Brand name: SIBELIUM (Flunarizine)

CALCIUM CHANNEL BLOCKING AGENTS (Systemic)

Some commonly used brand names are: In the U.S.—

Adalat 7 Adalat CC 7 Calan 9 Calan SR 9 Cardene 6 Cardizem 2 Cardizem CD 2 Cardizem SR 2 Dilacor-XR 2 DynaCirc 5 Isoptin 9 Isoptin SR 9 Nimotop 8 Plendil 3 Procardia 7 Procardia XL 7 Vascor 1 Verelan 9

In Canada— Adalat 7 Adalat PA 7 Adalat XL 7 Apo-Diltiaz 2 Apo-Nifed 7 Apo-Verap 9 Cardizem 2 Cardizem SR 2 Isoptin 9 Isoptin SR 9 Nimotop 8 Novo-Diltazem 2 Novo-Nifedin 7 Novo-Veramil 9 Nu-Diltiaz 2 Nu-Nifed 7 Nu-erap 9 Plendil 3 Renedil 3 Sibelium 4 Syn-Diltiazem 2 Verelan

Important info:

For quick reference, the following calcium channel blocking agents are numbered to match the corresponding brand names.
This information applies to the following medicines:
1. Bepridil (BE-pri-dil)† 2. Diltiazem (dil-TYE-a-zem)‡§ 3. Felodipine (fe-LOE-di-peen) 4. Flunarizine (floo-NAR-i-zeen) 5. Isradipine (is-RA-di-peen)† 6. Nicardipine (nye-KAR-de-peen)†‡
7. Nifedipine (nye-FED-i-peen)‡ 8. Nimodipine (nye-MOE-di-peen) 9. Verapamil (ver-AP-a-mil)‡§ Not commercially available in the U.S.† Not commercially available in Canada‡ Generic name product may be available in the U.S.
§ Generic name product may be available in Canada
Category

Antianginal—Bepridil; Diltiazem; Felodipine; Isradipine; Nicardipine; Nifedipine; Verapamil
Antiarrhythmic—Diltiazem; Verapamil
Antihypertensive—Diltiazem; Felodipine; Isradipine; Nicardipine; Nifedipine; Verapamil
Hypertrophic cardiomyopathy therapy adjunct—Verapamil
Subarachnoid hemorrhage therapy—Flunarizine; Nicardipine; Nimodipine
Vascular headache prophylactic—Flunarizine; Verapamil

Description SIBELIUM (Flunarizine)

Bepridil, diltiazem, felodipine, flunarizine, isradipine, nicardipine, nifedipine, nimodipine, and verapamil belong to the group of medicines called calcium channel blocking agents.Calcium channel blocking agents affect the movement of calcium into the cells of the heart and blood vessels. As a result, they relax blood vessels and increase the supply of blood and oxygen to the heart while reducing its workload.Some of the calcium channel blocking agents are used to relieve and control angina pectoris (chest pain).Some are also used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.Flunarizine is used to prevent migraine headaches.Nimodipine is used to prevent and treat problems caused by a burst blood vessel around the brain (also known as a ruptured aneurysm or subarachnoid hemorrhage).Other calcium channel blocking agents may also be used for these and other conditions as determined by your doctor.

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For the calcium channel blocking agents, the following should be considered:Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to bepridil, diltiazem, felodipine, flunarizine, isradipine, nicardipine, nifedipine, nimodipine, or verapamil. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.Pregnancy—Calcium channel blocking agents have not been studied in pregnant women. However, studies in animals have shown that large doses of calcium channel blocking agents cause birth defects, prolonged pregnancy, poor bone development in the offspring, and stillbirth.

