Atorvastatin Aurovitas

Leaflet attached to the packaging: information for the user

Atorvastatin Aurovitas, 10 mg, film-coated tablets

Atorvastatin Aurovitas, 20 mg, film-coated tablets

Atorvastatin Aurovitas, 40 mg, film-coated tablets

Atorvastatin

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Atorvastatin Aurovitas and what is it used for
• 2. Important information before taking Atorvastatin Aurovitas
• 3. How to take Atorvastatin Aurovitas
• 4. Possible side effects
• 5. How to store Atorvastatin Aurovitas
• 6. Contents of the packaging and other information

1. What is Atorvastatin Aurovitas and what is it used for

Atorvastatin Aurovitas belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Atorvastatin Aurovitas is used to reduce the levels of lipids known as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own are not effective.
Atorvastatin Aurovitas may also be used to reduce the risk of heart disease, even if the cholesterol level is normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking Atorvastatin Aurovitas

When not to take Atorvastatin Aurovitas

• if the patient is allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6),
• if the patient has or has had liver disease,
• if the patient has unexplained, abnormal liver function test results,
• in women of childbearing age who do not use effective methods of contraception,
• in pregnant or breastfeeding women,
• in women who are planning to become pregnant,
• when taking glecaprevir/pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting treatment with Atorvastatin Aurovitas, the patient should discuss it with their doctor, pharmacist, or nurse.

• in case of severe respiratory failure,
• in case of a stroke with bleeding into the brain, or if there is a small amount of fluid in the brain from a previous stroke,
• in case of kidney problems,
• in case of hypothyroidism,
• in case of recurring or unexplained muscle pain, or muscle problems in the past, or similar problems in relatives,
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins may sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4);
• in case of muscle problems during previous treatment with other lipid-lowering medicines (e.g. other statins or fibrates),
• if the patient is taking or has taken fusidic acid orally or by injection in the last 7 days. There have been reports of rhabdomyolysis in patients receiving a statin in combination with fusidic acid.
• in case of regular consumption of large amounts of alcohol,
• in case of a history of liver disease,
• in patients over 70 years of age.

In patients who are affected by any of the above situations, the doctor will order a blood test before starting treatment with Atorvastatin Aurovitas and, if possible, during treatment to monitor the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, is higher when certain medicines are taken at the same time (see section 2 "Atorvastatin Aurovitas and other medicines").
The doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
During treatment with Atorvastatin Aurovitas, the doctor will closely monitor the patient for the development of diabetes or the risk of developing diabetes. Patients with high sugar and fat levels in the blood, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

Atorvastatin Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may change the effect of Atorvastatin Aurovitas or the effect of these medicines on the body may be changed by Atorvastatin Aurovitas. This type of interaction can lead to reduced efficacy of one or both medicines. At the same time, it can increase the risk of serious side effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressants, such as cyclosporine,
• certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-lowering medicines, such as gemfibrozil, other fibrates, colestyramine,
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem, as well as medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus disease
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir,
• other medicines that are known to interact with Atorvastatin Aurovitas include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine used to treat epilepsy), cimetidine (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (a medicine used to treat gout), and antacids (medicines used to treat indigestion, containing aluminum or magnesium),
• over-the-counter medicines: St. John's wort,
• if the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking Atorvastatin Aurovitas. The doctor will inform them when it is safe to resume taking Atorvastatin Aurovitas. Concurrent use of Atorvastatin Aurovitas and fusidic acid may rarely lead to muscle weakness, hypersensitivity, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria).

Atorvastatin Aurovitas with food and drink

Information on the use of Atorvastatin Aurovitas can be found in section 3. However, the following information should be noted:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may change the effect of Atorvastatin Aurovitas.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
Detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

Do not take Atorvastatin Aurovitas if you are pregnant or planning to become pregnant.
Do not take Atorvastatin Aurovitas in women of childbearing age, unless the patient uses effective methods of contraception.
Do not take Atorvastatin Aurovitas during breastfeeding.
The safety of atorvastatin during pregnancy or breastfeeding has not been established. Consult a doctor or pharmacist before taking the medicine.

