreased number of platelets 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 may rapidly spread to the rest of the body, possibly starting with flu-like symptoms and high fever (toxic epidermal necrolysis)
• Deep skin layer inflammation – including swelling of lips, eyelids, and tongue
• Inflammation or swelling of skeletal muscle, blistering rash, sudden and severe skin inflammation in an area
• Tendon inflammation, tendon injury
• Confusion
• Skin rash or mouth ulcers (drug-induced lichenoid reaction)

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

• Allergic reaction – symptoms may include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Reduction in 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)

Frequency not known: cannot be estimated from available data

• Persistent muscle weakness
• Sexual dysfunction
• Respiratory problems including persistent cough and/or difficulty breathing or fever
• Disorders involving a combination of stiffness, tremor, and/or movement disorders
• Diabetes. This is more likely if you have high levels of sugars 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 disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Astucor

Keep this medicine out of sight and reach of children.

Do not use Astucor after the expiry date which is stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater drains or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Astucor

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

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

Appearance of the product and contents of the pack

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

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

Only certain 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 most recent revision of this leaflet: January 2026

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