Adalat XL Plus: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

There are two medicines in this package: ADALAT XL

(nifedipine extended-release tablets) and ASPIRIN 81 mg (acetylsalicylic acid delayed-release tablets) and they have different uses:

High Blood Pressure (ADALAT XL)

There are two numbers used for measuring blood pressure: systolic and diastolic. The systolic number (stated first) represents the maximum pressure of the heart muscle contraction while the heart is beating. The diastolic number (listed second) measures the basic resting pressure when the heart is refilled between beats.

Blood pressure readings lower than 120 mmHg systolic and 80 mmHg diastolic are considered to be normal for adults. Patients with values above 139 mmHg systolic and 89 mmHg diastolic are regarded as having high blood pressure.

ADALAT XL may be used in patients to manage mild to moderate high blood pressure.

Prevention of a First Nonfatal Heart Attack

(ASPIRIN 81 mg)

Your doctor may recommend you take ASPIRIN 81 mg to help reduce the risk of a first nonfatal heart attack because you are at risk of having a heart attack. There is no evidence that this product reduces the risk of a first fatal heart attack, nor first strokes (fatal and nonfatal), nor death due to any cardiovascular problems. Your doctor will assess the appropriate balance of possible benefit of this product against the potential risk of stomach bleeding and stroke. Factors that increase your risk

include high blood pressure, high cholesterol, diabetes, family history of heart disease, increased age, overweight, and smoking. You should follow your doctor’s instructions carefully. Please notify your doctor if you intend to stop taking this medication.

Prevention of a Second Heart Attack or Stroke (ASPIRIN 81 mg)

Your doctor may recommend you take ASPIRIN 81 mg daily to help prevent a second heart attack or stroke. After having experienced a first heart attack or stroke, you can be at increased risk of experiencing a second one. You may also be at risk for heart disease and stroke because you may be overweight, a smoker, have an inactive lifestyle, high blood pressure, are under stress, or have high blood cholesterol.

Following your doctor’s instructions concerning the use of ASPIRIN 81 mg and the changes in diet, exercise, and lifestyle he/she may have prescribed will provide you with your best opportunity to avoid experiencing a second heart attack or stroke. Always contact your doctor if you experience any difficulties.

What it does:

ADALAT XL manages high blood pressure. It is called a “calcium channel blocker”. Although the mechanism by which ADALAT XL reduces blood pressure is not fully known, it is believed to be brought about as a result of the ability of ADALAT XL to widen and relax blood vessels.

ASPIRIN 81 mg belongs to a group of medicines called antiplatelet drugs. Platelets are very small structures in blood, smaller than red or white blood cells, which clump together during blood clotting. By preventing this clumping, antiplatelet drugs reduce the chances of blood clots forming (a process called thrombosis).

When it should not be used:

You should not use ADALAT XL PLUS if the following applies:

• you have had an allergic reaction to nifedipine,

  acetylsalicylic acid (ASA), or to any of the nonmedicinal ingredients

• you are pregnant, breastfeeding, or a woman of

  childbearing age

• you have severe low blood pressure
• you are taking the medicine rifampicin

• you are taking the medicine methotrexate at doses of

  15 mg/week or more

• you have a history of asthma that occurs after taking

  ASA or other drugs called nonsteroidal anti-inflammatory drugs (NSAIDs)

• you have an unusual susceptibility to bleeding (a

  condition known as hemorrhagic diathesis)

• you have an ulcer in your stomach or other part of the

  gastrointestinal tract

• you have a Kock pouch (a pouch or reservoir created

  inside the abdomen with a portion of large bowel for which a tube or catheter can be inserted through the abdominal wall to drain the reservoir)

See also SIDE EFFECTS AND WHAT TO DO ABOUT THEM.

What the medicinal ingredient is:

ADALAT XL PLUS contains two medicines. One is ADALAT XL which contains nifedipine. The other is ASPIRIN 81 mg, which contains acetylsalicylic acid (ASA).

What the nonmedicinal ingredients are:

ADALAT XL also contains cellulose acetate, hydroxypropyl cellulose, hypromellose, magnesium stearate, pharmaceutical shellac, polyethylene glycol 3350, polyethylene oxide, propylene glycol, red ferric oxide, sodium chloride, synthetic black iron oxide, and titanium dioxide.

ASPIRIN 81 mg also contains carnauba wax, corn starch, croscarmellose sodium, FD&C Blue #1, FD&C Blue #2, hypromellose, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium lauryl sulfate, titanium dioxide, triacetin.

What dosage forms it comes in:

The medication in ADALAT XL is packed within a nonabsorbable shell that has been specially designed to slowly release the drug so the body can absorb it.

ASPIRIN 81 mg has a special coating, enteric coating, which allows the tablet to pass, undissolved, through the stomach and on into the intestine. By using ASPIRIN 81 mg, the risk of stomach upset is reduced in those people with sensitive stomachs.

ADALAT XL PLUS is a Convenience Pack, which comes in strengths of 20 mg, 30 mg, or 60 mg tablets of ADALAT XL packed with ASPIRIN 81 mg tablets. The tablets are packaged in clear blisters and are arranged side by side. ADALAT XL tablets are round and dusty rose and ASPIRIN 81 mg tablets are pale blue.

WARNINGS AND PRECAUTIONS

Reactions to the drug in ADALAT XL vary from person to person. This may impair your ability to drive or to operate machinery, particularly at the start of treatment, when changing the medication, or in combination with alcohol.

