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Mylan-Amlodipine/Atorvastatin: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Current status: Cancelled Pre Market
Strength:
5 mg / 10 mg, 5 mg / 20 mg, 5 mg / 40 mg, 5 mg / 80 mg, 10 mg / 10 mg, 10 mg / 20 mg, 10 mg / 40 mg, 10 mg / 80 mg
Active ingredients:
ATC code:
Similar drugs:

Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Mylan-Amlodipine/Atorvastatin

ABOUT THIS MEDICATION

What is MYLAN-AMLODIPINE/ATORVASTATIN used for:

MYLAN-AMLODIPINE/ATORVASTATIN is a product that contains two active ingredients: amlodipine and atorvastatin and is to be used when your doctor deems it appropriate to use both medications.

Your doctor has prescribed MYLAN-AMLODIPINE/ATORVASTATIN to you to control your hypertension (high blood pressure) and/or to prevent angina attacks (chest pains) and to help lower your cholesterol or other fats in the blood (such as triglycerides). Even if you do not have high cholesterol, your doctor may still prescribe MYLAN-AMLODIPINE/ATORVASTATIN if you have high blood pressure and other risk factors in order to prevent your risk of cardiovascular disease such as heart attacks.

MYLAN-AMLODIPINE/ATORVASTATIN is just part of the treatment your doctor will plan with you to help keep you healthy. Depending on the condition of your health and your lifestyle, your doctor may recommend:

  • a change in your diet to control your weight, reduce your cholesterol, reduce intake of saturated fats and increase fiber
  • exercise that is right for you
  • quitting smoking or avoiding smoky places
  • giving up alcohol or drinking less

MYLAN-AMLODIPINE/ATORVASTATIN is not recommended in children.

What MYLAN-AMLODIPINE/ATORVASTATIN does:

The amlodipine portion of MYLAN-AMLODIPINE/ATORVASTATIN belongs to a class of medications called calcium channel blockers. Calcium channel blockers, like amlodipine, block the transfer of calcium into the cells of the heart and blood vessels. This helps the blood vessels to relax, thereby lowering blood pressure and resulting in less work for the heart.

The atorvastatin portion of MYLAN-AMLODIPINE/ATORVASTATIN belongs to the class of medicines known as “statins”, more

specifically called HMG-CoA reductase inhibitors. HMG-CoA reductase is an enzyme involved in regulating cholesterol levels in your body. Statins are used along with changes to exercise and diet to help control the amount of cholesterol produced by the body. High levels of cholesterol and other fats can cause heart disease by clogging the blood vessels that feed blood and oxygen to the heart.

Atorvastatin can help your body:

  • Decreases LDL (bad) cholesterol, triglyceride levels and other lipids/fats in the blood.
  • Increase HDL (good) cholesterol
  • Decrease the Total Cholesterol HDL-Cholesterol Ratio (TC: HDL-C Ratio). The ratio represents the balance between bad and good cholesterol.

Follow your doctor’s instructions carefully.

When MYLAN-AMLODIPINE/ATORVASTATIN should not be used:

Do not take MYLAN-AMLODIPINE/ATORVASTATIN if you:

  • are allergic to either amlodipine besylate and/or atorvastatin calcium or other medications known as dihydropyridines (for example, felodipine, and nifedipine) or any of the nonmedicinal ingredients (see “What the nonmedicinal ingredients are”).
  • have been diagnosed with low blood pressure (less than 90 mm Hg systolic).
  • have active liver disease or unexplained increases in liver enzymes.
  • are pregnant or breast-feeding.

What the medicinal ingredients are:

amlodipine besylate and atorvastatin calcium.

What the nonmedicinal ingredients are:

Cellulose microcrystalline, colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl cellulose, L-arginine, magnesium stearate, pregelatinized starch and sodium carbonate anhydrous, Opadry AMB White OY-B-28920 or Opadry AMB Blue 80W50829.

