Lipitor (Atorvastatin) 30 Tablets

• Excipients: Calcium carbonate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, pure water, magnesium stearate, film coating (Hydroxypropyl methylcellulose, Polyethylene glycol 8000; Titanium dioxide and film-containing talc), simethicone emulsion (simethicone, stearate emulsifiers, thickener, benzoic acid, sorbic acid and water-containing emulsion),

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is LIPITOR and what is it used for? 2. Things to consider before using LIPITOR 3. How to use LIPITOR? 4. What are the possible side effects? 5. LIPITOR storage

headers are included.

When using

LIPITOR, do not drink more than one or two small cups of grapefruit juice per day. Because drinking large amounts of grapefruit juice can change the effects of LIPITOR.

Pregnancy

Consult your doctor or pharmacist before using the medicine. Do not use LIPITOR if you are pregnant or trying to get pregnant. If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine. Do not use LIPITOR if you are breastfeeding.

use of machine tools and

On thethe ability to use LIPID use of tools and machinery not expected to have any negative effect. Do not drive if this medication affects your driving ability. Do not use them if you believe your ability to operate tools and machines has been affected.

Important information about some of the excipients contained in

LIPITOR contains LIPITOR lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product. LIPITOR contains sodium. If you are on a controlled sodium diet, consider this.

Use with other drugs

Certain drugs may alter the effectiveness of LIPITOR or the effectiveness of certain drugs may be altered by LIPITOR. Such an interaction can reduce the effectiveness of one or both of the drugs. It can also increase the risk or severity of side effects, including rhabdomyolysis, which is an important but rare case of muscle weakness. Your doctor will take this into consideration when deciding on your LIPITOR dose.

Some drugs that may interfere with LIPITOR:

• drugs that alter the functioning of the immune system; drugs effective against allergic diseases such as cyclosporine or terfenadine, astemizoledrugs effective against

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•certain infectious diseases or against fungal diseases; for example erythromycin, clarithromycin, ketoconazole, itraconazole, rifampin, fusidic acid

• Other lipid regulating drugs; eg gemfibrozil, fenofibrate, cholestipol

• Some calcium channel blockers used for high blood pressure or angina (chest pain caused by narrowing / obstruction of the heart-feeding vessels); for example, verapamil, diltiazem

; eg digoxin, amiodarone

• Ritonavir, lopinavir, atazanavir, indinavir, darunavir, nelfinavir (protease inhibitors) used in the treatment of AIDS (HIV)

• Boceprevir (protease inhibitor) used in the treatment of hepatitis C

• Other drugs known to interact with LIPITOR; ezetimib (cholesterol lowering), warfarin (reduces blood clotting), contraceptive pills, styipentol (seizure inhibitor), cimetidine (used for ulcers and heartburn), fenazon (pain reliever), antacids (indigestion drugs containing aluminum and magnesium) and St. John's Wort (St. John's Wort)

Please tell your doctor or pharmacist if you are currently using any prescription or non-prescription medicine or if you have recently used it.

3. How to use LIPITOR?

Instructions for appropriate use and dose / frequency of administration:

• Daily starting dose of LIPITOR for adults and children 10 years and older is 10 mg.

• This dose can be increased by your doctor until you have determined the amount you need. Your doctor will check the dose at intervals of 4 weeks or longer, making it suitable for you. The highest dose of LIPITOR in adults is 80 mg once a day and 20 mg once daily in children.

• Before starting LIPITOR therapy, a stardart cholesterol-lowering diet should be entered and this diet should be continued during LIPITOR treatment.

• Take LIPITOR as your doctor says. If in doubt, check with your doctor and pharmacist.

Method and method of:

administration• LIPITOR tablets should be swallowed whole with water.

• Doses may be taken at any time of the day, with or without food.

• However, try taking your dose at the same time of day.

Different age groups:

Use in children: The recommended starting dose is 10 mg in children 10 years of age and the maximum recommended dose is 20 mg per day.

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Elderly Use: No differences were observed between the elderly and the whole population in terms of the safety, efficacy and achievement of lipid treatment goals.

Special Use Cases:

Renal insufficiency: Dose adjustment is not necessary in patients with renal insufficiency. Hepatic impairment: LIPITOR should not be used in patients with active liver disease. Patients with a history of liver disease should be used with caution. Liver function tests should be performed periodically before and after starting the treatment with LIPITOR.

Talk to your doctor or pharmacist if you have an impression that LIPITOR's effect is too strong or too weak.

If you have used LIPITOR more than you should use:

If you have used more than you should use LIPITOR, talk to a doctor or pharmacist.