Driving and using machines

Normally, the medicine does not affect the ability to drive or use machines. However, the patient should not drive if the medicine affects their ability to do so. Do not use any tools or machines if taking the medicine affects the ability to use them.
Atorvastatin Aurovitas containslactose monohydrate and soy lecithin. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains soy lecithin. Do not take this medicine if you are allergic to peanuts or soy.

Atorvastatin Aurovitas contains sodium

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

3. How to take Atorvastatin Aurovitas

Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvastatin Aurovitas.
Usually, the initial dose of Atorvastatin Aurovitas in adults and children over 10 years of age is 10 mg once a day. This dose may be increased by the doctor if necessary, up to a dose suitable for the patient. The doctor will adjust the dose of Atorvastatin Aurovitas at intervals of at least 4 weeks. The maximum dose of Atorvastatin Aurovitas is 80 mg once a day.
Atorvastatin Aurovitas tablets should be swallowed whole, with a glass of water; they can be taken at any time of day, with or without food. However, the patient should try to take the tablet at the same time every day. This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

The duration of treatment with Atorvastatin Aurovitas is determined by the doctor.

If the patient feels that the effect of Atorvastatin Aurovitas is too strong or too weak, they should consult their doctor.

Taking a higher dose of Atorvastatin Aurovitas than recommended

In case of accidental ingestion of too many Atorvastatin Aurovitas tablets (more than the usual daily dose), the patient should contact their doctor or the nearest hospital for advice.

Missing a dose of Atorvastatin Aurovitas

In case of forgetting to take the medicine, the patient should simply take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Atorvastatin Aurovitas

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Atorvastatin Aurovitas can cause side effects, although not everybody gets them.

If the patient experiences any of the serious side effects or symptoms, they should stop taking the medicine and contact their doctor or go to the emergency department of the nearest hospital immediately.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can cause severe breathing difficulties.
• Severe disease characterized by skin peeling and swelling, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the hands or feet, with possible blisters.
• Muscle weakness, tenderness, pain, or rupture, or reddish-brown urine, especially if accompanied by malaise or high fever, may be caused by the breakdown of striated muscles (rhabdomyolysis). Rhabdomyolysis may not always resolve, even if the patient stops taking atorvastatin, and may also be life-threatening and cause kidney problems.
  Very rare(may affect up to 1 in 10,000 people):
  • if the patient experiences unexpected or unusual bleeding or bruising, it may indicate liver problems. The patient should consult their doctor as soon as possible,
  • lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

  Other possible side effects of Atorvastatin Aurovitas:

  Common(may affect up to 1 in 10 people):

  • nasal congestion, sore throat, nosebleeds
  • allergic reactions
  • increased glucose levels in the blood (in diabetic patients, blood glucose levels should continue to be closely monitored), increased creatine kinase levels in the blood
  • headaches
  • nausea, constipation, bloating, indigestion, diarrhea
  • joint pain, muscle pain, and back pain
  • blood test results indicating abnormal liver function

  Uncommon(may affect up to 1 in 100 people):

  • loss of appetite, weight gain, decreased glucose levels in the blood (in diabetic patients, blood glucose levels should continue to be closely monitored)
  • nightmares, insomnia
  • dizziness, numbness or tingling in the fingers of the hands and feet, decreased sensitivity to pain and touch, changes in taste, memory loss
  • blurred vision
  • ringing in the ears and (or) head
  • vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)
  • liver inflammation
  • skin rash, skin rash, and itching, hives, hair loss
  • neck pain, muscle fatigue
  • fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated temperature
  • presence of white blood cells in the urine

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

  • vision disorders
  • unexpected bleeding or bruising (bruises)
  • cholestasis (yellowing of the skin and whites of the eyes)
  • tendon rupture
  • skin rash, which may occur on the skin, or ulcers in the mouth (drug-induced lichenoid reaction)
  • purple skin changes (symptoms of vasculitis)

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

  • allergic reactions - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
  • hearing loss
  • gynecomastia (excessive growth of breast tissue in men).