What dosage forms it comes in:

MYLAN-AMLODIPINE/ATORVASTATIN tablets are available in 8 combinations of amlodipine/atorvastatin: 5mg/10mg, 5mg/20mg,

5mg/40mg, 5mg/80mg, 10mg/10mg, 10mg/20mg,

10mg/40mg, 10mg/80mg. MYLAN-AMLODIPINE/ATORVASTATIN tablets which contain 5 mg amlodipine are film-coated white, and those with 10 mg amlodipine are film-coated blue.

WARNINGS AND PRECAUTIONS

WAR

Serious Warnings and Precautions

Tell your doctor if you have any muscle pain, tenderness, soreness or weakness during treatment with MYLAN-AMLODIPINE/ATORVASTATIN

Never change the dose of MYLAN-AMLODIPINE/ATORVASTATIN unless your doctor tells you to.

Before you use MYLAN-AMLODIPINE/ATORVASTATIN talk to your doctor or pharmacist if

  • you have thyroid problems
  • you have had a stroke or a mini stroke called a transient ischemic attack (TIA)
  • you regularly drink three or more alcoholic drinks daily
  • you are taking any other cholesterol lowering medication such as fibrates (gemfibrozil, fenofibrate), niacin or ezetimibe
  • you are taking any other prescription, nonprescription or over-the-counter products especially those listed under the section “Interactions With This Medication”
  • you have a family history of muscular disorders
  • you had any past problems with the muscles (pain, tenderness), after using an HMG-CoA reductase inhibitor (“statin”) such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin or simvastatin
  • you have kidney or liver problems
  • you have diabetes (as the dosage of MYLAN-AMLODIPINE/ATORVASTATIN may need to be adjusted)
  • you have undergone surgery or other tissue injury
  • you do excessive physical exercise
  • you are 65 years old or older
  • you have taken any of the following medicines before, and you had an allergic reaction:

  • amlodipine or other derivatives

    -nifedipine

    -felodipine

  • atorvastatin or other derivatives

    -simvastatin

    -lovastatin

    -pravastatin

    -fluvastatin

    -rosuvastatin

  • you are taking cyclosporine
  • you are taking fusidic acid

Slightly increased blood sugar can occur when you take MYLAN-AMLODIPINE/ATORVASTATIN. Discuss with the doctor your risk of developing diabetes.

MYLAN-AMLODIPINE/ATORVASTATIN may cause muscle pain, aching or weakness that does not go away even after stopping the drug.

Pregnancy:

  • Before using this medication, discuss the following with your doctor:

    • If you are breast-feeding your baby, you should not take MYLAN-AMLODIPINE/ATORVASTATIN. This medicine may be present in your breast milk.

    • Cholesterol compounds are essential elements for the development of a fetus. Cholesterol-lowering drugs can harm the fetus. If you are of child-bearing age, discuss with your doctor the potential hazards to the fetus and the importance of birth control methods.

      • This medicine should not be used by pregnant women. If you become pregnant, discontinue use immediately and discuss with your doctor.

INTERACTIONS WITH THIS MEDICATION

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines. Also mention if you drink alcoholic beverages.

Drugs that may interact with MYLAN-AMLODIPINE/ATORVASTATIN include:

  • corticosteroids (cortisone-like medicines)
  • cyclosporine, tacrolimus
  • gemfibrozil
  • fenofibrate
  • bezafibrate
  • lipid-modifying doses of niacin (nicotinic acid)
  • spironolactone
  • cimetidine
  • erythromycin, clarithromycin or azole antifungal agents (ketoconazole or itraconazole)
  • nefazodone
  • indinavir sulfate, nelfinavir mesylate, ritonavir, saquinavir mesylate, lopinavir/ritonavir, telaprevir, tipranavir, darunavir, fosamprenavir, boceprevir
  • fusidic acid
  • digoxin
  • diltiazem
  • efavirenz, rifampin
  • sildenafil may lower your blood pressure
  • beta-blockers (medicines used to lower your blood pressure)
  • antacids (frequent use) and MYLAN-AMLODIPINE/ATORVASTATIN should be taken 2 hours apart
  • St. John’s Wort (hypericum perforatum)
  • grapefruit juice
  • colchicine

