Atorvastatin Us Pharmacia

Leaflet accompanying the packaging: patient information

Atorvastatin US Pharmacia,10 mg, film-coated tablets
Atorvastatin

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

Please keep this leaflet, so you can read it again if you need to.

• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Atorvastatin US Pharmacia and what is it used for

Atorvastatin US Pharmacia belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Atorvastatin US Pharmacia 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 US Pharmacia 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 US Pharmacia

When not to take Atorvastatin US Pharmacia:

• if the patient is allergic to atorvastatin or any other similar medicine used to lower blood lipid levels, peanuts or soy, 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 pregnant or breast-feeding women,
• in women of childbearing age who do not use effective methods of contraception.

Warnings and precautions

Before starting treatment with Atorvastatin US Pharmacia, the patient should discuss it with their doctor, pharmacist, or nurse:

• if the patient has severe respiratory failure;

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• if the patient is taking or has taken fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection in the last 7 days. Taking fusidic acid with Atorvastatin US Pharmacia can lead to serious muscle problems (rhabdomyolysis);
• in case of a stroke with bleeding into the brain, or if there is a small amount of fluid from a previous stroke in the brain;
• 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;
• in case of muscle problems during previous treatment with other lipid-lowering medicines (e.g., other statins or fibrates);
• if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4);
• 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 in any of these situations, the doctor will order a blood test before starting treatment with Atorvastatin US Pharmacia 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 US Pharmacia and other medicines").
The doctor or pharmacist should also be informed if muscle weakness persists.
Additional tests and medications may be necessary to diagnose and treat this condition.
During treatment with the medicine, the doctor will closely monitor the patient for the development of diabetes or the risk of diabetes. Patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

Atorvastatin US Pharmacia and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. Some medicines may change the effect of Atorvastatin US Pharmacia or the effect of these medicines on the body may be changed by Atorvastatin US Pharmacia. 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,
• 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,
• other medicines known to interact with Atorvastatin US Pharmacia, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine

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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 for indigestion, containing aluminum or magnesium) and boceprevir (used to treat liver diseases such as hepatitis C),

• if the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking Atorvastatin US Pharmacia. The doctor will inform the patient when it is safe to restart treatment with Atorvastatin US Pharmacia. Taking Atorvastatin US Pharmacia with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.,
• over-the-counter medicines: St. John's Wort,
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria).

Atorvastatin US Pharmacia with food, drink, and alcohol

Information on the use of Atorvastatin US Pharmacia can be found in section 3.
However, please note the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can change the effect of Atorvastatin US Pharmacia.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
Detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breast-feeding

Taking Atorvastatin US Pharmacia during pregnancy or when planning to become pregnant is contraindicated.
Taking Atorvastatin US Pharmacia by women of childbearing age is contraindicated if they do not use effective methods of contraception.
Taking Atorvastatin US Pharmacia during breast-feeding is contraindicated.
The safety of Atorvastatin US Pharmacia during pregnancy and breast-feeding has not been established.
Before taking any medicine, consult a doctor or pharmacist.

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 their ability to use them.
The medicine contains Atorvastatin US Pharmacialactose monohydrate, soy lecithin, and sodium.
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.
The medicine contains 3.9 mg of sodium (the main component of common salt) per tablet. This corresponds to 0.2% of the maximum recommended daily intake of sodium in the diet for adults.
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3. How to take Atorvastatin US Pharmacia

Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvastatin US Pharmacia.
Usually, the initial dose of Atorvastatin US Pharmacia for 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 the medicine at intervals of at least 4 weeks. The maximum dose of Atorvastatin US Pharmacia is 80 mg once a day.
Atorvastatin US Pharmacia 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.

Duration of treatment with Atorvastatin US Pharmacia is determined by the doctor

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

Taking a higher dose of Atorvastatin US Pharmacia than recommended

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

Missing a dose of Atorvastatin US Pharmacia

If the patient forgets to take a dose, they should take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Atorvastatin US Pharmacia

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 US Pharmacia can cause side effects, although not everybody gets them.
If the patient experiences any serious side effects or symptoms, they should stop taking the medicine and contact their doctor or go to the nearest emergency department 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, or pain, or brownish discoloration of urine, especially if accompanied by malaise or fever, may be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney disease.

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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.

Other possible side effects of Atorvastatin US Pharmacia:
Common side effects (may affect up to 1 in 10 people):

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

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

• loss of appetite, weight gain, decreased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored)
• nightmares, insomnia,
• dizziness, numbness or tingling in the fingers and toes, decreased sensitivity to pain and touch, changes in taste, memory loss,
• blurred vision,
• ringing in the ears and (or) head,
• vomiting, belching, upper and lower abdominal pain, pancreatitis (causing abdominal pain),
• hepatitis,
• 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 urine analysis.

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

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

Very rare side effects (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 breast tissue growth in men).

Side effects of unknown frequency:

• persistent muscle weakness,

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• myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing),
• Ocular myasthenia (a disease causing muscle weakness in the eyes).

The patient should talk to their doctor if they experience weakness in their 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 blood sugar and fat levels, 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw,
phone: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Atorvastatin US Pharmacia

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP".
The expiry date refers to the last day of the month.
There are no special precautions for storage.
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 US Pharmacia contains

• The active substance of the medicine is atorvastatin. Each film-coated tablet contains 10 mg of atorvastatin (in the form of atorvastatin calcium trihydrate).
• Other ingredients are: Core:mannitol, copovidone, anhydrous sodium carbonate, sodium croscarmellose, microcrystalline cellulose (Grade 50 and Grade 90 contain colloidal silicon dioxide and microcrystalline cellulose), lactose monohydrate, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate.

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Coating:partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171),
talc, soy lecithin, xanthan gum.

What Atorvastatin US Pharmacia looks like and what the pack contains

White, elliptical, film-coated tablets, with "Y" embossed on one side and "77" on the other side.
PA/Aluminum/PVC/Aluminum blister or HDPE bottle with PP closure, containing a desiccant.
Pack sizes – 30 film-coated tablets.

Marketing authorization holder and importer

Marketing authorization holder

US Pharmacia Sp. z o.o.
Ziębicka 40, 50-507 Wrocław

Importer

APL Swift Services (Malta) Limited
HF 26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
To obtain more detailed information about this medicine, please contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
Poleczki 35
02-822 Warsaw
phone: +48 (22) 543 60 00

Date of last revision of the leaflet: October 2024

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