Astucor 5 mg/10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Astucor 5 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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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, chest pain, 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 suffering 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 (chest pain, 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 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 the section “Warnings and precautions” below)
• 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 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 pain, 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 had a previous 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 causing 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 you to have 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 together 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 whether you have diabetes or are at 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 medicines. 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 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 antifungal medicines such as ketoconazole, itraconazole
• 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 combination of 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 for treating heart failure, for example beta-blockers
• Medicines for treating high blood pressure, for example angiotensin II antagonists, ACE inhibitors, verapamil, and diuretics
• Alpha-blockers used for treating 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 will need to 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 amounts of grapefruit juice 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 age who take Astucor or any other medicine should use appropriate contraceptive measures. 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 instructions for administration of this medicine provided in this leaflet or those indicated 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 tablets 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 feel that 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 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 difficulty in breathing, which may develop within 24–48 hours after ingestion.

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

If you forget to take Astucor

If you forget to take a dose, take the next dose at the scheduled time.

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

If you stop taking Astucor

Do not stop taking Astucor unless instructed by your doctor. If you have any other 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 experiences 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 difficulties
• 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 progress 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 diarrhoea, 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 that may rarely lead to rhabdomyolysis (destruction of muscle cells) and abnormal muscle rupture. Abnormal muscle breakdown does not always resolve even after stopping Astucor, and may 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 which may rapidly spread to other parts of the body, possibly starting with flu-like symptoms accompanied by high fever (toxic epidermal necrolysis)
• swelling of deeper layers of the skin – including swelling of the 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 levels
• increased muscle tension 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 disturbances

• diabetes. This is more likely if you have high levels of sugar 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 reactions

If you experience any adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction 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 reactions, 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 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 or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 5 mg/10 mg tablets contain 5 mg of amlodipine as amlodipine besylate and 10 mg of atorvastatin as atorvastatin calcium trihydrate.

The other components are: calcium carbonate (E-170), croscarmellose sodium, 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 5 mg/10 mg tablets contains: Opadry II White 85F28751 [polyvinyl alcohol, titanium dioxide (E-171), macrogol 3000, and talc (E-553b)].

Appearance of the product and contents of the pack

Astucor 5 mg/10 mg tablets are white, oval-shaped, and marked with "CDT 051".

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 summary: January 2026

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