Certain non-prescription drugs may be harmful to you or may interfere with MYLAN-AMLODIPINE/ATORVASTATIN.CTNS

ATION

PROPER USE OF THIS MEDICATION

PPER USE OF THIS MEDICATION

Take MYLAN-AMLODIPINE/ATORVASTATIN exactly as prescribed by your doctor, nurse or pharmacist. Swallow MYLAN-AMLODIPINE/ATORVASTATIN with water.

Usual Dose: The dose range for MYLAN-AMLODIPINE/ATORVASTATIN is 5/10 to 10/80 mg once daily. The maximum dose of MYLAN-AMLODIPINE/ATORVASTATIN is 10/80 mg once daily. MYLAN-AMLODIPINE/ATORVASTATIN is available in a broad dose-range. Your doctor will decide on the best dose for you. Your individual health and tolerance to medications will help your doctor decide how much of each ingredient will be best for you.

Follow your doctor’s dosing instructions carefully. Take your MYLAN-AMLODIPINE/ATORVASTATIN as a single dose once a day. Never change the dose unless your doctor tells you to. It does not matter if you take MYLAN-AMLODIPINE/ATORVASTATIN with food or without food. Ideally, so you won’t forget, you should get in the habit of taking your medicine at the same time every day. Follow the plan that you and your doctor make for diet, exercise, weight control and smoking cessation.

We often cannot see or feel the problems that high cholesterol and high blood pressure cause until a lot of time has passed or until a major event like a heart attack occurs. You and your doctor will be following your cholesterol and blood pressure levels to bring them down and keep them in a safe range. Here are

some important tips to consider:

  • Report to all follow-up visits scheduled by your doctor. This is important to follow through with all lab tests requested by your doctor. These tests will help to follow/track your health in general, for example, your kidneys, liver and blood sugar levels.
  • It is important to take all of your medication and to refill your prescription on time so as not to miss any doses.
  • Don't drink too much alcohol while you are taking MYLAN-AMLODIPINE/ATORVASTATIN. Talk to your doctor about how much is too much for you.
  • If you get sick, have an operation, or need medical treatment, inform your doctor or pharmacist that you are taking MYLAN-AMLODIPINE/ATORVASTATIN.
  • If you have to take any other medicine –prescription, non-prescription or over-the-counter-while you are taking MYLAN-AMLODIPINE/ATORVASTATIN, talk to your doctor or pharmacist first.
  • If you have to see a different doctor for any reason, be sure to inform him/her that you are taking MYLAN-AMLODIPINE/ATORVASTATIN.

Missed Dose:

If you miss taking your medicine, take it as soon as you can. But if it is almost time for your next dose, skip the missed dose and just take the next dose. Don't take a double dose.

Overdose:

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its intended action, any medication may cause unwanted effects. MYLAN-AMLODIPINE/ATORVASTATIN is generally well tolerated. However, check with your doctor or pharmacist promptly if any of the following persist or become troublesome:

  • stomach pain or upset, vomiting or throwing up, loss of appetite and inability to eat, or malaise (general feeling of being unwell), burping
  • gas, constipation, diarrhea
  • headache, neck pain
  • fever
  • hair loss
  • skin rash, hives, itchiness
  • insomnia (difficulty sleeping), drowsiness, fatigue, nightmares
  • impotence (inability to develop or maintain an erection of the penis)
  • blurred vision, ringing in the ears

Possible side effects reported with some statins:

  • breathing problems including persistent cough and/or shortness of breath or fever
  • mood related disorders including depression
  • poor memory, confusion and memory loss

MYLAN-AMLODIPINE/ATORVASTATIN can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

If you think you have taken too much MYLAN-AMLODIPINE/ATORVASTATIN

contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison control centre immediately, even if there are no symptoms.