Your doctor will have asked you many questions about your health, lifestyle, and medications before recommending ADALAT XL PLUS. That is why it is very important that you tell your doctor all such information.

Before you use ADALAT XL PLUS, talk to your doctor or pharmacist if:

• you are pregnant or breastfeeding
• you have asthma, heart failure, stomach problems, peptic ulcer, liver disease, kidney disease, severe anemia, or coronary artery disease
• you have recently had a heart attack or you have a heart condition called aortic stenosis (narrowing of a valve in your heart)
• you have a history of blood clotting defects or are receiving blood thinners
• you will be having surgery in five to seven days
• you are allergic to salicylates
• you take ibuprofen regularly. Long-term daily use of ibuprofen can interfere with the preventative benefits of the Delayed-Release ASA component of ADALAT XL PLUS.

• you take other non-steroidal anti-inflammatory drugs

  (NSAIDs)

REMEMBER: This product is not recommended for children or teenagers.

INTERACTIONS WITH THIS MEDICATION

Some medicines may interact with ADALAT XL PLUS. Let your healthcare professional know what other medicines (including over-the-counter medicines, vitamins, and herbal products) you are taking.

If you have forgotten to tell your doctor about any of the following, call your doctor or pharmacist before you take this medicine (or any medicine) if you are receiving:

• anti-inflammatory drugs
• anticonvulsants
• antidiabetic medicine

• azole antifungals (ketoconazole, itraconazole or

  fluconazole)

• blood thinners
• cyclosporine
• carbamazepine
• cimetidine
• diltiazem
• digoxin
• erythromycin
• fluoxetine
• gout medicine

• HIV protease inhibitors (indinavir, nelfinavir,

  ritonavir, saquinavir, or amprenavir)

• ibuprofen (Advil^® or Motrin^®) or other non-steroidal

  anti-inflammatory drugs (NSAIDs)

• medications containing salicylates and acetaminophen
• nefazodone
• phenobarbital
• phenytoin
• quinidine
• quinupristin/dalfopristin
• tacrolimus
• rifampicin
• valproic acid

PROPER USE OF THIS MEDICATION

Usual Dose

Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Follow your doctor's treatment plan exactly so that you reach and maintain your blood pressure targets. Do not use more medicine or use it more often than your doctor tells you to.

The usual dose of ADALAT XL PLUS is one tablet of ADALAT XL (one dusty rose-colored pill) and one tablet of ASPIRIN 81 mg (one blue-colored pill) daily. You should take this medicine at the same time every day. This will help you to remember to take your medicine.

It is best to take the two pills after meals with plenty of liquid.

Do not discontinue a medication on your own. If you have a problem with a drug, always tell your doctor.

You must swallow ADALAT XL and ASPIRIN 81 mg tablets whole. Do not chew, divide or crush the tablets. This can result in a large immediate release of the drug and may increase the risk of an upset stomach due to the loss of the protective covering.

The medication in ADALAT XL is packed within a nonabsorbable shell that has been specially designed to slowly release the drug over 18 hours so that the body can absorb it. The shell will pass into your stool after your body has absorbed the medicine. This is normal and is nothing to worry about.

ASPIRIN 81 mg contains a smaller dose of ASA than you would need to take for a headache or other types of pain and is unlike other pain reliever products such as acetaminophen (Tylenol^®) and ibuprofen (Advil^®). Ask your doctor or pharmacist about other ASPIRIN products available (or other pain relievers such as acetaminophen or ibuprofen) and the correct dosage for the relief of your headache, fever or arthritic pain. Always consult with your physician or pharmacist before taking other medications.

DO NOT eat grapefruit or drink grapefruit juice while you are using this medicine.

See also ABOUT THIS MEDICATION: When it should not be used: and SIDE EFFECTS AND WHAT TO DO ABOUT THEM.

Missed Dose

If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose unless instructed by your doctor.

Overdose

In case of accidental overdose call your healthcare professional or poison control centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

ADALAT XL PLUS can cause unwanted side effects. The most common side effects include swelling of tissues (edema), headaches, chest pain (angina pectoris), dizziness, nausea, and constipation.

You should call your doctor if you experience any of the following:

• nausea
• vomiting

• loss of hearing, including ringing or buzzing in the

  ears

This is not a complete list of side effects. For any unexpected effects while taking ADALAT XL PLUS, contact your doctor or pharmacist.

HOW TO STORE IT

ADALAT XL PLUS should be stored at room temperature (15-30°C). Protect from light and humidity.

Keep all medicine away from children and never share your medicine with anyone.

Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

For more information, please contact your health professional or pharmacist first, or Bayer Medical Information at 1-800-265-7382 or canada.medinfo@bayer.com.

This document plus the full Product Monograph, prepared for health professionals can be found at: http://www.bayer.ca or by contacting the sponsor at the above-mentioned phone number and email address.

Bayer Inc.

77 Belfield Road

Toronto, Ontario M9W 1G6

Canada

Last revised: August 13, 2012

© 2012, Bayer Inc.

® ADALAT, Bayer, Bayer Cross and ASPIRIN are registered trademarks of Bayer AG, used under license by Bayer Inc. XL is a registered trademark of Bayer Inc. denoting its once-daily nifedipine. All other trademarks are owned by their respective owners.