Breast-feeding—Although bepridil, diltiazem, nifedipine, verapamil, and possibly other calcium channel blocking agents, pass into breast milk, they have not been reported to cause problems in nursing babies.Children—Although there is no specific information comparing use of this medicine in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults. Older adults—Elderly people may be especially sensitive to the effects of calcium channel blocking agents. This may increase the chance of side effects during treatment.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When taking calcium channel blocking agents it is especially important that your health care professional know if you are taking any of the following:

Acetazolamide (e.g., Diamox) or Amphotericin B by injection (e.g., Fungizone) or Corticosteroids (cortisone-like medicine) or Dichlorphenamide (e.g., Daranide) or Diuretics (water pills) or
Methazolamide (e.g., Naptazane)—These medicines can cause hypokalemia (low levels of potassium in the body), which can increase the unwanted effects of bepridil

Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], carteolol [e.g., Cartrol], labetalol [e.g., Normodyne], metoprolol [e.g., Lopressor], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Sotacor], timolol [e.g., Blocadren])—Effects of both may be increased. In addition, unwanted effects may occur if a calcium channel blocking agent or a beta-blocking agent is stopped suddenly after both have been used together

Carbamazepine (e.g., Tegretol) or Cyclosporine (e.g., Sandimmune) or Procainamide (e.g., Pronestyl) or Quinidine (e.g., Quinidex)—Effects of these medicines may be increased if they are used with some calcium channel blocking agents

In addition to the use of the medicine your doctor has prescribed, appropriate treatment for your high blood pressure may include weight control and care in the types of food you eat, especially foods high in sodium (salt). Your doctor will tell you which factors are most important for you. You should check with your doctor before changing your diet.
Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.
Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Dosing—The dose of these medicines will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking calcium channel blocking agents .

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits. This will allow your doctor to make sure the medicine is working properly and to change the dosage if needed.

If you have been using this medicine regularly for several weeks, do not suddenly stop using it. Stopping suddenly may bring on your previous problem. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely.

Chest pain resulting from exercise or physical exertion is usually reduced or prevented by this medicine. This may tempt you to be overly active. Make sure you discuss with your doctor a safe amount of exercise for your medical problem .

After taking a dose of this medicine you may get a headache that lasts for a short time. This effect is more common if you are taking felodipine, isradipine, or nifedipine. This should become less noticeable after you have taken this medicine for a while. If this effect continues or if the headaches are severe, check with your doctor.

In some patients, tenderness, swelling, or bleeding of the gums may appear soon after treatment with this medicine is started. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums .

For patients taking bepridil, diltiazem , or verapamil :

Ask your doctor how to count your pulse rate. Then, while you are taking this medicine, check your pulse regularly . If it is much slower than your usual rate, or less than 50 beats per minute, check with your doctor. A pulse rate that is too slow may cause circulation problems.

For patients taking flunarizine :

This medicine may cause some people to become drowsy or less alert than they are normally. This is more likely to happen when you begin to take it or when you increase the amount of medicine you are taking. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert .

For patients taking this medicine for high blood pressure :

Do not take other medicines unless they have been discussed with your doctor . This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Not all of the side effects listed below have been reported for each of these medicines, but they have been reported for at least one of them. Since many of the effects of calcium channel blocking agents are similar, some of these side effects may occur with any of these medicines. However, they may be more common with some of these medicines than with others.

Check with your doctor as soon as possible if any of the following side effects occur:Breathing difficulty, coughing, or wheezing; irregular or fast, pounding heartbeat; skin rash; slow heartbeat (less than 50 beats per minute—bepridil, diltiazem, and verapamil only); swelling of ankles, feet, or lower legs (more common with felodipine and nifedipine).Loss of balance control; mask-like face; mental depression; shuffling walk; stiffness of arms or legs; trembling and shaking of hands and fingers; trouble in speaking or swallowing

Bleeding, tender, or swollen gums; chest pain (may appear about 30 minutes after medicine is taken); fainting; painful, swollen joints (for nifedipine only); trouble in seeing (for nifedipine only)

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:Drowsiness (for flunarizine only); increased appetite and/or weight gain (for flunarizine only)

Constipation; diarrhea; dizziness or lightheadedness (more common with bepridil and nifedipine); dryness of mouth (for flunarizine only); flushing and feeling of warmth (more common with nicardipine and nifedipine); headache (more common with felodipine, isradipine, and nifedipine); nausea (more common with bepridil and nifedipine); unusual tiredness or weakness

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, calcium channel blocking agents are used in certain patients with the following medical conditions:

Hypertrophic cardiomyopathy (a heart condition) (verapamil)
Raynaud's phenomenon (circulation problems) (nicardipine and nifedipine)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.