This is not a complete list of side effects. If you notice anything unusual or any unexpected effects while taking MYLAN-AMLODIPINE/ATORVASTATIN, contact your doctor or pharmacist.

Keep your medicine at 15-30°C (room temperature), away from warm and damp places, like the bathroom or kitchen.

Always keep medicine well out of the reach of children.

REPORTING SUSPECTED SIDE EFFECTS

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
  • By calling 1-866-234-2345 (toll-free);

  • By completing a Consumer Side Effect Reporting Form and sending it by:

    • Fax to 1-866-678-6789 (toll-free), or

    • Mail to: Canada Vigilance Program

      Health Canada, Postal Locator 0701E Ottawa, ON

      K1A 0K9

      Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect. (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php)

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

Please note that the information contained in the enclosed pamphlet is general. Your doctor and pharmacist are your primary sources of information about your health and the medicine you take. Consult with your doctor or pharmacist if you have questions about your health, any medication you take or the information we are providing you.

This document can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

Etobicoke, Ontario M8Z 2S6

Revised on::April 14, 2016

HOW TO STORE IT

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom/ effectTalk with your doctor or pharmacist

Stop

taking the drug and seek emergency medical assistance

Only if severeIn all cases
Common

Swelling of the

ankles

√
Rare

Pancreatitis (severe upper abdominal pain

that radiates to the back)

√
Muscle pain that you cannot explain√
Muscle cramps, tenderness or weakness√

Generalized weakness,

especially if you don’t feel well

√

Brownish or discoloured

urine

√

Increased frequency,

severity, duration of

angina (chest pains)

√

Low blood pressure:

(dizziness, or dizziness when rising from

sitting or laying down)

√
Change in rhythm or pace of heart beats√

Numbness or tingling in

hands/fingers

√
Shortness of breath√
Abnormal vision√

Jaundice (yellowing of

the skin and eyes) from a liver disorder called hepatitis (inflammation

of the liver)

√
Unknown

Increased blood

sugar: frequent

urination, thirst

and hunger

√
Extrapyramidal symptoms: muscle stiffness, body spasms, upward eye rolling, exaggeration of reflexes, drooling, difficulty moving how and when you want√

Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02400758

Revision date stated in the text: April 14, 2016

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Mylan-Amlodipine/Atorvastatin

Rx or OTC
Prescription (Rx)?
DIN 02400758, 02400774, 02400782, 02400790, 02400804, 02400812, 02400820, 02400839
Schedule(s) PRESCRIPTION
Active ingredient(s) Amlodipine (amlodipine besylate), Atorvastatin (atorvastatin calcium)
Dosage form(s) Tablet
Route(s) of administration Oral
Drug class (WHO ATC)
  1. C Cardiovascular system drugs
    1. C10 Lipid modifying agents
      1. C10B Lipid modifying agents, combinations
        1. C10BX Lipid modifying agents in combination with other drugs
          1. C10BX03 Atorvastatin and amlodipine
Company MYLAN PHARMACEUTICALS ULC
Current status Cancelled Pre Market
Current status date November 2, 2016
Strengths and forms
DIN Strength Dosage form(s) Current status
02400758 5 MG / 10 MG Tablet Cancelled Pre Market November 2, 2016
02400774 5 MG / 20 MG Tablet Cancelled Pre Market November 2, 2016
02400782 5 MG / 40 MG Tablet Cancelled Pre Market November 2, 2016
02400790 5 MG / 80 MG Tablet Cancelled Pre Market November 2, 2016
02400804 10 MG / 10 MG Tablet Cancelled Pre Market November 2, 2016
02400812 10 MG / 20 MG Tablet Cancelled Pre Market November 2, 2016
02400820 10 MG / 40 MG Tablet Cancelled Pre Market November 2, 2016
02400839 10 MG / 80 MG Tablet Cancelled Pre Market November 2, 2016

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.