Atorvastatin us pharmacia

Package leaflet: Information for the patient

Atorvastatin US Pharmacia, 10 mg, film-coated tablets
Atorvastatin
Please read all of this leaflet carefully before 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet contents

1. What Atorvastatin US Pharmacia is and what it is 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 pack and other information

1. What Atorvastatin US Pharmacia is and what it is 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 blood levels of lipids known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes alone are not effective. Atorvastatin US Pharmacia may also be used to reduce the risk of heart disease, even when cholesterol levels are normal. You should continue to follow a cholesterol-lowering diet during treatment.

2. Important information before using Atorvastatin US Pharmacia

When not to use Atorvastatin US Pharmacia:

• if the patient is allergic to atorvastatin or to any other similar medicine used to lower blood lipids, to peanuts or soy, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has or has previously had liver disease;
• if the patient has unexplained abnormal liver function test results;
• in women who are pregnant or planning to become pregnant;
• in women who are breastfeeding;
• in women of childbearing age who are not using effective contraceptive methods.

Warnings and precautions
Before starting treatment with Atorvastatin US Pharmacia, discuss this with your doctor,
pharmacist, or nurse:

• if the patient has severe respiratory insufficiency;

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• if the patient is taking or has taken orally or by injection fusidic acid (a medicine used to treat bacterial infections) within the last 7 days. Concomitant use of fusidic acid with Atorvastatin US Pharmacia may lead to serious muscle problems (rhabdomyolysis);
• in case of 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 recurrent or unexplained muscle pain or muscle problems in the past, or similar problems in family members;
• in case of muscle problems during previous treatment with other lipid-lowering medicines (e.g., other statins or fibrates);
• if the patient currently has or has previously had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may occasionally worsen symptoms of the disease or lead to the occurrence of myasthenia (see section 4);
• in case of regular consumption of large amounts of alcohol;
• in case of previous liver disease;
• in patients aged over 70 years.

In patients affected by any of the above conditions, the doctor will order a blood test before starting treatment with Atorvastatin US Pharmacia and, whenever possible, during treatment to monitor the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, is higher when certain medicines are used concomitantly (see section 2 "Atorvastatin US Pharmacia and other medicines"). Inform your doctor or pharmacist if muscle weakness persists. Additional tests and additional medicines may be necessary to diagnose and treat this condition.
During treatment, the doctor will closely monitor the patient for the development of diabetes or risk of developing diabetes. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at increased risk of developing diabetes.

Atorvastatin US Pharmacia and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned to be used. Some medicines may alter the effect of Atorvastatin US Pharmacia or the effect of these medicines may be altered by Atorvastatin US Pharmacia. This type of interaction may reduce the effectiveness of one or both medicines. It may also increase the risk of serious adverse effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressive medicines, e.g., cyclosporine;
• certain antibiotics or antifungal medicines, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid;
• other lipid-regulating medicines, e.g., gemfibrozil, other fibrates, cholestyramine;
• certain calcium channel blockers used for angina or hypertension, e.g., amlodipine, diltiazem; and medicines regulating heart rhythm, e.g., digoxin, verapamil, amiodarone;
• medicines used to treat HIV infection, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.;
• certain medicines used to treat hepatitis C, e.g., telaprevir;
• other medicines known to interact with Atorvastatin US Pharmacia include ezetimibe (which lowers cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant medicine

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used to treat epilepsy), cimetidine (used to treat heartburn and stomach ulcers), phenazone (an analgesic), colchicine (a medicine used to treat gout), and antacids (medicines used for indigestion containing aluminium or magnesium), and boceprevir (used to treat liver diseases such as hepatitis C);

• if the patient needs to take oral fusidic acid to treat a bacterial infection, treatment with this medicine should be temporarily suspended. The doctor will inform the patient when it is safe to restart treatment with Atorvastatin US Pharmacia. Taking Atorvastatin US Pharmacia together with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information about 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 how to take Atorvastatin US Pharmacia is provided in section 3.
However, please note the following information:
Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may alter the effect of Atorvastatin US Pharmacia.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
Further details on this are provided in section 2 "Warnings and precautions".

Pregnancy and breastfeeding
Use of Atorvastatin US Pharmacia in women who are pregnant or planning to become pregnant is contraindicated.
Use of Atorvastatin US Pharmacia in women of childbearing age is contraindicated if they are not using effective contraceptive methods.
Use of Atorvastatin US Pharmacia during breastfeeding is contraindicated.
The safety of Atorvastatin US Pharmacia during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
This medicine usually does not affect the ability to drive or operate machinery. However, patients should not drive if the medicine affects their ability to do so. Do not use tools or machinery if taking this medicine affects your ability to operate them.

