Norvasc 5 Mg 30 Tablets ingredient Amlodipine

• Excipients: Ludiflash containing mannitol, crospovidone, polyvinyl acetate and Povidone K 30; Prosweet N & A FL PWD containing dextrose, natural and artificial sweetening agents; Flavoring components, maize maltodextrin, sugar, arabic gum (E414), citric acid esters of mono and diglycerides of fatty acids (E472c), silicon dioxide (E551) containing mint flavor; sucralose; crospovidone (Type B); colloidal silica, anhydrous; xylitol; yellow iron oxide (E172); magnesium stearate

Please read this INSTRUCTIONS carefully before using this medicine because it contains important information for you.

• 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 NORVASC and what is it used for? 2. Things to consider before using NORVASC 3. How to use NORVASC 4. What are the possible side effects? 5. The NORVASC Storage

Headers are included.

1. What is NORVASC and what is it used for?

• NORVASC is taken orally and each tablet contains amlodipine besylate equivalent to 5 mg amlodipine. It is included in the drug group known as calcium antagonists.

• NORVASC is available in blister package of 30, 60 and 90 tablets.

• NORVASC is a drug used in the treatment of high blood pressure (hypertension) or certain type of chest pain called angina.

• Hypertension: High blood pressure consists of blood pressure on the vessels. NORVASC reduces blood pressure by allowing blood vessels to expand, making blood circulate more easily in the vessels.

• Angina is a feeling of pain or discomfort that occurs when there is not enough blood to the heart muscle. Angina is usually felt in the form of chest pressure or compressive pain. Sometimes this pain is felt on the arms, shoulders, neck and back. NORVASC can pass this pain.

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2. Things to consider before using NORVASC Do NOT use NORVASC if:

• Amlodipine (amlodipine, dihydropyridine included in a group of drugs called calcium channel blockers), the active substance of NORVASC, dihydropridines or any constituents If you are allergic to any similar drugs (any calcium antagonists) that lower the pressure (hypersensitivity). This condition may be as itching, skin redness or shortness of breath.

• If you have severe low blood pressure (hypotension)

• If you have a aortic stenosis or cardiogenic shock (a condition in which your heart cannot supply enough blood to your body)you

• Ifcomplain of heart failure after a heart attack,

use the following inform your doctor if any of the following conditions have:

• A recent heart attack (in recent months)

• Heart failure

occurred• Severe increase in your heart pressure (hypertensive crisis)

• Liver disease

• If you are old and need to increase your dose

These warnings may please consult your doctor.

Use in children and adolescents: NORVASC has not been studied in children under 6 years of age. NORVASC should only be used for hypertension in children and adolescents aged 6 to 17 years. Talk to your doctor for further information.

Using the NORVASC with food and drink You can get NORVASC before or after food and drinks. People who use NORVASC should not take grapefruit or grapefruit juice. This is because grapefruit or grapefruit juice can cause an increase in plasma levels of amlodipine, the active substance, and may cause an unexpected increase in the blood pressure lowering effects of NORVASC.

Pregnancy Consult your doctor or pharmacist before using the medicine. The safety of NORVASC during pregnancy has not been established in humans. For this reason, your doctor may recommend NORVASC if you are pregnant, but there is no safer treatment option and your disease is at a greater risk for you and your baby. If you think you are pregnant or plan to become pregnant, tell your doctor before taking NORVASC. Women with childbearing potential should ensure that they use effective contraception. If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

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Breastfeeding Consult your doctor or pharmacist before using the medication. The safety of NORVASC in human breast feeding has not been established. It is not known whether NORVASC passes into breast milk. If you are breastfeeding or you start breastfeeding, tell your doctor before using the NORVASC.

Vehicle and machine use NORVASC may affect your ability to drive and use machines. If your tablets are sick, dizzy or tired, or have a headache, do not use a car or machine and tell your doctor immediately.

Important information about some excipients in the content of NORVASC If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

Use with other medicines If you are currently using any prescription or non-prescription medicine or have recently used it, please inform your doctor or pharmacist. Especially if you are taking any of the following medications or if you have recently taken it; Inform your doctor or pharmacist: Norvasc may affect the following medicines or be affected by the following drugs:

• a protease inhibitor called ritonavir, indinavir, nelfinavir (HIV, used to treat the virus that causes AIDS)

• ketoconazole or itraconazole (used for fungal infections, drugs)

• Verapamil diltiazem (heart drugs)

• rifampicin, erythromycin, clarithromycin (antibiotics)

• wort with herbal treatment used to treat mild depression

• Dantrolene (a drug used intravenously for severe increase in body temperature)

• simvastatin (cholesterol reducer)

currently for the treatment of high blood pressure If you use other drugs, NORVASC may lower your blood pressure even further.

3. How to use NORVASC

Instructions for proper use and dose / frequency of administration:

Always comply with the instructions of your doctor when using NORVASC. Ask your doctor or pharmacist if you are unsure. The usual starting dose is one (5 mg) tablet once a day. This dose can be increased to 10 mg NORVASC per day.

Continue to use the tablets. Do not wait until your tablets are finished before you see your doctor.

Method and method of administration: It is taken from the mouth.

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You should place the tablet on your tongue and let it dissolve before swallowing with water or without water, according to your preference. You can use your medicine before or after food and drinks. Do not take the NORVASC with grapefruit juice.

License Holder: PFIZER Pharmaceuticals Ltd. Sti. 34347 Ortaköy - İstanbul Production site: PFIZER İlaçları Ltd. Sti. 34347 Ortaköy - İstanbul

These operating instructions were approved on 10.04.2014.

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