Zocor 10 Mg 28 Tablets ingredient Simvastatin

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• 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:

headers are included.

2. Cautions before using

ZOCOR DO NOT use ZOCOR if: You

are allergic to any of the substances in simvastatin or any of the components of the drug (if you have excessive sensitivity), medications;

- Itraconozol, ketoconazole or posaconazole (drugs used for the treatment of fungal infection), - Erythromycin, clarithromycin or telithromycin (antibiotics used for infections) - Inhibitors of HIV protease (for AIDS infections) drugs used in the treatment of hepatitis C virus infections) - Nefazodon (a depression drug) - Gemfibrozil (cholesterol lowering drug) - Cyclosporine (a drug used in patients who have undergone organ transplantation) - Danazol (inflammation) - artificial hormone used in the treatment of uterine inflammation)

USE ZOCOR CAREFULLY

:If you

•have medical problems, including allergies,If you

•consume excessive amounts of alcohol,

• If you have previously had liver disease,have

• If you are going toany surgery, you may need to stop taking ZOCOR tablets for a while.

• Before using ZOCOR, your doctor will perform a blood test to see if your liver is working correctly.

• After you start using ZOCOR, your doctor will perform a blood test to see if your liver is working properly.

• You have a serious lung disease.

2

• If you have diabetes or have a risk of developing diabetes, your doctor will look closely at you when using ZOCOR. If your blood sugar and fat are high, if you are overweight and have high blood pressure, you are at risk of developing diabetes.

If you feel unexplained pain, tenderness or weakness in your muscles, contact your doctor immediately. Because, in rare cases, these muscular problems can become a serious muscle disease that causes kidney damage, and very rarely death can occur.

Patients with high doses of ZOCOR and some patients have a higher risk of muscle damage. Please report to your doctor if any of the following conditions apply to you:

• If you have a large amount of alcohol,

• If you have kidney problems,If you have

•thyroid problems

,over 65 years of age,

• If you are• If you are a woman,

• Previously, there are no cholesterol-lowering drugs called fibrates or statins. If you've had problems,

• If you or one of your close relatives hereditary muscle disease.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Using ZOCOR with food and drink ZOCOR can be taken on an empty stomach or with food.

One or more of the components present in grapefruit juice may alter the effect of certain medications in the body, including ZOCOR. Grapefruit juice should not be taken with ZOCOR.

Pregnancy Consult your doctor or pharmacist before using the medicine.

Do not use ZOCOR if you are pregnant or if you plan to become pregnant.

If you discover that you are pregnant during your treatment, stop using the medicine immediately and consult your doctor or pharmacist.

Breastfeeding Consult your doctor or pharmacist before using the medicine.

Do not use ZOCOR if you are breastfeeding. Because it is not known whether it has passed into breast milk.

Vehicle and machine use ZOCOR is not expected to affect vehicle and machine use; but some people may experience dizziness after using ZOCOR.

3

Important information about some excipients contained in ZOCOR If you have been told by your doctor that you are intolerant of some sugars, contact your doctor before taking this medicinal product.

Use with other drugs It is very important that you tell your doctor if you are taking one of the following drugs in particular. The use of these drugs in combination with ZOCOR may increase the risk of muscle problems (some of which are mentioned above in "Do not use ZOCOR in the following cases").

• Cyclosporin (usually a drug used by patients undergoing organ transplantation)

• Danazol (uterus inflammation-endometriyozis- synthetic hormone used in the treatment)

• İtrakanazol, ketoconazole, fluconazole, as voriconazole or posaconazole drugs (for treating fungal infections)

• fibrate type, such as gemfibrozil and bezafibrate Drugs (cholesterol-lowering drugs)

• Erythromycin, clarithromycin, telithromycin or fusidic acid (drugs against bacterial infections)

• Inhibitors of HIV protease such as indinavir, nelfinavir, ritonavir and seratonavir (AIDS medications)

• Boceprevir or telaprevir )

• nefazodone (a medication for depression)

• amiodarone (a medicine for an irregular heartbeat)

• verapamil, diltiazem or amlodipine (hypertension, medications for related chest pain with heart diseases and conditions related to other heart)

• Colchicine (gout treatment in a drug used)

Property la, tell your doctor if using one of the following:

• warfarin, phenprocoumon or acenocoumarol (anticoagulants) such that prevents blood from clotting drugs

• fenofibrate (cholesterol-lowering another drug)

• Niacin (cholesterol-lowering another drug)

• Rifampicin (a drug used in the treatment of tuberculosis)

If prescription Please inform your doctor or pharmacist if you are currently using or have recently used any medication without a prescription.