  Frequency not known (cannot be estimated from the available data):

  • persistent muscle weakness,
  • myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing);
  • ocular myasthenia (a disease that causes muscle weakness in the eyes). The patient should talk to their doctor if they experience muscle weakness in the arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

  Other possible side effects reported during treatment with some statins (medicines of the same type):

  • sexual disorders
  • depression
  • breathing problems, including persistent cough and (or) shortness of breath or fever
  • diabetes; the likelihood of developing this disease is higher in patients with high sugar and fat levels in the blood, patients who are overweight, and patients with high blood pressure. During treatment with this medicine, the doctor will perform the necessary tests on the patient.

  Reporting side effects

  If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
  Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
  By reporting side effects, more information can be collected on the safety of the medicine.

  5. How to store Atorvastatin Aurovitas

  The medicine should be stored out of sight and reach of children.
  Dose of 10 mg, 20 mg, and 40 mg (PA/Aluminum/PVC/Aluminum):
  There are no special instructions for storing the medicinal product.
  Dose of 10 mg and 20 mg (PVC/PE/PVdC/Aluminum):
  There are no special instructions for storing the medicinal product.
  Dose of 40 mg (PVC/PE/PVdC/Aluminum):
  Do not store above 30°C.
  Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
  The expiry date refers to the last day of the month.
  Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

  6. Contents of the packaging and other information

  What Atorvastatin Aurovitas contains

  • The active substance of the medicine is atorvastatin. Each film-coated tablet contains 10 mg of atorvastatin (in the form of a trihydrate calcium salt). Each film-coated tablet contains 20 mg of atorvastatin (in the form of a trihydrate calcium salt). Each film-coated tablet contains 40 mg of atorvastatin (in the form of a trihydrate calcium salt).
  • Other ingredients are: mannitol, copovidone, sodium carbonate, sodium carboxymethylcellulose, microcrystalline cellulose (contains silicon dioxide and microcrystalline cellulose), lactose monohydrate, sodium lauryl sulfate, silicon dioxide, magnesium stearate. Tablet coating:partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), talc, soy lecithin, xanthan gum.

  What Atorvastatin Aurovitas looks like and contents of the pack

  Film-coated tablet.
  Atorvastatin Aurovitas 10 mg film-coated tablets:
  White, elliptical [9.8 mm x 5.2 mm], film-coated tablets, with the inscription "AS" on one side and "10" on the other side.
  Atorvastatin Aurovitas 20 mg film-coated tablets
  White, elliptical [12.3 mm x 6.5 mm], film-coated tablets, with the inscription "AS" on one side and "20" on the other side.
  Atorvastatin Aurovitas 40 mg film-coated tablets
  White, elliptical [15.5 mm x 8.1 mm], film-coated tablets, with the inscription "AS" on one side and "40" on the other side.
  Atorvastatin Aurovitas, film-coated tablets, are available in blisters made of Polyamide/Aluminum/PVC/Aluminum.
  Atorvastatin Aurovitas is also available in blisters made of PVC/PE/PVdC/Aluminum as an alternative packaging type.
  Pack sizes:
  Blisters: 14, 20, 28, 30, 50, 56, 84, 90, 98, and 100 film-coated tablets.
  Not all pack sizes may be marketed.

  Marketing authorization holder:

  Aurovitas Pharma Polska Sp. z o.o.
  ul. Sokratesa 13D lokal 27
  01-909 Warsaw

  Manufacturer/Importer:

  APL Swift Services (Malta) Limited
  HF26, Hal Far Industrial Estate, Hal Far
  Birzebbugia, BBG 3000
  Malta
  Generis Farmacêutica, S.A.
  Rua João de Deus 19, Venda Nova
  2700-487 Amadora
  Portugal

  This medicinal product is authorized in the Member States of the European Economic Area under the following names:

  Belgium:
  Atorvastatin AB 10 mg/20 mg/40 mg/80 mg film-coated tablets
  Poland:
  Atorvastatin Aurovitas
  Portugal:
  Atorvastatina Aurovitas
  Spain:
  Atorvastatina Aurovitas Pharma 10 mg/20 mg/40 mg/80 mg film-coated tablets EFG

  Date of last revision of the leaflet: 10.2024