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.
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.
Warnings and precautions
Consult your doctor, pharmacist or nurse before starting to take Astucor
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):
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”.
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.
If any of the following occur, stop taking Astucor and inform your doctor immediately:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Rare (may affect up to 1 in 100 people)
Very rare (may affect up to 1 in 10,000 people)
Unknown frequency: cannot be estimated from available data
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.
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
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)
O preço médio do Astucor 10 mg/10 mg comprimidos recubiertos con pelicula em julho de 2025 é de cerca de 13.24 EUR. Os valores podem variar consoante a região, a farmácia e a necessidade de receita. Confirme sempre com uma farmácia local ou fonte online para obter informações atualizadas.
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