Medicine contains Atorvastatin US Pharmacia lactose monohydrate, soybean lecithin, and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains soybean lecithin. Do not use this medicine if you have a known hypersensitivity to peanuts or soy.
The medicine contains 3.9 mg of sodium (main component of table salt) in each tablet. This corresponds to 0.2% of the maximum recommended daily dietary sodium intake for adults.

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3. How to use Atorvastatin US Pharmacia

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvastatin US Pharmacia.
The usual initial dose of Atorvastatin US Pharmacia in adults and children aged 10 years or older is 10 mg once daily. If necessary, your doctor may increase this dose gradually to the dose appropriate for the patient. Your doctor will adjust the dose at intervals of at least 4 weeks. The maximum dose of Atorvastatin US Pharmacia is 80 mg once daily.
Atorvastatin US Pharmacia tablets should be swallowed whole with water; they may be taken at any time of day, with or without food. However, you should try to take the tablet at the same time each day.
This medicine should always be used exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with Atorvastatin US Pharmacia is determined by the doctor.
If you feel that the effect of Atorvastatin US Pharmacia is too strong or too weak, consult your doctor.
Taking more Atorvastatin US Pharmacia than prescribed
If you accidentally take too many Atorvastatin US Pharmacia tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
Missing a dose of Atorvastatin US Pharmacia
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 the missed dose.
Stopping Atorvastatin US Pharmacia
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the serious adverse reactions or symptoms listed below, stop using the medicine immediately and contact a doctor or go to the nearest hospital emergency department without delay.

Rare: may occur in 1 in 1,000 patients:

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe breathing difficulties.
• Severe illness characterized by skin peeling and swelling, skin blisters, blisters in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms or soles, possibly with blisters.
• Weakness, sensitivity to touch, muscle pain, or red-brown discoloration of urine, particularly if accompanied by malaise or fever, may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems.

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Very rare: may occur in 1 in 10,000 patients:

• If the patient experiences unexpected or unusual bleeding or bruising, this may indicate liver problems. Medical advice should be sought as soon as possible.

Other possible adverse reactions of Atorvastatin US Pharmacia:
Common adverse reactions (may occur in 1 in 10 patients):

• Nasal passage inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored), increased creatine kinase levels in blood
• Headaches
• Nausea, constipation, bloating, indigestion, diarrhoea
• Joint pain, muscle pain, and back pain
• Blood test results indicating abnormal liver function

Uncommon adverse reactions (may occur in 1 in 100 patients):

• Anorexia (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 fingers and toes, reduced sensitivity to pain and touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and (or) in the head
• Vomiting, belching, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, skin eruptions and itching, urticaria, 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 adverse reactions (may occur in 1 in 1,000 patients):

• Visual disturbances
• Unexpected bleeding or bruising (bruises)
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon rupture
• Skin rash or oral ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis)

Very rare adverse reactions (may occur in 1 in 10,000 patients):

• Allergic reactions – symptoms may include sudden shortness of breath and chest pain or tightness, eyelid, facial, lip, oral, tongue or throat swelling, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive growth of glandular breast tissue in men)

Adverse reactions with 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 weakness of the eye muscles)

Talk to a doctor if the patient experiences weakness in the arms or legs, worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Other possible adverse reactions reported during treatment with certain statins (medicines of the same type):

• Sexual dysfunction
• Depression
• Breathing problems, including persistent cough and (or) shortness of breath or fever
• Diabetes; the likelihood of developing this condition is higher in patients with high blood sugar and fat levels, overweight patients, and those with high blood pressure.

During treatment with this medicine, the doctor will perform appropriate tests on the patient.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to gather further information on the safety of using the medicine.

5. How to store Atorvastatin US Pharmacia

Keep this medicine out of the 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 stated month.
No special storage conditions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What the medicine Atorvastatin US Pharmacia contains

• The active substance is atorvastatin. Each coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
• Other components are:
  Tablet core: mannitol, copovidone, anhydrous sodium carbonate, sodium croscarmellose, silicified microcrystalline cellulose (Grade 50 and Grade 90 containing colloidal anhydrous silica and microcrystalline cellulose), lactose monohydrate, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate.

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Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171),
talc, soybean lecithin, xanthan gum.
What Atorvastatin US Pharmacia looks like and contents of the pack
White, elliptical, film-coated tablets, embossed with "Y" on one side and "77" on the other side.
Blister PA/Aluminium/PVC/Aluminium or HDPE bottle with PP closure, containing a desiccant.
Pack sizes – 30 film-coated tablets.
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
ul. Ziębicka 40, 50-507 Wrocław
Importer
APL Swift Services (Malta) Limited
HF 26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel. +48 (22) 543 60 00
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