Helidac

This package contains a combination of three different medicines. The individual medicines contained in this package should not be used alone or for other purposes than to treat ulcers related to infection with H. pylori.

This combination of medicines is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Tablet, Chewable


• Tablet


• Capsule

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Infants and children up to 8 years of age should not take this combination of medicines unless directed by the child`s doctor . Tetracycline may cause permanent discoloration of the teeth .

Children or teenagers who have or who are recovering from chickenpox or influenza should not use this combination of medicines unless directed by the child`s doctor . If nausea or vomiting occurs after taking this combination of medicines, check with the child`s doctor . Nausea or vomiting could be early signs of Reye`s syndrome, a rare but serious illness .

Geriatric

Many medicines have not been studied specifically in older people . Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people . There is no specific information comparing the use of this combination of medicines (bismuth subsalicylate, metronidazole, and tetracycline) in the elderly with its use in other age groups.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended . Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acitretin


• Amprenavir


• Dihydroergotamine


• Disulfiram


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Methylergonovine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone


• Busulfan


• Digoxin


• Fluorouracil


• Isotretinoin


• Methotrexate


• Mycophenolate Mofetil


• Tretinoin


• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Atovaquone


• Calcium


• Carbamazepine


• Cholestyramine


• Colestipol


• Cyclosporine


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Doxycycline


• Ethinyl Estradiol


• Iron


• Lithium


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• Mestranol


• Methoxyflurane


• Milk Thistle


• Norelgestromin


• Norethindrone


• Norgestrel


• Penicillin G


• Penicillin G Procaine


• Penicillin V


• Probenecid


• Sulfinpyrazone


• Tacrolimus


• Tamarind

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Dairy Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease or


• Liver diseasea€”Higher blood levels of metronidazole and tetracycline in this combination of medicines may occur, resulting in an increased risk of side effects.

Proper Use

This combination of medicines (bismuth subsalicylate, metronidazole, and tetracycline) comes with instructions for the patient included in the package . Make sure you read and understand the instructions, or ask your health care professional if you need additional information or explanation. It is important that you understand and follow the instructions exactly.

Also, it is important that you complete the full course of therapy with this combination of medicines to help clear up the infection from H. pylori related to your ulcer.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine 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 using the medicine.

Be sure to swallow the tablet of metronidazole and the capsule of tetracycline with a full glass (eight ounces) of water . This will help prevent irritation of the esophagus (tube between the throat and stomach) or stomach. Each dose of this combination of medicines (bismuth subsalicylate, metronidazole, and tetracycline) is taken four times a day, with meals and at bedtime, for fourteen days. Your doctor will also prescribe for you another medicine, a histamine H 2-receptor antagonist, which will come with its own directions and must be taken along with this combination of medicines.

Each day`s therapy is packaged on a blister card that contains eight chewable tablets (each containing 262.4 milligrams [mg] of bismuth subsalicylate), four tablets (each containing 250 mg of metronidazole), and four capsules (each containing 500 mg of tetracycline).

• For oral dosage forms (blister card containing chewable tablets, tablets, and capsules):
  
  
  
  • For the treatment of ulcers related to infection with H. pylori:
    
    
    
    • Adultsa€”For each dose of this combination of medicines:
      
      
      
      • Chew and swallow two tablets of bismuth subsalicylate (525 mg)
      
      
      • Swallow one tablet of metronidazole (250 mg)
      
      
      • Swallow one capsule of tetracycline (500 mg)
      
      
      
      
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss more than four doses of this combination of medicines, check with your doctor .

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

Check the labels of all over-the-counter (OTC), nonprescription, and prescription medicines you now take. If any contain aspirin or other salicylates, be especially careful. Using other salicylate-containing products while taking bismuth subsalicylate in this combination of medicines may lead to overdose. If you have any questions about this, check with your health care professional .

Do not take milk, milk formulas, or other dairy products within 1 to 2 hours of the time you take tetracycline in this combination of medicines. Milk and other dairy products may keep tetracycline from working properly.

Do not take antacids or sodium bicarbonate within 1 to 2 hours of the time you take tetracycline in this combination of medicines. Also, do not take iron preparations (including vitamin preparations that contain iron) within 2 to 3 hours of the time you take tetracycline in this combination of medicines. To do so may keep tetracycline from working properly.

Drinking alcoholic beverages while taking metronidazole in this combination of medicines may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Other alcohol-containing preparations (for example, elixirs, cough syrups, tonics) may also cause problems . These problems may last for at least a day after you stop taking metronidazole. Also, metronidazole may cause alcoholic beverages to taste different. Therefore, you should not drink alcoholic beverages or take other alcohol-containing preparations while you are taking metronidazole in this combination of medicines and for at least a day after stopping it.

The metronidazole in this combination of medicines may cause some people to become dizzy or lightheaded. Make sure you know how you react to this combination of medicines before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Oral contraceptives (birth control pills) may not work properly if you take them while you are taking tetracycline in this combination of medicines. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking tetracycline in this combination of medicines. If you have any questions about this, check with your health care professional .

The tetracycline in this combination of medicines may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking the tetracycline in this combination of medicines:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.


• Wear protective clothing, including a hat. Also, wear sunglasses.


• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional .


• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.


• Do not use a sunlamp or tanning bed or booth.

You may still be more sensitive to sunlight or sunlamps for 2 weeks to several months or more after stopping tetracycline in this combination of medicines. If you have a severe reaction, check with your doctor .

Before having surgery (including dental surgery) with a general anesthetic, tell the medical doctor or dentist in charge that you are taking tetracycline in this combination of medicines.

Side Effects

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 .

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Abdominal pain


• Bloody or black, tarry stools


• Diarrhea


• Nausea

Less common

• Burning, prickling, or tingling sensations


• Dizziness


• Vomiting

Rare

• Bloody vomit


• Convulsions (seizures)


• Fainting


• Heart attack


• High blood pressure


• Irritation of the mouth


• Irritation of the tongue


• Joint pain and swelling


• Pain


• Sensitivity of skin to sunlight


• Skin rash


• Trouble in swallowing

Symptoms of overdose

• Clumsiness or unsteadiness


• Confusion


• Continuing ringing or buzzing in ears


• Convulsions


• Diarrhea


• Fast heartbeat


• Fast or deep breathing


• Fever


• Nausea


• Pain, numbness, or tingling in arms, legs, hands, or feet


• Unusual tiredness


• Vomiting

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

• Burning or itching around anus


• Constipation


• General feeling of discomfort or illness


• Loss of appetite


• Nervousness


• Trouble in sleeping


• Unusual tiredness or weakness

In some patients, bismuth subsalicylate in this combination of medicines may cause dark tongue and/or grayish black stools. This is only temporary and will go away when you stop taking bismuth subsalicylate.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.