3. How to use ZOCOR?

Instructions for appropriate use and dose / frequency of administration: Always use ZOCOR as instructed by your doctor. Ask your doctor or pharmacist if you are unsure.

You should also apply a cholesterol-lowering diet while using ZOCOR.

The recommended dose is:

• ZOCOR's dosage range is 10mg, 20mg, 40mg, 80mg / day.

• Your doctor will tell you which dosage is the most appropriate dose for you.

Your

doctor may make a minimum dose of 80 mg at a minimum of 4 weeks.

Do not use more than 80 mg per day. Your doctor will recommend a lower dose if you are taking medication listed above or if you have kidney disease.

If your doctor has prescribed ZOCOR with a drug called bile acid secretagogue (sSekestranı), you should use ZOCOR at least 2 hours before or at least 4 hours later.

Method and method of

administration • Must be taken orally.

• Take ZOCOR in the evening. You can get it on an empty stomach or with food.

• Remove the tablets with a sufficient amount of liquid (with a glass of water) without chewing.

Different age groups: Use in children: In children aged 10-17 years, the recommended initial dose is 10 mg daily in the evening. The recommended maximum dose is 40 mg daily.

The safety status and efficacy of the 10-17 year old males who had started at least one year before the period was examined. ZOCOR has not been studied in children under 10 years of age.

Use in the elderly: Same as the dose administered in adults.

Specific Use Conditions Kidney Failure: If you have

severe renal dysfunction, your doctor may need to adjust the dosage of your medicine.

Liver failure: Your doctor may ask for blood tests if you have symptoms of any liver disease in order to assess your liver condition before you start using ZOCOR or when you use ZOCOR. Do not use ZOCOR if you have liver disease. Tell your doctor if you consume a large amount of alcohol.

If you have an impression that the effect of ZOCOR is too strong or too weak, talk to your doctor or pharmacist.

If you have used more ZOCOR than you should use, talk to a doctor or pharmacist if you have used more than you should use from ZOCOR-.

If you forget to use ZOCOR If you forget to take a dose of the medicine, do not take this dose and then continue with normal use.

5

Do not take double doses to compensate for forgotten doses.

Effects that may occur when treatment is terminated with ZOCOR Your cholesterol may rise again.

4. What are the possible side effects?

Like all medicines, ZOCOR may have side effects in people who are sensitive to the substances found in its contents. Side effects are defined as shown in the following categories: Rare: Less than one in 1,000 patients. Very rare: less than one in 10,000 patients. Unknown: The frequency cannot be estimated with the existing data

Very rare:

• Sleep disorders (including nightmares),

• Difficulties to sleep,

• Loss of memory,

• Liver failure Uncommon:

• Anemia (Reduction in the number of red blood cells - anemia). Allergic (hypersensitivity) reactions, including;

• Swelling of the face, tongue and throat, which may cause breathing difficulties,

• Severe muscle pain, usually seen in the shoulders and buttocks,

• Rash with weakness in arms and legs and neck muscles,

• Pain and inflammation in joints,

• Inflammation of blood vessels,

• Infertility formation in the skin. , redness, swelling, hives, sensitization to the sun, fever, bloating,

• Shortness of breath and not feeling well,

• Lupus (reaction of a human's immune system to its own body cells) such as reaction, skin rash, joint disorder and effects on blood cells.

• Headache, tingling sensation, dizziness,

• Digestive disorders (abdominal pain, constipation, abdominal bloating, dyspepsia, diarrhea, nausea, vomiting, pancreatic inflammation with severe abdominal pain),

• Skin and eyes yellowing due to liver inflammation, itching, urine dark coloration or faint coloration of feces,

• Rash, itching, hair loss,

• Muscle pain, softening, weakness or cramps, weakness and numbness in the arms and legs,

• In rare cases, these muscle problems can become a serious muscle disease that causes kidney damage and very rarely, death can occur.

• Weakness,

• Some laboratory blood tests showed elevated liver function and a muscle enzyme (creatine kinase).

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Unknown:

• Diabetes (If your blood sugar and fat level or increase in your blood pressure, your doctor will follow you while using this drug),

• Sexual problems,

• Erectile dysfunction,

• Stubborn cough and / or breathing problems such as shortness of breath or fever, leading to inflammation in the lungs,

• Depression

Inform your doctor or pharmacist if you experience any side effects not mentioned in these instructions for use.

5. Storage ofKeep ZOCOR in a place

ZOCORwhere the child cannot see, reach and pack.

Store at room temperature below 25 ° C.

Use in accordance with expiration dates.

Do not use ZOCOR after the expiry date in its packaging.

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