Norvasc Amlodipine 30 Tablets

Excipients

Microcrystalline cellulose, dibasic calcium phosphate, sodium starch glycolate, magnesium stearate

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

• NORVASC is taken orally and each tablet contains amlodipine besylate equivalent to 10 mg amlodipine. It is included in the drug group known as calcium antagonists.

• NORVASC is available in blister package of 20, 30 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.

3. How to use NORVASC?

Instructions for proper use and dose / frequency of

administration The usual initial dose is one (5 mg) tablet once a day.

Always follow your doctor's instructions when using NORVASC. Ask your doctor or pharmacist if you are unsure.

It is important to keep the tablets you will use. Do not wait until your tablets are finished before you see your doctor.

The route and method of

administration are taken orally.

It is best practice to take NORVASC with water at the same time every day.

In children

aged 6-17 years, the recommended antihypertensive oral dose is 2.5-5 mg once daily. Doses above 5 mg per day were not examined in pediatric patients. The effect of NORVASC on blood pressure in patients under 6 years of age is unknown.

Use in the elderly

Your doctor will not make a special dose adjustment for you.

Special use cases

Your doctor will not make a specific dose adjustment for you. Amlodipine, the active ingredient of NORVASC, is not dialyzed.

Liver failure:

If you have liver failure, your doctor will adjust the dose of NORVASC for him. If you have an impression that the effect of NORVASC is too strong or too weak, talk to your doctor or pharmacist.

If you use more NORVASCuse from

than you should, talk to a doctor or pharmacist if you have used more than you should NORVASC.

Don't If you have forgotten to use NORVASC

worry. If you forget to take NORVASC, take it immediately when you remember. If 12 hours have elapsed after the last dose, completely bypass this dose. Take the next dose when you need to use it. Do not take double doses to compensate for forgotten doses.

Effects after termination of treatment with NORVASC

Your doctor will tell you how long you should use the NORVASC. Do not interrupt your medication without consulting your doctor.

If you have any questions about how to use the NORVASC, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, there may be side effects in subjects who are sensitive to the substances found in the content of NORVASC.

Very common (> 1/10), common (> 1/100 to <1/10), uncommon (> 1/1000 to <1/100), sparse (> 1/10000 to <1/1000), very sparse (<1/10000) and unknown (unpredictable from available data)

The following common side effects have been reported. If these side effects cause problems or persist for more than a week, contact your doctor .

Common

• Headache, dizziness, sleep flush, flushing of the face

• Palpitation, skin reddening

• Abdominal pain, feeling sickness (nausea)

• Swelling of the ankle (edema), fatigue

Other reported side effects are listed below. Tell your doctor or pharmacist if any of these side effects become serious, or if you notice any side effects not listed below in this manual.

Uncommon

• Depending on the blood leakage from the capillary walls, the presence of bleeding spots on the skin and mucous membranes initially seen in red and then purplish color (purpura), decrease in platelet blood platelet (thrombocytopenia), decrease in white blood cell count (leukopenia)

• Increase in blood sugar

• Mood fluctuations, insomnia, sexual weakness

• tremors, deterioration in taste, fainting, weakness, increased sweating, loss of sensation (hypoesthesia), numbness (paraesthesia), painful drowsiness in the hands and feet (peripheral neutropenia)

• vision impairment, tinnitus

• Low blood pressure, inflammation of the blood vessels (vasculitis)

• Shortness of breath (dyspnea), sneezing, runny nose, cough

• Change in bowel movements, difficulty in digestion (including gastritis), dry mouth, vomiting, gum growth (gingival hyperplasia)

• Hair loss, perspiration, skin itching, skin redness, skin discoloration, hives (urticaria)

• frequent urination at night, urinary disorder, chest pain, weakness, pain, muscle cramps, back pain, joint pain, muscle pain

• Weight gain or decrease

• In men the growth of breast

rare

Allergies result of the face and throat swelling (angioedema), usually spontaneously the hands, face and hypersensitivity state forming a similar rash standing lace (erythema multiforme)

Very rare

• allergic reactions

• heart attack, heart disorders

•liver inflammation (hepatitis) , liver dysfunctions, yellowing of the skin (jaundice)

2.NORVASC should be before using

considered DON'T use NORVASC in the following cases

:

• Amlodipine, which is the active ingredient of NORVASC, dihydropyridines or any component of its contents or similar drugs that lower blood pressure ( CALCIUM hypersensitivity (hypersensitivity). This condition may be as itching, skin redness or shortness of breath.

CAREFULLY USE NORVASC

if you have one of the following conditions:

• A recent heart attack (in recent months)

• Liver disease

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

Use of NORVASC with food and drink Use of

NORVASC with food and drink

significant effect on the blood levels of the drug when used in combination with alcohol

No.

Use of NORVASC with grapefruit or grapefruit juice; In some patients, it is not recommended as it may cause an increase in blood pressure lowering effect due to high plasma levels.

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 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 notice that you are pregnant at the time of your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine. The safety of NORVASC in human breast feeding has not been established.

Vehicle and machine use The use of

NORVASC is not expected to have an impact on the ability to drive and use machines.

Important information on certain excipients in the content of NORVASC

This product contains less than 1 mmol (23 mg) of sodium per tablet; that is essentially "sodium-free".

5. Storage of Keep NORVASC in a place

NORVASC where children cannot see, reach, and pack. Use in accordance with expiration dates.

Store at room temperature below 30 ° C.

4.1. Therapeutic indications

1. Essential Hypertension: May

be used alone or in combination with other antihypertensives to control blood pressure.