If you forget to use LIPITOR:

If you remember that you forgot to take a dose before the time of your next dose, remember that you will remember it. Do not take double doses to compensate for forgotten doses.

The effects that may occur when the treatment with LIPITOR is terminated; contact your doctor or pharmacist if you have additional problems with the use of this medication or if you wish to terminate your treatment.

4. What are the possible side effects?

Like all medicines, LIPITOR may have side effects in people who are sensitive to the substances contained in its content.

If you have any of the following, stop using LIPITOR and IMMEDIATELY tell your doctor or contact the emergency department of the hospital nearest you:

• Angioneurotic edema (percentage, swelling which may make breathing difficult in the tongue and the trachea). This very serious side effect is very rare. If you have one of these, tell your doctor immediately.

• In the skin, mouth, eyes, around the genitals; skin peeling, swelling, blistering and fever with severe disease state.

• Skin rash characterized by pink-red spots that can collect water on the soles of the feet and palms.

• Rarely, patients experience muscle weakness or inflammation and may very rarely become a serious, life-threatening potential (rhabdomyolysis). In case of weakness and fever, muscle weakness, tenderness or

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pain, stop using LIPITOR and inform your doctor immediately. Tell your doctor immediately if your muscle problems persist after you have recommended that you stop using LIPITOR. In this case, your doctor can do more tests to find the cause of your muscle problems.

Very rare cases affect less than 1 in 10,000 patients using LIPITOR (which means that 9,900 out of 10,000 patients using LIPITOR does not expect these side effects to be seen.).

• If you experience unexpected or unusual bleeding or if caries occur, this liver complaint may get tired. Your doctor should perform blood tests to check your liver before you start taking Lipitor or if you have symptoms of liver problems while taking Lipitor. If you have symptoms listed below, report to your doctor as soon as possible:

o Feeling fatigue or weakness o Appetite loss o Upper abdominal pain o Dark amber urineYellowing of the white area of ​​your skin or eyes

•• Stevens-Johnson syndrome (skin, mouth, eye, and erythema multiforme (stained red rash), visual impairment, blurred vision, hearing loss, tendon injuries, liver failure, change in taste, breast growth in men.

All these are serious side effects. If you have one of these, you may need emergency medical care or hospitalization. All of these very serious side effects are very rare.

Other possible side effects:affect

Common conditions1 to 10 of 100 patients using LIPITOR

• Inflammation of the nose, sore throat, nosebleeds

• Allergic reactions

• Increase in blood sugar levels (if you have diabetes, continue to monitor your blood sugar levels carefully), blood increase in creatine kinase levels

• Headache

• Nausea, constipation, gas, indigestion, diarrhea

• Joint pain, muscle pain and back pain

• Blood test results indicating that your liver function may be abnormal

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Uncommon cases 1 to 10 of 1000 patients effects.

• Loss of appetite, weight gain, decrease in blood sugar level (if you have diabetes, continue to monitor your blood sugar levels carefully)

• Night vision, insomnia

• Drowsiness, felting, tingling in fingers and toes, decreased sensitivity to pain or touch, change in taste , memory loss

• Blurred vision

• ears and / or head ringing

• vomiting, belching, upper and lower stomach pain, pancreatitis (pancreatic inflammation leads to stomach pain)

• hepatitis (liver inflammation)

• rash and itching, hives, hair loss

• Neck pain, muscle fatigue

• Fatigue, feeling unwell, weakness, chest pain, especially swelling of the ankle (edema), increased temperature

• Detection of white blood cells in urine test

Infrequent conditions affect 1 to 10 of 10,000 patients using LIPITOR

• Eye disturbance

• unexpected bleeding or bruising

• S Apiculture (yellowing of the skin and eyelids)

• Tendon injury

Very rare conditions affect 1 to 10 of 100,000 patients using LIPITOR

• An allergic reaction - symptoms; sudden wheezing and chest pain or stenosis, eyelids, face, lips, mouth, tongue and throat swelling, difficulty breathing, collapse

• Hearing loss

• Gynecomastia (breast growth in men and women)

Statins (with the same type of drugs as LIPITOR) reported Side effects:

• Sleep disorders including insomnia and nightmares, memory loss, confusion

• Sexual difficulties

• Depression

• Respiratory problems involving persistent cough and / or shortness of breath or fever,

• Diabetes (diabetes). If you have high sugar and fat levels in your blood, if you are overweight and have high blood pressure; diabetes is more likely to be seen. Your doctor will follow you while using this medicine.

Please inform your doctor or pharmacist if you experience any side effects not mentioned in these instructions.

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Use in accordance with the expiration date. Do not use LIPITOR after the expiry date indicated on the package.

Do not use LIPITOR if you notice any defects in the product and / or packaging.