2. Coronary Artery Disease:

Chronic stable angina: It is indicated for the symptomatic treatment of chronic stable angina. It can be used alone or in combination with other antianginal drugs. Vasospastic or Prinzmetal Anjina:

4.2. Posology and method of administration

Posology / frequency and duration of administration: The

usual initial dose for hypertension and angina is 5 mg NORVASC once daily, depending on the patient's personal response, the dose may be increased to a maximum of 10 mg. When NORVASC is used, thiazide diuretics, beta blockers and angiotensin converting enzyme inhibitors are not required to adjust the dose of NORVASC.

Application: For

oral use.

Additional information on the specific population: Liver failure:

Norvasc's half-life is prolonged in patients with impaired liver function. Dosage recommendations have not been established in these patients.

Renal failure:

NORVASC can be used in normal doses in these patients. Amlodipine plasma concentration changes are not related to the degree of renal impairment. Amlodipine cannot be dialyzed.

Pediatric population: In

pediatric hypertensive patients aged 6-17 years, the recommended antihypertensive oral dose is 2.5-5 mg once daily. Doses greater than 5 mg / day were not examined in pediatric patients (see sections 5.1 and 5.2).

The effect of amlodipine on blood pressure in patients under 6 years of age is unknown.

Geriatric population:

4.3. Contraindications

NORVASC is contraindicated in patients who are known to have sensitivity to dihydropyridines, amlodipine and any substance present in the composition of the drug.

4.4. Special warnings and precautions for use

General The

start of the vasodilator effect of NORVASC is gradual. Therefore, rare cases of acute hypotension have been reported after oral use of NORVASC. NORVASC should be used with caution, especially in patients with severe aortic stenosis, such as other peripheral vasodilators.

Cutting of beta-blockers

NORVASC is not a beta-blocker. Therefore, it does not provide any protection against the dangers that may arise if the use of beta-blockers is interrupted. In such a case, the dose of beta-blocker should be gradually reduced.

Use in patients with heart failure In the

PRAISE-2 study, a long-term placebo-controlled study, it was reported that the use of amlodipine did not significantly increase the incidence of worsening of heart failure compared with placebo, but not associated with an increase in pulmonary edema in patients with NYHA III and IV heart failure without ischemic etiology. . See. Section 5.1. Pharmacodynamic Properties

Use in patients with liver dysfunction As in

all other calcium channel antagonists, the half-life of NORVASC prolongs in patients with impaired liver function and no dosage recommendations have been identified in these patients. NORVASC should be administered with caution in these patients.

4.5. Interactions with other medicinal products and other forms of interaction areinwith

safely used combination NORVASC, thiazide diuretics, alpha-blockers, beta-blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, nonsteroidal anti-inflammatory drugs, antibiotics and oral hypoglycemic drugs. .

In vitro data of human plasma studies have shown that amlodipine does not have an effect on the binding of tested drugs (digoxin, phenytoin, warfarin, or indomethacin) to the protein.

Use of amlodipine with grapefruit or grapefruit juice; It is not recommended because some patients may cause an increase in blood pressure reduction effect due to the increase in bioavailability.

In the studies listed below, there is no significant change in the pharmacokinetics of NORVASC or other drugs when used together throughout the study.

Effect of other agents on amlodipine

Simethicone: Co-administration of NORVASC with cimetidine did not alter the pharmacokinetics of amlodipine.

Grapefruit juice: In 20 healthy volunteers, oral administration of a single dose of 10 mg amlodipine with 240 ml of grapefruit juice had no significant effect on the pharmacokinetics of NORVASC.

Aluminum / magnesium (antacid): Co-administration of an antacid containing an aluminum / magnesium with a single dose of NORVASC did not have a significant effect on the pharmacokinetics of NORVASC.

Sildenafil: A single dose of 100 mg sildenafil administered to patients with essential hypertension had no effect on the pharmacokinetic parameters of NORVASC. When NORVASC and sildenafil were used in combination, each agent independently showed its own blood pressure lowering effect.

CYP3A4 inhibitors: Plasma concentrations of amlodipine were increased by 22% and 50%, respectively, with concomitant use of CYP3A4 inhibitor erythromycin in young patients and diltiazem in elderly patients. The clinical significance of this finding is unclear. It cannot be said that strong CYP3A4 inhibitors (eg ketoconazole, itraconazole, ritonavir) will increase plasma concentrations of amlodipine more than diltiazem. Amlodipine should be used with caution in combination with CYP3A4 inhibitors; however, side effects associated with this interaction have not been reported.

CYP3A4 inducers: There is no data on the effects of CYP3A4 inducers on amlodipine. Concomitant use of CYP3A4 inducers (such as rifampicin, yellow centaury) may result in low amlodipine plasma concentrations. Caution must be exercised when using amlodipine with CYP3A4 inducers.

Effect of amlodipine on other agents

Atorvastatin: Atorvastatin administration with 10 mg NORVASC at repeated doses did not result in a significant change in the steady-state pharmacokinetic parameters of atorvastatin.

Digoxin: In normal volunteers, co-administration of NORVASC and digoxin did not alter serum digoxin levels or renal clearance of digoxin.

Ethanol (alcohol): Single and repeated doses of 10 mg NORVASC administration did not have a significant effect on ethanol pharmacokinetics.

Warfarin: Co-administration of NORVASC and warfarin did not alter the prothrombin response time of warfarin.

Cyclosporine: The pharmacokinetic studies with cyclosporine have shown that NORVASC does not significantly alter the pharmacokinetics of cyclosporine.

Drug / Laboratory Test Interactions: No known interference.